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WO2025158366A1 - Dispositifs et méthodes transcathéter - Google Patents

Dispositifs et méthodes transcathéter

Info

Publication number
WO2025158366A1
WO2025158366A1 PCT/IB2025/050800 IB2025050800W WO2025158366A1 WO 2025158366 A1 WO2025158366 A1 WO 2025158366A1 IB 2025050800 W IB2025050800 W IB 2025050800W WO 2025158366 A1 WO2025158366 A1 WO 2025158366A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent frame
expandable stent
hooks
aspects
leaflets
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/IB2025/050800
Other languages
English (en)
Inventor
Mike S. SIMPSON
Stephen Andrew HOWARD
Sachin JOSE
Emily C. FISHER
Niall F. Duffy
Maryrose MCLOONE
Sumeeyae Haribabu
Sarah Mallon
Andrea Quero MARTIN
Timothy Desmond FARRELL
David Currie
Alan T. MCGUINN
Kevin P. Ryan
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.)
Medtronic Inc
Original Assignee
Medtronic 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 Medtronic Inc filed Critical Medtronic Inc
Publication of WO2025158366A1 publication Critical patent/WO2025158366A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present disclosure relates generally to a transcatheter devices and methods, and more particularly to a transcatheter devices including a plurality of expandable hooks, and methods of replacing and/or managing leaflets of a defective heart valve with a transcatheter device including a plurality of expandable hooks.
  • a human heart includes four heart valves that determine the pathway of blood flow through the heart: the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve.
  • the mitral and tricuspid valves are atrio-ventricular valves, which are between the atria and the ventricles, while the aortic and pulmonary valves are semilunar valves, which are in the arteries leaving the heart.
  • native leaflets of a heart valve move apart from each other when the valve is in an open position and meet or “coapt” when the valve is in a closed position.
  • valves problems that may develop with valves include stenosis in which a valve does not open properly, and/or insufficiency or regurgitation in which a valve does not close properly. Stenosis and insufficiency may occur concomitantly in the same valve. The effects of valvular dysfunction vary, with regurgitation or backflow typically having relatively severe physiological consequences to the patient.
  • Heart valves can be repaired or replaced using a variety of different types of heart valve surgeries.
  • One conventional technique involves an open-heart surgical approach that is conducted under general anesthesia, during which the heart is stopped, and blood flow is controlled by a heart-lung bypass machine.
  • an expandable prosthetic valve is compressed about or within a catheter, inserted inside a body lumen of the patient, such as the femoral artery, and delivered to a desired location in the heart.
  • prosthetic heart valves may also begin to become damaged or diseased, such as for example, stenosis. Accordingly, the diseased or damaged prosthetic heart valve may need replaced. Similar to that described above, catheter-based approaches have also been used to repair or replace the damaged prosthetic heart valves.
  • transcatheter device having an expandable stent frame to facilitate the replacement of a damaged and/or diseased heart valve by managing one or more leaflets of the defective heart valve.
  • Providing a transcatheter device with an expandable stent frame that can manage the leaflets of the defective heart valve can allow a clinician to replace the defective heart valve while preventing obstructions that may be caused by the leaflets.
  • a transcatheter device comprises an expandable stent frame comprising an inner lumen extending along an elongated axis of the expandable stent frame.
  • the expandable stent frame is configured to expand from a contracted orientation to an expanded orientation.
  • the transcatheter device further comprises a plurality of hooks coupled to the expandable stent frame. The plurality of hooks are configured to expand from a loaded state to a deployed state.
  • the transcatheter device still further comprises an expansion device positioned within the inner lumen of the expandable stent frame and extending along the elongated axis.
  • the expansion device is configured to expand the expandable stent frame from the contracted orientation to the expanded orientation.
  • the transcatheter device comprises a sheath configured to receive the expandable stent frame in the contracted orientation.
  • yet another transcatheter device comprises an expandable stent frame comprising a proximal end and a distal end.
  • the expandable stent frame is configured to achieve a contracted orientation, a partially expanded orientation, and a fully expanded orientation.
  • the transcatheter device further comprises a plurality of hooks coupled to an intermediate portion of the expandable stent frame defined between the proximal end and the distal end. The plurality hooks are configured to expand from a loaded state to a deployed state.
  • the transcatheter device comprises a sheath configured to receive at least the proximal end of the expandable stent frame.
  • a method of replacing a heart valve comprises distally advancing a transcatheter device comprising an expandable stent frame in a contracted orientation into the heart valve.
  • the method further comprises aligning a portion of the transcatheter device within leaflets of the heart valve.
  • the method further comprises deploying a plurality of hooks coupled to the expandable stent frame from a loaded state to a deployed state.
  • the method further comprises expanding the expandable stent frame from the contracted orientation to an expanded orientation.
  • yet another method of replacing a heart valve comprises distally advancing a transcatheter device comprising an expandable stent frame in a contracted orientation into the heart valve, wherein the expandable stent frame comprises a proximal end and a distal end.
  • the method further comprises aligning a portion of the transcatheter device within leaflets of the heart valve.
  • the method still further comprises expanding the expandable stent frame from the contracted orientation to a partially expanded orientation, wherein an intermediate portion of the expandable stent frame defined between the proximal end and the distal end bends radially outward relative to the proximal end and the distal end.
  • the method comprises further deploying a plurality of hooks coupled to the intermediate portion of the expandable stent frame from a loaded state to a deployed state. Furthermore, the method comprises expanding the expandable stent frame from the partially expanded orientation to a fully expanded orientation by releasing the proximal end to radially expand and releasing the distal end to radially expand.
  • FIG. 1 is a schematic view of an exemplary transcatheter device in accordance with aspects of the present disclosure
  • FIG. 2 is an enlarged view of the distal end of the exemplary transcatheter device taken at view 2 of FIG. 1 ;
  • FIG. 3A is a schematic cross-sectional view of an embodiment of the distal end portion of the transcatheter device taken at line 3-3 of FIG. 2 showing an expandable stent frame in a contracted orientation;
  • FIG. 3B is a schematic cross-sectional view of the distal end portion of the transcatheter device of FIG. 3A illustrating a sheath proximally retracted to radially expand a plurality of hooks;
  • FIG. 4 is a side schematic view showing an expanded orientation of the expandable stent frame utilized within the distal end portion shown in FIGS. 3 A and 3B in accordance with aspects of the disclosure;
  • FIG. 5 is a schematic cross-sectional view of another exemplary embodiment of the distal end portion of the transcatheter device taken at line 3-3 of FIG. 2, showing another embodiment of an expandable stent frame in a contracted orientation;
  • FIG. 6 is a side schematic view showing a fully expanded orientation of the expandable stent frame utilized within the distal end portion shown in FIG. 5, in accordance with aspects of the disclosure;
  • FIG. 7 is a schematic side view showing an embodiment of a hook that can be coupled to the expandable stent frame illustrated in FIGS. 4 and 6;
  • FIGS. 8-12 are schematic bottom views of various embodiments of the hook shown in FIG. 7;
  • FIG. 13 is a schematic exploded view of an embodiment of the transcatheter device in accordance with aspects of the disclosure;
  • FIG. 14 schematically illustrates distally advancing a transcatheter device loaded with an expandable stent frame into a failing heart valve and aligning a portion of the transcatheter device with leaflets of the heart valve;
  • FIG. 15 schematically illustrates deploying a plurality of hooks coupled to the expandable stent frame
  • FIG. 16 schematically illustrates distally advancing the expandable stent frame in the contracted orientation after deploying the plurality of hooks to engage the leaflets of the heart valve with the deployed plurality of hooks to reposition the leaflets;
  • FIG. 17 schematically illustrates expanding the expandable stent frame from the contracted orientation to an expanded orientation;
  • FIG. 18 schematically illustrates proximally retracting the transcatheter device to remove the transcatheter device from the target treatment site
  • FIG. 19 schematically illustrates distally advancing another embodiment of a transcatheter device comprising an expandable stent frame in a contracted orientation into the heart valve;
  • FIG. 20 schematically illustrates aligning a portion of the transcatheter device with leaflets of a heart valve and expanding an expandable stent frame from a contracted orientation to a partially expanded orientation
  • FIG. 21 schematically illustrates distally advancing the partially expanded stent frame to reposition the leaflets of the heart valve
  • FIG. 22 schematically illustrates expanding the expandable stent frame from the partially expanded orientation to a fully expanded orientation
  • FIG. 23 schematically illustrates proximally retracting the transcatheter device to remove the transcatheter device from the heart valve.
  • the term “about” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not, and need not be, exact, but may be approximate and/or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art.
  • Ranges can be expressed herein as from “about” one value, and/or to “about” another value. When such a range is expressed, aspects include from the one value to the other value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it will be understood that the value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
  • first,” “second,” or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc.
  • a first end and a second end generally correspond to end A and end B or two different ends.
  • distal and proximal are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician.
  • self-expanding may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa.
  • Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal.
  • Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol.
  • polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof to include polymers such as polynorborene, transpolyisoprene, styrene -butadiene, and polyurethane.
  • polymers such as polynorborene, transpolyisoprene, styrene -butadiene, and polyurethane.
  • poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.
  • Diseases associated with heart valves can include stenosis and valvular insufficiency or regurgitation.
  • valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve.
  • Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient.
  • a diseased or damaged valve which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency.
  • Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and/or life threatening.
  • Heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves.
  • Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems.
  • Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame.
  • Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.
  • these heart valve prostheses may also fail and require another procedure to replace the damaged heart valve. Similar to replacing a native heart valve, in order to replace a failed prosthetic heart valve, a transcatheter device including a replacement prosthesis can be employed.
  • FIG. 1 illustrates an exemplary transcatheter device 102 in accordance with the present disclosure.
  • the transcatheter device 102 can comprise a shaft 1306, and a handle device 1302.
  • the shaft 1306 can couple a distal end portion 202 (discussed with initial reference to FIGS. 2-6) to the handle device 1302.
  • the handle device 1302 can be used to actuate one or more components of the distal end portion 202, which will become more apparent hereinafter.
  • the transcatheter device 102 illustrated in FIG. 1 should not be construed to be limited to the above-described components. Rather, any other suitable handle device and/or shaft may be used with the transcatheter device 102 and methods described hereinafter.
  • FIG. 2 illustrates the distal end portion 202 of the transcatheter device 102.
  • the distal end portion 202 can comprise a sheath 204 and a distal tip 206.
  • the distal tip 206 can be any suitable shape and/or size, such as for example, a rounded conical shape to be atraumatic, thereby minimizing/preventing damage while maneuvering the transcatheter device 102 through a patient’s vasculature.
  • the distal tip 206 can be sized to abut a distal end 208 of the sheath 204.
  • the distal tip 206 can abut the distal end 208 of the sheath 204 such that an atraumatic surface (e.g., a flush surface) between an outer surface 210 of the sheath 204 and an outer surface 212 of the distal tip 206 is formed.
  • an atraumatic surface e.g., a flush surface
  • the transcatheter device 102 can comprise an expandable stent frame 402 comprising an inner lumen 404 extending along an elongated axis 406 of the expandable stent frame 402.
  • the expandable stent frame 402 is configured to expand from a contracted orientation 302 (shown in FIG. 3A ) to an expanded orientation 408 (shown in FIG. 4).
  • the expandable stent frame 402 can comprise diamond-shaped cell structures 409.
  • the diamond-shaped cell structures 409 can be uniformly distributed around the expandable stent frame 402, as shown.
  • the transcatheter device 102 should not be limited to the expandable stent frame 402 shown, rather any other suitable expandable stent frame having a variety of cell structures (e.g., size, shape, etc.) will work with the transcatheter device 102 described herein.
  • an expansion device 304 can be positioned within the inner lumen 404 of the expandable stent frame 402.
  • the expansion device 304 can extend along the elongated axis 406.
  • the expansion device 304 can be configured to expand the expandable stent frame 402 from the contracted orientation 302 to the expanded orientation 408.
  • the expansion device 304 can comprise a balloon.
  • saline, a contrast solution, or compressed air may be delivered to the balloon to expand the expandable stent frame 402 from the contracted orientation 302 to the expanded orientation 408.
  • any other suitable balloon may be utilized for expanding the expandable stent frame 402 from the contracted orientation 302 to the expanded orientation 408.
  • the expansion device 304 can be circumferentially positioned around an inner shaft 305.
  • the inner shaft 305 can comprise an elongated lumen 307 extending through the length of the transcatheter device 102 and configured to receive an object.
  • the elongated lumen 307 can be configured to receive a guidewire along which the transcatheter device 102 can travel into and through a patient’s vasculature to a desired location (e.g., a native heart valve or a prosthetic heart valve).
  • the contracted orientation 302 can comprise the expandable stent frame 402 being in a collapsed state around the expansion device 304.
  • the expandable stent frame 402 can comprise a plurality of hooks 306 coupled to the expandable stent frame 402.
  • an elongated portion 412 of the plurality of hooks 306 can be coupled (e.g., fixed) to the expandable stent frame 402.
  • the plurality of hooks 306 can be coupled to the expandable stent frame 402 by welding, stitching, soldering, mechanical clamping, interlocking components, and/or any other suitable coupling means.
  • the plurality of hooks 306 can be configured to expand from a loaded state 308 (shown in FIG. 3A ) to a deployed state 410 (shown in FIGS. 3B and 4). In some aspects, the plurality of hooks 306 can be configured to expand radially outward with respect to the expandable stent frame 402 from the loaded state 308 to the deployed state 410. For example, when the plurality of hooks 306 are in the deployed state 410, the plurality of hooks 306 can expand past an outer diameter of the expandable stent frame 402 (e.g., an outer diameter of the expandable stent frame 402 with respect to the contracted orientation 302 or the expanded orientation 408).
  • an outer diameter of the expandable stent frame 402 e.g., an outer diameter of the expandable stent frame 402 with respect to the contracted orientation 302 or the expanded orientation 408.
  • the plurality of hooks 306 can expand past the outer diameter of the expandable stent frame 402 any number of suitable distances, such as for example, enough distance to capture a leaflet of a heart valve with the plurality of hooks 306 (e.g., a native heart valve or a prosthetic heart valve).
  • an end 414 of the plurality of hooks 306 can be configured to radially expand while an elongated portion 412 remains fixed to the expandable stent frame 402 .
  • any length along the elongated portion 412 can be coupled to the expandable stent frame 402, such as for example, coupling a bottom half of the elongated portion 412 to the expandable stent frame 402 such that a top half of the elongated portion 412 radially expands, while the bottom half ofthe elongated portion 412 remains coupled (e.g., fixed) to the expandable stent frame 402.
  • the elongated portion 412 can comprise a first elongated portion 413 and a second elongated portion 415 that extend in a direction from the end 414 towards a peak 417 of the elongated portion 412. In some aspects, described with reference to FIGS. 8-12, the peak 417 can be omitted.
  • the plurality of hooks 306 can comprise at least two hooks (e.g., a first hook and a second hook). Proving the plurality of hooks 306 with at least two hooks may be especially beneficial in preventing the coronary arteries (e.g., the left coronary artery and the right coronary artery) from being blocked. For example, by having at least two hooks, there will be a hook that can correspond to each of the left and right coronary arteries. In this way, each hook of the at least two hooks can facilitate repositioning its respective leaflet of a heart valve.
  • the plurality of hooks 306 can comprise at least three hooks (e.g., a first hook, a second hook, and a third hook), as shown in FIG. 4. It should be noted that while FIG. 4 illustrates an embodiment of the expandable stent frame 402 comprising three hooks, only two hooks are visible as the last hook is positioned behind the expandable stent frame 402. Although not shown, in some examples, the plurality of hooks 306 can comprise more or less than two or three hooks, such as for example, one hook, four hooks, five hooks, and so on.
  • the number of hooks of the plurality of hooks 306 can correspond to the number of leaflets of a heart valve in which the transcatheter device 102 is utilized with.
  • the plurality of hooks 306 can comprise two hooks (e.g., a hook to engage each of the two leaflets).
  • the plurality of hooks 306 can comprise three hooks (e.g., a hook to engage each of the three leaflets).
  • the plurality of hooks 306 can be circumferentially spaced around a periphery of the expandable stent frame 402.
  • the plurality of hooks 306 can be circumferentially spaced a substantially equal distance from one another around the periphery of the expandable stent frame 402.
  • each hook can be spaced substantially equal from one another such that a circumferential distance between each hook measured around the periphery of the expandable stent frame 402 is substantially equal.
  • the expandable stent frame 402 further comprises a proximal end 416 (outflow end) and a distal end 418 (inflow end), wherein the plurality of hooks 306 are centrally positioned between the proximal end 416 and the distal end 418 of the expandable stent frame 402.
  • the term centrally positioned as used herein should be construed to mean that the plurality of hooks 306 are positioned within a central third of the expandable stent frame 402.
  • the expandable stent frame 402 can be viewed, for the purposes of clarity, as being divided into three equal sections (e.g., each section being one third of a total length of the expandable stent frame 402) along the elongated axis 406, wherein a proximal section (e.g., one third of the total length of the expandable stent frame 402) can be adjacent to the proximal end 416, a distal section (e.g., one third of the total length of the expandable stent frame 402) can be adjacent to the distal end 208, and a central section (e.g., one third of the total length of the expandable stent frame 402) can be between the proximal section and the distal section.
  • the plurality of hooks 306 can be positioned at any location
  • the plurality of hooks 306 are not limited to being centrally positioned between the proximal end 416 and the distal end 208.
  • the plurality of hooks 306 can be located in either one of the proximal section or the distal section of the expandable stent frame 402.
  • the plurality of hooks 306 can be located between any one of the sections described above, such as for example, the plurality of hooks 306 can be positioned between the proximal section and the central section or between the distal section and the central section.
  • the end 414 of each hook of the plurality of hooks 306 can comprise a wire structure 702 (shown generally in FIG. 7).
  • the end 414 of each hook of the plurality of hooks 306 can comprise a bent and/or folded wire structure.
  • the wire structure 702 can comprise a single bent wire.
  • the single bent wire can be a single wire that is bent in multiple planes and/or directions (e.g., having more than one bend) to form the plurality of hooks 306.
  • the single bent wire can be a continuous structure (e.g., having no discontinuities along any length of the wire structure 702).
  • the elongated portion 412 can be contiguous with the wire structure 702.
  • the elongated portion 412 can be formed from the same single bent wire as the wire structure 702, such that each hook of the plurality of hooks 306 is a fully continuous structure.
  • the end 414 can be contiguous with the elongated portion 412, but not be formed from the same single bent wire as the wire structure 702 of the end 414.
  • the cross-sectional geometry (not shown) of the plurality of hooks 306 (e.g., the wire structures) can comprise any suitable geometry, such as for example but not limited to, circular, triangular, rectangle (e.g., a square), octagonal cross-sectional areas, and/or the like.
  • the plurality of hooks 306 can comprise a hollow cross-sectional area or a solid cross- sectional area.
  • the wire structure 702 can comprise a number of suitable shapes.
  • FIGS. 7-12 will now be referenced hereinafter to discuss a number of exemplary suitable shapes for the wire structure 702. More specifically, FIG. 7 schematically illustrates a side view of the plurality of hooks 306 (e.g., the elongated portion 412, the end 414, and generally the wire structure 702). It should be realized that the plurality of hooks 306 are not limited to the illustrated side view shown in FIG. 7, rather other suitable shaped hooks may be utilized in accordance with the present disclosure. As such, FIG. 7 is merely exemplary and utilized herein to discuss several acceptable shapes for the plurality of hooks 306.
  • the end 414 comprising the wire structure 702 when viewed from the side, can comprise a hooked portion 704 that is contiguous with and curves outward relative to the elongated portion 412.
  • the hooked portion 704 can comprise one or more bends and can further be configured to expand radially outward relative to the expandable stent frame 402 when in the deployed state 410.
  • the hooked portion 704 can comprise a J-shape.
  • the hooked portion 704 will be especially beneficial in capturing one or more leaflets of a heart valve (e.g., a native heart valve or a prosthetic heart valve).
  • the hooked portion 704 will be able to latch on to (e.g., hook on to) the leaflets of the heart valve to facilitate repositioning the leaflets while distally advancing and/or proximally retracting the transcatheter device 102, which will become more apparent later.
  • FIGS. 8-12 show a bottom view schematically illustrating various exemplary embodiments of the wire structure 702.
  • a wire structure 800 e.g., a continuous wire structure
  • the first elongated portion 413 can extend (in a direction that would be into the page) from any one of a first end 814 or a second end 816 of the peak 802, while the second elongated portion 415 can extend from the other one of the first end 814 or the second end 816 of the peak 802.
  • the first elongated portion 413 and the second elongated portion 415 can converge to form the peak 417.
  • the peak 417 can be omitted and the first elongated portion 413 and the second elongated portion 415 can be separately coupled to the expandable stent frame 402.
  • the wire structure 800 described above can be utilized for repositioning lacerated leaflets (see description for FIG. 14 for further detail on lacerated leaflets), the wire structure 800 may be especially beneficial in repositioning leaflets (e.g., prosthetic heart valve leaflets or native heart valve leaflets) that have not been lacerated.
  • the wires structure 800 e.g., a paddle shape
  • the wires structure 800 will help to provide a uniform repositioning of the non-lacerated leaflets, such as for example, to allow blood flow to the coronary arteries.
  • the wire structure 800 will be beneficial in repositioning non-lacerated leaflets.
  • a wire structure 900 can comprise a double hook.
  • each hook of the plurality of hooks 306 can comprise a first hook 902 and a second hook 904.
  • the first hook 902 can comprise one or more bend sections 906 to form a first U-shaped hook.
  • the second hook 904 can comprise one or more bend sections 908 to form a second U-shaped hook.
  • the wire structure 900 can comprise an intermediate section 910 positioned between the first hook 902 and the second hook 904.
  • the intermediate section 910 can comprise a first bend section 912, a second bend section 914, and a third bend section 916 that connect (e .g ., continuously connect) the first hook 902 to the second hook 904.
  • the first bend section 912 and the third bend section 916 bend in a direction perpendicular to the page towards the second bend section 914.
  • the first bend section 912 and the third bend section 916 bend towards the second bend section 914 in substantially the same plane as the first hook 902 and the second hook 904, thereby providing a third hook that is in the same plane (e.g., a plane parallel with the page) as the first hook 902 and the second hook 904.
  • the first hook 902 can comprise a first segment 903 extending from the one or more bend sections 906 in a first direction to connect to a first end 918.
  • the first hook 902 can further comprise a second segment 913 extending from the one or more bend sections 906 in a second direction to connect to the first bend section 912 of the intermediate section 910. In this way, the first U-shaped hook can be formed and connected to the intermediate section 910.
  • the second hook 904 can comprise a third segment 905 extending from the one or more bend sections 908 in a third direction to connect to a second end 920.
  • the second hook 904 can further comprise a fourth segment 917 extending from the one or more bend sections 908 in a fourth direction to connect to the third bend section 916 of the intermediate section 910. In this way, the second U-shaped hook can be formed and connected to the intermediate section 910.
  • the intermediate section 910 can comprise a fifth segment 919 extending from the second bend section 914 of the intermediate section 910 in a fifth direction to connect to the first bend section 912 of the intermediate section 910.
  • the intermediate section 910 can further comprise a sixth segment 921 extending from the second bend section 914 of the intermediate section 910 in a sixth direction to connect to the third bend section 916 of the intermediate section 910. In this way, the intermediate section 910 can be formed.
  • the first elongated portion 413 can extend from one of the first end 918 of the wire structure 900 or the second end 920 of the wire structure 900.
  • the first elongated portion 413 can extent (in a direction that would be into the page) from any one of the first end 918 or the second end 920 of the wire structure 900, while the second elongated portion 415 can extend from the other one of the first end 918 or the second end 920 of the wire structure 900.
  • the first elongated portion 413 and the second elongated portion 415 can converge to form the peak 417.
  • the peak 417 can be omitted as described above with reference to FIG. 8.
  • the wire structure 900 described above can be utilized for repositioning non-lacerated leaflets
  • the wire structure 900 may be especially beneficial in repositioning leaflets (e.g., prosthetic heart valve leaflets or native heart valve leaflets) that have been lacerated (see description for FIG. 14 for further detail on lacerated leaflets).
  • each hook of the double hook will be beneficial in latching on to (e.g., hooking on to) the lacerated leaflets of the heart valve to facilitate repositioning (e.g., to allow blood flow to the coronary arteries) the leaflets while distally advancing and/or proximally retracting the transcatheter device 102.
  • each hook e.g., the first hook 902 and the second hook 904
  • each hook can latch on to (e.g., hook on to) a different piece of the lacerated leaflet to facilitate repositioning the lacerated leaflet.
  • a wire structure 1000 can comprise a U-shaped hook.
  • each hook of the plurality of hooks 306 can comprise a single U-shaped hook, as illustrated.
  • the U-shaped hook can comprise a bend section 1002 (e.g., a single bend section).
  • the U-shaped hook can comprise a first end 1004 and a second end 1006 that converge in a direction towards the bend section 1002.
  • the first end 1004 and the second end 1006 can converge in a substantially parallel direction to one another (as shown) towards the bend section 1002.
  • the bend section 1002 can connect the first end 1004 and the second end 1006 by an extend arch.
  • first end 1004 and the second end 1006 can converge towards the bend section 1002 with arced segments (e.g., a curved segments). In this way, the first end 1004 and the second end 1006 can converge with a rounded transition to form the U- shaped hook (e.g., devoid of edges). The first end 1004 and the second end 1006 can converge in any other suitable way.
  • the first elongated portion 413 can extent (in a direction that would be into the page) from any one of the first end 1004 or the second end 1006 of the wire structure 1000, while the second elongated portion 415 can extend (in a direction that would be into the page) from the other one of the first end 1004 or the second end 1006 of the wire structure 1000.
  • the first elongated portion 413 and the second elongated portion 415 can converge to form the peak 417.
  • the peak 417 can be omitted as described above with reference to FIG. 8.
  • the wire structure 1000 described above can be utilized for repositioning non-lacerated leaflets
  • the wire structure 1000 may be especially beneficial in repositioning leaflets (e.g., prosthetic heart valve leaflets or native heart valve leaflets) that have been lacerated (see description for FIG. 14 for further detail on lacerated leaflets).
  • the elongated U-shaped hook will be beneficial in latching on to (e.g., hooking on to) the lacerated leaflets of the heart valve to facilitate repositioning (e.g., to allow blood flow to the coronary arteries) the leaflets while distally advancing and/or proximally retracting the transcatheter device 102.
  • the elongated portions (e.g., the portions extending from the first end 1004 and the second end 1006) of the U-shaped hook can provide secure latching (e.g., hooking on to) between each different piece of the lacerated leaflets to facilitate repositioning the lacerated leaflets.
  • FIG. 11 shows an embodiment of a wire structure 1100 that is substantially the same as that of the wire structure 1000.
  • the wire structure 1100 can comprise a U-shaped hook.
  • each hook of the plurality of hooks 306 can comprise a single U-shaped hook.
  • a bend section 1102 of the wire structure 1100 can comprise a shorter distance between a first end 1104 and a second end 1106 than that of the first end 1004 and the second end 1006 of the wire structure 1000. In this way, the bend section 1102 of the wire structure 1100 will comprise a smaller radius than that of the bend section 1002 of the wire structure 1000.
  • the wire structure 1100 described above can be utilized for repositioning lacerated leaflets (see description for FIG. 14 for further detail on lacerated leaflets), the wire structure 1100 may be especially beneficial in repositioning leaflets (e.g., prosthetic heart valve leaflets or native heart valve leaflets) that have not been lacerated.
  • the wires structure 1100 e.g., the small U-shaped hook
  • FIG. 12 shows an embodiment of a wire structure 1200 that can comprise a V-shaped hook.
  • the wire structure 1200 can comprise a first end 1202 and a second end 1204 that converge in a direction of a pointed bend section 1206.
  • the first end 1202 and the second end 1204 can comprise substantially straight segments that converge and connect to the pointed bend section 1206. In this way, the V-shaped hook can be formed.
  • the first elongated portion 413 can extend (in a direction that would be into the page) from any one of the first end 1202 or the second end 1204 of the wire structure 1200, while the second elongated portion 415 can extend from the other one of the first end 1202 or the second end 1204 of the wire structure 1200.
  • the first elongated portion 413 and the second elongated portion 415 can converge to form the peak 417.
  • the peak 417 can be omitted as described above with reference to FIG. 8.
  • the wire structure 1200 described above can be utilized for repositioning non-lacerated leaflets
  • the wire structure 1200 may be especially beneficial in repositioning leaflets (e.g., prosthetic heart valve leaflets or native heart valve leaflets) that have been lacerated (see description for FIG. 14 for further detail on lacerated leaflets).
  • the elongated V-shaped hook will be beneficial in latching on to (e.g., hooking on to) the lacerated leaflets of the heart valve to facilitate repositioning (e.g., to allow blood flow to the coronary arteries) the leaflets while distally advancing and/or proximally retracting the transcatheter device 102.
  • the elongated portions (e.g., the portions extending from the first end 1202 and the second end 1204) of the V-shaped hook can provide secure latching (e.g., hooking on to) between each different piece of the lacerated leaflets to facilitate repositioning the lacerated leaflets.
  • the sheath 204 of the transcatheter device 102 can be configured to receive the expandable stent frame 402 in the contracted orientation 302.
  • the sheath 204 can be slidably positioned overtop the expandable stent frame 402.
  • the sheath 204 can be configured to be proximally and/or distally retracted, such as for example, the sheath 204 can be configured to slide in a distal direction and/or a proximal direction.
  • the sheath 204 can be configured to contact one or more portions of the expandable stent frame 402 along a length of the expandable stent frame 402.
  • the sheath 204 can be configured to apply a radial compression force around an entire length or a portion of the entire length of the expandable stent frame 402.
  • the plurality of hooks 306 can be configured to be collapsed within the sheath 204 in the loaded state 308.
  • the sheath 204 can be slidably positioned over the plurality of hooks 306 to apply a radial compression force to the expandable stent frame 402 and the plurality of hooks 306. Accordingly, the plurality of hooks 306 will be collapsed within the sheath 204 in the loaded state 308.
  • the plurality of hooks 306 can comprise self-expanding hooks.
  • the plurality of hooks 306 can be configured to be biased outward relative to the expandable stent frame 402.
  • the plurality of hooks 306 can radially self-expand from the loaded state 308 to the deployed state 410 when the sheath 204 is proximally and/or distally advanced.
  • the sheath 204 can alternatively be distally advanced to radially self-expand the plurality of hooks 306 from the loaded state 308 to the deployed state 410.
  • the plurality of hooks 306 can comprise a self-expandable material, such as for example, a material that is resilient and has a tendency to expand back to its original shape.
  • the plurality of hooks 306 can comprise nitinol.
  • the plurality of hooks 306 can comprise any other suitable self-expandable material.
  • the hooked portion 704 can be bent radially inward towards the expandable stent frame 402.
  • the hooked portion 704 will be prevented from hindering movement of the sheath 204.
  • the sheath 204 can still be proximally retracted and/or distally advanced without interference of the hooked portion 704 (e.g., getting caught and/or stuck on the hooked portion 704).
  • the transcatheter device 102 can further comprise a prosthetic heart valve 420 comprising the expandable stent frame 402.
  • the prosthetic heart valve 420 can comprise one or more prosthetic heart valve leaflets 422, such as for example, three leaflets to emulate a tricuspid valve.
  • the prosthetic heart valve leaflets 422 can comprise two leaflets, such as for example, to emulate a bicuspid valve.
  • the prosthetic heart valve 420 can comprise any other number of suitable prosthetic heart valve leaflets.
  • the prosthetic heart valve leaflets 422 can be positioned within the inner lumen 404 and coupled to the expandable stent frame 402.
  • the prosthetic heart valve leaflets 422 can be coupled to the expandable stent frame 402 by a stitching pattern.
  • the prosthetic heart valve leaflets 422 can comprise any suitable leaflet material known to one of ordinary skill in the art of prosthetic valve construction.
  • FIGS. 5 and 6 will be used hereinafter to discuss another embodiment of a distal end portion 502 of the transcatheter device 102 in accordance with the present disclosure.
  • the transcatheter device 102 can comprise an expandable stent frame 602 comprising a proximal end 604 (outflow end) and a distal end 606 (inflow end).
  • the expandable stent frame can comprise an inner lumen 607 extending along an elongated axis 609.
  • the expandable stent frame 602 can be configured to achieve a contracted orientation 504 (shown in FIG. 5), a partially expanded orientation 2002 (shown in FIG. 20), and a fully expanded orientation 608 (shown in FIG. 6).
  • the term “fully expanded orientation” should be construed to mean that the expandable stent frame 602 cannot expand any further with respect to the location at which the expandable stent frame 602 has been deployed (i.e., fully released from the transcatheter device 102).
  • the term “fully expanded orientation” will refer to the expandable stent frame 602 being fully released from the transcatheter device 102 whereby the expandable stent frame 602 has contacted the implanted prosthetic heart valve or the native heart valve such that the expandable stent frame 602 can no longer expand.
  • the term “fully expanded orientation” can mean that the expandable stent frame 602 cannot radially expand any further with respect to the location at which it has been deployed and implanted even though the expandable stent frame is still capable of further radial expansion if the expandable stent frame 602 were free from surrounding structure.
  • the term “fully expanded orientation” may refer to the expandable stent frame 602 not being capable of any further radial expansion regardless of the location at which the expandable stent frame 602 is deployed (e.g., the expandable stent frame 602 cannot radially expand any further, even when free from surrounding structure).
  • the transcatheter device 102 can comprise a sheath 510 configured to receive at least the proximal end 604 of the expandable stent frame 602. Furthermore, in aspects, the sheath 510 can comprise a proximal portion 512 configured to translate relative to a distal portion 514. In some embodiments, the sheath 510 can comprise a circumferential split 516 that separates the proximal portion 512 and the distal portion 514. In some aspects, the circumferential split 516 is configured to allow the proximal portion 512 to translate relative to the distal portion 514.
  • translate can mean the proximal portion 512 can rotate relative to the distal portion 514, such as for example, rotate 360 degrees relative to the distal portion 514.
  • translate can mean the proximal portion 512 can shift and/or slide relative to the distal portion 514, such as for example, the proximal portion 512 can proximally and/or distally slide and/or shift relative to the distal portion 514.
  • the distal portion 514 can be configured to translate relative to the proximal portion 512.
  • translate can mean the distal portion 514 can rotate relative to the proximal portion 512, such as for example, rotate 360 degrees relative to the proximal portion 512.
  • translate can mean the distal portion 514 can shift and/or slide relative to the proximal portion 512, such as for example, the distal portion 514 can proximally and/or distally slide and/or shift relative to the proximal portion 512.
  • the proximal portion 512 and/or the distal portion 514 of the sheath 510 can overlap one another.
  • the partially expanded orientation 2002 can comprise the intermediate portion 610 being bent radially outward relative to the sheath 510.
  • “bent” means that the intermediate portion 610 bows radially outwardly to form a substantially convex outer profile, as shown in FIG. 20.
  • the convex outer profile can resemble a balloon-shaped structure.
  • the partially expanded orientation 2002 can comprise the proximal end 604 of the expandable stent frame 602 being in a collapsed state within the proximal portion 512 of the sheath 510.
  • the partially expanded orientation can further comprise the distal end 606 of the expandable stent frame 602 being in the collapsed state within the distal portion 514 of the sheath 510.
  • the proximal end 604 and the distal end 606 may be held in their respective portions of the sheath by a tip/crown capture mechanism .
  • a crown capture mechanism may be one or more paddles connected to a crown of the prosthesis that is configured to be received within a pocket on a component of the transcatheter device 102, such as a spindle on the inner shaft 305.
  • the sheath may keep the paddle locked in the pocket until the sheath is translated past the pocket, at which point the paddle can release from the pocket.
  • crown capture mechanism This is merely one type of crown capture mechanism; however, any suitable mechanism may be used (e.g., suture-based retention mechanisms).
  • the intermediate portion 610 will bow radially outwardly, such as for example, when the proximal portion 512 of the sheath 510 is proximally retracted (e.g., by a clinician) far enough to maintain the proximal end 604 of the expandable stent frame 602 within the proximal portion 512 of the sheath 510, but not so far as to release the proximal end 520 from the collapsed state from within the proximal portion 512 of the sheath 510.
  • the partially expanded orientation can be achieved with the distal end 606 of the expandable stent frame 602 remaining within the distal portion 514 of the sheath 510 without the distal portion 514 translating (e.g., sliding).
  • the partially expanded orientation can be achieved by distally advancing the distal portion 514 of the sheath relative to the proximal portion 512, wherein the proximal portion 512 of the sheath 510 remains stationary.
  • proximal portion 512 and the distal portion 514 of the sheath 510 can be configured to both translate, such as for example, the proximal portion 512 proximally retracting and the distal portion 514 distally advancing relative to the expandable stent frame 602 to achieve the partially expanded orientation 2002.
  • the contracted orientation 504 can comprise the proximal end 604 of the expandable stent frame 602 being in the collapsed state within the proximal portion 512 of the sheath 510.
  • the contracted orientation 504 can further comprise the distal end 606 of the expandable stent frame 602 being in the collapsed state within the distal portion 514 of the sheath 510.
  • the contracted orientation 504 can comprise a distal end 518 of the proximal portion 512 of the sheath 510 abutting a proximal end 520 of the distal portion 514 of the sheath 510.
  • the expandable stent frame 602 when the distal end 518 of the proximal portion 512 of the sheath 510 abuts the proximal end 520 of the distal portion 514 of the sheath 510, the expandable stent frame 602 will be in the contracted orientation 504.
  • the expandable stent frame 602 can be completely collapsed within the sheath 510 (e.g., the proximal portion 512 and the distal portion 514).
  • the contracted orientation 504 can comprise the expandable stent frame 602 being in the collapsed state around an inner shaft 522.
  • the inner shaft 522 can comprise an elongated lumen 524 configured to receive an object.
  • the elongated lumen 524 can be configured to receive a guidewire, such as for example, for the transcatheter device 102 to be guided along while being maneuvered through the vasculature of a patient.
  • the distal end 606 of the expandable stent frame 602 can be collapsed within a portion of the distal tip 206.
  • the distal end 606 can be collapsed within a portion of the distal tip 206.
  • distally advancing the distal portion 514 of the sheath 510 will also distally advance the distal tip 206 and thus the expandable stent frame 602 can expand from the contracted orientation 504 to the partially expanded orientation 2002.
  • the expandable stent frame 602 can comprise a selfexpanding material.
  • the self-expanding material can have a mechanical memory such that the expandable stent frame 602 is biased to return to the fully expanded orientation 608.
  • the self-expanding material comprises nitinol. However, this is not meant to be limiting, any other suitable self-expanding material may be utilized.
  • the transcatheter device 102 can comprise a plurality of hooks 506 coupled to an intermediate portion 610 of the expandable stent frame 602 defined between the proximal end 604 and the distal end 606.
  • the plurality of hooks 506 can be configured to expand from a loaded state 508 (shown in FIG. 5) to a deployed state 612 (shown in FIG. 6).
  • the plurality of hooks 506 can comprise any of the hooks (e.g., size, shape, and/or quantity) described previously with reference to FIGS. 3A-4 and 7-12 and thus will not be described in further detail with reference to FIGS. 5 and 6.
  • the plurality of hooks 506 can be any of the hooks described with reference to FIGS. 3A-4 and FIGS. 7-12 including any functionality (e.g., self-expanding) and/or material described (e.g., nitinol). Furthermore, the plurality of hooks 506 may be positioned along the length of the expandable stent frame 602 as described with reference to FIG. 4.
  • the plurality of hooks 506, can be circumferentially positioned around the expandable stent frame 602 along an axial length of the elongated axis 609 that is axially located on any one of a diamond-shaped cell structure that is four diamond-shaped cell structures from the distal end 606 of the expandable stent frame 602.
  • the plurality of hooks 506 can be located along any axial portion of the fourth diamond-shaped cell structure from the distal end 606, such as for example, axially along any one of a distal portion, proximal portion, and/or central portion (e.g., located between the distal portion and proximal portion).
  • the plurality of hooks 506, can be circumferentially positioned around the expandable stent frame 602 along an axial length of the elongated axis 609 that is axially located on any one of a diamond-shaped cell structure that is one and a half diamond-shaped cell structures from the distal end 606 of the expandable stent frame 602.
  • the plurality of hooks 506 can be located substantially centered on any one of a second diamond-shaped cell structure from the distal end 606 (e.g., a central third of any one of the second diamond-shaped cell structures).
  • the plurality of hooks can be coupled to the expandable stent frame 602 by any means previously described.
  • the plurality of hooks 506 are configured to be collapsed within the sheath 510 in the loaded state 508.
  • the plurality of hooks 506 can be coupled to the expandable stent frame 602 such that they are positioned within the proximal portion 512 of the sheath 510. In this way, the plurality of hooks 506 can expand from the loaded state 508 to the deployed state 612 by retracting the proximal portion of the sheath 510.
  • the plurality of hooks 506 can be coupled to the expandable stent frame 602 such that they are positioned within the distal portion 514 of the sheath 510.
  • the plurality of hooks 506 can expand from the loaded state 508 to the deployed state 612 by distally advancing the distal portion of the sheath 510.
  • the plurality of hooks 506 can be positioned within both the proximal portion 512 and the distal portion 514 of the sheath 510. In this way, the plurality of hooks 506 will not expand from the loaded state 508 to the deployed state 612 until both the proximal portion 512 and the distal portion 514 of the sheath 510 are proximally retracted and distally advanced respectively.
  • the transcatheter device 102 can further comprise a prosthetic heart valve 614 comprising the expandable stent frame 602.
  • the prosthetic heart valve 614 can comprise one or more prosthetic heart valve leaflets 616, such as for example, three leaflets to emulate a tricuspid valve.
  • the prosthetic heart valve leaflets 616 can comprise two leaflets, such as for example, to emulate a bicuspid valve.
  • the prosthetic heart valve 614 can comprise any other number of suitable prosthetic heart valve leaflets.
  • the prosthetic heart valve leaflets 616 can be positioned within the inner lumen 607 and coupled to the expandable stent frame 602.
  • the prosthetic heart valve leaflets 616 can be coupled to the expandable stent frame 602 by a stitching pattern.
  • the prosthetic heart valve leaflets 616 can comprise any suitable leaflet material known to one of ordinary skill in the art of prosthetic valve construction.
  • FIG. 13 illustrates an exploded view of an other embodiment of the transcatheter device 102 illustrating the handle device 1302 comprising one or more actuators 1304.
  • the one or more actuators 1304 can be configured to actuate the sheath 204, 510 (e.g., by a sliding movement of the actuator).
  • the one or more actuators 1304 can proximally advance and/or distally retract the sheath 204, 510.
  • the one or more actuators 1304 can actuate the proximal portion 512 of the sheath 510 and/or the distal portion 514 of the sheath 510.
  • a first actuator can actuate a proximal portion 512 of the sheath 510 (e.g., by a sliding movement of the first actuator) while a second actuator can actuate the distal portion 514 of the sheath 510 (e.g., by a slide movement of the second actuator).
  • the one or more actuators 1304 can be configured to rotate (e.g., 360 degree) the transcatheter device 102.
  • a first actuator can rotate a proximal portion 512 of the sheath 510 (e.g., by a rotational movement of the first actuator) while a second actuator can rotate the distal portion 514 of the sheath 510 (e.g., by a rotational movement of the second actuator).
  • the one or more actuators 1304 can proximally and/or distally retract the sheath 204, 510 by way of a shaft 1306 interconnected to the sheath 204, 510.
  • a first actuator can proximally advance and/or distally retract the proximal portion 512 by the shaft 1306 and a second actuator can proximally and/or distally retract the distal portion 514 by a second shaft 1308.
  • the handle device 1302 can be configured to actuate components of the transcatheter device 102 by any suitable actuating means.
  • the handle device 1302 can actuate components of the transcatheter device 102 by sliding movements (e.g., proximally and/or distally sliding the actuator in a proximal or distal direction), rotational movements (e.g., clockwise and/or counter clockwise rotation), and/or pressure actuated movements (e.g., button presses).
  • the handle device 1302 can be configured to be mechanically actuated, electrically actuated, electromechanically actuated, and/or any other suitable actuating means. It should be understood that the above examples are not meant to be limiting, and any other suitable handle devices may be utilized with the transcatheter device 102 described herein.
  • the handle device 1302 is merely exemplary, and thus any other suitable configurations for actuating the transcatheter device 102 can be utilized.
  • the handle device 1302 should not be construed as being configured to only actuate the above-mentioned components. Rather, the handle device 1302 can actuate any other suitable components of the transcatheter device 102, such as for example, the distal tip 206, the inner shaft 305, 322, etc.
  • any other suitable handle device may be utilized in actuating the transcatheter device 102.
  • FIGS. 14-18 will now describe a method of replacing a heart valve 1402 (e.g., a failing heart valve) with initial reference to FIGS. 1-13 with the understanding that similar or identical methods may be provided in the other embodiments of the disclosure.
  • the heart valve 1402 can comprise an implanted prosthetic heart valve (e.g., a failing implanted prosthetic heart valve), as shown in FIGS. 14-18.
  • the heart valve 1402 can comprise a native heart valve (e.g., a failing native heart valve), such as for example, a tricuspid valve, a pulmonary valve, a mitral valve, and/or an aortic valve.
  • the method can comprise distally advancing a transcatheter device 102 comprising an expandable stent frame 402 (see FIG. 15, showing the expandable stent frame 402) in a contracted orientation 302 into the heart valve 1402.
  • the transcatheter device 102 can be distally advanced along a guide wire (not shown) through an incision that is made at an anatomical location of the patient’s vessel.
  • a transfemoral approach that involves making an incision in the groin and operates as a passageway for guiding the transcatheter device 102 into the heart valve 1402.
  • the transcatheter device 102 can be distally advanced along the guide wire by way of an elongated lumen 307 extending through the transcatheter device 102.
  • the method can further comprise, aligning a portion 1404 of the transcatheter device 102 within leaflets 1406 of the heart valve 1402.
  • the leaflets 1406 can comprise prosthetic heart valve leaflets.
  • the leaflets 1406 can comprise one or more leaflets, such as for example, two leaflets, three leaflets, etc.
  • the leaflets 1406 can comprise native heart valve leaflets.
  • the leaflets 1406 can comprise tricuspid valve leaflets, pulmonary valve leaflets, mitral valve leaflets, and/or aortic valve leaflets.
  • the leaflets 1406 can be lacerated to bisect (e.g., lacerated to divide the prosthetic heart valve leaflets 1406 into two substantially equal parts) one or more of the leaflets 1406.
  • lacerating the leaflets 1406 can comprise lacerating the leaflets 1406 to create a first lacerated portion and a second laceration portion that are substantially equal in size.
  • various other locations along one or more of the leaflets 1406 can be lacerated such that the first lacerated portion and the second lacerated portion are not substantially equal.
  • the leaflets 1406 can be lacerated to form more than two lacerated pieces.
  • the leaflets 1406 may be lacerated prior to inserting the transcatheter device 102.
  • the prosthetic heart valve leaflets 1406 may be lacerated while concurrently inserting the transcatheter device 102 into the patient and/or may be lacerated with a lacerating feature of the transcatheter device 102.
  • the leaflets 1406 may not be lacerated wherein the heart valve 1402 may be replaced without lacerating the leaflets 1406.
  • the leaflets 1406 may have been previously lacerated or resected in a prior procedure.
  • each leaflet may have been cut, skived, or split via a cutting tool, which may have been a mechanical cutting tool (e.g., a blade), or a heating/energy cutting tool (e.g., RF electrode).
  • a cutting tool which may have been a mechanical cutting tool (e.g., a blade), or a heating/energy cutting tool (e.g., RF electrode).
  • the leaflets may be lacerated by varying lengths from the free end towards the cusp.
  • the portion 1404 of the transcatheter device 102 that is aligned with the leaflets 1406 of the heart valve 1402 can comprise a distal portion of the transcatheter device 102.
  • the distal portion can be a distal end 208 of a sheath 204.
  • the distal portion can be a portion of a distal tip 206 of the transcatheter device 102, such as for example, a proximal portion or a distal portion of the distal tip 206.
  • the distal portion can comprise any other suitable portion of the transcatheter device 102.
  • the method can comprise deploying a plurality of hooks 306 coupled to the expandable stent frame 402 from a loaded state 308 to a deployed state 410.
  • deploying the plurality of hooks 306 can comprise expanding the plurality of hooks 306 radially outward relative to the expandable stent frame 402.
  • deploying the plurality of hooks 306 can comprise retracting the sheath 204.
  • the sheath 204 can be proximally retracted (e.g., by a clinician) by proximally sliding one or more actuators 1304 (e.g., a single actuator) in a proximal direction.
  • the method can further comprise distally advancing the expandable stent frame 402 in the contracted orientation 302 after deploying the plurality of hooks 306 to engage the leaflets 1406 of the heart valve 1402 with the deployed plurality of hooks 306 to reposition the leaflets 1406.
  • repositioning the leaflets can comprise folding, collapsing, flattening, pushing, and/or bunching the leaflets 1406 in any one of a distal direction, a radial direction and/or a proximal direction within the heart valve 1402.
  • engaging the leaflets 1406 can mean contacting the leaflets 1406, hooking the leaflets 1406, piercing through the leaflets 1406, capturing the leaflets 1406, interacting with the leaflets 1406 (e.g., such as having the ability to move the leaflets 1406), and/or the like.
  • the method can comprise expanding the expandable stent frame 402 from the contracted orientation 302 to an expanded orientation 408.
  • the transcatheter device 102 can further comprise a prosthetic heart valve comprising the expandable stent frame 402, wherein expanding the expandable stent frame can further comprise deploying a valve structure.
  • the valve structure can comprise one or more leaflets (e.g., one or more leaflets that function similar to the leaflets 1406 being replaced).
  • expanding the expandable stent frame 402 can further comprise inflating an expansion device 304 positioned within an inner lumen 404 of the expandable stent frame 402.
  • the expandable stent frame 402 can be expanded from the contracted orientation 302 to the expanded orientation 408 after repositioning the leaflets 1406 with the deployed plurality of hooks 306.
  • the repositioned leaflets 1406 are pinned in place relative to the expandable frame, as shown generally at arrow 1702.
  • the leaflets 1406 are radially pinned against the heart valve 1402, such that they are prohibited from movement (e.g., radial, distal and/or proximal movement). This may be especially beneficial in preventing obstruction by the leaflets 1406, such as for example, by preventing the left and right coronary arteries from being obstructed by the leaflets 1406 while replacing the heart valve 1402.
  • expanding the expandable stent frame 402 can further comprise indexing the expandable stent frame 402 with the heart valve 1402.
  • “index” can mean contacting, engaging, holding, interlocking, interconnecting joining, mating, coupling, and/or the like.
  • the method can further comprise deflating the expansion device 304, and then removing the transcatheter device 102 from the heart valve 1402.
  • the method can comprise proximally retracting the transcatheter device 102 to remove the transcatheter device 102 from the heart valve 1402 and out of the patient’s vasculature.
  • removing the transcatheter device 102 from the heart valve 1402 can first comprise proximally retracting the distal tip 206, such as for example, proximally retracting the distal tip 206 to abut a distal end of the sheath 204, and then further comprising removing the transcatheter device 102 from the heart valve 1402.
  • removing the transcatheter device 102 from the heart valve 1402 can comprise proximally retracting the distal tip 206, thereby removing the transcatheter device 102 from the heart valve 1402. In this example, the transcatheter device 102 can then be proximally retracted from the patient’s vasculature.
  • the transcatheter device 102 comprises the prosthetic heart valve comprising the expandable stent frame 402
  • the heart valve 1402 will be entirely replaced by the prosthetic heart valve (e.g., comprising one or more leaflets) and, thus will begin to function (e.g., the one or more leaflets will begin to open and close).
  • FIGS. 19-23 will now describe yet another exemplary method for replacing a heart valve 1902 with initial reference to FIGS. 1-13 with the understanding that similar or identical methods may be provided in the other embodiments of the disclosure.
  • the heart valve 1902 can comprise an implanted prosthetic heart valve, as shown in FIGS. 14-18.
  • the heart valve 1902 can comprise a native heart valve, such as for example, a tricuspid valve, a pulmonary valve, a mitral valve, and/or an aortic valve.
  • the method can comprise distally advancing a transcatheter device 102 comprising an expandable stent frame 602 (shown in FIG. 20) in a contracted orientation 504 into the heart valve 1902.
  • the expandable stent frame 602 can comprise a proximal end 604 and a distal end 606.
  • the method can further comprise aligning a portion 1904 of the transcatheter device 102 within leaflets 1906 of the heart valve 1902. It should be understood that distally advancing the transcatheter device 102 and aligning a portion 1904 of the transcatheter device 102 are similar to that described with reference to FIG. 14, and thus, the description for FIG. 14 can be referenced for further detail pertaining to these method steps.
  • the method can comprise expanding the expandable stent frame 602 from the contracted orientation 504 to a partially expanded orientation 2002.
  • an intermediate portion 610 of the expandable stent frame 602 defined between the proximal end 604 and the distal end 606 bends radially outward relative to the proximal end 604 and the distal end 606.
  • partially expanding the expandable stent frame 602 further comprises maintaining both the proximal end 604 and the distal end 606 in a collapsed state.
  • the intermediate portion 610 can radially expand outward within the heart valve 1902, such that a distance between the intermediate portion 610 and the heart valve 1902 is decreased.
  • one or more sections of the intermediate portion 610 can contact one or more sections of the heart valve 1902.
  • a section e.g., the plurality of hooks 506 of the intermediate portion 610 can contact the leaflets 1906 of the heart valve 1902.
  • the leaflets 1906 that may be contacted by the intermediate portion 610 can be the prosthetic heart valve leaflets of an implanted prosthetic heart valve.
  • the leaflets 1906 that may be contacted by the intermediate portion 610 can be the leaflets of the native heart valve.
  • the intermediate portion 610 can bend radially outward, but not contact the heart valve 1902.
  • an apex (e.g., the plurality of hooks 506) of the intermediate portion 610 can be positioned to expand above an intermediate portion 2004 of the heart valve 1902, such that a point of contact (e.g., the apex and the intermediate portion 2004 of the heart valve 1902 with the smallest diameter) between the intermediate portion 610 of the expandable stent frame 602 and the intermediate portion 2004 of the heart valve 1902 is removed. In this way, the intermediate portion 610 will not contact the heart valve 1902.
  • the intermediate portion 2004 can be the intermediate portion of the implanted prosthetic heart valve. In some examples where the heart valve 1902 is the native heart valve, the intermediate portion 2004 can be an intermediate portion of the native heart valve. [00107] In some aspects, expanding the expandable stent frame 602 from the contracted orientation 504 to a partially expanded orientation 2002 can further comprise proximally retracting a proximal portion 512 of a sheath 510. In other examples, expanding the expandable stent frame 602 from the contracted orientation 504 to a partially expanded orientation 2002 can further comprise distally advancing a distal portion 514 of the sheath 510.
  • expanding the expandable stent frame 602 from the contracted orientation 504 to a partially expanded orientation 2002 can further comprise distally advancing the distal portion 514 of the sheath 510 while proximally retracting the proximal portion 512 of the sheath 510.
  • the method can comprise deploying a plurality of hooks 506 coupled to the intermediate portion 610 of the expandable stent frame 602 from a loaded state 508 to a deployed state 612.
  • deploying the plurality of hooks 506 can comprise expanding the plurality of hooks 506 radially outward relative to the expandable stent frame 602.
  • deploying the plurality of hooks 506 can comprise distally advancing the distal portion 514 of the sheath 510.
  • deploying the plurality of hooks 506 can comprise proximally retracting the proximal portion 512 of the sheath 510.
  • expanding the expandable stent frame 602 from the contracted orientation 504 to a partially expanded orientation 2002 and deploying the plurality of hooks 506 occurs simultaneously.
  • retracting the proximal portion 512 and/or the distal portion 514 can both expand the expandable stent frame 602 from the contracted orientation 504 to a partially expanded orientation 2002 and deploy the plurality of hooks 506.
  • the method can further comprise distally advancing the partially expanded stent frame (e.g., the expandable stent frame 602 in the partially expanded orientation 2002) to engage the leaflets 1906 of the heart valve 1902 with the deployed plurality of hooks 506 (e.g., the plurality of hooks 506 in the deployed state 612) to reposition the leaflets 1906.
  • repositioning the leaflets 1906 can comprise folding, collapsing, flattening, pushing, and/or bunching the leaflets 1906 in any one of a distal direction, a radial direction and/or a proximal direction within the heart valve 1402.
  • engaging the leaflets 1906 can mean contacting the leaflets 1906, hooking the leaflets 1906, piercing through the leaflets 1906, capturing the leaflets 1906, interacting with the leaflets 1906 (e.g., such as having the ability to move the leaflets 1906), and/or the like.
  • the method can further comprise recapturing the expandable stent frame 602 to collapse the expandable stent frame 602 from the partially expanded orientation 2002 to the contracted orientation 504 prior to expanding the expandable stent frame 602 from the partially expanded orientation 2002 to the fully expanded orientation 608.
  • recapturing the expandable stent frame 602 can comprise distally advancing the proximal portion 512 of the sheath 510. In this way, the proximal portion 512 of the sheath 510 can radially compress a proximal portion of the intermediate portion 610 within the proximal portion 512 of the sheath 510. In some examples, recapturing the expandable stent frame 602 can comprise proximally retracting the distal portion 514 of the sheath 510. In this way, the distal portion 514 of the sheath 510 can radially compress a distal portion of the intermediate portion 610 within the distal portion 514 of the sheath 510.
  • recapturing the expandable stent frame 602 can further comprise distally advancing the proximal portion 512 of the sheath 510 while simultaneously proximally retracting the distal portion 514 of the sheath 510.
  • recapturing the expandable stent frame 602 can comprise collapsing the plurality of hooks 506 within the sheath 510.
  • collapsing the plurality of hooks 506 within the sheath 510 can comprise distally advancing the proximal portion 512 of the sheath 510.
  • the method can comprise expanding the expandable stent frame 602 from the partially expanded orientation 2002 to the fully expanded orientation 608 by releasing the proximal end 604 to radially expand and releasing the distal end 606 to radially expand.
  • releasing the distal end 606 can comprise distally advancing the distal portion 514 of the sheath 510.
  • releasing the proximal end 604 can comprise proximally retracting the proximal portion 512 of the sheath 510.
  • expanding the expandable stent frame 602 from the partially expanded orientation 2002 to the fully expanded orientation 608 can comprise initially releasing the distal end 606 (e.g., distally advancing the distal portion 514 of the sheath 510) to radially expand prior to releasing the proximal end 604 (e.g., maintain the proximal end 604 in the collapsed state). In this way, the distal end 606 can achieve a radially expanded state while the proximal end 604 is maintained in the collapsed state.
  • expanding the expandable stent frame 602 from the partially expanded orientation 2002 to the fully expanded orientation 608 can then comprise releasing the proximal end 604 (e.g., proximally retracting the proximal portion 512 of the sheath 510) to radially expand after initially releasing the distal end 606.
  • expanding the expandable stent frame 602 from the partially expanded orientation 2002 to the fully expanded orientation 608 can comprise initially releasing the proximal end 604 (e.g., proximally retracting the proximal portion 512 of the sheath 510) to radially expand prior to releasing the distal end 606 (e.g., maintain the distal end 606 in the collapsed state).
  • the proximal end 604 can achieve a radially expanded state while the distal end 606 is maintained in the collapsed state.
  • expanding the expandable stent frame 602 from the partially expanded orientation 2002 to the fully expanded orientation 608 can then comprise releasing the distal end 606 (e.g., distal advancing the distal portion 514 of the sheath 510) to radially expand after initially releasing the proximal end 604.
  • expanding the expandable stent frame 602 from the partially expanded orientation 2002 to the fully expanded orientation 608 can further comprise indexing the expandable stent frame 602 with the heart valve 1902.
  • index can mean contacting, engaging, holding, interlocking, interconnecting joining, mating, coupling, and/or the like.
  • the expandable stent frame 602 is expanded from the partially expanded orientation 2002 to the fully expanded orientation 608 after repositioning the leaflets 1906 with the deployed plurality of hooks 506.
  • expanding the expandable stent frame 602 from the partially expanded orientation 2002 to the fully expanded orientation 608 pins the repositioned leaflets 1906 in place relative to the expandable stent frame 602.
  • the repositioned leaflets 1906 can be pinned against the heart valve 1902 (e.g., a native valve and/or a prosthetic heart valve).
  • the repositioned leaflet can be pinned against a stent frame of the prosthetic heart valve.
  • the method can comprise removing the transcatheter device 102 from the heart valve 1902.
  • the method can comprise proximally retracting the transcatheter device 102 to remove the transcatheter device 700 from the heart valve 1902 and out of the patient’s vasculature.
  • removing the transcatheter device 102 from the heart valve 1902 can first comprise proximally retracting the distal tip 206, such as for example, proximally retracting the distal tip 206 to abut a distal end of the sheath 510, and then further comprising removing the transcatheter device 102 from the heart valve 1902.
  • removing the transcatheter device 102 from the heart valve 1902 can comprise proximally retracting the distal tip 206, thereby removing the transcatheter device 102 from the heart valve 1902. In this example, the transcatheter device 102 can then be proximally retracted from the patient’s vasculature.
  • a transcatheter device comprising an expandable stent frame.
  • the expandable stent frame comprises an inner lumen along an elongated axis of the expandable stent frame.
  • the expandable stent frame is configured to expand from a contracted orientation to an expanded orientation.
  • the transcatheter device further comprises a plurality of hooks coupled to the expandable stent frame.
  • the plurality of hooks are configured to expand from a loaded state to a deployed state.
  • the transcatheter device further comprises an expansion device positioned within the inner lumen of the expandable stent frame and extending along the elongated axis.
  • the expansion device is configured to expand the expandable stent frame from the contracted orientation to the expanded orientation.
  • the transcatheter device further comprises a sheath configured to receive the expandable stent frame in the contracted orientation.
  • Aspect 2 The transcatheter device of aspect 1, wherein the plurality of hooks comprise nitinol.
  • Aspect 3 The transcatheter device of any one of aspects 1-2, wherein the plurality of hooks comprise at least two hooks.
  • Aspect 4 The transcatheter device of any one of aspects 1-3, wherein the plurality of hooks are circumferentially spaced around a periphery of the expandable stent frame.
  • Aspect 5 The transcatheter device of any one of aspects 1-4, wherein the plurality of hooks are circumferentially spaced a substantially equal distance from one another around the periphery of the expandable stent frame.
  • Aspect 6 The transcatheter device of any one of aspects 1-5, wherein the expandable stent frame further comprises a proximal end and a distal end, and wherein the plurality of hooks are centrally positioned between the proximal end and the distal end of the expandable stent frame.
  • Aspect 7 The transcatheter device of any one of aspects 1-6, wherein an end of each hook of the plurality of hooks comprises a wire structure.
  • Aspect 8 The transcatheter device of any one of aspects 1-7, wherein the wire structure comprises a peak comprising a first segment extending in a first direction from the peak to a first bend segment and a second segment extending in a second direction from the peak to a second bend segment, and wherein a third segment of the wire structure connects the first bend segment to the second bend segment.
  • Aspect 9 The transcatheter device of any one of aspects 1-8, wherein the wire structure comprises a double hook.
  • Aspect 10 The transcatheter device of any one of aspects 1-9, wherein the wire structure comprises a U-shaped hook.
  • Aspect 11 The transcatheter device of any one of aspects 1-10, wherein the wire structure comprises a V-shaped hook.
  • Aspect 12 The transcatheter device of any one of aspects 1-11, wherein the wire structure comprises a single bent wire.
  • Aspect 13 The transcatheter device of any one of aspects 1-12, wherein the plurality of hooks are configured to expand radially outward with respect to the expandable stent frame from the loaded state to the deployed state.
  • Aspect 14 The transcatheter device of any one of aspects 1-13, wherein the plurality of hooks are configured to be collapsed within the sheath in the loaded state.
  • Aspect 15 The transcatheter device of any one of aspects 1-14, further comprising a prosthetic heart valve comprising the expandable stent frame.
  • Aspect 16 The transcatheter device of any one of aspects 1-15, wherein the expansion device comprises a balloon.
  • Aspect 17 The transcatheter device of any one of aspects 1-16, wherein the plurality of hooks comprise self-expanding hooks.
  • a transcatheter device comprising an expanded stent frame comprising a proximal end and a distal end.
  • the stent frame is configured to achieve a contracted orientation, a partially expanded orientation, and a fully expanded orientation.
  • the transcatheter device further comprises a plurality of hooks coupled to an intermediate portion of the expandable stent frame defined between the proximal end and the distal end. The plurality of hooks are configured to expand from a loaded state to a deployed state.
  • the transcatheter device further comprises a sheath configured to receive at least the proximal end of the expandable stent frame.
  • Aspect 19 The transcatheter device of aspect 18, wherein the partially expanded orientation comprises the intermediate portion being bent radially outward relative to the sheath.
  • Aspect 20 The transcatheter device of any one of aspects 18-19, wherein the sheath comprises a proximal portion configured to translate relative to a distal portion.
  • Aspect 21 The transcatheter device of aspect 20, wherein the contracted orientation comprises the proximal end of the expandable stent frame being in a collapsed state within the proximal portion of the sheath.
  • Aspect 22 The transcatheter device of any one of aspects 20-21, wherein the contracted orientation further comprises the distal end of the expandable stent frame being in the collapsed state within the distal portion of the sheath.
  • Aspect 23 The transcatheter device of any one of aspects 20-22, wherein the partially expanded orientation comprises the proximal end of the expandable stent frame being in a collapsed state within the proximal portion of the sheath.
  • Aspect 24 The transcatheter device of any one of aspects 20-23, wherein the partially expanded orientation further comprises the distal end of the expandable stent frame being in the collapsed state within the distal portion of the sheath.
  • Aspect 25 The transcatheter device of any one of aspects 18-24, wherein the plurality of hooks comprise at least two hooks.
  • Aspect 26 The transcatheter device of any one of aspects 18-25, wherein the plurality of hooks are circumferentially spaced around the intermediate portion of the expandable stent frame.
  • Aspect 27 The transcatheter device of aspect 26, wherein the plurality of hooks are circumferentially spaced a substantially equal distance from one another around the intermediate portion of the expandable stent frame.
  • Aspect 28 The transcatheter device of any one of aspects 18-27, wherein an end of each hook of the plurality of hooks comprises a wire structure.
  • Aspect 29 The transcatheter device of aspect 28, wherein the wire structure comprises a peak comprising a first segment extending in a first direction from the peak to a first bend segment and a second segment extending in a second direction from the peak to a second bend segment, and wherein a third bend segment of the wire structure connects the first bend segment to the second bend segment.
  • Aspect 30 The transcatheter device of aspect 28, wherein the wire structure comprises a double hook.
  • Aspect 31 The transcatheter device of aspect 28, wherein the wire structure comprises a U-shaped hook.
  • Aspect 32 The transcatheter device of aspect 28, wherein the wire structure comprises a V-shaped hook.
  • Aspect 33 The transcatheter device of any one of aspects 28-32, wherein the wire structure comprises a single bent wire.
  • Aspect 34 The transcatheter device of any one of aspects 18-33, wherein the plurality of hooks are configured to expand radially outward with respect to the expandable stent frame from the loaded state to the deployed state.
  • Aspect 35 The transcatheter device of any one of aspects 18-34, wherein the plurality of hooks are configured to be collapsed within the sheath in the loaded state.
  • Aspect 36 The transcatheter device of any one of aspects 18-35, wherein the expandable stent frame comprises a self-expanding material.
  • Aspect 37 The transcatheter device of aspect 36, wherein the selfexpanding material comprises nitinol.
  • Aspect 38 The transcatheter device of any one of aspects 18-37, wherein the plurality of hooks comprises self-expanding hooks.
  • Aspect 39 The transcatheter device of any one of aspects 18-38, wherein the plurality of hooks comprises nitinol.
  • Aspect 40 The transcatheter device of any one of aspects 18-39, further comprising a prosthetic heart valve comprising the expandable stent frame.
  • a method of replacing a heart valve comprises distally advancing a transcatheter device comprising an expandable stent frame in a contracted orientation into the heart valve, wherein the expandable stent frame comprises a proximal end and a distal end.
  • the method comprises aligning a portion of the transcatheter device within leaflets of the heart valve.
  • the method further comprises expanding the expandable stent frame from the contracted orientation to a partially expanded orientation, wherein an intermediate portion of the expandable stent frame defined between the proximal end and the distal end bends radially outward relative to the proximal end and the distal end.
  • the method further comprises deploying a plurality of hooks coupled to the intermediate portion of the expandable stent frame from a loaded state to a deployed state.
  • the method then comprises expanding the expandable stent frame from the partially expanded orientation to a fully expanded orientation by releasing the proximal end to radially expand and releasing the distal end to radially expand.
  • Aspect 42 The method of aspect 41, wherein the heart valve comprises an implanted prosthetic heart valve.
  • Aspect 43 The method of any one of aspects 41-42, wherein partially expanding the expandable stent frame further comprises maintaining both the proximal end and the distal end in a collapsed state.
  • Aspect 44 The method of any one of aspects 41-43, further comprising distally advancing the partially expanded stent frame to engage leaflets of the heart valve with the deployed plurality of hooks to reposition the leaflets.
  • Aspect 45 The method of aspect 44, wherein the expandable stent frame is expanded from the partially expanded orientation to the fully expanded orientation after repositioning the leaflets with the deployed plurality of hooks, wherein expanding the expandable stent frame from the partially expanded to the fully expanded orientation pins the repositioned leaflets in place relative to the expandable stent frame.
  • Aspect 46 The method of any one of aspects 41-45, wherein releasing the distal end comprises distally advancing a distal portion of a sheath.
  • Aspect 47 The method of any one of aspects 41-46, wherein releasing the proximal end comprises proximally retracting a proximal portion of a sheath.
  • Aspect 48 The method of any one of aspects 43-47, wherein expanding the expandable stent frame from the partially expanded orientation to the fully expanded orientation comprises initially releasing the distal end to radially expand prior to releasing the proximal end, wherein the distal end achieves a radially expanded state while the proximal end is maintained in the collapsed state.
  • Aspect 49 The method of any one of aspects 43-48, wherein expanding the expandable stent frame from the partially expanded orientation to the fully expanded orientation comprises releasing the proximal end to radially expand after initially releasing the distal end.
  • Aspect 50 The method of any one of aspects 41-49, wherein, after expanding the expandable stent frame from the contracted orientation to the partially expanded orientation, further comprising recapturing the expandable stent frame to collapse the expandable stent frame from the partially expanded orientation to the contracted orientation prior to expanding the expandable stent frame from the partially expanded orientation to the fully expanded orientation.
  • Aspect 51 The method of any one of aspects 41-50, wherein deploying the plurality of hooks comprises expanding the plurality of hooks radially outward relative to the expandable stent frame.
  • Aspect 52 The method of any one of aspects 41-51, wherein deploying the plurality of hooks comprises distally advancing a distal portion of the sheath.
  • Aspect 53 The method of any one of aspects 41-51, wherein deploying the plurality of hooks comprises proximally retracting a proximal portion of a sheath.
  • Aspect 54 The method of any one of aspects 41-53, wherein expanding the expandable stent frame from the contracted orientation to a partially expanded orientation and deploying the plurality of hooks occurs simultaneously.
  • a method of replacing a heart valve comprises distally advancing a transcatheter device comprising an expandable stent frame in a contracted orientation into the heart valve.
  • the method further comprises aligning a portion of the transcatheter device within leaflets of the heart valve.
  • the method still further comprises deploying a plurality of hooks coupled to the expandable stent frame from a loaded state to a deployed state.
  • the method then comprises expanding the expandable stent frame from the contracted orientation to an expanded orientation.
  • Aspect 56 The method of aspect 55, wherein the heart valve comprises an implanted prosthetic heart valve.
  • Aspect 57 The methods of any one of aspects 55-56, wherein expanding the expandable stent frame further comprises inflating an expansion device positioned within an inner lumen of the expandable stent frame.
  • Aspect 58 The method of any one of aspects 55-57, further comprising distally advancing the expandable stent frame in the contracted orientation after deploying the plurality of hooks to engage the leaflets of the heart valve with the deployed plurality of hooks to reposition the leaflets.
  • Aspect 59 The method of aspect 58, wherein the expandable stent frame is expanded from the contracted orientation to the expanded orientation after repositioning the leaflets with the deployed plurality of hooks, wherein the repositioned leaflets are pinned in place relative to the expandable frame.
  • Aspect 60 The method of any one of aspects 55-59, wherein deploying the plurality of hooks comprises expanding the plurality of hooks radially outward relative to the expandable stent frame.
  • Aspect 61 The method of any one of aspects 55-60, wherein deploying the plurality of hooks comprises retracting a sheath.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Les dispositifs transcathéter comprennent une structure d'endoprothèse expansible conçue pour se déployer d'une orientation contractée à une orientation expansée. Les dispositifs transcathéter comprennent en outre une pluralité de crochets accouplés à la structure d'endoprothèse expansible. La pluralité de crochets est conçue pour se déployer d'un état chargé à un état déployé. Les méthodes consistent en le déploiement d'une pluralité de crochets accouplés à la structure d'endoprothèse expansible d'un état chargé à un état déployé et en l'expansion d'une structure d'endoprothèse expansible d'une orientation contractée à une orientation expansée.
PCT/IB2025/050800 2024-01-26 2025-01-24 Dispositifs et méthodes transcathéter Pending WO2025158366A1 (fr)

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US63/625,689 2024-01-26

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2068767B1 (fr) * 2006-09-19 2015-07-15 Medtronic Ventor Technologies Ltd. Élément de fixation pour valvule
US20160242901A1 (en) * 2013-10-08 2016-08-25 Medical Research, Infrastructure And Health Services Fund Of The Tel Aviv Medical Center Cardiac prostheses and their deployment
US20180235755A1 (en) * 2010-09-23 2018-08-23 Edwards Lifesciences Cardiaq Llc Replacement heart valves, delivery devices and methods

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2068767B1 (fr) * 2006-09-19 2015-07-15 Medtronic Ventor Technologies Ltd. Élément de fixation pour valvule
US20180235755A1 (en) * 2010-09-23 2018-08-23 Edwards Lifesciences Cardiaq Llc Replacement heart valves, delivery devices and methods
US20160242901A1 (en) * 2013-10-08 2016-08-25 Medical Research, Infrastructure And Health Services Fund Of The Tel Aviv Medical Center Cardiac prostheses and their deployment

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