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WO2025085070A1 - Handle assemblies for medical devices and methods of assembling the same - Google Patents

Handle assemblies for medical devices and methods of assembling the same Download PDF

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Publication number
WO2025085070A1
WO2025085070A1 PCT/US2023/076981 US2023076981W WO2025085070A1 WO 2025085070 A1 WO2025085070 A1 WO 2025085070A1 US 2023076981 W US2023076981 W US 2023076981W WO 2025085070 A1 WO2025085070 A1 WO 2025085070A1
Authority
WO
WIPO (PCT)
Prior art keywords
proximal
distal
handle assembly
magnetic disk
rotational shaft
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/US2023/076981
Other languages
French (fr)
Inventor
Austin T. Jones
Brian Zimmer
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.)
Bard Peripheral Vascular Inc
Original Assignee
Bard Peripheral Vascular Inc
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 Bard Peripheral Vascular Inc filed Critical Bard Peripheral Vascular Inc
Priority to PCT/US2023/076981 priority Critical patent/WO2025085070A1/en
Publication of WO2025085070A1 publication Critical patent/WO2025085070A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00477Coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00831Material properties
    • A61B2017/00876Material properties magnetic
    • 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M25/0136Handles therefor

Definitions

  • the present specification generally relates to handle assemblies for medical devices and methods of assembling the same, and more particularly to a handle assembly for medical devices for endovascular treatment of a vessel.
  • Endovascular treatments treat various blood vessel disorders from within the blood vessel using long, thin tubes called catheters, which are place inside the blood vessel to deliver the treatment.
  • Endovascular treatments may include, but are not limited to, atherectomy, thrombectomy, or similar procedures such as to remove clots or other occlusive material from a vessel.
  • Endovascular treatment devices may include rotational components which often include various components in a single handle.
  • One challenging aspect of endovascular treatment devices is that inclusion of the various components in a single handle results in an large, bulky packaging, which may result in increased material usage, increased shipping prices, and decreased storage capabilities of facilities and hospitals utilizing the endovascular treatment devices.
  • present embodiments address the above referenced concerns.
  • present disclosure is directed to systems, methods, and devices that include multi-piece handles that provide more economical packaging options.
  • some embodiments are directed to medical devices with interlock features in or on the handles which allow for simplified assembly of the medical device.
  • a handle assembly for a medical device includes a proximal handle assembly that includes a proximal rotational shaft and a proximal magnetic disk mounted to the proximal rotational shaft, the proximal magnetic disk including one or more proximal interlock features.
  • the handle assembly for the medical device also includes a distal handle assembly that includes a distal rotational shaft and a distal magnetic disk mounted to the distal rotational shaft, the distal magnetic disk including one or more distal interlock features. The proximal magnetic disk and the distal magnetic disk interlock with one another via interaction of the one or more proximal interlock features and the one or more distal interlock features.
  • a method of assembling a handle assembly of a medical device includes advancing a proximal handle assembly of the medical device toward a distal handle assembly of the medical device and interlocking one or more proximal interlock features of a proximal magnetic disk mounted to a proximal rotational shaft associated with the proximal handle assembly with one or more distal interlock features of a distal magnetic disk mounted to a distal rotational shaft associated with the distal handle assembly.
  • the method of assembling the medical device also includes locking a proximal body of the proximal handle assembly to a distal body of the distal handle assembly.
  • FIG. 1 schematically depicts an assembled medical device, according to one or more embodiments shown and described herein;
  • FIG. 2A schematically depicts an interior view of a handle assembly in a disassembled state, such as of the medical device of FIG. 1, according to one or more embodiments shown and described herein;
  • FIG. 2B schematically depicts the handle assembly of FIG. 2A in an assembled state, according to one or more embodiments shown and described herein;
  • FIG. 3 schematically depicts a proximal magnetic disk and a distal magnetic disk of the handle assembly such as that depicted in FIGS. 2A and 2B in isolation, according to one or more embodiments shown and described herein;
  • FIG. 4 schematically depicts a proximal magnetic disk and a distal magnetic disk for a handle assembly such as that depicted in FIGS. 2A and 2B in isolation, according to one or more embodiments shown and described herein;
  • FIG. 5A schematically depicts a front-view of interlock features of either a proximal magnetic disk or a distal magnetic disk of for a handle assembly such as that depicted in FIGS. 2A and 2B, according to one or more embodiments shown and described herein;
  • FIG. 5B schematically depicts a front- view of interlock features of the other of the proximal magnetic disk or the distal magnetic disk of FIG. 5A, according to one or more embodiments shown and described herein;
  • FIG. 6A schematically depicts a front-view of another embodiment of interlock features of either a proximal magnetic disk or a distal magnetic disk for a handle assembly such as that depicted in FIGS. 2A and 2B, according to one or more embodiments shown and described herein;
  • FIG. 6B schematically depicts a front-view of another embodiment of interlock features of the other of the proximal magnetic disk or the distal magnetic disk of FIG. 6B, according to one or more embodiments shown and described herein;
  • FIG. 7A schematically depicts a side view of a proximal body and a distal body of a handle assembly in an unassembled configuration, according to one or more embodiments shown and described herein;
  • FIG. 7B schematically depicts a side view of the proximal body and the distal body of FIG. 7A in an assembled configuration, according to one or more embodiments shown and described herein;
  • FIG. 7C schematically depicts a side view of the proximal body and the distal body of FIG. 7A rotated 90 degrees, according to one or more embodiments shown and described herein;
  • FIG. 8A schematically depicts a side view of a proximal body and a distal body of a handle assembly in an unassembled configuration, according to one or more embodiments shown and described herein;
  • FIG. 8B schematically depicts a side view of the proximal body and the distal body of FIG. 8A in an assembled configuration, according to one or more embodiments shown and described herein;
  • FIG. 9A schematically depicts a side view of a proximal body and a distal body of a handle assembly in an unassembled configuration, according to one or more embodiments shown and described herein;
  • FIG. 9B schematically depicts a side view of the proximal body and the distal body of FIG. 9A in an assembled configuration, according to one or more embodiments shown and described herein;
  • FIG. 10A schematically depicts a side view of a proximal body and a distal body of a handle assembly in an unassembled configuration, according to one or more embodiments shown and described herein;
  • FIG. 10B schematically depicts a side view of the proximal body and the distal body of FIG. 10A in an assembled configuration, according to one or more embodiments shown and described herein.
  • Embodiments as described herein are directed to handles assemblies for a medical device and methods of assembling the same.
  • handle assemblies as described herein are part of medical devices for endovascular treatment of a vessel.
  • Endovascular treatments may include but are not limited to atherectomy, thrombectomy, or similar devices for removing occlusions within a vessel.
  • atherectomy devices While various embodiments are directed to atherectomy devices, other vascular treatment devices are contemplated and possible.
  • the figures generally depict handle assemblies that allow for economical packaging of a medical device, such as an endovascular treatment device.
  • a handle assembly generally includes a proximal handle assembly and a distal handle assembly, an operator may assemble the proximal handle assembly and the distal handle assembly to construct the endovascular device, such as an atherectomy device.
  • endovascular device such as an atherectomy device.
  • single-piece endovascular devices may be large and bulky, resulting in difficulty of packaging and storage. Accordingly, handle assemblies as described herein allow for more economical and efficient packaging and storage of medical devices.
  • proximal designate an end, portion, end portion, length of the handle assembly intended to be nearer an operator and further from the subject, when the device is in use by the operator.
  • distal designate an end, portion, end portion, length of the handle assembly intended to be nearer the of the subject and further from the operator, when the device is in use by the operator.
  • proximal side or direction is designated by P and the distal side or direction is designated by D.
  • FIG. 2A and FIG. 2B an internal or cross-sectional view of the handle assembly 100 of FIG. 1 is depicted.
  • FIG. 2 A generally depicts a the handle assembly 100 in an unassembled state
  • FIG. 2B generally depicts an internal or cross-sectional view of the handle assembly 100 in the assembled state.
  • the proximal handle assembly 102 is separated from the distal handle assembly 104.
  • the proximal handle assembly 102 and the distal handle assembly 104 may be packaged or arranged in a non-inline or linear configuration relative to one another, which may allow for smaller, more economical packaging, and/or smaller storage space requirements. Accordingly, the proximal handle assembly 102 and the distal handle assembly 104 may be packaged on top of one another, at an angle to one another, etc. In some embodiments, the handle assembly 100 in an initially disassembled configuration may also allow for the proximal handle assembly 102 and the distal handle assembly 104 to be packaged separately.
  • proximal handle assembly 102 and the distal handle assembly 104 may permit an operator, user, or warehouse to store the handle assembly 100 more efficiently.
  • the larger packages accommodating the proximal handle assembly 102 and the distal handle assembly 104 in the assembled state may be difficult to store in a storage area.
  • the proximal handle assembly 102 and the distal handle assembly 104 are packaged separately in smaller packaging, or packaged together adjacent to one another, as opposed to longitudinally aligned with one another, the proximal handle assembly 102 and the distal handle assembly 104 may be stored in separate areas or packed/arranged in various configurations in the operator storage area, allowing for more efficient and economic storage.
  • Each of the proximal handle assembly 102 and the distal handle assembly 104 may include various components of the medical device 10.
  • the proximal handle assembly 102 may include a proximal rotational shaft portion 106 and a proximal magnetic disk 108 mounted to the proximal rotational shaft portion 106.
  • the distal handle assembly 104 may include a distal rotational shaft portion 112 and a distal magnetic disk 114 mounted to the distal rotational shaft portion 112.
  • the proximal magnetic disk 108 and the distal magnetic disk 114 may interlock with one another (as depicted in FIG.
  • the flexible elongate member 105 may attach to be part of the distal rotational shaft portion 112, such that rotation of the distal rotational shaft portion 112 rotates the flexible elongate member 105.
  • the flexible elongate member 105 may be removable from the distal rotational shaft portion 112.
  • the flexible elongate member 105 may be removably coupled to the distal rotational shaft portion 112 via any suitable interconnect such as fasteners, anchors, etc.
  • any suitable interconnect such as fasteners, anchors, etc.
  • allowing the flexible elongate member 105 to be removably coupled from the distal rotational shaft portion 112 may allow for further breakdown and reduction in storage space needs.
  • the proximal handle assembly 102 and the distal handle assembly 104 may include various components including the proximal rotational shaft portion 106 and the distal rotational shaft portion 112, respectively.
  • the proximal rotational shaft portion 106 and the distal rotational shaft portion 112 may be rotatable such as about a longitudinal axis 115, such that each may rotate when connected to a motor 118 (e.g., a rotary motor).
  • a motor 118 e.g., a rotary motor
  • the motor 118 may be connected to the proximal rotational shaft portion 106; however, it should be understood that in some embodiments, the motor 118 may be connected to the distal rotational shaft portion 112.
  • the motor 118 may be powered via a power source 120.
  • the power source 120 may include a power cable to an external power source (e.g., generator, battery, outlet, etc.).
  • the power source 120 may include a battery, such as a lithium ion battery, housed within the proximal handle assembly 102 (as depicted in FIG. 2 A and FIG. 2B) or the distal handle assembly 104.
  • the proximal rotational shaft portion 106 and the distal rotational shaft portion 112 may be freely rotatable.
  • the proximal rotational shaft portion 106 and the distal rotational shaft portion 112 may not be locked in place and may rotate freely upon being acted on by an external force, such as the operator rotating the proximal rotational shaft portion 106 or the distal rotational shaft portion 112 to align the proximal magnetic disk 108 and the distal magnetic disk 114 with one another as described below.
  • the proximal rotational shaft portion 106 and the distal rotational shaft portion 112 may be made of aluminum, carbon fiber, steel, a combination thereof, or any other suitable material.
  • the proximal rotational shaft portion 106 and the distal rotational shaft portion 112 may be made of the same or different materials.
  • the proximal handle assembly 102 may include the proximal magnetic disk 108 mounted to the proximal rotational shaft portion 106, while the distal handle assembly 104 may include the distal magnetic disk 114 mounted to the distal rotational shaft portion 112.
  • the proximal magnetic disk 108 and the distal magnetic disk 114 may be mounted through bolts, screws, hooks, welding, brazing, or any suitable means.
  • the proximal magnetic disk 108 and the distal magnetic disk 114 may be cast as part of the proximal rotational shaft portion 106 and the distal rotational shaft portion 112, respectively.
  • the proximal magnetic disk 108 and the distal magnetic disk 114 may also be made of any suitable material or combination of materials such as, but not limited to, aluminum, carbon fiber, steel, etc.
  • the proximal magnetic disk 108 and/or the distal magnetic disk 114 may be formed of a magnetic material (e.g., ferromagnetic material) or have one or more embedded magnets.
  • the proximal magnetic disk 108 and the distal magnetic disk 114 may include a plurality of magnets 109 such as embedded within, for example, a non-magnetic material that forms the disk.
  • the proximal magnetic disk 108 and the distal magnetic disk 114 may include one or more electromagnets, such that an electromagnetic field is generated when a current is supplied to the electromagnets.
  • the magnetism of the proximal magnetic disk 108 and the distal magnetic disk 114 may be turned on and off, reversed, strengthened, or the like, depending on the current supplied, the polarity generated, and the power level provided.
  • the proximal magnetic disk 108 and the distal magnetic disk 114 may be circular (as depicted in FIGS. 5 and 6), square, or any other suitable shape in cross-section.
  • the proximal magnetic disk 108 and the distal magnetic disk 114 may be sized to fit and rotate within the proximal handle assembly 102 and the distal handle assembly 104, such as from about 0.5 centimeters to about 3.5 centimeters in diameter, though other ranges are contemplated and possible.
  • Each of the proximal magnetic disk 108 and the distal magnetic disk 114 may include one or more interlock features.
  • the proximal magnetic disk 108 may include one or more proximal interlock features 110 and the distal magnetic disk 114 may include one or more distal interlock features 116.
  • the one or more proximal interlock features 110 and the one or more distal interlock features 116 may be configured to interlock within one another to substantially prevent radial motion and/or rotational motion of the proximal magnetic disk 108 and the distal magnetic disk 114 relative to one another.
  • the proximal magnetic disk 108 and the distal magnetic disk 114 are rotationally fixed relative to one another, such that when rotated by the motor 118, the proximal magnetic disk 108 and the distal magnetic disk 114 rotate together.
  • the proximal handle assembly 102 and/or the distal handle assembly 104 may include a rotational shaft lock 122.
  • the rotational shaft lock 122 is arranged to engage the proximal rotational shaft portion 106.
  • the rotational shaft lock 122 may prevent rotation of the proximal rotational shaft portion 106 when the rotational shaft lock 122 is engaged.
  • the proximal rotational shaft portion 106 may rotate freely, as described hereinabove.
  • the distal rotational shaft portion 112 may include the rotational shaft lock 122, such that the rotational shaft lock 122 may prevent rotation of the distal rotational shaft portion 112.
  • the rotational shaft lock 122 may be a clamp, cam lock lever, or any other suitable lock to prevent rotation of either the proximal rotational shaft portion 106 or the distal rotational shaft portion 112.
  • the proximal handle assembly 102 and/or the distal handle assembly 104 may also include a fluid inlet lumen 123 and a fluid outlet lumen 125.
  • the fluid inlet lumen 123 may provide a fluid, water, saline, or any other suitable fluid into or along the proximal rotational shaft portion 106 or the distal rotational shaft portion 112, such as to bead 101 or other abrasive element (as depicted in FIG. 1) for performing atherectomy, to reduce heat, assist in clot break-up, or the like.
  • the fluid inlet lumen 123 may be coupled to the distal handle assembly 104 (as depicted in FIG. 2A and FIG. 2B). However, in some embodiments, it is contemplated that the fluid inlet lumen 123 may be coupled to the proximal handle assembly 102, and may be fluidically coupled, via any suitable fluid coupling, to a fluid lumen in the distal handle assembly 104. Although the fluid inlet lumen 123 and the fluid outlet lumen 125 are depicted as entering the proximal handle assembly 102 from different entry points, in some embodiments, the fluid inlet lumen 123 and the fluid outlet lumen 125 may form a Y-junction or a T-junction. As such, the Y-junction may fluidically couple the fluid inlet lumen 123 and the fluid outlet lumen 125 to either of the proximal handle assembly 102 or the distal handle assembly 104 at the same entry point.
  • the fluid inlet lumen 123 may be coupled to a fluid source (not depicted).
  • the fluid source may be a vessel housing fluid, e.g., water, saline, or any other suitable fluid.
  • the handle assembly 100 may further include a first pump 127 fluidically coupled to the fluid inlet lumen 123.
  • the first pump 127 may pump the fluid from the fluid source into the handle assembly 100.
  • the first pump 127 may be coupled to the power source 120, or the pump 127 may include an internal power source.
  • the first pump 127 may be engaged when the handle assembly 100 is in the assembled state, and disengaged when the handle assembly is in the unassembled state.
  • the first pump 127 may be integrated into either of the proximal handle assembly 102 and/or the distal handle assembly 104. In other embodiments, the first pump 127 may be separate from the proximal handle assembly 102 and/or the distal handle assembly 104, such as at or near the fluid source.
  • the fluid outlet lumen 125 may withdraw the fluid, water, saline, or any other suitable fluid out of the handle assembly 100.
  • the fluid outlet 125 may be connected to a fluid waste container (not depicted), which may be a vessel housing the used fluid, water, saline, or other suitable fluid once it has run through the handle assembly 100.
  • the fluid outlet lumen 125 may also provide for removal of waste fluid from the atherectomy, thrombectomy, or other procedure involving waste fluid.
  • the waste fluid may include blood, a clot, or any other waste product from the procedure performed with the handle assembly 100.
  • the handle assembly 100 may include a second pump 129 fluidically coupled to the fluid outlet lumen 125.
  • the second pump 129 may be coupled to the power source 120, or the second pump 129 may include an internal power source.
  • the second pump 129 may be engaged when the handle assembly 100 is in the assembled state, and disengaged when the handle assembly is in the unassembled state.
  • the second pump 129 may be integrated into either of the proximal handle assembly 102 and/or the distal handle assembly 104.
  • the second pump 129 may be separate from the proximal handle assembly 102 and/or the distal handle assembly 104, such as at or near the fluid source.
  • the fluid outlet lumen 125 may be coupled to the distal handle assembly 104 (as depicted in FIG. 2A and FIG. 2B). However, in some embodiments, it is contemplated that the fluid outlet lumen 125 may be coupled to the proximal handle assembly 102, and may be fluidically coupled, via any suitable fluid coupling, to a fluid lumen in the distal handle assembly 104.
  • the proximal magnetic disk 108 may include the one or more proximal interlock features 110 and the distal magnetic disk 114 may include the one or more distal interlock features 116, such that the proximal magnetic disk 108 and the distal magnetic disk 114 interlock with one another through interaction of the one or more proximal interlock features 110 and the one or more distal interlock features 116.
  • the one or more proximal interlock features 110 and the one or more distal interlock features 116 may include one or more projections 124 extending from one of the proximal magnetic disk 108 and the distal magnetic disk 114 and one or more recesses 126 formed within the other of the proximal magnetic disk 108 and the distal magnetic disk 114, wherein the one or more projections 124 are sized to be received within the one or more recesses 126.
  • the one or more projections 124 of the proximal magnetic disk 108 are sized to be received by the one or more recesses 126 of the distal magnetic disk 114.
  • the one or more projections of the distal magnetic disk 114 are sized to be received by the one or more recesses 126 of the proximal magnetic disk 108.
  • dimensions of the one or more projections 124 generally correspond to dimensions of the one or more recesses 126.
  • the proximal interlock features 110 and the distal interlock features 116 may be angled and/or pointed, such that the one or more projections 124 and the one or more recesses 126 slide along one another before interlocking. This may assist in an operator in coupling the proximal magnetic disk 108 and the distal magnetic disk 114.
  • an operator may interlock the proximal magnetic disk 108 and the distal magnetic disk 114 by aligning the one or more projections 124 and the one or more recesses 126; the operator may rotate either the proximal rotational shaft portion 106 or the distal rotational shaft portion 112 to align the one or more projections 124 and the one or more recesses 126.
  • the other of the proximal rotational shaft portion 106 or the distal rotational shaft portion 112 may be rotated to align the one or more projections 124 and the one or more recesses 126.
  • the magnetic attraction between the proximal magnetic disk 108 and the distal magnetic disk 114 may aid in aligning and pulling together the proximal magnetic disk 108 and the distal magnetic disk 114 into engagement.
  • FIG. 5 A and FIG. 5B generally depict the an axial end view of either the proximal magnetic disk 108 and the distal magnetic disk 114, respectively.
  • the one or more projections 124 and the one or more recesses 126 may be radially positioned, such as along an outer perimeter of the proximal magnetic disk 108 or the distal magnetic disk 114. It is noted that while one pattern is illustrated on the proximal magnetic disk 108 and another pattern is illustrated on the distal magnetic disk 114, such patterning may be switched.
  • the one or more projections 124 and the one or more recesses 126 may extend radially from a centroid 128 of the proximal magnetic disk 108 and the distal magnetic disk 114. Again, it is noted that while one pattern is illustrated on the proximal magnetic disk 108 and another pattern is illustrated on the distal magnetic disk 114, such patterning may be switched.
  • the one or more projections 124 and the one or more recesses 126 may include any suitable pattern for interlocking the proximal magnetic disk 108 and the distal magnetic disk 114.
  • the one or more projections 124 and the one or more recesses 126 may be linear, square, rectangular, or any other suitable shape. Dimensions of the one or more projections 124 and the one or more recesses 126 generally correspond to one another, such that the one or more projections 124 may be inserted into the one or more recesses 126.
  • the one or more projections 124 may have a projection depth of 2 centimeters, be radially positioned (depicted in FIG. 5), and be generally rectangular in shape.
  • the one or more recesses 126 may have a recess depth of about 2 centimeters (depicted in FIG. 3), be radially positioned, and be generally rectangular in shape.
  • the projection depth and the recess depth may be about 1 centimeter, about 2 centimeters, about 3 centimeters, or any other suitable depth.
  • the projection depth and the recess depth may not be constant throughout either the one or more projections 124 and the one or more recesses 126, respectively, such that the one or more projections 124 and the one or more recesses 126 are angled tapered, as discussed hereinabove and as depicted in FIG. 4.
  • the proximal handle assembly 102 may include a proximal body 130 housing the proximal rotational shaft portion 106.
  • the distal handle assembly 104 may include a distal body 132 housing the distal rotational shaft portion 112.
  • the proximal handle assembly 102 may couple to the distal handle assembly 104 via, for example, one or more handle alignment tabs 134.
  • the one or more handle alignment tabs 134 on the proximal body 130 and the distal body 132 may correspond to one another, such that the one or more handle alignment tabs 134 are positioned on the proximal body 130 in the same angular positions that the one or more handle alignment tabs 134 are positioned on the distal body 132.
  • the one or more alignment tabs 134 may be one of the one or more alignment tabs 134 on both the proximal body 130 and the distal body 132.
  • the operator may align the one alignment tab 134 and press the proximal handle assembly 102 and the distal handle assembly 104 together.
  • the one or more alignment tabs 134 of the proximal body 130 and/or the distal body 132 may act as a retention spring, such that the proximal body 130 and/or the distal body 132 may bend out of place when the operator is assembling the handle assembly 100, and bend back into place when the handle assembly is in the assembled state.
  • the one or more alignment tabs 134 may act as a retention spring on the proximal body 130, the distal body 132, or both.
  • the one or more alignment tabs 134 may include at least one retention spring .
  • the retention spring may maintain alignment of the proximal body 130 and the distal body 132 through the one or more alignment tabs 134.
  • the one or more alignment tabs 134 may couple the proximal handle assembly 102 and the distal handle assembly 104 prior to the proximal magnetic disk 108 and the distal magnetic disk 114 interlocking, simultaneous with the proximal magnetic disk 108 and the distal magnetic disk 114 interlocking, or after the proximal magnetic disk 108 and the distal magnetic disk 114 interlock.
  • the operator may ensure the proximal interlock features 110 and the distal interlock features 116 are aligned before the proximal magnetic disk 108 and the distal magnetic disk 114 are enclosed and, thus, hidden when the proximal handle assembly 102 and the distal handle assembly 104 are coupled to one another.
  • the proximal rotational shaft portion 106 and/or the distal rotational shaft portion 112 may extend the proximal magnetic disk 108 and/or the distal magnetic disk 114 beyond the one or more alignment tabs 134 of the proximal body 130 and the distal body 132, respectively.
  • the proximal rotation shaft portion 106 and/or the distal rotational shaft portion 112 may be slidably disposed within the proximal body 130 and/or the distal body 132 to allow a user to more easily assemble the proximal magnetic disk 108 to the distal magnetic disk 114.
  • the proximal body 130 and the distal body 132 may be configured to couple to one another through a variety of features such as the alignment tabs 134 described above.
  • the proximal body 130 and the distal body 132 may be configured to couple to one another through a proximal tongue 136 and a distal slot 138 engagement, as depicted in FIGS. 7A- 7C.
  • the proximal body 130 may define the proximal tongue 136, while the distal body 132 may define the distal slot 138.
  • the proximal tongue 136 and the distal slot 138 may be configured to couple to one another, such that the proximal tongue 136 is inserted into the distal slot 138.
  • the proximal tongue 136 may include an elevated tongue feature 137, which protrudes radially from the proximal body 130, as depicted in FIG. 7C, which depicts the proximal body 130 and distal body 132 of FIG. 7A rotated 90 degrees to better depict an elevation of the tongue feature 137.
  • the proximal tongue 136 and the distal slot 138 may act as the alignment tabs 134, as discussed hereinabove, to assist the operator in coupling the proximal body 130 to the distal body 132. That is, the tongue may engage and extend into the slot 138 thereby coupling the proximal body 130 to the distal body 132.
  • the elevated tongue feature 137 may couple the proximal body 130 to the distal body 132 when the elevated tongue feature 137 is inserted into the distal slot 138, as depicted in FIG. 7B.
  • the proximal tongue 136 may also act as a retention spring, as discussed hereinabove.
  • the proximal tongue 136 and the distal slot 138 may be evenly spaced out along the proximal body 130 and the distal body 132, respectively.
  • the proximal tongue 136 and the distal slot 138 may be unevenly spaced out along the proximal body 130 and the distal body 132, respectively.
  • FIG. 7A depicts the proximal body 130 and the distal body 132 in the unassembled state. Once in the assembled state depicted in FIG. 7B, the proximal body 130 and the distal body 132 may be uncoupled through the operator applying a force to pull the proximal body 130 and the distal body 132 away from one another.
  • the operator may be unable to uncouple the proximal body 130 from this distal body 132, absent the operator applying enough force to pull the proximal body 130 and the distal body 132 away from one another to break the elevated tongue feature 137 or distal body 132 surrounding the slot 138.
  • the proximal body 130 and the distal body 132 may also be configured to couple to one another through a proximal post 140 and the distal slot 138.
  • the proximal body 130 may define the proximal post 140
  • the distal body 132 may define the distal slot 138.
  • the proximal post 140 and the distal slot 138 may be configured to couple to one another, such that the proximal post 140 is inserted into the distal slot 138.
  • the proximal post 140 may be about 0.05 centimeters in diameter, about 1.0 centimeters in diameter, about 2.0 centimeters in diameter, or any other suitable diameter.
  • the distal slot 138 may be equal to or slightly larger than the proximal post 140, such that the proximal post 140 may be inserted into the distal slot 138.
  • FIG. 8A depicts the proximal body 130 and the distal body 132 in the unassembled state. When the operator brings the proximal body 130 and the distal body 132 together, the proximal post 140 may be inserted into the distal slot 138 and the operator may further twist the proximal body 130 or the distal body 132, such that the proximal post 140 is further inserted into the distal slot 138 when the distal slot 138 is an L-shaped slot, as depicted in FIG. 8B.
  • the distal slot 138 may be a straight slot, an L-shaped slot (as depicted in FIG. 8 A and FIG. 8B), or any other suitable shape to couple the proximal body 130 to the distal body 132.
  • the post may be instead on the distal body 132 and the slot may be formed in the proximal body 130, or any combination thereof.
  • the handle assembly 100 may, in addition to or instead of the embodiments above, also include a rotating ring 150 to lock the proximal post 140 in place.
  • the rotating ring 150 may be placed over or around the proximal body 130, the distal body 132 (as depicted in FIG. 9A), or both.
  • the rotating ring 150 may include a ring slot 151 and/or ring dimples 152.
  • the distal body 132 may include distal body dimples 154.
  • the operator may rotate the rotating ring 150, such that the proximal post 140 is inserted into the ring slot 151. Rotation of the rotating ring 150 may lock the proximal post 140 into place, as depicted in FIG. 9B.
  • the ring dimples 152 and the distal body dimples 154 may interfere with one another, such that the rotating ring 150 does not slide off of the distal body 132. Similar to embodiments above, features of the slot and pin may be on the other of the proximal body 130 and the distal body 132, or any combination thereof.
  • the proximal body 130 and the distal body 132 may, in addition to or instead of the embodiments above, be configured to couple to one another through a proximal threaded surface 142 and a distal threaded surface 144.
  • the proximal body 130 may include the proximal threaded surface 142 and the distal body 132 may include the distal threaded surface 144.
  • the proximal body 130 may couple to the distal body 132 when the proximal threaded surface 142 and the distal threaded surface 144 are threadingly engaged with one another.
  • the proximal body 130 and the distal body 132 When the operator brings the proximal body 130 and the distal body 132 together, the proximal body 130 and the distal body 132, or both, may be twisted such that the proximal threaded surface 142 and the distal threaded surface 144 threadingly engage one another; the operator may twist the proximal body 130, the distal body 132, or both, until a tight seal is formed and the proximal threaded surface 142 and the distal threaded surface 144 are no longer visible (as depicted in FIG. 10B).
  • the proximal threaded surface 142 may be smaller in diameter and be enclosed within the distal threaded surface 144 when the proximal threaded surface 142 and the distal threaded surface 144 threadingly engage one another.
  • the distal threaded surface 144 may be smaller in diameter and be enclosed within the proximal threaded surface 142 when the proximal threaded surface 142 and the distal threaded surface 144 threadingly engage one another.
  • any features may be on either of, or both of, the proximal body 130 and the distal body 132.
  • Embodiments of the present disclosure may also include a method of assembling the handle assembly 100 of the medical device 10. As depicted in FIG. 2A and FIG. 2B, the method may include advancing the proximal handle assembly 102 toward a distal handle assembly 104 and interlocking the proximal interlock features 110 of the proximal magnetic disk 108 mounted to the proximal rotational shaft portion 106 associated with the proximal handle assembly 102 with the distal interlock features 116 of the distal magnetic disk 114 mounted to the distal rotational shaft portion 112. The method may also include locking the proximal body 130 of the proximal handle assembly 102 to the distal body 132 of the distal handle assembly 104.
  • interlocking the proximal interlock features 110 of the proximal magnetic disk 108 with the distal interlock features 116 of the distal magnetic disk 114 may include inserting the projections extending from one of the proximal magnetic disk 108 and the distal magnetic disk 114 into the recesses formed within the other of the proximal magnetic disk 108 and the distal magnetic disk 114.
  • locking the proximal body 130 to the distal body 132 may include coupling the proximal body 130 to the distal body 132 by inserting the proximal tongue 136 into the distal slot 138, as discussed hereinabove.
  • the method may also include rotating the proximal handle assembly 102 to lock the proximal post 140 into the distal slot 138.
  • Coupling the proximal body 130 to the distal body 132 may also include threadingly engaging the proximal threaded surface 142 with the distal threaded surface 144.
  • the method of assembly may include interlocking any of the features described herein.
  • a handle assembly for a medical device including: a proximal handle assembly including: a proximal rotational shaft; and a proximal magnetic disk mounted to the proximal rotational shaft, the proximal magnetic disk including one or more proximal interlock features; and a distal handle assembly including: a distal rotational shaft; and a distal magnetic disk mounted to the distal rotational shaft, the distal magnetic disk including one or more distal interlock features, wherein the proximal magnetic disk and the distal magnetic disk interlock with one another via interaction of the one or more proximal interlock features and the one or more distal interlock features.
  • the proximal handle assembly includes a proximal body housing the proximal rotational shaft;
  • the distal handle assembly includes a distal body housing the distal rotational shaft; and the proximal handle assembly is configured to couple to the distal handle assembly via one or more handle alignment tabs.
  • proximal rotational shaft includes a rotational shaft lock, wherein the rotational shaft lock prevents rotation of the proximal rotational shaft.
  • the one or more proximal interlock features and the one or more distal interlock features include one or more projections extending from one of the proximal magnetic disk and the distal magnetic disk and one or more recesses formed within the other of the proximal magnetic disk and the distal magnetic disk, wherein the one or more projections are sized to be received within the one or more recesses.
  • the proximal handle assembly includes a proximal body housing the proximal rotational shaft and the proximal magnetic disk
  • the distal handle assembly includes a distal body housing the distal rotational shaft and the distal magnetic disk
  • the proximal body is configured to couple to the distal body to enclose the proximal magnetic disk and the distal magnetic disk.
  • the proximal handle assembly includes a proximal body housing the proximal rotational shaft, the proximal body defining a proximal tongue
  • the distal handle assembly includes a distal body housing the distal rotational shaft, the distal body defining a distal slot
  • the proximal tongue and the distal slot are configured to couple to one another, such that the proximal tongue is inserted into the distal slot.
  • the proximal handle assembly includes a proximal body housing the proximal rotational shaft, the proximal body defining a proximal post;
  • the distal handle assembly includes a distal body housing the distal rotational shaft, the distal body defining a distal slot; and the proximal post and the distal slot are configured to couple to one another, such that the proximal post is inserted into the distal slot.
  • a method of assembling a handle assembly of a medical device including: advancing a proximal handle assembly of the medical device toward a distal handle assembly of the medical device; interlocking one or more proximal interlock features of a proximal magnetic disk mounted to a proximal rotational shaft associated with the proximal handle assembly with one or more distal interlock features of a distal magnetic disk mounted to a distal rotational shaft associated with the distal handle assembly; and locking a proximal body of the proximal handle assembly to a distal body of the distal handle assembly.
  • the one or more proximal interlock features and the one or more distal interlock features includes one or more projections extending from one of the proximal magnetic disk and the distal magnetic disk and one or more recesses formed within the other of the proximal magnetic disk and the distal magnetic disk, wherein the one or more projections are sized to be received within the one or more recesses; and interlocking the one or more proximal interlock features of the proximal magnetic disk associated with the one or more distal interlock features of a distal magnetic includes inserting the one or more projections extending from one of the proximal magnetic disk and the distal magnetic disk into the one or more recesses formed within the other of the proximal magnetic disk and the distal magnetic disk.
  • the proximal handle assembly includes the proximal body housing the proximal rotational shaft, the proximal body defining a proximal tongue
  • the distal handle assembly includes the distal body housing the distal rotational shaft, the distal body defining a distal slot
  • the proximal tongue and the distal slot are configured to couple to one another, such that the proximal tongue is inserted into the distal slot
  • locking the proximal body of the proximal handle assembly to the distal body of the distal handle assembly includes coupling the proximal body to the distal body by inserting the proximal tongue into the distal slot.
  • the proximal handle assembly includes a proximal body housing the proximal rotational shaft, the proximal body defining a proximal post;
  • the distal handle assembly includes a distal body housing the distal rotational shaft, the distal body defining a distal slot; and the proximal post and the distal slot are configured to couple to one another, such that the proximal post is inserted into the distal slot; and locking the proximal body of the proximal handle assembly to the distal body of the distal handle assembly includes coupling the proximal body to the distal body by inserting the proximal post into the distal slot.
  • the proximal handle assembly includes a proximal body housing the proximal rotational shaft, the proximal body including a proximal threaded surface;
  • the distal handle assembly includes a distal body housing the distal rotational shaft, the distal body including a distal threaded surface; and the distal threaded surface and the proximal threaded surface are configured to couple to one another; and locking the proximal body of the proximal handle assembly to the distal body of the distal handle assembly includes coupling the proximal body to the distal body by threadingly engaging the proximal threaded surface with the distal threaded surface.
  • a handle assembly for a medical device may include a multi-piece handle, resulting in ease of packaging and reduced storage needs of the device.
  • a handle assembly for a medical device includes a proximal handle assembly and a distal handle assembly.

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Abstract

A handle assembly for a medical device includes a proximal handle assembly that includes a proximal rotational shaft portion and a proximal magnetic disk mounted to the proximal rotational shaft portion, the proximal magnetic disk including one or more proximal interlock features. The medical device also includes a distal handle assembly that includes a distal rotational shaft portion and a distal magnetic disk mounted to the distal rotational shaft portion, the distal magnetic disk including one or more distal interlock features. The proximal magnetic disk and the distal magnetic disk interlock with one another via interaction of the one or more proximal interlock features and the one or more distal interlock features.

Description

HANDLE ASSEMBLIES FOR MEDICAL DEVICES AND METHODS OF ASSEMBLING THE SAME
TECHNICAL FIELD
[0001] The present specification generally relates to handle assemblies for medical devices and methods of assembling the same, and more particularly to a handle assembly for medical devices for endovascular treatment of a vessel.
BACKGROUND
[0002] Endovascular treatments treat various blood vessel disorders from within the blood vessel using long, thin tubes called catheters, which are place inside the blood vessel to deliver the treatment. Endovascular treatments may include, but are not limited to, atherectomy, thrombectomy, or similar procedures such as to remove clots or other occlusive material from a vessel. Endovascular treatment devices may include rotational components which often include various components in a single handle. One challenging aspect of endovascular treatment devices is that inclusion of the various components in a single handle results in an large, bulky packaging, which may result in increased material usage, increased shipping prices, and decreased storage capabilities of facilities and hospitals utilizing the endovascular treatment devices.
[0003] Accordingly, a need exists for alternative handle assemblies for medical devices that result in more economical packaging and/or easier storage.
SUMMARY
[0004] The present embodiments address the above referenced concerns. In particular, the present disclosure is directed to systems, methods, and devices that include multi-piece handles that provide more economical packaging options. Additionally, some embodiments are directed to medical devices with interlock features in or on the handles which allow for simplified assembly of the medical device.
[0005] In one embodiment, a handle assembly for a medical device includes a proximal handle assembly that includes a proximal rotational shaft and a proximal magnetic disk mounted to the proximal rotational shaft, the proximal magnetic disk including one or more proximal interlock features. The handle assembly for the medical device also includes a distal handle assembly that includes a distal rotational shaft and a distal magnetic disk mounted to the distal rotational shaft, the distal magnetic disk including one or more distal interlock features. The proximal magnetic disk and the distal magnetic disk interlock with one another via interaction of the one or more proximal interlock features and the one or more distal interlock features.
[0006] In another embodiment, a method of assembling a handle assembly of a medical device includes advancing a proximal handle assembly of the medical device toward a distal handle assembly of the medical device and interlocking one or more proximal interlock features of a proximal magnetic disk mounted to a proximal rotational shaft associated with the proximal handle assembly with one or more distal interlock features of a distal magnetic disk mounted to a distal rotational shaft associated with the distal handle assembly. The method of assembling the medical device also includes locking a proximal body of the proximal handle assembly to a distal body of the distal handle assembly.
[0007] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:
[0009] FIG. 1 schematically depicts an assembled medical device, according to one or more embodiments shown and described herein;
[0010] FIG. 2A schematically depicts an interior view of a handle assembly in a disassembled state, such as of the medical device of FIG. 1, according to one or more embodiments shown and described herein;
[0011] FIG. 2B schematically depicts the handle assembly of FIG. 2A in an assembled state, according to one or more embodiments shown and described herein;
[0012] FIG. 3 schematically depicts a proximal magnetic disk and a distal magnetic disk of the handle assembly such as that depicted in FIGS. 2A and 2B in isolation, according to one or more embodiments shown and described herein; [0013] FIG. 4 schematically depicts a proximal magnetic disk and a distal magnetic disk for a handle assembly such as that depicted in FIGS. 2A and 2B in isolation, according to one or more embodiments shown and described herein;
[0014] FIG. 5A schematically depicts a front-view of interlock features of either a proximal magnetic disk or a distal magnetic disk of for a handle assembly such as that depicted in FIGS. 2A and 2B, according to one or more embodiments shown and described herein;
[0015] FIG. 5B schematically depicts a front- view of interlock features of the other of the proximal magnetic disk or the distal magnetic disk of FIG. 5A, according to one or more embodiments shown and described herein;
[0016] FIG. 6A schematically depicts a front-view of another embodiment of interlock features of either a proximal magnetic disk or a distal magnetic disk for a handle assembly such as that depicted in FIGS. 2A and 2B, according to one or more embodiments shown and described herein;
[0017] FIG. 6B schematically depicts a front-view of another embodiment of interlock features of the other of the proximal magnetic disk or the distal magnetic disk of FIG. 6B, according to one or more embodiments shown and described herein;
[0018] FIG. 7A schematically depicts a side view of a proximal body and a distal body of a handle assembly in an unassembled configuration, according to one or more embodiments shown and described herein;
[0019] FIG. 7B schematically depicts a side view of the proximal body and the distal body of FIG. 7A in an assembled configuration, according to one or more embodiments shown and described herein;
[0020] FIG. 7C schematically depicts a side view of the proximal body and the distal body of FIG. 7A rotated 90 degrees, according to one or more embodiments shown and described herein;
[0021] FIG. 8A schematically depicts a side view of a proximal body and a distal body of a handle assembly in an unassembled configuration, according to one or more embodiments shown and described herein; [0022] FIG. 8B schematically depicts a side view of the proximal body and the distal body of FIG. 8A in an assembled configuration, according to one or more embodiments shown and described herein;
[0023] FIG. 9A schematically depicts a side view of a proximal body and a distal body of a handle assembly in an unassembled configuration, according to one or more embodiments shown and described herein;
[0024] FIG. 9B schematically depicts a side view of the proximal body and the distal body of FIG. 9A in an assembled configuration, according to one or more embodiments shown and described herein;
[0025] FIG. 10A schematically depicts a side view of a proximal body and a distal body of a handle assembly in an unassembled configuration, according to one or more embodiments shown and described herein; and
[0026] FIG. 10B schematically depicts a side view of the proximal body and the distal body of FIG. 10A in an assembled configuration, according to one or more embodiments shown and described herein.
DETAILED DESCRIPTION
[0027] Embodiments as described herein are directed to handles assemblies for a medical device and methods of assembling the same. Particularly, handle assemblies as described herein are part of medical devices for endovascular treatment of a vessel. Endovascular treatments may include but are not limited to atherectomy, thrombectomy, or similar devices for removing occlusions within a vessel. Accordingly, while various embodiments are directed to atherectomy devices, other vascular treatment devices are contemplated and possible. The figures generally depict handle assemblies that allow for economical packaging of a medical device, such as an endovascular treatment device. In particular, a handle assembly generally includes a proximal handle assembly and a distal handle assembly, an operator may assemble the proximal handle assembly and the distal handle assembly to construct the endovascular device, such as an atherectomy device. As noted previously, single-piece endovascular devices may be large and bulky, resulting in difficulty of packaging and storage. Accordingly, handle assemblies as described herein allow for more economical and efficient packaging and storage of medical devices. [0028] Within the context of the present disclosure, “proximal,” “a proximal end,” “a proximal portion,” “a proximal end portion,” and “a proximal length” of, for example, a handle assembly, designate an end, portion, end portion, length of the handle assembly intended to be nearer an operator and further from the subject, when the device is in use by the operator.
[0029] Within the context of the present disclosure, “distal,” “a distal end,” “a distal portion,” “a distal end portion,” and “a distal length” of, for example, a handle assembly, designate an end, portion, end portion, length of the handle assembly intended to be nearer the of the subject and further from the operator, when the device is in use by the operator.
[0030] In the accompanying figures, the proximal side or direction is designated by P and the distal side or direction is designated by D.
[0031] Referring now to FIG. 1, a medical device 10 is generally depicted. The medical device 10 may include a handle assembly 100 in an assembled state (discussed further below). The handle assembly may have two or more components combinable together in the assembled state. For example, the medical device 10 of the present embodiment includes a proximal handle assembly 102 and a distal handle assembly 104. Although the medical device 10 is depicted in FIG. 1 as an atherectomy device including a driven element (e.g., a flexible elongate member 105) with an atherectomy bead 101 or abrasive element coupled thereto, other vessel or vascular treatment devices are contemplated and possible. The flexible elongate member 105 may extend from the distal handle assembly 104 and may be rotated. For example the elongate member 105 may be coupled to or part of a rotational shaft (discussed further below).
[0032] Referring to FIG. 2A and FIG. 2B, an internal or cross-sectional view of the handle assembly 100 of FIG. 1 is depicted. FIG. 2 A generally depicts a the handle assembly 100 in an unassembled state, while FIG. 2B generally depicts an internal or cross-sectional view of the handle assembly 100 in the assembled state. In the unassembled state the proximal handle assembly 102 is separated from the distal handle assembly 104.
[0033] By providing the handle assembly 100 in an initially disassembled configuration as illustrated in FIG. 2A, the proximal handle assembly 102 and the distal handle assembly 104 may be packaged or arranged in a non-inline or linear configuration relative to one another, which may allow for smaller, more economical packaging, and/or smaller storage space requirements. Accordingly, the proximal handle assembly 102 and the distal handle assembly 104 may be packaged on top of one another, at an angle to one another, etc. In some embodiments, the handle assembly 100 in an initially disassembled configuration may also allow for the proximal handle assembly 102 and the distal handle assembly 104 to be packaged separately. Separate packaging of the proximal handle assembly 102 and the distal handle assembly 104 may permit an operator, user, or warehouse to store the handle assembly 100 more efficiently. For example, the larger packages accommodating the proximal handle assembly 102 and the distal handle assembly 104 in the assembled state may be difficult to store in a storage area. In contrast, when the proximal handle assembly 102 and the distal handle assembly 104 are packaged separately in smaller packaging, or packaged together adjacent to one another, as opposed to longitudinally aligned with one another, the proximal handle assembly 102 and the distal handle assembly 104 may be stored in separate areas or packed/arranged in various configurations in the operator storage area, allowing for more efficient and economic storage.
[0034] Each of the proximal handle assembly 102 and the distal handle assembly 104 may include various components of the medical device 10. For example, the proximal handle assembly 102 may include a proximal rotational shaft portion 106 and a proximal magnetic disk 108 mounted to the proximal rotational shaft portion 106. Similarly, the distal handle assembly 104 may include a distal rotational shaft portion 112 and a distal magnetic disk 114 mounted to the distal rotational shaft portion 112. As will be described in greater detail below, the proximal magnetic disk 108 and the distal magnetic disk 114 may interlock with one another (as depicted in FIG. 2B) through the interaction of the one or more interlock features (proximal interlock features 110 and distal interlock features 116), thereby connecting the proximal rotational shaft portion 106 and the distal rotational shaft portion 112 to provide an assembled rotational shaft 113, such as depicted in FIG. 2. Moreover, the flexible elongate member 105 may attach to be part of the distal rotational shaft portion 112, such that rotation of the distal rotational shaft portion 112 rotates the flexible elongate member 105. In embodiments, the flexible elongate member 105 may be removable from the distal rotational shaft portion 112. For example, the flexible elongate member 105 may be removably coupled to the distal rotational shaft portion 112 via any suitable interconnect such as fasteners, anchors, etc. In embodiments, allowing the flexible elongate member 105 to be removably coupled from the distal rotational shaft portion 112 may allow for further breakdown and reduction in storage space needs.
[0035] As noted above, the proximal handle assembly 102 and the distal handle assembly 104 may include various components including the proximal rotational shaft portion 106 and the distal rotational shaft portion 112, respectively. The proximal rotational shaft portion 106 and the distal rotational shaft portion 112 may be rotatable such as about a longitudinal axis 115, such that each may rotate when connected to a motor 118 (e.g., a rotary motor). Generally, as depicted in FIG. 2A and FIG. 2B, the motor 118 may be connected to the proximal rotational shaft portion 106; however, it should be understood that in some embodiments, the motor 118 may be connected to the distal rotational shaft portion 112. The motor 118 may be powered via a power source 120. The power source 120 may include a power cable to an external power source (e.g., generator, battery, outlet, etc.). In some embodiments, the power source 120 may include a battery, such as a lithium ion battery, housed within the proximal handle assembly 102 (as depicted in FIG. 2 A and FIG. 2B) or the distal handle assembly 104.
[0036] The proximal rotational shaft portion 106 and the distal rotational shaft portion 112 may be freely rotatable. For example, the proximal rotational shaft portion 106 and the distal rotational shaft portion 112 may not be locked in place and may rotate freely upon being acted on by an external force, such as the operator rotating the proximal rotational shaft portion 106 or the distal rotational shaft portion 112 to align the proximal magnetic disk 108 and the distal magnetic disk 114 with one another as described below. The proximal rotational shaft portion 106 and the distal rotational shaft portion 112 may be made of aluminum, carbon fiber, steel, a combination thereof, or any other suitable material. The proximal rotational shaft portion 106 and the distal rotational shaft portion 112 may be made of the same or different materials.
[0037] The proximal handle assembly 102 may include the proximal magnetic disk 108 mounted to the proximal rotational shaft portion 106, while the distal handle assembly 104 may include the distal magnetic disk 114 mounted to the distal rotational shaft portion 112. The proximal magnetic disk 108 and the distal magnetic disk 114 may be mounted through bolts, screws, hooks, welding, brazing, or any suitable means. In some embodiments, the proximal magnetic disk 108 and the distal magnetic disk 114 may be cast as part of the proximal rotational shaft portion 106 and the distal rotational shaft portion 112, respectively. The proximal magnetic disk 108 and the distal magnetic disk 114 may also be made of any suitable material or combination of materials such as, but not limited to, aluminum, carbon fiber, steel, etc. In embodiments, the proximal magnetic disk 108 and/or the distal magnetic disk 114 may be formed of a magnetic material (e.g., ferromagnetic material) or have one or more embedded magnets.
[0038] For example, the proximal magnetic disk 108 and the distal magnetic disk 114 may include a plurality of magnets 109 such as embedded within, for example, a non-magnetic material that forms the disk. In some embodiments, the proximal magnetic disk 108 and the distal magnetic disk 114 may include one or more electromagnets, such that an electromagnetic field is generated when a current is supplied to the electromagnets. In such embodiments, the magnetism of the proximal magnetic disk 108 and the distal magnetic disk 114 may be turned on and off, reversed, strengthened, or the like, depending on the current supplied, the polarity generated, and the power level provided. The proximal magnetic disk 108 and the distal magnetic disk 114 may be circular (as depicted in FIGS. 5 and 6), square, or any other suitable shape in cross-section. The proximal magnetic disk 108 and the distal magnetic disk 114 may be sized to fit and rotate within the proximal handle assembly 102 and the distal handle assembly 104, such as from about 0.5 centimeters to about 3.5 centimeters in diameter, though other ranges are contemplated and possible.
[0039] Each of the proximal magnetic disk 108 and the distal magnetic disk 114 may include one or more interlock features. In particular, the proximal magnetic disk 108 may include one or more proximal interlock features 110 and the distal magnetic disk 114 may include one or more distal interlock features 116. The one or more proximal interlock features 110 and the one or more distal interlock features 116 may be configured to interlock within one another to substantially prevent radial motion and/or rotational motion of the proximal magnetic disk 108 and the distal magnetic disk 114 relative to one another. That is, via the one or more proximal interlock features 110 and the one or more distal interlock features 116 (each of which is discussed further below), the proximal magnetic disk 108 and the distal magnetic disk 114 are rotationally fixed relative to one another, such that when rotated by the motor 118, the proximal magnetic disk 108 and the distal magnetic disk 114 rotate together.
[0040] In embodiments, the proximal handle assembly 102 and/or the distal handle assembly 104 may include a rotational shaft lock 122. In the depicted embodiment, the rotational shaft lock 122 is arranged to engage the proximal rotational shaft portion 106. The rotational shaft lock 122 may prevent rotation of the proximal rotational shaft portion 106 when the rotational shaft lock 122 is engaged. In contrast, when the rotational shaft lock 122 is disengaged, the proximal rotational shaft portion 106 may rotate freely, as described hereinabove. As noted above, in embodiments, the distal rotational shaft portion 112 may include the rotational shaft lock 122, such that the rotational shaft lock 122 may prevent rotation of the distal rotational shaft portion 112. The rotational shaft lock 122 may be a clamp, cam lock lever, or any other suitable lock to prevent rotation of either the proximal rotational shaft portion 106 or the distal rotational shaft portion 112. [0041] The proximal handle assembly 102 and/or the distal handle assembly 104 may also include a fluid inlet lumen 123 and a fluid outlet lumen 125. The fluid inlet lumen 123 may provide a fluid, water, saline, or any other suitable fluid into or along the proximal rotational shaft portion 106 or the distal rotational shaft portion 112, such as to bead 101 or other abrasive element (as depicted in FIG. 1) for performing atherectomy, to reduce heat, assist in clot break-up, or the like. The fluid inlet lumen 123 may be coupled to the distal handle assembly 104 (as depicted in FIG. 2A and FIG. 2B). However, in some embodiments, it is contemplated that the fluid inlet lumen 123 may be coupled to the proximal handle assembly 102, and may be fluidically coupled, via any suitable fluid coupling, to a fluid lumen in the distal handle assembly 104. Although the fluid inlet lumen 123 and the fluid outlet lumen 125 are depicted as entering the proximal handle assembly 102 from different entry points, in some embodiments, the fluid inlet lumen 123 and the fluid outlet lumen 125 may form a Y-junction or a T-junction. As such, the Y-junction may fluidically couple the fluid inlet lumen 123 and the fluid outlet lumen 125 to either of the proximal handle assembly 102 or the distal handle assembly 104 at the same entry point.
[0042] The fluid inlet lumen 123 may be coupled to a fluid source (not depicted). The fluid source may be a vessel housing fluid, e.g., water, saline, or any other suitable fluid. In embodiments, the handle assembly 100 may further include a first pump 127 fluidically coupled to the fluid inlet lumen 123. The first pump 127 may pump the fluid from the fluid source into the handle assembly 100. The first pump 127 may be coupled to the power source 120, or the pump 127 may include an internal power source. The first pump 127 may be engaged when the handle assembly 100 is in the assembled state, and disengaged when the handle assembly is in the unassembled state. In some embodiments, the first pump 127 may be integrated into either of the proximal handle assembly 102 and/or the distal handle assembly 104. In other embodiments, the first pump 127 may be separate from the proximal handle assembly 102 and/or the distal handle assembly 104, such as at or near the fluid source.
[0043] The fluid outlet lumen 125 may withdraw the fluid, water, saline, or any other suitable fluid out of the handle assembly 100. The fluid outlet 125 may be connected to a fluid waste container (not depicted), which may be a vessel housing the used fluid, water, saline, or other suitable fluid once it has run through the handle assembly 100. The fluid outlet lumen 125 may also provide for removal of waste fluid from the atherectomy, thrombectomy, or other procedure involving waste fluid. The waste fluid may include blood, a clot, or any other waste product from the procedure performed with the handle assembly 100. The handle assembly 100 may include a second pump 129 fluidically coupled to the fluid outlet lumen 125. The second pump 129 may be coupled to the power source 120, or the second pump 129 may include an internal power source. The second pump 129 may be engaged when the handle assembly 100 is in the assembled state, and disengaged when the handle assembly is in the unassembled state. In some embodiments, the second pump 129 may be integrated into either of the proximal handle assembly 102 and/or the distal handle assembly 104. In other embodiments, the second pump 129 may be separate from the proximal handle assembly 102 and/or the distal handle assembly 104, such as at or near the fluid source.
[0044] The fluid outlet lumen 125 may be coupled to the distal handle assembly 104 (as depicted in FIG. 2A and FIG. 2B). However, in some embodiments, it is contemplated that the fluid outlet lumen 125 may be coupled to the proximal handle assembly 102, and may be fluidically coupled, via any suitable fluid coupling, to a fluid lumen in the distal handle assembly 104.
[0045] Referring now to FIG. 3, a side view of the proximal magnetic disk 108 and the distal magnetic disk 114 is depicted. As described above, the proximal magnetic disk 108 may include the one or more proximal interlock features 110 and the distal magnetic disk 114 may include the one or more distal interlock features 116, such that the proximal magnetic disk 108 and the distal magnetic disk 114 interlock with one another through interaction of the one or more proximal interlock features 110 and the one or more distal interlock features 116.
[0046] The one or more proximal interlock features 110 and the one or more distal interlock features 116 may include one or more projections 124 extending from one of the proximal magnetic disk 108 and the distal magnetic disk 114 and one or more recesses 126 formed within the other of the proximal magnetic disk 108 and the distal magnetic disk 114, wherein the one or more projections 124 are sized to be received within the one or more recesses 126. For example, in FIG. 3, the one or more projections 124 of the proximal magnetic disk 108 are sized to be received by the one or more recesses 126 of the distal magnetic disk 114. Similarly, the one or more projections of the distal magnetic disk 114 are sized to be received by the one or more recesses 126 of the proximal magnetic disk 108. Thus, dimensions of the one or more projections 124 generally correspond to dimensions of the one or more recesses 126. [0047] In embodiments,, as depicted in FIG. 4, the proximal interlock features 110 and the distal interlock features 116 may be angled and/or pointed, such that the one or more projections 124 and the one or more recesses 126 slide along one another before interlocking. This may assist in an operator in coupling the proximal magnetic disk 108 and the distal magnetic disk 114. For example, an operator may interlock the proximal magnetic disk 108 and the distal magnetic disk 114 by aligning the one or more projections 124 and the one or more recesses 126; the operator may rotate either the proximal rotational shaft portion 106 or the distal rotational shaft portion 112 to align the one or more projections 124 and the one or more recesses 126. In embodiments where either the proximal rotational shaft portion 106 or the distal rotational shaft portion 112 is locked in place, the other of the proximal rotational shaft portion 106 or the distal rotational shaft portion 112 may be rotated to align the one or more projections 124 and the one or more recesses 126. The magnetic attraction between the proximal magnetic disk 108 and the distal magnetic disk 114 may aid in aligning and pulling together the proximal magnetic disk 108 and the distal magnetic disk 114 into engagement.
[0048] FIG. 5 A and FIG. 5B generally depict the an axial end view of either the proximal magnetic disk 108 and the distal magnetic disk 114, respectively. As depicted in FIG. 5A and FIG. 5B, in some embodiments, the one or more projections 124 and the one or more recesses 126 may be radially positioned, such as along an outer perimeter of the proximal magnetic disk 108 or the distal magnetic disk 114. It is noted that while one pattern is illustrated on the proximal magnetic disk 108 and another pattern is illustrated on the distal magnetic disk 114, such patterning may be switched.
[0049] In another embodiment, such as illustrated in FIGS. 6A and 6B, the one or more projections 124 and the one or more recesses 126 may extend radially from a centroid 128 of the proximal magnetic disk 108 and the distal magnetic disk 114. Again, it is noted that while one pattern is illustrated on the proximal magnetic disk 108 and another pattern is illustrated on the distal magnetic disk 114, such patterning may be switched.
[0050] The one or more projections 124 and the one or more recesses 126 may include any suitable pattern for interlocking the proximal magnetic disk 108 and the distal magnetic disk 114. For example, the one or more projections 124 and the one or more recesses 126 may be linear, square, rectangular, or any other suitable shape. Dimensions of the one or more projections 124 and the one or more recesses 126 generally correspond to one another, such that the one or more projections 124 may be inserted into the one or more recesses 126. In one embodiment, the one or more projections 124 may have a projection depth of 2 centimeters, be radially positioned (depicted in FIG. 5), and be generally rectangular in shape. In such an embodiment, the one or more recesses 126 may have a recess depth of about 2 centimeters (depicted in FIG. 3), be radially positioned, and be generally rectangular in shape. The projection depth and the recess depth may be about 1 centimeter, about 2 centimeters, about 3 centimeters, or any other suitable depth. In some embodiments, the projection depth and the recess depth may not be constant throughout either the one or more projections 124 and the one or more recesses 126, respectively, such that the one or more projections 124 and the one or more recesses 126 are angled tapered, as discussed hereinabove and as depicted in FIG. 4.
[0051] Different magnetic disks may be desired for different medical procedures, due to different speeds and forces that the magnetic disks may be subject to. As such, the proximal magnetic disk 108 and the distal magnetic disk 114 may be removed from the proximal rotational shaft portion 106 and the distal rotational shaft portion 112, respectively, and be replaced or interchanged. The proximal magnetic disk 108 an the distal magnetic disk 114 may be unscrewed, unhooked, or otherwise uncoupled from the proximal rotational shaft portion 106 and the distal rotational shaft portion 112, respectively.
[0052] Referring again to FIG. 2 A, the proximal handle assembly 102 may include a proximal body 130 housing the proximal rotational shaft portion 106. The distal handle assembly 104 may include a distal body 132 housing the distal rotational shaft portion 112. The proximal handle assembly 102 may couple to the distal handle assembly 104 via, for example, one or more handle alignment tabs 134. The one or more handle alignment tabs 134 on the proximal body 130 and the distal body 132 may correspond to one another, such that the one or more handle alignment tabs 134 are positioned on the proximal body 130 in the same angular positions that the one or more handle alignment tabs 134 are positioned on the distal body 132.
[0053] There may be one of the one or more alignment tabs 134 on both the proximal body 130 and the distal body 132. When an operator is coupling the proximal body 130 to the distal body 132, the operator may align the one alignment tab 134 and press the proximal handle assembly 102 and the distal handle assembly 104 together. As depicted in FIG. 2A, the one or more alignment tabs 134 of the proximal body 130 and/or the distal body 132 may act as a retention spring, such that the proximal body 130 and/or the distal body 132 may bend out of place when the operator is assembling the handle assembly 100, and bend back into place when the handle assembly is in the assembled state. The one or more alignment tabs 134 may act as a retention spring on the proximal body 130, the distal body 132, or both. In some embodiments, the one or more alignment tabs 134 may include at least one retention spring . The retention spring may maintain alignment of the proximal body 130 and the distal body 132 through the one or more alignment tabs 134.
[0054] The one or more alignment tabs 134 may couple the proximal handle assembly 102 and the distal handle assembly 104 prior to the proximal magnetic disk 108 and the distal magnetic disk 114 interlocking, simultaneous with the proximal magnetic disk 108 and the distal magnetic disk 114 interlocking, or after the proximal magnetic disk 108 and the distal magnetic disk 114 interlock. As such, in embodiments where the proximal magnetic disk 108 and the distal magnetic disk 114 interlock prior to the proximal handle assembly 102 coupling to the distal handle assembly 104 via the one or more alignment tabs 134, the operator may ensure the proximal interlock features 110 and the distal interlock features 116 are aligned before the proximal magnetic disk 108 and the distal magnetic disk 114 are enclosed and, thus, hidden when the proximal handle assembly 102 and the distal handle assembly 104 are coupled to one another. In such embodiments, the proximal rotational shaft portion 106 and/or the distal rotational shaft portion 112 may extend the proximal magnetic disk 108 and/or the distal magnetic disk 114 beyond the one or more alignment tabs 134 of the proximal body 130 and the distal body 132, respectively. In some embodiments, the proximal rotation shaft portion 106 and/or the distal rotational shaft portion 112 may be slidably disposed within the proximal body 130 and/or the distal body 132 to allow a user to more easily assemble the proximal magnetic disk 108 to the distal magnetic disk 114.
[0055] The proximal body 130 and the distal body 132 may be configured to couple to one another through a variety of features such as the alignment tabs 134 described above. In some embodiments, the proximal body 130 and the distal body 132 may be configured to couple to one another through a proximal tongue 136 and a distal slot 138 engagement, as depicted in FIGS. 7A- 7C. The proximal body 130 may define the proximal tongue 136, while the distal body 132 may define the distal slot 138. The proximal tongue 136 and the distal slot 138 may be configured to couple to one another, such that the proximal tongue 136 is inserted into the distal slot 138. The proximal tongue 136 may include an elevated tongue feature 137, which protrudes radially from the proximal body 130, as depicted in FIG. 7C, which depicts the proximal body 130 and distal body 132 of FIG. 7A rotated 90 degrees to better depict an elevation of the tongue feature 137. The proximal tongue 136 and the distal slot 138 may act as the alignment tabs 134, as discussed hereinabove, to assist the operator in coupling the proximal body 130 to the distal body 132. That is, the tongue may engage and extend into the slot 138 thereby coupling the proximal body 130 to the distal body 132.
[0056] When the operator brings together the proximal body 130 and the distal body 132 together, the elevated tongue feature 137 may couple the proximal body 130 to the distal body 132 when the elevated tongue feature 137 is inserted into the distal slot 138, as depicted in FIG. 7B. The proximal tongue 136 may also act as a retention spring, as discussed hereinabove. There may be one, two, three, four, or more of the proximal tongue 136 and the distal slot 138 on the proximal body 130 and the distal body 132. The proximal tongue 136 and the distal slot 138 may be evenly spaced out along the proximal body 130 and the distal body 132, respectively. Alternatively, the proximal tongue 136 and the distal slot 138 may be unevenly spaced out along the proximal body 130 and the distal body 132, respectively.
[0057] FIG. 7A depicts the proximal body 130 and the distal body 132 in the unassembled state. Once in the assembled state depicted in FIG. 7B, the proximal body 130 and the distal body 132 may be uncoupled through the operator applying a force to pull the proximal body 130 and the distal body 132 away from one another. In other embodiments, once the proximal body 130 and the distal body 132 are coupled together through the proximal tongue 136 and the distal slot 138, the operator may be unable to uncouple the proximal body 130 from this distal body 132, absent the operator applying enough force to pull the proximal body 130 and the distal body 132 away from one another to break the elevated tongue feature 137 or distal body 132 surrounding the slot 138.
[0058] The proximal body 130 and the distal body 132 may also be configured to couple to one another through a proximal post 140 and the distal slot 138. Referring now to FIG. 8A and FIG. 8B, the proximal body 130 may define the proximal post 140, while the distal body 132 may define the distal slot 138. The proximal post 140 and the distal slot 138 may be configured to couple to one another, such that the proximal post 140 is inserted into the distal slot 138. The proximal post 140 may be about 0.05 centimeters in diameter, about 1.0 centimeters in diameter, about 2.0 centimeters in diameter, or any other suitable diameter. The distal slot 138 may be equal to or slightly larger than the proximal post 140, such that the proximal post 140 may be inserted into the distal slot 138. [0059] FIG. 8A depicts the proximal body 130 and the distal body 132 in the unassembled state. When the operator brings the proximal body 130 and the distal body 132 together, the proximal post 140 may be inserted into the distal slot 138 and the operator may further twist the proximal body 130 or the distal body 132, such that the proximal post 140 is further inserted into the distal slot 138 when the distal slot 138 is an L-shaped slot, as depicted in FIG. 8B. The distal slot 138 may be a straight slot, an L-shaped slot (as depicted in FIG. 8 A and FIG. 8B), or any other suitable shape to couple the proximal body 130 to the distal body 132. In embodiments, the post may be instead on the distal body 132 and the slot may be formed in the proximal body 130, or any combination thereof.
[0060] As depicted in FIG. 9 A (the handle assembly 100 in the unassembled state) and FIG. 9B (the handle assembly 100 in the assembled state), the handle assembly 100 may, in addition to or instead of the embodiments above, also include a rotating ring 150 to lock the proximal post 140 in place. The rotating ring 150 may be placed over or around the proximal body 130, the distal body 132 (as depicted in FIG. 9A), or both. The rotating ring 150 may include a ring slot 151 and/or ring dimples 152. In embodiments, the distal body 132 may include distal body dimples 154. Once the proximal post 140 is inserted into the distal slot 138 (i.e., once the proximal body 130 and the distal body 132 are in the assembled state), the operator may rotate the rotating ring 150, such that the proximal post 140 is inserted into the ring slot 151. Rotation of the rotating ring 150 may lock the proximal post 140 into place, as depicted in FIG. 9B. The ring dimples 152 and the distal body dimples 154 may interfere with one another, such that the rotating ring 150 does not slide off of the distal body 132. Similar to embodiments above, features of the slot and pin may be on the other of the proximal body 130 and the distal body 132, or any combination thereof.
[0061] As depicted in FIG. 10A (the handle assembly 100 in the unassembled state) and FIG. 10B (the handle assembly 100 in the assembled state), the proximal body 130 and the distal body 132 may, in addition to or instead of the embodiments above, be configured to couple to one another through a proximal threaded surface 142 and a distal threaded surface 144. The proximal body 130 may include the proximal threaded surface 142 and the distal body 132 may include the distal threaded surface 144. The proximal body 130 may couple to the distal body 132 when the proximal threaded surface 142 and the distal threaded surface 144 are threadingly engaged with one another. When the operator brings the proximal body 130 and the distal body 132 together, the proximal body 130 and the distal body 132, or both, may be twisted such that the proximal threaded surface 142 and the distal threaded surface 144 threadingly engage one another; the operator may twist the proximal body 130, the distal body 132, or both, until a tight seal is formed and the proximal threaded surface 142 and the distal threaded surface 144 are no longer visible (as depicted in FIG. 10B). The proximal threaded surface 142 may be smaller in diameter and be enclosed within the distal threaded surface 144 when the proximal threaded surface 142 and the distal threaded surface 144 threadingly engage one another. In other embodiments, the distal threaded surface 144 may be smaller in diameter and be enclosed within the proximal threaded surface 142 when the proximal threaded surface 142 and the distal threaded surface 144 threadingly engage one another.
[0062] Although the aforementioned features are depicted on either of the proximal body 130 or the distal body 132, it should be noted any features may be on either of, or both of, the proximal body 130 and the distal body 132.
[0063] Embodiments of the present disclosure may also include a method of assembling the handle assembly 100 of the medical device 10. As depicted in FIG. 2A and FIG. 2B, the method may include advancing the proximal handle assembly 102 toward a distal handle assembly 104 and interlocking the proximal interlock features 110 of the proximal magnetic disk 108 mounted to the proximal rotational shaft portion 106 associated with the proximal handle assembly 102 with the distal interlock features 116 of the distal magnetic disk 114 mounted to the distal rotational shaft portion 112. The method may also include locking the proximal body 130 of the proximal handle assembly 102 to the distal body 132 of the distal handle assembly 104.
[0064] In embodiments, interlocking the proximal interlock features 110 of the proximal magnetic disk 108 with the distal interlock features 116 of the distal magnetic disk 114 may include inserting the projections extending from one of the proximal magnetic disk 108 and the distal magnetic disk 114 into the recesses formed within the other of the proximal magnetic disk 108 and the distal magnetic disk 114.
[0065] In embodiments, as discussed hereinabove, locking the proximal body 130 to the distal body 132 may include coupling the proximal body 130 to the distal body 132 by inserting the proximal tongue 136 into the distal slot 138, as discussed hereinabove. The method may also include rotating the proximal handle assembly 102 to lock the proximal post 140 into the distal slot 138. Coupling the proximal body 130 to the distal body 132 may also include threadingly engaging the proximal threaded surface 142 with the distal threaded surface 144. The method of assembly may include interlocking any of the features described herein.
[0066] Embodiments can be further described with reference to the following numerical clauses:
[0067] 1. A handle assembly for a medical device including: a proximal handle assembly including: a proximal rotational shaft; and a proximal magnetic disk mounted to the proximal rotational shaft, the proximal magnetic disk including one or more proximal interlock features; and a distal handle assembly including: a distal rotational shaft; and a distal magnetic disk mounted to the distal rotational shaft, the distal magnetic disk including one or more distal interlock features, wherein the proximal magnetic disk and the distal magnetic disk interlock with one another via interaction of the one or more proximal interlock features and the one or more distal interlock features.
[0068] 2. The handle assembly according to the previous clause, wherein: the proximal handle assembly includes a proximal body housing the proximal rotational shaft; the distal handle assembly includes a distal body housing the distal rotational shaft; and the proximal handle assembly is configured to couple to the distal handle assembly via one or more handle alignment tabs.
[0069] 3. The handle assembly according to clause 2, wherein the one or more handle alignment tabs act as a retention spring.
[0070] 4. The handle assembly according to either of clauses 2 or 3, wherein the proximal magnetic disk and the distal magnetic disk interlock prior to the proximal handle assembly coupling to the distal handle assembly via the one or more handle alignment tabs.
[0071] 5. The handle assembly according to any of the preceding clauses, wherein the proximal rotational shaft and the distal rotational shaft are freely rotatable.
[0072] 6. The handle assembly according to any of the preceding clauses, wherein the proximal rotational shaft includes a rotational shaft lock, wherein the rotational shaft lock prevents rotation of the proximal rotational shaft.
[0073] 7. The handle assembly according to any of the preceding clauses, wherein the one or more proximal interlock features and the one or more distal interlock features include one or more projections extending from one of the proximal magnetic disk and the distal magnetic disk and one or more recesses formed within the other of the proximal magnetic disk and the distal magnetic disk, wherein the one or more projections are sized to be received within the one or more recesses.
[0074] 8. The handle assembly according to clause 7, wherein the one or more projections and the one or more recesses are positioned radially along an outer perimeter of the proximal magnetic disk or the distal magnetic disk.
[0075] 9. The handle assembly according to either of clauses 7 or 8, wherein the one or more projections and the one or more recesses extend radially from a centroid of the proximal magnetic disk and the distal magnetic disk.
[0076] 10. The handle assembly according to any of the preceding clauses, wherein: the proximal handle assembly includes a proximal body housing the proximal rotational shaft and the proximal magnetic disk; the distal handle assembly includes a distal body housing the distal rotational shaft and the distal magnetic disk; and the proximal body is configured to couple to the distal body to enclose the proximal magnetic disk and the distal magnetic disk.
[0077] 11. The handle assembly according to any of the preceding clauses, further including a motor coupled to the proximal rotational shaft within the proximal handle assembly.
[0078] 12. The handle assembly according to any of the preceding clauses, wherein: the proximal handle assembly includes a proximal body housing the proximal rotational shaft, the proximal body defining a proximal tongue; the distal handle assembly includes a distal body housing the distal rotational shaft, the distal body defining a distal slot; and the proximal tongue and the distal slot are configured to couple to one another, such that the proximal tongue is inserted into the distal slot.
[0079] 13. The handle assembly according to any of the preceding clauses, wherein: the proximal handle assembly includes a proximal body housing the proximal rotational shaft, the proximal body defining a proximal post; the distal handle assembly includes a distal body housing the distal rotational shaft, the distal body defining a distal slot; and the proximal post and the distal slot are configured to couple to one another, such that the proximal post is inserted into the distal slot.
[0080] 14. The handle assembly according to any of the preceding clauses, wherein the proximal magnetic disk and the distal magnetic disk include a plurality of magnets. [0081] 15. A method of assembling a handle assembly of a medical device, the method including: advancing a proximal handle assembly of the medical device toward a distal handle assembly of the medical device; interlocking one or more proximal interlock features of a proximal magnetic disk mounted to a proximal rotational shaft associated with the proximal handle assembly with one or more distal interlock features of a distal magnetic disk mounted to a distal rotational shaft associated with the distal handle assembly; and locking a proximal body of the proximal handle assembly to a distal body of the distal handle assembly.
[0082] 16. The method according to clause 15, wherein: the one or more proximal interlock features and the one or more distal interlock features includes one or more projections extending from one of the proximal magnetic disk and the distal magnetic disk and one or more recesses formed within the other of the proximal magnetic disk and the distal magnetic disk, wherein the one or more projections are sized to be received within the one or more recesses; and interlocking the one or more proximal interlock features of the proximal magnetic disk associated with the one or more distal interlock features of a distal magnetic includes inserting the one or more projections extending from one of the proximal magnetic disk and the distal magnetic disk into the one or more recesses formed within the other of the proximal magnetic disk and the distal magnetic disk.
[0083] 17. The method according to either of clauses 15 or 16, wherein: the proximal handle assembly includes the proximal body housing the proximal rotational shaft, the proximal body defining a proximal tongue; the distal handle assembly includes the distal body housing the distal rotational shaft, the distal body defining a distal slot; and the proximal tongue and the distal slot are configured to couple to one another, such that the proximal tongue is inserted into the distal slot; and locking the proximal body of the proximal handle assembly to the distal body of the distal handle assembly includes coupling the proximal body to the distal body by inserting the proximal tongue into the distal slot.
[0084] 18. The method according to any of clauses 15-17, wherein: the proximal handle assembly includes a proximal body housing the proximal rotational shaft, the proximal body defining a proximal post; the distal handle assembly includes a distal body housing the distal rotational shaft, the distal body defining a distal slot; and the proximal post and the distal slot are configured to couple to one another, such that the proximal post is inserted into the distal slot; and locking the proximal body of the proximal handle assembly to the distal body of the distal handle assembly includes coupling the proximal body to the distal body by inserting the proximal post into the distal slot.
[0085] 19. The method according to clause 18, further including rotating the proximal handle assembly to lock the proximal post into the distal slot.
[0086] 20. The method according to any of clauses 15-19, wherein: the proximal handle assembly includes a proximal body housing the proximal rotational shaft, the proximal body including a proximal threaded surface; the distal handle assembly includes a distal body housing the distal rotational shaft, the distal body including a distal threaded surface; and the distal threaded surface and the proximal threaded surface are configured to couple to one another; and locking the proximal body of the proximal handle assembly to the distal body of the distal handle assembly includes coupling the proximal body to the distal body by threadingly engaging the proximal threaded surface with the distal threaded surface.
[0087] It should now be understood that embodiments of the present disclosure are directed to systems, methods, and devices for treatment of a vessel. In embodiments, treatments may include but are not limited to fistula formation, vessel occlusion, angioplasty, thrombectomy, atherectomy, crossing, drug coated balloon angioplasty, stenting (uncovered and covered), lytic therapy. More specifically, a handle assembly for a medical device may include a multi-piece handle, resulting in ease of packaging and reduced storage needs of the device. For example, in some embodiments, a handle assembly for a medical device includes a proximal handle assembly and a distal handle assembly. The proximal handle assembly includes a proximal rotational shaft and a proximal magnetic disk mounted to the proximal rotational shaft, the proximal magnetic disk including one or more proximal interlock features. The distal handle assembly includes a distal rotational shaft and a distal magnetic disk mounted to the distal rotational shaft, the distal magnetic disk including one or more distal interlock features.
[0088] It is noted that the terms "substantially" and "about" may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. [0089] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

1. A handle assembly for medical device comprising: a proximal handle assembly comprising: a proximal rotational shaft portion; and a proximal magnetic disk mounted to the proximal rotational shaft portion, the proximal magnetic disk comprising one or more proximal interlock features; and a distal handle assembly comprising: a distal rotational shaft portion; and a distal magnetic disk mounted to the distal rotational shaft portion, the distal magnetic disk comprising one or more distal interlock features, wherein the proximal magnetic disk and the distal magnetic disk interlock with one another via interaction of the one or more proximal interlock features and the one or more distal interlock features.
2. The handle assembly of claim 1, wherein: the proximal handle assembly comprises a proximal body housing the proximal rotational shaft portion; the distal handle assembly comprises a distal body housing the distal rotational shaft portion; and the proximal handle assembly is configured to couple to the distal handle assembly via one or more handle alignment tabs.
3. The handle assembly of claim 2, wherein the one or more handle alignment tabs act as a retention spring.
4. The handle assembly of claim 2, wherein the proximal magnetic disk and the distal magnetic disk interlock prior to the proximal handle assembly coupling to the distal handle assembly via the one or more handle alignment tabs.
5. The handle assembly of claim 1, wherein the proximal rotational shaft portion and the distal rotational shaft portion are freely rotatable.
6. The handle assembly of claim 1, wherein the proximal rotational shaft portion comprises a rotational shaft lock, wherein the rotational shaft lock prevents rotation of the proximal rotational shaft portion.
7. The handle assembly of claim 1, wherein the one or more proximal interlock features and the one or more distal interlock features comprises one or more projections extending from one of the proximal magnetic disk and the distal magnetic disk and one or more recesses formed within the other of the proximal magnetic disk and the distal magnetic disk, wherein the one or more projections are sized to be received within the one or more recesses.
8. The handle assembly of claim 7, wherein the one or more projections and the one or more recesses are positioned radially along an outer perimeter of the proximal magnetic disk or the distal magnetic disk.
9. The handle assembly of claim 7, wherein the one or more projections and the one or more recesses extend radially from a centroid of the proximal magnetic disk and the distal magnetic disk.
10. The handle assembly of claim 1, wherein: the proximal handle assembly comprises a proximal body housing the proximal rotational shaft portion and the proximal magnetic disk; the distal handle assembly comprises a distal body housing the distal rotational shaft portion and the distal magnetic disk; and the proximal body is configured to couple to the distal body to enclose the proximal magnetic disk and the distal magnetic disk.
11. The handle assembly of claim 1, further comprising a motor coupled to the proximal rotational shaft portion within the proximal handle assembly.
12. The handle assembly of claim 1, wherein: the proximal handle assembly comprises a proximal body housing the proximal rotational shaft portion, the proximal body defining a proximal tongue; the distal handle assembly comprises a distal body housing the distal rotational shaft portion, the distal body defining a distal slot; and the proximal tongue and the distal slot are configured to couple to one another, such that the proximal tongue is inserted into the distal slot.
13. The handle assembly of claim 1, wherein: the proximal handle assembly comprises a proximal body housing the proximal rotational shaft portion, the proximal body defining a proximal post; the distal handle assembly comprises a distal body housing the distal rotational shaft portion, the distal body defining a distal slot; and the proximal post and the distal slot are configured to couple to one another, such that the proximal post is inserted into the distal slot.
14. The handle assembly of claim 1, wherein the proximal magnetic disk and the distal magnetic disk comprise a plurality of magnets.
15. A method of assembling handle assembly of a medical device, the method comprising: advancing a proximal handle assembly of the medical device toward a distal handle assembly of the medical device; interlocking one or more proximal interlock features of a proximal magnetic disk mounted to a proximal rotational shaft portion associated with the proximal handle assembly with one or more distal interlock features of a distal magnetic disk mounted to a distal rotational shaft portion associated with the distal handle assembly; and locking a proximal body of the proximal handle assembly to a distal body of the distal handle assembly.
16. The method of claim 15, wherein: the one or more proximal interlock features and the one or more distal interlock features comprises one or more projections extending from one of the proximal magnetic disk and the distal magnetic disk and one or more recesses formed within the other of the proximal magnetic disk and the distal magnetic disk, wherein the one or more projections are sized to be received within the one or more recesses; and interlocking the one or more proximal interlock features of the proximal magnetic disk associated with the one or more distal interlock features of a distal magnetic comprises inserting the one or more projections extending from one of the proximal magnetic disk and the distal magnetic disk into the one or more recesses formed within the other of the proximal magnetic disk and the distal magnetic disk.
17. The method of claim 15, wherein: the proximal handle assembly comprises the proximal body housing the proximal rotational shaft portion, the proximal body defining a proximal tongue; the distal handle assembly comprises the distal body housing the distal rotational shaft portion, the distal body defining a distal slot; and the proximal tongue and the distal slot are configured to couple to one another, such that the proximal tongue is inserted into the distal slot; and locking the proximal body of the proximal handle assembly to the distal body of the distal handle assembly comprises coupling the proximal body to the distal body by inserting the proximal tongue into the distal slot.
18. The method of claim 15, wherein: the proximal handle assembly comprises a proximal body housing the proximal rotational shaft portion, the proximal body defining a proximal post; the distal handle assembly comprises a distal body housing the distal rotational shaft portion, the distal body defining a distal slot; and the proximal post and the distal slot are configured to couple to one another, such that the proximal post is inserted into the distal slot; and locking the proximal body of the proximal handle assembly to the distal body of the distal handle assembly comprises coupling the proximal body to the distal body by inserting the proximal post into the distal slot.
19. The method of claim 18, further comprising rotating the proximal handle assembly to lock the proximal post into the distal slot.
20. The method of claim 15, wherein: the proximal handle assembly comprises a proximal body housing the proximal rotational shaft portion, the proximal body comprising a proximal threaded surface; the distal handle assembly comprises a distal body housing the distal rotational shaft portion, the distal body comprising a distal threaded surface; and the distal threaded surface and the proximal threaded surface are configured to couple to one another; and locking the proximal body of the proximal handle assembly to the distal body of the distal handle assembly comprises coupling the proximal body to the distal body by threadingly engaging the proximal threaded surface with the distal threaded surface.
PCT/US2023/076981 2023-10-16 2023-10-16 Handle assemblies for medical devices and methods of assembling the same Pending WO2025085070A1 (en)

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Citations (5)

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US20110077673A1 (en) * 2009-09-29 2011-03-31 Cardiovascular Systems, Inc. Rotational atherectomy device with frictional clutch having magnetic normal force
US20150257783A1 (en) * 2010-05-13 2015-09-17 Rex Medical, L.P. Rotational thrombectomy wire
WO2016073710A1 (en) * 2014-11-07 2016-05-12 Cardiovascular Systems, Inc. Rotational atherectomy device with exchangeable drive shaft and meshing gears
US20220040450A1 (en) * 2020-08-06 2022-02-10 Canon U.S.A., Inc. Magnetic connector for steerable medical device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5888200A (en) * 1996-08-02 1999-03-30 Stryker Corporation Multi-purpose surgical tool system
US20110077673A1 (en) * 2009-09-29 2011-03-31 Cardiovascular Systems, Inc. Rotational atherectomy device with frictional clutch having magnetic normal force
US20150257783A1 (en) * 2010-05-13 2015-09-17 Rex Medical, L.P. Rotational thrombectomy wire
WO2016073710A1 (en) * 2014-11-07 2016-05-12 Cardiovascular Systems, Inc. Rotational atherectomy device with exchangeable drive shaft and meshing gears
US20220040450A1 (en) * 2020-08-06 2022-02-10 Canon U.S.A., Inc. Magnetic connector for steerable medical device

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