WO2025019957A1 - Medical devices and related methods - Google Patents
Medical devices and related methods Download PDFInfo
- Publication number
- WO2025019957A1 WO2025019957A1 PCT/CA2024/051004 CA2024051004W WO2025019957A1 WO 2025019957 A1 WO2025019957 A1 WO 2025019957A1 CA 2024051004 W CA2024051004 W CA 2024051004W WO 2025019957 A1 WO2025019957 A1 WO 2025019957A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- connector
- interconnector
- medical device
- end portion
- subject body
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/871—Energy supply devices; Converters therefor
- A61M60/88—Percutaneous cables
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/205—Non-positive displacement blood pumps
- A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/871—Energy supply devices; Converters therefor
- A61M60/878—Electrical connections within the patient's body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
- A61N1/3622—Heart stimulators for treating or preventing abnormally high heart rate comprising two or more electrodes co-operating with different heart regions
Definitions
- This disclosure generally relates to medical devices and related methods.
- Some medical devices may be implanted inside a subject body and have one or more of their drivelines, either it be an electrical wire or a driveshaft, routed therefrom to the outside of the subject body where the driveline(s) may be connected to one or more controllers and/or power sources for operating the medical devices inside the subject body.
- Examples of such medical devices in the cardiovascular field include mechanical circulatory support devices, ventricular assist devices, pacemakers, and implantable cardioverter defibrillators.
- the medical devices may be implanted in the subject body, such as intraluminally in natural or surgically made anatomical hollow structures, or subcutaneously, and have the driveline(s) thereof routed outside the subject body through one or more intraluminal and/or percutaneous access site(s).
- Such access site(s) are, however, generally associated with various potential complications, including pain and infections.
- intravascular and/or percutaneous access site(s) are also generally associated with further potential complications, including hemorrhage, vascular trauma, pseudoaneurysm, arterial thrombosis, arteriovenous fistula, and hematoma.
- the larger the intravascular and/or percutaneous access site(s) the greater the risks of complications.
- the implanted medical devices may need to be removed or replaced by other medical devices.
- Replacement of medical devices like it may be the case for infection complications, may be risky for subjects and generality incur additional economic burdens, to name a few.
- An aspect of this disclosure is directed to an interconnector device, including: an interconnector body configured to be implanted in a subject body and having a first end portion and a second end portion; a first connector disposed to the first end portion of the connector body; a second connector disposed to the second end portion of the connector body; and a driveline configured to operatively couple the first connector and the second connector together.
- the connector body may be configured to be transcatheterly implanted in the subject body.
- the connector body may be configured to be tunneled in the subject body.
- the connector body may have an elongated shape.
- the connector body may have a tapered cross-sectional shape for engaging in a fluid thigh manner an access site of the subject body.
- the connector body may be flexible.
- At least one of the first end portion and the second end portion of the interconnector body may be configured to be atraumatic when the interconnector device is introduced through an access site of the subject body and navigated inside the subject body.
- At least one of the first end portion and the second end portion of the interconnector body may have an atraumatic tapered shape.
- the first connector and the second connector may be electrical connectors, and the driveline may include an electrical conductor.
- the first connector and the second connector may be mechanical connectors, and the driveline may include a driveshaft.
- the first connector and the second connector may be removably connectable.
- the first connector may be configured to connect to an implantable medical device, and the second connector may be configured to connect to a controller configured to operate the implantable medical device.
- the first connector may be included in a plurality of first connectors, the plurality of first connectors may be configured to connect to a corresponding plurality of implantable medical devices, and the second connector may be configured to connect to a controller configured to operate the plurality of implantable medical devices.
- At least one of the first end portion and the second end portion of the interconnector body may include a seal configured to provide a fluid thigh engagement with a medical device.
- At least one of the first connector and the second connector may include a seal configured to provide a fluid thigh engagement with a medical device.
- the seal may be a connector cavity seal.
- the connector cavity seal may be movable upon connection.
- the seal may be a connector periphery seal.
- the interconnector device may include an interconnector seal 1200 configured to provide a fluid thigh engagement with an access site of a subject body.
- the interconnector seal 1200 may be self-expandable.
- At least one of the first end portion and the second end portion of the interconnector body may include a magnet configured to magnetically interact with a medical device.
- the interconnector body may include a fluid passageway configured to supply a fluid to at least one of the first connector and the second connector.
- At least one of the first connector and the second connector may include a fluid evacuation port configured to evacuate a fluid from the at least one of the first connector and the second connector.
- the interconnector body may include a wire guide configured to guide a guidewire therethrough.
- the wire guide may be configured to assist a connection of at least one of the first connector and the second connector to a medical device.
- the interconnector device may include a locking mechanism configured to lock at least one of the first connector and the second connector to a medical device, and to unlock at least one of the first connector and the second connector from the medical device.
- the locking mechanism may include a retaining element configured to retain the medical device, and an elongated control element coupled to the retaining element for operating the retaining element.
- the interconnector device may include an anchor configured to anchor the interconnector device in the subject body.
- the interconnector device may include an embedded controller operatively coupled to at least one of the first connector and the second connector for operating a medical device connected thereto.
- the embedded controller may be wirelessly rechargeable.
- At least one of the first end portion and the second end portion of the interconnector body may be branched out and may comprise a plurality of sub-end portions having at least one first connector and at least one second connector.
- An aspect of this disclosure is directed to a medical device connector, including: a connector body; a wire guide configured to guide a guidewire, and a connector configured to connect to a medical device railed over the guidewire guided by the wire guide.
- the wire guide may be configured to guide the guidewire therethrough.
- the wire guide may be configured to guide the guidewire therealong.
- the wire guide and the connector may be associated together on the connector body.
- the wire guide and the connector may be disposed on a same surface of the connector body.
- the wire guide may be coaxially disposed relative to the connector.
- the wire guide may be concentrically disposed relative to the connector.
- the wire guide may be parallelly disposed relative to the connector.
- the wire guide may be coplanarly disposed relative to the connector.
- the connector may be circumferentially disposed relative to the wire guide.
- the connector may be an electrical connector.
- the electrical connector may be of the female type.
- the electrical connector may be of the male type.
- the electrical connector may be a projecting electrical contact.
- the electrical connector may be a recessed electrical contact.
- the electrical connector may be an annular electrical contact.
- An aspect of this disclosure is directed to a hemostatic device, including: an installation sheet configured to attach to a subject body; and a receiver tube projecting from the installation sheet, the receiver tube defining a passage configured to receive a portion of an implantable medical device therethrough.
- the installation sheet may be configured to attach to the subject body by at least one of a suture, a staple, a glue, and a formation of scar tissue.
- the passage of the receiver tube may be configured to prevent fluid leak therefrom when the portion of the implantable medical device is received therethrough.
- the hemostatic device may include a device-receiving seal configured to provide a fluid thigh engagement between the receiver tube and the portion of the implantable medical device when received through the passage.
- the hemostatic device may include a protective cover coupled to the hemostatic device and configured to attach to the medical device.
- the protective cover may be coupled to the receiver tube.
- the hemostatic device may have a non-expanded configuration in which the hemostatic device is configured to be transcatheterly delivered to the subject body, and an expanded configuration in which the hemostatic device is configured to be transcatheterly implanted to the subject body.
- At least one of the installation sheet and the receiver tube may include a membrane and a wire network frame covered by the membrane.
- the hemostatic device may include a perforated installation sheet defining a perforation configured to receive the receiver tube therethrough.
- the hemostatic device may include a tube-receiving seal configured to provide a fluid thigh engagement between the perforation and the receiver tube when received in the perforation.
- the hemostatic device may include a connector configured to connect the perforated installation sheet and the hemostatic device together.
- the connector may include a first connector portion disposed to the receiver tube, and a second connector portion disposed to the periphery of the perforation of the perforated installation sheet.
- the connector may be adjustable for locking the receiver tube and the perforated installation sheet together at a desired distance between the installation sheet and the perforated installation sheet.
- the connector may include one of a threaded connector and an interference fit connector.
- An aspect of this disclosure is directed to a medical device in a subject body, the method including: connecting the medical device to another medical device; connecting the medical device to a controller; and implanting the medical device in the subject body.
- the method may include implanting the other medical device in the subject body.
- Implanting the other medical device may include transcatheterly implanting the other medical in the subject body.
- Implanting the other medical device may include implanting by open surgery the other medical in the subject body.
- the method may include intracorporeally rinsing at least one of a first connector of the medical device that is configured to connect to the other medical device, and a second connector of the medical device that is configured to connect to the controller.
- Connecting the medical device to another medical device and connecting the medical device to a controller may include intracorporeally connecting the medical device.
- connection of the medical device to at least one of the other medical device and the controller may be fluid thigh.
- the method may include locking at least one of a first connecting portion of the medical device to the other medical device, and a second connecting connection of the medical device to the controller.
- Implanting the medical device may include implanting the medical device partially in the subject body so that the medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
- Implanting the medical device may include implanting the medical device entirely in the subject body so that the medical device is entirely intracorporeally disposed.
- Implanting the medical device may include intraluminally navigating the medical device in the subject body.
- Implanting the medical device may include transcatheterly implanting the medical device in the subject body.
- Implanting the medical device may include railing the medical device over a guidewire.
- Railing the medical device may assist the connection of the medical device to at least one of the other medical device and the controller.
- Implanting the medical device may include engaging in a fluid thigh manner the medical device with at least one of an intraluminal access and a percutaneous access of the subject body.
- the method may include anchoring the medical device in the subject body.
- the anchored medical device may anchor in the subject body at least one of the other medical device and the controller.
- the method may include installing a hemostatic device to the subject body to provide hemostasis to the implanted medical device.
- the method may include operating the other medical device via the medical device by the controller.
- Operating the other medical device may produce a therapeutic effect in the subject body.
- the therapeutic effect may include a hemodynamic effect.
- the other medical device may include a blood pump.
- An aspect of this disclosure is directed to a method of using an implanted medical device in a subject body, the method comprising: explanting the implanted medical device from the subject body; disconnecting the implanted medical device from another implanted medical device and from a controller; connecting a replacement medical device to the other implanted medical device and to the controller; and implanting the replacement medical device in the subject body.
- the implanted medical device may be implanted partially in the subject body so that the implanted medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
- the implanted medical device may be implanted entirely in a subject body so that the implanted medical device is entirely intracorporeally disposed.
- Explanting the implanted medical device may include pulling the implanted medical device from the subject body.
- Explanting the implanted medical device may include removing the implanted medical device from at least one of an intraluminal access and a percutaneous access of the subject body.
- Explanting the implanted medical device may include transcatheterly explanting the implanted medical device.
- Explanting the implanted medical device may include explanting by open surgery the implanted medical device.
- Disconnecting the implanted medical device may include intracorporeally disconnecting the implanted medical device from at least one of the other medical device and the controller.
- Disconnecting the implanted medical device may include disconnecting a wire connection of the implanted medical device from at least one of the other medical device and the controller.
- Disconnecting the implanted medical device may include disconnecting a wireless connection of the implanted medical device from at least one of the other medical device and the controller.
- Disconnecting the implanted medical device may include disconnecting a mechanical connection of the implanted medical device from at least one of the other medical device and the controller.
- the method may include intracorporeally rinsing at least one of a first connector of the replacement medical device that is configured to connect to the other medical device, and a second connector of the replacement medical device that is configured to connect to the controller.
- Connecting a replacement medical device may include intracorporeally connecting the replacement medical device to at least one of the other medical device and the controller.
- connection of the replacement medical device to at least one of the other medical device and the controller may be fluid thigh.
- Connecting a replacement medical device may include locking at least one of a first connecting portion of the replacement medical device to the other medical device, and a second connecting portion of the replacement medical device to the controller.
- Implanting the replacement medical device may include implanting the replacement medical device partially in the subject body so that the replacement medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
- Implanting the replacement medical device may include implanting the replacement medical device entirely in the subject body so that the replacement medical device is entirely intracorporeally disposed.
- Implanting the replacement medical device may include pushing the replacement medical device in the subject body.
- Implanting the replacement medical device may include intraluminally navigating the replacement medical device in the subject body.
- Implanting the replacement medical device may include transcatheterly implanting the replacement medical device in the subject body.
- Implanting the replacement medical device may include railing the replacement medical device over a guidewire.
- Railing the replacement medical device may include assist the connection of the replacement medical device to at least one of the other medical device and the controller.
- Implanting the replacement medical device may include engaging in a fluid thigh manner the replacement medical device with at least one of an intraluminal access and a percutaneous access of the subject body.
- the method may include anchoring the replacement medical device in the subject body.
- anchored replacement medical device may anchor in the subject body at least one of the other medical device and the controller.
- the method may include installing a hemostatic device to the subject body to provide hemostasis to the replacement medical device.
- the implanted medical device may be operated by the controller.
- the method may include operating the other medical device via the replacement medical device by the controller.
- Operating the other medical device may produce a therapeutic effect in the subject body.
- the therapeutic effect may include a hemodynamic effect.
- the other medical device may include a blood pump.
- An aspect of this disclosure is directed to a method of using a first medical device and a second medical device in a subject body, the method comprising: railing over a guidewire in the subject body the first medical device and the second medical device so that at least one of the first medical device and the second medical device is advanced toward the other one of the first medical device and the second medical device; and connecting the first medical device and the second medical device together over the guidewire in the subject body.
- the method may include implanting the first medical device partially in the subject body so that the first medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
- the method may include implanting the first medical device entirely in the subject body so that the first medical device is entirely intracorporeally disposed.
- the method may include implanting the second medical device partially in the subject body so that the second medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
- the method may include implanting the second medical device entirely in the subject body so that the second medical device is entirely intracorporeally disposed.
- Implanting the first and/or second medical device may include intraluminally navigating at least one of the first medical device and the second medical device in the subject body.
- Implanting the first and/or second medical device may include transcatheterly implanting at least one of the first medical device and the second medical device in the subject body.
- Implanting the first and/or second medical device may include engaging in a fluid thigh manner at least one of the first medical device and the second medical device with at least one of an intraluminal access and a percutaneous access of the subject body.
- the method may include anchoring at least one of the first medical device and the second medical device in the subject body.
- one of the first medical device and the second medical device anchors in the subject body the other one of the first medical device and the second medical device.
- the method may include intracorporeally rinsing at least one of a connector of the first medical device that is configured to connect to the second medical device and a connector of the second medical device that is configured to connect to the first medical device.
- connection between the first medical device and the second medical may be fluid thigh.
- the method may include locking at least one of a connecting portion of the first medical device and a connecting portion of the second medical device to the other one of the connecting portion of the first medical device and the connecting portion of the second medical device.
- the first medical device and the second medical device may be operative connected together so that the first medical device is operated via the second medical device.
- the method may include installing a hemostatic device to the subject body to provide hemostasis to one of the first medical device and the second medical device.
- the method may include operating the first medical device via the second medical device connected to a controller for operating the first medical device.
- Operating the first medical device may produce a therapeutic effect in the subject body.
- the therapeutic effect may include a hemodynamic effect.
- the first medical device may include a blood pump.
- FIG. 1 is a schematic representation of an interconnector device, in accordance with an aspect of this disclosure. Dash lines indicate optional feature(s).
- FIG. 2 is a schematic representation of a first implantation modality of an interconnector device, such as one schematically illustrated in FIG. 1 , to a subject body, in accordance with one or more embodiments.
- FIG. 3 is a schematic representation of a second implantation modality of an interconnector device, such as one schematically illustrated in FIG. 1 , to a subject body, in accordance with one or more embodiments.
- FIG. 4 is a schematic representation of a third implantation modality of an interconnector device, such as one schematically illustrated in FIG. 1 , to a subject body, in accordance with one or more embodiments.
- FIG. 5 is a schematic representation of an installation modality of an interconnector device, such as one schematically illustrated in FIG. 1 , to a subject body, in accordance with one or more embodiments.
- FIG. 6 is a longitudinal cross-section view of an interconnector device, such as one schematically illustrated in FIG. 1 , in accordance with one or more embodiments.
- FIG. 7 is an enlarged longitudinal cross-section view of a first end portion of the interconnector device of FIG. 6, in accordance with one or more embodiments.
- FIG. 8 is an enlarged perspective view of the first end portion of the interconnector device of FIG. 7.
- FIG. 9 is a longitudinal cross-section view of an interconnector device provided with a fluid passageway and fluid evacuation ports, in accordance with one or more embodiments.
- FIG. 10 is an enlarged longitudinal cross-section view of the first end portion of the interconnector device of FIG. 9.
- FIG. 11 is a longitudinal cross-section view of an interconnector device provided with a guidewire passageway, in accordance with one or more embodiments.
- the interconnector device is illustrated with fluid evacuation ports.
- FIG. 12 is an enlarged longitudinal cross-section view of the first end portion of the interconnector device of FIG. 11 and of an implantable medical device connectable thereto, in accordance with one or more embodiments.
- the interconnector device is illustrated without fluid evacuation ports.
- An optional guidewire is illustrated be dash lines.
- FIGS. 13 and 14 are enlarged perspective views and FIG. 15 is a longitudinal crosssection view of an interconnector device, such as one schematically illustrated in FIG. 1, provided with an interconnector seal, in accordance with one or more embodiments.
- FIGS. 16 and 17 are perspective views of the interconnector device provided with an interconnector anchor, such as one schematically illustrated in FIG. 1 , in accordance with one or more embodiments.
- FIG. 18 is a longitudinal cross-section view of an interconnector device, such as one schematically illustrated in FIG. 1 , provided with an embedded power source, in accordance with one or more embodiments.
- FIGS. 19, 20, and 21 are perspective views of several interconnector devices, such as one or more schematically illustrated in FIG. 1 , having multiple sub-end portions, in accordance with embodiments.
- FIG. 22 is a schematic representation of a hemostatic device installed to a subject body and used in combination with an interconnector device, such as one schematically illustrated in FIG. 1 , in accordance with an aspect of this disclosure.
- FIG. 23 is a longitudinal cross-section view of the hemostatic device of FIG. 22 implanted to a conduit of a subject body and used in combination with an interconnector device, such as one schematically illustrated in FIG. 1 , in accordance with one or more embodiments.
- FIG. 24 is a longitudinal cross-section view of the hemostatic device of FIG. 22 implanted with a perforated installation sheet to a conduit of a subject body and used in combination with an interconnector device, such as one schematically illustrated in FIG. 1, in accordance with one or more embodiments.
- FIG. 25 is a schematic representation of a method of using a medical device in a subject body, in accordance an aspect of this disclosure. Dash lines indicate optional feature(s).
- FIG. 26 is a schematic representation of a method of using an implanted medical device in a subject body, in accordance an aspect of this disclosure. Dash lines indicate optional feature(s).
- FIG. 27 is a schematic representation of a method of using a first medical device and a second medical device in a subject body, in accordance an aspect of this disclosure. Dash lines indicate optional feature(s).
- this disclosure relates generally to an interconnector device 100 that is configured to interconnect one or more implantable medical devices and one or more controllers and/or power sources (collectively referred to hereinafter as “controller(s)”) together for operating the implantable medical device(s) through the interconnector device 100 by the controller(s), according to an aspect of this disclosure.
- the first interconnector device 100 may be replaced by a second, sterile interconnector device 100 without having to remove or explant the implanted medical devices, which remain(s) implanted in vivo.
- the implanted medical device is required to be removed or explanted and replaced by another implantable medical device.
- FIG. 1 schematically illustrates the interconnector device 100 that includes an interconnector body 102, a first connector 104, a second connector 106, and a first driveline 108 operatively coupling the first connector 104 and the second connector 106 together, according to one or more embodiment(s).
- the first connector 104 may be connectable to a first implantable medical device (in this case, the first connector 104 may be referred to as a “first medical device connector 104”).
- the second connector 106 may be connectable to a controller for operating the first implantable medical device through the interconnector device 100 by the controller (in this case, the second connector 106 may be referred to as a “first controller connector 106”).
- the first connector 104 of an interconnector device 100 may also be connectable to the second connector 106 of another interconnector device 100 to increase the overall length of any particular interconnector device 100.
- the interconnector device 100 may further optionally include a third connector 110, a fourth connector 112, and a second driveline 114 operatively coupling the third connector 110 and the fourth connector 112 together, according to one or more embodiment(s).
- the third connector 110 may be connectable to a second implantable medical device (in this case, the third connector 110 may be referred to as a “second medical device connector 110”).
- the fourth connector 112 may be connectable to a controller, either it be the same controller for connecting the second connector 106 or another controller (not shown), for operating the second implantable medical device through the interconnector device 100 by the controller (in this case, the fourth connector 112 may be referred to as a “second controller connector 112”).
- the third connector 110 of an interconnector device 100 may also be connectable to the fourth controller 110 or to the second connector 106 of another interconnector device 100 to increase the overall length of any particular interconnector device 100.
- Each of the first, second, third, and fourth connectors 104, 106, 110, 110 may respectively provide for a disconnectable connection or a non-disconnectable connection.
- the first driveline 108 may operatively couple the first connector 104 to the second connector 106 (i.e., an operative non-cross-coupling) and/or to the fourth connector 112 (i.e., an operative cross-coupling).
- the second driveline 114 may operatively couple the third connector 110 to the fourth connector 112 (i.e., an operative non-cross-coupling) and/or to the second connector 106 (i.e., an operative cross-coupling).
- Each of the first and second drivelines 108, 114 may independently be one or more electrical wires (not shown) and/or one or more driveshafts (not shown) optionally coupled to a gearbox (not shown) of the interconnector device 100.
- the gearbox may be controlled by the controller operating the implantable medical device connected to the interconnector device 100 or another controller.
- the first, second, third, and fourth connectors 104, 106, 110, 112 may be embodied as electrical connectors, and the controller may be configured to supply electrical power to the interconnector device 100.
- the first, second, third, and fourth connectors 104, 106, 110, 112 may be embodied as mechanical connectors, and the controller may be configured to transmit mechanical power, such as torque, to the interconnector device 100.
- the interconnector device 100 may integrate both or either the electrical connector(s) and the electrical wire(s), and/or the mechanical connector(s) and driveshaft(s).
- the interconnector device 100 may include any number of first, second, third, and fourth connectors 104, 106, 110, 112, which may be operatively non-cross- or cross-coupled.
- the interconnector device 100 may optionally include any number and any combination of the following features, for example: a magnet 700; first, second, and third connectors seals 800, 802, 804; a fluid passageway 900; fluid evacuation port 902; a wire guide 1000; a locking mechanism 1300; an interconnector seal 1200; an interconnector anchor 1500; and an embedded controller 1700 and/or embedded power source 1700 (collectively referred to herein as an “embedded controller”).
- a magnet 700 first, second, and third connectors seals 800, 802, 804
- a fluid passageway 900 fluid evacuation port 902
- a wire guide 1000 a locking mechanism 1300
- an interconnector seal 1200 an interconnector anchor 1500
- an embedded controller 1700 and/or embedded power source 1700 collectively referred to herein as an “embedded controller”.
- the third and fourth connectors 110, 112, the driveline 114, the operative cross-coupling of the first and second drivelines 108 and 114, the controller, and finally the first and second implantable medical devices are shown in dash lines as optional features of the interconnector device 100.
- FIGS. 2 to 4 illustrate the interconnector device 100 partially or entirely implanted, such as by catheterization, tunnelization, and/or open surgery, in a subject body (“intracorporeally”), according to one or more embodiments.
- the first, second, third, and/or fourth connectors 104, 106, 110, 112 of the interconnector device 100 may be intracorporeally connectable to and/or intracorporeally disconnectable from a corresponding connector of an implanted medical device or of another implanted interconnector device 100.
- the interconnector device 100 may be pushed toward an implanted medical device or another implanted interconnector device 100 for intracorporeal connection thereto and/or pushed away from an implanted medical device or another implanted interconnector device 100 for intracorporeal disconnection therefrom.
- FIG. 5 illustrates the interconnector device 100 installed outside a subject body (“extracorporeally”), according to an embodiment.
- the first end portion 200 of the interconnector device 100 is connected to two implantable medical devices, namely a first implantable blood pump 001 and a second implantable blood pump 002, which are implanted in the subject’s vasculature (“intravascularly”), in particular in the descending aorta.
- the second end portion 202 of the interconnector device 100 is connected to a controller 003 outside the subject body for operating the implanted first and second implantable blood pumps 001 , 002 through the interconnector device 100.
- the interconnector device 100 is partially implanted in a subject body and received through a percutaneous access site 004 (also referred to herein as an “interconnector-receiving body access site”), according to an embodiment.
- the first end portion 200 of the interconnector device 100 including the first connector 104 and the third connector 110 (when present), is positioned intracorporeally but outside a subject’s vasculature where the first and second implantable blood pumps 001 , 002 are implanted.
- the first end portion 200 may be positioned subcutaneously.
- the first and third connectors 104, 110 are operatively connected to the first and second implantable blood pumps 001 , 002, respectively, by two corresponding wires running therefrom and passing through at least one intraluminal access site 005 of the subject’s vasculature.
- the intraluminal access site 005 is an intravascular access site.
- the first end portion 200 of the interconnector device 100 may be wirelessly operatively connected through the vasculature wall to the first and second implantable blood pumps 001 , 002, such as to the implantable blood pump bodies, or to the wires thereof or similar structure(s).
- the second end portion 202 of the interconnector device 100 is positioned extracorporeally and has the second connector 106 and the fourth connector 112 (when present) operatively connected to the controller by one or more wires.
- the second end portion 202 of the interconnector device 100 may be wirelessly operatively connected to the controller.
- the interconnector device 100 is partially implanted in a subject body and received through a percutaneous access site 004 and an intraluminal access site 005 (also referred to herein as an “interconnector-receiving body access sites”), according to an embodiment.
- the intraluminal access site 005 is an intravascular access site.
- the first end portion 200 of the interconnector device 100 including the first connector 104 and the third connector 110 (when present), is positioned in the subject’s vasculature where the first and second implantable blood pumps 001 , 002 are implanted.
- the first and third connectors 104, 110 are operatively connected to the first and second implantable blood pumps 001 , 002, respectively, by two corresponding wires running therefrom along the subject’s vasculature.
- the first end portion 200 of the interconnector device 100 may be wirelessly operatively connected in the vasculature to the first and second implantable blood pumps 001 , 002, such as to the implantable blood pump bodies, or to the wires thereof or similar structure(s).
- the second end portion 202 of the interconnector device 100 is positioned extracorporeally and has the second connector 106 and the fourth connector 112 (when present) operatively connected to the controller by one or more wires.
- the second end portion 202 of the interconnector device 100 may be wirelessly operatively connected to the controller.
- the interconnector device 100 is partially implanted in a subject body and received through an intraluminal access site 005 (also referred to herein as an “interconnector-receiving body access site”), according to an embodiment.
- the intraluminal access site 005 is an intravascular access site.
- the first end portion 200 of the interconnector device 100, including the first connector 104 and the third connector 110 (when present), is positioned in the subject’s vasculature where the first and second implantable blood pumps 001 , 002 are implanted.
- the first and third connectors 104, 110 are operatively connected to the first and second implantable blood pumps 001 , 002, respectively, by two corresponding wires running therefrom along the subject’s vasculature.
- the first end portion 200 of the interconnector device 100 may be wirelessly operatively connected in the vasculature to the first and second implantable blood pumps 001 , 002, such as to the implantable blood pump bodies, or to the wires thereof or similar structure(s).
- the second end portion 202 of the interconnector device 100 including the second connector 106 and the fourth connector 112 (when present), is positioned intracorporeally but outside a subject’s vasculature where the first and second implantable blood pumps 001 , 002 are implanted.
- the second end portion 202 may be positioned subcutaneously.
- the second connector 106 and the fourth connector 112 are operatively connected to the first and second implantable blood pumps 001 , 002, respectively, by two corresponding wires running therefrom and passing through at least one percutaneous access site 004 of the subject body.
- the second end portion 202 of the interconnector device 100 may be wirelessly operatively connected to the controller 003, such as by transcutaneous energy transfer (TET).
- TET transcutaneous energy transfer
- the first and/or second end portion(s) 200, 202 of the interconnector device 100 may be configured to be atraumatic to the percutaneous access site, intraluminal access site, and intraluminal wall upon introduction and navigation.
- the first and/or second end portion(s) 200, 202 may be of a tapered or profiled shape while preserving their connectivity capability.
- the interconnector device 100 is entirely installed outside a subject body, according to an embodiment.
- the first end portion 200 of the interconnector device 100 is positioned extracorporeally and has the first connector 104 and the third connector 110 (when present) operatively connected to the first and second implantable blood pumps 001 , 002, respectively, by two corresponding wires running therefrom and passing through at least one intraluminal access site 005 and at least one percutaneous access site 004 (also collectively referred to herein as an “device-receiving body access site”) of the subject body.
- the intraluminal access site 005 is an intravascular access site.
- the first end portion 200 of the interconnector device 100 may be wirelessly operatively connected to the first and second implantable blood pumps 001 , 002, such as to the wires thereof or similar structure(s) which may be positioned subcutaneously.
- the second end portion 202 of the interconnector device 100 is also positioned extracorporeally and has the second connector 106 and the fourth connector 112 (when present) operatively connected to the controller by one or more wires thereof.
- the second end portion 202 of the interconnector device 100 may be wirelessly operatively connected to the controller.
- the interconnector device 100 may serve has an interconnecting extension 100 that is receivable in both an optional access sheath (not shown) installed through the percutaneous access site 004 and an optional access sheath sleeve (not shown) attached to the access sheath.
- an optional access sheath not shown
- an optional access sheath sleeve not shown
- the interconnecting extension 100 may be replaced by a new one(s) without having to remove or explant the implanted medical devices, which remain(s) implanted in vivo.
- FIGS. 2 to 5 illustrate the first and second implantable blood pumps 001 , 002 implanted in a subject’s vasculature
- each of a first implantable medical device and a second implantable medical device may be implanted elsewhere in a same or different anatomical location(s) of a subject body, such as in natural and surgically made lumen(s) or cavity(ies) thereof.
- the first implantable medical device may be implanted in a first blood vessel
- the second implantable medical device may be implanted in a second blood vessel.
- the percutaneous access site(s) 004 and/or the intravascular access site(s) 005 of the first and second medical devices may be the same or different access site(s).
- the percutaneous access site(s) 004 and/or the intravascular access site(s) 005 may or may not be the access site(s) used to implant one or the other of the first and second implantable medical device(s).
- FIGS. 2 to 5 illustrate the interconnector device 100 connected to respective wires of the first and second implantable blood pumps 001 , 002 and also to a wire of the controller 003, the interconnector device 100 may be connectable directly to any medical device and/or controller without the need of wire(s).
- first and second implantable blood pumps 001 , 002 as well as the controller 003 are shown in dash lines as optional features of the interconnector device 100.
- any number and any type of medical devices may be connected to and operated via the interconnector device 100 by a controller, including mechanical circulatory support devices, ventricular assist devices, pacemakers, implantable cardioverter defibrillators, and the combination thereof.
- one of the first and second end portions 200, 202 of the interconnector device 100 may be provided with multiple connectors that are connectable to multiple medical devices, and the other one of the first and second end portions 200, 202 may be provided with a single connector that is connectable to a controller for operating the multiple medical devices.
- a single access site receiving the interconnector device 100 therethrough such as an intraluminal and/or percutaneous access site, is required for operating multiple implanted medical devices instead of having an access site for each one of the multiple medical devices.
- FIGS. 6 to 21 the interconnector device 100 will now be described, according to embodiments.
- FIG. 6 illustrates the interconnector device 100 with the first connector 104 provided as a first electrical connector 500, the second connector 106 provided as a second electrical connector 502, the third connector 110 provided as a third electrical connector 504, and the fourth connector 112 provided as a fourth electrical connector 506, according to one or more embodiment(s).
- the first and second electrical connectors 500, 502 are female-type connectors integrated to the first end portion 200 of the interconnector device 100.
- Each of the first and second electrical connectors 500, 502 is removably or non- removably connectable to a respective medical device, such as the first and second implantable blood pumps 001 , 002 (not shown), respectively.
- the third and fourth electrical connectors 504, 506 are male-type connectors integrated to the second end portion 202 of the interconnector device 100.
- Each of the third and fourth electrical connectors 504, 506 are removably or non-removably connectable to at least one controller (not shown).
- the interconnector device 100 may be provided with the female-type connectors 500, 502 to the second end portion 202 thereof, and with the male-type connectors 504, 506 to the first end portion 200 thereof.
- only female-type connectors or only male-type connectors may be provided to both the first and second end portions 200, 202 of the interconnector device 100.
- the interconnector device 100 is illustrated herein with the first and second end portions 200, 202 thereof having a cross-sectional size that is bigger than the cross-sectional size of the interconnector body 102 for illustration purpose, so that the first, second, third, and fourth connectors 104, 106, 110, 112 are more easily visible. Accordingly, the first and/or second end portion(s) 200, 202 of the interconnector device 100 and the interconnector body 102 may have the same cross-sectional diameter. The first and/or second end portion(s) 200, 202 of the interconnector device 100 may also have a cross-sectional diameter that is smaller than the cross-sectional diameter of the interconnector body 102.
- the cross-sectional size of the first and/or second end portion(s) 200, 202 is preferably - but not necessarily - of the same and/or smaller size(s) as the interconnector body 102.
- the interconnector device 100 is also illustrated with the first driveline 108 provided as one or more first electrical conductors 508 and with the second driveline 114 provided as one or more second electrical conductors 510, according to one or more embodiment(s).
- Each of the first and second electrical conductors 508, 510 extends at least partially along the interconnector body 102 between the first and second end portions 200, 202 of the interconnector device 100.
- the first and second electrical conductors 508, 510 may be integrated to the interconnector body 102 and/or may be provided as electrical cables or electrical wires that may or may not form at least a part of the interconnector body 102 by being bundled together. Alternatively or additionally, when provided as such, the electrical cables or electrical wires may run outside the interconnector body 102 at least partially along the interconnector body 102.
- the one or more first electrical conductors 508 electrically operatively couple(s) the first and second electrical connectors 500, 504 together for electrical transmission therebetween.
- the one or more second electrical conductors 510 electrically operatively couple(s) the second and fourth electrical connectors 502, 506 together for electrical transmission therebetween.
- the second electrical connector 504 is of the male type and has an elongated shape that projects outwardly from the second end portion 202 of the interconnector device 100, according to one or more embodiment(s).
- the second electrical connector 504 may be parallelly aligned relative to the fourth electrical connector 506 and/or relative to a reference longitudinal axis illustrated by dash lines.
- the second electrical connector 504 is configured to electrically connect to one or more controller (not shown) for operating a medical device, such as the first or second implantable blood pump 001 , 002, that is connected to the first electrical connector 500.
- the second electrical connector 504 includes one or more electrical pins, such as five electrical pins 514, 516, 518, 520, 522 as illustrated, that are disposed to the periphery of the second electrical connector 504 and spaced apart from each other along the length of the second electrical connector 504.
- Each one of the five electrical pins 514-522 is electrically coupled by a first electrical conductor 508 (which corresponds to the second electrical conductor 510 in the case of the fourth electrical connector 506) to a corresponding one of five electrical sockets 604-612 of the first electrical connector 500.
- Multiple first and second electrical conductors 508, 510 are not shown in FIGS. 6, 7, and 8 for the sake of clarity.
- the first electrical connector 500 is of the female type and defines a connector cavity 512 (best shown in FIG. 8) that projects within the first end portion 200 of the interconnector device 100, according to one or more embodiment(s).
- the first electrical connector 500 may be parallelly aligned relative to the second electrical connector 502 and/or relative to the reference longitudinal axis illustrated in dash lines in FIG. 6.
- the connector cavity 512 is configured to receive a corresponding male-type connector of a medical device, such as a connector of the first or second implantable blood pump 001 , 002, or one of the first or second electrical connector 504, 506 of another interconnector device 100.
- the first electrical connector 500 includes one or more electrical sockets, such as five electrical sockets 604, 606, 608, 610, 612 as illustrated, disposed inside the connector cavity 512, on the periphery thereof, and spaced apart from one another along the length of the connector cavity 512, according to one or more embodiment(s).
- Each one of the electrical sockets 604-612 has an annular shape that defines an aperture therethrough.
- the annular shape of the electrical sockets 604-612 is partially shown in FIG. 8 for the electrical sockets 612.
- the connector cavity 512 of the first electrical connector 500 is configured to receive a male-type connector therein such that an electrical contact is established between each one of the electrical sockets 604-612 and a respective one of the electrical pins of male-type connector.
- the annular shape of one or more of the electrical sockets 604-612 may be sized and shaped to have an interference fit with one or more corresponding electrical pins of the male-type connector.
- one or more of the electrical sockets 604-612 may be annular springs defining the aperture, similar to a SYGNUS® Implantable Contact System of Bal Seal Engineering By KAMAN (https://www.balseal.com/industry/medical/; May 29, 2023).
- one or more electrical sockets 604-612 may be spring-loaded toward the electrical pins of the male-type connector when electrically connected to the first electrical connector 500.
- one or more electrical sockets 604-612 may be made of a compressible or memory material such that a pressure is exerted on one or more corresponding electrical pins of the male-type connector when electrically connected to the first electrical connector 500.
- One or more electrical sockets 604-612 may have an unoccupied state in absence of electrical connection with corresponding electric pins of the male-type connector and an occupied state in presence of electrical connection with corresponding electric pins of the male-type connector.
- One or more electrical sockets 604-612 may also be biased toward the unoccupied state for establishing the electrical contact between each one of the electrical sockets 604-612 and the respective one of the electrical pins of the male-type connector.
- the first electrical connector 500 and the male-type connector are connectable together by pushing the male-type connector inside the connector cavity 512 of the first electrical connector 500. Conversely, the first electrical connector 500 and the male-type connector are electrically disconnectable from each other by pulling the male-type connector out of the connector cavity 512 of the first electrical connector 500.
- each of the first and third electrical connectors 500, 504 may optionally include, at an entry end portion 600 thereof, with an threaded portion 602 configured to be screwed to the male-type connector for maintaining an electrical connection therewith, according to one or more embodiment(s).
- the second and fourth electrical connectors 502, 506 may also be provided with a threaded portion (not shown) at the base end portion 524 thereof.
- the first and/or second end portion(s) 200, 202 of the interconnector device 100 may include a screwable portion running along the periphery thereof and configured to couple to a medical device and/or a connector.
- the first electrical connector 500 and/or the male-type connector may be rotated in one direction for screwing them to each other and in an opposite direction for unscrewing them from each other.
- the first and/or third electrical connector(s) 500, 504 may optionally include the first seal 800 (may also be referred to herein as a “connector cavity seal”) that covers the entry end portion 600 of the connector cavity 512 (FIG. 7 shows the first seal 800 only for the first electrical connector 500 for comparison purpose with the third electrical connectors 504), according to one or more embodiment(s).
- the first seal 800 is configured to provide a fluid tight contact, such as by interference fit, with each of the first and third electrical connectors 500, 504 to prevent fluid, such as blood, from entering the connector cavity 512 thereof when the interconnector device 100 is implanted in vivo.
- the first seal 800 is displaceable along the connector cavity 512, from the entry end portion 600 to a bottom end portion 614 thereof, as a corresponding male-type connector is inserted inside the connector cavity 512.
- the first seal 800 is at the bottom end portion 614, and all the electrical sockets 604-612 contact the electrical pins of the male-type connector.
- the first seal 800 may also be biased toward the entry end portion 600 of the connector cavity 512, such as by a spring (not shown) that is received within the connector cavity 512. The biasing action progressively returns the first seal 800 to the entry end portion 600 of the connector cavity 512 as the male-type connector is removed from the connector cavity 512.
- the first seal 800 may be rupturable and/or perforable by the male-type connector upon insertion in the connector cavity 512. As such, the first seal 800 may be configured not to be able to reseal upon removal of the male-type connector therefrom. In this case, the first seal 800 may be for a single use. Alternatively, the first seal 800 may be configured to be able to reseal upon removal of the male-type connector therefrom. In this case, the first seal 800 may be for multiple use.
- FIG. 8 illustrates the first end portion 200 of the interconnector device 100 that may optionally include a second seal 802 (may also be referred to herein as a “connector periphery seal”) (FIG. 8 shows the second seal 802 only for the first electrical connector 500 for comparison purpose with the third electrical connectors 504) and/or a third seal 804 (may also be referred to herein as an “interconnector end portion seal”), according to one or more embodiments.
- the second seal 802 is disposed to the periphery of the connector cavity 512 of the first and third electrical connector(s) 500, 504, and the third seal 804 is disposed to the periphery of the first end portion 200 of the interconnector device 100.
- the second and third seals 802, 804 are configured to provide a fluid thigh engagement with a corresponding maletype connector connecting the first and third electrical connectors 500, 504 to prevent fluid, such as blood, from entering the connector cavity 512, when the interconnector device 100 is implanted in vivo.
- the second seal 802 may also be configured to snug fit with the male-type connector upon insertion and when inserted in the connector cavity 512 to provide a slidable fluid tight engagement therewith.
- the second seal 802 may contact the first seal 800 positioned at the entry end portion 600 of the connector cavity 512 to provide a fluid tight contact therewith.
- first and/or third electrical connector(s) 500, 504 may include one or more of the first, second, and third connector seals 800, 802, 804 whether or not provided with the threaded portion 602.
- the second end portion 202 of the interconnector device 100 may also be provided with a fourth seal (may also be referred to herein as a “connector periphery seal”); not shown) and/or a fifth seal (may also be referred to herein as an “interconnector end portion seal”; not shown), according to one or more embodiments.
- the fourth seal is disposed to the periphery of the base portion 524 of the second and fourth electrical connectors 502, 506, and the fifth seal is disposed to the periphery of the second end portion 202 of the interconnector device 100.
- the fourth seal is configured to provide a fluid thigh engagement with a corresponding female-type connector connecting the second and fourth electrical connectors 502, 506 to prevent fluid, such as blood, from entering a cavity of the female-type connector, when the interconnector device 100 is implanted in vivo.
- the first, second, and third connector seals 800, 802, 804 prevent the first and third electrical connectors 500, 504, including the electrical sockets 604-612 thereof, to be damaged due to exposition to a body fluid. Blood, for example, may damage the first and third electrical connectors 500, 504 and may also form blood clothes that can prevent appropriate intracorporal connection.
- FIG. 8 also illustrates the first end portion 200 of the interconnector device 100 that may optionally include one or more magnets 700, according to one or more embodiment(s).
- the magnet(s) 700 may be integrated to the distal end wall 702 of the first end portion 200 (as shown), or to the first and/or third electrical connector(s) 500, 502 (not shown).
- the second end portion 202 of the interconnector device 100 may be provided with one or more magnets 700.
- the magnet(s) 700 may be similarly integrated to the distal end wall thereof and/or to one or more of the second and fourth electrical connector(s) 502, 506.
- the magnet(s) 700 is configured to magnetically couple to one or more corresponding connectors, such as a male-type connector, of a medical device and/or of another interconnector device 100.
- the magnet(s) 700 may be natural magnet(s) and/or electromagnet(s). The strength of the natural magnet(s) and/or electromagnet(s) may provide for a disconnectable connection of the implanted interconnector device 100, for example by pulling thereto, or for a non-disconnectable connection of the implanted interconnector device 100.
- the electromagnet(s) may be configured to be operated by the controller operating the medical device(s) operatively connected to the interconnector device 100, or by another controller. The electromagnet(s) may be operated to attract one or more corresponding connectors for connection thereto, or to repulse one or more corresponding connectors for disconnection therefrom.
- first and/or second end portion(s) 200, 202 of the interconnector device 100 may be provided with a material, such as a ferromagnetic material, configured to electromagnetically interact with one or more magnetic connectors of a medical device or of another interconnector device 100 for the same purpose as describe hereinbefore.
- a material such as a ferromagnetic material
- the magnet(s) 700 may not only maintains or help to maintain a connection between the interconnector device 100 and a medical device and/or another interconnector device 100, but also establishes or helps to establish such an electrical connection therebetween. Indeed, as the first and/or second end portion(s) 200, 202 of the interconnector device 100 get closer to one or more connectors of a medical device or another interconnector device 100 intracorporeally, the magnetic interaction becomes stronger up to a point where the first and/or second end portion(s) 200, 202 contact(s) the medical device or the other interconnector device 100. Depending on their configurations, such contact may result in the operative connection between the interconnector device 100 and the medical device and/or the other interconnector device 100.
- this magnetic interaction may align or may help to align the corresponding connectors for connection.
- the establishment of intracorporeal connection may be difficult to accomplish owing, for example, to the lack of suitable visual indication(s), anatomical marker(s), and/or tactile feedback allowing the operator to move a connector of the interconnector device 100, a medical device, and/or a controller in such a way that they can meet intracorporeally and appropriately connect together intracorporeally.
- FIGS. 9 and 10 illustrate the interconnector device 100 that may optionally include a fluid passageway 900 for supplying a fluid to the first and second electrical connectors 500, 504, and/or two fluid evacuation ports 902 for evacuating a fluid from the first and second electrical connectors 500, 504, according to one or more embodiment(s).
- a fluid passageway 900 for supplying a fluid to the first and second electrical connectors 500, 504, and/or two fluid evacuation ports 902 for evacuating a fluid from the first and second electrical connectors 500, 504, according to one or more embodiment(s).
- Any number of fluid passageway 900 and/or any number of fluid evacuation port 902 may alternatively be provided to the first and/or third electrical connector(s) 500, 504.
- the first and second electrical conductors 508, 510 have been omitted from FIGS. 9 and 10.
- the fluid passageway 900 and the fluid evacuation ports 902 may be used, for example, to flush or rinse the first and second electrical connectors 500, 504 in a blood vessel with an anticoagulant in order to prevent or mitigate blood clot formation and/or remove a blood clot in vicinity of the connectors or inside the tubular cavities 512 thereof. Prevention and/or removal of blood clots may be required or desirable in order to establish an appropriate electrical connection with a corresponding male-type connector.
- the fluid passageway 900 and the fluid evacuation ports 902 may also be used for drug delivery and/or fluid sampling inside a subject body.
- the fluid passageway 900 extends at least partially between the first and second end portions 200, 202 of the interconnector device 100.
- the fluid passageway 900 is removably connectable at the second end portion 202 to a fluid reservoir 009 (shown in dash lines in FIG. 9 as an optional component of the interconnector device 100), and is in fluid communication at a first end portion 200 with the first and second electrical connectors 500, 504, such as with the tubular cavities 512 as illustrated.
- the fluid reservoir 009 may supply a fluid, such as an anticoagulant, to the interconnector device 100 according to one or more predetermined settings, which may include a predetermined time (e.g., continuous or intermittent) and/or flow setting(s).
- Each of the fluid evacuation ports 902 extend between the respective first and third electrical connectors 500, 504, such as the bottom end portion 614 of the connector cavity 512, and the outside environment of the interconnector device 100.
- a one-way valve (not shown) may be provided to the fluid evacuation port(s) 902.
- the fluid passageway 900 and the fluid evacuation ports 902 are configured to supply fluid to and evacuate fluid from, respectively, the connector cavity 512.
- a fluid may be supplied by the fluid passageway 900 to the connector cavity 512, which may or may not receive the male-type connector therein, and may be evacuated through the fluid evacuation port 902.
- a first fluid, such as blood, initially present in the connector cavity 512 may be displaced by a second fluid coming from the fluid passageway 900, such that the first fluid is displaced and evacuated through the fluid evacuation port 902.
- a fluid initially present in the connector cavity 512 may be displaced and evacuated through the fluid evacuation port 902 by the action of the male-type connector being inserted in the connector cavity 512.
- the fluid passageway 900 and fluid evacuation ports 902 may be used in combination with any of the first, second, and third connector seals 800, 802, 804.
- first, second, third, and/or fourth connectors 104, 106, 110, 112, including the first, second, third, and/or fourth electrical connectors 500, 502, 504, 506, may be embodied as any type of connector configured to mechanically and/or electrically connect any medical device(s) and/or controller(s). Any number of such connector may be provided to the interconnector device 100.
- the connector(s) of the interconnector device 100 may be electrical connectors, similar to the electrical connectors 500-506, but provided with annular electrical contacts disposed concentrically on the distal end wall(s) of the first and/or second end portion(s) of the interconnector device 100.
- the first and/or second end portion(s) of the interconnector device 100 may be provided with a threaded portion and a seal, such as the third seal 804.
- the first, second, third, and/or fourth connectors 104, 106, 110, 112 may be embodied as mechanical connector(s) configured to connect the interconnector device 100 to one or more medical devices and to one or more controller(s).
- mechanical power such as torque
- the controller which may be for example an actuator, to the medical device(s).
- FIGS. 11 and 12 illustrate the interconnector device 100 that may optionally include a wire guide 1000, such as a guidewire passageway, extending at least partially between the first and second end portions 200, 202 of the interconnector device 100, according to one or more embodiment(s).
- the wire guide 1000 is configured to receive a guidewire 011 (shown in dash lines in FIGS. 11-12 as an optional component of the interconnector device 100) therethrough for railing the interconnector device 100 over the guidewire 011 inside a subject body, such as intraluminally.
- the wire guide 1000 include any structure configured to or capable of guiding a guidewire therethrough or therealong.
- the wire guide 1000 may be configured to guide the guidewire 011 therethrough and/or therealong.
- the first and second electrical conductors 508, 510 have been omitted from FIGS. 11 and 12.
- the interconnector device 100 may be configured to be railed with an implantable medical device 012 (shown in dash lines as an optional component of the interconnector device 100) over the guidewire 011 for connecting the interconnector device 100 and the implantable medical device 012 together inside a subject body, according to one or more embodiment(s).
- the interconnector device 100 may include a medical device connector that has a connector body, the wire guide 1000 configured to guide the guidewire 011 , and a connector, such as the first and/or third electrical connectors 500, 502 as illustrated.
- the medical device connector may be provided as a standalone device. Any connector(s) may be provided to the interconnector device 100 and medical device connector for this purpose.
- the connector(s) may be an electrical connector of the female or male type, a connector with projecting electrical contact(s), recessed electrical contact(s), and/or annular electrical contact(s).
- the connector is configured to connect to the medical device 012 that is railed over the guidewire which itself is guided by the wire guide 1000.
- the wire guide 1000 and the connector may be associated together on the connector body or on the interconnector device 100.
- the end portion 1100 of the wire guide 1000 and the first and/or third electrical connector(s) 500, 504 may be disposed on a same surface, such as on the distal end wall 702 of the first end portion 200 of the interconnector device 100.
- first and/or third electrical connector(s) 500, 504 align(s) and/or coincide(s) with one or more respective connectors 012, 013 of the implantable medical device 012 for connection, when the interconnector device 100 and the implantable medical device 012 are railed over the guidewire 011 and advanced toward each other therealong.
- wire guide 1000 may be coaxially, concentrically, circumferentially, parallelly, coplanarly, and/or equidistantly arranged or disposed relative to each other.
- the controller when connected to the interconnector device 100, may be configured to detect which of the first and/or third electrical connector(s) 500, 504 is connected to which of the connectors 012, 013 and adjust its output accordingly.
- the magnet(s) 700 may assist and/or facilitate that the first and/or third electrical connector(s) 500, 504 align(s) and/or coincide(s) with one or more for the connectors 012, 013 for connection.
- the wire guide 1000 may similarly be integrated to the second end portion 202 of the interconnector device 100 so that the second and/or fourth electrical connector(s) 502, 506 may connect to one or more corresponding connectors, when the interconnector device 100 and an implantable medical device are railed over the guidewire 011.
- FIG. 12 also illustrates the interconnector device 100 that may optionally include a locking mechanism 1300 for maintaining connection(s) between the interconnector device 100 and an implantable medical device, such as one of the first and second implantable blood pumps 001 , 002, according to one or more embodiment(s).
- the locking mechanism 1300 includes a retaining element 1302 and an elongated control element 1304 coupled to the retaining element 1302 for operating the retaining element 1302.
- the retaining element 1302 is configured to retain a portion of the implantable medical device, such as one or more connectors thereof, for maintaining physical and/or electrical connection(s) with the implantable medical device.
- the retaining element 1302 is disposed to the first end portion 200 of the interconnector device 100 and may be a mechanical retaining element, such as a retaining pin, a latch coupling, a camlock-type coupler, and/or any other similar structure, or an electrical retaining element, such as an electromagnet (somewhat similar to the magnet(s) 700 when embodied as electromagnet(s)).
- the locking mechanism 1300 may or may not be auto-locking, such as by auto-latching, when the retaining element 1302 contacts or abuts the implantable medical device.
- the locking mechanism 1300 may be provided to the first electrical connector 500 (as illustrated), the second electrical connector 502, and/or the distal end wall 702 of the first end portion 200.
- the elongated control element 1304 extends at least partially between the first end portion 200 and the second end portion 202 of the interconnector device 100.
- the elongated control element 1304 is configured to be controlled and/or manipulated from the second end portion 202 of the interconnector device 100 for operating the retaining element 1302 at the first end portion 200 of the interconnector device 100. So operated, the retaining element 1300 may be converted between a retaining state, in which the implantable medical device is retained or secured to the interconnector device 100, and a non-retaining state, in which the implantable medical device is not retained and not secured to the interconnector device 100.
- the locking mechanism 1300 may include only the retaining element 1302 that is directly controllable and/or manipulable for locking or not the implantable medical device at the first end portion 200 of the interconnector device 100.
- FIGS. 13, 14, and 15 illustrate the interconnector device 100 that optionally includes an interconnector seal 1200 configured to provide a fluid tight engagement with an access site of a subject body where the interconnector device 100 is installed, according to one or more embodiment(s).
- Such access site may be the percutaneous access site 004 and/or the intraluminal access site 005, as illustrated in FIGS. 2-4.
- the interconnector seal 1200 may prevents or reduces (i) bleeding and oozing at the access site, for example by providing hemostasis, (ii) possible movements of the interconnector device 100 through the access site, reducing trauma and improving healing at the access site; and/or (iii) the risk of infection by acting as a barrier against pathogens at the access site.
- the interconnector seal 1200 is coupled to the interconnector device 100 and generally have a disk-like shape, according to one or more embodiment(s).
- the interconnector seal 1200 may project at any angle for appropriate engagement with the access site from the interconnector body 102 (as shown) or from any of the first and second end portions 200, 202 of the interconnector device 100, including the from first, second, third, and/or fourth connector 104, 106, 110, 112.
- the interconnector seal 1200 may be convertible between a non-expanded state for transcatheter delivery and implantation or installation at the access site and an expanded state (as shown) for fluid thigh engagement at the access site.
- the interconnector seal 1200 In the non-expanded configuration, the interconnector seal 1200 has a cross-sectional size that is similar to the cross-sectional size of the interconnector device 100.
- the interconnector seal 1200 In the expanded configuration, the interconnector seal 1200 has a cross-sectional size that is larger than the cross-sectional size of the interconnector device 100.
- the interconnector seal 1200 may include a frame (not shown) and a membrane (not shown) coupled to the frame.
- the membrane is deployable upon conversion of the frame from the non-expanded state to the expanded frame, and vice-versa.
- the frame may be biased toward the expanded state such that the interconnector seal 1200 is self-expandable.
- the frame may be convertible from the non-expanded state to the expanded state by inflation of the membrane or by inflation of an optional catheter ballon inside the frame, and vice-versa.
- the interconnector seal 1200 may optionally be inflatable for engaging the access site in a fluid thigh manner.
- the interconnector device 100 optionally includes one or more fluid channels (not shown) that are in fluid communication with the interconnector seal 1200 and an optional controller, such as the one operating the medical device(s) connected to the interconnector device 100, that is configured to inflate and deflate the interconnector seal 1200.
- the interconnector device 100 including the interconnector seal 1200, may also optionally includes a pressure sensor (not shown) for measuring fluid pressure inside the interconnector seal 1200 and/or a biological fluid sensor (not shown) for detecting the presence of a biological fluid, such as blood, outside the access site, such as on the subject’s skin.
- the pressure and biological fluid sensors are connected to the controller.
- Fluid thigh engagement of the interconnector seal 1200 with the access site is monitored by the pressure and/or biological fluid sensor(s) and adjusted in response to one or more of their respective signals.
- fluid pressure inside the interconnector seal 1200 may be increase and/or decrease to optimize fluid thigh engagement in response to the pressure sensor and/or if the biological fluid sensor detects the presence of one or more biological fluids.
- the controller may be operated independently of the pressure and/or biological fluid sensor(s) for adjusting the fluid thigh engagement.
- FIGS. 14 and 15 illustrate the interconnector device 100 with the interconnector seal 1200 that engages an access site of a physiological structure (shown in dash lines to represent the environment of the interconnector device 100).
- the interconnector seal 1200 optionally includes a peripheral groove 1202 running along the outer periphery of the interconnector seal 1200.
- the peripheral groove 1202 is configured to receive an edge portion of the access site for fluid tight engagement therewith.
- the interconnector seal 1200 in the expanded configuration may exert a force against the edge portion such that the inner portion of the peripheral groove 1202 is pressed against the edge portion of the access site.
- the force may be exerted by the biasing action of the frame or by inflation, as described herein. Depending on the material of the frame, such pressure may or may not be preserved upon deflation.
- the frame may be provided as a wire network made or not of a memory material, such as nitinol, stainless steel, and biocompatible polymer(s).
- the membrane may include a biocompatible material, an antiseptic material, an/or antithrombotic material.
- the peripheral groove 1202, the inner portion 1204, and/or the outer portion 1206 of the membrane may also include or be covered by an antiseptic drug, an antithrombotic drug, an antiseptic drug, and/or an antibiotic drug.
- FIGS. 16 and 17 illustrate the interconnector device 100 that optionally includes an interconnector anchor 1500 for anchoring the interconnector device 100 in a subject body, such as intraluminally, according to one or more embodiment(s).
- the interconnector anchor 1500 generally has an open tubularlike shape in which the interconnector device 100 is longitudinally received.
- the interconnector device 100 may be coaxially disposed in the interconnector anchor 1500 (as illustrated) or not.
- the interconnector device 100 may be provided as a wire network having one or more arms 1502 coupled to the interconnector body 102 (as shown) and/or to one or more of the first and second end portion(s) of the interconnector device 100.
- the interconnector anchor 1500 may be convertible between a non-anchored state for transcatheter delivery of the interconnector device 100 intracorporeally and an anchored state (as shown in FIGS. 16-17) for anchoring the interconnector device 100 intracorporeally.
- FIG. 17 illustrates the interconnector anchor 1500 in the anchored state that anchors the interconnector device 100 intraluminally in a physiological structure, which is shown in dash lines to represent the environment of the interconnector device 100.
- the interconnector anchor 1500 may also be configured to anchor one or more implantable medical devices (shown in FIG. 17 in dash lines as an optional component of the interconnector device 100) connected thereto intracorporeally. As illustrated in FIG. 17, the implantable medical devices are connected to the interconnector device 100 by their wires extending from their bodies; however, the implantable medical devices may be connected to the interconnector device 100 by their bodies.
- the interconnector anchor 1500 In the non-expanded configuration, the interconnector anchor 1500 has a cross-sectional size that is similar to the cross-sectional size of the interconnector device 100. In the expanded configuration, the interconnector anchor 1500 has a cross-sectional size that is larger than the cross-sectional size of the interconnector device 100.
- the interconnector anchor 1500 may be biased toward the anchored state such that the interconnector anchor 1500 is self-expandable.
- the interconnector anchor 1500 may be convertible from the non-anchored state to the anchored state by inflation of an optional catheter ballon inside the interconnector anchor 1500, and vice-versa.
- the interconnector anchor 1500 may be made of a memory material, such as nitinol, stainless steel, and biocompatible polymer(s), and/or an antithrombotic material.
- FIG. 18 illustrates the interconnector device 100 that optionally includes an embedded controller 010, according to one or more embodiment(s).
- the embedded controller 010 may be integrated to the interconnector body 102 (as shown) and/or to one or more of the first and second end portion(s) 200, 202 of the interconnector device 100.
- the embedded controller 010 may be operatively connected to one or more of the first, second, third, fourth connectors 104, 106, 110, 112.
- the controller 010 which may include a power source like a battery, may be configured to be rechargeable by one or more of the first, second, third, fourth connectors 104, 106, 110, 112 when embodied as electrical connector.
- FIGS. 19, 20, and 21 illustrate the interconnector device 100 according to various embodiments.
- the first end portion 200 of the interconnector device 100 is branched out and have multiple end portions, such as three end portions 1800, 1802, 1804 as illustrated.
- Each of the first end portions 1800, 1802, 1804 has the first and third connectors 104, 100 embodied as the first and third electrical connectors 500, 504.
- the second end portion 202 of the interconnector device 100 is branched out and have multiple end portions, such as three end portions 1900, 1902, 1904 as illustrated.
- Each of the first end portions 1900, 1902, 1904 has the second and fourth connectors 106, 112 embodied as the second and fourth electrical connectors 502, 506.
- the first and second end portions 200, 202 of the interconnector device 100 are branched out and have multiple end portions, such as three end portions 1800, 1802, 1804 and three end portions 1900, 1902, 1904 as illustrated, respectively.
- Each of the first end portions 1800, 1802, 1804 has the first and third connectors 104, 100 embodied as the first and third electrical connectors 500, 504.
- Each of the first end portions 1900, 1902, 1904 has the second and fourth connectors 106, 112 embodied as the second and fourth electrical connectors 502, 506.
- the interconnector device 100 may have a one-to-one relationship between a single controller and a single implantable medical device.
- the interconnector device 100 may also have a one-to-many relationship between a single controller and many implantable medical devices, or between a single implantable medical devices and many controllers.
- the interconnector device 100 may also have a many-to-many relationship between a many controllers and many implantable medical devices.
- the interconnector device 100 may have a circular cross-sectional shape, as illustrated herein, but not necessarily. In any case, the interconnector device 100 preferably - but not necessarily - has a cross-sectional shape void of sharp edge to avoid damaging intraluminal and/or percutaneous access site(s).
- the overall cross-sectional size of the interconnector device 100, including the interconnector body 102 and the first and second end portions 200, 202 thereof, may be about between 1 mm (3 FR) and 10 mm (30 FR).
- the cross-sectional shape and/or cross-sectional size of the interconnector device 100 may vary along the length thereof.
- the cross-sectional size of the interconnector device 100 may progressively increase along the length thereof such that the interconnector device 100 has a tapered and/or profiled shape.
- the most tapered and/or profiled end portion of the interconnector device 100 may be introduced first in an intraluminal and/or percutaneous access site(s). Then, the interconnector device 100 may be advanced therethrough until a fluid thigh engagement with the access site(s) is achieved. In vascular applications, this may provide hemostasis or may help to obtain hemostasis.
- the interconnector device 100 may have an elongated shape or a shape that substantially corresponds to the length of the connector(s) provided to the first and/or second end portion(s) 200,202.
- the overall length of the interconnector body 102 may about between 5 cm and 60 cm.
- the interconnector device 100 may generally have any size and any shape so long as the interconnector device 100 can be interconnected.
- the interconnector device 100 may be flexible and may be made of a biocompatible material, such as thermoplastic polyurethane (TPU), polytetrafluoroethylene (PTFE), Pebax® Elastomers, and the like. Such flexibility may allow the interconnector device 100 to be routed and/or navigated though elbows or other kinked segments intraluminally.
- the interconnector device 100 may also be configured for and made of a material(s) for single use and thus be disposable. Alternatively, the interconnector device 100 may be configured for and made of material(s) for repeated use and for example be autoclavable.
- the interconnector device 100 disclosed herein enables one or more intracorporeally implanted medical devices having multiple control wires or cables thereof routed outside a subject body to be operated through a single interconnector structure passing through at least one access site of the subject body.
- having a single interconnector structure passing through an access site not only facilitates the management of multiple medical devices’ control cables, but also reduces the infection risk associated with the bodily opening(s), as opposed to the infection risk associated with multiple medical devices’ control cables passing through one or more bodily openings.
- wound care is simplified since there is a single site of skin breach. This is of particular importance for permanently implanted devices where the subject is likely to perform wound care by himself.
- a health professional such as an interventional cardiologist, may replace the implanted interconnector 100 by a new, sterile interconnector 100 without replacing the implanted medical device(s).
- the implanted interconnector 100 may be disconnected from the implanted medical device(s) and connected to the new, sterile interconnector 100 inside or outside the subject body.
- the interconnector device 100 may be useful when multiple implanted medical devices are operated. Depending on the nature of the medical devices and their operation mode(s), the operation of a plurality of such medical devices implanted in a subject body may be preferable over the operation of only one of them. Notably, the operation at a given speed of the plurality of blood pumps implanted in the vasculature to produce a combined blood outflow therefrom may result in a blood integrity profile that is better than the blood integrity profile resulting from the operation at a higher speed than the given speed of only one of the blood pumps to produce a blood outflow that is similar to the combined blood outflow, as described in the International Application Number PCT/ZA2020/050,022.
- This disclosure also relates generally to a hemostatic device 2300 for an implantable medical device, such as the interconnector device 100, according to an aspect of this disclosure.
- FIGS. 22, 23, and 24 illustrate a hemostatic device 2300 (may also be referred to herein as an “implantable medical device-receiving sleeve”) and the interconnector device 100 taken as a device example, according to embodiments.
- the hemostatic device 2300 serves as a physical interface between a subject body where it is installed and the interconnector device 100 implanted in the subject body, for example as illustrated in FIGS. 2 to 4. So installed, the hemostatic device 2300 provides access to the interconnector device 100 inside the subject body, such as to an intraluminal location thereof or a subdermal location thereof.
- the hemostatic device 2300 may be provided as a standalone unit, separately from the interconnector device 100, or may be provided with the interconnector device 100. Accordingly, the hemostatic device 2300 is illustrated and described herein with the interconnector device 100 only as an example of an implantable medical device that may be used with the hemostatic device 2300.
- the hemostatic device 2300 may be used with any other implantable medical devices, with the necessary change(s), appreciable to the skilled addressee, having been made, if applicable.
- the hemostatic device 2300 may be used with one or more wires, cables, cords, and the like of corresponding implantable blood pump(s).
- the hemostatic device 2300 may also be used with one or more wires, cables, cords, and the like of one or more power sources used to operate corresponding implantable medical device(s).
- the hemostatic device 2300 may also be used with one or more catheter devices and the like used to deliver a liquid to the subject body, such as to the vasculature, or to sample a fluid, such as blood, from the subject body.
- the hemostatic device 2300 includes an installation sheet 2302 and a receiver tube 2304, or similar structure, projecting therefrom, according to one or more embodiment(s).
- the installation sheet 2302 and the receiver tube 2304 may form a monolithic structure together or may be attached to one another.
- the installation sheet 2302 and the receiver tube 2304 may be removably attached together such that they can be attached to and detached from one another when the hemostatic device 2300 is installed to a subject body.
- the installation sheet 2302 and the receiver tube 2304 may be rotatably attached together such that the installation sheet 2302 and the receiver tube 2304 can rotate relative to one another when the hemostatic device 2300 is installed to a subject body.
- the installation sheet 2302 is configured to be installed and attached to a subject body in order to maintain the receiver tube 2304 in place thereto, for example when the hemostatic device 2300 is installed to an intraluminal and/or percutaneous access site(s).
- the installation sheet 2302 may be installed to the epidermis of the skin (as illustrated in FIG. 22).
- the installation sheet 2302 may also be installed to the skin subcutaneously (not shown), to a bodily conduit outside the lumen thereof (as illustrated in FIG. 23; e.g. outside a blood vessel), and to a bodily conduit inside the lumen thereof (as illustrated in FIG. 24; e.g. inside a blood vessel).
- the installation sheet 2302 may be attached to the subject body by sutures, staples, glue, formation of scar tissue, and the like.
- the installation sheet 2302 may be made of a biocompatible material, such as silicone, polyetheretherketone (PEEK), ceramic, titanium, aluminum, stainless steel, and the like.
- the installation sheet 2302 may be made of a biocompatible material, such as Dacron®, Polytetrafluoroethylene (PTFE), and the like.
- the installation sheet 2302 may be generally thin and may have any shape, such as a circular shape (e.g., as illustrated in FIG. 22), a square shape, a triangle shape, an oblong shape, and the like.
- the installation sheet 2302 may also be sized and shaped to appropriately fit a specific anatomical structure of a subject body in order to be appropriately installed and attached thereto.
- the installation sheet 2302 may have a hollow cylindrical shape or a hollow semi-cylindrical shape that may be sized and shaped to appropriately fit and engage a wall of a blood vessel inside the lumen thereof.
- the installation sheet 2302 may also have a shape that is free of corners, which are generally prone to peel off when the installation sheet 2302 is installed on the epidermis of the skin, for example.
- the receiver tube 2304 Projecting from the installation sheet 2302, defines a passage 2400 that opens at each one of first and second end portions 2402, 2404 thereof, and extends at least partially along the receiver tube 2304.
- the passage 2400 is configured to partially receive the interconnector device 100, such as the interconnector body 102 as illustrated, along its length therein.
- the cross-sectional area of the passage 2400 may be sized and shaped to substantially match the cross-sectional area of the interconnector device 100 in such a way that a fluid, for example blood, is prevented to leak therefrom when the interconnector device 100 is received in the passage 2400.
- the receiver tube 2304 may have an elbow, such as a descending elbow 2306 as illustrated in the embodiment of FIG. 22 that directs the interconnector device 100 toward the subject’s hip where a controller (not shown) may be present for connection to one or more implanted medical devices, each having a portion thereof configured to pass through the passage 2400.
- the receiver tube 2304 may have a straight shape, as illustrated in the embodiments of FIGS. 23 and 24.
- the receiver tube 2304 may be made of a flexible material, such as silicone, latex, polyurethane, rubber and the like, which facilitates ease of movement of the subject.
- the interconnector device 100 is illustrated in FIGS. 23 and 24 with the first and third electrical connectors 500, 504 having the same cross-sectional size as the interconnector body 102, such that the interconnector body 102 can be inserted and removed from the receiver tube 2304 without interference of the first and third electrical connectors 500, 504 due to their comparatively larger cross-sectional size.
- FIG. 23 illustrates that the interconnector body 102 can be inserted and removed from the receiver tube 2304 without interference of the first and third electrical connectors 500, 504 due to their comparatively larger cross-sectional size.
- the first and third electrical connectors 500, 504, as well as the first and third connectors 104, 110 as the case may be, may have a cross-sectional size larger than the cross-sectional size of the interconnector body 102, such that the interconnector device 100 cannot be inserted and removed from the receiver tube 2304 due to the larger cross-sectional size and interference of the first and third electrical connectors 500, 504, or the first and third connectors 102, 110.
- the first and third electrical connectors 500, 504, or the first and third connectors 102, 110 may serve as abutment stoppers, as described herein.
- the size and shape of the receiver tube 2304 and/or passage 2400 may be determined by the medical device used in combination with the hemostatic device 2300.
- the receiver tube 2304 and passage 2400 of the hemostatic device 2300 may be sized and shaped to receive a portion of an implantable medical device therethrough.
- such shapes may include a square shape, a rectangle shape, a triangle shape, an oblong shape, and the like.
- the receiver tube 2304 may include at least one device-receiving seal (not shown) disposed inside the passage 2400 and/or to one of the first and second end portions 2402, 2404 thereof.
- the device-receiving seal is configured to provide a fluid thigh engagement with the interconnector device 100, such as the interconnector body 102 thereof, when it is received and moved therein by being rotated, pulled, and/or pushed inside the passage 2400.
- the hemostatic device 2300 may also include a protective cover (not shown) coupled thereto, such as to the receiver tube 2304, and configured to attach to the interconnector device 100, such as to the interconnector body 102 thereof.
- the protective cover is also configured such that its length may vary when the interconnector device 100 moves, for example by being pulled and/or pushed inside the passage 2400.
- the protective cover may be made of a stretchable material, may be telescopic, and/or may have a bellows-like shape.
- the inside portion of the receiver tube 2304 and the inside portion of the protective cover (when present) may be coated with an antiseptic drug and/or an antiseptic material, such as antibiotic(s), silver, honey, and the like.
- an antiseptic drug and/or an antiseptic material such as antibiotic(s), silver, honey, and the like.
- the inside portion of the receiver tube 2304 and the inside portion of the protective cover (when present) may also be coated with an antithrombotic drug and/or an antithrombotic material, such as heparin, argatroban and the like.
- the interconnector device 100 may include at least one of first and second abutment tabs (not shown) or similar abutting structures, such as connectors of larger cross-sectional size than the interconnector body 102, as described hereinbefore (collectively referred to herein as “abutment stopper(s)”).
- first abutment stopper is provided to the interconnector device 100 on the side of the first end portion 2402 of the passage 2400
- second stopper is provided to the interconnector device 100 on the side of the second end portion 2404 of the passage 2400.
- At least one of the first and second abutment stoppers may be configured to limit or prevent rotation of the interconnector device 100 inside the passage 2400.
- at least one of the first and second abutment stoppers may be removably coupled to the interconnector device 100, such that the interconnector device 100 can be inserted inside the passage 2400 in absence of one or more of them, and then the removed abutment stopper(s) may be put back in place to fulfill their role.
- the device-receiving seal and/or the protective cover help(s) to maintain a sterile environment at, for example, any of a percutaneous access site and an intraluminal access site, and thus helps to reduce or prevent infection of these access site openings.
- the passage of the hemostatic device 2300 is configured to receive at least a portion of one or more implantable medical devices therein.
- the cross-sectional area of the passage may be sized and shaped to substantially match the cross-sectional area of one or more wires, cables, cords, catheters, and the like.
- a device-receiving seal that may be provided to the hemostatic device 2300 may be configured to provide a fluid thigh engagement with these wires, cables, cords, catheters, and the like.
- a protective cover that may be provided to the hemostatic device 2300 is coupled thereto and may be configured to attach to an implantable medical device having a portion thereof configured to pass through the receiver tube 2304.
- the hemostatic device 2300 may be transcatheterly implantable to a subject body, according to one or more embodiment(s). As such, the hemostatic device 2300 may have a non-expanded configuration in which the hemostatic device 2300 is configured to be transcatheterly delivered to a subject body, and an expanded configuration in which the hemostatic device 2300 is configured to be transcatheterly implanted to the subject body.
- a sheath containing the hemostatic device 2300 in the non-expanded configuration therein may be routed inside the subject body up to an implantation site-of- interest, such as an intraluminal implantation site or a subcutaneous implantation site.
- an implantation site-of- interest such as an intraluminal implantation site or a subcutaneous implantation site.
- the hemostatic device 2300 is caused to come out of the sheath in order to be delivered to the implantation site-of- interest.
- the installation sheet 2302 and/or the receiver tube 2304 auto-convert(s) or is/are converted from their corresponding non-expanded configurations to their corresponding expanded configurations in order to be installed to the implantation site-of-interest.
- the installation sheet 2302 and/or the receiver tube 2304 may progressively autoconvert from corresponding non-expanded configurations to corresponding expanded configurations as the hemostatic device 2300 comes out of the sheath and constraints imposed to the hemostatic device 2300 by the sheath are removed.
- the installation sheet 2302 and/or the receiver tube 2304 is/are overcomeably biased toward their corresponding expanded configurations and is/are made of a memory material that is selfexpandable, such as nitinol, stainless steel, and/or biocompatible polymer(s).
- the receiver tube 2304 may be converted from its corresponding non-expanded configuration to its corresponding expanded configuration by a balloon catheter that is inserted inside the passage 2400 and then inflated.
- the receiver tube 2304 is made of a malleable material, such as stainless steel, titanium, cobalt-chromium alloy and the like.
- the installation sheet 2302 and/or the receiver tube 2304 may include a wire network frame (not shown) at least partially covered with a membrane serving as a fluid barrier.
- the wire network frame may be made of a memory material that is self-expandable and overcomeably biased toward the expanded configuration, or may be made of a malleable material, as described hereinbefore.
- the installation sheet 2302 and the receiver tube 2304 may form a monolithic wire network frame structure together.
- the wire network frame of the installation sheet 2302 and the wire network frame of the receiver tube 2304 may be removably and/or rotatably attached to one another, as also described hereinbefore.
- the wire network frame(s) may integrate stress-relief structure(s) for reducing material fatigue, for example when the installation sheet 2302 is folded in the first and second arrangements relative to the receiver tube 2304, as also described hereinbefore.
- the hemostatic device 2300 may be surgically installed to a subject body.
- the installation sheet 2302 may be installed to a subject body by sutures, staples, glue, formation of scar tissue, and the like, while the receiver tube 2304 may be positioned through a percutaneous access site and/or an intraluminal access site.
- the installation sheet 2302 in the expanded configuration has generally a planar shape having an outer periphery, such as circular shape (as illustrated in FIG. 22 with an outer periphery 2308), a square shape, a triangle shape, an oblong shape, and the like.
- the installation sheet 2302 may have two arrangements when having generally a planar shape.
- the installation sheet 2302 is folded away from the receiver tube 2304 such that the installation sheet 2302 defines generally a cylindrical shape extending away from the receiver tube 2304. So folded away, the outer periphery of the installation sheet 2302 is positioned toward the distal end of the sheath and is thus the first portion of the hemostatic device 2300 to come out during transcatheter delivery.
- the installation sheet 2302 is folded toward and over the receiver tube 2304 such that the installation sheet 2302 defines generally a cylindrical shape that overlaps with the receiver tube 2304.
- FIG. 24 illustrates the hemostatic device 2300 provided with a perforated installation sheet 2500, according to one or more embodiment(s).
- the perforated installation sheet 2500 includes a perforation 2502 configured to receive the receiver tube 2304 therethrough, such that a biological tissue is sandwiched between the installation sheet 2302 and the perforated installation sheet 2500 when the hemostatic device 2300 is installed to a subject body.
- a bodily conduit wall such as a blood vessel wall (as illustrated in FIG.
- the receiver tube 2304 may be positioned through a percutaneous access site and/or an intraluminal access site.
- the length of the receiver tube 2304 is required to be shorter when the receiver tube 2304 is positioned through only one of a percutaneous access site and an intraluminal access site (as illustrated in FIG. 24), than when it is positioned through both a percutaneous access site and an intraluminal access site (not shown).
- the perforated installation sheet 2500 may be installed and attached to a subject body in a similar way as described hereinbefore forthe installation and attachment of the installation sheet 2302.
- the installation sheet 2302 may be installed and attached to the skin subcutaneously, while the perforated installation sheet 2500 may be installed and attached to the epidermis of the skin.
- the installation sheet 2302 may be installed and attached to the wall of a bodily conduit inside the lumen thereof, while the perforated installation sheet 2500 may be installed and attached to the wall of the bodily conduit outside the lumen thereof.
- the installation sheet 2302 may be installed and attached to the wall of a bodily conduit, either inside or outside the lumen thereof, while the perforated installation sheet 2500 may be installed and attached to the epidermis of the skin or to the skin subcutaneously.
- the perforated installation sheet 2500 and the installation sheet 2302 may be attached to the subject body separately from one another.
- each one of the perforated installation sheet 2500 and the installation sheet 2302 may be sutured, stapled, glued, attached via the formation of scar tissue, and the like independently from one another to different anatomical locations, or to different portions or sides of a same biological tissue.
- the perforated installation sheet 2500 and the installation sheet 2302 may be attached together through a biological tissue of a subject body, for example with sutures and/or staples passing through the skin or the wall of a bodily conduit.
- the hemostatic device 2300 is illustrated in FIG. 24 with the installation sheet 2302 installed and attached to a blood vessel inside the lumen thereof, and the perforated installation sheet 2500 installed and attached to the blood vessel outside the lumen thereof, the installation sheet 2302 alone may be installed and attached to a blood vessel inside the lumen thereof without the perforated installation sheet 2500.
- the installation sheet 2302 alone may also be installed and attached to the skin subcutaneously without the perforated installation sheet 2500.
- the perforated installation sheet 2500 may also include a tube-receiving seal (not shown) disposed to the periphery of the perforation, such as the perforation 2502.
- the tubereceiving seal is configured to provide a fluid thigh engagement with the receiver tube 2304 when received therethrough.
- the tube-receiving seal may facilitate the obtention of hemostasis.
- the hemostatic device 2300 may include a connector (not shown) configured to connect the perforated installation sheet 2500 and the receiver tube 2304 together.
- the connector may be adjustable in order to secure perforated installation sheet 2500 to the receiver tube 2304 at a desired distance between the perforated installation sheet 2500 and the installation sheet 2302, which desired distance may depend on the thickness of the biological tissue to which the hemostatic device 2300 is installed thereto. Such adjustment may be used to maintain a pressure on a biological tissue sandwiched between the installation sheet 2302 and the perforated installation sheet 2500, which in turn may also facilitate the obtention of hemostasis.
- the connector may include a first connector portion disposed to the outer face of the receiver tube 2304, and a second connector portion disposed to the perforated installation sheet 2500, such as to the periphery of the perforation 2502.
- the connector may be a standalone connector that is physically separated from the hemostatic device 2300.
- the connector may include a threaded connector having a first portion thereof provided to the receiver tube 2304, such as to the outer face thereof, and a second portion thereof provided to the perforated installation sheet 2500, such as to the periphery of the perforation 2502, as well as any other similar connecting structures. Screwing the perforated installation sheet 2500 to the receiver tube 2304 allows for adjusting the distance between the installation sheet 2302 and the perforated installation sheet 2500 as well as the pressure on the biological tissue.
- the standalone connector may include a tightening ring (not shown) configured to threadedly engage the receiver tube 2304, or may include a press fit ring configured to engage the receiver tube 2304 with an interference fit.
- a first connector portion may include multiple connecting structures that are disposed along the length of the receiver tube 2304 and configured to sequentially engage the second connector portion of the perforated installation sheet 2500 as the receiver tube 2304 is received in the perforation 2502. In this way, the distance between the installation sheet 2302 and the perforated installation sheet 2500 as well as the pressure on the biological tissue may be adjusted.
- the perforated installation sheet 2500 may be made of the same material(s) as described hereinbefore for the installation sheet 2302.
- a stronger attachment may be required depending on the specific condition of utilization of the hemostatic device 2300 and the hemostatic device 2300, such as the anatomical location of implantation of these two sleeves and the implanted medical device(s) used in combination therewith, including the operation mode of the implanted medical device(s).
- the hemostatic device 2300 prevent or reduce the risk associated with one or more implanted medical devices received through an access site, such as an intraluminal and/or percutaneous access site(s).
- the hemostatic device 2300 may prevents or reduces (i) bleeding and oozing at the access site, for example by providing hemostasis, (ii) possible movements of the interconnector device 100 through the access site, reducing trauma and improving healing at the access site; and/or (iii) the risk of infection by acting as a barrier against pathogens.
- mechanical stress caused by movement(s) of the implanted medical device(s) through the access site is distributed to a larger surface area corresponding to the surface area of the installation sheet 2302 and the perforated installation sheet 2500 (when present) instead of being focally applied to the access site.
- the hemostatic device 2300 improve subject comfort, but also facilitate routine maintenance and care of the access site.
- a kit may be provided with the interconnector device 100, one or more implantable medical devices, such one or more implantable blood pumps, and/or the hemostatic device 2300.
- This disclosure also relates generally to a method 2500 of using a medical device in a subject body, according to an aspect of this disclosure.
- reference(s) to the interconnector device 100, other device(s), and/or any other feature(s) made in relation to the method 2500, as the case may be, is/are made solely as example(s) to facilitate an understanding of how the method 2500 may be implemented and practiced. Accordingly, such reference(s) is/are not intended to limit the scope of the method 2500.
- the method 2500 may be practiced with any medical device.
- FIG. 25 schematically illustrates the method 2500, according to one or more embodiment(s).
- the method 2500 includes: connecting the medical device to another medical device, at 2502; connecting the medical device to a controller configured to operate the other medical device, at 2504; and implanting the medical device in the subject body, at 2506, such as for example illustrated in FIGS. 2 to 4.
- the medical device may be for example the interconnector device 100, and the other medical device may be for example an implantable medical device, such as the first or second implantable blood pump 001 , 002 or the implantable medical device 012.
- Optional feature(s) is/are represented in dash lines in FIG. 25.
- the method 2500 may also include: implanting the other medical device in the subject body, at 2508, if not already implanted therein. Implanting the other medical may be performed, for example, by transcatheter technique and/or by open surgery.
- the method 2500 may also include: intracorporeally rinsing or washing at least one of a first connector of the medical device that is configured to connect to the other medical device, and a second connector of the medical device that is configured to connect to the controller, at 2510.
- the first and/or second connector(s) may be one or more of the first, second, third, and fourth connectors 104, 106, 110, 112, and/or one or more of the first, second, third, and fourth electrical connectors 500, 502, 504, 506.
- the connector(s) may be intracorporeally rinsing or washing by the fluid passageway 900 and the fluid evacuation port 902.
- Connecting at 2502 may include intracorporeally connecting the medical device to another medical device.
- Connecting at 2504 may include intracorporeally connecting the medical device to a controller.
- Connecting at 2502 and/or 2504 may be connecting a fluid thigh connection, such as for example in the case of connector(s) provided with one or more first, second, and third seals 800, 802, 804 and fourth and fifth seals.
- Connecting at 2502 and/or 2504 may include electrically connecting, mechanically connecting, magnetically connecting, and/or connecting in a fluid thigh manner.
- the method 2500 may include: locking at least one of a first connecting portion of the medical device to the other medical device, and a second connecting connection of the medical device to the controller, at 2512.
- the first and/or second connecting portion(s) may include for example the first and/or second end portion(s) 200, 202 and/or the connector(s) of the interconnector device 100.
- the locking may be performed for example with the locking mechanism 1300.
- Implanting at 2506 may include implanting the medical device partially in the subject body so that the medical device has an intracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100, and an extracorporeally disposed portion, such as the other one of the first and second end portions 200, 202 of the interconnector 100.
- Implanting at 2506 may include implanting the medical device entirely in the subject body so that the medical device is entirely intracorporeally disposed.
- Implanting at 2506 may include intraluminally navigating the medical device, such as the interconnector device 100, in the subject body.
- Implanting at 2506 may include transcatheterly implanting the medical device, such as the interconnector device 100, in the subject body.
- Implanting at 2506 may include railing the medical device, such as the interconnector device 100, over a guidewire, such as the guidewire 011 , at 2514.
- Railing at 2514 may assist the connection of the medical device to at least one of the other medical device and the controller.
- Implanting at 2506 may include engaging in a fluid thigh manner the medical device with at least one of an intraluminal access and a percutaneous access of the subject body. This may be performed, for example, by the tapered or profiled cross-sectional shape of the connector body 102 and/or by the interconnector seal 1200.
- the method 2500 may include anchoring the medical device in the subject body, at 2516. This may be performed, for example, by the by the tapered or profiled cross-sectional shape of the connector body 102 engaging the subject body and/or by the interconnector anchor 1500.
- Anchoring at 2516 may include anchoring the other medical device and/or the controller connected to the medical device.
- the method 2500 may include installing a hemostatic device, such as the hemostatic device 2300, to the subject body to provide hemostasis to the implanted medical device, at 2518.
- a hemostatic device such as the hemostatic device 2300
- the method 2500 may include operating the other medical device via the medical device by the controller, at 2520.
- Operating at 2520 may include electrically operating, mechanically operating, such as by a driveshaft and the like.
- Operating at 2520 may produce a therapeutic effect, such as a hemodynamic effect, in the subject body.
- the other medical device may be or may include a blood pump.
- the interconnector device 100 may also be useful when multiple implanted medical devices are operated therewith and produce a synergistic effect. For example, with left and right implantable pacemaker leads for cardiac resynchronization therapy and a left ventricular assist device interconnected to the interconnector device 100 and providing an optimal cardiac unloading and more physiologic blood flow, such as by increasing left ventricular assist device during ventricular stimulation (i.e., the systole) and reducing speed during diastole.
- This disclosure also relates generally to a method 2600 of using an implanted medical device of a subject body (may be also referred to herein as “a method of replacing an implanted medical device of a subject body”), according to an aspect of this disclosure.
- a method of replacing an implanted medical device of a subject body may be also referred to herein as “a method of replacing an implanted medical device of a subject body”
- reference(s) to the interconnector device 100, other device(s), and/or any other feature(s) made in relation to the method 2600, as the case may be, is/are made solely as example(s) to facilitate an understanding of how the method 2600 may be implemented and practiced. Accordingly, such reference(s) is/are not intended to limit the scope of the method 2600.
- the method 2600 may be practiced with any medical device.
- FIG. 26 schematically illustrates the method 2600, according to one or more embodiment(s).
- the method 2600 includes: explanting the implanted medical device from the subject body, at 2602; disconnecting the implanted medical device from another implanted medical device and from a controller, at 2604; connecting a replacement medical device to the other implanted medical device and to the controller, at 2606; and implanting the replacement medical device in the subject body, at 2608.
- the implanted medical device may be for example the interconnector device 100.
- the replacement medical device may be for example a replacement interconnector device 100.
- the other implanted medical device may be for example an implantable medical device, such as the first or second implantable blood pump 001 , 002 or the implantable medical device 012.
- the implanted medical device and/or the replacement medical device may be implanted as illustrated for example in FIGS. 2 to 4.
- Optional feature(s) is/are represented in dash lines in FIG. 26.
- the implanted medical device may be implanted partially in the subject body so that the implanted medical device has an intracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100, and an extracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100.
- the implanted medical device may be implanted entirely in a subject body so that the implanted medical device is entirely intracorporeally disposed.
- Explanting at 2602 may include pulling the implanted medical device from the subject body, such through an access site thereof.
- Explanting at 2602 may include removing the implanted medical device from at least one access site, such as at least one of an intraluminal access and a percutaneous access, of the subject body.
- Explanting at 2602 may include transcatheterly explanting the implanted medical device.
- Explanting at 2602 may include explanting by open surgery the implanted medical device.
- Disconnecting at 2604 may include intracorporeally disconnecting the implanted medical device from at least one of the other medical device and the controller. Intracorporeally disconnecting may include intravascularly disconnecting.
- Disconnecting at 2604 may include disconnecting a wire connection of the implanted medical device from at least one of the other medical device and the controller. Such wire connection may be hard wired for example to one or more of the first, second, third, and fourth connectors 104, 106, 110, 112, and/or one or more of the first, second, third, and fourth electrical connectors 500, 502, 504, 506 of the interconnector device 100. [0325] Disconnecting at 2604 may include disconnecting a wireless connection of the implanted medical device from at least one of the other medical device and the controller.
- Disconnecting at 2604 may include disconnecting a mechanical connection of the implanted medical device from at least one of the other medical device and the controller. This may be the case, for example, for the interconnector device 100 having the first and/or second drivelines(s) 108, 114 embodied as one or more driveshafts.
- the method 2600 may include intracorporeally rinsing or washing at least one of a first connector of the replacement medical device that is configured to connect to the other medical device, and a second connector of the replacement medical device that is configured to connect to the controller, at 2610.
- the first and/or second connector(s) may be one or more of the first, second, third, and fourth connectors 104, 106, 110, 112, and/or one or more of the first, second, third, and fourth electrical connectors 500, 502, 504, 506.
- the connector(s) may be intracorporeally rinsing or washing by the fluid passageway 900 and the fluid evacuation port 902.
- Connecting at 2606 may include intracorporeally connecting the replacement medical device to at least one of the other medical device and the controller.
- Connecting at 2606 may be connecting a fluid thigh connection, such as for example in the case of connector(s) provided with one or more first, second, and third seals 800, 802, 804 and fourth and fifth seals.
- Connecting at 2606 may include electrically connecting, mechanically connecting, magnetically connecting, and/or connecting in a fluid thigh manner.
- the method 2606 may include locking at least one of a first connecting portion of the replacement medical device to the other medical device, and a second connecting portion of the replacement medical device to the controller, at 2612.
- the first and/or second connecting portion(s) may include for example the first and/or second end portion(s) 200, 202 and/or the connector(s) of the interconnector device 100.
- the locking may be performed for example with the locking mechanism 1300.
- Implanting at 2608 may include implanting the replacement medical device partially in the subject body so that the replacement medical device has an intracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100, and an extracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100.
- Implanting at 2608 may include implanting the replacement medical device entirely in the subject body so that the replacement medical device is entirely intracorporeally disposed.
- Implanting at 2608 may include pushing the replacement medical device, such as the interconnector device, in the subject body, such as through an access site thereof.
- Implanting at 2608 may include intraluminally navigating the replacement medical device, such as the interconnector device, in the subject body.
- Implanting at 2608 may include transcatheterly implanting the replacement medical device, such as the interconnector device, in the subject body.
- Implanting at 2608 may include railing the replacement medical device, such as the interconnector device, over a guidewire, such as the guidewire 011 , at 2614.
- Railing at 2614 may assist the connection of the replacement medical device to at least one of the other medical device and the controller.
- Implanting at 2608 may include engaging in a fluid thigh manner the replacement medical device with at least one of an intraluminal access and a percutaneous access of the subject body. This may be performed, for example, by the tapered or profiled cross-sectional shape of the connector body 102 and/or by the interconnector seal 1200.
- the method 2600 may include anchoring the replacement medical device in the subject body, at 2616. This may be performed, for example, by the by the tapered or profiled cross-sectional shape of the connector body 102 engaging the subject body and/or by the interconnector anchor 1500.
- Anchoring at 2616 may include anchoring the other medical device and/or the controller connected to the medical device.
- the method 2600 may include installing a hemostatic device, such as the hemostatic device 2300, to the subject body to provide hemostasis to the replacement medical device therethrough, at 2618.
- a hemostatic device such as the hemostatic device 2300
- the implanted medical device may be operated by the controller.
- the method 2600 may include operating the other medical device via the replacement medical device by the controller, at 2620.
- Operating at 2620 may include electrically operating, mechanically operating, such as by a driveshaft and the like.
- the other medical device may be or may include a blood pump.
- This disclosure also relates generally to a method 2700 of using a first medical device and a second medical device in a subject body (may be also referred to herein as “method of connecting a first medical device and a second medical device together in a subject body”), according to an aspect of this disclosure.
- reference(s) to the interconnector device 100, other device(s), and/or any other feature(s) made in relation to the method 2700, as the case may be, is/are made solely as example(s) to facilitate an understanding of how the method 2700 may be implemented and practiced. Accordingly, such reference(s) is/are not intended to limit the scope of the method 2700.
- the method 2700 may be practiced with any medical device.
- FIG. 27 schematically illustrates the method 2700, according to one or more embodiment(s).
- the method 2700 includes: railing over a guidewire in the subject body the first medical device and the second medical device so that at least one of the first medical device and the second medical device is advanced toward the other one of the first medical device and the second medical device, at 2702; and connecting the first medical device and the second medical device together over the guidewire in the subject body, at 2704.
- the first and/or second medical device(s) may be for example one of the interconnector device 100 and an implantable medical device, such as the first or second implantable blood pump 001 , 002 or the implantable medical device 012.
- the guidewire may be for example the guidewire 011.
- the first and second medical devices may or may not be implanted as illustrated for example in FIGS. 2 to 4.
- Optional feature(s) is/are represented in dash lines in FIG. 27.
- the method 2700 may include implanting the first and/or second medical device(s) in the subject body, at 2706.
- the first and/or second medical device(s) may be implanted partially in the subject body so that the first medical device has an intracorporeally disposed portion, such as such as one of the first and second end portions 200, 202 of the interconnector 100, and an extracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100.
- the first and/or second medical device(s) may be implanted entirely in the subject body so that the first medical device is entirely intracorporeally disposed.
- Implanting at 2706 may include intraluminally navigating at least one of the first medical device and the second medical device, such as the interconnector device 100, in the subject body.
- Implanting at 2706 may include transcatheterly implanting at least one of the first medical device and the second medical device, such as the interconnector device 100, in the subject body.
- Implanting at 2706 may include engaging in a fluid thigh manner at least one of the first medical device and the second medical device, such as the interconnector device 100, in the subject body with an access site of the subject body, such as at least one of an intraluminal access and a percutaneous access of the subject body. This may be performed, for example, by the tapered or profiled cross-sectional shape of the connector body 102 and/or by the interconnector seal 1200.
- the method 2700 may include anchoring at least one of the first medical device and the second medical device in the subject body, at 2708. This may be performed, for example, by the by the tapered or profiled cross-sectional shape of the connector body 102 engaging the subject body and/or by the interconnector anchor 1500.
- Anchoring at 2708 may include that one of the first medical device and the second medical device anchors in the subject body the other one of the first medical device and the second medical device.
- the method 2700 may include intracorporeally rinsing or washing at least one of a connector of the first medical device that is configured to connect to the second medical device and a connector of the second medical device that is configured to connect to the first medical device, at 2710.
- the first and/or second connector(s) may be one or more of the first, second, third, and fourth connectors 104, 106, 110, 112, and/or one or more of the first, second, third, and fourth electrical connectors 500, 502, 504, 506.
- the connector(s) may be intracorporeally rinsing or washing by the fluid passageway 900 and the fluid evacuation port 902.
- Connecting at 2704 may be connecting a fluid thigh connection, such as for example in the case of connector(s) provided with one or more first, second, and third seals 800, 802, 804 and fourth and fifth seals.
- Connecting at 2704 may include electrically connecting, mechanically connecting, magnetically connecting, and/or connecting in a fluid thigh manner.
- the method 2700 may include locking at least one of a connecting portion of the first medical device and a connecting portion of the second medical device to the other one of the connecting portion of the first medical device and the connecting portion of the second medical device, at 27.
- the first and/or second connecting portion(s) may include for example the first and/or second end portion(s) 200, 202 and/or the connector(s) of the interconnector device 100.
- the locking may be performed for example with the locking mechanism 1300.
- the first medical device and the second medical device may be operative connected together so that the first medical device is operated via the second medical device.
- the method 2700 may include installing a hemostatic device, such as the hemostatic device 2300, to the subject body to provide hemostasis to one of the first medical device and the second medical device.
- a hemostatic device such as the hemostatic device 2300
- the method 2700 may include operating the first medical device via the second medical device connected to a controller for operating the first medical device, at 2714.
- Operating at 2714 may produce a therapeutic effect, which may be a hemodynamic effect, in the subject body.
- one of the first and second medical devices may be a blood pump, and the other one of the first and second medical devices may be an interconnector device, such as the interconnector device 100, or a controller for operating the blood pump.
- a reference to an “element A” and/or an “element B” can refer to the “element A” only (optionally including element(s) other than the “element B”), to the “element B” only (optionally including element(s) other than the “element A”), or to both the “element A” and the “element B” (optionally including element(s) other than the “element A” and the “element B”).
- Adjectives of numbers also known as definite numeral adjectives, such as first, second, third, etc., and the like are intended herein only to distinguish between the terms they are associated with from one another without necessarily implying or requiring any actual order, ranking, hierarchy, relationship, and the like between such associated terms.
- a medical device connector comprising: a connector body; a wire guide configured to guide a guidewire, and a connector configured to connect to a medical device railed over the guidewire guided by the wire guide.
- a hemostatic device comprising: an installation sheet configured to attach to a subject body; and a receiver tube projecting from the installation sheet, the receiver tube defining a passage configured to receive a portion of an implantable medical device therethrough.
- the installation sheet is configured to attach to the subject body by at least one of a suture, a staple, a glue, and a formation of scar tissue.
- hemostatic device further comprising a device-receiving seal configured to provide a fluid thigh engagement between the receiver tube and the portion of the implantable medical device when received through the passage.
- the hemostatic device according to clause 1 further comprising a protective cover coupled to the hemostatic device and configured to attach to the medical device. 6. The hemostatic device according to clause 5, wherein the protective cover is coupled to the receiver tube.
- hemostatic device according to clause 1 , wherein the hemostatic device has a nonexpanded configuration in which the hemostatic device is configured to be transcatheterly delivered to the subject body, and an expanded configuration in which the hemostatic device is configured to be transcatheterly implanted to the subject body.
- At least one of the installation sheet and the receiver tube comprises a membrane and a wire network frame covered by the membrane.
- hemostatic device further comprising a perforated installation sheet defining a perforation configured to receive the receiver tube therethrough.
- hemostatic device further comprising a tube-receiving seal configured to provide a fluid thigh engagement between the perforation and the receiver tube when received in the perforation.
- the hemostatic device according to clause 9 further comprising a connector configured to connect the perforated installation sheet and the hemostatic device together.
- the connector comprises a first connector portion disposed to the receiver tube, and a second connector portion disposed to the periphery of the perforation of the perforated installation sheet.
- the connector comprises one of a threaded connector and an interference fit connector.
- a method of using a medical device in a subject body comprising: connecting the medical device to another medical device; connecting the medical device to a controller; and implanting the medical device in the subject body.
- the method according to clause 1 further comprising implanting the other medical device in the subject body.
- said implanting comprises transcatheterly implanting the other medical in the subject body.
- said implanting comprises implanting by open surgery the other medical in the subject body.
- the method according to any one of clauses 1 to 4 further comprising intracorporeally rinsing at least one of a first connector of the medical device that is configured to connect to the other medical device, and a second connector of the medical device that is configured to connect to the controller.
- the method according to any one of clauses 1 to 5, wherein said connecting the medical device to another medical device and said connecting the medical device to a controller comprises intracorporeally connecting the medical device.
- said implanting comprises implanting the medical device partially in the subject body so that the medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
- said implanting comprises implanting the medical device entirely in the subject body so that the medical device is entirely intracorporeally disposed.
- said implanting comprises intraluminally navigating the medical device in the subject body.
- said implanting comprises transcatheterly implanting the medical device in the subject body.
- said implanting comprises railing the medical device over a guidewire. 14.
- said railing assists the connection of the medical device to at least one of the other medical device and the controller.
- a method of using an implanted medical device in a subject body comprising: explanting the implanted medical device from the subject body; disconnecting the implanted medical device from another implanted medical device and from a controller; connecting a replacement medical device to the other implanted medical device and to the controller; and implanting the replacement medical device in the subject body.
- the method according to clause 1 wherein the implanted medical device is implanted partially in the subject body so that the implanted medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
- the method according to clause 1 wherein the implanted medical device is implanted entirely in a subject body so that the implanted medical device is entirely intracorporeally disposed.
- the method according to any one of clauses 1 to 11 further comprising intracorporeally rinsing at least one of a first connector of the replacement medical device that is configured to connect to the other medical device, and a second connector of the replacement medical device that is configured to connect to the controller.
- said connecting comprises intracorporeally connecting the replacement medical device to at least one of the other medical device and the controller.
- the connection of the replacement medical device to at least one of the other medical device and the controller is fluid thigh.
- said implanting comprises implanting the replacement medical device partially in the subject body so that the replacement medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
- said implanting comprises implanting the replacement medical device entirely in the subject body so that the replacement medical device is entirely intracorporeally disposed.
- said implanting comprises pushing the replacement medical device in the subject body.
- said implanting comprises intraluminally navigating the replacement medical device in the subject body.
- said implanting comprises transcatheterly implanting the replacement medical device in the subject body.
- said implanting comprises railing the replacement medical device over a guidewire.
- said railing assists the connection of the replacement medical device to at least one of the other medical device and the controller.
- said implanting comprises engaging in a fluid thigh manner the replacement medical device with at least one of an intraluminal access and a percutaneous access of the subject body.
- a method of using a first medical device and a second medical device in a subject body comprising: railing over a guidewire in the subject body the first medical device and the second medical device so that at least one of the first medical device and the second medical device is advanced toward the other one of the first medical device and the second medical device; and connecting the first medical device and the second medical device together over the guidewire in the subject body.
- the method according to clause 1 further comprising implanting the first medical device partially in the subject body so that the first medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
- the method according to clause 1 further comprising implanting the first medical device entirely in the subject body so that the first medical device is entirely intracorporeally disposed.
- the method according to any one of clauses 1 to 4 further comprising implanting the second medical device entirely in the subject body so that the second medical device is entirely intracorporeally disposed.
- said implanting comprises intraluminally navigating at least one of the first medical device and the second medical device in the subject body.
- said implanting comprises transcatheterly implanting at least one of the first medical device and the second medical device in the subject body.
- said implanting comprises engaging in a fluid thigh manner at least one of the first medical device and the second medical device with at least one of an intraluminal access and a percutaneous access of the subject body.
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Abstract
Medical devices include an interconnector device, a medical device connector, and a hemostatic device. The interconnector device includes an interconnector body configured to be implanted, a first connector, a second connector, and a driveline configured to operatively couple the first connector and the second connector together. The medical device connector includes a connector body, a wire guide configured to guide a guidewire, and a connector configured to connect to a medical device railed over the wire guided by the wire guide. The hemostatic device includes an installation sheet configured to attach to a subject body, and a receiver tube defining a passage configured to receive a portion of an implantable medical device therethrough. Related methods of using the interconnector device and the medical device connector are described.
Description
Medical Devices and Related Methods
FIELD
[0001] This disclosure generally relates to medical devices and related methods.
BACKGROUND
[0002] Some medical devices may be implanted inside a subject body and have one or more of their drivelines, either it be an electrical wire or a driveshaft, routed therefrom to the outside of the subject body where the driveline(s) may be connected to one or more controllers and/or power sources for operating the medical devices inside the subject body. Examples of such medical devices in the cardiovascular field include mechanical circulatory support devices, ventricular assist devices, pacemakers, and implantable cardioverter defibrillators.
[0003] Depending on the medical applications, the medical devices may be implanted in the subject body, such as intraluminally in natural or surgically made anatomical hollow structures, or subcutaneously, and have the driveline(s) thereof routed outside the subject body through one or more intraluminal and/or percutaneous access site(s). Such access site(s) are, however, generally associated with various potential complications, including pain and infections. In cardiovascular applications where the medical devices may be implanted intravascularly, intravascular and/or percutaneous access site(s) are also generally associated with further potential complications, including hemorrhage, vascular trauma, pseudoaneurysm, arterial thrombosis, arteriovenous fistula, and hematoma. Generally, the larger the intravascular and/or percutaneous access site(s), the greater the risks of complications.
Depending on the complication(s), the implanted medical devices may need to be removed or replaced by other medical devices. Replacement of medical devices, like it may be the case for infection complications, may be risky for subjects and generality incur additional economic burdens, to name a few.
[0004] Therefore, in view of the foregoing, there is an on-going need in the field of implantable medical device.
SUMMARY
[0005] An aspect of this disclosure is directed to an interconnector device, including: an interconnector body configured to be implanted in a subject body and having a first end portion
and a second end portion; a first connector disposed to the first end portion of the connector body; a second connector disposed to the second end portion of the connector body; and a driveline configured to operatively couple the first connector and the second connector together.
[0006] The connector body may be configured to be transcatheterly implanted in the subject body.
[0007] The connector body may be configured to be tunneled in the subject body.
[0008] The connector body may have an elongated shape.
[0009] The connector body may have a tapered cross-sectional shape for engaging in a fluid thigh manner an access site of the subject body.
[0010] The connector body may be flexible.
[0011] At least one of the first end portion and the second end portion of the interconnector body may be configured to be atraumatic when the interconnector device is introduced through an access site of the subject body and navigated inside the subject body.
[0012] At least one of the first end portion and the second end portion of the interconnector body may have an atraumatic tapered shape.
[0013] The first connector and the second connector may be electrical connectors, and the driveline may include an electrical conductor.
[0014] The first connector and the second connector may be mechanical connectors, and the driveline may include a driveshaft.
[0015] The first connector and the second connector may be removably connectable.
[0016] The first connector may be configured to connect to an implantable medical device, and the second connector may be configured to connect to a controller configured to operate the implantable medical device.
[0017] The first connector may be included in a plurality of first connectors, the plurality of first connectors may be configured to connect to a corresponding plurality of implantable medical devices, and the second connector may be configured to connect to a controller configured to operate the plurality of implantable medical devices.
[0018] At least one of the first end portion and the second end portion of the interconnector body may include a seal configured to provide a fluid thigh engagement with a medical device.
[0019] At least one of the first connector and the second connector may include a seal configured to provide a fluid thigh engagement with a medical device.
[0020] The seal may be a connector cavity seal.
[0021] The connector cavity seal may be movable upon connection.
[0022] The seal may be a connector periphery seal.
[0023] The interconnector device may include an interconnector seal 1200 configured to provide a fluid thigh engagement with an access site of a subject body.
[0024] The interconnector seal 1200 may be self-expandable.
[0025] At least one of the first end portion and the second end portion of the interconnector body may include a magnet configured to magnetically interact with a medical device.
[0026] The interconnector body may include a fluid passageway configured to supply a fluid to at least one of the first connector and the second connector.
[0027] At least one of the first connector and the second connector may include a fluid evacuation port configured to evacuate a fluid from the at least one of the first connector and the second connector.
[0028] The interconnector body may include a wire guide configured to guide a guidewire therethrough.
[0029] The wire guide may be configured to assist a connection of at least one of the first connector and the second connector to a medical device.
[0030] The interconnector device may include a locking mechanism configured to lock at least one of the first connector and the second connector to a medical device, and to unlock at least one of the first connector and the second connector from the medical device.
[0031] The locking mechanism may include a retaining element configured to retain the medical device, and an elongated control element coupled to the retaining element for operating the retaining element.
[0032] The interconnector device may include an anchor configured to anchor the interconnector device in the subject body.
[0033] The interconnector device may include an embedded controller operatively coupled to at least one of the first connector and the second connector for operating a medical device connected thereto.
[0034] The embedded controller may be wirelessly rechargeable.
[0035] At least one of the first end portion and the second end portion of the interconnector body may be branched out and may comprise a plurality of sub-end portions having at least one first connector and at least one second connector.
[0036] An aspect of this disclosure is directed to a medical device connector, including: a connector body; a wire guide configured to guide a guidewire, and a connector configured to connect to a medical device railed over the guidewire guided by the wire guide.
[0037] The wire guide may be configured to guide the guidewire therethrough.
[0038] The wire guide may be configured to guide the guidewire therealong.
[0039] The wire guide and the connector may be associated together on the connector body.
[0040] The wire guide and the connector may be disposed on a same surface of the connector body.
[0041] The wire guide may be coaxially disposed relative to the connector.
[0042] The wire guide may be concentrically disposed relative to the connector.
[0043] The wire guide may be parallelly disposed relative to the connector.
[0044] The wire guide may be coplanarly disposed relative to the connector.
[0045] The connector may be circumferentially disposed relative to the wire guide.
[0046] The connector may be an electrical connector.
[0047] The electrical connector may be of the female type.
[0048] The electrical connector may be of the male type.
[0049] The electrical connector may be a projecting electrical contact.
[0050] The electrical connector may be a recessed electrical contact.
[0051] The electrical connector may be an annular electrical contact.
[0052] An aspect of this disclosure is directed to a hemostatic device, including: an installation sheet configured to attach to a subject body; and a receiver tube projecting from the installation sheet, the receiver tube defining a passage configured to receive a portion of an implantable medical device therethrough.
[0053] The installation sheet may be configured to attach to the subject body by at least one of a suture, a staple, a glue, and a formation of scar tissue.
[0054] The passage of the receiver tube may be configured to prevent fluid leak therefrom when the portion of the implantable medical device is received therethrough.
[0055] The hemostatic device may include a device-receiving seal configured to provide a fluid thigh engagement between the receiver tube and the portion of the implantable medical device when received through the passage.
[0056] The hemostatic device may include a protective cover coupled to the hemostatic device and configured to attach to the medical device.
[0057] The protective cover may be coupled to the receiver tube.
[0058] The hemostatic device may have a non-expanded configuration in which the hemostatic device is configured to be transcatheterly delivered to the subject body, and an expanded configuration in which the hemostatic device is configured to be transcatheterly implanted to the subject body.
[0059] At least one of the installation sheet and the receiver tube may include a membrane and a wire network frame covered by the membrane.
[0060] The hemostatic device may include a perforated installation sheet defining a perforation configured to receive the receiver tube therethrough.
[0061] The hemostatic device may include a tube-receiving seal configured to provide a fluid thigh engagement between the perforation and the receiver tube when received in the perforation.
[0062] The hemostatic device may include a connector configured to connect the perforated installation sheet and the hemostatic device together.
[0063] The connector may include a first connector portion disposed to the receiver tube, and a second connector portion disposed to the periphery of the perforation of the perforated installation sheet.
[0064] The connector may be adjustable for locking the receiver tube and the perforated installation sheet together at a desired distance between the installation sheet and the perforated installation sheet.
[0065] The connector may include one of a threaded connector and an interference fit connector.
[0066] An aspect of this disclosure is directed to a medical device in a subject body, the method including: connecting the medical device to another medical device; connecting the medical device to a controller; and implanting the medical device in the subject body.
[0067] The method may include implanting the other medical device in the subject body.
[0068] Implanting the other medical device may include transcatheterly implanting the other medical in the subject body.
[0069] Implanting the other medical device may include implanting by open surgery the other medical in the subject body.
[0070] The method may include intracorporeally rinsing at least one of a first connector of the medical device that is configured to connect to the other medical device, and a second connector of the medical device that is configured to connect to the controller.
[0071] Connecting the medical device to another medical device and connecting the medical device to a controller may include intracorporeally connecting the medical device.
[0072] The connection of the medical device to at least one of the other medical device and the controller may be fluid thigh.
[0073] The method may include locking at least one of a first connecting portion of the medical device to the other medical device, and a second connecting connection of the medical device to the controller.
[0074] Implanting the medical device may include implanting the medical device partially in the subject body so that the medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
[0075] Implanting the medical device may include implanting the medical device entirely in the subject body so that the medical device is entirely intracorporeally disposed.
[0076] Implanting the medical device may include intraluminally navigating the medical device in the subject body.
[0077] Implanting the medical device may include transcatheterly implanting the medical device in the subject body.
[0078] Implanting the medical device may include railing the medical device over a guidewire.
[0079] Railing the medical device may assist the connection of the medical device to at least one of the other medical device and the controller.
[0080] Implanting the medical device may include engaging in a fluid thigh manner the medical device with at least one of an intraluminal access and a percutaneous access of the subject body.
[0081] The method may include anchoring the medical device in the subject body.
[0082] Anchoring the medical device
[0083] The anchored medical device may anchor in the subject body at least one of the other medical device and the controller.
[0084] The method may include installing a hemostatic device to the subject body to provide hemostasis to the implanted medical device.
[0085] The method may include operating the other medical device via the medical device by the controller.
[0086] Operating the other medical device may produce a therapeutic effect in the subject body.
[0087] The therapeutic effect may include a hemodynamic effect.
[0088] The other medical device may include a blood pump.
[0089] An aspect of this disclosure is directed to a method of using an implanted medical device in a subject body, the method comprising: explanting the implanted medical device from the subject body; disconnecting the implanted medical device from another implanted medical device and from a controller; connecting a replacement medical device to the other
implanted medical device and to the controller; and implanting the replacement medical device in the subject body.
[0090] The implanted medical device may be implanted partially in the subject body so that the implanted medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
[0091] The implanted medical device may be implanted entirely in a subject body so that the implanted medical device is entirely intracorporeally disposed.
[0092] Explanting the implanted medical device may include pulling the implanted medical device from the subject body.
[0093] Explanting the implanted medical device may include removing the implanted medical device from at least one of an intraluminal access and a percutaneous access of the subject body.
[0094] Explanting the implanted medical device may include transcatheterly explanting the implanted medical device.
[0095] Explanting the implanted medical device may include explanting by open surgery the implanted medical device.
[0096] Disconnecting the implanted medical device may include intracorporeally disconnecting the implanted medical device from at least one of the other medical device and the controller.
[0097] Disconnecting the implanted medical device may include disconnecting a wire connection of the implanted medical device from at least one of the other medical device and the controller.
[0098] Disconnecting the implanted medical device may include disconnecting a wireless connection of the implanted medical device from at least one of the other medical device and the controller.
[0099] Disconnecting the implanted medical device may include disconnecting a mechanical connection of the implanted medical device from at least one of the other medical device and the controller.
[0100] The method may include intracorporeally rinsing at least one of a first connector of the replacement medical device that is configured to connect to the other medical device, and a
second connector of the replacement medical device that is configured to connect to the controller.
[0101] Connecting a replacement medical device may include intracorporeally connecting the replacement medical device to at least one of the other medical device and the controller.
[0102] The connection of the replacement medical device to at least one of the other medical device and the controller may be fluid thigh.
[0103] Connecting a replacement medical device may include locking at least one of a first connecting portion of the replacement medical device to the other medical device, and a second connecting portion of the replacement medical device to the controller.
[0104] Implanting the replacement medical device may include implanting the replacement medical device partially in the subject body so that the replacement medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
[0105] Implanting the replacement medical device may include implanting the replacement medical device entirely in the subject body so that the replacement medical device is entirely intracorporeally disposed.
[0106] Implanting the replacement medical device may include pushing the replacement medical device in the subject body.
[0107] Implanting the replacement medical device may include intraluminally navigating the replacement medical device in the subject body.
[0108] Implanting the replacement medical device may include transcatheterly implanting the replacement medical device in the subject body.
[0109] Implanting the replacement medical device may include railing the replacement medical device over a guidewire.
[0110] Railing the replacement medical device may include assist the connection of the replacement medical device to at least one of the other medical device and the controller.
[0111] Implanting the replacement medical device may include engaging in a fluid thigh manner the replacement medical device with at least one of an intraluminal access and a percutaneous access of the subject body.
[0112] The method may include anchoring the replacement medical device in the subject body.
[0113] Then anchored replacement medical device may anchor in the subject body at least one of the other medical device and the controller.
[0114] The method may include installing a hemostatic device to the subject body to provide hemostasis to the replacement medical device.
[0115] The implanted medical device may be operated by the controller.
[0116] The method may include operating the other medical device via the replacement medical device by the controller.
[0117] Operating the other medical device may produce a therapeutic effect in the subject body.
[0118] The therapeutic effect may include a hemodynamic effect.
[0119] The other medical device may include a blood pump.
[0120] An aspect of this disclosure is directed to a method of using a first medical device and a second medical device in a subject body, the method comprising: railing over a guidewire in the subject body the first medical device and the second medical device so that at least one of the first medical device and the second medical device is advanced toward the other one of the first medical device and the second medical device; and connecting the first medical device and the second medical device together over the guidewire in the subject body.
[0121] The method may include implanting the first medical device partially in the subject body so that the first medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
[0122] The method may include implanting the first medical device entirely in the subject body so that the first medical device is entirely intracorporeally disposed.
[0123] The method may include implanting the second medical device partially in the subject body so that the second medical device has an intracorporeally disposed portion and an extracorporeally disposed portion.
[0124] The method may include implanting the second medical device entirely in the subject body so that the second medical device is entirely intracorporeally disposed.
[0125] Implanting the first and/or second medical device may include intraluminally navigating at least one of the first medical device and the second medical device in the subject body.
[0126] Implanting the first and/or second medical device may include transcatheterly implanting at least one of the first medical device and the second medical device in the subject body.
[0127] Implanting the first and/or second medical device may include engaging in a fluid thigh manner at least one of the first medical device and the second medical device with at least one of an intraluminal access and a percutaneous access of the subject body.
[0128] The method may include anchoring at least one of the first medical device and the second medical device in the subject body.
[0129] When anchored, one of the first medical device and the second medical device anchors in the subject body the other one of the first medical device and the second medical device.
[0130] The method may include intracorporeally rinsing at least one of a connector of the first medical device that is configured to connect to the second medical device and a connector of the second medical device that is configured to connect to the first medical device.
[0131] The connection between the first medical device and the second medical may be fluid thigh.
[0132] The method may include locking at least one of a connecting portion of the first medical device and a connecting portion of the second medical device to the other one of the connecting portion of the first medical device and the connecting portion of the second medical device.
[0133] The first medical device and the second medical device may be operative connected together so that the first medical device is operated via the second medical device.
[0134] The method may include installing a hemostatic device to the subject body to provide hemostasis to one of the first medical device and the second medical device.
[0135] The method may include operating the first medical device via the second medical device connected to a controller for operating the first medical device.
[0136] Operating the first medical device may produce a therapeutic effect in the subject body.
[0137] The therapeutic effect may include a hemodynamic effect.
[0138] The first medical device may include a blood pump.
BRIEF DESCRIPTION OF THE DRAWINGS
[0139] In order that this disclosure be readily understood, at least some selected embodiments thereof are illustrated by way of example(s) in the accompanying drawings. Accordingly, the accompanying drawings and figures are illustrative in nature only and are not intended to be construed and interpreted as limiting the extent of the subject matter protected by the claims. Similarly, any text that might appear in any drawings and figures is illustrative in nature only and is not intended to necessitate that any particular component needs to be included in the embodiment.
[0140] It is noted that like reference numerals identify similar or equivalent elements and/or features throughout the drawings. If present in the claims, reference numerals are provided only to make claims easier to comprehend and are not intended to be construed and interpreted as limiting the extent of the subject matter protected by the claims. The elements and/or features illustrated throughout the drawings are not necessarily drawn to scale.
[0141] FIG. 1 is a schematic representation of an interconnector device, in accordance with an aspect of this disclosure. Dash lines indicate optional feature(s).
[0142] FIG. 2 is a schematic representation of a first implantation modality of an interconnector device, such as one schematically illustrated in FIG. 1 , to a subject body, in accordance with one or more embodiments.
[0143] FIG. 3 is a schematic representation of a second implantation modality of an interconnector device, such as one schematically illustrated in FIG. 1 , to a subject body, in accordance with one or more embodiments.
[0144] FIG. 4 is a schematic representation of a third implantation modality of an interconnector device, such as one schematically illustrated in FIG. 1 , to a subject body, in accordance with one or more embodiments.
[0145] FIG. 5 is a schematic representation of an installation modality of an interconnector device, such as one schematically illustrated in FIG. 1 , to a subject body, in accordance with one or more embodiments.
[0146] FIG. 6 is a longitudinal cross-section view of an interconnector device, such as one schematically illustrated in FIG. 1 , in accordance with one or more embodiments.
[0147] FIG. 7 is an enlarged longitudinal cross-section view of a first end portion of the interconnector device of FIG. 6, in accordance with one or more embodiments.
[0148] FIG. 8 is an enlarged perspective view of the first end portion of the interconnector device of FIG. 7.
[0149] FIG. 9 is a longitudinal cross-section view of an interconnector device provided with a fluid passageway and fluid evacuation ports, in accordance with one or more embodiments.
[0150] FIG. 10 is an enlarged longitudinal cross-section view of the first end portion of the interconnector device of FIG. 9.
[0151] FIG. 11 is a longitudinal cross-section view of an interconnector device provided with a guidewire passageway, in accordance with one or more embodiments. The interconnector device is illustrated with fluid evacuation ports.
[0152] FIG. 12 is an enlarged longitudinal cross-section view of the first end portion of the interconnector device of FIG. 11 and of an implantable medical device connectable thereto, in accordance with one or more embodiments. The interconnector device is illustrated without fluid evacuation ports. An optional guidewire is illustrated be dash lines.
[0153] FIGS. 13 and 14 are enlarged perspective views and FIG. 15 is a longitudinal crosssection view of an interconnector device, such as one schematically illustrated in FIG. 1, provided with an interconnector seal, in accordance with one or more embodiments.
[0154] FIGS. 16 and 17 are perspective views of the interconnector device provided with an interconnector anchor, such as one schematically illustrated in FIG. 1 , in accordance with one or more embodiments.
[0155] FIG. 18 is a longitudinal cross-section view of an interconnector device, such as one schematically illustrated in FIG. 1 , provided with an embedded power source, in accordance with one or more embodiments.
[0156] FIGS. 19, 20, and 21 are perspective views of several interconnector devices, such as one or more schematically illustrated in FIG. 1 , having multiple sub-end portions, in accordance with embodiments.
[0157] FIG. 22 is a schematic representation of a hemostatic device installed to a subject body and used in combination with an interconnector device, such as one schematically illustrated in FIG. 1 , in accordance with an aspect of this disclosure.
[0158] FIG. 23 is a longitudinal cross-section view of the hemostatic device of FIG. 22 implanted to a conduit of a subject body and used in combination with an interconnector device, such as one schematically illustrated in FIG. 1 , in accordance with one or more embodiments.
[0159] FIG. 24 is a longitudinal cross-section view of the hemostatic device of FIG. 22 implanted with a perforated installation sheet to a conduit of a subject body and used in combination with an interconnector device, such as one schematically illustrated in FIG. 1, in accordance with one or more embodiments.
[0160] FIG. 25 is a schematic representation of a method of using a medical device in a subject body, in accordance an aspect of this disclosure. Dash lines indicate optional feature(s).
[0161] FIG. 26 is a schematic representation of a method of using an implanted medical device in a subject body, in accordance an aspect of this disclosure. Dash lines indicate optional feature(s).
[0162] FIG. 27 is a schematic representation of a method of using a first medical device and a second medical device in a subject body, in accordance an aspect of this disclosure. Dash lines indicate optional feature(s).
[0163] It is to be noted that like reference numerals identify similar or equivalent elements and/or features throughout the drawings. If present in the claims, reference numerals are provided only to make claims easier to comprehend; therefore, reference numerals are not intended to be construed and interpreted as limiting the extent of the subject matter protected by the claims. The elements and/or features illustrated throughout the drawings are not necessarily drawn to scale.
DETAILED DESCRIPTION
[0164] The subject-matter of this disclosure is described and explained in the following detailed description with reference to the non-limiting aspect(s), embodiment(s), example(s), feature(s), element(s), step(s), and/or other piece(s) of information presented hereinafter and illustrated in the accompanying non-limiting drawings and/or figures, as the case may be. Recognizing that the foregoing may vary, the skilled addressee shall readily appreciate that any other variants thereof as well as any combination of these other variants are contemplated without departing from the scope of this disclosure, even if not explicitly disclosed herein.
[0165] The explicit and implicit content of this disclosure are intended merely for the purpose of understanding one or more ways in which the subject-matter claimed herein may be reduced to practice by the skilled addressee. Therefore, the explicit and implicit content of this disclosure shall not to be construed as limiting the scope of the subject-matter claimed herein which scope is defined solely by the accompanying claims and applicable law.
[0166] Similarly, the terminology used herein is merely for the purpose of describing and explaining the subject-matter claimed and is not intended to limit the scope thereof. Unless defined otherwise, all technical, engineering, scientific, and other relevant terminology used herein have the same meanings as commonly understood by the skilled addressee.
Interconnector Device
[0167] With the foregoing in mind, this disclosure relates generally to an interconnector device 100 that is configured to interconnect one or more implantable medical devices and one or more controllers and/or power sources (collectively referred to hereinafter as “controller(s)”) together for operating the implantable medical device(s) through the interconnector device 100 by the controller(s), according to an aspect of this disclosure. In an application when a percutaneous access site receiving a first implanted interconnector device 100 therethrough become infected, for example, the first interconnector device 100 may be replaced by a second, sterile interconnector device 100 without having to remove or explant the implanted medical devices, which remain(s) implanted in vivo. Generally, when a percutaneous access site receiving an implanted medical device, or a component thereof such as a driveline, therethrough become infected, the implanted medical device is required to be removed or explanted and replaced by another implantable medical device.
[0168] FIG. 1 schematically illustrates the interconnector device 100 that includes an interconnector body 102, a first connector 104, a second connector 106, and a first driveline 108 operatively coupling the first connector 104 and the second connector 106 together, according to one or more embodiment(s). The first connector 104 may be connectable to a first implantable medical device (in this case, the first connector 104 may be referred to as a “first medical device connector 104”). The second connector 106 may be connectable to a controller for operating the first implantable medical device through the interconnector device 100 by the controller (in this case, the second connector 106 may be referred to as a “first controller connector 106”). The first connector 104 of an interconnector device 100 may also be connectable to the second connector 106 of another interconnector device 100 to increase the overall length of any particular interconnector device 100.
[0169] The interconnector device 100 may further optionally include a third connector 110, a fourth connector 112, and a second driveline 114 operatively coupling the third connector 110 and the fourth connector 112 together, according to one or more embodiment(s). The third connector 110 may be connectable to a second implantable medical device (in this case, the third connector 110 may be referred to as a “second medical device connector 110”). The fourth connector 112 may be connectable to a controller, either it be the same controller for connecting the second connector 106 or another controller (not shown), for operating the second implantable medical device through the interconnector device 100 by the controller (in this case, the fourth connector 112 may be referred to as a “second controller connector 112”). The third connector 110 of an interconnector device 100 may also be connectable to the fourth controller 110 or to the second connector 106 of another interconnector device 100 to increase the overall length of any particular interconnector device 100.
[0170] Each of the first, second, third, and fourth connectors 104, 106, 110, 110 may respectively provide for a disconnectable connection or a non-disconnectable connection.
[0171] The first driveline 108 may operatively couple the first connector 104 to the second connector 106 (i.e., an operative non-cross-coupling) and/or to the fourth connector 112 (i.e., an operative cross-coupling). The second driveline 114 may operatively couple the third connector 110 to the fourth connector 112 (i.e., an operative non-cross-coupling) and/or to the second connector 106 (i.e., an operative cross-coupling). Each of the first and second drivelines 108, 114 may independently be one or more electrical wires (not shown) and/or one or more driveshafts (not shown) optionally coupled to a gearbox (not shown) of the interconnector device 100. The gearbox may be controlled by the controller operating the implantable medical device connected to the interconnector device 100 or another controller.
[0172] In the case of electrical wire(s), the first, second, third, and fourth connectors 104, 106, 110, 112 may be embodied as electrical connectors, and the controller may be configured to supply electrical power to the interconnector device 100. In the case of driveshaft(s), the first, second, third, and fourth connectors 104, 106, 110, 112 may be embodied as mechanical connectors, and the controller may be configured to transmit mechanical power, such as torque, to the interconnector device 100.
[0173] The interconnector device 100 may integrate both or either the electrical connector(s) and the electrical wire(s), and/or the mechanical connector(s) and driveshaft(s). The interconnector device 100 may include any number of first, second, third, and fourth connectors 104, 106, 110, 112, which may be operatively non-cross- or cross-coupled.
[0174] According to one or more embodiments, the interconnector device 100 may optionally include any number and any combination of the following features, for example: a magnet 700; first, second, and third connectors seals 800, 802, 804; a fluid passageway 900; fluid evacuation port 902; a wire guide 1000; a locking mechanism 1300; an interconnector seal 1200; an interconnector anchor 1500; and an embedded controller 1700 and/or embedded power source 1700 (collectively referred to herein as an “embedded controller”).
[0175] Still in FIG. 1 , the third and fourth connectors 110, 112, the driveline 114, the operative cross-coupling of the first and second drivelines 108 and 114, the controller, and finally the first and second implantable medical devices are shown in dash lines as optional features of the interconnector device 100.
[0176] FIGS. 2 to 4 illustrate the interconnector device 100 partially or entirely implanted, such as by catheterization, tunnelization, and/or open surgery, in a subject body (“intracorporeally”), according to one or more embodiments. Partially or entirely implanted, the first, second, third, and/or fourth connectors 104, 106, 110, 112 of the interconnector device 100 may be intracorporeally connectable to and/or intracorporeally disconnectable from a corresponding connector of an implanted medical device or of another implanted interconnector device 100. For example, the interconnector device 100 may be pushed toward an implanted medical device or another implanted interconnector device 100 for intracorporeal connection thereto and/or pushed away from an implanted medical device or another implanted interconnector device 100 for intracorporeal disconnection therefrom.
[0177] FIG. 5 illustrates the interconnector device 100 installed outside a subject body (“extracorporeally”), according to an embodiment.
[0178] As illustrated in FIGS. 2 to 5, the first end portion 200 of the interconnector device 100 is connected to two implantable medical devices, namely a first implantable blood pump 001 and a second implantable blood pump 002, which are implanted in the subject’s vasculature (“intravascularly”), in particular in the descending aorta. The second end portion 202 of the interconnector device 100 is connected to a controller 003 outside the subject body for operating the implanted first and second implantable blood pumps 001 , 002 through the interconnector device 100.
[0179] As illustrated in FIG. 2, the interconnector device 100 is partially implanted in a subject body and received through a percutaneous access site 004 (also referred to herein as an “interconnector-receiving body access site”), according to an embodiment. The first end portion 200 of the interconnector device 100, including the first connector 104 and the third connector 110 (when present), is positioned intracorporeally but outside a subject’s
vasculature where the first and second implantable blood pumps 001 , 002 are implanted. For example, the first end portion 200 may be positioned subcutaneously. The first and third connectors 104, 110 are operatively connected to the first and second implantable blood pumps 001 , 002, respectively, by two corresponding wires running therefrom and passing through at least one intraluminal access site 005 of the subject’s vasculature. In this case, the intraluminal access site 005 is an intravascular access site. Alternatively, the first end portion 200 of the interconnector device 100 may be wirelessly operatively connected through the vasculature wall to the first and second implantable blood pumps 001 , 002, such as to the implantable blood pump bodies, or to the wires thereof or similar structure(s). The second end portion 202 of the interconnector device 100 is positioned extracorporeally and has the second connector 106 and the fourth connector 112 (when present) operatively connected to the controller by one or more wires. Alternatively, the second end portion 202 of the interconnector device 100 may be wirelessly operatively connected to the controller.
[0180] As illustrated in FIG. 3, the interconnector device 100 is partially implanted in a subject body and received through a percutaneous access site 004 and an intraluminal access site 005 (also referred to herein as an “interconnector-receiving body access sites”), according to an embodiment. In this case, the intraluminal access site 005 is an intravascular access site. The first end portion 200 of the interconnector device 100, including the first connector 104 and the third connector 110 (when present), is positioned in the subject’s vasculature where the first and second implantable blood pumps 001 , 002 are implanted. The first and third connectors 104, 110 are operatively connected to the first and second implantable blood pumps 001 , 002, respectively, by two corresponding wires running therefrom along the subject’s vasculature. Alternatively, the first end portion 200 of the interconnector device 100 may be wirelessly operatively connected in the vasculature to the first and second implantable blood pumps 001 , 002, such as to the implantable blood pump bodies, or to the wires thereof or similar structure(s). The second end portion 202 of the interconnector device 100 is positioned extracorporeally and has the second connector 106 and the fourth connector 112 (when present) operatively connected to the controller by one or more wires. Alternatively, the second end portion 202 of the interconnector device 100 may be wirelessly operatively connected to the controller.
[0181] As illustrated in FIG. 4, the interconnector device 100 is partially implanted in a subject body and received through an intraluminal access site 005 (also referred to herein as an “interconnector-receiving body access site”), according to an embodiment. In this case, the intraluminal access site 005 is an intravascular access site. The first end portion 200 of the interconnector device 100, including the first connector 104 and the third connector 110 (when present), is positioned in the subject’s vasculature where the first and second implantable
blood pumps 001 , 002 are implanted. The first and third connectors 104, 110 are operatively connected to the first and second implantable blood pumps 001 , 002, respectively, by two corresponding wires running therefrom along the subject’s vasculature. Alternatively, the first end portion 200 of the interconnector device 100 may be wirelessly operatively connected in the vasculature to the first and second implantable blood pumps 001 , 002, such as to the implantable blood pump bodies, or to the wires thereof or similar structure(s). The second end portion 202 of the interconnector device 100, including the second connector 106 and the fourth connector 112 (when present), is positioned intracorporeally but outside a subject’s vasculature where the first and second implantable blood pumps 001 , 002 are implanted. For example, the second end portion 202 may be positioned subcutaneously. The second connector 106 and the fourth connector 112 are operatively connected to the first and second implantable blood pumps 001 , 002, respectively, by two corresponding wires running therefrom and passing through at least one percutaneous access site 004 of the subject body. Alternatively, the second end portion 202 of the interconnector device 100 may be wirelessly operatively connected to the controller 003, such as by transcutaneous energy transfer (TET).
[0182] In order to be intraluminally navigated, for example, in a subject’s vasculature, the first and/or second end portion(s) 200, 202 of the interconnector device 100 may be configured to be atraumatic to the percutaneous access site, intraluminal access site, and intraluminal wall upon introduction and navigation. For this purpose, for example, the first and/or second end portion(s) 200, 202 may be of a tapered or profiled shape while preserving their connectivity capability.
[0183] As illustrated in FIG. 5, the interconnector device 100 is entirely installed outside a subject body, according to an embodiment. The first end portion 200 of the interconnector device 100 is positioned extracorporeally and has the first connector 104 and the third connector 110 (when present) operatively connected to the first and second implantable blood pumps 001 , 002, respectively, by two corresponding wires running therefrom and passing through at least one intraluminal access site 005 and at least one percutaneous access site 004 (also collectively referred to herein as an “device-receiving body access site”) of the subject body. In this case, the intraluminal access site 005 is an intravascular access site. Alternatively, the first end portion 200 of the interconnector device 100 may be wirelessly operatively connected to the first and second implantable blood pumps 001 , 002, such as to the wires thereof or similar structure(s) which may be positioned subcutaneously. The second end portion 202 of the interconnector device 100 is also positioned extracorporeally and has the second connector 106 and the fourth connector 112 (when present) operatively connected to the controller by one or more wires thereof. Alternatively, the second end portion 202 of the interconnector device 100 may be wirelessly operatively connected to the controller.
[0184] As such, the interconnector device 100 may serve has an interconnecting extension 100 that is receivable in both an optional access sheath (not shown) installed through the percutaneous access site 004 and an optional access sheath sleeve (not shown) attached to the access sheath. For example, when the percutaneous access site, the access sheath, the access sheath sleeve, and/or the interconnecting extension 100 become(s) infected, or is otherwise compromised, the access sheath, the access sheath sleeve, and/or the interconnecting extension 100 may be replaced by a new one(s) without having to remove or explant the implanted medical devices, which remain(s) implanted in vivo.
[0185] Although FIGS. 2 to 5 illustrate the first and second implantable blood pumps 001 , 002 implanted in a subject’s vasculature, each of a first implantable medical device and a second implantable medical device may be implanted elsewhere in a same or different anatomical location(s) of a subject body, such as in natural and surgically made lumen(s) or cavity(ies) thereof. For example, the first implantable medical device may be implanted in a first blood vessel, while the second implantable medical device may be implanted in a second blood vessel. Accordingly, the percutaneous access site(s) 004 and/or the intravascular access site(s) 005 of the first and second medical devices may be the same or different access site(s). Also, the percutaneous access site(s) 004 and/or the intravascular access site(s) 005 may or may not be the access site(s) used to implant one or the other of the first and second implantable medical device(s).
[0186] Further, although FIGS. 2 to 5 illustrate the interconnector device 100 connected to respective wires of the first and second implantable blood pumps 001 , 002 and also to a wire of the controller 003, the interconnector device 100 may be connectable directly to any medical device and/or controller without the need of wire(s).
[0187] Still in FIGS. 2 to 5, the first and second implantable blood pumps 001 , 002 as well as the controller 003 are shown in dash lines as optional features of the interconnector device 100.
[0188] It will be appreciated that any number and any type of medical devices may be connected to and operated via the interconnector device 100 by a controller, including mechanical circulatory support devices, ventricular assist devices, pacemakers, implantable cardioverter defibrillators, and the combination thereof. For example, one of the first and second end portions 200, 202 of the interconnector device 100 may be provided with multiple connectors that are connectable to multiple medical devices, and the other one of the first and second end portions 200, 202 may be provided with a single connector that is connectable to a controller for operating the multiple medical devices.
[0189] Advantageously, a single access site receiving the interconnector device 100 therethrough, such as an intraluminal and/or percutaneous access site, is required for operating multiple implanted medical devices instead of having an access site for each one of the multiple medical devices.
[0190] Turning now to FIGS. 6 to 21 , the interconnector device 100 will now be described, according to embodiments.
[0191] FIG. 6 illustrates the interconnector device 100 with the first connector 104 provided as a first electrical connector 500, the second connector 106 provided as a second electrical connector 502, the third connector 110 provided as a third electrical connector 504, and the fourth connector 112 provided as a fourth electrical connector 506, according to one or more embodiment(s). In the illustrated embodiment, the first and second electrical connectors 500, 502 are female-type connectors integrated to the first end portion 200 of the interconnector device 100. Each of the first and second electrical connectors 500, 502 is removably or non- removably connectable to a respective medical device, such as the first and second implantable blood pumps 001 , 002 (not shown), respectively. The third and fourth electrical connectors 504, 506 are male-type connectors integrated to the second end portion 202 of the interconnector device 100. Each of the third and fourth electrical connectors 504, 506 are removably or non-removably connectable to at least one controller (not shown). In other embodiments, however, the interconnector device 100 may be provided with the female-type connectors 500, 502 to the second end portion 202 thereof, and with the male-type connectors 504, 506 to the first end portion 200 thereof. Alternatively, only female-type connectors or only male-type connectors may be provided to both the first and second end portions 200, 202 of the interconnector device 100.
[0192] It is to be noted that the interconnector device 100 is illustrated herein with the first and second end portions 200, 202 thereof having a cross-sectional size that is bigger than the cross-sectional size of the interconnector body 102 for illustration purpose, so that the first, second, third, and fourth connectors 104, 106, 110, 112 are more easily visible. Accordingly, the first and/or second end portion(s) 200, 202 of the interconnector device 100 and the interconnector body 102 may have the same cross-sectional diameter. The first and/or second end portion(s) 200, 202 of the interconnector device 100 may also have a cross-sectional diameter that is smaller than the cross-sectional diameter of the interconnector body 102. For transcatheter and/or percutaneous application(s), the cross-sectional size of the first and/or second end portion(s) 200, 202 is preferably - but not necessarily - of the same and/or smaller size(s) as the interconnector body 102.
[0193] The interconnector device 100 is also illustrated with the first driveline 108 provided as one or more first electrical conductors 508 and with the second driveline 114 provided as one or more second electrical conductors 510, according to one or more embodiment(s). Each of the first and second electrical conductors 508, 510 extends at least partially along the interconnector body 102 between the first and second end portions 200, 202 of the interconnector device 100. The first and second electrical conductors 508, 510 may be integrated to the interconnector body 102 and/or may be provided as electrical cables or electrical wires that may or may not form at least a part of the interconnector body 102 by being bundled together. Alternatively or additionally, when provided as such, the electrical cables or electrical wires may run outside the interconnector body 102 at least partially along the interconnector body 102. The one or more first electrical conductors 508 electrically operatively couple(s) the first and second electrical connectors 500, 504 together for electrical transmission therebetween. The one or more second electrical conductors 510 electrically operatively couple(s) the second and fourth electrical connectors 502, 506 together for electrical transmission therebetween.
[0194] As illustrated in FIG. 6, taking the second electrical connector 504 as a representative example of the fourth electrical connector 506, the second electrical connector 504 is of the male type and has an elongated shape that projects outwardly from the second end portion 202 of the interconnector device 100, according to one or more embodiment(s). The second electrical connector 504 may be parallelly aligned relative to the fourth electrical connector 506 and/or relative to a reference longitudinal axis illustrated by dash lines. The second electrical connector 504 is configured to electrically connect to one or more controller (not shown) for operating a medical device, such as the first or second implantable blood pump 001 , 002, that is connected to the first electrical connector 500.
[0195] The second electrical connector 504 includes one or more electrical pins, such as five electrical pins 514, 516, 518, 520, 522 as illustrated, that are disposed to the periphery of the second electrical connector 504 and spaced apart from each other along the length of the second electrical connector 504. Each one of the five electrical pins 514-522 is electrically coupled by a first electrical conductor 508 (which corresponds to the second electrical conductor 510 in the case of the fourth electrical connector 506) to a corresponding one of five electrical sockets 604-612 of the first electrical connector 500. Multiple first and second electrical conductors 508, 510 are not shown in FIGS. 6, 7, and 8 for the sake of clarity.
[0196] As illustrated for example in FIGS. 6, 7, and 8, taking the first electrical connector 500 as a representative example of the third electrical connector 502, the first electrical connector 500 is of the female type and defines a connector cavity 512 (best shown in FIG. 8) that
projects within the first end portion 200 of the interconnector device 100, according to one or more embodiment(s). The first electrical connector 500 may be parallelly aligned relative to the second electrical connector 502 and/or relative to the reference longitudinal axis illustrated in dash lines in FIG. 6. The connector cavity 512 is configured to receive a corresponding male-type connector of a medical device, such as a connector of the first or second implantable blood pump 001 , 002, or one of the first or second electrical connector 504, 506 of another interconnector device 100.
[0197] As best illustrated in FIG. 7, the first electrical connector 500 includes one or more electrical sockets, such as five electrical sockets 604, 606, 608, 610, 612 as illustrated, disposed inside the connector cavity 512, on the periphery thereof, and spaced apart from one another along the length of the connector cavity 512, according to one or more embodiment(s). Each one of the electrical sockets 604-612 has an annular shape that defines an aperture therethrough. The annular shape of the electrical sockets 604-612 is partially shown in FIG. 8 for the electrical sockets 612. In particular, the connector cavity 512 of the first electrical connector 500 is configured to receive a male-type connector therein such that an electrical contact is established between each one of the electrical sockets 604-612 and a respective one of the electrical pins of male-type connector.
[0198] For example, the annular shape of one or more of the electrical sockets 604-612 may be sized and shaped to have an interference fit with one or more corresponding electrical pins of the male-type connector. Alternatively or additionally, one or more of the electrical sockets 604-612 may be annular springs defining the aperture, similar to a SYGNUS® Implantable Contact System of Bal Seal Engineering By KAMAN (https://www.balseal.com/industry/medical/; May 29, 2023). Still alternatively or additionally, one or more electrical sockets 604-612 may be spring-loaded toward the electrical pins of the male-type connector when electrically connected to the first electrical connector 500. Yet alternatively or additionally, one or more electrical sockets 604-612 may be made of a compressible or memory material such that a pressure is exerted on one or more corresponding electrical pins of the male-type connector when electrically connected to the first electrical connector 500.
[0199] One or more electrical sockets 604-612 may have an unoccupied state in absence of electrical connection with corresponding electric pins of the male-type connector and an occupied state in presence of electrical connection with corresponding electric pins of the male-type connector. One or more electrical sockets 604-612 may also be biased toward the unoccupied state for establishing the electrical contact between each one of the electrical sockets 604-612 and the respective one of the electrical pins of the male-type connector.
[0200] The first electrical connector 500 and the male-type connector are connectable together by pushing the male-type connector inside the connector cavity 512 of the first electrical connector 500. Conversely, the first electrical connector 500 and the male-type connector are electrically disconnectable from each other by pulling the male-type connector out of the connector cavity 512 of the first electrical connector 500.
[0201] Still illustrated in FIG. 7, each of the first and third electrical connectors 500, 504 may optionally include, at an entry end portion 600 thereof, with an threaded portion 602 configured to be screwed to the male-type connector for maintaining an electrical connection therewith, according to one or more embodiment(s). The second and fourth electrical connectors 502, 506 may also be provided with a threaded portion (not shown) at the base end portion 524 thereof. Alternatively or additionally, the first and/or second end portion(s) 200, 202 of the interconnector device 100 may include a screwable portion running along the periphery thereof and configured to couple to a medical device and/or a connector. In this case, in addition to pushing and pulling the first electrical connector 500 and/or the male-type connector to achieve connection and disconnection, respectively, the first electrical connector 500 and/or the male-type connector may be rotated in one direction for screwing them to each other and in an opposite direction for unscrewing them from each other.
[0202] Also, the first and/or third electrical connector(s) 500, 504 may optionally include the first seal 800 (may also be referred to herein as a “connector cavity seal”) that covers the entry end portion 600 of the connector cavity 512 (FIG. 7 shows the first seal 800 only for the first electrical connector 500 for comparison purpose with the third electrical connectors 504), according to one or more embodiment(s). The first seal 800 is configured to provide a fluid tight contact, such as by interference fit, with each of the first and third electrical connectors 500, 504 to prevent fluid, such as blood, from entering the connector cavity 512 thereof when the interconnector device 100 is implanted in vivo. The first seal 800 is displaceable along the connector cavity 512, from the entry end portion 600 to a bottom end portion 614 thereof, as a corresponding male-type connector is inserted inside the connector cavity 512. When the male-type connector is fully inserted in the connector cavity 512, the first seal 800 is at the bottom end portion 614, and all the electrical sockets 604-612 contact the electrical pins of the male-type connector. The first seal 800 may also be biased toward the entry end portion 600 of the connector cavity 512, such as by a spring (not shown) that is received within the connector cavity 512. The biasing action progressively returns the first seal 800 to the entry end portion 600 of the connector cavity 512 as the male-type connector is removed from the connector cavity 512.
[0203] Alternatively, the first seal 800 may be rupturable and/or perforable by the male-type connector upon insertion in the connector cavity 512. As such, the first seal 800 may be configured not to be able to reseal upon removal of the male-type connector therefrom. In this case, the first seal 800 may be for a single use. Alternatively, the first seal 800 may be configured to be able to reseal upon removal of the male-type connector therefrom. In this case, the first seal 800 may be for multiple use.
[0204] FIG. 8 illustrates the first end portion 200 of the interconnector device 100 that may optionally include a second seal 802 (may also be referred to herein as a “connector periphery seal”) (FIG. 8 shows the second seal 802 only for the first electrical connector 500 for comparison purpose with the third electrical connectors 504) and/or a third seal 804 (may also be referred to herein as an “interconnector end portion seal”), according to one or more embodiments. The second seal 802 is disposed to the periphery of the connector cavity 512 of the first and third electrical connector(s) 500, 504, and the third seal 804 is disposed to the periphery of the first end portion 200 of the interconnector device 100. The second and third seals 802, 804 are configured to provide a fluid thigh engagement with a corresponding maletype connector connecting the first and third electrical connectors 500, 504 to prevent fluid, such as blood, from entering the connector cavity 512, when the interconnector device 100 is implanted in vivo. The second seal 802 may also be configured to snug fit with the male-type connector upon insertion and when inserted in the connector cavity 512 to provide a slidable fluid tight engagement therewith. The second seal 802 may contact the first seal 800 positioned at the entry end portion 600 of the connector cavity 512 to provide a fluid tight contact therewith.
[0205] Although not illustrated in FIG. 8, the first and/or third electrical connector(s) 500, 504 may include one or more of the first, second, and third connector seals 800, 802, 804 whether or not provided with the threaded portion 602.
[0206] The second end portion 202 of the interconnector device 100 may also be provided with a fourth seal (may also be referred to herein as a “connector periphery seal”); not shown) and/or a fifth seal (may also be referred to herein as an “interconnector end portion seal”; not shown), according to one or more embodiments. The fourth seal is disposed to the periphery of the base portion 524 of the second and fourth electrical connectors 502, 506, and the fifth seal is disposed to the periphery of the second end portion 202 of the interconnector device 100. Similarly to the second and third seals 802, 804, the fourth seal is configured to provide a fluid thigh engagement with a corresponding female-type connector connecting the second and fourth electrical connectors 502, 506 to prevent fluid, such as blood, from entering a cavity of the female-type connector, when the interconnector device 100 is implanted in vivo.
[0207] The first, second, and third connector seals 800, 802, 804 prevent the first and third electrical connectors 500, 504, including the electrical sockets 604-612 thereof, to be damaged due to exposition to a body fluid. Blood, for example, may damage the first and third electrical connectors 500, 504 and may also form blood clothes that can prevent appropriate intracorporal connection.
[0208] FIG. 8 also illustrates the first end portion 200 of the interconnector device 100 that may optionally include one or more magnets 700, according to one or more embodiment(s). The magnet(s) 700 may be integrated to the distal end wall 702 of the first end portion 200 (as shown), or to the first and/or third electrical connector(s) 500, 502 (not shown). Alternatively or additionally, the second end portion 202 of the interconnector device 100 may be provided with one or more magnets 700. In this case, the magnet(s) 700 may be similarly integrated to the distal end wall thereof and/or to one or more of the second and fourth electrical connector(s) 502, 506. The magnet(s) 700 is configured to magnetically couple to one or more corresponding connectors, such as a male-type connector, of a medical device and/or of another interconnector device 100. The magnet(s) 700 may be natural magnet(s) and/or electromagnet(s). The strength of the natural magnet(s) and/or electromagnet(s) may provide for a disconnectable connection of the implanted interconnector device 100, for example by pulling thereto, or for a non-disconnectable connection of the implanted interconnector device 100. The electromagnet(s) may be configured to be operated by the controller operating the medical device(s) operatively connected to the interconnector device 100, or by another controller. The electromagnet(s) may be operated to attract one or more corresponding connectors for connection thereto, or to repulse one or more corresponding connectors for disconnection therefrom.
[0209] Alternatively, the first and/or second end portion(s) 200, 202 of the interconnector device 100 may be provided with a material, such as a ferromagnetic material, configured to electromagnetically interact with one or more magnetic connectors of a medical device or of another interconnector device 100 for the same purpose as describe hereinbefore.
[0210] The magnet(s) 700 may not only maintains or help to maintain a connection between the interconnector device 100 and a medical device and/or another interconnector device 100, but also establishes or helps to establish such an electrical connection therebetween. Indeed, as the first and/or second end portion(s) 200, 202 of the interconnector device 100 get closer to one or more connectors of a medical device or another interconnector device 100 intracorporeally, the magnetic interaction becomes stronger up to a point where the first and/or second end portion(s) 200, 202 contact(s) the medical device or the other interconnector device 100. Depending on their configurations, such contact may result in the operative
connection between the interconnector device 100 and the medical device and/or the other interconnector device 100. For example, this magnetic interaction may align or may help to align the corresponding connectors for connection. Generally, the establishment of intracorporeal connection may be difficult to accomplish owing, for example, to the lack of suitable visual indication(s), anatomical marker(s), and/or tactile feedback allowing the operator to move a connector of the interconnector device 100, a medical device, and/or a controller in such a way that they can meet intracorporeally and appropriately connect together intracorporeally.
[0211] FIGS. 9 and 10 illustrate the interconnector device 100 that may optionally include a fluid passageway 900 for supplying a fluid to the first and second electrical connectors 500, 504, and/or two fluid evacuation ports 902 for evacuating a fluid from the first and second electrical connectors 500, 504, according to one or more embodiment(s). Any number of fluid passageway 900 and/or any number of fluid evacuation port 902 may alternatively be provided to the first and/or third electrical connector(s) 500, 504. For the sake of clarity, the first and second electrical conductors 508, 510 have been omitted from FIGS. 9 and 10.
[0212] The fluid passageway 900 and the fluid evacuation ports 902 may be used, for example, to flush or rinse the first and second electrical connectors 500, 504 in a blood vessel with an anticoagulant in order to prevent or mitigate blood clot formation and/or remove a blood clot in vicinity of the connectors or inside the tubular cavities 512 thereof. Prevention and/or removal of blood clots may be required or desirable in order to establish an appropriate electrical connection with a corresponding male-type connector. The fluid passageway 900 and the fluid evacuation ports 902 may also be used for drug delivery and/or fluid sampling inside a subject body.
[0213] In particular, the fluid passageway 900 extends at least partially between the first and second end portions 200, 202 of the interconnector device 100. The fluid passageway 900 is removably connectable at the second end portion 202 to a fluid reservoir 009 (shown in dash lines in FIG. 9 as an optional component of the interconnector device 100), and is in fluid communication at a first end portion 200 with the first and second electrical connectors 500, 504, such as with the tubular cavities 512 as illustrated. When connected thereto, the fluid reservoir 009 may supply a fluid, such as an anticoagulant, to the interconnector device 100 according to one or more predetermined settings, which may include a predetermined time (e.g., continuous or intermittent) and/or flow setting(s).
[0214] Each of the fluid evacuation ports 902 extend between the respective first and third electrical connectors 500, 504, such as the bottom end portion 614 of the connector cavity
512, and the outside environment of the interconnector device 100. To prevent fluid, such as blood, from entering the connector cavity 512, a one-way valve (not shown) may be provided to the fluid evacuation port(s) 902. The fluid passageway 900 and the fluid evacuation ports 902 are configured to supply fluid to and evacuate fluid from, respectively, the connector cavity 512. For example, a fluid may be supplied by the fluid passageway 900 to the connector cavity 512, which may or may not receive the male-type connector therein, and may be evacuated through the fluid evacuation port 902. A first fluid, such as blood, initially present in the connector cavity 512 may be displaced by a second fluid coming from the fluid passageway 900, such that the first fluid is displaced and evacuated through the fluid evacuation port 902. A fluid initially present in the connector cavity 512 may be displaced and evacuated through the fluid evacuation port 902 by the action of the male-type connector being inserted in the connector cavity 512.
[0215] The fluid passageway 900 and fluid evacuation ports 902 may be used in combination with any of the first, second, and third connector seals 800, 802, 804.
[0216] It is to be realized that the first, second, third, and/or fourth connectors 104, 106, 110, 112, including the first, second, third, and/or fourth electrical connectors 500, 502, 504, 506, may be embodied as any type of connector configured to mechanically and/or electrically connect any medical device(s) and/or controller(s). Any number of such connector may be provided to the interconnector device 100.
[0217] For example, the connector(s) of the interconnector device 100 may be electrical connectors, similar to the electrical connectors 500-506, but provided with annular electrical contacts disposed concentrically on the distal end wall(s) of the first and/or second end portion(s) of the interconnector device 100. In this case, the first and/or second end portion(s) of the interconnector device 100 may be provided with a threaded portion and a seal, such as the third seal 804.
[0218] Still for example, in one or more embodiments where the first and/or second drivelines 108, 114 is/are driveshaft(s), the first, second, third, and/or fourth connectors 104, 106, 110, 112 may be embodied as mechanical connector(s) configured to connect the interconnector device 100 to one or more medical devices and to one or more controller(s). As such, mechanical power, such as torque, may be transmitted through the interconnector device 100 by the controller, which may be for example an actuator, to the medical device(s).
[0219] FIGS. 11 and 12 illustrate the interconnector device 100 that may optionally include a wire guide 1000, such as a guidewire passageway, extending at least partially between the first and second end portions 200, 202 of the interconnector device 100, according to one or
more embodiment(s). The wire guide 1000 is configured to receive a guidewire 011 (shown in dash lines in FIGS. 11-12 as an optional component of the interconnector device 100) therethrough for railing the interconnector device 100 over the guidewire 011 inside a subject body, such as intraluminally. The wire guide 1000 include any structure configured to or capable of guiding a guidewire therethrough or therealong. For example, the wire guide 1000 may be configured to guide the guidewire 011 therethrough and/or therealong. For the sake of clarity, the first and second electrical conductors 508, 510 have been omitted from FIGS. 11 and 12.
[0220] As illustrated in FIG. 12, the interconnector device 100 may be configured to be railed with an implantable medical device 012 (shown in dash lines as an optional component of the interconnector device 100) over the guidewire 011 for connecting the interconnector device 100 and the implantable medical device 012 together inside a subject body, according to one or more embodiment(s). As such, the interconnector device 100 may include a medical device connector that has a connector body, the wire guide 1000 configured to guide the guidewire 011 , and a connector, such as the first and/or third electrical connectors 500, 502 as illustrated. The medical device connector may be provided as a standalone device. Any connector(s) may be provided to the interconnector device 100 and medical device connector for this purpose. For example, the connector(s) may be an electrical connector of the female or male type, a connector with projecting electrical contact(s), recessed electrical contact(s), and/or annular electrical contact(s).
[0221] The connector is configured to connect to the medical device 012 that is railed over the guidewire which itself is guided by the wire guide 1000. The wire guide 1000 and the connector may be associated together on the connector body or on the interconnector device 100. For example, as illustrated in FIG. 12, the end portion 1100 of the wire guide 1000 and the first and/or third electrical connector(s) 500, 504 may be disposed on a same surface, such as on the distal end wall 702 of the first end portion 200 of the interconnector device 100. As such, the first and/or third electrical connector(s) 500, 504 align(s) and/or coincide(s) with one or more respective connectors 012, 013 of the implantable medical device 012 for connection, when the interconnector device 100 and the implantable medical device 012 are railed over the guidewire 011 and advanced toward each other therealong.
[0222] Multiple relative arrangements and/or dispositions between wire guide 1000 and the connector, including the electrical contacts thereof when embodied as an electrical connector, are possible. For example, the connector and the wire guide 1000 may be coaxially, concentrically, circumferentially, parallelly, coplanarly, and/or equidistantly arranged or disposed relative to each other.
[0223] The controller, when connected to the interconnector device 100, may be configured to detect which of the first and/or third electrical connector(s) 500, 504 is connected to which of the connectors 012, 013 and adjust its output accordingly.
[0224] When provided to the first end portion 200 of the interconnector device 100 and/or to one or more of the first and third electrical connectors 500, 504, the magnet(s) 700 may assist and/or facilitate that the first and/or third electrical connector(s) 500, 504 align(s) and/or coincide(s) with one or more for the connectors 012, 013 for connection.
[0225] The wire guide 1000 may similarly be integrated to the second end portion 202 of the interconnector device 100 so that the second and/or fourth electrical connector(s) 502, 506 may connect to one or more corresponding connectors, when the interconnector device 100 and an implantable medical device are railed over the guidewire 011.
[0226] FIG. 12 also illustrates the interconnector device 100 that may optionally include a locking mechanism 1300 for maintaining connection(s) between the interconnector device 100 and an implantable medical device, such as one of the first and second implantable blood pumps 001 , 002, according to one or more embodiment(s). The locking mechanism 1300 includes a retaining element 1302 and an elongated control element 1304 coupled to the retaining element 1302 for operating the retaining element 1302.
[0227] The retaining element 1302 is configured to retain a portion of the implantable medical device, such as one or more connectors thereof, for maintaining physical and/or electrical connection(s) with the implantable medical device. The retaining element 1302 is disposed to the first end portion 200 of the interconnector device 100 and may be a mechanical retaining element, such as a retaining pin, a latch coupling, a camlock-type coupler, and/or any other similar structure, or an electrical retaining element, such as an electromagnet (somewhat similar to the magnet(s) 700 when embodied as electromagnet(s)). The locking mechanism 1300 may or may not be auto-locking, such as by auto-latching, when the retaining element 1302 contacts or abuts the implantable medical device. For example, the locking mechanism 1300 may be provided to the first electrical connector 500 (as illustrated), the second electrical connector 502, and/or the distal end wall 702 of the first end portion 200.
[0228] The elongated control element 1304 extends at least partially between the first end portion 200 and the second end portion 202 of the interconnector device 100. The elongated control element 1304 is configured to be controlled and/or manipulated from the second end portion 202 of the interconnector device 100 for operating the retaining element 1302 at the first end portion 200 of the interconnector device 100. So operated, the retaining element 1300 may be converted between a retaining state, in which the implantable medical device is
retained or secured to the interconnector device 100, and a non-retaining state, in which the implantable medical device is not retained and not secured to the interconnector device 100.
[0229] Alternatively, the locking mechanism 1300 may include only the retaining element 1302 that is directly controllable and/or manipulable for locking or not the implantable medical device at the first end portion 200 of the interconnector device 100.
[0230] FIGS. 13, 14, and 15 illustrate the interconnector device 100 that optionally includes an interconnector seal 1200 configured to provide a fluid tight engagement with an access site of a subject body where the interconnector device 100 is installed, according to one or more embodiment(s). Such access site may be the percutaneous access site 004 and/or the intraluminal access site 005, as illustrated in FIGS. 2-4. The interconnector seal 1200 may prevents or reduces (i) bleeding and oozing at the access site, for example by providing hemostasis, (ii) possible movements of the interconnector device 100 through the access site, reducing trauma and improving healing at the access site; and/or (iii) the risk of infection by acting as a barrier against pathogens at the access site.
[0231] As illustrated in FIG. 13, the interconnector seal 1200 is coupled to the interconnector device 100 and generally have a disk-like shape, according to one or more embodiment(s). The interconnector seal 1200 may project at any angle for appropriate engagement with the access site from the interconnector body 102 (as shown) or from any of the first and second end portions 200, 202 of the interconnector device 100, including the from first, second, third, and/or fourth connector 104, 106, 110, 112.
[0232] The interconnector seal 1200 may be convertible between a non-expanded state for transcatheter delivery and implantation or installation at the access site and an expanded state (as shown) for fluid thigh engagement at the access site. In the non-expanded configuration, the interconnector seal 1200 has a cross-sectional size that is similar to the cross-sectional size of the interconnector device 100. In the expanded configuration, the interconnector seal 1200 has a cross-sectional size that is larger than the cross-sectional size of the interconnector device 100.
[0233] The interconnector seal 1200 may include a frame (not shown) and a membrane (not shown) coupled to the frame. The membrane is deployable upon conversion of the frame from the non-expanded state to the expanded frame, and vice-versa. The frame may be biased toward the expanded state such that the interconnector seal 1200 is self-expandable. Alternatively, the frame may be convertible from the non-expanded state to the expanded state by inflation of the membrane or by inflation of an optional catheter ballon inside the frame, and vice-versa.
[0234] The interconnector seal 1200 may optionally be inflatable for engaging the access site in a fluid thigh manner. In this case, the interconnector device 100 optionally includes one or more fluid channels (not shown) that are in fluid communication with the interconnector seal 1200 and an optional controller, such as the one operating the medical device(s) connected to the interconnector device 100, that is configured to inflate and deflate the interconnector seal 1200. The interconnector device 100, including the interconnector seal 1200, may also optionally includes a pressure sensor (not shown) for measuring fluid pressure inside the interconnector seal 1200 and/or a biological fluid sensor (not shown) for detecting the presence of a biological fluid, such as blood, outside the access site, such as on the subject’s skin. The pressure and biological fluid sensors are connected to the controller. Fluid thigh engagement of the interconnector seal 1200 with the access site is monitored by the pressure and/or biological fluid sensor(s) and adjusted in response to one or more of their respective signals. For example, fluid pressure inside the interconnector seal 1200 may be increase and/or decrease to optimize fluid thigh engagement in response to the pressure sensor and/or if the biological fluid sensor detects the presence of one or more biological fluids. Alternatively or additionally, the controller may be operated independently of the pressure and/or biological fluid sensor(s) for adjusting the fluid thigh engagement.
[0235] FIGS. 14 and 15 illustrate the interconnector device 100 with the interconnector seal 1200 that engages an access site of a physiological structure (shown in dash lines to represent the environment of the interconnector device 100). As illustrated in FIG. 15, the interconnector seal 1200 optionally includes a peripheral groove 1202 running along the outer periphery of the interconnector seal 1200. The peripheral groove 1202 is configured to receive an edge portion of the access site for fluid tight engagement therewith. The interconnector seal 1200 in the expanded configuration may exert a force against the edge portion such that the inner portion of the peripheral groove 1202 is pressed against the edge portion of the access site. The force may be exerted by the biasing action of the frame or by inflation, as described herein. Depending on the material of the frame, such pressure may or may not be preserved upon deflation.
[0236] The frame may be provided as a wire network made or not of a memory material, such as nitinol, stainless steel, and biocompatible polymer(s). The membrane may include a biocompatible material, an antiseptic material, an/or antithrombotic material. The peripheral groove 1202, the inner portion 1204, and/or the outer portion 1206 of the membrane may also include or be covered by an antiseptic drug, an antithrombotic drug, an antiseptic drug, and/or an antibiotic drug.
[0237] FIGS. 16 and 17 illustrate the interconnector device 100 that optionally includes an interconnector anchor 1500 for anchoring the interconnector device 100 in a subject body, such as intraluminally, according to one or more embodiment(s).
[0238] As illustrated in FIG. 16, the interconnector anchor 1500 generally has an open tubularlike shape in which the interconnector device 100 is longitudinally received. The interconnector device 100 may be coaxially disposed in the interconnector anchor 1500 (as illustrated) or not. The interconnector device 100 may be provided as a wire network having one or more arms 1502 coupled to the interconnector body 102 (as shown) and/or to one or more of the first and second end portion(s) of the interconnector device 100.
[0239] The interconnector anchor 1500 may be convertible between a non-anchored state for transcatheter delivery of the interconnector device 100 intracorporeally and an anchored state (as shown in FIGS. 16-17) for anchoring the interconnector device 100 intracorporeally. In particular, FIG. 17 illustrates the interconnector anchor 1500 in the anchored state that anchors the interconnector device 100 intraluminally in a physiological structure, which is shown in dash lines to represent the environment of the interconnector device 100.
[0240] The interconnector anchor 1500 may also be configured to anchor one or more implantable medical devices (shown in FIG. 17 in dash lines as an optional component of the interconnector device 100) connected thereto intracorporeally. As illustrated in FIG. 17, the implantable medical devices are connected to the interconnector device 100 by their wires extending from their bodies; however, the implantable medical devices may be connected to the interconnector device 100 by their bodies. In the non-expanded configuration, the interconnector anchor 1500 has a cross-sectional size that is similar to the cross-sectional size of the interconnector device 100. In the expanded configuration, the interconnector anchor 1500 has a cross-sectional size that is larger than the cross-sectional size of the interconnector device 100.
[0241] The interconnector anchor 1500 may be biased toward the anchored state such that the interconnector anchor 1500 is self-expandable. Alternatively, the interconnector anchor 1500 may be convertible from the non-anchored state to the anchored state by inflation of an optional catheter ballon inside the interconnector anchor 1500, and vice-versa.
[0242] The interconnector anchor 1500 may be made of a memory material, such as nitinol, stainless steel, and biocompatible polymer(s), and/or an antithrombotic material.
[0243] FIG. 18 illustrates the interconnector device 100 that optionally includes an embedded controller 010, according to one or more embodiment(s). The embedded controller 010 may
be integrated to the interconnector body 102 (as shown) and/or to one or more of the first and second end portion(s) 200, 202 of the interconnector device 100. The embedded controller 010 may be operatively connected to one or more of the first, second, third, fourth connectors 104, 106, 110, 112. The controller 010, which may include a power source like a battery, may be configured to be rechargeable by one or more of the first, second, third, fourth connectors 104, 106, 110, 112 when embodied as electrical connector.
[0244] FIGS. 19, 20, and 21 illustrate the interconnector device 100 according to various embodiments. As illustrated in FIG. 19, the first end portion 200 of the interconnector device 100 is branched out and have multiple end portions, such as three end portions 1800, 1802, 1804 as illustrated. Each of the first end portions 1800, 1802, 1804 has the first and third connectors 104, 100 embodied as the first and third electrical connectors 500, 504.
[0245] As illustrated in FIG. 20, the second end portion 202 of the interconnector device 100 is branched out and have multiple end portions, such as three end portions 1900, 1902, 1904 as illustrated. Each of the first end portions 1900, 1902, 1904 has the second and fourth connectors 106, 112 embodied as the second and fourth electrical connectors 502, 506.
[0246] As illustrated in FIG. 21 , the first and second end portions 200, 202 of the interconnector device 100 are branched out and have multiple end portions, such as three end portions 1800, 1802, 1804 and three end portions 1900, 1902, 1904 as illustrated, respectively. Each of the first end portions 1800, 1802, 1804 has the first and third connectors 104, 100 embodied as the first and third electrical connectors 500, 504. Each of the first end portions 1900, 1902, 1904 has the second and fourth connectors 106, 112 embodied as the second and fourth electrical connectors 502, 506.
[0247] The interconnector device 100 may have a one-to-one relationship between a single controller and a single implantable medical device. The interconnector device 100 may also have a one-to-many relationship between a single controller and many implantable medical devices, or between a single implantable medical devices and many controllers. The interconnector device 100 may also have a many-to-many relationship between a many controllers and many implantable medical devices.
[0248] The interconnector device 100 may have a circular cross-sectional shape, as illustrated herein, but not necessarily. In any case, the interconnector device 100 preferably - but not necessarily - has a cross-sectional shape void of sharp edge to avoid damaging intraluminal and/or percutaneous access site(s). The overall cross-sectional size of the interconnector device 100, including the interconnector body 102 and the first and second end portions 200, 202 thereof, may be about between 1 mm (3 FR) and 10 mm (30 FR).
[0249] The cross-sectional shape and/or cross-sectional size of the interconnector device 100 may vary along the length thereof. In particular, the cross-sectional size of the interconnector device 100 may progressively increase along the length thereof such that the interconnector device 100 has a tapered and/or profiled shape. The most tapered and/or profiled end portion of the interconnector device 100 may be introduced first in an intraluminal and/or percutaneous access site(s). Then, the interconnector device 100 may be advanced therethrough until a fluid thigh engagement with the access site(s) is achieved. In vascular applications, this may provide hemostasis or may help to obtain hemostasis.
[0250] The interconnector device 100 may have an elongated shape or a shape that substantially corresponds to the length of the connector(s) provided to the first and/or second end portion(s) 200,202. The overall length of the interconnector body 102 may about between 5 cm and 60 cm.
[0251] Alternatively, the interconnector device 100 may generally have any size and any shape so long as the interconnector device 100 can be interconnected.
[0252] The interconnector device 100 may be flexible and may be made of a biocompatible material, such as thermoplastic polyurethane (TPU), polytetrafluoroethylene (PTFE), Pebax® Elastomers, and the like. Such flexibility may allow the interconnector device 100 to be routed and/or navigated though elbows or other kinked segments intraluminally. The interconnector device 100 may also be configured for and made of a material(s) for single use and thus be disposable. Alternatively, the interconnector device 100 may be configured for and made of material(s) for repeated use and for example be autoclavable.
[0253] Advantageously, the interconnector device 100 disclosed herein enables one or more intracorporeally implanted medical devices having multiple control wires or cables thereof routed outside a subject body to be operated through a single interconnector structure passing through at least one access site of the subject body. Amongst other things, having a single interconnector structure passing through an access site not only facilitates the management of multiple medical devices’ control cables, but also reduces the infection risk associated with the bodily opening(s), as opposed to the infection risk associated with multiple medical devices’ control cables passing through one or more bodily openings. In addition, wound care is simplified since there is a single site of skin breach. This is of particular importance for permanently implanted devices where the subject is likely to perform wound care by himself. In the event that the access site through which an implanted interconnector 100 passes therethrough gets infected, a health professional, such as an interventional cardiologist, may replace the implanted interconnector 100 by a new, sterile interconnector 100 without
replacing the implanted medical device(s). Conveniently, the implanted interconnector 100 may be disconnected from the implanted medical device(s) and connected to the new, sterile interconnector 100 inside or outside the subject body.
[0254] The interconnector device 100 may be useful when multiple implanted medical devices are operated. Depending on the nature of the medical devices and their operation mode(s), the operation of a plurality of such medical devices implanted in a subject body may be preferable over the operation of only one of them. Notably, the operation at a given speed of the plurality of blood pumps implanted in the vasculature to produce a combined blood outflow therefrom may result in a blood integrity profile that is better than the blood integrity profile resulting from the operation at a higher speed than the given speed of only one of the blood pumps to produce a blood outflow that is similar to the combined blood outflow, as described in the International Application Number PCT/ZA2020/050,022.
Hemostatic Device
[0255] This disclosure also relates generally to a hemostatic device 2300 for an implantable medical device, such as the interconnector device 100, according to an aspect of this disclosure.
[0256] FIGS. 22, 23, and 24 illustrate a hemostatic device 2300 (may also be referred to herein as an “implantable medical device-receiving sleeve”) and the interconnector device 100 taken as a device example, according to embodiments. The hemostatic device 2300 serves as a physical interface between a subject body where it is installed and the interconnector device 100 implanted in the subject body, for example as illustrated in FIGS. 2 to 4. So installed, the hemostatic device 2300 provides access to the interconnector device 100 inside the subject body, such as to an intraluminal location thereof or a subdermal location thereof.
[0257] The hemostatic device 2300 may be provided as a standalone unit, separately from the interconnector device 100, or may be provided with the interconnector device 100. Accordingly, the hemostatic device 2300 is illustrated and described herein with the interconnector device 100 only as an example of an implantable medical device that may be used with the hemostatic device 2300. The hemostatic device 2300 may be used with any other implantable medical devices, with the necessary change(s), appreciable to the skilled addressee, having been made, if applicable. For example, the hemostatic device 2300 may be used with one or more wires, cables, cords, and the like of corresponding implantable blood pump(s). The hemostatic device 2300 may also be used with one or more wires, cables, cords, and the like of one or more power sources used to operate corresponding implantable medical device(s). The hemostatic device 2300 may also be used with one or more catheter devices
and the like used to deliver a liquid to the subject body, such as to the vasculature, or to sample a fluid, such as blood, from the subject body.
[0258] As illustrated in FIGS. 22 and 23, the hemostatic device 2300 includes an installation sheet 2302 and a receiver tube 2304, or similar structure, projecting therefrom, according to one or more embodiment(s). The installation sheet 2302 and the receiver tube 2304 may form a monolithic structure together or may be attached to one another. In particular, the installation sheet 2302 and the receiver tube 2304 may be removably attached together such that they can be attached to and detached from one another when the hemostatic device 2300 is installed to a subject body. Alternatively or additionally, the installation sheet 2302 and the receiver tube 2304 may be rotatably attached together such that the installation sheet 2302 and the receiver tube 2304 can rotate relative to one another when the hemostatic device 2300 is installed to a subject body.
[0259] The installation sheet 2302 is configured to be installed and attached to a subject body in order to maintain the receiver tube 2304 in place thereto, for example when the hemostatic device 2300 is installed to an intraluminal and/or percutaneous access site(s). The installation sheet 2302 may be installed to the epidermis of the skin (as illustrated in FIG. 22). The installation sheet 2302 may also be installed to the skin subcutaneously (not shown), to a bodily conduit outside the lumen thereof (as illustrated in FIG. 23; e.g. outside a blood vessel), and to a bodily conduit inside the lumen thereof (as illustrated in FIG. 24; e.g. inside a blood vessel). As such, the installation sheet 2302 may be attached to the subject body by sutures, staples, glue, formation of scar tissue, and the like. When attached by sutures, staples, and glue, the installation sheet 2302 may be made of a biocompatible material, such as silicone, polyetheretherketone (PEEK), ceramic, titanium, aluminum, stainless steel, and the like. When attached by the formation of scar tissue, the installation sheet 2302 may be made of a biocompatible material, such as Dacron®, Polytetrafluoroethylene (PTFE), and the like.
[0260] The installation sheet 2302 may be generally thin and may have any shape, such as a circular shape (e.g., as illustrated in FIG. 22), a square shape, a triangle shape, an oblong shape, and the like. The installation sheet 2302 may also be sized and shaped to appropriately fit a specific anatomical structure of a subject body in order to be appropriately installed and attached thereto. For example, the installation sheet 2302 may have a hollow cylindrical shape or a hollow semi-cylindrical shape that may be sized and shaped to appropriately fit and engage a wall of a blood vessel inside the lumen thereof. The installation sheet 2302 may also have a shape that is free of corners, which are generally prone to peel off when the installation sheet 2302 is installed on the epidermis of the skin, for example.
[0261] Projecting from the installation sheet 2302, the receiver tube 2304 defines a passage 2400 that opens at each one of first and second end portions 2402, 2404 thereof, and extends at least partially along the receiver tube 2304. The passage 2400 is configured to partially receive the interconnector device 100, such as the interconnector body 102 as illustrated, along its length therein. In particular, the cross-sectional area of the passage 2400 may be sized and shaped to substantially match the cross-sectional area of the interconnector device 100 in such a way that a fluid, for example blood, is prevented to leak therefrom when the interconnector device 100 is received in the passage 2400.
[0262] The receiver tube 2304 may have an elbow, such as a descending elbow 2306 as illustrated in the embodiment of FIG. 22 that directs the interconnector device 100 toward the subject’s hip where a controller (not shown) may be present for connection to one or more implanted medical devices, each having a portion thereof configured to pass through the passage 2400. Alternatively, the receiver tube 2304 may have a straight shape, as illustrated in the embodiments of FIGS. 23 and 24. The receiver tube 2304 may be made of a flexible material, such as silicone, latex, polyurethane, rubber and the like, which facilitates ease of movement of the subject.
[0263] The interconnector device 100 is illustrated in FIGS. 23 and 24 with the first and third electrical connectors 500, 504 having the same cross-sectional size as the interconnector body 102, such that the interconnector body 102 can be inserted and removed from the receiver tube 2304 without interference of the first and third electrical connectors 500, 504 due to their comparatively larger cross-sectional size. However, as illustrated in FIG. 22, the first and third electrical connectors 500, 504, as well as the first and third connectors 104, 110 as the case may be, may have a cross-sectional size larger than the cross-sectional size of the interconnector body 102, such that the interconnector device 100 cannot be inserted and removed from the receiver tube 2304 due to the larger cross-sectional size and interference of the first and third electrical connectors 500, 504, or the first and third connectors 102, 110. In this latter case, the first and third electrical connectors 500, 504, or the first and third connectors 102, 110, may serve as abutment stoppers, as described herein.
[0264] It will be appreciated that the size and shape of the receiver tube 2304 and/or passage 2400 may be determined by the medical device used in combination with the hemostatic device 2300. In particular, the receiver tube 2304 and passage 2400 of the hemostatic device 2300 may be sized and shaped to receive a portion of an implantable medical device therethrough. For example, such shapes may include a square shape, a rectangle shape, a triangle shape, an oblong shape, and the like.
[0265] The receiver tube 2304 may include at least one device-receiving seal (not shown) disposed inside the passage 2400 and/or to one of the first and second end portions 2402, 2404 thereof. The device-receiving seal is configured to provide a fluid thigh engagement with the interconnector device 100, such as the interconnector body 102 thereof, when it is received and moved therein by being rotated, pulled, and/or pushed inside the passage 2400.
[0266] The hemostatic device 2300 may also include a protective cover (not shown) coupled thereto, such as to the receiver tube 2304, and configured to attach to the interconnector device 100, such as to the interconnector body 102 thereof. The protective cover is also configured such that its length may vary when the interconnector device 100 moves, for example by being pulled and/or pushed inside the passage 2400. The protective cover may be made of a stretchable material, may be telescopic, and/or may have a bellows-like shape.
[0267] The inside portion of the receiver tube 2304 and the inside portion of the protective cover (when present) may be coated with an antiseptic drug and/or an antiseptic material, such as antibiotic(s), silver, honey, and the like. The inside portion of the receiver tube 2304 and the inside portion of the protective cover (when present) may also be coated with an antithrombotic drug and/or an antithrombotic material, such as heparin, argatroban and the like.
[0268] When the protective cover is provided to the receiver tube 2304, the interconnector device 100 may include at least one of first and second abutment tabs (not shown) or similar abutting structures, such as connectors of larger cross-sectional size than the interconnector body 102, as described hereinbefore (collectively referred to herein as “abutment stopper(s)”). With the interconnector device 100 received in the passage 2400, the first abutment stopper is provided to the interconnector device 100 on the side of the first end portion 2402 of the passage 2400, and the second stopper is provided to the interconnector device 100 on the side of the second end portion 2404 of the passage 2400. Abutment of the first and second abutment stoppers to the first and second end portions 2402, 2404 of the passage 2400, respectively, prevent the interconnector device 100 from being inappropriately moved inside or outside the passage 2400. At least one of the first and second abutment stoppers may be configured to limit or prevent rotation of the interconnector device 100 inside the passage 2400. Further, at least one of the first and second abutment stoppers may be removably coupled to the interconnector device 100, such that the interconnector device 100 can be inserted inside the passage 2400 in absence of one or more of them, and then the removed abutment stopper(s) may be put back in place to fulfill their role.
[0269] The device-receiving seal and/or the protective cover help(s) to maintain a sterile environment at, for example, any of a percutaneous access site and an intraluminal access site, and thus helps to reduce or prevent infection of these access site openings.
[0270] The passage of the hemostatic device 2300 is configured to receive at least a portion of one or more implantable medical devices therein. For example, the cross-sectional area of the passage may be sized and shaped to substantially match the cross-sectional area of one or more wires, cables, cords, catheters, and the like. In addition, a device-receiving seal that may be provided to the hemostatic device 2300 may be configured to provide a fluid thigh engagement with these wires, cables, cords, catheters, and the like. Furthermore, a protective cover that may be provided to the hemostatic device 2300 is coupled thereto and may be configured to attach to an implantable medical device having a portion thereof configured to pass through the receiver tube 2304.
[0271] The hemostatic device 2300 may be transcatheterly implantable to a subject body, according to one or more embodiment(s). As such, the hemostatic device 2300 may have a non-expanded configuration in which the hemostatic device 2300 is configured to be transcatheterly delivered to a subject body, and an expanded configuration in which the hemostatic device 2300 is configured to be transcatheterly implanted to the subject body.
[0272] In particular, a sheath containing the hemostatic device 2300 in the non-expanded configuration therein may be routed inside the subject body up to an implantation site-of- interest, such as an intraluminal implantation site or a subcutaneous implantation site. With the sheath appropriately positioned at the implantation site-of-interest, the hemostatic device 2300 is caused to come out of the sheath in order to be delivered to the implantation site-of- interest. Then, the installation sheet 2302 and/or the receiver tube 2304 auto-convert(s) or is/are converted from their corresponding non-expanded configurations to their corresponding expanded configurations in order to be installed to the implantation site-of-interest.
[0273] The installation sheet 2302 and/or the receiver tube 2304 may progressively autoconvert from corresponding non-expanded configurations to corresponding expanded configurations as the hemostatic device 2300 comes out of the sheath and constraints imposed to the hemostatic device 2300 by the sheath are removed. In this case, the installation sheet 2302 and/or the receiver tube 2304 is/are overcomeably biased toward their corresponding expanded configurations and is/are made of a memory material that is selfexpandable, such as nitinol, stainless steel, and/or biocompatible polymer(s). Alternatively, the receiver tube 2304 may be converted from its corresponding non-expanded configuration to its corresponding expanded configuration by a balloon catheter that is inserted inside the
passage 2400 and then inflated. In this case, the receiver tube 2304 is made of a malleable material, such as stainless steel, titanium, cobalt-chromium alloy and the like.
[0274] The installation sheet 2302 and/or the receiver tube 2304 may include a wire network frame (not shown) at least partially covered with a membrane serving as a fluid barrier. The wire network frame may be made of a memory material that is self-expandable and overcomeably biased toward the expanded configuration, or may be made of a malleable material, as described hereinbefore. The installation sheet 2302 and the receiver tube 2304 may form a monolithic wire network frame structure together. Alternatively, the wire network frame of the installation sheet 2302 and the wire network frame of the receiver tube 2304 may be removably and/or rotatably attached to one another, as also described hereinbefore. The wire network frame(s) may integrate stress-relief structure(s) for reducing material fatigue, for example when the installation sheet 2302 is folded in the first and second arrangements relative to the receiver tube 2304, as also described hereinbefore.
[0275] Alternatively to a transcatheter installation, the hemostatic device 2300 may be surgically installed to a subject body. For example, as described hereinbefore, the installation sheet 2302 may be installed to a subject body by sutures, staples, glue, formation of scar tissue, and the like, while the receiver tube 2304 may be positioned through a percutaneous access site and/or an intraluminal access site. When installed, the installation sheet 2302 in the expanded configuration has generally a planar shape having an outer periphery, such as circular shape (as illustrated in FIG. 22 with an outer periphery 2308), a square shape, a triangle shape, an oblong shape, and the like.
[0276] Contained in the sheath in the non-expanded configuration, the installation sheet 2302 may have two arrangements when having generally a planar shape. In the first arrangement, the installation sheet 2302 is folded away from the receiver tube 2304 such that the installation sheet 2302 defines generally a cylindrical shape extending away from the receiver tube 2304. So folded away, the outer periphery of the installation sheet 2302 is positioned toward the distal end of the sheath and is thus the first portion of the hemostatic device 2300 to come out during transcatheter delivery. In the second arrangement, the installation sheet 2302 is folded toward and over the receiver tube 2304 such that the installation sheet 2302 defines generally a cylindrical shape that overlaps with the receiver tube 2304. So folded forward and over, the outer periphery of the installation sheet 2302 is positioned toward the proximal end of the sheath and is thus the last portion, along with the first end portion 2402 of the passage 2400, to come out during transcatheter delivery.
[0277] FIG. 24 illustrates the hemostatic device 2300 provided with a perforated installation sheet 2500, according to one or more embodiment(s). The perforated installation sheet 2500 includes a perforation 2502 configured to receive the receiver tube 2304 therethrough, such that a biological tissue is sandwiched between the installation sheet 2302 and the perforated installation sheet 2500 when the hemostatic device 2300 is installed to a subject body. For example, a bodily conduit wall, such as a blood vessel wall (as illustrated in FIG. 24), or the skin of a subject may be sandwiched between the installation sheet 2302 and the perforated installation sheet 2500 when the hemostatic device 2300 is installed. So installed, the receiver tube 2304 may be positioned through a percutaneous access site and/or an intraluminal access site. Generally, the length of the receiver tube 2304 is required to be shorter when the receiver tube 2304 is positioned through only one of a percutaneous access site and an intraluminal access site (as illustrated in FIG. 24), than when it is positioned through both a percutaneous access site and an intraluminal access site (not shown).
[0278] The perforated installation sheet 2500 may be installed and attached to a subject body in a similar way as described hereinbefore forthe installation and attachment of the installation sheet 2302. For example, the installation sheet 2302 may be installed and attached to the skin subcutaneously, while the perforated installation sheet 2500 may be installed and attached to the epidermis of the skin. The installation sheet 2302 may be installed and attached to the wall of a bodily conduit inside the lumen thereof, while the perforated installation sheet 2500 may be installed and attached to the wall of the bodily conduit outside the lumen thereof. The installation sheet 2302 may be installed and attached to the wall of a bodily conduit, either inside or outside the lumen thereof, while the perforated installation sheet 2500 may be installed and attached to the epidermis of the skin or to the skin subcutaneously.
[0279] In particular, the perforated installation sheet 2500 and the installation sheet 2302 may be attached to the subject body separately from one another. For example, each one of the perforated installation sheet 2500 and the installation sheet 2302 may be sutured, stapled, glued, attached via the formation of scar tissue, and the like independently from one another to different anatomical locations, or to different portions or sides of a same biological tissue. Alternatively, the perforated installation sheet 2500 and the installation sheet 2302 may be attached together through a biological tissue of a subject body, for example with sutures and/or staples passing through the skin or the wall of a bodily conduit.
[0280] Although the hemostatic device 2300 is illustrated in FIG. 24 with the installation sheet 2302 installed and attached to a blood vessel inside the lumen thereof, and the perforated installation sheet 2500 installed and attached to the blood vessel outside the lumen thereof, the installation sheet 2302 alone may be installed and attached to a blood vessel inside the
lumen thereof without the perforated installation sheet 2500. The installation sheet 2302 alone may also be installed and attached to the skin subcutaneously without the perforated installation sheet 2500.
[0281] The perforated installation sheet 2500 may also include a tube-receiving seal (not shown) disposed to the periphery of the perforation, such as the perforation 2502. The tubereceiving seal is configured to provide a fluid thigh engagement with the receiver tube 2304 when received therethrough. The tube-receiving seal may facilitate the obtention of hemostasis.
[0282] The hemostatic device 2300 may include a connector (not shown) configured to connect the perforated installation sheet 2500 and the receiver tube 2304 together. The connector may be adjustable in order to secure perforated installation sheet 2500 to the receiver tube 2304 at a desired distance between the perforated installation sheet 2500 and the installation sheet 2302, which desired distance may depend on the thickness of the biological tissue to which the hemostatic device 2300 is installed thereto. Such adjustment may be used to maintain a pressure on a biological tissue sandwiched between the installation sheet 2302 and the perforated installation sheet 2500, which in turn may also facilitate the obtention of hemostasis.
[0283] The connector may include a first connector portion disposed to the outer face of the receiver tube 2304, and a second connector portion disposed to the perforated installation sheet 2500, such as to the periphery of the perforation 2502. Alternatively, the connector may be a standalone connector that is physically separated from the hemostatic device 2300.
[0284] The connector may include a threaded connector having a first portion thereof provided to the receiver tube 2304, such as to the outer face thereof, and a second portion thereof provided to the perforated installation sheet 2500, such as to the periphery of the perforation 2502, as well as any other similar connecting structures. Screwing the perforated installation sheet 2500 to the receiver tube 2304 allows for adjusting the distance between the installation sheet 2302 and the perforated installation sheet 2500 as well as the pressure on the biological tissue.
[0285] The standalone connector may include a tightening ring (not shown) configured to threadedly engage the receiver tube 2304, or may include a press fit ring configured to engage the receiver tube 2304 with an interference fit. As described hereinbefore, the distance between the installation sheet 2302 and the perforated installation sheet 2500 as well as pressure on the biological structure or the biological tissue may also be adjusted with the standalone connector.
[0286] In the case of interference fit, for example, a first connector portion may include multiple connecting structures that are disposed along the length of the receiver tube 2304 and configured to sequentially engage the second connector portion of the perforated installation sheet 2500 as the receiver tube 2304 is received in the perforation 2502. In this way, the distance between the installation sheet 2302 and the perforated installation sheet 2500 as well as the pressure on the biological tissue may be adjusted.
[0287] The perforated installation sheet 2500 may be made of the same material(s) as described hereinbefore for the installation sheet 2302.
[0288] A stronger attachment to the subject body of the hemostatic device 2300 and the hemostatic device 2300, as the case may be, is achieved with the perforated installation sheet 2500 (in comparison to use without the perforated installation sheet 2500). A stronger attachment may be required depending on the specific condition of utilization of the hemostatic device 2300 and the hemostatic device 2300, such as the anatomical location of implantation of these two sleeves and the implanted medical device(s) used in combination therewith, including the operation mode of the implanted medical device(s).
[0289] The hemostatic device 2300 prevent or reduce the risk associated with one or more implanted medical devices received through an access site, such as an intraluminal and/or percutaneous access site(s). In particular, the hemostatic device 2300 may prevents or reduces (i) bleeding and oozing at the access site, for example by providing hemostasis, (ii) possible movements of the interconnector device 100 through the access site, reducing trauma and improving healing at the access site; and/or (iii) the risk of infection by acting as a barrier against pathogens. For example, mechanical stress caused by movement(s) of the implanted medical device(s) through the access site is distributed to a larger surface area corresponding to the surface area of the installation sheet 2302 and the perforated installation sheet 2500 (when present) instead of being focally applied to the access site. For long-term implantation of medical device(s), not only the use of the hemostatic device 2300 improve subject comfort, but also facilitate routine maintenance and care of the access site.
[0290] A kit may be provided with the interconnector device 100, one or more implantable medical devices, such one or more implantable blood pumps, and/or the hemostatic device 2300.
Methods
[0291] This disclosure also relates generally to a method 2500 of using a medical device in a subject body, according to an aspect of this disclosure. It is to be noted that reference(s) to the interconnector device 100, other device(s), and/or any other feature(s) made in relation to
the method 2500, as the case may be, is/are made solely as example(s) to facilitate an understanding of how the method 2500 may be implemented and practiced. Accordingly, such reference(s) is/are not intended to limit the scope of the method 2500. The method 2500 may be practiced with any medical device.
[0292] FIG. 25 schematically illustrates the method 2500, according to one or more embodiment(s). The method 2500 includes: connecting the medical device to another medical device, at 2502; connecting the medical device to a controller configured to operate the other medical device, at 2504; and implanting the medical device in the subject body, at 2506, such as for example illustrated in FIGS. 2 to 4. The medical device may be for example the interconnector device 100, and the other medical device may be for example an implantable medical device, such as the first or second implantable blood pump 001 , 002 or the implantable medical device 012. Optional feature(s) is/are represented in dash lines in FIG. 25.
[0293] The method 2500 may also include: implanting the other medical device in the subject body, at 2508, if not already implanted therein. Implanting the other medical may be performed, for example, by transcatheter technique and/or by open surgery.
[0294] The method 2500 may also include: intracorporeally rinsing or washing at least one of a first connector of the medical device that is configured to connect to the other medical device, and a second connector of the medical device that is configured to connect to the controller, at 2510. For example, the first and/or second connector(s) may be one or more of the first, second, third, and fourth connectors 104, 106, 110, 112, and/or one or more of the first, second, third, and fourth electrical connectors 500, 502, 504, 506. Still for example, the connector(s) may be intracorporeally rinsing or washing by the fluid passageway 900 and the fluid evacuation port 902.
[0295] Connecting at 2502 may include intracorporeally connecting the medical device to another medical device.
[0296] Connecting at 2504 may include intracorporeally connecting the medical device to a controller.
[0297] Connecting at 2502 and/or 2504 may be connecting a fluid thigh connection, such as for example in the case of connector(s) provided with one or more first, second, and third seals 800, 802, 804 and fourth and fifth seals.
[0298] Connecting at 2502 and/or 2504 may include electrically connecting, mechanically connecting, magnetically connecting, and/or connecting in a fluid thigh manner.
[0299] The method 2500 may include: locking at least one of a first connecting portion of the medical device to the other medical device, and a second connecting connection of the medical device to the controller, at 2512. The first and/or second connecting portion(s) may include for example the first and/or second end portion(s) 200, 202 and/or the connector(s) of the interconnector device 100. The locking may be performed for example with the locking mechanism 1300.
[0300] Implanting at 2506 may include implanting the medical device partially in the subject body so that the medical device has an intracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100, and an extracorporeally disposed portion, such as the other one of the first and second end portions 200, 202 of the interconnector 100.
[0301] Implanting at 2506 may include implanting the medical device entirely in the subject body so that the medical device is entirely intracorporeally disposed.
[0302] Implanting at 2506 may include intraluminally navigating the medical device, such as the interconnector device 100, in the subject body.
[0303] Implanting at 2506 may include transcatheterly implanting the medical device, such as the interconnector device 100, in the subject body.
[0304] Implanting at 2506 may include railing the medical device, such as the interconnector device 100, over a guidewire, such as the guidewire 011 , at 2514.
[0305] Railing at 2514 may assist the connection of the medical device to at least one of the other medical device and the controller.
[0306] Implanting at 2506 may include engaging in a fluid thigh manner the medical device with at least one of an intraluminal access and a percutaneous access of the subject body. This may be performed, for example, by the tapered or profiled cross-sectional shape of the connector body 102 and/or by the interconnector seal 1200.
[0307] The method 2500 may include anchoring the medical device in the subject body, at 2516. This may be performed, for example, by the by the tapered or profiled cross-sectional shape of the connector body 102 engaging the subject body and/or by the interconnector anchor 1500.
[0308] Anchoring at 2516 may include anchoring the other medical device and/or the controller connected to the medical device.
[0309] The method 2500 may include installing a hemostatic device, such as the hemostatic device 2300, to the subject body to provide hemostasis to the implanted medical device, at 2518.
[0310] The method 2500 may include operating the other medical device via the medical device by the controller, at 2520.
[0311] Operating at 2520 may include electrically operating, mechanically operating, such as by a driveshaft and the like.
[0312] Operating at 2520 may produce a therapeutic effect, such as a hemodynamic effect, in the subject body.
[0313] In the method 2500, the other medical device may be or may include a blood pump.
[0314] The interconnector device 100 may also be useful when multiple implanted medical devices are operated therewith and produce a synergistic effect. For example, with left and right implantable pacemaker leads for cardiac resynchronization therapy and a left ventricular assist device interconnected to the interconnector device 100 and providing an optimal cardiac unloading and more physiologic blood flow, such as by increasing left ventricular assist device during ventricular stimulation (i.e., the systole) and reducing speed during diastole.
[0315] This disclosure also relates generally to a method 2600 of using an implanted medical device of a subject body (may be also referred to herein as “a method of replacing an implanted medical device of a subject body”), according to an aspect of this disclosure. It is to be noted that reference(s) to the interconnector device 100, other device(s), and/or any other feature(s) made in relation to the method 2600, as the case may be, is/are made solely as example(s) to facilitate an understanding of how the method 2600 may be implemented and practiced. Accordingly, such reference(s) is/are not intended to limit the scope of the method 2600. The method 2600 may be practiced with any medical device.
[0316] FIG. 26 schematically illustrates the method 2600, according to one or more embodiment(s). The method 2600 includes: explanting the implanted medical device from the subject body, at 2602; disconnecting the implanted medical device from another implanted medical device and from a controller, at 2604; connecting a replacement medical device to the other implanted medical device and to the controller, at 2606; and implanting the replacement medical device in the subject body, at 2608. The implanted medical device may
be for example the interconnector device 100. The replacement medical device may be for example a replacement interconnector device 100. The other implanted medical device may be for example an implantable medical device, such as the first or second implantable blood pump 001 , 002 or the implantable medical device 012. The implanted medical device and/or the replacement medical device may be implanted as illustrated for example in FIGS. 2 to 4. Optional feature(s) is/are represented in dash lines in FIG. 26.
[0317] In the method 2600, the implanted medical device may be implanted partially in the subject body so that the implanted medical device has an intracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100, and an extracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100.
[0318] In the method 2600, the implanted medical device may be implanted entirely in a subject body so that the implanted medical device is entirely intracorporeally disposed.
[0319] Explanting at 2602 may include pulling the implanted medical device from the subject body, such through an access site thereof.
[0320] Explanting at 2602 may include removing the implanted medical device from at least one access site, such as at least one of an intraluminal access and a percutaneous access, of the subject body.
[0321] Explanting at 2602 may include transcatheterly explanting the implanted medical device.
[0322] Explanting at 2602 may include explanting by open surgery the implanted medical device.
[0323] Disconnecting at 2604 may include intracorporeally disconnecting the implanted medical device from at least one of the other medical device and the controller. Intracorporeally disconnecting may include intravascularly disconnecting.
[0324] Disconnecting at 2604 may include disconnecting a wire connection of the implanted medical device from at least one of the other medical device and the controller. Such wire connection may be hard wired for example to one or more of the first, second, third, and fourth connectors 104, 106, 110, 112, and/or one or more of the first, second, third, and fourth electrical connectors 500, 502, 504, 506 of the interconnector device 100.
[0325] Disconnecting at 2604 may include disconnecting a wireless connection of the implanted medical device from at least one of the other medical device and the controller.
[0326] Disconnecting at 2604 may include disconnecting a mechanical connection of the implanted medical device from at least one of the other medical device and the controller. This may be the case, for example, for the interconnector device 100 having the first and/or second drivelines(s) 108, 114 embodied as one or more driveshafts.
[0327] The method 2600 may include intracorporeally rinsing or washing at least one of a first connector of the replacement medical device that is configured to connect to the other medical device, and a second connector of the replacement medical device that is configured to connect to the controller, at 2610. For example, the first and/or second connector(s) may be one or more of the first, second, third, and fourth connectors 104, 106, 110, 112, and/or one or more of the first, second, third, and fourth electrical connectors 500, 502, 504, 506. Still for example, the connector(s) may be intracorporeally rinsing or washing by the fluid passageway 900 and the fluid evacuation port 902.
[0328] Connecting at 2606 may include intracorporeally connecting the replacement medical device to at least one of the other medical device and the controller.
[0329] Connecting at 2606 may be connecting a fluid thigh connection, such as for example in the case of connector(s) provided with one or more first, second, and third seals 800, 802, 804 and fourth and fifth seals.
[0330] Connecting at 2606 may include electrically connecting, mechanically connecting, magnetically connecting, and/or connecting in a fluid thigh manner.
[0331] The method 2606 may include locking at least one of a first connecting portion of the replacement medical device to the other medical device, and a second connecting portion of the replacement medical device to the controller, at 2612. The first and/or second connecting portion(s) may include for example the first and/or second end portion(s) 200, 202 and/or the connector(s) of the interconnector device 100. The locking may be performed for example with the locking mechanism 1300.
[0332] Implanting at 2608 may include implanting the replacement medical device partially in the subject body so that the replacement medical device has an intracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100, and an extracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100.
[0333] Implanting at 2608 may include implanting the replacement medical device entirely in the subject body so that the replacement medical device is entirely intracorporeally disposed.
[0334] Implanting at 2608 may include pushing the replacement medical device, such as the interconnector device, in the subject body, such as through an access site thereof.
[0335] Implanting at 2608 may include intraluminally navigating the replacement medical device, such as the interconnector device, in the subject body.
[0336] Implanting at 2608 may include transcatheterly implanting the replacement medical device, such as the interconnector device, in the subject body.
[0337] Implanting at 2608 may include railing the replacement medical device, such as the interconnector device, over a guidewire, such as the guidewire 011 , at 2614.
[0338] Railing at 2614 may assist the connection of the replacement medical device to at least one of the other medical device and the controller.
[0339] Implanting at 2608 may include engaging in a fluid thigh manner the replacement medical device with at least one of an intraluminal access and a percutaneous access of the subject body. This may be performed, for example, by the tapered or profiled cross-sectional shape of the connector body 102 and/or by the interconnector seal 1200.
[0340] The method 2600 may include anchoring the replacement medical device in the subject body, at 2616. This may be performed, for example, by the by the tapered or profiled cross-sectional shape of the connector body 102 engaging the subject body and/or by the interconnector anchor 1500.
[0341] Anchoring at 2616 may include anchoring the other medical device and/or the controller connected to the medical device.
[0342] The method 2600 may include installing a hemostatic device, such as the hemostatic device 2300, to the subject body to provide hemostasis to the replacement medical device therethrough, at 2618.
[0343] In the method 2600 the implanted medical device may be operated by the controller.
[0344] The method 2600 may include operating the other medical device via the replacement medical device by the controller, at 2620.
[0345] Operating at 2620 may include electrically operating, mechanically operating, such as by a driveshaft and the like.
[0346] In the method 2600, the other medical device may be or may include a blood pump.
[0347] This disclosure also relates generally to a method 2700 of using a first medical device and a second medical device in a subject body (may be also referred to herein as “method of connecting a first medical device and a second medical device together in a subject body”), according to an aspect of this disclosure. It is to be noted that reference(s) to the interconnector device 100, other device(s), and/or any other feature(s) made in relation to the method 2700, as the case may be, is/are made solely as example(s) to facilitate an understanding of how the method 2700 may be implemented and practiced. Accordingly, such reference(s) is/are not intended to limit the scope of the method 2700. The method 2700 may be practiced with any medical device.
[0348] FIG. 27 schematically illustrates the method 2700, according to one or more embodiment(s). The method 2700 includes: railing over a guidewire in the subject body the first medical device and the second medical device so that at least one of the first medical device and the second medical device is advanced toward the other one of the first medical device and the second medical device, at 2702; and connecting the first medical device and the second medical device together over the guidewire in the subject body, at 2704. The first and/or second medical device(s) may be for example one of the interconnector device 100 and an implantable medical device, such as the first or second implantable blood pump 001 , 002 or the implantable medical device 012. The guidewire may be for example the guidewire 011. The first and second medical devices may or may not be implanted as illustrated for example in FIGS. 2 to 4. Optional feature(s) is/are represented in dash lines in FIG. 27.
[0349] The method 2700 may include implanting the first and/or second medical device(s) in the subject body, at 2706.
[0350] The first and/or second medical device(s) may be implanted partially in the subject body so that the first medical device has an intracorporeally disposed portion, such as such as one of the first and second end portions 200, 202 of the interconnector 100, and an extracorporeally disposed portion, such as one of the first and second end portions 200, 202 of the interconnector 100. The first and/or second medical device(s) may be implanted entirely in the subject body so that the first medical device is entirely intracorporeally disposed.
[0351] Implanting at 2706 may include intraluminally navigating at least one of the first medical device and the second medical device, such as the interconnector device 100, in the subject body.
[0352] Implanting at 2706 may include transcatheterly implanting at least one of the first medical device and the second medical device, such as the interconnector device 100, in the subject body.
[0353] Implanting at 2706 may include engaging in a fluid thigh manner at least one of the first medical device and the second medical device, such as the interconnector device 100, in the subject body with an access site of the subject body, such as at least one of an intraluminal access and a percutaneous access of the subject body. This may be performed, for example, by the tapered or profiled cross-sectional shape of the connector body 102 and/or by the interconnector seal 1200.
[0354] The method 2700 may include anchoring at least one of the first medical device and the second medical device in the subject body, at 2708. This may be performed, for example, by the by the tapered or profiled cross-sectional shape of the connector body 102 engaging the subject body and/or by the interconnector anchor 1500.
[0355] Anchoring at 2708 may include that one of the first medical device and the second medical device anchors in the subject body the other one of the first medical device and the second medical device.
[0356] The method 2700 may include intracorporeally rinsing or washing at least one of a connector of the first medical device that is configured to connect to the second medical device and a connector of the second medical device that is configured to connect to the first medical device, at 2710. For example, the first and/or second connector(s) may be one or more of the first, second, third, and fourth connectors 104, 106, 110, 112, and/or one or more of the first, second, third, and fourth electrical connectors 500, 502, 504, 506. Still for example, the connector(s) may be intracorporeally rinsing or washing by the fluid passageway 900 and the fluid evacuation port 902.
[0357] Connecting at 2704 may be connecting a fluid thigh connection, such as for example in the case of connector(s) provided with one or more first, second, and third seals 800, 802, 804 and fourth and fifth seals.
[0358] Connecting at 2704 may include electrically connecting, mechanically connecting, magnetically connecting, and/or connecting in a fluid thigh manner.
[0359] The method 2700 may include locking at least one of a connecting portion of the first medical device and a connecting portion of the second medical device to the other one of the connecting portion of the first medical device and the connecting portion of the second medical device, at 27. The first and/or second connecting portion(s) may include for example the first and/or second end portion(s) 200, 202 and/or the connector(s) of the interconnector device 100. The locking may be performed for example with the locking mechanism 1300.
[0360] In the method 2700, the first medical device and the second medical device may be operative connected together so that the first medical device is operated via the second medical device.
[0361] The method 2700 may include installing a hemostatic device, such as the hemostatic device 2300, to the subject body to provide hemostasis to one of the first medical device and the second medical device.
[0362] The method 2700 may include operating the first medical device via the second medical device connected to a controller for operating the first medical device, at 2714.
[0363] Operating at 2714 may produce a therapeutic effect, which may be a hemodynamic effect, in the subject body.
[0364] In the method 2700, one of the first and second medical devices may be a blood pump, and the other one of the first and second medical devices may be an interconnector device, such as the interconnector device 100, or a controller for operating the blood pump.
Definitions
[0365] The sub-sections of the “Detailed Description” are strictly for facilitating reading and are not intended to describe or define any subject-matter herein.
[0366] The singular and plural uses of the term “aspect(s)” are intended herein to mean “at least one - but not all - aspect of this disclosure”, unless expressly specified otherwise. Similarly, the singular and plural uses of the term “embodiment(s)” are intended herein to mean “at least one - but not all - embodiment of this disclosure”, unless expressly specified otherwise. Moreover, references to “another aspect”, “another embodiment”, and the like do not necessarily imply that the referenced aspect and referenced embodiment are mutually exclusive with any other aspect(s) and embodiment(s), respectively, unless expressly specified otherwise.
[0367] The terms “comprising”, “including”, “having”, and variations thereof shall be construed herein as open-ended terms and, thus, are not intended to exclude other elements, technical features, limitations, steps, and the like.
[0368] The expression “and/or” is intended herein to mean “one or more” of the elements so combined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Other elements may optionally be present other than the elements specifically identified by the expression “and/or”, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to an “element A” and/or an “element B” can refer to the “element A” only (optionally including element(s) other than the “element B”), to the “element B” only (optionally including element(s) other than the “element A”), or to both the “element A” and the “element B” (optionally including element(s) other than the “element A” and the “element B”).
[0369] Adjectives of numbers, also known as definite numeral adjectives, such as first, second, third, etc., and the like are intended herein only to distinguish between the terms they are associated with from one another without necessarily implying or requiring any actual order, ranking, hierarchy, relationship, and the like between such associated terms.
[0370] Perspective-based terms such as up/down, top/bottom, front/back, proximal/distal, and the like are intended herein, notably in reference to the accompanying non-limiting drawings and/or figures, only to facilitate the description and explanation of this disclosure. These perspective-based terms are not necessarily intended to be a limitation, such as a spatial limitation, of the terms they are associated with in any way herein.
[0371] The terms “about” and “approximately” when used in conjunction with numbers, values, ranges, and other like features generally are intended herein to refer to these numbers, values, ranges, and like features that are near to the recited numbers, values, ranges, and like features. These terms generally refer to numbers, values, ranges, and like features that the skilled addressee would consider equivalent, for example, to achieve an equivalent result or the same result. In many instances, these terms may include numbers, values, ranges, and like features that are rounded to the nearest significant figure. The terms “about” and “approximately” may be used interchangeably herein.
[0372] The term “substantially” when used to define numerical, geometrical, structural, chemical, biological, and other like features is intended herein to convey that these so defined features include the nominal features and also some feature variance, although equality may be desirable. Such feature variance may result for example from manufacturing tolerances, approximations, and/or other practical considerations.
[0373] Operations and/or method steps may be described and explained herein as multiple discrete operations and/or method steps in turn to facilitate the description and explanation of this disclosure. These operations and/or method steps, including the discrete ones, are intended herein to be order-independent, unless expressly specified otherwise.
Clause Sets for National Phase Entries
First Clause Set
1 . A medical device connector, comprising: a connector body; a wire guide configured to guide a guidewire, and a connector configured to connect to a medical device railed over the guidewire guided by the wire guide.
2. The medical device connector according to clause 1 , wherein the wire guide is configured to guide the guidewire therethrough.
3. The medical device connector according to any one of clauses 1 and 2, wherein the wire guide is configured to guide the guidewire therealong.
4. The medical device connector according to any one of clauses 1 to 3, wherein the wire guide and the connector are associated together on the connector body.
5. The medical device connector according to any one of clauses 1 to 4, wherein the wire guide and the connector are disposed on a same surface of the connector body.
6. The medical device connector according to any one of clauses 1 to 5, wherein the wire guide is coaxially disposed relative to the connector.
7. The medical device connector according to any one of clauses 1 to 6, wherein the wire guide is concentrically disposed relative to the connector.
8. The medical device connector according to any one of clauses 1 to 7, wherein the wire guide is parallelly disposed relative to the connector.
9. The medical device connector according to any one of clauses 1 to 8, wherein the wire guide is coplanarly disposed relative to the connector.
10. The medical device connector according to any one of clauses 1 to 9, wherein the connector is circumferentially disposed relative to the wire guide.
11. The medical device connector according to any one of clause 1 to 10, wherein the connector is an electrical connector.
12. The medical device connector according to any one of clause 1 to 10, wherein the electrical connector is of the female type.
13. The medical device connector according to any one of clause 1 to 10, wherein the electrical connector is of the male type.
14. The medical device connector according to any one of clause 1 to 12, wherein the electrical connector comprises a projecting electrical contact.
15. The medical device connector according to any one of clause 1 to 12, wherein the electrical connector comprises a recessed electrical contact.
16. The medical device connector according to any one of clause 1 to 12, wherein the electrical connector comprises an annular electrical contact.
Second Clause Set
1. A hemostatic device, comprising: an installation sheet configured to attach to a subject body; and a receiver tube projecting from the installation sheet, the receiver tube defining a passage configured to receive a portion of an implantable medical device therethrough.
2. The hemostatic device according to clause 1 , wherein the installation sheet is configured to attach to the subject body by at least one of a suture, a staple, a glue, and a formation of scar tissue.
3. The hemostatic device according to clause 1 , wherein the passage of the receiver tube is configured to prevent fluid leak therefrom when the portion of the implantable medical device is received therethrough.
4. The hemostatic device according to clause 1 , further comprising a device-receiving seal configured to provide a fluid thigh engagement between the receiver tube and the portion of the implantable medical device when received through the passage.
5. The hemostatic device according to clause 1 , further comprising a protective cover coupled to the hemostatic device and configured to attach to the medical device.
6. The hemostatic device according to clause 5, wherein the protective cover is coupled to the receiver tube.
7. The hemostatic device according to clause 1 , wherein the hemostatic device has a nonexpanded configuration in which the hemostatic device is configured to be transcatheterly delivered to the subject body, and an expanded configuration in which the hemostatic device is configured to be transcatheterly implanted to the subject body.
8. The hemostatic device according to clause 7, wherein at least one of the installation sheet and the receiver tube comprises a membrane and a wire network frame covered by the membrane.
9. The hemostatic device according to clause 1 , further comprising a perforated installation sheet defining a perforation configured to receive the receiver tube therethrough.
10. The hemostatic device according to clause 9, further comprising a tube-receiving seal configured to provide a fluid thigh engagement between the perforation and the receiver tube when received in the perforation.
11 . The hemostatic device according to clause 9, further comprising a connector configured to connect the perforated installation sheet and the hemostatic device together.
12. The hemostatic device according to clause 11 , wherein the connector comprises a first connector portion disposed to the receiver tube, and a second connector portion disposed to the periphery of the perforation of the perforated installation sheet.
13. The hemostatic device according to clause 12, wherein the connector is adjustable for locking the receiver tube and the perforated installation sheet together at a desired distance between the installation sheet and the perforated installation sheet.
14. The hemostatic device according to clause 13, wherein the connector comprises one of a threaded connector and an interference fit connector.
Third Clause Set
1 . A method of using a medical device in a subject body, the method comprising: connecting the medical device to another medical device; connecting the medical device to a controller; and implanting the medical device in the subject body.
The method according to clause 1 , further comprising implanting the other medical device in the subject body. The method according to clause 2, wherein said implanting comprises transcatheterly implanting the other medical in the subject body. The method according to clause 2, wherein said implanting comprises implanting by open surgery the other medical in the subject body. The method according to any one of clauses 1 to 4, further comprising intracorporeally rinsing at least one of a first connector of the medical device that is configured to connect to the other medical device, and a second connector of the medical device that is configured to connect to the controller. The method according to any one of clauses 1 to 5, wherein said connecting the medical device to another medical device and said connecting the medical device to a controller comprises intracorporeally connecting the medical device. The method according to any one of clauses 1 to 6, wherein the connection of the medical device to at least one of the other medical device and the controller is fluid thigh. The method according to any one of clauses 1 to 7, further comprising locking at least one of a first connecting portion of the medical device to the other medical device, and a second connecting connection of the medical device to the controller. The method according to any one of clauses 1 to 8, wherein said implanting comprises implanting the medical device partially in the subject body so that the medical device has an intracorporeally disposed portion and an extracorporeally disposed portion. The method according to any one of clauses 1 to 8, wherein said implanting comprises implanting the medical device entirely in the subject body so that the medical device is entirely intracorporeally disposed. The method according to any one of clauses 1 to 10, wherein said implanting comprises intraluminally navigating the medical device in the subject body. The method according to any one of clauses 1 to 11 , wherein said implanting comprises transcatheterly implanting the medical device in the subject body. The method according to any one of clauses 1 to 12, wherein said implanting comprises railing the medical device over a guidewire.
14. The method according to clause 13, wherein said railing assists the connection of the medical device to at least one of the other medical device and the controller.
15. The method according to any one of clauses 1 to 14, wherein said implanting comprises engaging in a fluid thigh manner the medical device with at least one of an intraluminal access and a percutaneous access of the subject body.
16. The method according to any one of clauses 1 to 15, further comprising anchoring the medical device in the subject body.
17. The method according to clause 16, wherein the anchored medical device anchors in the subject body at least one of the other medical device and the controller.
18. The method according to any one of clauses 1 to 17, further comprising installing a hemostatic device to the subject body to provide hemostasis to the implanted medical device.
19. The method according to any one of clauses 1 to 18, further comprising operating the other medical device via the medical device by the controller.
20. The method according to clause 19, wherein said operating produces a therapeutic effect in the subject body.
21. The method according to clause 20, wherein the therapeutic effect comprises a hemodynamic effect.
22. The method according to any one of clauses 1 to 21 , wherein the other medical device comprises a blood pump.
Fourth Clause Set
1. A method of using an implanted medical device in a subject body, the method comprising: explanting the implanted medical device from the subject body; disconnecting the implanted medical device from another implanted medical device and from a controller; connecting a replacement medical device to the other implanted medical device and to the controller; and implanting the replacement medical device in the subject body.
The method according to clause 1 , wherein the implanted medical device is implanted partially in the subject body so that the implanted medical device has an intracorporeally disposed portion and an extracorporeally disposed portion. The method according to clause 1 , wherein the implanted medical device is implanted entirely in a subject body so that the implanted medical device is entirely intracorporeally disposed. The method according to any one of clauses 1 to 3, wherein said explanting comprises pulling the implanted medical device from the subject body. The method according to any one of clauses 1 and 4, wherein said explanting comprises removing the implanted medical device from at least one of an intraluminal access and a percutaneous access of the subject body. The method according to any one of clauses 1 to 5, wherein said explanting comprises transcatheterly explanting the implanted medical device. The method according to any one of clauses 1 to 6, wherein said explanting comprises explanting by open surgery the implanted medical device. The method according to any one of clauses 1 to 7, wherein said disconnecting comprises intracorporeally disconnecting the implanted medical device from at least one of the other medical device and the controller. The method according to any one of clauses 1 to 8, wherein said disconnecting comprises disconnecting a wire connection of the implanted medical device from at least one of the other medical device and the controller. The method according to any one of clauses 1 to 9, wherein said disconnecting comprises disconnecting a wireless connection of the implanted medical device from at least one of the other medical device and the controller. The method according to any one of clauses 1 to 10, wherein said disconnecting comprises disconnecting a mechanical connection of the implanted medical device from at least one of the other medical device and the controller. The method according to any one of clauses 1 to 11 , further comprising intracorporeally rinsing at least one of a first connector of the replacement medical device that is
configured to connect to the other medical device, and a second connector of the replacement medical device that is configured to connect to the controller. The method according to any one of clauses 1 to 12, wherein said connecting comprises intracorporeally connecting the replacement medical device to at least one of the other medical device and the controller. The method according to any one of clauses 1 to 13, wherein the connection of the replacement medical device to at least one of the other medical device and the controller is fluid thigh. The method according to any one of clauses 1 to 14, further comprising locking at least one of a first connecting portion of the replacement medical device to the other medical device, and a second connecting portion of the replacement medical device to the controller. The method according to any one of clauses 1 to 15, wherein said implanting comprises implanting the replacement medical device partially in the subject body so that the replacement medical device has an intracorporeally disposed portion and an extracorporeally disposed portion. The method according to any one of clauses 1 to 15, wherein said implanting comprises implanting the replacement medical device entirely in the subject body so that the replacement medical device is entirely intracorporeally disposed. The method according to any one of clauses 1 to 17, wherein said implanting comprises pushing the replacement medical device in the subject body. The method according to any one of clauses 1 to 18, wherein said implanting comprises intraluminally navigating the replacement medical device in the subject body. The method according to any one of clauses 1 to 19, wherein said implanting comprises transcatheterly implanting the replacement medical device in the subject body. The method according to any one of clauses 1 to 20, wherein said implanting comprises railing the replacement medical device over a guidewire. The method according to clause 21 , wherein said railing assists the connection of the replacement medical device to at least one of the other medical device and the controller.
23. The method according to any one of clauses 1 to 22, wherein said implanting comprises engaging in a fluid thigh manner the replacement medical device with at least one of an intraluminal access and a percutaneous access of the subject body.
24. The method according to any one of clauses 1 to 23, further comprising anchoring the replacement medical device in the subject body.
25. The method according to clause 24, wherein the anchored replacement medical device anchors in the subject body at least one of the other medical device and the controller.
26. The method according to any one of clauses 1 to 25, further comprising installing a hemostatic device to the subject body to provide hemostasis to the replacement medical device.
27. The method according to any one of clauses 1 to 26, wherein the implanted medical device is operated by the controller.
28. The method according to any one of clauses 1 to 27, further comprising operating the other medical device via the replacement medical device by the controller.
29. The method according to clause 28, wherein said operating produces a therapeutic effect in the subject body.
30. The method according to clause 29, wherein the therapeutic effect comprises a hemodynamic effect.
31 . The method according to any one of clauses 1 to 30, wherein the other medical device comprises a blood pump.
Fifth Clause Set
1 . A method of using a first medical device and a second medical device in a subject body, the method comprising: railing over a guidewire in the subject body the first medical device and the second medical device so that at least one of the first medical device and the second medical device is advanced toward the other one of the first medical device and the second medical device; and connecting the first medical device and the second medical device together over the guidewire in the subject body.
The method according to clause 1 , further comprising implanting the first medical device partially in the subject body so that the first medical device has an intracorporeally disposed portion and an extracorporeally disposed portion. The method according to clause 1 , further comprising implanting the first medical device entirely in the subject body so that the first medical device is entirely intracorporeally disposed. The method according to any one of clauses 1 to 3, further comprising implanting the second medical device partially in the subject body so that the second medical device has an intracorporeally disposed portion and an extracorporeally disposed portion. The method according to any one of clauses 1 to 4, further comprising implanting the second medical device entirely in the subject body so that the second medical device is entirely intracorporeally disposed. The method according to any one of clauses 2 to 5, wherein said implanting comprises intraluminally navigating at least one of the first medical device and the second medical device in the subject body. The method according to any one of clauses 2 to 6, wherein said implanting comprises transcatheterly implanting at least one of the first medical device and the second medical device in the subject body. The method according to any one of clauses 2 to 7, wherein said implanting comprises engaging in a fluid thigh manner at least one of the first medical device and the second medical device with at least one of an intraluminal access and a percutaneous access of the subject body. The method according to any one of clauses 1 to 8, further comprising anchoring at least one of the first medical device and the second medical device in the subject body. The method according to clause 9, wherein when anchored one of the first medical device and the second medical device anchors in the subject body the other one of the first medical device and the second medical device. The method according to any one of clauses 1 to 10, further comprising intracorporeally rinsing at least one of a connector of the first medical device that is configured to connect to the second medical device and a connector of the second medical device that is configured to connect to the first medical device.
12. The method according to any one of clauses 1 to 11 , wherein the connection between the first medical device and the second medical is fluid thigh.
13. The method according to any one of clauses 1 to 12, further comprising locking at least one of a connecting portion of the first medical device and a connecting portion of the second medical device to the other one of the connecting portion of the first medical device and the connecting portion of the second medical device.
14. The method according to any one of clauses 1 to 13, wherein the first medical device and the second medical device are operative connected together so that the first medical device is operated via the second medical device.
15. The method according to any one of clauses 1 to 14, further comprising installing a hemostatic device to the subject body to provide hemostasis to one of the first medical device and the second medical device.
16. The method according to any one of clauses 1 to 15, further comprising operating the first medical device via the second medical device connected to a controller for operating the first medical device.
17. The method according to clause 16, wherein said operating produces a therapeutic effect in the subject body.
18. The method according to clause 17, wherein the therapeutic effect comprises a hemodynamic effect.
The method according to any one of clauses 1 to 18, wherein the first medical device comprises a blood pump.
Claims
1 . An interconnector device, comprising: an interconnector body configured to be implanted in a subject body and having a first end portion and a second end portion; a first connector disposed to the first end portion of the connector body; a second connector disposed to the second end portion of the connector body; and a driveline configured to operatively couple the first connector and the second connector together.
2. The interconnector device according to claim 1 , wherein the connector body is configured to be transcatheterly implanted in the subject body.
3. The interconnector device according to claim 1 , wherein the connector body is configured to be tunneled in the subject body.
4. The interconnector device according to any one of claims 1 and 3, wherein the connector body has an elongated shape.
5. The interconnector device according to any one of claims 1 to 4, wherein the connector body has a tapered cross-sectional shape for engaging in a fluid thigh manner an access site of the subject body.
6. The interconnector device according to any one of claims 1 to 5, wherein the connector body is flexible.
7. The interconnector device according to any one of claims 1 to 6, wherein at least one of the first end portion and the second end portion of the interconnector body is configured to be atraumatic when the interconnector device is introduced through an access site of the subject body and navigated inside the subject body.
8. The interconnector device according to any one of claims 1 to 7, wherein at least one of the first end portion and the second end portion of the interconnector body has an atraumatic tapered shape.
9. The interconnector device according to any one of claims 1 to 8, wherein the first connector and the second connector are electrical connectors, and the driveline comprises an electrical conductor.
10. The interconnector device according to any one of claims 1 to 8, wherein the first connector and the second connector are mechanical connectors, and the driveline comprises a driveshaft.
11. The interconnector device according to any one of claims 1 to 10, wherein the first connector and the second connector are removably connectable.
12. The interconnector device according to any one of claims 1 to 11 , wherein the first connector is configured to connect to an implantable medical device, and the second connector is configured to connect to a controller configured to operate the implantable medical device.
13. The interconnector device according to any one of claims 1 to 12, wherein the first connector is comprised in a plurality of first connectors, the plurality of first connectors being configured to connect to a corresponding plurality of implantable medical devices, and the second connector is configured to connect to a controller configured to operate the plurality of implantable medical devices.
14. The interconnector device according to any one of claims 1 to 13, wherein at least one of the first end portion and the second end portion of the interconnector body comprises a seal configured to provide a fluid thigh engagement with a medical device.
15. The interconnector device according to any one of claims 1 to 14, wherein at least one of the first connector and the second connector comprises a seal configured to provide a fluid thigh engagement with a medical device.
16. The interconnector device according to claim 15, wherein the seal is a connector cavity seal.
17. The interconnector device according to claim 16, wherein the connector cavity seal is movable upon connection.
18. The interconnector device according to any one of claims 15 and 17, wherein the seal is a connector periphery seal.
19. The interconnector device according to any one of claims 1 to 18, further comprising an interconnector seal 1200 configured to provide a fluid thigh engagement with an access site of a subject body.
20. The interconnector device according to claim 19, wherein the interconnector seal 1200 is self-expandable.
21 . The interconnector device according to any one of claims 1 to 20, wherein at least one of the first end portion and the second end portion of the interconnector body comprises a magnet configured to magnetically interact with a medical device.
22. The interconnector device according to any one of claims 1 to 21 , wherein the interconnector body comprises a fluid passageway configured to supply a fluid to at least one of the first connector and the second connector.
23. The interconnector device according to any one of claims 1 to 22, wherein at least one of the first connector and the second connector comprises a fluid evacuation port configured to evacuate a fluid from the at least one of the first connector and the second connector.
24. The interconnector device according to any one of claims 1 to 23, wherein the interconnector body comprises a wire guide configured to guide a guidewire therethrough.
25. The interconnector device according to claim 24, wherein the wire guide is configured to assist a connection of at least one of the first connector and the second connector to a medical device.
26. The interconnector device according to any one of claims 1 to 25, further comprising a locking mechanism configured to lock at least one of the first connector and the second connector to a medical device, and to unlock at least one of the first connector and the second connector from the medical device.
27. The interconnector device according to claim 26, wherein the locking mechanism comprises a retaining element configured to retain the medical device, and an elongated control element coupled to the retaining element for operating the retaining element.
28. The interconnector device according to any one of claim 1 to 27, further comprising an anchor configured to anchor the interconnector device in the subject body.
29. The interconnector device according to any one of claim 1 to 28, further comprising an embedded controller operatively coupled to at least one of the first connector and the second connector for operating a medical device connected thereto.
30. The interconnector device according to claim 29, wherein the embedded controller is wirelessly rechargeable.
31 . The interconnector device according to any one of claims 1 to 30, wherein at least one of the first end portion and the second end portion of the interconnector body is branched out and comprises a plurality of sub-end portions having at least one first connector and at least one second connector.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202363516011P | 2023-07-27 | 2023-07-27 | |
| US63/516,011 | 2023-07-27 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025019957A1 true WO2025019957A1 (en) | 2025-01-30 |
Family
ID=94373823
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/CA2024/051004 Pending WO2025019957A1 (en) | 2023-07-27 | 2024-07-26 | Medical devices and related methods |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2025019957A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US12383723B2 (en) | 2019-10-05 | 2025-08-12 | Puzzle Medical Devices Inc. | Mammalian body implantable fluid flow influencing device |
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| US20150320991A1 (en) * | 2012-06-28 | 2015-11-12 | Plugmed Heart | Percutaneous connection device with a socket and with an extension member |
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| WO2010133567A1 (en) * | 2009-05-18 | 2010-11-25 | Cardiobridge Gmbh | Catheter pump |
| US20120046515A1 (en) * | 2010-08-20 | 2012-02-23 | Yi-Ren Woo | Assembly and method for stabilizing a percutaneous cable |
| US20120149229A1 (en) * | 2010-12-08 | 2012-06-14 | Keith Hamilton Kearsley | Modular driveline |
| US20150320991A1 (en) * | 2012-06-28 | 2015-11-12 | Plugmed Heart | Percutaneous connection device with a socket and with an extension member |
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| US12383723B2 (en) | 2019-10-05 | 2025-08-12 | Puzzle Medical Devices Inc. | Mammalian body implantable fluid flow influencing device |
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