[go: up one dir, main page]

WO2025217502A1 - Implantable medical systems with electrical canisters directly attached to anchor structures - Google Patents

Implantable medical systems with electrical canisters directly attached to anchor structures

Info

Publication number
WO2025217502A1
WO2025217502A1 PCT/US2025/024253 US2025024253W WO2025217502A1 WO 2025217502 A1 WO2025217502 A1 WO 2025217502A1 US 2025024253 W US2025024253 W US 2025024253W WO 2025217502 A1 WO2025217502 A1 WO 2025217502A1
Authority
WO
WIPO (PCT)
Prior art keywords
canister
attachment portion
implantable medical
wire
anchor structure
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
Application number
PCT/US2025/024253
Other languages
French (fr)
Inventor
Miles Alexander
Isabel MULVIHILL
Matthew Lane Pease
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shifamed Holdings LLC
Original Assignee
Shifamed Holdings LLC
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Shifamed Holdings LLC filed Critical Shifamed Holdings LLC
Publication of WO2025217502A1 publication Critical patent/WO2025217502A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00234Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/11Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139Side-to-side connections, e.g. shunt or X-connections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/068Modifying the blood flow model, e.g. by diffuser or deflector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M27/00Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/006Cerebrospinal drainage; Accessories therefor, e.g. valves

Definitions

  • the present technology generally relates to implantable medical devices and/or medical systems and, in particular, to implantable shunting systems with electrical canisters directly attached to an anchor structure.
  • Implantable devices and systems are utilized in modem medicine to provide a host of diagnostic and/or therapeutic benefits.
  • implantable shunting systems are widely used to treat a variety of patient conditions by shunting fluid from a first body region/cavity to a second body region/cavity.
  • the flow of fluid through the shunting systems is primarily controlled by the pressure gradient across the shunt lumen and the geometry (e.g., size) of the shunt lumen.
  • One challenge with conventional shunting systems is selecting the appropriate geometry of the shunt lumen for a particular patient. A lumen that is too small may not provide enough therapy to the patient, while a lumen that is too large may create new issues in the patient.
  • most conventional shunts cannot be adjusted once they have been implanted. Accordingly, once the system is implanted, the therapy provided by the shunting system cannot be adjusted or titrated to meet the patient’s individual needs.
  • Some implantable medical systems use sensors to measure physiological parameters (e.g., a shunt device that includes sensors to measure parameters in the first body region and/or the second body region).
  • sensors can give rise to certain challenges such as proper delivery of such sensors with the rest of the implantable medical system to the patient, proper positioning and orienting of the sensors once the medical system is implanted, and ensuring adequate protection of the electrical and/or mechanical components of the sensors from the external environment, which can include fluid, particulates, tissue grow th, etc. that may damage and/or interference with operation of the sensor components.
  • FIG. 1 illustrates an implantable medical system in a deployed configuration and configured in accordance w ith select embodiments of the present technology 7 .
  • FIGS. 2A and 2B are side and perspective views, respectively, of an implantable medical system configured in accordance with select embodiments of the present technology .
  • FIG. 3 illustrates select components of an anchor structure configured in accordance with select embodiments of the present technology.
  • FIG. 4 illustrates select components of the anchor structure of FIG. 3 configured in accordance with select embodiments of the present technology.
  • FIGS. 5A and 5B illustrate the implantable medical system of FIG. 2A in an unassembled state and in a partially assembled state, respectively, in accordance with select embodiments of the present technology.
  • FIG. 6 is an enlarged view of the implantable medical system of FIG. 2A configured in accordance with select embodiments of the present technology.
  • FIG. 7 is a schematic illustration of an implantable medical system configured in accordance with select embodiments of the present technology.
  • FIG. 8A is an enlarged perspective, partially cross-sectional view 7 of the implantable medical system of FIG. 2A in a fully assembled state, configured in accordance with select embodiments of the present technology.
  • FIG. 8B is an enlarged view 7 of a portion of the implantable medical system of FIG. 2A in an assembled state and having strain relief features, configured in accordance with select embodiments of the present technology.
  • FIG. 9A is a perspective view of a catheter containing the implantable medical system of FIG. 2A configured in accordance with select embodiments of the present technology’.
  • FIG. 9B is a perspective view of a catheter containing the implantable medical system of FIG. 2A with the strain relief features of FIG. 8B, configured in accordance with select embodiments of the present technology.
  • FIG. 10 is a schematic illustration of the implantable medical system of FIG. 2A implanted in a septal wall and configured in accordance with select embodiments of the present technology 7 .
  • FIG. 11 illustrates select components of an anchor structure configured in accordance with other select embodiments of the present technology.
  • the present technology is generally directed to implantable medical systems including an anchoring structure and one or more canisters housing sensors and/or other electronics.
  • the anchoring structure can be sized and shaped to securely anchor the system at a target anatomical structure within a patient, such as at or across a septal wall in the patient's heart.
  • the canisters can therefore be positioned within chambers, vessels, or other cavities adjacent the anatomical structure, such as within the right atrium and/or left atrium of the patient's heart.
  • the canisters are directly attached to the anchoring structure, e.g., via one or more wires or filaments that also form part of the anchoring structure. As described in detail throughout this Detailed Description, directly attaching the canisters to the anchoring structure is expected to provide several advantages.
  • an implantable shunting system includes an anchor structure defining a central opening, a first canister, and a second canister.
  • the anchor structure can include a wire that forms (i) a plurality of petals sized and shaped to stabilize the anchor structure across a target anatomical structure, (ii) a first attachment portion comprising a first loop, and (iii) a second attachment portion comprising a second loop.
  • the first canister can have a first end cap coupled to the first attachment portion via the first loop.
  • the second canister can have a second end cap coupled to the second attachment portion via the second loop.
  • first and second attachment portions can pull and rotate the canisters, e.g., to assist with positioning the canisters in a desired position and orientation. Positioning the canisters in the desired position may in turn further promote tissue overgrowth around the canisters.
  • the anchor frame of the shunting element can have a geometry conducive to delivery of the medical system through a catheter.
  • interatrial device As used herein, the terms “interatrial device”, “interatrial shunt device”, “IAD”, “IASD”, “interatrial shunt”, and “shunt” are used interchangeably to refer to a device that, in at least one configuration, includes a shunting element that provides a blood flow between a first chamber (e.g., a left atrium of a heart) and a second chamber (e.g., a right atrium or coronary sinus of the heart) of a patient.
  • a first chamber e.g., a left atrium of a heart
  • second chamber e.g., a right atrium or coronary sinus of the heart
  • a shunt between the atria namely the left and right atria
  • the technology' may be applied equally to devices positioned between other chambers and passages of the heart, between other parts of the cardiovascular system, or between other parts of the body.
  • any of the shunts described herein, including those referred to as “interatrial,” may nevertheless be used and/or modified to shunt between the left atria and the coronary sinus, or between the right pulmonary vein and the superior vena cava.
  • the present technology can be readily adapted for medical devices used to shunt other fluids — for example, devices used for aqueous shunting or cerebrospinal fluid shunting.
  • the present technology may also be adapted to a variety of implanted medical devices in addition to shunts.
  • the headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.
  • FIG. 1 illustrates an implantable medical system 100 (“the system 100”) in a deployed configuration and configured in accordance with select embodiments of the present technology.
  • the system 100 can be configured to shunt fluid between a first body region and a second body region when implanted in a patient (not shown).
  • the system 100 can be an adjustable shunting system configured to be implanted across a septal wall of a patient to shunt blood from the left atrium to the right atrium of the patient.
  • the system 100 includes an anchoring or stabilizing feature or structure 102 (“the anchor structure 102”) and one or more canisters (individually labeled 140a and 140b, collectively referred to as “the canisters 140”).
  • the anchor structure 102 can be configured to secure the system 100 to patient tissue and/or stabilize the position of the system 100 in a desired anatomic location.
  • the canisters 140 can be hermetically sealed housings that hold various electronic components, including, for example, sensors, energy storage components (e.g., capacitor, battery, etc.), data storage components (e.g., memory), processors, telemetry components, or the like.
  • the anchor structure 102 is composed of one or more wire or filament structures (e.g., a braided or woven wire structure) having a generally annular geometry. In some embodiments, the anchor structure 102 is composed of two separate wire structures that are woven together to collectively form the anchor structure 102.
  • a radially inward portion 111 of the anchor structure 102 defines a central opening or passage 1 13.
  • an actuation assembly 120 can be coupled to the anchor structure 102 and sit at least partially within the opening 113 and/or extend from a perimeter of the radially inward portion 111.
  • the actuation assembly 120 can define or at least partially define a lumen 104 extending through the opening 113, as descnbed in greater detail below.
  • the wire or filament structures of the anchor structure 102 form a first plurality of petals or appendages 112 and a second plurality of petals or appendages 114.
  • the wire forming pattern of the anchor structure 102 results in immediately adjacent petals of the first petals 112 not being formed by an adjacent segment of the wire structure forming the anchor structure 102.
  • the wire structure can alternate between forming a first petal 112 on a first side of the system 100 and a second petal 114 on the second side of the system 100 (e.g..
  • the portion of the wire structure that forms an individual first petal 112 at a 12:00 position may cross to the other side of the anchor structure 102 to form an individual second petal at a 3:00 position before crossing back to form another individual first petal 112 at a 5:00 position, and so on).
  • the first plurality' of petals 112 and the second plurality of petals 114 are separated by a gap (not shown).
  • the system 100 When the system 100 is deployed across a tissue structure (e.g., a septal wall — not shown), the system 100 is configured to receive patient tissue between the first petals 112 and the second petals 114, e.g., in the gap. Additionally, the first plurality of petals 112 and the second plurality of petals 114 can be at least partially biased toward one another such that the first petals 112 and the second petals 114 at least partially squeeze patient tissue received within the gap to further secure the system 100 to patient tissue.
  • a tissue structure e.g., a septal wall — not shown
  • the first petals 112 when deployed across the septal wall, the first petals 112 may reside within the left atrium, the second petals 114 may reside within the right atrium, and the gap between the first petals 112 and the second petals 114 may receive a portion of the patient’s septal wall (e.g., at the fossa ovalis).
  • the first petals 112 may be biased at least slightly toward the second petals 114 (and/or the second petals 114 may be biased at least slightly toward the first petals 112) such that the anchor structure 102 forms a slight clamping force on the portion of the septal wall within the gap 118.
  • the first petals 112 and the second petals 114 are at least partially staggered such that individual first petals 112 do not entirely overlap with individual second petals 114. Without being bound by theory, this is expected to spread the pinching force over a larger area of the septal wall.
  • the anchor structure 102 can be at least partially composed of a self-expanding material such that, after being exposed to stress and strain induced by being collapsed into a delivery tool (e.g., catheter, sheath, etc.) for delivery, it exhibits an elastic response when being deployed at body temperature.
  • a delivery tool e.g., catheter, sheath, etc.
  • the anchor structure 102 can be composed, at least in part, of Nitinol that has an austenite finish temperature below body temperature. Accordingly, the anchor structure 102 can automatically deploy (e.g.. self-expand without additional input or manipulation by a clinician) from a collapsed delivery configuration (e.g., as positioned in a deli very tool such as a catheter or sheath) to an expanded deployed configuration when released from the delivery tool.
  • the self-expanding or superelastic properties of the anchor structure 102 may also enable the anchor structure 102 to resist plastic mechanical deformation once deployed, and thus can provide a generally stable anchoring mechanism for
  • the anchor structure 102 can include an insulative or coating material.
  • suitable materials include, but are not limited to, parylene, urethane, ePTFE, or the like.
  • the anchor structure 102 can include multiple insulative/ coating layers (e.g., parylene and urethane in alternating layers).
  • the coating material can be selected to (a) improve the biocompatibility of the anchor structure 102, (b) improve the lubriciousness of the anchor structure 102, (c) improve inductive properties of the anchor structure 102, (d) improve electrical insulative properties of the anchor structure 102, and/or (e) improve thermal insulative properties of the anchor structure 102. Additional details regarding anchoring features suitable for use with the system 100 are described in International Patent Application Publication Nos. WO 2023/064479 and WO 2024/137843, the disclosures of which are incorporated by reference herein in their entireties.
  • the actuation assembly 120 includes an actuator 121 partially or fully covered by a membrane 105 that is fluidically impermeable or at least substantially fluidically impermeable to blood and/or other bodily fluids (the portion of the actuator 121 covered by the membrane 105 is shown in broken line in FIG. 1). Together, the actuator 121 and the membrane 105 form a generally conical, frustoconical, funnel, cylindrical, or hyperboloid shape with an opening on both ends of the “cone.”’ In this way, the actuation assembly 120 at least partially defines the lumen 104 extending through the system 100, as described above.
  • the actuation assembly 120 is configured to change one or more therapy parameters associated with the shunt (e.g., fluid resistance, lumen size, orifice size, flow rate, etc.) to control the therapy provided by the system 100.
  • the actuation assembly 120 can be transitioned between a plurality of unique positions or configurations, with each unique position or configuration providing a different fluid resistance through the lumen 104. Additional details regarding actuation assemblies such as the actuation assembly 120 are described in International Patent Application Publication No. WO 2024/137843, previously incorporated by reference herein.
  • the actuator 121 is omitted and the system 100 provides a static (e.g., not adjustable) lumen.
  • each of the canisters 140 can include sensors (e.g.. temperature sensors, pressure sensors) and/or other electrical components (e.g., energy storage components, telemetry components, data storage components, etc.).
  • the canisters 140 can be connected to each other and/or other components via one or more electrical leads 130 that extend from end portions of the canisters 140.
  • the electrical leads 130 can be configured to transfer power and/or data.
  • the data gathered by the electrical components in the canisters 140 can be used to control the actuation assembly 120. While the canisters 140 are shown separated from the anchor structure 102 in FIG.
  • each of the canisters 140 can be directly attached to the anchor structure 102 as indicated by the dashed lines, e.g., via one or more wires or filaments that also form part of the anchoring structure.
  • the canisters 140 can be positioned in apposition with (e.g., overlapping and/or directly touching) the anchor structure 102. Further details regarding coupling the canisters 140 to the anchoring structure 102, as well as the position and orientation of the canisters 140 relative to the anchor structure 102, are described below with respect to FIGS. 2 A. 2B. 6, 7, and 10.
  • FIGS. 2A and 2B are side and perspective views, respectively, of an implantable medical system 200 (“the system 200”) configured in accordance with select embodiments of the present technology.
  • the system 200 can be generally similar to the system 100 described with reference to FIG. 1, and can therefore also be implanted in a septal wall for shunting fluid between atria, or elsewhere in a patient, as discussed above with respect to the system 100 of FIG. 1. Accordingly, comparing FIGS. 1 and 2. similarly labeled components can represent components that are identical or generally similar in structure and/or function.
  • the system 200 includes an anchor structure 202, a first canister 240a, a second canister 240b (collectively referred to as “the canisters 240”), and a charge coil 250.
  • the anchor structure 202 can include a first end portion 203a (e.g., comprising a plurality of first petals, fingers, or the like) and a second end portion 203b (e.g.. comprising a plurality of second petals, fingers, or the like) opposite the first end portion 203a.
  • the charge coil 250 can be disposed at least partially between the first end portion 203a and the second end portion 203b, e.g., in the gap formed between the first end portion 203a and the second end portion 203b that is sized and shaped to receive patient tissue when the system 200 is implanted in a patient. As a result, when the system 200 is deployed across a tissue wall, the charge coil 250 is positioned between either the first end portion 203a or the second end portion 203b and the tissue wall.
  • the system 200 can also include an actuation assembly 220 (FIG. 2B). which can be generally similar to or the same as the actuation assembly 120 described with respect to FIG. 1.
  • the actuation assembly 220 includes a plurality of petals or projections 206 (FIG. 2B) that define a lumen 204 for blood flow therethrough.
  • a portion of the actuation assembly 220 e.g., a wire frame
  • the system 200 can also include a first connector subassembly 210 (e.g., a first cap) for electrically connecting the actuation assembly 220 to a portion of the anchor structure 202 to enable resistive heating of the actuation assembly 220, as described in further detail below with reference to FIG. 4 and in International Patent Application Publication No. WO 2024/137843, previously incorporated by reference herein.
  • a first connector subassembly 210 e.g., a first cap
  • the canisters 240 can include sensors and/or other electronics for measuring and/or processing one or more physiological parameters.
  • the canisters 240 can also house one or more energy storage components (e.g., a supercapacitor, a battery, etc.), one or more data storage components (e.g., memory), one or more processors, one or more telemetry components, or other electronic components.
  • the first canister 240a and the second canister 240b can be connected to one another via an electrical lead 230.
  • One or more aspects of the system 200 can be covered by a membrane, e.g., to improve biocompatibility, lubriciousness, tissue response characteristics, etc.
  • the anchor structure 202, the canisters 240, and/or the components thereof can each be covered with one or more membranes 205 such as a layer of ePTFE or other suitable material.
  • each of the first canister 240a, the second canister 240b, the anchor structure 202, and the actuation assembly 220 are covered by separate (e.g., distinct) membranes 205, which can be of the same or different materials.
  • the anchor structure 202 can be formed via one or more wires. End portions of at least one of the one or more wires can be secured in a second connector subassembly 212. described in greater detail below with reference to FIG. 4.
  • the canisters 240 Prior to delivery of the system 200 to the implantation site within a patient, the canisters 240 can be directly attached to a portion of the one or more wires that form the anchor structure 202, and the electrical lead 230 can be intertwined with the charge coil 250.
  • the first end portion 203a of the anchor structure 202 and the first canister 240a can be positioned in the left atrium, and the second end portion 203b of the anchor structure 202 and the second canister 240b can be positioned in the right atrium.
  • directly attaching the canisters 240 to the anchor structure 202 may help properly position and orient the canisters 240, and also promote tissue growth around the canisters 240.
  • FIG. 3 illustrates an anchor frame 300 of the anchor structure 202 configured in accordance with select embodiments of the present technology.
  • the anchor frame 300 can include a first wire 310 and a second wire 320 that are intertwined and/or arranged in a braided or woven structure having a generally annular geometry’ to define the lumen 204.
  • the first wire 310 and the second wire 320 can be composed at least in part of a common material, such as Nitinol, set to have superelastic properties at body temperature.
  • the first wire 310 can further include a conductive cladding/coating (e.g., silver or copper cladding) surrounding the Nitinol core, whereas the second wire 320 does not include the conductive cladding.
  • the conductive portion of the material can be interior to a Nitinol shell.
  • the conductive material may be combined with or interfaced with materials other than Nitinol to comprise a hybrid material structure.
  • the first wire 310 can therefore have more favorable electrical properties to function as an inductor or antenna to wirelessly receive energy transmissions (e.g., to resistively heat the actuation assembly 220 (FIG. 2B) and/or to charge one or more active components such as the sensors included in the canisters 240, etc.), while the second wire 320 can function with more favorable mechanical properties (e.g., stronger superelasticity’) to mechanically stabilize the system 200.
  • the first wire 310 and/or the second wire 320 can interface with other components (e.g., capacitors, inductors, resistors, microcontrollers, etc.) to aid in the functions of acting as an inductor or antenna.
  • the first wire 310 can include a first end portion 315 that is electrically coupled to a capacitor (not shown) and the actuation assembly 220 (FIG. 2B), such that the first wire 310, the capacitor, and the actuation assembly 220 form an RLC circuit, described in greater detail below with reference to FIG. 4.
  • the first wire 310 and the second wire 320 are part of the same wire.
  • first wire 310 and the second wire 320 are part of different wires. Additional details regarding using stabilizing/anchoring features as inductors are described in International Patent Application Publication No. WO 2022/081980 and International Patent Application Publication No. WO 2024/137843, the disclosures of which are incorporated by reference herein in their entireties.
  • the first wire 310 and the second wire 320 can each form a plurality of curved portions 31 1 , 321 (e.g., pointed portions, triangular portions).
  • the curved portions 311 , 321 can correspond to the petals of the first end portion 203a and the second end portion 203b (FIG. 2B).
  • individual and adjacent curved portions 311 of the first wire 310 can alternate between forming part of the first end portion 203a and the second end portion 203b
  • individual and adjacent curved portions 321 of the second wire 320 can alternate between being forming part of the first end portion 203a and the second end portion 203b. In this way, both the first wire 310 and the second wire 320 form portions of the first end portion 203a and the second end portion 203b.
  • the second wire 320 also forms a first attachment portion 322a and a second attachment portion 322b (collectively referred to as “‘the attachment portions 322") in addition to forming the curved portions 321.
  • each of the attachment portions 322 comprises an elongate, curved loop that extends longer than each of the curved portions 321.
  • the attachment portions 322 can be used to directly attach the canisters 240 (FIG. 2B) to the anchor structure 202.
  • each attachment portion 322 acts as the only attachment portion for the corresponding canister.
  • a first canister (not shown) is coupled to the anchor structure 202 only via the first attachment portion 322a
  • a second canister (not shown) is coupled to the anchor structure 202 only via the second attachment portion 322b.
  • the attachment portions 322 can nevertheless control a position and/or orientation of the canisters through biasing forces.
  • the first attachment portion 322a and the second attachment portion 322b are connected to the remainder of the second wire 320 via two first wire portions 324a and two second wire portions 324b, respectively.
  • the attachment portions 322 are positioned and oriented such that the two wire portions 324a extending from the first attachment portion 322a are positioned on a first side of the anchor frame 300 without intertwining with other wire portions until closer to the lumen 204, and the two wire portions 324b extending from the second attachment portion 322b are positioned on a second side of the anchor frame 300 without intertwining with other wire portions until closer to the lumen 204.
  • attachment portions 322 and corresponding first and second wire portions 324a, 324b is expected to improve the flexibility of the anchor frame 300, which in some embodiments may assist with deliver ⁇ ' of the system 200 to a patient as discussed further below.
  • the shape and orientation of the attachment portions 322 and the wire portions 324 can also be set to control the position and orientation of the canisters 240, as described in greater detail below with reference to FIG. 10.
  • the first attachment portion 322a and the second attachment portion 322b are also directly connected to each other via a straight wire portion 326 that generally extends linearly or at least substantially linearly therebetween.
  • the wire portion 326 can serve as a backbone to assist with deliver ⁇ 7 of the system 200 (e.g., through a catheter).
  • the wire portion 326 can directly transfer a pushing force applied to the first canister 240a coupled to the first attachment portion 322a to the second canister 240b coupled to the second attachment portion 322b.
  • This geometry is expected to be advantageous over other geometries in which, for example, the first attachment portion 322a is indirectly connected to the second attachment portion 322b through one or more of the curved portions 321 because in such embodiments, the curved portions 321a may act as a spring that absorbs at least some of the pushing force.
  • FIG. 4 illustrates the anchor frame 300 with additional aspects of the system 200, but with the canisters 240 omitted for purposes of illustration.
  • FIG. 4 illustrates the membrane 205 coupled to and at least partially covering the anchor frame 300.
  • the membrane 205 covers the curved portions 311, 321 (FIG. 3), but does not cover the attachment portions 322. That is, the attachment portions 311, 321 extend beyond the membrane 205, which enables the canisters 240 (FIGS. 2A and 2B) to be coupled thereto.
  • FIG. 4 also illustrates the actuation assembly 220 coupled to the anchor frame 300.
  • the actuation assembly can be electrically coupled to the anchor frame 300 at the first connector subassembly 210.
  • the first connector subassembly 210 can comprise a housing (e.g., a potted cap) that encloses the first end portion 315 (FIG. 3) of the first wire 310, one or more electrical components such as capacitors (e.g., resonant capacitors; not shown), and an end wire portion of the actuation assembly 220.
  • FIG. 4 also more clearly illustrates the second connector subassembly 212. Similar to the first connector subassembly 210, the second connector subassembly 212 can comprise a housing (e.g., a potted cap) that encloses the second end portion 325 (FIG. 3) of the second wire 320.
  • a housing e.g., a potted cap
  • the second connector subassembly can be designed to keep the two ends of the second wire 320 electrically isolated such that the second wire 320 forms an open circuit.
  • the second connector subassembly 212 can maintain a gap between the two open ends of the second wire 320. and can be filled (e.g., potted) with a non-conductive material (e.g., an epoxy). Separating the two open ends of the second end portion 325 can effectively create an open circuit and thereby prevent, or at least reduce, current flow through the second wire 320.
  • the system 200 includes fewer (e.g., one) or more (e.g., three, four, five, six, etc.) canisters 240 and a corresponding number of attachment portions 322.
  • the first end portion 315 and/or the second end portion 325 are disposed inside of the first and/or second canisters 240a, 240b instead of the first or second caps 410, 420.
  • the anchor structure 202 is illustrated in FIGS. 2A, 2B, and 4 as being coupled to the actuation assembly 220 including the plurality of petals 206 that define the lumen 204 for blood flow therethrough, in some embodiments, the anchor structure 202 can be implanted without the actuation assembly 220.
  • the canisters 240 can be attached to the attachment portions 322 and form an implantable medical system that provides sensors readings (e.g., pressure readings) via the canisters 240. but does not shunt fluid betw een adjacent chambers.
  • the anchor structure 202 may not form the lumen 204 (e.g., the first wire 310 and/or the second wire 320 can extend across the area of the lumen 204) or the lumen 204 may be covered by a membrane or other structure.
  • FIGS. 5A and 5B illustrate the implantable medical system 200 in a first partially assembled state and in a second partially assembled state, respectively, in accordance with select embodiments of the present technology.
  • the anchor structure 202 is illustrated separate from (e.g., not yet coupled to) the charge coil 250.
  • the charge coil 250 can include an outer coiled portion 252 and an inner loop portion 254. Also, the first canister 240a and the second canister 240b are coupled together via the electrical lead 230, but are likewise illustrated separate from (e.g., not yet coupled to) the anchor structure 202.
  • the charge coil 250 (not visible in FIG. 5B) is coupled to the anchor structure 202.
  • both the outer coiled portion 252 and the inner loop portion 254 can be disposed at least partially between the first end portion 203a and the second end portion 203b, as illustrated in FIGS. 2A and 2B and below in FIG. 7.
  • the canisters 240 and the electrical lead 230 are not yet coupled to the anchor structure 202 or the charge coil 250. Moreover, while the canisters 240 are shown in FIGS. 5A and 5B without a membrane, a membrane can be applied to each of the canisters 240 at a later stage during the assembly process.
  • FIG. 6 is an enlarged view of the implantable medical system 200 showing a third partially assembled state that occurs later in the assembly process than the first partially assembled state (FIG. 5A) and the second partially assembled state (FIG. 5B).
  • FIG. 6 shows the first canister 240a, without the membrane 205, in the process of being coupled to the anchor structure 202 at the first attachment portion 322a.
  • the first canister 240a can include a cylindrical body portion 642 and a primary end cap 644 coupled to (e.g., welded to) an end of the cylindrical body portion 642.
  • the primary end cap 644 comprises a dome-shaped or hemispherical end cap.
  • the primary end cap 644 can comprise other shapes, such as ellipsoidal, rectangular, flat, etc.
  • the cylindrical body portion 642 and the primary end cap 644 can be composed of metal (e.g., titanium) or other suitable materials, and can be manufactured via machining, additive manufacturing (e.g., 3D printing), etc.
  • the cylindrical body portion 642 of the first canister 240a can be slid in between the two wire portions 324a, e.g., such that the loop of the first attachment portion 322a extends around the end cap 644 and the electrical lead 230 extends through the loop.
  • the two wire portions 324a can be at least partially displaced (e.g., spread apart) while the cylindrical body portion 642 is passed therethrough.
  • the electrical lead 230 is shown as extending from the primary end cap 644, in some embodiments, the electrical lead 230 is attached to the first canister 240a at the end opposite the end cap 644 to avoid the step of sliding the first canister 240a in between the two wire portions 324a.
  • FIG. 7 is a schematic illustration of the system 200 showing yet another partially assembled state that occurs during the process of coupling the canisters 240 to the anchor structure 202.
  • the second canister 240b can be slid or weaved inside of the outer coiled portion 252 of the charge coil 250 but outside of the inner loop portion 254 of the charge coil 250.
  • the second canister 240b can be weaved through the charge coil 250 such that the electrical lead 230 is positioned between the outer coiled portion 252 and the inner loop portion 254.
  • first canister 240a can be positioned adjacent the first end portion 203a while the second canister 240b is positioned adjacent the second end portion 203b.
  • the second canister 240b can then be coupled to the anchor structure 202 via the second attachment portion 322b (not shown in FIG. 7) by sliding the second canister 240b in between the two wire portions 324b in a manner similar to the technique described above for attaching the first canister 240a to the first attachment portion 322a.
  • FIG. 8 A is an enlarged perspective view of a portion of the system 200, with certain components show n in cross-section for purposes of illustration.
  • the first canister 240a includes one or more wires 840 extending from within the cylindrical body portion 642, through a header 843, through the primary end cap 644. and into the electrical lead 230.
  • the wires 840 can transfer power and/or data between electrical components (not shown) housed in the interior of the first canister 240a and external components via the electrical lead 230.
  • the header 843 can be coupled (e.g., welded) between the cylindrical portion 642 and the primary end cap 644, e.g., to hermetically seal the interior of the cylindrical body portion 642.
  • the system 200 can also include a secondary end cap 846a for securing the first canister 240a to the first attachment portion 322a of the anchor structure 202.
  • the secondary end cap 846a can be sized and shaped to extend over or otherwise be positioned around the primary end cap 644.
  • the secondary end cap 846a can be coupled (e.g., wielded) to the primary end cap 644 or another structure (e.g., the header 843) while the first attachment portion 322a is disposed between the primary end cap 644 and the secondary end cap 846a, e.g., to fixedly couple the first canister 240a to the first attachment portion 322a.
  • the first canister 240a is coupled to the first attachment portion 322a at the primary end cap 644.
  • the secondary end cap 846a can include a slot, an aperture, or other opening (not visible in FIG. 8A) to allow the first attachment portion 322a to pass therethrough.
  • FIG. 8B illustrates a portion of the system 200 including a portion of the first canister 240a, the first attachment portion 322a, and another embodiment of a secondary' end cap 846b configured in accordance with select embodiments of the present technology.
  • the secondary end cap 846b includes a collar portion 847 that is sized and shaped to be positioned over the primary end cap 644.
  • the collar portion 847 can include a gap or opening 849 that enables the secondary' end cap 846b to be installed over the primary end cap 644 after the electrical lead 230 (not shown in FIG. 8B) is coupled to the first canister 240a.
  • the secondary end cap 846b further includes a pair of strain relief features 848.
  • the strain relief features 848 are curved fingers or appendages that are each aligned with individual segments 823a-b of the first attachment portion 322a as the segments 823a-b extend away 7 from first canister 240a.
  • the strain relief features 848 curve at least sightly away from the collar 847 and act as a bumper or frame against which the segments 823 a-b of the first attachment portion 322 seat when the system 200 is collapsed into a delivery configuration in a delivery catheter, as described below with reference to FIG. 9B. In this way.
  • the strain relief features 848 are expected to reduce the strain induced in the first attachment portion 322a by prefixing the degree to which the first attachment portion 322 can bend, thus reducing the likelihood of the first attachment portion 322 kinking or otherwise deforming as a result of being collapsed into a delivery configuration.
  • the curvature of the strain relief features 848 can be set based on an acceptable degree of curvature/bending for the corresponding first attachment portion 322a.
  • any gap or space between the primary' end cap 644 and the secondary end cap 846a-b is filled with a filler material to keep the first attachment portion 322a fixed in position.
  • a filler material for example, after welding or otherw ise coupling the secondary end cap 846a-b to the primary end cap 844, epoxy or other adhesives can be applied to fill the gap.
  • epoxy, another adhesive, or other suitable materials can be applied to the weld seam and/or any other gaps to ensure that the filler material does not leak out.
  • the second canister 240b (not shown in FIGS. 8A or 8B) can also include a secondary end cap and filler material between the primary and secondary end caps to keep the second attachment portion 322b fixed in position.
  • FIG. 9A is a perspective view of a catheter 900 containing the system 200 configured in accordance with select embodiments of the present technology.
  • the catheter 900 can be used to deliver the system 200 to the implantation site, such as the septal wall of a patient.
  • the system 200 can be in a collapsed delivery' state, as shown.
  • the first canister 240a and the second canister 240b can be positioned on either side of the anchor structure 202 and oriented such that the end cap of each canister 240 faces the anchor structure 202, and the electrical lead 230 extends therebetween and adjacent the anchor structure 202.
  • the charge coil 250 can be positioned adjacent the first canister 240a.
  • FIG. 9B is another perspective view of the catheter 900 containing the system 200 in an embodiment that illustrates the secondary end cap 846b with the strain relief features 848 described above with reference to FIG. 8B.
  • the strain relief features 848 define a maximum amount of curvature/bend the first attachment portion 322a can assume when in the collapsed configuration and positioned within the catheter 200. As set forth above, this is expected to advantageously reduce strain in the first attachment portion 322a, reduce kinking in the first attachment portion 322a, and reduce the likelihood of interfering with the shape set of the first attachment portion 322a.
  • the anchor frame 300 of the anchor structure 202 can be made from Nitinol and/or other suitable material such that the anchor structure 202 can be collapsed in the catheter 900 without material damage, and the anchor structure 202 can return to its original shape upon deployment from the catheter 900 at the implantation site. Also, referring back to FIG. 3, because each of the first attachment portion 322a and the second attachment portion 322b does not intertwine with other wire portions until closer to the lumen 204, the anchor structure 202 is expected to have greater flexibility than anchor structures with other wire arrangements. Furthermore, the straight wire portion 326 (FIG.
  • each of the first and second wires 310, 320 of the anchor frame 300 is a contiguous loop to better withstand the radial compressive force applied by the catheter 900 during deliver ⁇ ’.
  • FIG. 10 is a schematic illustration of the system 200 implanted in the septal wall S of a patient and configured in accordance with select embodiments of the present technology.
  • the first canister 240a is positioned in the left atrium LA and the second canister 240b is positioned in the right atrium RA.
  • the first and second canisters 240a. 240b are generally aligned with the anchor structure 202, similar to how the system 200 is illustrated in FIGS. 2 A and 2B.
  • the first and second canisters 240a, 240b are oriented in opposite directions such that the electrical lead 230 extends from each of the first and second canisters 240a, 240b in opposite directions. This positioning and orienting can help avoid contact between the components of the system 200 and certain anatomical parts of the patient.
  • the Nitinol or other material forming the anchor frame 300 of the anchor structure 202 undergoes a shape setting process such that the anchor structure 202 deploys into the desired shape when released from the catheter 900 (FIGS. 9A and 9B).
  • the first and second attachment portions 322a, 322b can exert both a force F and a moment M to the first and second canisters 240a, 240b, respectively, when the system 200 is deployed and implanted as shown in FIG. 10 (e.g.. through the primary and secondary end caps and the epoxy therebetween).
  • the forces F and the moments M can position and orient the canisters 240 in a desired manner, e.g., to extend at specific angles and to overlap when viewed in a direction normal to the septal wall S.
  • the shape setting process can be used to tune the attachment portions 322 to achieve any desired positions and orientations of the canisters 240 based on anatomical or other considerations.
  • the force F can pull the end caps of each canister 240, and thus the entire canister 240, toward the septal wall.
  • the moment M can rotate the canisters 240 such that the distal ends of the canisters 240a opposite the end caps are similarly pulled toward the septal wall.
  • the first and second attachment portions 322a, 322b can be tuned to bias the canisters 240 toward positions and orientations that may be obstructed by another system component (e.g., the anchor structure 202) and/or an anatomical structure (e.g., the septal wall).
  • the attachment portions 322 can continue to apply the forces F and the moments M to bias the canisters 240 toward apposition with the septal wall and/or the anchor structure 202, which can promote tissue growth around the canisters 240.
  • the atachment portions 322 can control a position and orientation of the canisters 240. even in embodiments in which they are coupled to only one end of the canisters 240.
  • system 200 and the components thereof can be deployed in positions and/or orientations different from the illustrated embodiment.
  • schematic illustration of FIG. 10 is not necessarily to scale, and that the components of the system 200 can have different dimensions and spacings therebetween.
  • the anchor structure 202 (i) does not include a lumen or includes an at least partially obstructed lumen (e.g., covered by a membrane) and (ii) is implanted without an actuation assembly such that the anchor structure 202 forms an implantable medical system that provides sensor readings via the canisters 240 attached to the attachment portions 322, but does not shunt fluid (e.g., between the right atrium RA and the left atrium LA).
  • FIG. 11 illustrates an anchor frame 1100 of an anchor structure 1102 configured in accordance with select embodiments of the present technology.
  • the anchor frame 1100 is generally similar to the anchor frame 300 illustrated in and described above with reference to FIG. 3. How ever, unlike the anchor frame 300 of FIG. 3 in which respective ends of the second wire 320 that form the attachment portions 322 are located spaced apart from the attachment portions 322 at the open end portion 325. respective end portions 1125a and 1 125b of the second wire 1120 of the anchor frame 1100 are located at the attachment portions 1122a, 1122b. Accordingly, as shown in FIG.
  • each of the first and second attachment portions 1122a, 1122b terminates after forming a partial, e.g., incomplete, loop, and the anchor frame 1100 does not include a backbone (e.g.. the straight wire portion 326 illustrated in FIG. 3) that extends between the first and second attachment portions 1 122a, 1122b.
  • the partial loops can terminate tow ards where the straight wire portion 326 exists in the anchor frame 300 of FIG. 3.
  • the anchor frame 1100 forms an open circuit that can prevent, or at least reduce, current flow through the second wire 1120.
  • the first and second attachment portions 1122a, 1122b of the anchor frame 1100 are not directly connected by a straight wire portion extending therebetween, and are connected only via the remainder of the second ware 1120 that is intertwined with the first wire 1110 and forms the plurality of curved portions 1121.
  • the second wire 1120 can composed of a superelastic material (e.g., Nitinol) that is shape set with sufficient stiffness to keep the canisters attached to the first and second attachment portions 322a, 322b.
  • An implantable medical system for fluidly connecting a first body region and a second body region of a patient, the system comprising: an anchor structure defining a central opening, wherein the anchor structure includes a contiguous wire, and wherein the continuous wire forms: a plurality of petals sized and shaped to stabilize the anchor structure across a target anatomical structure, a first attachment portion comprising a first at least partial loop, and a second attachment portion comprising a second at least partial loop; and a first canister having a first end cap coupled to the first attachment portion via the first at least partial loop; and a second canister having a second end cap coupled to the second attachment portion via the second at least partial loop.
  • first attachment portion is configured to position the first canister to extend across the anchor structure and offset from the opening
  • second attachment portion is configured to position the second canister to extend across the anchor structure and offset from the opening
  • first and second canisters are oriented in opposite directions.
  • each of the first and second end caps comprises a primary end cap and a secondary end cap positioned around and coupled to the primary end cap. wherein each of the first and second attachment portions is at least partially disposed in a gap between the primary end cap and the secondary end cap of the first and second canisters, respectively.
  • each of the secondary end caps include a pair of curved strain relief features sized and shaped to define a maximum curvature for a corresponding portion of the first attachment portion or the second attachment portion.
  • each of the first and second attachment portions is configured to apply a force and a moment on each of the first and second canisters, respectively, wherein the force pulls each of the first and second end caps towards the anchor structure, and wherein the moment rotates each of the first and second canisters such that distal end portions of the first and second canisters opposite the first and second end caps are biased toward the anchor structure.
  • first attachment portion and the second attachment portion are configured to apply a continuous force on the first canister and the second canister, respectively, toward the target anatomical structure while the system is implanted at the target anatomical structure and in operation.
  • first at least partial loop comprises a first loop
  • second at least partial loop comprises a second loop
  • respective ends of the contiguous wire are spaced apart from the first loop and the second loop.
  • first at least partial loop comprises a first incomplete loop structure
  • second at least partial loop comprises a second incomplete loop structure
  • respective ends of the contiguous wire are located at the first incomplete loop structure and the second incomplete loop structure.
  • An implantable medical device comprising: an anchor structure sized and shaped to secure the implantable device across an anatomical structure of a patient and formed at least in part by a wire, the wire having — a first portion configured to reside on a first side of the anatomical structure, a first attachment portion connected to the first portion, a second portion configured to reside on a second side of the anatomical structure, opposite the first side, and a second attachment portion connected to the second portion; a first canister housing a first sensor, wherein the first canister is coupled to the first attachment portion of the anchor structure; and a second canister housing a second sensor, wherein the second canister is coupled to the second attachment portion of the anchor structure.
  • the implantable medical device of example 14 wherein the first portion includes a plurality of first petals, and wherein the second portion includes a plurality of second petals. 16. The implantable medical device of example 15 wherein the wire alternates between forming individual first petals of the first portion and individual second petals of the second portion.
  • the first canister has a first end region and a second end region spaced apart from the first end region by a length of the first canister, the first canister is coupled to the first attachment portion at the first end region, and the second end region is not directly attached to the anchor structure.
  • strain relief features include a projection that curves away from an end portion of the first canister and that is aligned with a segment of the first attachment portion.
  • An implantable medical device comprising: an anchor structure sized and shaped to secure the implantable device across an anatomical structure of a patient, wherein the anchor structure is formed at least in part by a wire, the wire having a first portion configured to reside on a first side of the anatomical structure, a second portion configured to reside on a second side of the anatomical structure opposite the first side, and an attachment portion, wherein the attachment portion is integral with the first portion and/or the second portion; and a canister housing a sensor configured to measure a physiological parameter of the patient, wherein the canister is coupled to the anchor structure at the attachment portion.
  • Embodiments of the present disclosure may include some or all of the following components: a battery, supercapacitor, or other suitable power source; a microcontroller, FPGA, ASIC, or other programmable component or system capable of storing and executing software and/or firmware that drives operation of an implant; memory such as RAM or ROM to store data and/or software/firmware associated with an implant and/or its operation; wireless communication hardware such as an antenna system configured to transmit via Bluetooth, WiFi, or other protocols known in the art; energy harvesting means, for example a coil or antenna which is capable of receiving and/or reading an externally-provided signal which may be used to power the device, charge a battery, initiate a reading from a sensor, or for other purposes.
  • Embodiments may also include one or more sensors, such as pressure sensors, impedance sensors, accelerometers, force/strain sensors, temperature sensors, flow sensors, optical sensors, cameras, microphones or other acoustic sensors, ultrasonic sensors, ECG or other cardiac rhythm sensors, SpCh and other sensors adapted to measure tissue and/or blood gas levels, blood volume sensors, and other sensors known to those who are skilled in the art.
  • Embodiments may include portions that are radiopaque and/or ultrasonically reflective to facilitate image-guided implantation or image guided procedures using techniques such as fluoroscopy, ultrasonography, or other imaging methods.
  • Embodiments of the system may include specialized delivery catheters/sy stems that are adapted to deliver an implant and/or carry out a procedure.
  • Systems may include components such as guidewires, sheaths, dilators, and multiple deliver ⁇ ' catheters. Components may be exchanged via over- the- wire, rapid exchange, combination, or other approaches.
  • the words “comprise,” “comprising,” and the like are to be constmed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.”
  • the terms “connected,” “coupled,” or any variant thereof means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof.
  • the words ‘'herein,’’ ‘'above,” ‘'below,” and words of similar import when used in this application, shall refer to this application as a whole and not to any particular portions of this application.

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The present technology is generally directed to implantable medical systems including an anchoring structure and one or more canisters housing sensors and/or other electronics. The anchoring structure can be sized and shaped to securely anchor the system at a target anatomical structure within a patient. In many of the embodiments described herein, the canisters are directly attached to the anchoring structure, e.g., via one or more wires or filaments that also form part of the anchoring structure. Directly attaching the canisters to the anchor structure is expected to improve the positioning of the canisters, promote tissue growth around the canisters, and/or provide other expected advantages.

Description

IMPLANTABLE MEDICAL SYSTEMS WITH ELECTRICAL
CANISTERS DIRECTLY ATTACHED TO ANCHOR STRUCTURES
CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] The present application claims priority to U.S. Provisional Patent Application No. 63/633,253, filed April 12, 2024, and U.S. Provisional Patent Application No. 63/643,716, filed May 7, 2024, the disclosures of which are incorporated by reference herein in their entireties.
TECHNICAL FIELD
[0002] The present technology generally relates to implantable medical devices and/or medical systems and, in particular, to implantable shunting systems with electrical canisters directly attached to an anchor structure.
BACKGROUND
[0003] Implantable devices and systems are utilized in modem medicine to provide a host of diagnostic and/or therapeutic benefits. For example, implantable shunting systems are widely used to treat a variety of patient conditions by shunting fluid from a first body region/cavity to a second body region/cavity. The flow of fluid through the shunting systems is primarily controlled by the pressure gradient across the shunt lumen and the geometry (e.g., size) of the shunt lumen. One challenge with conventional shunting systems is selecting the appropriate geometry of the shunt lumen for a particular patient. A lumen that is too small may not provide enough therapy to the patient, while a lumen that is too large may create new issues in the patient. Despite this, most conventional shunts cannot be adjusted once they have been implanted. Accordingly, once the system is implanted, the therapy provided by the shunting system cannot be adjusted or titrated to meet the patient’s individual needs.
[0004] Some implantable medical systems use sensors to measure physiological parameters (e.g., a shunt device that includes sensors to measure parameters in the first body region and/or the second body region). However, including such sensors can give rise to certain challenges such as proper delivery of such sensors with the rest of the implantable medical system to the patient, proper positioning and orienting of the sensors once the medical system is implanted, and ensuring adequate protection of the electrical and/or mechanical components of the sensors from the external environment, which can include fluid, particulates, tissue grow th, etc. that may damage and/or interference with operation of the sensor components.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology'. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the component is necessarily transparent. Components may also be shown schematically.
[0006] FIG. 1 illustrates an implantable medical system in a deployed configuration and configured in accordance w ith select embodiments of the present technology7.
[0007] FIGS. 2A and 2B are side and perspective views, respectively, of an implantable medical system configured in accordance with select embodiments of the present technology .
[0008] FIG. 3 illustrates select components of an anchor structure configured in accordance with select embodiments of the present technology.
[0009] FIG. 4 illustrates select components of the anchor structure of FIG. 3 configured in accordance with select embodiments of the present technology.
[0010] FIGS. 5A and 5B illustrate the implantable medical system of FIG. 2A in an unassembled state and in a partially assembled state, respectively, in accordance with select embodiments of the present technology.
[0011] FIG. 6 is an enlarged view of the implantable medical system of FIG. 2A configured in accordance with select embodiments of the present technology.
[0012] FIG. 7 is a schematic illustration of an implantable medical system configured in accordance with select embodiments of the present technology.
[0013] FIG. 8A is an enlarged perspective, partially cross-sectional view7 of the implantable medical system of FIG. 2A in a fully assembled state, configured in accordance with select embodiments of the present technology.
[0014] FIG. 8B is an enlarged view7 of a portion of the implantable medical system of FIG. 2A in an assembled state and having strain relief features, configured in accordance with select embodiments of the present technology. [0015] FIG. 9A is a perspective view of a catheter containing the implantable medical system of FIG. 2A configured in accordance with select embodiments of the present technology’.
[0016] FIG. 9B is a perspective view of a catheter containing the implantable medical system of FIG. 2A with the strain relief features of FIG. 8B, configured in accordance with select embodiments of the present technology.
[0017] FIG. 10 is a schematic illustration of the implantable medical system of FIG. 2A implanted in a septal wall and configured in accordance with select embodiments of the present technology7.
[0018] FIG. 11 illustrates select components of an anchor structure configured in accordance with other select embodiments of the present technology.
DETAILED DESCRIPTION
[0019] The present technology is generally directed to implantable medical systems including an anchoring structure and one or more canisters housing sensors and/or other electronics. The anchoring structure can be sized and shaped to securely anchor the system at a target anatomical structure within a patient, such as at or across a septal wall in the patient's heart. The canisters can therefore be positioned within chambers, vessels, or other cavities adjacent the anatomical structure, such as within the right atrium and/or left atrium of the patient's heart. In many of the embodiments described herein, the canisters are directly attached to the anchoring structure, e.g., via one or more wires or filaments that also form part of the anchoring structure. As described in detail throughout this Detailed Description, directly attaching the canisters to the anchoring structure is expected to provide several advantages.
[0020] In some embodiments, an implantable shunting system includes an anchor structure defining a central opening, a first canister, and a second canister. The anchor structure can include a wire that forms (i) a plurality of petals sized and shaped to stabilize the anchor structure across a target anatomical structure, (ii) a first attachment portion comprising a first loop, and (iii) a second attachment portion comprising a second loop. The first canister can have a first end cap coupled to the first attachment portion via the first loop. The second canister can have a second end cap coupled to the second attachment portion via the second loop.
[0021] As explained in detail below, directly attaching the canisters to the anchoring element or shunting element may provide several advantages. For example, the first and second attachment portions can pull and rotate the canisters, e.g., to assist with positioning the canisters in a desired position and orientation. Positioning the canisters in the desired position may in turn further promote tissue overgrowth around the canisters. Also, as discussed further herein, the anchor frame of the shunting element can have a geometry conducive to delivery of the medical system through a catheter. Some embodiments of the present technology may have other advantages in addition to or in lieu of those identified above.
[0022] The terminology' used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below: however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology' can include other embodiments that are within the scope of the examples but are not described in detail with respect to FIGS. 1-11.
[0023] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.
[0024] Reference throughout this specification to relative terms such as, for example, “substantially,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%.
[0025] As used herein, the terms “interatrial device”, “interatrial shunt device”, “IAD”, “IASD”, “interatrial shunt”, and “shunt” are used interchangeably to refer to a device that, in at least one configuration, includes a shunting element that provides a blood flow between a first chamber (e.g., a left atrium of a heart) and a second chamber (e.g., a right atrium or coronary sinus of the heart) of a patient. Although described in terms of a shunt between the atria, namely the left and right atria, one will appreciate that the technology' may be applied equally to devices positioned between other chambers and passages of the heart, between other parts of the cardiovascular system, or between other parts of the body. For example, any of the shunts described herein, including those referred to as “interatrial,” may nevertheless be used and/or modified to shunt between the left atria and the coronary sinus, or between the right pulmonary vein and the superior vena cava. Moreover, while the disclosure herein primarily describes medical devices for shunting blood in the heart, the present technology can be readily adapted for medical devices used to shunt other fluids — for example, devices used for aqueous shunting or cerebrospinal fluid shunting. The present technology may also be adapted to a variety of implanted medical devices in addition to shunts. The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.
A. Select Embodiments of Implantable Medical Systems with Electrical Canisters Directly Attached to an Anchor Structure
[0026] FIG. 1 illustrates an implantable medical system 100 (“the system 100”) in a deployed configuration and configured in accordance with select embodiments of the present technology. As described in detail below, the system 100 can be configured to shunt fluid between a first body region and a second body region when implanted in a patient (not shown). For example, the system 100 can be an adjustable shunting system configured to be implanted across a septal wall of a patient to shunt blood from the left atrium to the right atrium of the patient.
[0027] The system 100 includes an anchoring or stabilizing feature or structure 102 (“the anchor structure 102”) and one or more canisters (individually labeled 140a and 140b, collectively referred to as “the canisters 140”). The anchor structure 102 can be configured to secure the system 100 to patient tissue and/or stabilize the position of the system 100 in a desired anatomic location. The canisters 140 can be hermetically sealed housings that hold various electronic components, including, for example, sensors, energy storage components (e.g., capacitor, battery, etc.), data storage components (e.g., memory), processors, telemetry components, or the like.
[0028] In the illustrated embodiment, the anchor structure 102 is composed of one or more wire or filament structures (e.g., a braided or woven wire structure) having a generally annular geometry. In some embodiments, the anchor structure 102 is composed of two separate wire structures that are woven together to collectively form the anchor structure 102. A radially inward portion 111 of the anchor structure 102 defines a central opening or passage 1 13. As described in detail below, an actuation assembly 120 can be coupled to the anchor structure 102 and sit at least partially within the opening 113 and/or extend from a perimeter of the radially inward portion 111. The actuation assembly 120 can define or at least partially define a lumen 104 extending through the opening 113, as descnbed in greater detail below. [0029] In the illustrated embodiment, the wire or filament structures of the anchor structure 102 form a first plurality of petals or appendages 112 and a second plurality of petals or appendages 114. In some embodiments, the wire forming pattern of the anchor structure 102 results in immediately adjacent petals of the first petals 112 not being formed by an adjacent segment of the wire structure forming the anchor structure 102. Instead, the wire structure can alternate between forming a first petal 112 on a first side of the system 100 and a second petal 114 on the second side of the system 100 (e.g.. the portion of the wire structure that forms an individual first petal 112 at a 12:00 position may cross to the other side of the anchor structure 102 to form an individual second petal at a 3:00 position before crossing back to form another individual first petal 112 at a 5:00 position, and so on). The first plurality' of petals 112 and the second plurality of petals 114 are separated by a gap (not shown).
[0030] When the system 100 is deployed across a tissue structure (e.g., a septal wall — not shown), the system 100 is configured to receive patient tissue between the first petals 112 and the second petals 114, e.g., in the gap. Additionally, the first plurality of petals 112 and the second plurality of petals 114 can be at least partially biased toward one another such that the first petals 112 and the second petals 114 at least partially squeeze patient tissue received within the gap to further secure the system 100 to patient tissue. For example, when deployed across the septal wall, the first petals 112 may reside within the left atrium, the second petals 114 may reside within the right atrium, and the gap between the first petals 112 and the second petals 114 may receive a portion of the patient’s septal wall (e.g., at the fossa ovalis). The first petals 112 may be biased at least slightly toward the second petals 114 (and/or the second petals 114 may be biased at least slightly toward the first petals 112) such that the anchor structure 102 forms a slight clamping force on the portion of the septal wall within the gap 118. In some embodiments, the first petals 112 and the second petals 114 are at least partially staggered such that individual first petals 112 do not entirely overlap with individual second petals 114. Without being bound by theory, this is expected to spread the pinching force over a larger area of the septal wall.
[0031] The anchor structure 102 can be at least partially composed of a self-expanding material such that, after being exposed to stress and strain induced by being collapsed into a delivery tool (e.g., catheter, sheath, etc.) for delivery, it exhibits an elastic response when being deployed at body temperature. For example, the anchor structure 102 can be composed, at least in part, of Nitinol that has an austenite finish temperature below body temperature. Accordingly, the anchor structure 102 can automatically deploy (e.g.. self-expand without additional input or manipulation by a clinician) from a collapsed delivery configuration (e.g., as positioned in a deli very tool such as a catheter or sheath) to an expanded deployed configuration when released from the delivery tool. In some embodiments, the self-expanding or superelastic properties of the anchor structure 102 may also enable the anchor structure 102 to resist plastic mechanical deformation once deployed, and thus can provide a generally stable anchoring mechanism for the system 100.
[0032] In some embodiments, some or all of the anchor structure 102 can include an insulative or coating material. Examples of suitable materials include, but are not limited to, parylene, urethane, ePTFE, or the like. In some embodiments, the anchor structure 102 can include multiple insulative/ coating layers (e.g., parylene and urethane in alternating layers). The coating material can be selected to (a) improve the biocompatibility of the anchor structure 102, (b) improve the lubriciousness of the anchor structure 102, (c) improve inductive properties of the anchor structure 102, (d) improve electrical insulative properties of the anchor structure 102, and/or (e) improve thermal insulative properties of the anchor structure 102. Additional details regarding anchoring features suitable for use with the system 100 are described in International Patent Application Publication Nos. WO 2023/064479 and WO 2024/137843, the disclosures of which are incorporated by reference herein in their entireties.
[0033] The actuation assembly 120 includes an actuator 121 partially or fully covered by a membrane 105 that is fluidically impermeable or at least substantially fluidically impermeable to blood and/or other bodily fluids (the portion of the actuator 121 covered by the membrane 105 is shown in broken line in FIG. 1). Together, the actuator 121 and the membrane 105 form a generally conical, frustoconical, funnel, cylindrical, or hyperboloid shape with an opening on both ends of the “cone."’ In this way, the actuation assembly 120 at least partially defines the lumen 104 extending through the system 100, as described above. Accordingly, when the system 100 is implanted in a patient (e.g., across a septal wall of the patient), fluid can flow through the system 100 via the lumen 104 extending through the actuation assembly 120. The actuation assembly 120 is configured to change one or more therapy parameters associated with the shunt (e.g., fluid resistance, lumen size, orifice size, flow rate, etc.) to control the therapy provided by the system 100. For example, the actuation assembly 120 can be transitioned between a plurality of unique positions or configurations, with each unique position or configuration providing a different fluid resistance through the lumen 104. Additional details regarding actuation assemblies such as the actuation assembly 120 are described in International Patent Application Publication No. WO 2024/137843, previously incorporated by reference herein. In some embodiments, the actuator 121 is omitted and the system 100 provides a static (e.g., not adjustable) lumen.
[0034] As set forth above, each of the canisters 140 can include sensors (e.g.. temperature sensors, pressure sensors) and/or other electrical components (e.g., energy storage components, telemetry components, data storage components, etc.). The canisters 140 can be connected to each other and/or other components via one or more electrical leads 130 that extend from end portions of the canisters 140. The electrical leads 130 can be configured to transfer power and/or data. In some embodiments, the data gathered by the electrical components in the canisters 140 can be used to control the actuation assembly 120. While the canisters 140 are shown separated from the anchor structure 102 in FIG. 1 for illustrative purposes, each of the canisters 140 (e.g., a hemispherical or other end portion thereol) can be directly attached to the anchor structure 102 as indicated by the dashed lines, e.g., via one or more wires or filaments that also form part of the anchoring structure. In such embodiments, the canisters 140 can be positioned in apposition with (e.g., overlapping and/or directly touching) the anchor structure 102. Further details regarding coupling the canisters 140 to the anchoring structure 102, as well as the position and orientation of the canisters 140 relative to the anchor structure 102, are described below with respect to FIGS. 2 A. 2B. 6, 7, and 10.
[0035] FIGS. 2A and 2B are side and perspective views, respectively, of an implantable medical system 200 (“the system 200”) configured in accordance with select embodiments of the present technology. The system 200 can be generally similar to the system 100 described with reference to FIG. 1, and can therefore also be implanted in a septal wall for shunting fluid between atria, or elsewhere in a patient, as discussed above with respect to the system 100 of FIG. 1. Accordingly, comparing FIGS. 1 and 2. similarly labeled components can represent components that are identical or generally similar in structure and/or function.
[0036] Referring to FIGS. 2A and 2B together, the system 200 includes an anchor structure 202, a first canister 240a, a second canister 240b (collectively referred to as “the canisters 240”), and a charge coil 250. The anchor structure 202 can include a first end portion 203a (e.g., comprising a plurality of first petals, fingers, or the like) and a second end portion 203b (e.g.. comprising a plurality of second petals, fingers, or the like) opposite the first end portion 203a. The charge coil 250 can be disposed at least partially between the first end portion 203a and the second end portion 203b, e.g., in the gap formed between the first end portion 203a and the second end portion 203b that is sized and shaped to receive patient tissue when the system 200 is implanted in a patient. As a result, when the system 200 is deployed across a tissue wall, the charge coil 250 is positioned between either the first end portion 203a or the second end portion 203b and the tissue wall.
[0037] The system 200 can also include an actuation assembly 220 (FIG. 2B). which can be generally similar to or the same as the actuation assembly 120 described with respect to FIG. 1. For example, similar to the actuation assembly 120 of FIG. 1, the actuation assembly 220 includes a plurality of petals or projections 206 (FIG. 2B) that define a lumen 204 for blood flow therethrough. A portion of the actuation assembly 220 (e.g., a wire frame) can be composed at least in part of a shape memory material for facilitating adjustment of the actuation assembly 220. The system 200 can also include a first connector subassembly 210 (e.g., a first cap) for electrically connecting the actuation assembly 220 to a portion of the anchor structure 202 to enable resistive heating of the actuation assembly 220, as described in further detail below with reference to FIG. 4 and in International Patent Application Publication No. WO 2024/137843, previously incorporated by reference herein.
[0038] The canisters 240 can include sensors and/or other electronics for measuring and/or processing one or more physiological parameters. In some embodiments, the canisters 240 can also house one or more energy storage components (e.g., a supercapacitor, a battery, etc.), one or more data storage components (e.g., memory), one or more processors, one or more telemetry components, or other electronic components. The first canister 240a and the second canister 240b can be connected to one another via an electrical lead 230.
[0039] One or more aspects of the system 200 can be covered by a membrane, e.g., to improve biocompatibility, lubriciousness, tissue response characteristics, etc. For example, the anchor structure 202, the canisters 240, and/or the components thereof can each be covered with one or more membranes 205 such as a layer of ePTFE or other suitable material. In the illustrated embodiment, for example, each of the first canister 240a, the second canister 240b, the anchor structure 202, and the actuation assembly 220 are covered by separate (e.g., distinct) membranes 205, which can be of the same or different materials.
[0040] As discussed above with reference to the system 100 of FIG. 1 and described in further detail below with reference to FIGS. 4-7, the anchor structure 202 can be formed via one or more wires. End portions of at least one of the one or more wires can be secured in a second connector subassembly 212. described in greater detail below with reference to FIG. 4. Prior to delivery of the system 200 to the implantation site within a patient, the canisters 240 can be directly attached to a portion of the one or more wires that form the anchor structure 202, and the electrical lead 230 can be intertwined with the charge coil 250. When the system 200 is implanted at or adjacent a septal wall of a patient, the first end portion 203a of the anchor structure 202 and the first canister 240a can be positioned in the left atrium, and the second end portion 203b of the anchor structure 202 and the second canister 240b can be positioned in the right atrium. As also discussed in further detail below, directly attaching the canisters 240 to the anchor structure 202 may help properly position and orient the canisters 240, and also promote tissue growth around the canisters 240.
[0041] FIG. 3 illustrates an anchor frame 300 of the anchor structure 202 configured in accordance with select embodiments of the present technology. The anchor frame 300 can include a first wire 310 and a second wire 320 that are intertwined and/or arranged in a braided or woven structure having a generally annular geometry’ to define the lumen 204. The first wire 310 and the second wire 320 can be composed at least in part of a common material, such as Nitinol, set to have superelastic properties at body temperature. The first wire 310 can further include a conductive cladding/coating (e.g., silver or copper cladding) surrounding the Nitinol core, whereas the second wire 320 does not include the conductive cladding. In alternate embodiments, the conductive portion of the material can be interior to a Nitinol shell. In further variations, the conductive material may be combined with or interfaced with materials other than Nitinol to comprise a hybrid material structure. In such embodiments, the first wire 310 can therefore have more favorable electrical properties to function as an inductor or antenna to wirelessly receive energy transmissions (e.g., to resistively heat the actuation assembly 220 (FIG. 2B) and/or to charge one or more active components such as the sensors included in the canisters 240, etc.), while the second wire 320 can function with more favorable mechanical properties (e.g., stronger superelasticity’) to mechanically stabilize the system 200.
[0042] In some embodiments, the first wire 310 and/or the second wire 320 can interface with other components (e.g., capacitors, inductors, resistors, microcontrollers, etc.) to aid in the functions of acting as an inductor or antenna. For example, the first wire 310 can include a first end portion 315 that is electrically coupled to a capacitor (not shown) and the actuation assembly 220 (FIG. 2B), such that the first wire 310, the capacitor, and the actuation assembly 220 form an RLC circuit, described in greater detail below with reference to FIG. 4. In some embodiments, the first wire 310 and the second wire 320 are part of the same wire. In other embodiments, the first wire 310 and the second wire 320 are part of different wires. Additional details regarding using stabilizing/anchoring features as inductors are described in International Patent Application Publication No. WO 2022/081980 and International Patent Application Publication No. WO 2024/137843, the disclosures of which are incorporated by reference herein in their entireties.
[0043] The first wire 310 and the second wire 320 can each form a plurality of curved portions 31 1 , 321 (e.g., pointed portions, triangular portions). The curved portions 311 , 321 can correspond to the petals of the first end portion 203a and the second end portion 203b (FIG. 2B). Of note, individual and adjacent curved portions 311 of the first wire 310 can alternate between forming part of the first end portion 203a and the second end portion 203b, and individual and adjacent curved portions 321 of the second wire 320 can alternate between being forming part of the first end portion 203a and the second end portion 203b. In this way, both the first wire 310 and the second wire 320 form portions of the first end portion 203a and the second end portion 203b.
[0044] Of note, the second wire 320 also forms a first attachment portion 322a and a second attachment portion 322b (collectively referred to as "‘the attachment portions 322") in addition to forming the curved portions 321. In the illustrated embodiment, each of the attachment portions 322 comprises an elongate, curved loop that extends longer than each of the curved portions 321. As described in further detail herein, the attachment portions 322 can be used to directly attach the canisters 240 (FIG. 2B) to the anchor structure 202. In some embodiments, each attachment portion 322 acts as the only attachment portion for the corresponding canister. For example, a first canister (not shown) is coupled to the anchor structure 202 only via the first attachment portion 322a, and a second canister (not shown) is coupled to the anchor structure 202 only via the second attachment portion 322b. As described below, the attachment portions 322 can nevertheless control a position and/or orientation of the canisters through biasing forces.
[0045] The first attachment portion 322a and the second attachment portion 322b are connected to the remainder of the second wire 320 via two first wire portions 324a and two second wire portions 324b, respectively. In the illustrated embodiment, the attachment portions 322 are positioned and oriented such that the two wire portions 324a extending from the first attachment portion 322a are positioned on a first side of the anchor frame 300 without intertwining with other wire portions until closer to the lumen 204, and the two wire portions 324b extending from the second attachment portion 322b are positioned on a second side of the anchor frame 300 without intertwining with other wire portions until closer to the lumen 204. This configuration of the attachment portions 322 and corresponding first and second wire portions 324a, 324b is expected to improve the flexibility of the anchor frame 300, which in some embodiments may assist with deliver}' of the system 200 to a patient as discussed further below. The shape and orientation of the attachment portions 322 and the wire portions 324 can also be set to control the position and orientation of the canisters 240, as described in greater detail below with reference to FIG. 10.
[0046] The first attachment portion 322a and the second attachment portion 322b are also directly connected to each other via a straight wire portion 326 that generally extends linearly or at least substantially linearly therebetween. The wire portion 326 can serve as a backbone to assist with deliver}7 of the system 200 (e.g., through a catheter). For example, as described further below, the wire portion 326 can directly transfer a pushing force applied to the first canister 240a coupled to the first attachment portion 322a to the second canister 240b coupled to the second attachment portion 322b. This geometry is expected to be advantageous over other geometries in which, for example, the first attachment portion 322a is indirectly connected to the second attachment portion 322b through one or more of the curved portions 321 because in such embodiments, the curved portions 321a may act as a spring that absorbs at least some of the pushing force.
[0047] FIG. 4 illustrates the anchor frame 300 with additional aspects of the system 200, but with the canisters 240 omitted for purposes of illustration. For example. FIG. 4 illustrates the membrane 205 coupled to and at least partially covering the anchor frame 300. In the illustrated embodiment, the membrane 205 covers the curved portions 311, 321 (FIG. 3), but does not cover the attachment portions 322. That is, the attachment portions 311, 321 extend beyond the membrane 205, which enables the canisters 240 (FIGS. 2A and 2B) to be coupled thereto.
[0048] FIG. 4 also illustrates the actuation assembly 220 coupled to the anchor frame 300. As set forth above, the actuation assembly can be electrically coupled to the anchor frame 300 at the first connector subassembly 210. In particular, the first connector subassembly 210 can comprise a housing (e.g., a potted cap) that encloses the first end portion 315 (FIG. 3) of the first wire 310, one or more electrical components such as capacitors (e.g., resonant capacitors; not shown), and an end wire portion of the actuation assembly 220. As set forth above, the first end portion 315 of the first wire 310 and the actuation assembly 220 can be electrically coupled via the capacitor in the first connector subassembly, e.g., to form an RLC circuit and drive resistive heating of the actuation assembly 220. [0049] FIG. 4 also more clearly illustrates the second connector subassembly 212. Similar to the first connector subassembly 210, the second connector subassembly 212 can comprise a housing (e.g., a potted cap) that encloses the second end portion 325 (FIG. 3) of the second wire 320. However, unlike in the first connector subassembly 210, the second connector subassembly can be designed to keep the two ends of the second wire 320 electrically isolated such that the second wire 320 forms an open circuit. For example, the second connector subassembly 212 can maintain a gap between the two open ends of the second wire 320. and can be filled (e.g., potted) with a non-conductive material (e.g., an epoxy). Separating the two open ends of the second end portion 325 can effectively create an open circuit and thereby prevent, or at least reduce, current flow through the second wire 320.
[0050] In some embodiments, the system 200 includes fewer (e.g., one) or more (e.g., three, four, five, six, etc.) canisters 240 and a corresponding number of attachment portions 322. Also, in some embodiments, the first end portion 315 and/or the second end portion 325 are disposed inside of the first and/or second canisters 240a, 240b instead of the first or second caps 410, 420. Furthermore, although the anchor structure 202 is illustrated in FIGS. 2A, 2B, and 4 as being coupled to the actuation assembly 220 including the plurality of petals 206 that define the lumen 204 for blood flow therethrough, in some embodiments, the anchor structure 202 can be implanted without the actuation assembly 220. For example, the canisters 240 can be attached to the attachment portions 322 and form an implantable medical system that provides sensors readings (e.g., pressure readings) via the canisters 240. but does not shunt fluid betw een adjacent chambers. In such embodiments, the anchor structure 202 may not form the lumen 204 (e.g., the first wire 310 and/or the second wire 320 can extend across the area of the lumen 204) or the lumen 204 may be covered by a membrane or other structure.
B. Select Embodiments of Assembling Implantable Medical Systems with Electrical Canisters Directly Attached to an Anchor Structure
[0051] As set forth above, the present technology includes electrical canisters that are directly coupled to anchor structures. The description below with reference to FIGS. 5A-8 provides additional details for directly coupling the electrical canisters 240 of the system 200 to the anchor structure 202. However, one skilled in the art will appreciate that the following description can apply equally to other implantable medical systems having anchor structures and canisters. [0052] FIGS. 5A and 5B illustrate the implantable medical system 200 in a first partially assembled state and in a second partially assembled state, respectively, in accordance with select embodiments of the present technology. Referring first to FIG. 5A, the anchor structure 202 is illustrated separate from (e.g., not yet coupled to) the charge coil 250. The charge coil 250 can include an outer coiled portion 252 and an inner loop portion 254. Also, the first canister 240a and the second canister 240b are coupled together via the electrical lead 230, but are likewise illustrated separate from (e.g., not yet coupled to) the anchor structure 202.
[0053] Referring next to FIG. 5B. in the second partially assembled state, the charge coil 250 (not visible in FIG. 5B) is coupled to the anchor structure 202. In particular, both the outer coiled portion 252 and the inner loop portion 254 can be disposed at least partially between the first end portion 203a and the second end portion 203b, as illustrated in FIGS. 2A and 2B and below in FIG. 7.
[0054] In the assembly stage shown in FIG. 5B, the canisters 240 and the electrical lead 230 are not yet coupled to the anchor structure 202 or the charge coil 250. Moreover, while the canisters 240 are shown in FIGS. 5A and 5B without a membrane, a membrane can be applied to each of the canisters 240 at a later stage during the assembly process.
[0055] FIG. 6 is an enlarged view of the implantable medical system 200 showing a third partially assembled state that occurs later in the assembly process than the first partially assembled state (FIG. 5A) and the second partially assembled state (FIG. 5B). In particular, FIG. 6 shows the first canister 240a, without the membrane 205, in the process of being coupled to the anchor structure 202 at the first attachment portion 322a. As shown, the first canister 240a can include a cylindrical body portion 642 and a primary end cap 644 coupled to (e.g., welded to) an end of the cylindrical body portion 642. In the illustrated embodiment, the primary end cap 644 comprises a dome-shaped or hemispherical end cap. In other embodiments, the primary end cap 644 can comprise other shapes, such as ellipsoidal, rectangular, flat, etc. The cylindrical body portion 642 and the primary end cap 644 can be composed of metal (e.g., titanium) or other suitable materials, and can be manufactured via machining, additive manufacturing (e.g., 3D printing), etc.
[0056] To couple the first canister 240a to the anchor structure 202, the cylindrical body portion 642 of the first canister 240a can be slid in between the two wire portions 324a, e.g., such that the loop of the first attachment portion 322a extends around the end cap 644 and the electrical lead 230 extends through the loop. To facilitate this, the two wire portions 324a can be at least partially displaced (e.g., spread apart) while the cylindrical body portion 642 is passed therethrough. Although the electrical lead 230 is shown as extending from the primary end cap 644, in some embodiments, the electrical lead 230 is attached to the first canister 240a at the end opposite the end cap 644 to avoid the step of sliding the first canister 240a in between the two wire portions 324a.
[0057] FIG. 7 is a schematic illustration of the system 200 showing yet another partially assembled state that occurs during the process of coupling the canisters 240 to the anchor structure 202. As shown, once the first canister 240a has been attached to the anchor structure 202 via the first attachment portion 322a (not shown in FIG. 7), the second canister 240b can be slid or weaved inside of the outer coiled portion 252 of the charge coil 250 but outside of the inner loop portion 254 of the charge coil 250. In other words, the second canister 240b can be weaved through the charge coil 250 such that the electrical lead 230 is positioned between the outer coiled portion 252 and the inner loop portion 254. Furthermore, the first canister 240a can be positioned adjacent the first end portion 203a while the second canister 240b is positioned adjacent the second end portion 203b. The second canister 240b can then be coupled to the anchor structure 202 via the second attachment portion 322b (not shown in FIG. 7) by sliding the second canister 240b in between the two wire portions 324b in a manner similar to the technique described above for attaching the first canister 240a to the first attachment portion 322a.
[0058] FIG. 8 A is an enlarged perspective view of a portion of the system 200, with certain components show n in cross-section for purposes of illustration. As shown, the first canister 240a includes one or more wires 840 extending from within the cylindrical body portion 642, through a header 843, through the primary end cap 644. and into the electrical lead 230. The wires 840 can transfer power and/or data between electrical components (not shown) housed in the interior of the first canister 240a and external components via the electrical lead 230. The header 843 can be coupled (e.g., welded) between the cylindrical portion 642 and the primary end cap 644, e.g., to hermetically seal the interior of the cylindrical body portion 642.
[0059] The system 200 can also include a secondary end cap 846a for securing the first canister 240a to the first attachment portion 322a of the anchor structure 202. The secondary end cap 846a can be sized and shaped to extend over or otherwise be positioned around the primary end cap 644. The secondary end cap 846a can be coupled (e.g., wielded) to the primary end cap 644 or another structure (e.g., the header 843) while the first attachment portion 322a is disposed between the primary end cap 644 and the secondary end cap 846a, e.g., to fixedly couple the first canister 240a to the first attachment portion 322a. As a result, the first canister 240a is coupled to the first attachment portion 322a at the primary end cap 644. In some embodiments, the secondary end cap 846a can include a slot, an aperture, or other opening (not visible in FIG. 8A) to allow the first attachment portion 322a to pass therethrough.
[0060] For example, FIG. 8B illustrates a portion of the system 200 including a portion of the first canister 240a, the first attachment portion 322a, and another embodiment of a secondary' end cap 846b configured in accordance with select embodiments of the present technology. As shown, the secondary end cap 846b includes a collar portion 847 that is sized and shaped to be positioned over the primary end cap 644. The collar portion 847 can include a gap or opening 849 that enables the secondary' end cap 846b to be installed over the primary end cap 644 after the electrical lead 230 (not shown in FIG. 8B) is coupled to the first canister 240a.
[0061] The secondary end cap 846b further includes a pair of strain relief features 848. The strain relief features 848 are curved fingers or appendages that are each aligned with individual segments 823a-b of the first attachment portion 322a as the segments 823a-b extend away7 from first canister 240a. The strain relief features 848 curve at least sightly away from the collar 847 and act as a bumper or frame against which the segments 823 a-b of the first attachment portion 322 seat when the system 200 is collapsed into a delivery configuration in a delivery catheter, as described below with reference to FIG. 9B. In this way. the strain relief features 848 are expected to reduce the strain induced in the first attachment portion 322a by prefixing the degree to which the first attachment portion 322 can bend, thus reducing the likelihood of the first attachment portion 322 kinking or otherwise deforming as a result of being collapsed into a delivery configuration. Thus, the curvature of the strain relief features 848 can be set based on an acceptable degree of curvature/bending for the corresponding first attachment portion 322a.
[0062] In some embodiments, and referring collectively to FIGS. 8A and 8B. any gap or space between the primary' end cap 644 and the secondary end cap 846a-b is filled with a filler material to keep the first attachment portion 322a fixed in position. For example, after welding or otherw ise coupling the secondary end cap 846a-b to the primary end cap 844, epoxy or other adhesives can be applied to fill the gap. In some embodiments, prior to filling the gap with the filler material, epoxy, another adhesive, or other suitable materials can be applied to the weld seam and/or any other gaps to ensure that the filler material does not leak out. Similarly, the second canister 240b (not shown in FIGS. 8A or 8B) can also include a secondary end cap and filler material between the primary and secondary end caps to keep the second attachment portion 322b fixed in position.
[0063] FIG. 9A is a perspective view of a catheter 900 containing the system 200 configured in accordance with select embodiments of the present technology. The catheter 900 can be used to deliver the system 200 to the implantation site, such as the septal wall of a patient. When the system 200 is positioned inside the catheter 900 for delivery, the system 200 can be in a collapsed delivery' state, as shown. In particular, the first canister 240a and the second canister 240b can be positioned on either side of the anchor structure 202 and oriented such that the end cap of each canister 240 faces the anchor structure 202, and the electrical lead 230 extends therebetween and adjacent the anchor structure 202. The charge coil 250 can be positioned adjacent the first canister 240a.
[0064] The secondary' end cap 846 is omitted from FIG. 9A for purposes of clarity'. However, FIG. 9B is another perspective view of the catheter 900 containing the system 200 in an embodiment that illustrates the secondary end cap 846b with the strain relief features 848 described above with reference to FIG. 8B. As shown, the strain relief features 848 define a maximum amount of curvature/bend the first attachment portion 322a can assume when in the collapsed configuration and positioned within the catheter 200. As set forth above, this is expected to advantageously reduce strain in the first attachment portion 322a, reduce kinking in the first attachment portion 322a, and reduce the likelihood of interfering with the shape set of the first attachment portion 322a.
[0065] Referring collectively to FIGS. 9A and 9B, and as discussed above with reference to FIG. 3, the anchor frame 300 of the anchor structure 202 can be made from Nitinol and/or other suitable material such that the anchor structure 202 can be collapsed in the catheter 900 without material damage, and the anchor structure 202 can return to its original shape upon deployment from the catheter 900 at the implantation site. Also, referring back to FIG. 3, because each of the first attachment portion 322a and the second attachment portion 322b does not intertwine with other wire portions until closer to the lumen 204, the anchor structure 202 is expected to have greater flexibility than anchor structures with other wire arrangements. Furthermore, the straight wire portion 326 (FIG. 3) can serve as a backbone to improve delivery of the system 200 through the catheter 900 by directly transferring a pushing force (e g., a mechanical force, a hydraulic force) applied to the first canister 240a, which can be coupled to the first attachment portion 322a, to the second canister 240b, which can be coupled to the second attachment portion 322b. In addition, in some embodiments, each of the first and second wires 310, 320 of the anchor frame 300 (FIG. 3) is a contiguous loop to better withstand the radial compressive force applied by the catheter 900 during deliver}’.
[0066] FIG. 10 is a schematic illustration of the system 200 implanted in the septal wall S of a patient and configured in accordance with select embodiments of the present technology. In the illustrated embodiment, the first canister 240a is positioned in the left atrium LA and the second canister 240b is positioned in the right atrium RA. In particular, the first and second canisters 240a. 240b are generally aligned with the anchor structure 202, similar to how the system 200 is illustrated in FIGS. 2 A and 2B. Moreover, the first and second canisters 240a, 240b are oriented in opposite directions such that the electrical lead 230 extends from each of the first and second canisters 240a, 240b in opposite directions. This positioning and orienting can help avoid contact between the components of the system 200 and certain anatomical parts of the patient.
[0067] In some embodiments, during the manufacturing stage, the Nitinol or other material forming the anchor frame 300 of the anchor structure 202 undergoes a shape setting process such that the anchor structure 202 deploys into the desired shape when released from the catheter 900 (FIGS. 9A and 9B). Also, the first and second attachment portions 322a, 322b can exert both a force F and a moment M to the first and second canisters 240a, 240b, respectively, when the system 200 is deployed and implanted as shown in FIG. 10 (e.g.. through the primary and secondary end caps and the epoxy therebetween). The forces F and the moments M can position and orient the canisters 240 in a desired manner, e.g., to extend at specific angles and to overlap when viewed in a direction normal to the septal wall S. In particular, the shape setting process can be used to tune the attachment portions 322 to achieve any desired positions and orientations of the canisters 240 based on anatomical or other considerations. For example, the force F can pull the end caps of each canister 240, and thus the entire canister 240, toward the septal wall. The moment M can rotate the canisters 240 such that the distal ends of the canisters 240a opposite the end caps are similarly pulled toward the septal wall. In some embodiments, the first and second attachment portions 322a, 322b can be tuned to bias the canisters 240 toward positions and orientations that may be obstructed by another system component (e.g., the anchor structure 202) and/or an anatomical structure (e.g., the septal wall). Thus, even when the system 200 is fully deployed, the attachment portions 322 can continue to apply the forces F and the moments M to bias the canisters 240 toward apposition with the septal wall and/or the anchor structure 202, which can promote tissue growth around the canisters 240. In this way, the atachment portions 322 can control a position and orientation of the canisters 240. even in embodiments in which they are coupled to only one end of the canisters 240.
[0068] One of ordinary skill in the art will appreciate that the system 200 and the components thereof can be deployed in positions and/or orientations different from the illustrated embodiment. One of ordinary skill in the art will also appreciate that the schematic illustration of FIG. 10 is not necessarily to scale, and that the components of the system 200 can have different dimensions and spacings therebetween. Furthermore, as discussed above with respect to FIGS. 2A-4, in some embodiments, the anchor structure 202 (i) does not include a lumen or includes an at least partially obstructed lumen (e.g., covered by a membrane) and (ii) is implanted without an actuation assembly such that the anchor structure 202 forms an implantable medical system that provides sensor readings via the canisters 240 attached to the attachment portions 322, but does not shunt fluid (e.g., between the right atrium RA and the left atrium LA).
[0069] The anchor frames described herein can have other configurations that directly attach to canisters. For example, FIG. 11 illustrates an anchor frame 1100 of an anchor structure 1102 configured in accordance with select embodiments of the present technology. The anchor frame 1100 is generally similar to the anchor frame 300 illustrated in and described above with reference to FIG. 3. How ever, unlike the anchor frame 300 of FIG. 3 in which respective ends of the second wire 320 that form the attachment portions 322 are located spaced apart from the attachment portions 322 at the open end portion 325. respective end portions 1125a and 1 125b of the second wire 1120 of the anchor frame 1100 are located at the attachment portions 1122a, 1122b. Accordingly, as shown in FIG. 11, each of the first and second attachment portions 1122a, 1122b terminates after forming a partial, e.g., incomplete, loop, and the anchor frame 1100 does not include a backbone (e.g.. the straight wire portion 326 illustrated in FIG. 3) that extends between the first and second attachment portions 1 122a, 1122b. In other words, the partial loops can terminate tow ards where the straight wire portion 326 exists in the anchor frame 300 of FIG. 3.
[0070] Therefore, the anchor frame 1100, like the anchor frame 300, forms an open circuit that can prevent, or at least reduce, current flow through the second wire 1120. However, unlike in the anchor frame 300, the first and second attachment portions 1122a, 1122b of the anchor frame 1100 are not directly connected by a straight wire portion extending therebetween, and are connected only via the remainder of the second ware 1120 that is intertwined with the first wire 1110 and forms the plurality of curved portions 1121. Similar to the embodiment of FIG. 3, the second wire 1120 can composed of a superelastic material (e.g., Nitinol) that is shape set with sufficient stiffness to keep the canisters attached to the first and second attachment portions 322a, 322b.
C. Examples
[0071] Several aspects of the present technology are set forth in the following examples:
1. An implantable medical system for fluidly connecting a first body region and a second body region of a patient, the system comprising: an anchor structure defining a central opening, wherein the anchor structure includes a contiguous wire, and wherein the continuous wire forms: a plurality of petals sized and shaped to stabilize the anchor structure across a target anatomical structure, a first attachment portion comprising a first at least partial loop, and a second attachment portion comprising a second at least partial loop; and a first canister having a first end cap coupled to the first attachment portion via the first at least partial loop; and a second canister having a second end cap coupled to the second attachment portion via the second at least partial loop.
2. The system of example 1 wherein the first attachment portion is configured to position the first canister to extend across the anchor structure and offset from the opening, wherein the second attachment portion is configured to position the second canister to extend across the anchor structure and offset from the opening, and wherein the first and second canisters are oriented in opposite directions.
3. The system of example 1 or example 2 wherein the first attachment portion and the second attachment portion are interconnected by a single linear wire portion of the wire, wherein, during delivery of the system, the single linear wire portion is configured to transfer a pushing force applied to the first canister to the second canister.
4. The system of any one of examples 1-3 wherein each of the first and second end caps comprises a primary end cap and a secondary end cap positioned around and coupled to the primary end cap. wherein each of the first and second attachment portions is at least partially disposed in a gap between the primary end cap and the secondary end cap of the first and second canisters, respectively.
5. The system of example 4 wherein the gap between the primary end cap and the secondary end cap of each of the first and second canisters is at least partially filled with a filler material configured to fix a position of each of the first and second attachment portions relative to the first and second canisters.
6. The system of example 4 or example 5 wherein each of the secondary end caps include a pair of curved strain relief features sized and shaped to define a maximum curvature for a corresponding portion of the first attachment portion or the second attachment portion.
7. The system of any one of examples 1-6 wherein each of the first and second attachment portions is configured to apply a force and a moment on each of the first and second canisters, respectively, wherein the force pulls each of the first and second end caps towards the anchor structure, and wherein the moment rotates each of the first and second canisters such that distal end portions of the first and second canisters opposite the first and second end caps are biased toward the anchor structure.
8. The system of any one of examples 1-7 wherein the first attachment portion and the second attachment portion are configured to apply a continuous force on the first canister and the second canister, respectively, toward the target anatomical structure while the system is implanted at the target anatomical structure and in operation.
9. The system of any of examples 1-8, further comprising an electrical lead extending between the first canister and the second canister.
10. The system of example 9, further comprising a charge coil having an outer coiled portion and an inner loop portion positioned around the anchor structure, wherein the electrical lead extends between the outer coiled portion and the inner loop portion. 11. The system of any of examples 1-10 wherein the wire is a first wire, further comprising a second wire intertwined with the first wire and composed at least in part of one or more inductive materials.
12. The system of any of examples 1-11 wherein the first at least partial loop comprises a first loop, wherein the second at least partial loop comprises a second loop, and wherein respective ends of the contiguous wire are spaced apart from the first loop and the second loop.
13. The system of any of examples 1-11 wherein the first at least partial loop comprises a first incomplete loop structure, the second at least partial loop comprises a second incomplete loop structure, and wherein respective ends of the contiguous wire are located at the first incomplete loop structure and the second incomplete loop structure.
14. An implantable medical device, comprising: an anchor structure sized and shaped to secure the implantable device across an anatomical structure of a patient and formed at least in part by a wire, the wire having — a first portion configured to reside on a first side of the anatomical structure, a first attachment portion connected to the first portion, a second portion configured to reside on a second side of the anatomical structure, opposite the first side, and a second attachment portion connected to the second portion; a first canister housing a first sensor, wherein the first canister is coupled to the first attachment portion of the anchor structure; and a second canister housing a second sensor, wherein the second canister is coupled to the second attachment portion of the anchor structure.
15. The implantable medical device of example 14 wherein the first portion includes a plurality of first petals, and wherein the second portion includes a plurality of second petals. 16. The implantable medical device of example 15 wherein the wire alternates between forming individual first petals of the first portion and individual second petals of the second portion.
17. The implantable medical device of any of examples 14-16 wherein the anchor structure has an annular shape with an opening extending therethrough.
18. The implantable medical device of any of examples 14-17 wherein the first attachment portion includes a first loop, and wherein the second attachment portion includes a second loop.
19. The implantable medical device of any of examples 14-18 wherein the first attachment portion directs the first canister into an orientation that overlaps with the first portion of the anchor structure, and wherein the second attachment portion directs the second canister into an orientation that overlaps with the second portion of the anchor structure.
20. The implantable medical device of example 19 wherein the first canister and the second canister area aligned.
21. The implantable medical device of any of examples 14-20 wherein: the first canister has a first end region and a second end region spaced apart from the first end region by a length of the first canister, the first canister is coupled to the first attachment portion at the first end region, and the second end region is not directly attached to the anchor structure.
22. The implantable medical device of any of examples 14-21 wherein the first canister is coupled to the anchor structure only via the first attachment portion, and wherein the second canister is coupled to the anchor structure only via the second attachment portion.
23. The implantable medical device of any of examples 14-22, further comprising one or more membranes covering the first portion and the second portion. 24. The implantable medical device of example 23 wherein the first attachment portion and the second attachment portion are not covered by the one or more membranes.
25. The implantable medical device of any of examples 14-24, further comprising an end cap extending at least partially over the first canister, wherein the first attachment portion extends between the first canister and the end cap, and wherein the end cap includes one or more strain relief features.
26. The implantable medical device of example 25 wherein the one or more strain relief features include a projection that curves away from an end portion of the first canister and that is aligned with a segment of the first attachment portion.
27. An implantable medical device, comprising: an anchor structure sized and shaped to secure the implantable device across an anatomical structure of a patient, wherein the anchor structure is formed at least in part by a wire, the wire having a first portion configured to reside on a first side of the anatomical structure, a second portion configured to reside on a second side of the anatomical structure opposite the first side, and an attachment portion, wherein the attachment portion is integral with the first portion and/or the second portion; and a canister housing a sensor configured to measure a physiological parameter of the patient, wherein the canister is coupled to the anchor structure at the attachment portion.
28. The implantable medical device of example 27 wherein, when in a deployed configuration, the attachment portion directs the canister into a position that overlaps with the first portion and/or the second portion.
29. The implantable medical device of example 27 or example 28 wherein the canister is coupled to the anchor structure only via the attachment portion. 30. The implantable medical device of any of examples 27-29, further comprising a membrane covering the first portion and the second portion of the wire, wherein the attachment portion extends out of the membrane.
31. The implantable medical device of any of examples 27-30 wherein the attachment portion includes an at least partial loop structure extending around a portion of the canister.
32. The implantable medical device of any of examples 27-31 wherein the anchor structure is generally annular shaped such that it has a central opening extending therethrough.
33. The implantable medical device of any of examples 27-32 wherein the wire is composed at least in part of Nitinol.
34. The implantable medical device of any of examples 27-33, further comprising an end cap extending at least partially over the canister, wherein the attachment portion extends between the canister and the end cap.
35. The implantable medical device of example 34 wherein the end cap includes a proj ection that curves away from an end portion of the canister and that is aligned with a segment of the attachment portion.
Conclusion
[0072] Embodiments of the present disclosure may include some or all of the following components: a battery, supercapacitor, or other suitable power source; a microcontroller, FPGA, ASIC, or other programmable component or system capable of storing and executing software and/or firmware that drives operation of an implant; memory such as RAM or ROM to store data and/or software/firmware associated with an implant and/or its operation; wireless communication hardware such as an antenna system configured to transmit via Bluetooth, WiFi, or other protocols known in the art; energy harvesting means, for example a coil or antenna which is capable of receiving and/or reading an externally-provided signal which may be used to power the device, charge a battery, initiate a reading from a sensor, or for other purposes. Embodiments may also include one or more sensors, such as pressure sensors, impedance sensors, accelerometers, force/strain sensors, temperature sensors, flow sensors, optical sensors, cameras, microphones or other acoustic sensors, ultrasonic sensors, ECG or other cardiac rhythm sensors, SpCh and other sensors adapted to measure tissue and/or blood gas levels, blood volume sensors, and other sensors known to those who are skilled in the art. Embodiments may include portions that are radiopaque and/or ultrasonically reflective to facilitate image-guided implantation or image guided procedures using techniques such as fluoroscopy, ultrasonography, or other imaging methods. Embodiments of the system may include specialized delivery catheters/sy stems that are adapted to deliver an implant and/or carry out a procedure. Systems may include components such as guidewires, sheaths, dilators, and multiple deliver}' catheters. Components may be exchanged via over- the- wire, rapid exchange, combination, or other approaches.
[0073] The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technolog ' as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments. For example, although this disclosure has been written to describe devices that are generally described as being used to create a path of fluid communication betw een the left atrium and right atrium, the left ventricle and the right ventricle, or the left atrium and the coronary sinus, it should be appreciated that similar embodiments could be utilized for shunts betw een other chambers of heart or for shunts in other regions of the body.
[0074] From the foregoing, it will be appreciated that specific embodiments of the technolog}' have been described herein for purposes of illustration, but w ell-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.
[0075] Unless the context clearly requires otherwise, throughout the description and the examples, the words “comprise,” “comprising,” and the like are to be constmed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words ‘'herein,’’ ‘'above,” ‘'below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number, respectively. As used herein, the phrase “and/or” as in “A and/or B” refers to A alone, B alone, and A and B. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMS I/'W e claim:
1. An implantable medical system for fluidly connecting a first body region and a second body region of a patient, the system comprising: an anchor structure defining a central opening, wherein the anchor structure includes a contiguous wire, and wherein the continuous wire forms: a plurality of petals sized and shaped to stabilize the anchor structure across a target anatomical structure, a first attachment portion comprising a first at least partial loop, and a second attachment portion comprising a second at least partial loop; and a first canister having a first end cap coupled to the first attachment portion via the first at least partial loop; and a second canister having a second end cap coupled to the second attachment portion via the second at least partial loop.
2. The system of claim 1 wherein the first attachment portion is configured to position the first canister to extend across the anchor structure and offset from the opening, wherein the second attachment portion is configured to position the second canister to extend across the anchor structure and offset from the opening, and wherein the first and second canisters are oriented in opposite directions.
3. The system of claim 1 wherein the first attachment portion and the second attachment portion are interconnected by a single linear wire portion of the wire, w herein, during delivery of the system, the single linear wire portion is configured to transfer a pushing force applied to the first canister to the second canister.
4. The system of claim 1 wherein each of the first and second end caps comprises a primary end cap and a secondary end cap positioned around and coupled to the primary end cap, wherein each of the first and second attachment portions is at least partially disposed in a gap between the primary end cap and the secondary end cap of the first and second canisters, respectively.
5. The system of claim 4 wherein the gap between the primary' end cap and the secondary end cap of each of the first and second canisters is at least partially filled with a filler material configured to fix a position of each of the first and second attachment portions relative to the first and second canisters.
6. The system of claim 4 wherein each of the secondary end caps include a pair of curved strain relief features sized and shaped to define a maximum curvature for a corresponding portion of the first attachment portion or the second attachment portion.
7. The system of claim 1 wherein each of the first and second attachment portions is configured to apply a force and a moment on each of the first and second canisters, respectively, wherein the force pulls each of the first and second end caps towards the anchor structure, and wherein the moment rotates each of the first and second canisters such that distal end portions of the first and second canisters opposite the first and second end caps are biased toward the anchor structure.
8. The system of claim 1 wherein the first attachment portion and the second attachment portion are configured to apply a continuous force on the first canister and the second canister, respectively, toward the target anatomical structure while the system is implanted at the target anatomical structure and in operation.
9. The system of claim 1. further comprising an electrical lead extending between the first canister and the second canister.
10. The system of claim 9, further comprising a charge coil having an outer coiled portion and an inner loop portion positioned around the anchor structure, wherein the electrical lead extends between the outer coiled portion and the inner loop portion.
11. The system of claim 1 wherein the wire is a first wire, further comprising a second wire intertwined with the first wire and composed at least in part of one or more inductive materials.
12. The system of claim 1 wherein the first at least partial loop comprises a first loop, wherein the second at least partial loop comprises a second loop, and wherein respective ends of the contiguous wire are spaced apart from the first loop and the second loop.
13. The system of claim 1 wherein the first at least partial loop comprises a first incomplete loop structure, the second at least partial loop comprises a second incomplete loop structure, and wherein respective ends of the contiguous wire are located at the first incomplete loop structure and the second incomplete loop structure.
14. An implantable medical device, comprising: an anchor structure sized and shaped to secure the implantable device across an anatomical structure of a patient and formed at least in part by a wire, the wire having — a first portion configured to reside on a first side of the anatomical structure, a first attachment portion connected to the first portion, a second portion configured to reside on a second side of the anatomical structure, opposite the first side, and a second attachment portion connected to the second portion; a first canister housing a first sensor, wherein the first canister is coupled to the first attachment portion of the anchor structure; and a second canister housing a second sensor, wherein the second canister is coupled to the second attachment portion of the anchor structure.
15. The implantable medical device of claim 14 wherein the first portion includes a plurality of first petals, and wherein the second portion includes a plurality of second petals.
16. The implantable medical device of claim 15 wherein the wire alternates between forming individual first petals of the first portion and individual second petals of the second portion.
17. The implantable medical device of claim 14 wherein the anchor structure has an annular shape with an opening extending therethrough.
-SO-
18. The implantable medical device of claim 14 wherein the first attachment portion includes a first loop, and wherein the second attachment portion includes a second loop.
19. The implantable medical device of claim 14 wherein the first attachment portion directs the first canister into an orientation that overlaps with the first portion of the anchor structure, and wherein the second attachment portion directs the second canister into an orientation that overlaps with the second portion of the anchor structure.
20. The implantable medical device of claim 19 wherein the first canister and the second canister area aligned.
21. The implantable medical device of claim 14 wherein: the first canister has a first end region and a second end region spaced apart from the first end region by a length of the first canister, the first canister is coupled to the first attachment portion at the first end region, and the second end region is not directly attached to the anchor structure.
22. The implantable medical device of claim 14 wherein the first canister is coupled to the anchor structure only via the first attachment portion, and wherein the second canister is coupled to the anchor structure only via the second attachment portion.
23. The implantable medical device of claim 14, further comprising one or more membranes covenng the first portion and the second portion.
24. The implantable medical device of claim 23 wherein the first attachment portion and the second attachment portion are not covered by the one or more membranes.
25. The implantable medical device of claim 14, further comprising an end cap extending at least partially over the first canister, wherein the first attachment portion extends between the first canister and the end cap. and wherein the end cap includes one or more strain relief features.
26. The implantable medical device of claim 25 wherein the one or more strain relief features include a projection that curves away from an end portion of the first canister and that is aligned with a segment of the first attachment portion.
27. An implantable medical device, comprising: an anchor structure sized and shaped to secure the implantable device across an anatomical structure of a patient, wherein the anchor structure is formed at least in part by a wire, the wire having a first portion configured to reside on a first side of the anatomical structure, a second portion configured to reside on a second side of the anatomical structure opposite the first side, and an attachment portion, wherein the attachment portion is integral with the first portion and/or the second portion; and a canister housing a sensor configured to measure a physiological parameter of the patient, wherein the canister is coupled to the anchor structure at the attachment portion.
28. The implantable medical device of claim 27 wherein, when in a deployed configuration, the attachment portion directs the canister into a position that overlaps with the first portion and/or the second portion.
29. The implantable medical device of claim 27 wherein the canister is coupled to the anchor structure only via the attachment portion.
30. The implantable medical device of claim 27, further comprising a membrane covering the first portion and the second portion of the wire, wherein the attachment portion extends out of the membrane.
31. The implantable medical device of claim 27 wherein the attachment portion includes an at least partial loop structure extending around a portion of the canister.
32. The implantable medical device of claim 27 wherein the anchor structure is generally annular shaped such that it has a central opening extending therethrough.
33. The implantable medical device of claim 27 wherein the wire is composed at least in part of Nitinol.
34. The implantable medical device of claim 27, further comprising an end cap extending at least partially over the canister, wherein the attachment portion extends between the canister and the end cap.
35. The implantable medical device of claim 34 wherein the end cap includes a proj ection that curves away from an end portion of the canister and that is aligned with a segment of the attachment portion.
PCT/US2025/024253 2024-04-12 2025-04-11 Implantable medical systems with electrical canisters directly attached to anchor structures Pending WO2025217502A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202463633253P 2024-04-12 2024-04-12
US63/633,253 2024-04-12
US202463643716P 2024-05-07 2024-05-07
US63/643,716 2024-05-07

Publications (1)

Publication Number Publication Date
WO2025217502A1 true WO2025217502A1 (en) 2025-10-16

Family

ID=97350814

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/024253 Pending WO2025217502A1 (en) 2024-04-12 2025-04-11 Implantable medical systems with electrical canisters directly attached to anchor structures

Country Status (1)

Country Link
WO (1) WO2025217502A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060190070A1 (en) * 2005-02-23 2006-08-24 Dieck Martin S Rail stent and methods of use
US20220151618A1 (en) * 2020-11-13 2022-05-19 V-Wave Ltd. Interatrial shunt having physiologic sensor
WO2023064479A1 (en) * 2021-10-13 2023-04-20 Shifamed Holdings, Llc Shunting systems and methods, including systems and methods for delivering and deploying the same

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060190070A1 (en) * 2005-02-23 2006-08-24 Dieck Martin S Rail stent and methods of use
US20220151618A1 (en) * 2020-11-13 2022-05-19 V-Wave Ltd. Interatrial shunt having physiologic sensor
WO2023064479A1 (en) * 2021-10-13 2023-04-20 Shifamed Holdings, Llc Shunting systems and methods, including systems and methods for delivering and deploying the same

Similar Documents

Publication Publication Date Title
EP2061373B1 (en) Anchor for an implantable medical device
US20230084193A1 (en) Implantable shunt systems and methods
US12090290B2 (en) Shape memory actuators for adjustable shunting systems, and associated systems and methods
US11577085B2 (en) Delivery devices and methods for leadless cardiac devices
US20230371953A1 (en) Dual purpose inductors for implantable medical devices and associated systems and methods
WO2007090013A2 (en) Intravascular medical device
EP3843618B1 (en) Anchors for implantable devices
WO2024137843A2 (en) Adjustable shunting systems with shape memory actuators and associated systems and methods
US20240408359A1 (en) Shunting systems and methods, including systems and methods for delivering and deploying the same
US20240252792A1 (en) Implantable medical devices having canisters enclosed in anchors with cavities, and associated systems and methods
WO2025217502A1 (en) Implantable medical systems with electrical canisters directly attached to anchor structures
WO2014035600A1 (en) Segmented hernia patch frame
US20200406024A1 (en) Recapture Assembly for a Catheter System, Catheter System and Method for Retrieval of an Implant
EP3562547B1 (en) Leadless delivery catheter with conductive pathway
WO2025006701A1 (en) Systems and methods for selectively adjusting and/or calibrating implantable shunting systems
HK40090036A (en) Dual purpose inductors for implantable medical devices and associated systems and methods
WO2025076234A1 (en) Systems and methods for delivering adjustable shunting systems
WO2023028192A1 (en) Anchors and wireless sensor attachment

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 25787305

Country of ref document: EP

Kind code of ref document: A1