Method and apparatus for removing valve repair device

Abstract

An implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to create a more efficient seal. The implantable device may be removed using one or more of a cutting device and a stabilizing member. The stabilizing member may control a position of the implantable device when the cutting device resects one or more leaflets engaged with the implantable device.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 399,360 filed on August 19, 2022 and the benefit of U.S. Provisional Patent Application No. 63 / 331,762 filed on April 15, 2022, which are incorporated herein by reference in their entirety. Background Art

[0003] The native heart valves (i.e. aortic valve, pulmonary valve, tricuspid valve and mitral valve) play a key role in ensuring the forward flow of sufficient blood supply through the cardiovascular system. These heart valves may be damaged, for example, due to congenital malformations, inflammatory processes, infectious conditions, diseases, etc., and thus reduce effectiveness. Such damage to the valve may cause serious cardiovascular damage or death. The damaged valve can be repaired or replaced by surgery during open heart surgery. However, open heart surgery is highly invasive and complications may occur. Transvascular technology can be used to introduce and implant prosthetic devices in a much less invasive manner than open heart surgery. As an example, the transvascular technology that can be used to enter the native mitral valve and aortic valve is the transseptal technology. The transseptal technology includes advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, upward along the inferior vena cava and entering the right atrium). Then pierce the septum and allow the catheter to enter the left atrium. A similar transvascular technique can be used to implant the device within the tricuspid valve, which is initially similar to the transseptal technique, but instead of puncturing the septum, the delivery catheter is directed toward the tricuspid valve in the right atrium.

[0004] A healthy heart is generally conical in shape, tapering to a lower tip. The heart is four-chambered and includes a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has an anatomical structure that is distinct from other native heart valves. The mitral valve includes a valve ring portion and a pair of cusps or leaflets, which are annular portions of native valve tissue surrounding the mitral valve orifice, and the pair of cusps or leaflets extend downward from the valve ring into the left ventricle. The mitral valve ring can form a "D" shape, an elliptical or other non-circular cross-sectional shape with a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, thereby forming a generally "C" shaped boundary between the adjacent sides of the leaflets when the leaflets are closed together.

[0005] When operating correctly, the anterior and posterior leaflets act together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expands (also known as "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as "ventricular contraction" or "systole"), the increased blood pressure in the left ventricle pushes the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back into the left atrium, but instead is discharged from the left ventricle through the aortic valve. In order to prevent the two leaflets from prolapsing under pressure and folding in half toward the left atrium through the mitral valve annulus, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0006] Valvular regurgitation involves the valve improperly allowing some blood to flow through the valve in the wrong direction. For example, mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of the heart contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, papillary muscle dysfunction, left ventricular dilation causing stretching of the mitral annulus, more than one of these, and so on. Mitral regurgitation at the central portion of the leaflet may be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the leaflets (i.e., the location where the leaflets meet) may be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, and therefore the valve does not close and regurgitation is present. Tricuspid regurgitation may be similar, but on the right side of the heart. Summary of the invention

[0007] The present invention is intended to provide some examples, and is not intended to limit the scope of the present invention in any way. For example, any feature included in the example of the present invention is not necessary for the claims, unless the claims clearly describe these features. In addition, the features, parts, steps, concepts, etc. described in the examples of the present invention and elsewhere in the present disclosure can be combined in various ways. Various features and steps as described elsewhere in the present disclosure can be included in the examples summarized here.

[0008] Disclosed are devices for repairing and / or treating a patient's native valve. The device may be a valve repair device, an implantable device, a valve treatment device, an implant, etc. Although sometimes described as an implantable device for illustrative purposes in various examples herein, similar configurations may be used on other devices that are not necessarily implanted and may be removed after treatment, such as valve repair devices, etc.

[0009] In some embodiments, an implantable device or implant (eg, implantable device, etc.) is provided that is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal.

[0010] In some embodiments, the implantable device or implant comprises an anchor portion. Each anchor comprises a plurality of paddles, each paddle being movable between an open position and a closed position.

[0011] Certain states or situations may require the removal of an implantable device from a native heart valve. In some embodiments, a retrieval catheter may be used to remove the implantable device, through which a cutting device and / or an optional stabilizing component is delivered to the device. An optional stabilizing component can control the position of the implantable device when the cutting device excises one or more leaflets engaged with the implantable device. In some embodiments, the stabilizing component retracts the implantable device into the retrieval catheter. In some embodiments, the same elements function in the form of a stabilizing method and a cutting device. In some embodiments, the retrieval catheter may also optionally deploy an indicator and / or instrument to guide the cutting device.

[0012] In some embodiments, a device for resecting a native valve leaflet comprises a catheter, a cutting device, and a stabilizing component. The cutting device is disposed within the catheter. The cutting device comprises a snare capable of cutting off or ablating the native valve leaflet. The stabilizing component comprises an element for grasping an implantable device.

[0013] In some embodiments, the cutting device can be formed by electrodes, which can be composed of metal elements that allow current to flow. The cutting device can be made of nitinol. The cutting device can include a surface that enables radiofrequency energy to ablate the native valve leaflet. The cutting device can be used as a stabilizing member. The element used to grasp the implantable device can be a snare. The element used to grasp the implantable device can be a clamp, a grasper, or a vacuum suction device. The second cutting device can include a second snare that can cut off or ablate the native valve leaflet.

[0014] In some embodiments, a device for resecting a native valve leaflet comprises a catheter, a cutting device, and a stabilizing component. The cutting device comprises at least one coring element disposed adjacent to the catheter. At least one coring element comprises a feature capable of severing or ablating the native valve leaflet. The stabilizing component has an element for grasping an implantable device.

[0015] In some embodiments, at least one coring element is disposed along the outer surface of the catheter. A single coring element may surround the outer surface of the catheter. The device includes a first coring element and a second coring element. At least one coring element may be arcuate. The feature capable of severing or ablating the native leaflet may be a blade, may be a cutting tip formed by an electrode that may be composed of a metal element that allows current to flow, and / or may be a surface that conducts radiofrequency energy. At least one coring element may be made of nitinol. The element for grasping the implantable device may be a snare, a clamp, a grasper, or a vacuum suction device.

[0016] In some embodiments, a device for resecting a native valve leaflet comprises a catheter, a cutting device, and an indicator or meter. The cutting device comprises at least one electrosurgical element. A stabilizing component is configured to grasp an implantable device.

[0017] In some embodiments, the cutting device can be made of nitinol. The electrosurgical element can be a cutting tip or blade, or can be a ring. The element for grasping the implantable device can be a snare, clamp, gripper, or vacuum suction device. The device can include a second cutting device. The indicator or meter can include a radiopaque feature. The indicator or meter can be a depth gauge. The indicator or meter can be a long flexible positioning wire or rod. The indicator or meter can be configured to guide the cutting device and engage the tissue to be cut before the cutting device.

[0018] In some embodiments, a method of resecting a native leaflet comprises deploying a catheter to an implantable device secured to at least one leaflet of a native heart valve. A cutting device is deployed from the catheter to the at least one leaflet. At least one of the cutting device and a stabilizing component is secured to a portion of the implantable device. The native leaflet is resected with the cutting device. A second native leaflet is resected with the cutting device. The implantable device is removed from the native heart valve via the catheter using at least one of the cutting device and the stabilizing component.

[0019] The above method can be performed on a living animal or on a simulated object, such as a cadaver, a cadaver heart, a simulated body (eg, having simulated body parts, hearts, tissues, etc.), and the like.

[0020] In some embodiments, a device for resecting a native valve leaflet comprises a catheter and a clamp. The clamp comprises a first grasping arm and a second grasping arm. The clamp comprises an element configured to cut, sever or resect the native valve leaflet.

[0021] In some embodiments, when the first and second gripping arms of the clamp are closed, the first and second gripping arms form a complete enclosure with a void in the center thereof to secure the implantable device. The first and second gripping arms may each include a serrated edge or blade and / or an electrocautery element.

[0022] In some embodiments, a device for resecting a native valve leaflet comprises a catheter, a cutting device, and a stabilizing component. The cutting device comprises a central wire, a first fork, and a second fork. The first fork and the second fork are configured to cut, sever, and / or ablate the native valve leaflet. The stabilizing component is configured to grasp an implantable device.

[0023] In some embodiments, the first fork and the second fork include sharp blades and / or electrocautery elements. The cutting device can be connected to an infrared generator so that heat can be used to sever the native leaflets. The first fork and the second fork can include surfaces that enable radiofrequency energy to ablate the native leaflets. The cutting device can be made of nitinol. The device can include a device including a balloon. The balloon can include a cutting structure that can cut, sever and / or ablate the native leaflets, such as by using electrocautery, vibration, a blade or heat.

[0024] In some embodiments, a device for resecting a native valve leaflet can include a hook and a loop configured to engage around and cut the native valve leaflet.

[0025] In some embodiments, the hook can extend from the first catheter and the loop can extend from the second catheter. The device can include a stabilizing component configured to grasp an implantable device. The hook and loop can cut, sever and / or ablate the native leaflets, for example, by using friction, heat, electrocautery, vibration, blades and / or saw teeth. The hook and loop can be formed by electrodes, which can be composed of metal elements that allow current to flow. The hook and loop can be connected to an infrared generator so that heat can be used to cut off the native leaflets. The hook and loop can be made of nitinol or spring wire. When the ring is deployed, the ring can be aligned vertically with the ring. The hook can be aligned to enter the ring, thereby forming a lasso that can be used to cut off the native leaflets.

[0026] In some embodiments, a device for removing autologous valve leaflets comprises a catheter and a retrieval device. The retrieval device can include a positioning element (e.g., a wire, a line, etc.), a snare and / or a bag. The snare can cut, sever and / or ablate the autologous valve leaflets, for example, by using friction, heat, electrocautery, vibration, a blade, a sawtooth. In some embodiments, the bag is connected to the snare and is configured to accommodate and recycle the valve repair device and the severed valve leaflet portion.

[0027] In some embodiments, the retrieval device (e.g., snare, etc.) can be composed of an electrocautery element. The retrieval device (e.g., snare, etc.) can be connected to an infrared generator so that heat can be used to sever the native leaflets. The retrieval device, snare, and / or bag can be made of nitinol or spring wire to achieve shape memory properties. The retrieval device (e.g., snare, etc.) can be composed of a surface that enables radiofrequency energy to ablate the native leaflets.

[0028] In some embodiments, a device for resecting an autologous valve leaflet comprises a catheter, a cover, a cutting element, and / or an actuating element. The cover is attached to the catheter so that the cover can move between an open position and a closed position relative to the catheter. The actuating element can be configured to move the cover between an open position and a closed position. The cutting element can cut, sever, or ablate the autologous valve leaflet. The cutting element can be attached to the cover and / or the catheter. The cover is configured to capture the valve repair device.

[0029] In some embodiments, the cutting element may be comprised of an electrocautery element. The cutting element may be connected to an infrared generator so that heat may be used to sever the native leaflets. The cutting element and / or cover may be made of nitinol or spring wire to achieve shape memory properties. The cutting element may be comprised of a surface that enables radiofrequency energy to ablate the native leaflets.

[0030] In some embodiments, the lid is biased in a closed position, and the actuating element is used to move the lid from the closed position to the open position. In some embodiments, the lid is biased in an open position, and the actuating element is used to move the lid from the open position to the closed position.

[0031] In some embodiments, a method for excising one or more native leaflets of a native valve and implanting a replacement valve in the native valve comprises deploying a cutting device so that the cutting device is positioned proximate to the native valve. The method may further comprise cutting one or more native leaflets with a cutting device so that a valve repair device is removed from the one or more native leaflets, wherein the valve repair device remains connected to at least one other native leaflet of the native valve. The method may further comprise deploying a replacement valve so that the replacement valve is positioned proximate to the native valve, wherein the replacement valve has a body and one or more anchors. The method may further comprise attaching the replacement valve to at least a portion of the one or more native leaflets and at least one other native leaflet, such that the valve repair device is captured by the replacement valve between the body and the one or more anchors.

[0032] In some embodiments, one or more native leaflets are engaged with the cutting device prior to cutting the one or more native leaflets, and if propping up of the one or more native leaflets is not detected, the cutting device is repositioned relative to the one or more native leaflets.

[0033] In some embodiments, cutting includes using at least one of friction, electrocautery, vibration, and saw teeth.

[0034] In some embodiments, the cutting device comprises one or more blades.

[0035] In some embodiments, the cutting device includes an electrosurgical tip formed from an electrode comprising a metallic element configured to allow the flow of an electric current.

[0036] In some embodiments, the cutting device includes an electrosurgical tip formed from an electrode comprising a metallic element configured to allow the flow of an electric current.

[0037] In some embodiments, the cutting device is connected to an infrared generator so that heat can be used to sever one or more native leaflets.

[0038] In some embodiments, the cutting device includes a device that enables radiofrequency energy to ablate one or more surfaces of one or more native leaflets.

[0039] In some embodiments, the delivery system is positioned proximate to the native valve, and the delivery system is configured to deploy the cutting device and the replacement valve.

[0040] In some embodiments, a stabilizing component connects the valve repair device to the delivery system prior to cutting one or more native valve leaflets.

[0041] In some embodiments, the cutting device is deployed from a first catheter of the delivery system and the replacement valve is deployed from a second catheter of the delivery system.

[0042] In some embodiments, the body includes an inner body or frame and an outer body or frame.

[0043] In some embodiments, a system for resecting a native valve leaflet comprises: a catheter having a first lumen and a second lumen, a first cutter delivery catheter configured to deliver through the first lumen, a second cutter delivery catheter configured to deliver through the second lumen, and a cutting element configured to extend through a third lumen.

[0044] In some embodiments, the first distal tip of the first cutter delivery catheter comprises a first coupling element configured to connect to a second coupling element on the second distal tip of the second cutter delivery catheter such that the cutting element can be advanced through the second lumen.

[0045] In some embodiments, the first coupling element is configured to magnetically couple to the second coupling element. In some embodiments, the second cutter delivery catheter comprises a fourth lumen, and when the first distal tip is connected to the second distal tip, the third lumen is aligned with the fourth lumen. In some embodiments, the cutting element can be advanced through the second lumen via the fourth lumen.

[0046] In some embodiments, the first coupling element and / or the second coupling element is a magnet. In some embodiments, the first coupling element is a first annular magnet and the second coupling element is a second annular magnet.

[0047] In some embodiments, the first coupling element is configured to be mechanically coupled to the second coupling element. In some embodiments, the first coupling element is configured as a female connector, and the second coupling element is configured as a male connector. In some embodiments, the first coupling element is configured to be received in the third lumen at the first distal tip. In some embodiments, the first coupling element has a first outer surface having a shape complementary to the inner surface of the first distal tip.

[0048] In some embodiments, the first coupling element comprises a distal end and a proximal end, wherein the cutting element is attached to the proximal end. In some embodiments, the distal end is configured to receive the second coupling element. In some embodiments, the second coupling element comprises one or more projections extending radially outward.

[0049] In some embodiments, the first coupling element comprises one or more radially inwardly extending projections configured to engage one or more radially outwardly extending projections to prevent the second coupling element from separating from the first coupling element. In some embodiments, the first coupling element is configured to be removed from the first cutter delivery catheter once coupled to the second coupling element.

[0050] In some embodiments, the cutting element is a conductive wire. In some embodiments, the activation source is configured to energize the cutting element. In some embodiments, the activation source is a radio frequency generator.

[0051] In some embodiments, the first cutter delivery catheter has a steerable distal end portion. In some embodiments, the first cutter delivery catheter comprises a distal end portion having shape memory properties.

[0052] In some embodiments, the inflatable balloon is attached to the outer surface of the first cutter delivery catheter adjacent to the first distal tip. In some embodiments, the inflatable balloon is attached to the outer surface of the second cutter delivery catheter adjacent to the second distal tip.

[0053] In some embodiments, a system for resecting an autologous valve leaflet comprises a delivery catheter and a cutting device configured to be delivered by the delivery catheter. In some embodiments, the cutting element comprises a first arm having a first distal end, a second arm having a second distal end spaced apart from the first distal end, and a cutting element extending between the first distal end and the second distal end.

[0054] In some embodiments, the cutting element is a conductive wire. In some embodiments, the conductive wire is in a relaxed state between the first distal end and the second distal end. In some embodiments, the first arm and the second arm form a V-shape.

[0055] In some embodiments, the first arm and the second arm are insulated conductive wires, and the cutting element is an uninsulated conductive wire. In some embodiments, the activation source is configured to energize the cutting element. In some embodiments, the activation source is a radio frequency generator.

[0056] In some embodiments, a method for resecting a native valve leaflet captured by an implantable device comprises: extending a first cutter delivery catheter from an atrial side to a ventricular side of the native valve leaflet on a first side of the implantable device; extending a second cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflet on a second side of the implantable device opposite to the first side; and / or connecting the first cutter delivery catheter to the second cutter delivery catheter on the ventricular side of the native valve leaflet.

[0057] In some embodiments, the method further includes: extending the cutting element through a first lumen in a first cutter delivery catheter and a second lumen in a second cutter delivery catheter; withdrawing the first cutter delivery catheter to expose the cutting element adjacent to the native valve leaflets; and / or moving the cutting element from the ventricular side through the native valve leaflets to the atrial side to detach the native valve leaflets from the implantable device.

[0058] In some embodiments, connecting the first cutter delivery catheter to the second cutter delivery catheter further comprises magnetically coupling the first cutter delivery catheter to the second cutter delivery catheter.

[0059] In some embodiments, connecting the first cutter delivery catheter to the second cutter delivery catheter further comprises aligning a first lumen in the first cutter delivery catheter with a second lumen in the second cutter delivery catheter. In some embodiments, the method comprises turning a first distal tip of the first cutter delivery catheter toward a second distal tip of the second cutter delivery catheter on the ventricular side.

[0060] In some embodiments, the method comprises connecting the cutting element to an activation source. In some embodiments, the activation source is a radio frequency generator. In some embodiments, the method comprises activating the cutting element with radio frequency energy. In some embodiments, the cutting element is a conductive wire.

[0061] In some embodiments, extending the first cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflets further comprises inflating a balloon on an outer surface of the first cutter delivery catheter.

[0062] In some embodiments, extending the second cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflets further comprises inflating a second balloon on an outer surface of the second cutter delivery catheter.

[0063] In some embodiments, a method for resecting a native valve leaflet captured by an implantable device comprises: extending a first cutter delivery catheter from an atrial side to a ventricular side of the native valve leaflet on a first side of the implantable device; extending a second cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflet on a second side of the implantable device opposite to the first side; and connecting the first cutter delivery catheter to the second cutter delivery catheter on the ventricular side of the native valve leaflet.

[0064] In some embodiments, the cutting element is connected to a first coupling element associated with a first cutter delivery catheter. In some embodiments, the method further comprises: withdrawing the first cutter delivery catheter to expose the cutting element adjacent to the native valve leaflets; and moving the cutting element from the ventricular side through the native valve leaflets to the atrial side to detach the native valve leaflets from the implantable device.

[0065] In some embodiments, connecting the first cutter delivery catheter to the second cutter delivery catheter further comprises mechanically coupling the first cutter delivery catheter to the second cutter delivery catheter. In some embodiments, mechanically coupling the first cutter delivery catheter to the second cutter delivery catheter further comprises receiving the male connector into the female connector.

[0066] In some embodiments, withdrawing the first cutter delivery catheter further comprises detaching the female connector from the first cutter delivery catheter. In some embodiments, detaching the female connector from the first cutter delivery catheter further comprises applying tension to one or both of the first cutter delivery catheter and the second cutter delivery catheter.

[0067] In some embodiments, the method comprises connecting the cutting element to an activation source. In some embodiments, the activation source is a radio frequency generator. In some embodiments, the method comprises activating the cutting element with radio frequency energy. In some embodiments, the cutting element is a conductive wire.

[0068] In some embodiments, extending the first cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflets further comprises inflating a balloon on an outer surface of the first cutter delivery catheter.

[0069] In some embodiments, connecting the first cutter delivery catheter to the second cutter delivery catheter on the ventricular side of the native valve leaflets further comprises turning a distal end portion of the first cutter delivery catheter toward the second cutter delivery catheter.

[0070] In some embodiments, a method of resecting a native valve leaflet captured by an implantable device comprises: delivering a distal tip of a delivery catheter to the atrial side of the native valve leaflet; supporting a cutting element near the atrial side of the native valve leaflet; and moving the cutting element from the atrial side through the native valve leaflet to the ventricular side to detach the native valve leaflet from the implantable device. In some embodiments, the cutting element is supported near the atrial side of the native valve leaflet in a relaxed state.

[0071] In some embodiments, the method further comprises connecting the cutting element to an activation source. In some embodiments, the activation source is a radio frequency generator. In some embodiments, the method further comprises activating the cutting element with radio frequency energy. In some embodiments, the cutting element is a conductive wire.

[0072] In some embodiments, supporting the cutting element near the atrial side of the native valve leaflet further comprises extending the cutting element between a first distal end of the first arm and a second distal end of the second arm. In some embodiments, the method further comprises extending the first arm and the second arm from a distal tip of the delivery catheter.

[0073] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). In the case of a simulator, the body part can alternatively be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.), and can include, for example, a computerized and / or physical representation.

[0074] Any of the above-described systems, components, devices, equipment, parts, etc. may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use by patients, and the above-described methods may include (or the additional method includes or consists of) sterilization (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, equipment, parts, etc. described herein.

[0075] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts have like reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] In order to further clarify various aspects of the examples in the present disclosure, certain examples and embodiments will be described in more detail with reference to various aspects of the drawings. These drawings depict only exemplary embodiments of the present disclosure and should not be considered as limiting the scope of the present disclosure. In addition, although the drawings may be drawn to scale for some examples, they are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained in conjunction with additional features and details through the use of the drawings, in which:

[0077] Figure 1 shows a cross-sectional view of a human heart in diastole;

[0078] Figure 2 shows a cross-sectional view of a human heart in the systolic phase;

[0079] Figure 3 shows a cross-sectional view of a human heart in phase of systole, illustrating valvular regurgitation;

[0080] Figure 4 yes Figure 3 A cross-sectional view of the mitral valve with annotations illustrating the natural shape of the mitral valve leaflets during systole;

[0081] Figure 5 A healthy mitral valve is shown with the leaflets closed as viewed from the atrial side of the mitral valve;

[0082] Figure 6 shows a dysfunctional mitral valve with visible gaps between the leaflets as viewed from the atrial side of the mitral valve;

[0083] Figure 7 The tricuspid valve is shown as viewed from the atrial side of the tricuspid valve;

[0084] Figure 8-14 Examples of implantable devices or implants are shown in various stages of deployment;

[0085] Fig.15 An example of an implantable device or implant is shown, which is similar to Figure 8-14 The device shown, but in which the paddles are independently controllable;

[0086] Figure 16-21 Delivered and deployed within a native valve Figure 8-14 Exemplary devices or implants of;

[0087] Fig. 22 shows a perspective view of an exemplary device or implant in a closed position;

[0088] Fig.23 shows a perspective view of an exemplary device or implant in a closed position;

[0089] Fig.24 An exemplary valve repair device is shown with paddles in an open position;

[0090] Fig.25A Another exemplary valve repair device is shown having paddles in a closed position;

[0091] Fig.25B shows a top view of an exemplary valve repair device;

[0092] Fig.26 shows a perspective view of an exemplary device having a width-adjustable paddle;

[0093] Fig. 27 yes Fig.26 a cross-section of an implantable device, wherein the implantable device is bisected;

[0094] Fig.28 yes Fig.26 Another cross-sectional view of an implantable device, wherein the implantable device is arranged perpendicular to Fig.28 The plane shown in the figure is bisected;

[0095] Fig.29 is a schematic diagram of an exemplary implant catheter assembly coupled to an implantable device, wherein an actuation element is coupled to a paddle actuation control and a driver head of the implantable device;

[0096] Fig.30 yes Fig.29 a schematic diagram of an assembly of wherein the implantable device is rotated 90 degrees to illustrate a paddle width adjustment element coupled to an inner end of a connector of the implantable device and coupled to a paddle width control;

[0097] Fig.31 showing a front view of an exemplary implantable device in a closed position engaged with the anterior and posterior leaflets of a mitral valve;

[0098] Fig.32 shows a front view of an exemplary retrieval catheter, cutting device, and optional stabilizing component;

[0099] Fig.33 Shows Fig.32 A side view of an exemplary retrieval catheter, cutting device, and optional stabilizing component;

[0100] Fig.34 Shows Fig.32 A front view of an exemplary retrieval catheter, cutting device, and optional stabilizing member of the embodiment of the present invention, wherein the cutting device is partially retracted and the retrieval catheter is proximate to the anterior leaflet and the posterior leaflet;

[0101] Fig.35 Shown as Fig.34 A side view of an exemplary retrieval catheter, cutting device, and optional stabilization component is shown;

[0102] Fig.36 shows a front view of an exemplary retrieval catheter, two cutting devices, and an optional stabilizing component;

[0103] Fig.37 Shows Fig.36 A side view of an exemplary retrieval catheter, two cutting devices, and an optional stabilizing component;

[0104] Fig.38 Shows Fig.36 A front view of an exemplary retrieval catheter, two cutting devices, and an optional stabilizing member, wherein the cutting devices are partially retracted and the retrieval catheter is proximal to the anterior and posterior leaflets;

[0105] Fig.39 Shown as Fig.38 A side view of an exemplary retrieval catheter, cutting device, and optional stabilization component is shown;

[0106] Fig.40 An exemplary retrieval catheter, cutting device, and stabilizing component are shown;

[0107] Fig.41 Shows Fig.40 an exemplary retrieval catheter, cutting device, and stabilizing member, wherein the cutting device and catheter are advanced to the leaflet;

[0108] Fig.42 Shows Fig.40 An exemplary retrieval catheter, cutting device, and stabilizing member of the present invention, wherein the cutting device is cutting through the valve leaflet;

[0109] Fig.43 Shows Fig.40 An exemplary retrieval catheter, cutting device and stabilizing member of the present invention, wherein the valve leaflets and valve repair device are pulled into the retrieval catheter by the stabilizing member;

[0110] Fig.44 A top view of an exemplary retrieval catheter, stabilizing member, cutting device, and indicator or meter is shown. The retrieval catheter is shown off-center to allow all features of the drawing to be visible;

[0111] Fig.45 yes Fig.44A front view of an exemplary retrieval catheter, stabilizing member, cutting device, and indicator or meter;

[0112] Fig.46 is a front view of an exemplary retrieval catheter, a stabilizing component, and two cutting devices;

[0113] Fig.47 yes Fig.46 A top view of an exemplary retrieval catheter, a stabilizing component, and two cutting devices;

[0114] Fig.48 is a front view of an exemplary retrieval catheter, stabilizing component, and cutting device;

[0115] Fig.49 yes Fig.48 A top view of an exemplary retrieval catheter, stabilizing member, and cutting device;

[0116] Figures 50A-50B A method of removing an exemplary implantable device using an exemplary cutting device is shown;

[0117] Figures 51A-51C A method of removing an exemplary implantable device using an exemplary cutting device is shown;

[0118] Fig.52 is a front view of an exemplary cutting device;

[0119] Fig.53 Shows Fig.52 An exemplary retrieval catheter and cutting device of;

[0120] Figures 54A-54C Shows Fig.52 Exemplary locations of the retrieval catheter and cutting device;

[0121] Figures 54D-54F Shows the use of Fig.52 A method of cutting a valve leaflet attached to an exemplary implantable device using a retrieval catheter and a cutting device;

[0122] Figures 55A-55B The exemplary cutting device is shown retracted to Fig.52 A method of retrieval of the catheter;

[0123] Figures 56A-56B Shows the use of Fig.52 Methods of removing an exemplary implantable device from a valve leaflet using a retrieval catheter and a cutting device;

[0124] Figures 57A-57B A method of retrieving an exemplary implantable device using a first retrieval catheter, a second retrieval catheter, and two cutting devices is shown;

[0125] Figures 58A-58BA method of retrieving an exemplary implantable device using a retrieval catheter, a cutting device, and a stabilizing component is shown;

[0126] Figures 59A-59B Shows the Figures 58A-58B a method for retracting the cutting device and stabilizing component into a retrieval catheter;

[0127] Figures 60A-60B An exemplary retrieval catheter and cutting device are shown;

[0128] Figures 61A-61C Shows the use of Figures 60A-60B A method of recovering an exemplary implantable device using a retrieval catheter and a cutting device;

[0129] Figures 62A-62H A method of removing an exemplary implantable device from at least one leaflet of a native heart valve using an exemplary cutting device is shown;

[0130] Figures 63A-63D A method of implanting a replacement valve onto a native valve such that the replacement valve captures an implantable device attached to the native valve is shown;

[0131] Fig.64 An exemplary replacement valve is shown;

[0132] Figures 65A-65E Shows the Fig.64 Method of implanting a replacement valve onto a native valve such that the replacement valve captures an implantable device attached to the native valve;

[0133] Figures 66-71 An exemplary cutting device for detaching an implantable device from a valve leaflet is shown;

[0134] Fig.72 An exemplary cutting device for detaching an implantable device from a valve leaflet is shown;

[0135] Figures 73-77 An exemplary cutting device for detaching an implantable device from a valve leaflet is shown;

[0136] Figures 78-83 An exemplary cutting device for detaching an implantable device from a valve leaflet is shown; and

[0137] Fig.84 An exemplary cutting device for detaching an implantable device from a valve leaflet is shown. DETAILED DESCRIPTION

[0138] The following description refers to the accompanying drawings, which illustrate exemplary embodiments of the present disclosure. Other embodiments having different structures and operations do not depart from the scope of the present disclosure.

[0139] Exemplary embodiments of the present disclosure relate to systems, devices, methods, etc. for repairing defective heart valves. For example, various embodiments of valve repair devices, implantable devices, implants, and systems (including systems for delivering the same) are disclosed herein, and any combination of these options may be made unless specifically excluded. In other words, the various components of the disclosed devices and systems may be combined unless mutually exclusive or otherwise physically impossible.

[0140] The therapeutic techniques, methods, operations, steps, etc. described or suggested herein or in the references cited herein may be performed on a living subject (e.g., a human, other animal, etc.) or on a non-living simulator (e.g., a cadaver, a cadaver heart, a simulated body, a virtual human, etc.). When performed on a simulator, a body part (e.g., a heart, tissue, a valve, etc.) may alternatively be referred to as "simulated" (e.g., a simulated heart, simulated tissue, simulated valve, etc.), and may include, for example, a computerized and / or physical representation of a body part, tissue, etc.

[0141] As described herein, when one or more components are described as being connected, linked, fixed, coupled, attached, or otherwise interconnected, such interconnection may be a direct interconnection between the components, or may be an indirect interconnection, such as through the use of one or more intermediate components. Also as described herein, references to "member," "component," or "portion" should not be limited to a single structural member, component, or element, but may include an assembly of components, components, or elements. Also as described herein, the terms "substantially" and "approximately" are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%). The terms "fastener" and "fastener arm" are generally used herein for specific instances, but the terms "clamping member" and / or "clamping arm" may be used in place of and function in the same or similar manner, even if they are constructed differently from typical fasteners.

[0142] Figure 1 and 2 are cross-sectional views of a human heart H in diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV (i.e., the atrioventricular valves), respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., Figure 3-6 The leaflets 20, 22 and Figure 7The valve leaflets 30, 32, 34 shown in the figure are flexible valve leaflets that extend inwardly across corresponding orifices that meet or "combine" in the flow stream to form a one-way fluid blocking surface. The autologous valve repair system of the present application is mainly described and / or illustrated with respect to the mitral valve MV. Therefore, the anatomical structure of the left atrium LA and the left ventricle LV will be explained in more detail. However, the devices described herein can also be used to repair other autologous valves, for example, these devices can be used to repair the tricuspid valve TV, the aortic valve AV and the pulmonary valve PV.

[0143] The left atrium LA receives oxygenated blood from the lungs. During diastole or relaxation, e.g. Figure 1 As seen in FIG, blood previously collected in the left atrium LA (during systole) moves through the mitral valve MV and into the left ventricle LV by the expansion of the left ventricle LV. Figure 2 As seen in the , the left ventricle LV contracts to force blood into the body through the aortic valve AV and the ascending aorta AA. During contraction, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV and into the left atrium LA, and blood is collected in the left atrium from the pulmonary veins. In some embodiments, the devices described in this application are used to repair the function of a defective mitral valve MV. That is, these devices are configured to help close the leaflets of the mitral valve to prevent, inhibit or reduce the backflow of blood from the left ventricle LV and into the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the native leaflets around the apposition element or spacer, which beneficially acts as a filler in the regurgitation orifice to prevent or inhibit backflow or regurgitation during contraction, but this is not required.

[0144] Reference now Figure 1-7 The mitral valve MV includes two leaflets, namely an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes a valve ring 24 (see Figure 5 ), the valve annulus is a variably dense fibrous ring of tissue surrounding the leaflets 20, 22. Figure 3 and 4 , the mitral valve MV is anchored to the wall of the left ventricle LV by the chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located at the base of the chordae tendineae CT and within the wall of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM serve to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from reversing. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Instead, the papillary muscles PM support or brace the leaflets 20, 22 to resist the high pressure required to circulate blood throughout the body. The papillary muscles PM and the chordae tendineae CT are together referred to as the subvalvular structures, which serve to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed. As seen from Figure 3 As seen from the left ventricular outflow tract (LVOT) view shown in , the anatomical structure of the leaflets 20, 22 causes the inner sides of the leaflets to coapt at the free end portions, and the leaflets 20, 22 begin to retreat or stretch away from each other. The leaflets 20, 22 stretch in the atrial direction until each leaflet meets the mitral annulus.

[0145] Various disease processes can impair the normal function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic defects, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) may distort the geometry of the native valve, which can lead to native valve dysfunction. However, the vast majority of patients who undergo valve surgery (e.g., surgery on the mitral valve MV) suffer from a degenerative disease that causes dysfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), which leads to prolapse and regurgitation.

[0146] Generally speaking, native valves may malfunction in different ways: including (1) valvular stenosis; and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not fully open and thereby causes blood flow to be obstructed. Typically, valvular stenosis is caused by the accumulation of calcified material on the valve leaflets, which causes the leaflets to thicken and impairs the ability of the valve to fully open to allow forward blood flow. Valvular regurgitation occurs when the leaflets of the valve do not fully close, thereby causing blood to leak back into the previous chamber (for example, causing blood to leak from the left ventricle into the left atrium).

[0147] There are three main mechanisms by which a native valve becomes regurgitant (or incompetent), including Carpentier Type I, II, and III dysfunctions. Carpentier Type I dysfunction involves dilation of the annulus, causing the normally functioning leaflets to diverge from each other and fail to form a tight seal (i.e., the leaflets do not appose properly). Type I mechanism dysfunction includes leaflet perforations present in endocarditis. Carpentier Type II dysfunction involves prolapse of one or more leaflets of the native valve above the plane of apposition. Carpentier Type III dysfunction involves restraining the movement of one or more leaflets of the native valve, causing the leaflets to be abnormally restrained below the plane of the annulus. Leaflet restriction may be caused by rheumatic disease or ventricular dilatation.

[0148] refer to Figure 5When the healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 are in close contact, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Figure 3 and 6 Mitral regurgitation MR occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA during contraction so that the edges of the leaflets 20, 22 do not touch each other. This failure to coapt creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back from the left ventricle LV into the left atrium LA during contraction, as shown in FIG. Figure 3 The MR flow path of mitral regurgitation is shown. Figure 6 , the width W of gap 26 may be between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some cases, gap 26 may have a width W greater than 15 mm or even 17.5 mm. As described above, leaflets (e.g., leaflets 20, 22 of the mitral valve MV) may malfunction in a number of different ways, which may result in valvular regurgitation.

[0149] In any of the above situations, it is desirable that the valve repair device or implant engages the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit blood regurgitation through the mitral valve MV. Figure 4 As can be seen, an abstract representation of a valve repair device, implantable device or implant 10 is shown, which is implanted between the leaflets 20, 22 so that regurgitation does not occur during contraction (the Figure 3 and Figure 4 In some embodiments, the apposition element (e.g., spacer, engagement element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) of device 10 has a generally conical or triangular shape that naturally adapts to the native valve geometry and its expanded leaflet properties (toward the annulus). In this application, the terms spacer, engagement element, apposition element, gap filler, plug, etc. are used interchangeably and refer to an element that fills a portion of the space between the leaflets of the native valve and / or is configured to cause the leaflets of the native valve to engage or "apposition" (e.g., cause the native leaflets to apposition with the engagement element, apposition element, spacer, etc., rather than just apposition with each other).

[0150] Although stenosis or regurgitation can affect any valve, stenosis is primarily found to affect the aortic valve AV or the pulmonary valve PV, and regurgitation is primarily found to affect the mitral valve MV or the tricuspid valve TV. Both valvular stenosis and valvular regurgitation increase the workload of the heart H and, if left untreated, can lead to very serious conditions; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Since the left side of the heart (i.e., the left atrium LA, left ventricle LV, mitral valve MV, and aortic valve AV) are primarily responsible for circulating blood throughout the body. Therefore, cardiac dysfunction of the mitral valve MV or aortic valve AV is particularly problematic and often life-threatening, as the pressures on the left side are significantly higher.

[0151] Dysfunctional native heart valves may be repaired or replaced. Repair typically involves preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and the pulmonary valve PV are more prone to stenosis. Because the stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or a stenotic pulmonary valve may be to remove the valve and replace the valve with a surgically implanted heart valve, or to replace the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more susceptible to deformation of the valve leaflets and / or surrounding tissue, which, as described above, may prevent the mitral valve MV or tricuspid valve TV from closing properly and allow blood to flow back or reflux from the ventricles into the atria (e.g., a deformed mitral valve MV may allow blood to flow back or reflux from the left ventricle LV into the left atrium LA, as described above). Figure 3 ). Regurgitation or backflow of blood from the ventricles to the atria results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are generally repairable. In addition, regurgitation may occur due to the chordae tendineae CT becoming dysfunctional (e.g., the chordae CT may stretch or rupture), which allows the anterior leaflet 20 and the posterior leaflet 22 to reverse, allowing blood to flow back into the left atrium LA. Problems that arise due to chordae tendineae CT dysfunction can be repaired by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0152] The devices and procedures disclosed herein are generally directed to repairing the structure of the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve and any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit the backflow of blood from the left ventricle into the left atrium. Regarding the tricuspid valve TV ( Figure 7), any device and concept provided herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent or inhibit blood from flowing back from the right ventricle to the right atrium. In addition, any device and concept provided herein can be used together on all three leaflets 30, 32, 34 to prevent or inhibit blood from flowing back from the right ventricle to the right atrium. That is, the valve repair device or implant provided herein can be centrally located between the three leaflets 30, 32, 34.

[0153] Optionally, an exemplary device or implant may have an apposition element (e.g., a spacer, a coupling element, a gap filler, a membrane, a sheet, a plug, a wedge, a balloon, etc.) and at least one anchor (e.g., one, two, three or more). In some embodiments, an implantable device or implant may have any combination or subcombination of the features disclosed herein without an apposition element. When an apposition element (e.g., a spacer, a coupling element, a gap filler, a membrane, a sheet, a plug, a wedge, a balloon, etc.) is included, the apposition element may be configured to be positioned within the orifice of the native heart valve to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting the above-mentioned regurgitation. The apposition element may have a structure that is impermeable to blood (or prevents blood from flowing therethrough) and allows the native leaflets to close around the apposition element during ventricular contraction to prevent blood from flowing back from the left ventricle or right ventricle into the left atrium or right atrium, respectively. The device or implant can be configured to seal against two or three native valve leaflets; that is, the device can be used for native mitral or bicuspid valves and tricuspid valves. The apposition element is sometimes referred to herein as a spacer because the apposition element can fill the space between the non-functional native valve leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that are not fully closed.

[0154] Optional apposition elements (e.g., spacers, engagement elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) may have various shapes. In some embodiments, the apposition element may have an elongated cylindrical shape having a circular cross-sectional shape. In some embodiments, the apposition element may have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some embodiments, the apposition element may have an atrial portion positioned in or adjacent to the atrium, a ventricle or lower portion positioned in or adjacent to the ventricle, and a side surface extending between the native tricuspid valve leaflets. In some embodiments configured for use in a tricuspid valve, the atrium or upper portion is positioned in or adjacent to the right atrium, and the ventricle or lower portion is positioned in or adjacent to the right ventricle, and the side surface extends between the native tricuspid valve leaflets.

[0155] In some embodiments, the anchor can be configured to fix the device to one or two native leaflets so that the apposition element is positioned between the two native leaflets. In some embodiments configured for the tricuspid valve, the anchor is configured to fix the device to one, two or three tricuspid leaflets of the tricuspid valve so that the apposition element is positioned between the three native leaflets. In some embodiments, the anchor can be attached to the apposition element at a position adjacent to the ventricular portion of the apposition element. In some embodiments, the anchor can be attached to an actuating element (e.g., an actuating shaft, an actuating tube, an actuating wire, etc.), and the apposition element is also attached to the actuating element. In some embodiments, the anchor and the apposition element can be positioned independently relative to each other by individually moving each of the anchor and the apposition element along the longitudinal axis of the actuating element (e.g., an actuating shaft, an actuating rod, an actuating tube, an actuating wire, etc.). In some embodiments, the anchor and the coaptation element can be positioned simultaneously by moving the anchor and the coaptation element together along the longitudinal axis of the actuation element (e.g., shaft, actuation wire, etc.) The anchor can be configured to be positioned behind the native leaflets when implanted so that the leaflets are grasped by the anchor.

[0156] The device or implant may be configured to be implanted via a delivery system or other delivery tool. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, a combination of these, and the like. The apposition element and the anchor may be compressed to a radially compressed state, and may self-expand to a radially expanded state when the compression pressure is released. The device may be configured to radially expand the anchor away from the still compressed apposition element first, so as to create a gap between the apposition element and the anchor. The autologous leaflet may then be positioned in the gap. The apposition element may radially expand, thereby closing the gap between the apposition element and the anchor, and capturing the leaflet between the apposition element and the anchor. In some embodiments, the anchor and the apposition element may optionally be configured to self-expand. The implantation methods of various embodiments may be different, and a more comprehensive discussion is provided below regarding each embodiment. Additional information about these and other delivery methods can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, each of which is incorporated herein by reference in its entirety for all purposes. These methods can be performed, mutatis mutandis, on live animals or on simulated objects, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulated bodies (e.g., simulated body parts, hearts, tissues, etc.), etc.

[0157] The disclosed device or implant can be configured so that the anchors are connected to the leaflets, using tension from native chordae tendineae to resist high systolic pressures that push the device toward the left atrium. During diastole, the device can rely on compression and retention forces exerted on the leaflets grasped by the anchors.

[0158] Reference now Figure 8-15 , a schematically illustrated device or implant 100 (e.g., a prosthetic device, a valve repair device, an implantable device, etc.) is shown in various stages of deployment. The device or implant 100 and other similar devices / implants are described in more detail in PCT patent application publications No. WO2018 / 195215, No. WO2020 / 076898, and No. WO 2019 / 139904, which are incorporated herein by reference in their entirety. The device 100 may include any other features for another device or implant discussed in the present or above application, and the device 100 may be positioned to engage valve tissue (e.g., leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present or above application).

[0159] The device or implant 100 is deployed from a delivery system 102. The delivery system 102 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a passageway, combinations of these, etc. The device or implant 100 includes an apposition portion 104 and an anchoring portion 106.

[0160] In some embodiments, the apposition portion 104 of the device or implant 100 includes an apposition element 110, which is suitable for implantation between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and is slidably attached to an actuation element 112 (e.g., an actuation wire, shaft, tube, hypotube, thread, suture, braid, etc.). The anchoring portion 106 includes one or more anchors 108, which are actuable between an open state and a closed state and can take various forms, such as paddles, clamping elements, etc. Actuation of the actuation element 112 opens and closes the anchoring portion 106 of the device 100 to grasp the leaflets of the native valve during implantation. The actuation element 112 (and other actuation elements disclosed herein) can take a variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, threads, strips, combinations of these, etc.), can be made of a variety of different materials, and can have a variety of configurations. As an example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the mating portion 104. Alternatively, the actuation element can be non-threaded such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the mating portion 104.

[0161] The anchoring portion 106 and / or anchoring member of the device 100 includes an outer paddle 120 and an inner paddle 122, which in some embodiments are connected between the cover 114 and the coaptation element 110 by portions 124, 126, 128. Portions 124, 126, 128 can be connected and / or flexible to move between all positions described below. The interconnection of the outer paddle 120, the inner paddle 122, the coaptation element 110, and the cover 114 by portions 124, 126, and 128 can constrain the device to the positions and movements shown herein.

[0162] In some embodiments, the delivery system 102 comprises a steerable catheter, an implant catheter, and an actuating element 112 (e.g., an actuating wire, shaft, tube, hypotube, thread, suture, braid, etc.). These can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some embodiments, the actuating element 112 extends through the delivery catheter and the apposition element 110 to the distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchoring portion 106). Extending and retracting the actuating element 112 increases and decreases the spacing between the apposition element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some embodiments, a loop or other attachment element (e.g., a clamp, clip, lock, suture, friction fit, clasp, snap fit, lasso, etc.) removably attaches the mating element 110 directly or indirectly to the delivery system 102 such that the actuating element 112 slides through the loop or other attachment element, and in some embodiments, slides through the mating element 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0163] In some embodiments, the anchor portion 106 and / or the anchor member 108 may include an attachment portion or clamping member (e.g., a clamping arm, a buckle arm, etc.). The illustrated clamping member may include a buckle 130 that includes a base or fixed arm 132, a movable arm 134, an optional friction enhancing element, other fixing structures 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner blade 122. In some embodiments, the fixed arm 132 is attached to the inner blade 122, wherein the joint portion 138 is disposed proximate to the mating element 110. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the buckle 130. The joint portion 138 may be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, etc. In some embodiments, the joint portion 138 is a flexible piece of material integrally formed with the fixed arm 132 and the movable arm 134. The stationary arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary relative to the inner paddle 122 when the movable arm 134 is opened to open the catch 130 and expose the optional barb or other friction enhancing element 136 .

[0164] In some embodiments, the buckle 130 is opened by applying tension to an actuation wire 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, flex, or pivot on the joint portion 138. The actuation wire 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible.

[0165] The actuation wire 116 can take a variety of forms, such as a thread, suture, wire, rod, catheter, etc. The buckle 130 can be spring loaded so that in the closed position, the buckle 130 continues to provide a clamping force on the grasped native leaflet. The optional barbs or other friction enhancing elements 136 of the buckle 130 can grasp, clamp and / or pierce the native leaflet to further secure the native leaflet.

[0166] During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp native leaflets (e.g., native mitral leaflets, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the apposition element 110 (e.g., a spacer, a plug, a membrane, etc.). The fastener 130 can be used to grasp and / or further secure the native leaflets by engaging the leaflets with optional barbs or other friction enhancing elements 136 and clamping the leaflets between the movable arm 134 and the fixed arm 132. The optional barbs or other friction enhancing elements 136 of the fastener 130 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) increase friction with the leaflets, or can partially or completely pierce the leaflets. The actuation wires 116 can be actuated individually so that each fastener 130 can be opened and closed individually. Separate manipulation allows grasping of one leaflet at a time, or allows repositioning of an insufficiently grasped catch 130 on a leaflet without altering successful grasping of another leaflet. Catch 130 can be opened and closed relative to the position of inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing grasping of the leaflet in a variety of positions as desired for a particular situation.

[0167] Reference now Figure 8 , the device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of a delivery system 102. The device 100 is disposed at the end of a catheter of the delivery system 102 in a fully open position. In the extended state, the cover 114 is spaced apart from the apposition element 110 so that the paddles 120, 122 are fully extended. In some embodiments, the angle formed between the outer paddle 120 and the interior of the inner paddle 122 is approximately 180 degrees. The fastener 130 can remain in a closed state during deployment through the delivery system. The actuation wire 116 can extend and be attached to the movable arm 134.

[0168] Reference now Fig. 9 , the device 100 is shown in an extended state, similar to Figure 8 , but where the buckle 130 is in the fully open position, the range between the fixed arm 132 and the movable arm 134 of the buckle 130 is about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees.

[0169] Reference now Fig.10, the device 100 is shown in a shortened or fully closed state. In order to move the device 100 from the elongated state to the shortened state, the actuating element 112 is retracted to pull the cover 114 toward the mating element 110. The movement of the connecting portion 126 (e.g., a joint, a flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is restricted so that the compressive force acting on the outer paddle 120 from the cover 114 retracted toward the mating element 110 causes the paddle or clamping element to move radially outward. During the movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with the actuating element 112. The outer paddle 120 can optionally be biased toward the closed position. During the same movement, the inner paddle 122 moves through a considerable angle because they are oriented away from the mating element 110 in the open state and collapse along the sides of the mating element 110 in the closed state.

[0170] Reference now Figure 11-13 , the device 100 is shown in a partially open, ready-to-grasp state. In order to transition from the fully closed state to the partially open state, the actuating element (e.g., an actuating wire, shaft, tube, hypotube, thread, suture, braid, etc.) is extended to push the cover 114 away from the mating element 110, thereby pulling the outer paddle 120, and then pulling the inner paddle 122, so that the anchor or anchoring portion 106 is partially deployed. The actuating wire 116 is also retracted to open the fastener 130 so that the leaflet can be grasped. In some embodiments, a pair of inner and outer paddles 122, 120 are moved together by a single actuating element 112, rather than independently. And, the position of the fastener 130 depends on the position of the paddles 122, 120. For example, referring to Fig.10 , closing the paddles 122, 120 will also close the buckle. In some embodiments, the paddles 120, 122 may be independently controllable. Fig.15 In the example shown, the device 100 may have two actuating elements 111, 113 and two independent covers 115, 117 (or other attached portions), such that one independent actuating element (e.g., an actuating wire, shaft, tube, hypotube, thread, suture, braid, etc.) and cover (or other attached portion) is used to control one paddle and another independent actuating element and cover (or other attached portion) is used to control the other paddle.

[0171] Reference now Fig.12 , one of the actuation wires 116 is extended to allow one of the clasps 130 to close. Referring now to Fig.13 , the other actuation wire 116 extends to allow the other clasp 130 to close. Either or both of the actuation wires 116 can be repeatedly actuated to repeatedly open and close the clasp 130.

[0172] Reference now Fig.14, the device 100 is shown in a fully closed and deployed state. The delivery system 102 and the actuating element 112 are retracted, and the paddles 120, 122 and the fastener 130 are maintained in a fully closed position. Once deployed, the device 100 can be maintained in a fully closed position with a mechanical latch, or can be biased to remain closed by using a spring material such as steel, other metals, plastics, composite materials, etc., or a shape memory alloy such as nitinol. For example, the connecting portion 124, 126, 128, the joint portion 138 and / or the inner and outer paddles 122 and / or an additional biasing member (not shown) can be formed of a metal such as steel or a shape memory alloy such as nitinol (e.g., produced in wire, sheet, tubing or laser sintering powder), and is biased to keep the outer paddle 120 closed around the apposition element 110 and the fastener 130 clamped around the native valve leaflet. Similarly, the fixed arm 132 and the movable arm 134 of the buckle 130 are biased to clamp the leaflets. In certain embodiments, the attachment or connecting portions 124, 126, 128, the joint portion 138 and / or the inner and outer paddles 122 and / or additional biasing members (not shown) can be formed of any other suitable resilient material, such as a metal or polymer material, to maintain the device 100 in a closed state after implantation.

[0173] Fig.15 An example is shown where blades 120, 122 are independently controllable. Fig.15 The device 101 shown is Fig.11 The device shown is similar except that Fig.15 The device 100 includes an actuation element configured as two independent actuation elements 111, 113 coupled to two independent covers 115, 117. To transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, the actuation element 111 extends to push the cover 115 away from the mate element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, thereby partially deploying the first anchor 108. To transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, the actuation element 113 extends to push the cover 115 away from the spacer or mate element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, thereby partially deploying the second anchor 108. Fig.15 The independent blade control shown can be implemented on any device disclosed in this application. Fig.11 In the illustrated example, a pair of inner blades 122 and outer blades 120 are moved together by a single actuating element 112 rather than independently.

[0174] Reference now Figure 16-21 , Figure 8-14The device 100 is shown delivered and deployed within the native mitral valve MV of the heart H. Fig.16 , the delivery sheath / catheter is inserted through the septum into the left atrium LA, and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state, as shown. Fig.16 Next, the actuator 112 is retracted to move the implant / device to Fig.17 Shown in fully closed position.

[0175] exist Fig.18 As can be seen in FIG. 1 , the implant / device is moved to a position within the mitral valve MV, into the ventricle LV, and partially opened so that the leaflets 20, 22 can be grasped. For example, the steerable catheter can be advanced and steered or deflected to position the steerable catheter, such as Fig.18 An implant catheter connected to the implant / device may be advanced from within the steerable catheter to position the implant, such as Fig.18 shown.

[0176] Reference now Fig.19 , the implant catheter can be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 in the catches 130. The actuation wire 116 is extended to close one of the catches 130, thereby capturing the leaflet 20. Fig. 20 Another actuation wire 116 is shown, which then extends to close another catch 130, thereby capturing the remaining leaflets 22. Fig.21 As can be seen in FIG. 1 , the delivery system 102 (eg, steerable catheter, implant catheter, etc.), actuation element 112, and actuation wire 116 are then retracted, and the device or implant 100 is fully closed and deployed in the native mitral valve MV.

[0177] Any of the features disclosed in this application may be used in a variety of different valve repair devices. Figure 22-24 An example of a valve repair device that can be modified to include any of the features disclosed in this application is shown. Any combination or subcombination of the features disclosed in this application can be combined with Figure 8-24 Any combination or subcombination of the features of the valve repair devices shown may be combined, substituted and / or added.

[0178] Reference now Fig. 22 , showing an example of an implantable device or implant 200. The device 200 is Figure 8-14100 can be one of many different configurations that the device 100 schematically shown in FIG. 100 can include any other features of the implantable devices or implants discussed in this application, and the device 200 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The device / implant 200 can be a prosthetic spacer device, a valve repair device, or another type of implant attached to the leaflets of a native valve.

[0179] In some embodiments, the implantable device or implant 200 includes a commissure portion 204, a proximal or attachment portion 205, an anchoring portion 206, and a distal portion 207. In some embodiments, the commissure portion 204 of the device optionally includes a commissure element 210 (e.g., a spacer, a coaptation element, a gap filler, a membrane, a sheet, a plug, a wedge, a balloon, etc.) between the leaflets of the implanted autologous valve. In some embodiments, the anchoring portion 206 includes a plurality of anchors 208. The anchors can be constructed in various ways. In some embodiments, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a fastener 230. In some embodiments, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engaging with a capture mechanism of a delivery system. The delivery system of device 200 can be the same or similar to the delivery system 102 described above, and can include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, tubing, a channel, a passage, combinations of these, etc. The capture mechanism can be configured in a variety of ways, and in some embodiments, can include one or more of a clamp, a clip, a pin, a suture, a thread, a lasso, a lanyard, a snare, a buckle, a lock, a latch, etc.

[0180] In some embodiments, the apposition element 210 and the paddles 220, 222 are formed of a flexible material, which may be a metal fabric (e.g., a mesh) that is woven, braided, or formed in any other suitable manner, or a flexible material that is cut by laser or otherwise. The material may be cloth, a shape memory alloy wire such as Nitinol to provide shape holding capability, or any other flexible material suitable for implantation in a human body.

[0181] An actuation element (e.g., an actuation wire, shaft, tube, hypotube, thread, suture, braid, etc.) can extend from a delivery system (not shown) to engage the device or implant 200 and effect actuation of the device or implant. In some embodiments, the actuation element extends through the proximal collar 211 and the spacer or apposition element 210 to engage the cap 214 of the distal portion 207. The actuation element can be configured to removably engage the cap 214 using a threaded connection or the like, so that the actuation element can be disengaged and removed from the device 200 after implantation.

[0182] The mating element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddle 222. In some embodiments, the mating element 210 has a generally elongated and circular shape, but other shapes and configurations are possible. In some embodiments, the mating element 210 has an elliptical shape or cross-section when viewed from above, and a conical shape or cross-section when viewed from the front, and a circular shape or cross-section when viewed from the side. The combination of these three geometric shapes can produce the three-dimensional shape of the mating element 210 shown, which achieves the benefits described herein. When viewed from above, it can also be seen that the circular shape of the mating element 210 substantially follows or approximates the shape of the paddle frame 224.

[0183] The size and / or shape of the apposition element 210 can be selected to minimize the number of implants (preferably one) that a single patient will need while maintaining a low transvalvular gradient. In some embodiments, the front-to-back distance at the top of the apposition element is about 5 mm, and the inside-outside distance of the apposition element at its widest point is about 10 mm. In some embodiments, the overall geometry of the device 200 can be based on these two dimensions and the above-mentioned overall shape strategy. It should be easily apparent that using other front-to-back distances and inside-outside distances as the starting point of the device will cause the device to have different sizes. In addition, using other sizes and the above-mentioned shape strategy will also cause the device to have different sizes.

[0184] In some embodiments, outer paddle 220 is connectably attached to cover 214 of distal portion 207 via connecting portion 221 and is connectably attached to inner paddle 222 via connecting portion 223. Inner paddle 222 is connectably attached to the apposition element via connecting portion 225. In this manner, anchor 208 is configured to resemble a leg, as inner paddle 222 resembles an upper portion of a leg, outer paddle 220 resembles a lower portion of a leg, and connecting portion 223 resembles a knee portion of a leg.

[0185] In some embodiments, inner blade 222 is hard, relatively hard, rigid, has rigid portions and / or is reinforced by reinforcing members or fixed portions of fastener 230. Inner blade 222, outer blade 220, and mate elements may all be interconnected as described herein.

[0186] In some embodiments, paddle frame 224 is attached to cover 214 at distal portion 207 and extends to connecting portion 223 between inner paddle 222 and outer paddle 220. In some embodiments, paddle frame 224 is formed of a material that is more rigid and harder than the material forming paddles 222, 220, such that paddle frame 224 provides support for paddles 222, 220.

[0187] Paddle frame 224 can provide additional clamping force between inner paddle 222 and coaptation element 210 and help wrap the leaflet around the side of coaptation element 210. That is, paddle frame 224 can be configured to have a rounded three-dimensional shape with a connection portion 223 extending from cover 214 to anchor 208. The connection between paddle frame 224, outer and inner paddles 220, 222, cover 214, and coaptation element 210 can constrain each of these components to movement and position as described herein. In particular, connection portion 223 is constrained by its connection between outer and inner paddles 220, 222 and by its connection to paddle frame 224. Similarly, paddle frame 224 is constrained by its attachment to connection portion 223 (and therefore inner and outer paddles 222, 220) and cover 214.

[0188] The wide configuration of paddle frame 224 provides an increased surface area compared to the individual inner paddles 222. The increased surface area can distribute the clamping force of paddle 220 and paddle frame 224 on the native leaflet over a relatively larger surface of the native leaflet to further protect the native leaflet tissue.

[0189] Additional features of the device 200, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215). Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO 2018 / 195215). Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) is incorporated herein by reference in its entirety.

[0190] Reference now Fig.23 , showing an example of a device or implant 300. The device 300 is Figure 8-14100. The device 300 may include any other features for the devices or implants discussed in this application, and the device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0191] The device or implant 300 includes a proximal or attachment portion 305, an anchoring portion 306, and a distal portion 307. In some embodiments, the device / implant 300 includes a commissure portion 304, and the commissure portion 304 may optionally include a commissure element 310 (e.g., a spacer, a plug, a membrane, a sheet, etc.) between the leaflets 20, 22 of the implanted native valve. In some embodiments, the anchoring portion 306 includes a plurality of anchors 308. In some embodiments, each anchor 308 may include one or more paddles, e.g., an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchor may also include a fastener 330 and / or be coupled to a fastener. In some embodiments, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism of a delivery system.

[0192] The anchors 308 can be attached to other portions of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, welded, sutured, adhesive, linkage, latch, integrally formed, a combination of some or all of these, etc.) In some embodiments, the anchor 308 is attached to the apposition element 310 via a connecting portion 325 and to the cover 314 via a connecting portion 321.

[0193] Anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. Connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached to cover 314 or other attachment portion. In this manner, anchor 308 is configured to resemble a leg, as inner paddle 322 resembles an upper portion of a leg, outer paddle 320 resembles a lower portion of a leg, and connecting portion 323 resembles a knee portion of a leg.

[0194] In embodiments of the apposition element 310, the apposition element 310 and the anchor 308 can be coupled together in various ways. As shown in the illustrated example, the apposition element 310 and the anchor 308 can be coupled together by integrally forming the apposition element 310 and the anchor 308 as a single unitary component. This can be achieved, for example, by forming the apposition element 310 and the anchor 308 from a continuous strip 301 of a braided or woven material, such as a braided or woven nitinol wire. In the illustrated example, the apposition element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous fabric strip 301.

[0195] Similar to the anchor 208 of the device or implant 200 described above, the anchor 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement can be along a longitudinal axis extending between the distal end of the device (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.).

[0196] In some embodiments, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some embodiments, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the spacer or apposition element 310. For example, the anchor 308 can be moved from the straight configuration to a fully folded configuration (e.g., Fig.23 ).

[0197] In some embodiments, the clasp includes a movable arm coupled to an anchor. In some embodiments, clasp 330 includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and a joint portion 338. Fixed arm 332 is attached to inner paddle 322, wherein joint portion 338 is disposed proximate to mating element 310. Joint portion 338 is spring loaded so that fixed arm 332 and movable arm 334 are biased toward each other when clasp 330 is in a closed state.

[0198] The fixed arm 332 is attached to the inner paddle 322 with sutures through a hole or slot. The fixed arm 332 can be attached to the inner paddle 322 with any suitable means (e.g., screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc.). The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened to open the catch 330 and optionally expose the optional barb 336. The catch 330 is opened by applying tension to an actuation wire attached to the movable arm 334, thereby causing the movable arm 334 to articulate, pivot and / or flex on the joint portion 338.

[0199] In short, the device or implant 300 is similar in construction and operation to the device or implant 200 described above, but the apposition element 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed by a single material strip 301. In some embodiments, the material strip 301 is attached to the proximal collar 311, the cover 314, and the paddle frame 324 by weaving or inserting through an opening in the proximal collar 311, the cover 314, and the paddle frame 324 configured to receive the continuous material strip 301. The continuous strip 301 can be a single layer of material or can include two or more layers. In some embodiments, portions of the device 300 have a single layer of material strip 301, and other portions are formed by multiple overlapping or superimposed layers of the material strip 301.

[0200] For example, Fig.23 The juxtaposed element 310 and inner paddle 322 are shown formed from multiple overlapping layers of a strip of material 301. A single continuous strip of material 301 may begin and end at various locations of the device 300. The ends of the strip of material 301 may be at the same location or at different locations of the device 300. For example, at Fig.23 In the example shown, the material strip 301 begins and ends at the location of the inner blade 322.

[0201] As with the device or implant 200 described above, the dimensions of the apposition element 310 can be selected to minimize the number of implants (preferably one) that will be required for a single patient while maintaining a low transvalvular gradient. In particular, forming many of the components of the device 300 from the strip of material 301 allows the device 300 to be made smaller than the device 200. For example, in some embodiments, the anterior-posterior distance at the top of the apposition element 310 is less than 2 mm, and the medial-lateral distance of the device 300 at its widest point (i.e., the width of the paddle frame 324, which is wider than the apposition element 310) is about 5 mm.

[0202] Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) is incorporated herein by reference in its entirety.

[0203] Fig.24 An example of one valve repair system among many valve repair systems 40056 for repairing a patient's native valve to which the concepts of the present application may be applied is shown. Valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0204] The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656 and a pair of clamping members 40856 (e.g., a fastener, a fastener arm, a clamp, a clamp arm, a latch, etc.). In one example, the paddle 40656 can be formed integrally with the base assembly. For example, the paddle 40656 can be formed as an extension of the connecting rod of the base assembly. In the example shown, the base assembly 40456 of the valve repair device 40256 has an axis 40356, a coupler 40556 configured to move along the axis, and a lock 40756 configured to lock the coupler in a fixed position on the axis. The coupler 40556 is mechanically connected to the paddle 40656 so that the movement of the coupler 40556 along the axis 40356 causes the paddle to move between an open position and a closed position. In this manner, coupler 40556 serves as a tool for mechanically coupling paddle 40656 to shaft 40356 and, when moved along shaft 40356, moving paddle 40656 between its open and closed positions.

[0205] In some embodiments, clamping member 40856 is pivotally connected to base assembly 40456 (e.g., clamping member 40856 can be pivotally connected to shaft 40356 or any other suitable member of the base assembly) such that the clamping member can be moved to adjust the width of opening 41456 between paddle 40656 and clamping member 40856. Clamping member 40856 can include optional barbed portion 40956 to attach the clamping member to valve tissue when valve repair device 40256 is attached to valve tissue. When paddle 40656 is in a closed position, the paddle engages clamping member 40856 such that when valve tissue is attached to the barbed portion 40956 of the clamping member, the paddle secures valve repair device 40256 to valve tissue. In some embodiments, the clamping member 40856 is configured to engage the paddle 40656 so that the optional barbed portion 40956 engages the valve tissue component and the paddle 40656 to secure the valve repair device 40256 to the valve tissue component. For example, in some cases, it may be desirable to maintain the paddle 40656 in an open position and move the clamping member 40856 outward toward the paddle 40656 to engage the valve tissue and the paddle 40656.

[0206] although Fig.24 The example shown in shows a pair of paddles 40656 and a pair of clamping members 40856, but it will be appreciated that the valve repair device 40256 may include any suitable number of paddles and clamping members.

[0207] In some embodiments, the valve repair system 40056 includes a placement shaft 41356 that is removably attached to the shaft 40356 of the base assembly 40456 of the valve repair device 40256. After the valve repair device 40256 is secured to the valve tissue, the placement shaft 41356 is removed from the shaft 40356 to remove the valve repair device 40256 from the rest of the valve repair system 40056 such that the valve repair device 40256 can remain attached to the valve tissue and the delivery device 40156 can be removed from the patient.

[0208] The valve repair system 40056 can also include a paddle control mechanism 41056, a clamp control mechanism 41156, and a lock control mechanism 41256. The paddle control mechanism 41056 is mechanically attached to the coupler 40556 to move the coupler along the shaft, which moves the paddle 40656 between an open position and a closed position. The paddle control mechanism 41056 can take any suitable form and can include, for example, a shaft, wire, tube, hypotube, rod, suture, wire, etc. For example, the paddle control mechanism can include a hollow shaft, catheter, or sleeve that fits over the placement shaft 41356 and the shaft 40356 and is connected to the coupler 40556.

[0209] The clamp control mechanism 41156 is configured to move the clamp member 40856 so that the width of the opening 41456 between the clamp member and the paddle 40656 can be changed. The clamp control mechanism 41156 can take any suitable form, such as a thread, suture, wire, rod, catheter, tube, hypotube, etc.

[0210] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 locks the coupler 40556 in a fixed position relative to the shaft 40356 and can take a variety of different forms, and the type of lock control mechanism 41256 can be dictated by the type of lock used. In instances where the lock 40756 includes a pivotable plate, the lock control mechanism 41256 is configured to engage the pivotable plate to move the plate between an inclined position and a substantially non-inclined position. The lock control mechanism 41256 can be, for example, a rod, a suture, a wire, or any other member capable of moving the pivotable plate of the lock 40756 between an inclined position and a substantially non-inclined position.

[0211] The valve repair device 40256 is movable from an open position to a closed position. The base assembly 40456 includes a connecting rod that is moved by a coupler 40556. The coupler 40556 is movably attached to the shaft 40356. To move the valve repair device from the open position to the closed position, the coupler 40556 is moved along the shaft 40356, thereby moving the connecting rod.

[0212] The clamp control mechanism 41156 moves the clamp member 40856 to provide a wider or narrower gap at the opening 41456 between the clamp member and the paddle 40656. In the example shown, the clamp control mechanism 41156 includes a line, such as a suture, wire, etc., connected to the opening in the end of the clamp member 40856. When the line is pulled, the clamp member 40856 moves inward, which widens the opening 41456 between the clamp member and the paddle 40656.

[0213] To move the valve repair device 40256 from the open position to the closed position, the lock 40756 is moved to the unlocked state by the lock control mechanism 41256. Once the lock 40756 is in the unlocked state, the coupler 40556 can be moved along the shaft 40356 by the paddle control mechanism 41056.

[0214] After paddle 40656 is moved to the closed position, lock 40756 is moved to the locked state by lock control mechanism 41256 to maintain valve repair device 40256 in the closed position. After valve repair device 40256 is maintained in the locked state by lock 40756, valve repair device 40256 is removed from delivery device 40156 by disconnecting shaft 40356 from placement shaft 41356. In addition, valve repair device 40256 is disengaged from paddle control mechanism 41056, gripper control mechanism 41156, and lock control mechanism 41256.

[0215] Additional features of device 40256, modified versions of the device, delivery systems of the device, and methods of using the device and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) is incorporated herein by reference in its entirety.

[0216] The fasteners or leaflet clamping devices disclosed herein can take a variety of different forms. Examples of fasteners are disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO 2018195201). Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO 2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO 2018195201) is incorporated herein by reference in its entirety.

[0217] refer to Figures 25A-25B , an exemplary embodiment of a valve repair device 40256 has a coaptation element 3800. The valve repair device 40256 may have a Fig.24 The valve repair device shown in FIG. 4 is of the same construction, with the addition of an apposition element. The apposition element 3800 can take a variety of different forms. The apposition element 3800 can be compressible and / or expandable. For example, the apposition element can be compressed to fit inside one or more catheters of a delivery system, can be expanded when removed from one or more catheters, and / or can be compressed by paddles 40656 to adjust the size of the apposition element. Fig.25Aand 25B In the example shown, the size of the apposition element 3800 can be reduced by compressing the apposition element with the paddles 40656, and the size of the apposition element can be increased by moving the paddles 40656 away from each other. As shown, the apposition element 3800 can extend beyond the outer edge 4001 of the clamping member or clasp 40856 to provide additional surface area for closing the gap of the mitral valve.

[0218] The apposition element 3800 can be coupled to the valve repair device 40256 in a variety of different ways. For example, the apposition element 3800 can be fixed to the shaft 40356, can be slidably disposed about the shaft, can be connected to the coupler 40556, can be connected to the lock 40755, and / or can be connected to the central portion of the clasp or clamp member 40856. In some embodiments, the coupler 40656 405 can take the form of the apposition element 3800. That is, a single element can serve as the coupler 40556 that moves the paddle 40656 between the open position and the closed position, and the apposition element 3800 that closes the gap between the leaflets 20, 22 when the valve repair device 40256 is attached to the leaflets.

[0219] The coaptation element 3800 can be disposed around one or more of the shafts or other control elements of the valve repair system 40056. For example, the coaptation element 3800 can be disposed around the shaft 40356, the shaft 41356, the paddle control mechanism 41056, and / or the lock control mechanism 41256.

[0220] The valve repair device 40256 may include any other features for the valve repair devices discussed in the present application, and the valve repair device 40256 may be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). Additional features of the device 40256, modified versions of the device, delivery systems of the device, and methods of using the device and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904). Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904).

[0221] Figure 26-30 An example of one valve repair system among many valve repair systems for repairing a patient's native valve to which the concepts of the present application may be applied is shown. Fig.29 and 30, the valve repair system includes an implant catheter assembly 1611 and an implantable valve repair device 8200. Figure 26-28 , device 8200 includes a proximal or attachment portion 8205, a paddle frame 8224, and a distal portion 8207. The attachment portion 8205, the distal portion 8207, and the paddle frame 8224 can be configured in a variety of ways.

[0222] exist Fig.26 In the example shown in , the blade frame 8224 can be symmetrical along the longitudinal axis YY. However, in some embodiments, the blade frame 8224 is not symmetrical about the axis YY. Fig.26 , the blade frame 8224 includes an outer frame portion 8256 and an inner frame portion 8260.

[0223] In some embodiments, a connector 8266 (e.g., a formed metal part, a formed plastic part, a tether, a wire, a strut, a line, a rope, a suture, etc.) is attached to the outer frame portion 8256 at an outer end of the connector 8266 and to a coupler 8972 (see FIG. 89A ) at an inner end 8968 of the connector 8266. Fig.28 ). Between the connector 8266 and the attachment portion 8205, the outer frame portion 8256 forms a curved shape. For example, in the example shown, the shape of the outer frame portion 8256 resembles an apple shape, wherein the outer frame portion 8256 is wider toward the attachment portion 8205 and narrower toward the distal portion 8207. However, in some embodiments, the outer frame portion 8256 can be shaped in other ways.

[0224] The inner frame portion 8260 extends from the attachment portion 8205 toward the distal portion 8207. The inner frame portion 8260 then extends inwardly to form a retaining portion 8272 that is attached to the actuation cover 8214. The retaining portion 8272 and the actuation cover 8214 can be configured to be attached in any suitable manner.

[0225] In some embodiments, the inner frame portion 8260 is a rigid frame portion and the outer frame portion 8256 is a flexible frame portion. Fig.26 As shown, the proximal end of the outer frame portion 8256 is connected to the proximal end of the inner frame portion 8260.

[0226] The width adjustment element 8211 (e.g., a width adjustment wire, a width adjustment shaft, a width adjustment tube, a width adjustment line, a width adjustment rope, a width adjustment suture, a width adjustment screw or bolt, etc.) is configured to be configured such that the inner end 8968 ( Fig.28 ) and a portion of the connector 8266 are pulled into the actuation cap 8214 to move the outer frame portion 8256 from the expanded position to the narrowed position. According to some embodiments disclosed herein, the actuation element 8102 is configured to move the inner frame portion 8260 to open and close the paddle.

[0227] like Fig. 27 and 28 As shown, the connector 8266 has an inner end 8968 engaged with the width adjustment element 8211, so that the user can move the inner end 8968 inside the receiver 8912 (e.g., an internal threaded element, a column, a pipe, a hollow member, a receiving portion with a notch, a tube, a shaft, a sleeve, a pillar, a housing, a cylinder, a track, etc.) to move the outer frame portion 8256 between a narrowed position and an expanded position. In the example shown, the inner end 8968 includes a pillar 8970 attached to the outer frame portion 8256 and a coupler 8972 extending from the pillar 8970. The coupler 8972 is configured to attach both the width adjustment element 8211 and the receiver 8912 and detach from both. The coupler 8972 can take a variety of different forms. For example, the coupler 8972 can include one or more of a threaded connection, a feature that cooperates with a thread, a pawl connection, such as an arm, a wall or other part that is biased outward. When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver 8912. When the coupler 8972 is detached from the width adjustment element 8211, the coupler is fixed to the receiver. However, the inner end 8968 of the connector can be configured in a variety of ways. Any configuration that can appropriately attach the outer frame portion 8256 to the coupler to allow the width adjustment element 8211 to move the outer frame portion 8256 between the narrowed position and the expanded position can be used. The coupler can also be configured in a variety of ways and can be a separate component or integrated with another part of the device (e.g., the connector or the inner end of the connector).

[0228] The width adjustment element 8211 allows a user to expand or contract the outer frame portion 8256 of the device 8200. Fig. 27 and 28 In the example shown, the width adjustment element 8211 includes an externally threaded end that screws into the coupler 8972. The width adjustment element 8211 moves the coupler in the receiver 8912 to adjust the width of the outer frame portion 8256. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages the inner surface of the receiver 8912 to set the width of the outer frame portion 8256.

[0229] In some embodiments, the receiver 8912 can be integrally formed with the distal cover 8214. Moving the cover 8214 relative to the body of the attachment portion 8205 opens and closes the paddle. In the example shown, the receiver 8912 slides inside the body of the attachment portion. When the coupler 8972 is detached from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed, and the actuating element 8102 moves the receiver 8912 and the cover 8214 relative to the body of the attachment portion 8205. Movement of the cover can open and close the device in the same manner as other embodiments disclosed above.

[0230] In the example shown, the driver head 8916 is disposed at the proximal end of the actuating element 8102. The driver head 8916 releasably couples the actuating element 8102 to the receiver 8912. In the example shown, the width adjustment element 8211 extends through the actuating element 8102. The actuating element is axially advanced in a direction opposite to the direction Y to move the distal cover 8214. Fig. 27 As indicated by the arrow in , the movement of the distal cover 8214 relative to the attachment portion 8205 effectively opens and closes the paddle. That is, the movement of the distal cover 8214 in the direction Y closes the device, and the movement of the distal cover in the direction opposite to the direction Y opens the device.

[0231] Still Fig. 27 and 28 8968 to engage the coupler 8972 attached to the inner end 8968. Movement of the outer frame portion 8256 to the narrowed position can allow the device or implant 8200 to be more easily manipulated into position for implantation in the heart by reducing contact and / or friction between the heart's native structures (e.g., chordae tendineae) and the device 8200. Movement of the outer frame portion 8256 to the expanded position provides a larger surface area for the anchoring portion of the device or implant 8200 to engage and capture the leaflets of the native heart valve.

[0232] refer to Fig.29 and 30, an embodiment of an implant catheter assembly 1611 wherein a fastener actuation wire 624 extends through a handle 1616, an actuation element 8102 is coupled to a paddle actuation control 1626, and a width adjustment element 8211 is coupled to a paddle width control 1628. A proximal end portion 1622a of a shaft or catheter of the implant catheter assembly 1611 may be coupled to the handle 1616, and a distal end portion 1622b of the shaft or catheter may be coupled to the device 8200. The actuation element 8102 may extend distally from the paddle actuation control 1626, through the handle 1616, through a delivery shaft or catheter of the implant catheter assembly 1611, and through a proximal end of the device 8200 where it is coupled to a driver head 8916. The actuation element 8102 may be axially movable relative to the outer shaft and handle 1616 of the implant catheter assembly 1611 to open and close the device.

[0233] The width adjustment element 8211 can extend distally from the blade width control 1628, through the blade actuation control 1626 and through the actuation element 8102 (and therefore through the handle 1616, the outer shaft of the implant catheter assembly 1611 and through the device 8200), where it is connected to the movable connector 8972. The width adjustment element 8211 can be axially movable relative to the actuation element 8102, the outer shaft of the implant catheter assembly 1611 and the handle 1616. The fastener actuation line 624 can extend through the handle 1616 and the outer shaft of the implant catheter assembly 1611 and be axially movable relative to the handle and the outer shaft. The fastener actuation line 624 can also be axially movable relative to the actuation element 8102.

[0234] refer to Fig.29 and 30 , width adjustment element 8211 may be releasably coupled to coupler 8972 of device 8200. Advancing and retracting width adjustment element 8211 with paddle width control 1628 widens or narrows the paddle. Advancing and retracting actuation element 8102 with paddle actuation control 1626 opens and closes the paddle of the device.

[0235] exist Fig.29 and 30 In the example of , the catheter or shaft of the implant catheter assembly 1611 is an elongated shaft extending axially between a proximal end portion 1622a coupled to the handle 1616 and a distal end portion 1622b coupled to the device 8200. The outer shaft of the implant catheter assembly 1611 may also include an intermediate portion 1622c disposed between the proximal end portion 1622a and the distal end portion 1622b.

[0236] Now turn to reference Figure 31-59B, various devices and methods for recovering an implantable device from a native heart valve are shown. Sometimes, it may be necessary to remove the native valve leaflets (e.g., mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) and remove the implantable device from the patient's body. Existing solutions for removing implantable devices generally require surgical intervention. Therefore, it is advantageous to utilize a minimally invasive transcatheter-based method to recover the implantable device. The devices and methods described below, such as Figure 31-59B , can be used to recover any implantable device described herein from a patient's body or any other type of implantable valve repair device. Although the anterior leaflet 20 and posterior leaflet 22 of the mitral valve are shown and described in the exemplary embodiments below, Figure 31-59B The use of the devices and methods is not limited to the mitral valve leaflets 20, 22, and can be used for any native heart valve described herein. In each of the embodiments described below, the various devices can be deployed using a transfemoral, transapical, or transaortic approach, such as from the atrial or ventricular side of the patient's heart. In addition, these methods can be performed on a living animal or on a simulator, such as a cadaver, a cadaver heart, an anthropomorphic false target, a simulator (e.g., a simulated body part, heart, tissue, etc.), etc.

[0237] Figure 31-39 A method for using at least one cutting device 3140 (see Fig.32 ) Exemplary devices and methods for retrieving an implantable device 3100, wherein the cutting device 3140 comprises a snare or lasso 3141. Fig.31 A front view of an implantable device 3100 is shown attached to native leaflets (e.g., the anterior leaflet 20 and the posterior leaflet 22 of the mitral valve, as shown). In some embodiments, the implantable device 3100 has a collar 3111 at the proximal end of the implantable device 3100 and a cap 3114 at the distal end. Fig.32 A front view of an exemplary retrieval catheter 3160, cutting device 3140, and optional stabilization member 3150 is shown.

[0238] An exemplary retrieval catheter 3160 provides a conduit through which the cutting device 3140 and the stabilizing member 3150 are delivered to the implantable device 3100. In some embodiments, the implantable device 3100 is removed from the native heart valve via the retrieval catheter 3160. In some embodiments, the distal end of the retrieval catheter 3160 can also be used to provide a downward force on the anterior and posterior leaflets 20, 22 and / or the proximal side of the implantable device 3100 to keep the anterior and posterior leaflets 20, 22 taut and / or the implantable device 3100 stable during the resection process. In some embodiments, the stabilizing member 3150 and the cutting device 3140 are each deployed via separate catheters, or the stabilizing member 3150 and the cutting device 3140 can be deployed via a single catheter, such as Fig.32 The inner diameter of the retrieval catheter 3160 can have an increased inner diameter so that the implantable device 3100 and portions of the dissected anterior and posterior leaflets 20, 22 can be retracted therethrough.

[0239] In some embodiments, the cutting device 3140 includes a snare or lasso 3141. The cutting device 3140 may have a first end 3142 and a second end 3144, wherein at least one end, and in some embodiments both ends 3142, 3144, extend upwardly past the distal end of the retrieval catheter 3160 and are secured to a retrieval component or device at the proximal end of the retrieval catheter 3160, such that a user can extend or retract the cutting device 3140 within the retrieval catheter 3160. In some embodiments, the snare or lasso 3141 is equipped with features for cutting, severing, or ablating the anterior and posterior leaflets 20, 22, such as by using friction, electrocautery, vibration, serrations, sharp edges, etc. In some embodiments, the cutting device 3140 includes an electrocautery snare or lasso 3141, wherein the snare or lasso 3141 is formed of an electrode, which may be composed of a metal element that allows an electric current to flow. In some embodiments, the cutting device 3140 is made of nitinol to achieve shape memory properties. In some embodiments, the snare or lasso 3141 can be comprised of a surface that enables radiofrequency energy to ablate tissue surrounding the implantable device 3100 .

[0240] The snare or lasso 3141 can be used as a cutting device 3140 and also as a stabilizing member. In some embodiments, a separate stabilizing member 3150 can be used. In some embodiments, the stabilizing member 3150 can be deployed by a retrieval catheter 3160 or a separate catheter (not shown). In some embodiments, the stabilizing member 3150 includes an element for grasping and stabilizing the implantable device 3100, such as a stabilizing snare 3152. The stabilizing snare 3152 can be secured around a portion of the implantable device 3100, such as around the collar 3111 or the cover 3114. In some embodiments, the portion of the implantable device 3100 to which the stabilizing snare 3152 is attached, such as the cover 3114 or the collar 3111, can be configured (e.g., using a radiopaque material) to be visible under imaging (e.g., fluoroscopy, X-ray, etc.) so that the user can more easily secure the stabilizing member 3150 to the implantable device 3100. In some embodiments, the stabilizing member 3150 may include a clamp, a gripper, a vacuum suction device, or any other connection or docking tool. In some embodiments, the stabilizing member 3150 stabilizes the implantable device 3100 and also allows the implantable device 3100 to be drawn upwardly into the retrieval catheter 3160, partially into the retrieval catheter, or drawn adjacent to the retrieval catheter.

[0241] like Figure 32-33 , in some embodiments, the cutting device 3140 is deployed through a retrieval catheter 3160 and extends through the native heart valve between the anterior leaflet 20 and the posterior leaflet 22 and along the side of the implantable device until the snare or lasso 3141 is disposed below the distal end of the implantable device 3100. Optionally, the stabilizing member 3150 can be secured around a portion of the implantable device 3100, such as by placing a stabilizing snare 3152 around the collar 3111 before or after the cutting device 3140 is deployed. Alternatively or in addition, the cutting device 3140 can first be used to stabilize the implantable device 3100, such as by securing the snare or lasso 3141 around a portion of the implantable device 3100 (e.g., the cap 3114).

[0242] like Fig.34 and 35 3160, and / or the distal end of the retrieval catheter 3160 can be advanced toward at least one of the cutting device 3140 and the stabilizing member 3150. As described above, the distal end of the retrieval catheter 3160 can be used to further stabilize the anterior and posterior leaflets 20, 22 and / or the implantable device 3100 during resection. In some embodiments, prior to resection, the implantable device 3100 is first retracted and / or the distal end of the retrieval catheter 3160 is advanced such that the anterior and posterior leaflets 20, 22 are proximal to the distal end of the retrieval catheter 3160. In some embodiments, the snare or lasso 3141 is retracted upward such that it surrounds the implantable device 3100. As the snare or lasso 3141 continues to be retracted around the implantable device 3100, the snare or lasso 3141 will come into contact with tissue of the anterior and posterior leaflets 20, 22 on either side and / or around the implantable device 3100. Using any of the cutting or resection methods described above, such as electrocautery, the snare or lasso 3141 will sever the anterior and posterior leaflets 20, 22 proximal to the implantable device 3100 such that the portions of the anterior and posterior leaflets 20, 22 grasped by the implantable device 3100 will remain attached thereto. The implantable device 3100 can then be retracted upwardly toward the distal end of the retrieval catheter 3160 by at least one of the cutting device 3140 or the stabilizing member 3150.

[0243] like Fig.36 and 37As shown in , in some embodiments, two cutting devices 3140A, 3140B are deployed through a retrieval catheter 3160 and extend through the native heart valve between the anterior leaflet 20 and the posterior leaflet 22, extending below the distal end of the implantable device 3100. In some embodiments, the cutting devices 3140A, 3140B each include a snare or lasso 3141A, 3141B. The cutting devices 3140A, 3140B can each have a first end 3142A, 3142B and a second end 3144A, 3144B, wherein at least one end, and in some embodiments all ends 3142A, 3142B, 3144A, 3144B extend proximally through the distal end of the retrieval catheter 3160 and are secured to a retrieval component or device at the proximal end of the retrieval catheter 3160 so that a user can extend or retract the cutting devices 3140A, 3140B within the retrieval catheter 3160.

[0244] In some embodiments, the cutting devices 3140A, 3140B are deployed on opposite sides of the implantable device 3100. Optionally, the stabilizing component 3150 can be secured around a portion of the implantable device 3100, such as by placing a stabilizing snare 3152 around the loop 3111 before or after the cutting device 3140 is deployed. Alternatively or in addition, at least one of the cutting devices 3140A, 3140B can first be used to stabilize the implantable device 3100, such as by securing at least one of the snares or lassos 3141A, 3141B of each cutting device 3140 around a portion of the implantable device 3100 (e.g., the cap 3114).

[0245] like Fig.38 and 39 , in some embodiments, at least one of the cutting devices 3140A, 3140B and the stabilizing member 3150 can be used to retract the implantable device 3100 proximally toward the distal end of the retrieval catheter 3160, and / or the distal end of the retrieval catheter 3160 can be advanced toward at least one of the cutting device 3140 and the stabilizing member 3150. As described above, the distal end of the retrieval catheter 3160 can be used to further stabilize the anterior and posterior leaflets 20, 22 and / or the implantable device 3100 during resection. In some embodiments, prior to resection, the implantable device 3100 is first retracted and / or the retrieval catheter 3160 is advanced such that the anterior and posterior leaflets 20, 22 are proximal to the distal end of the retrieval catheter 3160.

[0246] In some embodiments, at least one of the snares or lassos 3141A, 3141B is retracted upward so that they surround the implantable device 3100. As the snares or lassos 3141A, 3141B continue to be retracted around the implantable device 3100, the snares or lassos 3141A, 3141B will come into contact with tissue of the anterior and posterior leaflets 20, 22 on either side of the implantable device 3100. In some embodiments, a first snare or lasso 3141A resects the anterior leaflet 20, and a second snare or lasso 3141B resects the posterior leaflet 22. Using any of the cutting or resection methods described above, such as electrocautery, the snares or lassos 3141A, 3141B will sever the anterior and posterior leaflets 20, 22 proximal to the implantable device 3100, such that the portions of the anterior and posterior leaflets 20, 22 grasped by the implantable device 3100 will remain attached thereto. The implantable device 3100 can then be retracted proximally toward the distal end of the retrieval catheter 3160 by at least one of the cutting devices 3140A, 3140B or the stabilization component 3150.

[0247] Figure 40-43 Exemplary devices and methods for retrieving an implantable device 3100 using at least one cutting device 3140 are shown, wherein the cutting device 3140 includes at least one of coring elements 3170A, 3170B. Fig.40 A side view of an exemplary retrieval catheter 3160, a cutting device 3140 including at least one coring element 3170A, 3170B, and a stabilizing member 3150 is shown. Fig.40 As shown in , in some embodiments, the implantable device 3100 can include a cap 3114 at the distal end of the implantable device 3100 and a collar 3111 at the proximal end. An exemplary retrieval catheter 3160 provides a conduit through which the cutting device 3140 and the stabilizing member 3150 are delivered to the implantable device 3100. In some embodiments, the implantable device 3100 is removed from the native heart valve via the retrieval catheter 3160.

[0248] In some embodiments, the distal end of the retrieval catheter 3160 can also be used to provide a downward force on the proximal side of the anterior and posterior leaflets 20, 22 and / or the implantable device 3100 to keep the leaflets 20, 22 taut and / or the implantable device 3100 stable during the resection process. The inner diameter of the retrieval catheter 3160 can have an increased inner diameter so that the implantable device 3100 and the dissected portions of the anterior and posterior leaflets 20, 22 can be retracted therefrom.

[0249] In some embodiments, at least one coring element 3170A, 3170B is deployed along the outer surface of the retrieval catheter 3160. In some embodiments, at least one coring element 3170A, 3170B is deployed from the inner surface of the retrieval catheter 3160. In some embodiments, the cutting device includes two coring elements 3170A, 3170B deployed on opposite sides of the retrieval catheter 3160. In some embodiments, the cutting device 3140 includes a single coring element around the entire retrieval catheter 3160 (in this embodiment, the reference numerals 3170A, 3170B represent two parts of a single coring element). For example, the coring elements 3170A, 3170B can be annular or semi-annular, or can include annular or semi-annular cutting portions. In some embodiments, the coring elements 3170A, 3170B are equipped with features for cutting, severing or ablating the front leaflet 20 and the rear leaflet 22, such as by using friction, electrocautery, vibration, saw teeth, etc. In some embodiments, at least one coring element 3170A, 3170B can be circular, arc-shaped or annular. In some embodiments, at least one coring element 3170A, 3170B can enter the tissue of the front leaflet 20 and the back leaflet 22, thereby cutting off the tissue when the tissue rotates. In some embodiments, at least one coring element 3170A, 3170B can be equipped with a blade or sawtooth to cut the tissue of the front leaflet 20 and the back leaflet 22. In some embodiments, the coring elements 3170A, 3170B include an electrosurgical tip or blade formed by an electrode, which can be composed of a metal element that allows current to flow. In some embodiments, the coring elements 3170A, 3170B are made of nitinol to achieve shape memory properties. In some embodiments, the coring elements 3170A, 3170B can be composed of a surface that enables radiofrequency energy to ablate the tissue surrounding the implantable device 3100.

[0250] In some embodiments, the stabilization member 3150 can be deployed by the retrieval catheter 3160 or a separate catheter (not shown). In some embodiments, the stabilization member 3150 includes an element for grasping and stabilizing the implantable device 3100, such as a stabilization snare 3152. The stabilization snare 3152 can be fixed around a portion of the implantable device 3100, such as around the collar 3111 or the cover 3114. In some embodiments, the portion of the implantable device 3100 to which the stabilization snare 3152 is attached, such as the cover 3114 or the collar 3111, can be configured to enhance imaging so that the user can more easily secure the stabilization member 3150 to the implantable device 3100. In some embodiments, the stabilization member 3150 can include a clamp, a gripper, a vacuum suction device, or any other docking tool. In some embodiments, the stabilization member 3150 stabilizes the implantable device 3100 and also allows the implantable device 3100 to be sucked upward into the retrieval catheter 3160.

[0251] like Fig.40 As shown in FIG. 3 , in some embodiments, a stabilizing member 3150 is secured around a portion of the implantable device 3100, such as by placing a stabilizing snare 3152 around the loop 3111. Fig.41 As shown in , the stabilizing member 3150 can be used to retract the implantable device 3100 proximally toward the distal end of the retrieval catheter 3160, and the coring elements 3170A, 3170B and / or the retrieval catheter 3160 and / or the coring elements 3170A, 3170B can be advanced toward the implantable device 3100. As described above, the distal end of the retrieval catheter 3160 can be used to further stabilize the anterior and posterior leaflets 20, 22 and / or the implantable device 3100 during resection. In some embodiments, prior to resection, the implantable device 3100 is first retracted so that the anterior and posterior leaflets 20, 22 are proximal to the distal end of the retrieval catheter 3160. As shown in FIG. Fig.42 As shown in , as the stabilizing member 3150 continues to retract the implantable device 3100 upward into the distal end of the retrieval catheter 3160 and / or the retrieval catheter 3160 and the coring elements 3170A, 3170B are further advanced, the coring elements 3170A, 3170B will use any of the above-described cutting or excision methods (e.g., using a sharp blade) to cut off the anterior and posterior leaflets 20, 22 near the implantable device. The portion of the anterior and posterior leaflets 20, 22 grasped by the implantable device 3100 will remain attached thereto. Fig.43As shown in , in some embodiments, the coring elements 3170A, 3170B can be deployed further distally so that they can completely sever the anterior leaflet 20 and the posterior leaflet 22. In some embodiments, the coring elements 3170A, 3170B can be moved in several directions, such as longitudinally, laterally, transversely, or radially, such as in a radial path around the entire implantable device 3100 to completely sever the implantable device 3100 from the anterior leaflet 20 and the posterior leaflet 22. The implantable device 3100 can then be retracted upwardly toward the distal end of the retrieval catheter 3160 via the stabilizing member 3150.

[0252] Figures 44-47 An exemplary apparatus and method for retrieving an implantable device 3100 using at least one cutting device 3140 is shown, wherein the cutting device 3140 includes a movable cutting tip 3143, such as a blade or an electrosurgical tip. For purposes of illustration, the retrieval catheter is shown offset from the central axis of the implantable device 3100. In some embodiments, the retrieval catheter 3160 can be aligned directly above the proximal end of the implantable device 3100. Fig.44 As shown in , in some embodiments, the implantable device 3100 can include a collar 3111 at the proximal end of the implantable device 3100 .

[0253] Fig.44 A top view of an exemplary retrieval catheter 3160, a cutting device 3140 including a cutting tip 3143, a stabilizing member 3150, and an optional indicator or meter 3180 is shown. The indicator or meter 3180 can be configured to be in the same path as the movable cutting tip, but guide the movable cutting tip 3143 to engage the tissue to be cut before the cutting tip 3143. The engagement of the tissue with the indicator or meter 3180 can provide an indication to the user that the tissue is about to be cut. In some embodiments, the indicator or meter 3180 can be configured to distinguish between different types of tissue. For example, the indicator or meter 3180 can be configured to distinguish valve leaflet tissue from other types of tissue, such as chordae tendineae.

[0254] In some embodiments, the retrieval catheter 3160 provides a conduit through which the cutting device 3140, the stabilizing member 3150, and the indicator or meter 3180 are delivered to the implantable device 3100. In some other embodiments, each of the cutting device 3140, the stabilizing member 3150, and / or the indicator or meter 3180 can be deployed via a separate catheter. In some embodiments, the implantable device 3100 is removed from the native heart valve via the retrieval catheter 3160. In some embodiments, the distal end of the retrieval catheter 3160 can also be used to provide a downward force on the front leaflet 20 and the rear leaflet 22 and / or the proximal side of the implantable device 3100 to keep the front leaflet 20 and the rear leaflet 22 taut and / or the implantable device 3100 stable during the resection process. The inner diameter of the retrieval catheter 3160 can have an increased inner diameter so that the implantable device 3100 and the dissected portions of the front leaflet 20 and the rear leaflet 22 can be retracted therefrom.

[0255] like Fig.45 As shown in , in some embodiments, the cutting device 3140 includes a single cutting tip 3143 formed by an electrode, which can be composed of a metal element that allows current to flow. In some embodiments, the cutting device 3140 is made of nitinol to achieve shape memory properties. In some embodiments, the stabilizing member 3150 and the indicator or meter 3180 can be deployed by the retrieval catheter 3160 or a separate catheter (not shown). In some embodiments, the stabilizing member 3150 includes an element for grasping and stabilizing the implantable device 3100, such as a stabilizing snare 3152. The stabilizing snare 3152 can be fixed around a portion of the implantable device 3100, such as around the collar 3111. In some embodiments, the portion of the implantable device 3100 to which the stabilizing snare 3152 is attached, such as the collar 3111, can be configured to enhance imaging so that the user can more easily fix the stabilizing member 3150 to the implantable device 3100. In some embodiments, the stabilizing member 3150 may include a clamp, a gripper, a vacuum suction device, or any other docking tool. In some embodiments, the stabilizing member 3150 stabilizes the implantable device 3100 and also allows the implantable device 3100 to be suctioned upward into the retrieval catheter 3160.

[0256] The indicator or meter 3180 can be used before or simultaneously with the cutting device 3140 to indicate the position of the anterior leaflet 20 and the posterior leaflet 22, and in particular the position of any portions of the anterior leaflet 20 and the posterior leaflet 22 that remain uncut. For example, the indicator or meter 3180 can include a radiopaque feature. In some embodiments, the indicator or meter 3180 can be a radiopaque feature and / or a depth gauge. In some embodiments, the indicator or meter can be made of a long flexible wire or rod. In some embodiments, the indicator or meter 3180 will come into contact with tissue within the ventricle, including the anterior leaflet 20 and the posterior leaflet 22. This indicator or meter 3180 can be used Figure 31-59B In any of the examples of devices and methods for retrieving an implantable device shown and described in . The indicator or meter 3180 can be deployed from the same or a different catheter as the cutting device 3140 and / or the stabilizing component 3150 .

[0257] In some embodiments, the cutting tip 3143 of the cutting device 3140 is deployed parallel to the implantable device 3100 between the anterior leaflet 20 and the posterior leaflet 22. The cutting tip 3143 will then rotate around the implantable device 3100, thereby cutting off the anterior leaflet 20 and the posterior leaflet 22 near the implantable device. The indicator or meter 3180 can move with the cutting tip 3143 to guide the cutting process. A portion of the anterior leaflet 20 and the posterior leaflet 22 grasped by the implantable device 3100 will remain attached to it. In some embodiments, the cutting tip 3143 can move in several directions, such as longitudinally, laterally, transversely, or radially, such as in an arcuate 360-degree path around the entire implantable device 3100 to completely cut off the implantable device 3100 from the anterior leaflet 20 and the posterior leaflet 22. The implantable device 3100 can then be retracted upward toward the distal end of the retrieval catheter 3160 through the stabilizing member 3150. In some embodiments, the cutting tip 3143 can move in an arcuate 180 degree or similar path around enough of the implantable device 3100 to cut the implantable device 3100 from one leaflet while leaving the device attached to the other leaflet. Any of the embodiments disclosed herein can be configured to cut the implantable device 3100 from one leaflet while leaving the device attached to the other leaflet.

[0258] Two cutting devices 3140A, 3140B, each having a cutting tip 3143A, 3143B, may also be used. Fig.47A top view of an exemplary retrieval catheter 3160 and two cutting devices 3140A, 3140B, each including a cutting tip 3143A, 3143B, and a stabilizing member 3150 is shown. In some embodiments, the cutting tips 3143A, 3143B are attached so that the cutting devices 3140A, 3140B form a loop or snare. An optional indicator or meter (not shown) as described above may also be used. For illustrative purposes, the retrieval catheter is shown as being offset from the central axis of the implantable device 3100. In some embodiments, the retrieval catheter 3160 can be aligned directly above the proximal end of the implantable device 3100. As shown in FIG. Figures 46-47 As shown in , in some embodiments, the implantable device 3100 can include a collar 3111 at the proximal end of the implantable device 3100 .

[0259] In some embodiments, an exemplary retrieval catheter 3160 provides a conduit through which the cutting devices 3140A, 3140B, the stabilizing member 3150, and optional indicators or meters are delivered to the implantable device 3100. In some other embodiments, each of the cutting devices 3140A, 3140B and the stabilizing member 3150 can be deployed via a separate catheter, such as a second catheter 3162. In some embodiments, the implantable device 3100 is removed from the native heart valve via the retrieval catheter 3160. In some embodiments, the distal end of the retrieval catheter 3160 can also be used to provide a downward force on the leaflets 20, 22 and / or the proximal side of the implantable device 3100 to keep the anterior leaflet 20 and the posterior leaflet 22 taut and / or the implantable device 3100 stable during the resection process. The inner diameter of the retrieval catheter 3160 can have an increased inner diameter so that the implantable device 3100 and the dissected portions of the anterior leaflet 20 and the posterior leaflet 22 can be retracted therefrom.

[0260] like Fig.46As shown in , in some embodiments, the cutting devices 3140A, 3140B each include a single cutting tip 3143A, 3143B formed by an electrode, which can be composed of a metal element that allows current to flow. In some embodiments, the cutting devices 3140A, 3140B are made of nitinol to achieve shape memory properties. In some embodiments, the stabilizing member 3150 can be deployed by a retrieval catheter 3160 or a separate catheter 3162. In some embodiments, the stabilizing member 3150 includes an element for grasping and stabilizing the implantable device 3100, such as a stabilizing snare 3152. The stabilizing snare 3152 can be fixed around a portion of the implantable device 3100, such as around the collar 3111. In some embodiments, the portion of the implantable device 3100 to which the stabilizing snare 3152 is attached, such as the collar 3111, can be configured to enhance imaging so that the user can more easily fix the stabilizing member 3150 to the implantable device 3100. In some embodiments, the stabilizing member 3150 may include a clamp, a gripper, a vacuum suction device, or any other docking tool. In some embodiments, the stabilizing member 3150 stabilizes the implantable device 3100 and also allows the implantable device 3100 to be suctioned upward into the retrieval catheter 3160.

[0261] In some embodiments, the first cutting tip 3143A of the first cutting device 3140A is deployed from the retrieval catheter 3160 into the space between the anterior leaflet 20 and the posterior leaflet 22, below the center of the anterior leaflet 20 and / or above the fastener of the valve repair device attached to the anterior leaflet. Then (or simultaneously), the second cutting tip 3143B of the second cutting device 3140B is deployed from the second catheter 3162 into the second space between the anterior leaflet 20 and the posterior leaflet 22, below the center of the anterior leaflet 20 and / or above the fastener of the valve repair device attached to the anterior leaflet. Then, in some embodiments, the cutting tips 3143A, 3143B will cut away from each other toward the outer edge of the anterior leaflet 20, each severing the anterior leaflet 20 near the implantable device. In some embodiments, the cutting tips 3143A, 3143B are attached to each other before or after deployment to form a snare or ring, wherein the cutting devices 3140A, 3140B surround the anterior leaflet 20 using the snare formed by the cutting tips 3143A, 3143B.

[0262] In some embodiments, the implantable device 3100 can remain attached to the second leaflet, such as the posterior leaflet 22, or the above process can be optionally repeated on the second leaflet, such as the posterior leaflet 22, to completely sever the implantable device 3100 from the anterior leaflet 20 and the posterior leaflet 22. To sever the posterior leaflet 22, each of the cutting tips 3143A, 3143B can be retracted upward into the ventricle and then deployed at the posterior leaflet 22. In some embodiments, the cutting devices 3140A, 3140B can remain attached via the cutting tips 3143A, 3143B and thus wrap around and under the posterior leaflet 22, where the posterior leaflet 22 will be severed by moving the cutting tips 3143A, 3143B upward toward the distal end of the retrieval catheter 3160. The portion of the anterior leaflet 20 and the posterior leaflet 22 grasped by the implantable device 3100 will remain attached thereto. In some embodiments, the cutting tips 3143A, 3143B can be moved in several directions, such as longitudinally, laterally, transversely, and / or radially, to sever the implantable device 3100 from one or both leaflets. If severing from both leaflets, the implantable device 3100 can be retracted upwardly toward the distal end of the retrieval catheter 3160 by the stabilizing member 3150.

[0263] Fig.49 A top view of an exemplary retrieval catheter 3160, a cutting device 3140 including an electrosurgical ring 3145, a stabilizing member 3150, and an optional indicator or meter (not shown) is shown. For purposes of illustration, the retrieval catheter is shown offset from the central axis of the implantable device 3100. In some embodiments, the retrieval catheter 3160 can be aligned directly above the proximal end of the implantable device 3100. Figure 48-49 As shown in , in some embodiments, the implantable device 3100 can include a collar 3111 at the proximal end of the implantable device 3100. In some embodiments, an exemplary retrieval catheter 3160 provides a conduit through which the cutting device 3140, the stabilizing member 3150, and the indicator or instrument are delivered to the implantable device 3100. In some other embodiments, each of the cutting device 3140, the stabilizing member 3150, and the indicator or instrument can be deployed via a separate catheter, such as a second catheter 3162. In some embodiments, the implantable device 3100 is removed from the native heart valve via the retrieval catheter 3160. In some embodiments, the distal end of the retrieval catheter 3160 can also be used to provide a downward force on the proximal side of the leaflets 20, 22 and / or the implantable device 3100 to keep the leaflets 20, 22 taut and / or the implantable device 3100 stable during the resection process. The inner diameter of the retrieval catheter 3160 may have an increased inner diameter so that the implantable device 3100 and portions of the dissected anterior and posterior leaflets 20, 22 may be retracted therethrough.

[0264] like Fig.48 As shown in , in some embodiments, the cutting device 3140 includes an electrosurgical ring 3145 formed by one or more electrodes, which can be composed of metal elements that allow current to flow. In some embodiments, the cutting device 3140 is made of nitinol to achieve shape memory properties. In some embodiments, the stabilizing member 3150 and the indicator or meter can be deployed through the retrieval catheter 3160, and the electrosurgical ring 3145 can be deployed using an optional second catheter 3162. In some embodiments, the stabilizing member 3150 includes an element for grasping and stabilizing the implantable device 3100, such as a stabilizing snare 3152. The stabilizing snare 3152 can be fixed around a portion of the implantable device 3100, such as around the collar 3111. In some embodiments, the portion of the implantable device 3100 to which the stabilizing snare 3152 is attached, such as the collar 3111, can be enhanced to facilitate imaging so that the user can more easily fix the stabilizing member 3150 to the implantable device 3100. In some embodiments, the stabilizing member 3150 may include a clamp, a gripper, a vacuum suction device, or any other docking tool. In some embodiments, the stabilizing member 3150 stabilizes the implantable device 3100 and also allows the implantable device 3100 to be suctioned upward into the retrieval catheter 3160.

[0265] In some embodiments, the electrosurgical ring 3145 of the cutting device 3140 is deployed distally toward the anterior leaflet 20 and the posterior leaflet 22 just above the implantable device 3100. When the electrosurgical ring 3145 contacts the anterior leaflet 20 and the posterior leaflet 22, the electrosurgical ring 3145 can be caused to radially sever the anterior leaflet 20 and the posterior leaflet 22 around the implantable device 3100. The portion of the anterior leaflet 20 and the posterior leaflet 22 grasped by the implantable device 3100 will remain attached thereto. In some embodiments, the electrosurgical ring 3145 can be moved in several directions, such as longitudinally, laterally, transversely, or radially, to completely sever the implantable device 3100 from the anterior leaflet 20 and the posterior leaflet 22. The implantable device 3100 can then be retracted upward toward the distal end of the retrieval catheter 3160 through the stabilizing member 3150.

[0266] Figure 50A-5 0C shows an exemplary apparatus and method for retrieving an implantable device 3200 using a clamp 3148 having a first grasping arm 3146 and a second grasping arm 3147. Fig.50AA first grasping arm 3146 and a second grasping arm 3147 of a clamp 3148 are shown, along with an implantable device 3200 secured to the anterior leaflet 20 and the posterior leaflet 22. In some embodiments, each grasping arm 3146, 3147 has a c-shaped profile and is substantially cup-shaped or shell-shaped, such that when the clamp 3148 is closed, the two grasping arms 3146, 3147 form a complete enclosure with a void in the center thereof to secure the implantable device 3200 during removal. The clamp 3148 can be equipped with various features for cutting, severing, and / or resecting the anterior leaflet 20 and the posterior leaflet 22, such as serrated edges, blades, electrocautery, ultrasound, mechanical vibration, or friction. In some embodiments, the grasping arms 3146, 3147 are equipped with serrated edges or blades to cut through the anterior leaflet 20 and the posterior leaflet 22 like scissors. In some embodiments, the grasping arms 3146, 3147 will each be at least partially formed by electrodes, which may be composed of metal elements that allow electric current to flow, so that the grasping arms 3146, 3147 form an electro-cautery tool that will remove tissue of the anterior leaflet 20 and the posterior leaflet 22 when the grasping arms 3146, 3147 are closed around the implantable device 3200.

[0267] like Fig.50A and 50B As shown in , the first grasping arm 3146 and the second grasping arm 3147 will each extend into the space formed by the anterior leaflet 20 and the posterior leaflet 22 on either side of the implantable device 3200. In some embodiments, the clamp 3148 can be guided into position using various methods, such as the above-mentioned indicators or meters, or echocardiography. In some embodiments, the grasping arms 3146, 3147 are aligned with the implantable device 3200 using fluoroscopy to ensure that the implantable device 3200 is positioned between the grasping arms 3146, 3147 before cutting the anterior leaflet 20 and the posterior leaflet 22. As shown in FIG. Figure 50B-5 0C , once the grasping arms 3146, 3147 are in place around the implantable device 3200, the grasping arms 3146, 3147 are moved toward each other while cutting through the tissue of the anterior leaflet 20 and the posterior leaflet 22 using one of the methods described above. Once the clamp 3148 is closed and the grasping arms 3146, 3147 are in contact with each other, the implantable device 3200 can be completely enclosed within the clamp 3148, allowing the implantable device 3200 to be securely stored after being completely severed from the anterior leaflet 20 and the posterior leaflet 22. In some embodiments, the grasping arms 3146, 3147 are moved in a medial-lateral direction, and each grasping arm cuts both the anterior leaflet 20 and the posterior leaflet 22 when the clamp 3148 is moved to a closed position.

[0268] In some embodiments, the grasping arms 3146, 3147 equipped with blades will also be equipped with blade guards or sheaths that can cover the blades when the grasping arms 3146, 3147 are in place, thereby preventing or inhibiting any accidental cutting from occurring. Once the grasping arms 3146, 3147 are properly positioned, the sheaths (not shown) can be removed and the grasping arms 3146, 3147 can be closed around the implantable device 3200, thereby severing the anterior and posterior leaflets 20, 22. The sheaths can cover the entire clamp 3148 or each grasping arm 3146, 3147 individually.

[0269] Fig.51A A front view of the clamp 3148, the first grasping arm 3146, and the second grasping arm 3147 is shown, with the implantable device 3200 positioned in the void space between the grasping arms 3146, 3147. Fig.51B A top view along cross section AA′ of the implantable device 3200 secured to the anterior and posterior leaflets 20, 22 is shown, with the grasping arms 3146, 3147 located in the space between the anterior and posterior leaflets 20, 22. Fig.51C A side view of the grasping arm 3146 along cross section BB′ is shown, showing the implantable device 3200 enclosed within the grasping arm 3146 . Figure 52-5 6 shows an exemplary device and method for retrieving an implantable device using a cutting device 3340 shaped like a tuning fork. Fig.52 A cutting device 3340 is shown, which includes a central wire 3346, a first fork 3342 and a second fork 3344. In some embodiments, the first fork 3342 and the second fork 3344 are equipped with features for cutting, severing or ablating the front leaflet 20 and the rear leaflet 22, for example by using friction, heat, electrocautery, vibration, blades, saw teeth, etc. In some embodiments, the first fork 3342 and the second fork 3344 are formed by extremely sharp blades. In some embodiments, the first fork 3342 and the second fork 3344 are formed by electrodes, which can be composed of metal elements that allow current to flow. In some embodiments, the cutting device 3340 is connected to an infrared generator so that heat can be used to sever the autologous leaflet. In some embodiments, the cutting device 3340 is made of nitinol or spring wire to achieve shape memory properties. In some embodiments, the cutting device 3340 can be composed of a surface that enables radiofrequency energy to ablate the tissue surrounding the implantable device 3300. The grasping arms 3146, 3147 close to cut through the leaflets and hold the detached implantable device.

[0270] Fig.52 and 53 A system for removing a valve repair device 3300 from one or more leaflets 20, 22 of a native heart valve is shown. Fig.53 In the illustrated embodiment, the cutting device 3340 is delivered from a steerable sheath, such as a retrieval catheter 3360 controlled by an attached control handle. The control handle can be used to advance the catheter 3360, steer the catheter, advance the cutting device 3340 relative to the catheter, and / or control the cutting device 3340. In some embodiments, the cutting device 3340 is deployed to the heart valve via the retrieval catheter 3360. In some embodiments, as described above, the stabilizing component can also be deployed by the retrieval catheter 3360 or a separate catheter (not shown). The exemplary retrieval catheter 3360 provides a conduit through which the cutting device 3340 and an optional stabilizing component (not shown) are delivered to the implantable device.

[0271] Figures 54A-54F Operation of the cutting device 3340 with the catheter 3360 and / or control handle is shown. Fig.54A is a side view of the cutting device 3340 in an extended position, wherein the first prong 3342 and the second prong 3344 are outside the retrieval catheter 3360, but at least a portion of the center wire 3346 remains within the retrieval catheter 3360. Fig.54B is a side view of the cutting device 3340 in a closed position, wherein the retrieval catheter 3360 extends distally toward the junction of the center wire 3346 and the first fork 3342 and the second fork 3344, and / or the cutting device 3340 is retracted into the retrieval catheter 3360 such that the first fork 3342 and the second fork 3344 are forced closer together by the wall of the retrieval catheter 3360. Fig.54C is a side view of the cutting device 3340 in a shearing position, wherein the retrieval catheter 3360 is further extended distally above a portion of the first fork 3342 and the second fork 3344, and / or the cutting device 3340 is further retracted within the retrieval catheter 3360 such that the first fork 3342 and the second fork 3344 are forced into a crisscross, transverse or shearing position.

[0272] Figures 54D-54F Shows Figures 54A-54C The position of the cutting device 3340 shown in FIG. 1 works to sever the implantable device 3300 from the anterior leaflet 20 and the posterior leaflet 22 . Fig.54D 3300 is shown as a top view of an implantable device 3300 secured to the anterior leaflet 20 and the posterior leaflet 22. The cutting device 3340 can be deployed such that the first prong 3342 and the second prong 3344 each enter one of the openings formed by the anterior leaflet 20 and the posterior leaflet 22 on either side of the implantable device 3300. Fig.54EAs shown in , when the cutting device 3340 enters the closed position, the first fork 3342 and the second fork 3344 move inward from the opening toward one of the front leaflet 20 and the rear leaflet 22 (e.g., the front leaflet 20). Once the first fork 3342 and the second fork 3344 contact the side of the front leaflet 20, the cutting device 3340 begins to use any method for cutting the above-mentioned tissue, such as electrocautery, infrared or radiofrequency ablation to cut the tissue of the front leaflet. Fig.54F As shown in , as the retrieval catheter 3360 continues to advance over the cutting device 3340 , the first fork 3342 and the second fork 3344 cross each other, thereby completely severing the anterior leaflet 20 .

[0273] Figures 54D-54E The process shown in can then be repeated on the posterior leaflet 22. In some embodiments, the implantable device 3300 is removed from the native heart valve via the retrieval catheter 3360. In some embodiments, the distal end of the retrieval catheter 3360 can also be used to provide a downward force on the proximal side of the anterior leaflet 20 and the posterior leaflet 22 and / or the implantable device 3300 to keep the anterior leaflet 20 and the posterior leaflet 22 taut and / or the implantable device 3300 stable during the resection process. The inner diameter of the retrieval catheter 3160 can have an increased inner diameter so that the implantable device 3100 and the dissected portions of the anterior leaflet 20 and the posterior leaflet 22 can be retracted therefrom.

[0274] Alternatively, if Figures 55A-55B As shown in FIG. , in some embodiments, the cutting device 3340 can sever the anterior leaflet 20 and the posterior leaflet 22 by moving the first prong 3342 and the second prong 3344 away from each other rather than toward each other. Fig.55A is a side view of the cutting device 3340 in a closed position, wherein the retrieval catheter 3360 extends distally toward the junction of the center wire 3346 and the first fork 3342 and the second fork 3344, and / or the cutting device 3340 is retracted into the retrieval catheter 3360 such that the first fork 3342 and the second fork 3344 are forced closer together by the wall of the retrieval catheter 3360. Fig.55B is a side view of the cutting device 3340 in an extended position, wherein the first prong 3342 and the second prong 3344 are outside the retrieval catheter 3360, but at least a portion of the center wire 3346 remains within the retrieval catheter 3360.

[0275] Fig.56A and 56B Shows Figures 55A-55B The position of the cutting device 3340 shown in FIG. 1 works to sever the implantable device 3300 from the anterior leaflet 20 and the posterior leaflet 22 . Fig.56AA top view of an implantable device 3300 fixed to the anterior leaflet 20 and the posterior leaflet 22 is shown. The cutting device 3340 can be deployed so that the first fork 3342 and the second fork 3344 each enter the center of one of the anterior leaflet 20 and the posterior leaflet 22 (e.g., the anterior leaflet 20) in a closed position. A space is shown between the first fork 3342 and the second fork 3344 to show the presence of two forks. However, in some embodiments, the two forks can contact each other, cross each other, and / or form a single hole in the leaflet tissue so that there is no tissue bridge or only a small / tearable tissue bridge between the forks.

[0276] like Fig.56B As shown in , when the cutting device 3340 moves to the extended position, the first fork 3342 and the second fork 3344 move outward from the center of the anterior leaflet 20 toward the edge of the anterior leaflet 20. Once the first fork 3342 and the second fork 3344 contact the side of the anterior leaflet 20, the cutting device 3340 uses any method for severing the above-mentioned tissue, such as via electrocautery, infrared or radiofrequency ablation to sever the tissue of the anterior leaflet.

[0277] In some embodiments, a balloon (not shown) can be inserted into the perforations in the anterior leaflet 20 and the posterior leaflet 22 created by the first prong 3342 and the second prong 3344. The balloon can be inflated within the perforations, passively tearing the anterior leaflet 20 and the posterior leaflet 22 as it is inflated. The balloon (not shown) can also be equipped with features for cutting, severing, or ablating tissue, such as by using electrocautery, vibration, a blade, heat, etc.

[0278] Figures 56A-56B The process shown in can then be repeated on the posterior leaflet 22. In some embodiments, the implantable device 3300 is removed from the native heart valve via the retrieval catheter 3360. In some embodiments, the distal end of the retrieval catheter 3360 can also be used to provide a downward force on the proximal side of the anterior leaflet 20 and the posterior leaflet 22 and / or the implantable device 3300 to keep the anterior leaflet 20 and the posterior leaflet 22 taut and / or the implantable device 3300 stable during the resection process. The inner diameter of the retrieval catheter 3160 can have an increased inner diameter so that the implantable device 3100 and the dissected portions of the anterior leaflet 20 and the posterior leaflet 22 can be retracted therefrom.

[0279] Figures 57A-57B An exemplary device and method for removing an implantable device using hook 3350 and loop 3352 is shown. Fig.57AAs shown in , the exemplary device includes a retrieval catheter 3360. A first catheter 3362 and a second catheter 3364 are provided in the retrieval catheter, the hook 3350 is deployed through the first catheter, and the loop is deployed through the second catheter. In some embodiments, the hook 3350 and the loop 3352 are equipped with features for cutting, severing or ablating the front leaflet 20 and the rear leaflet 22, for example by using friction, heat, electrocautery, vibration, blades, saw teeth, etc. In some embodiments, the hook 3350 and the loop 3352 are formed by electrodes, which can be composed of metal elements that allow current to flow. In some embodiments, at least one of the hook 3350 and the loop 3352 is connected to an infrared generator so that heat can be used to sever the front leaflet 20 and the rear leaflet 22. In some embodiments, at least one of the hook 3350 and the loop 3352 is made of nitinol or spring wire to achieve shape memory properties. In some embodiments, at least one of the hook 3350 and the loop 3352 can be composed of a surface that enables radiofrequency energy to ablate the tissue surrounding the implantable device 3300. In some embodiments, the shape memory properties of the hook 3350 and the loop 3352 are such that when the hook 3350 is deployed from the first catheter and when the loop 3352 is deployed from the second catheter 3364, the hook is vertically aligned with the loop, with the hook 3350 aligned to enter the loop 3352, thereby forming a loop or lasso that can be used to cut off the anterior leaflet 20 and the posterior leaflet 22.

[0280] Fig.57B An implantable device 3300 is shown fixed to the anterior leaflet 20 and the posterior leaflet 22. In some embodiments, the hook 3350 is first deployed from the retrieval catheter 3360 or from a first catheter 3362 disposed therein to the opening between the anterior leaflet 20 and the posterior leaflet 22. Then, the ring 3352 is deployed from the retrieval catheter 3360 or from a second catheter 3364 disposed therein through the relative opening between the anterior leaflet 20 and the posterior leaflet 22. The hook 3350 then enters the ring 3352 under the anterior leaflet 20 and the posterior leaflet 22 and the implantable device 3300, thereby forming a loop or lasso around one of the native leaflets (e.g., the anterior leaflet 20). The hook 3350 and the ring 3352 can then be simultaneously retracted into their respective catheters 3360, 3362, 3364 so that the loop or lasso formed by the hook 3350 and the ring 3352 contacts one side of the anterior leaflet 20. The hook 3350 and loop 3352 will be cut through its tissue using any of the above methods, such as via electrocautery, infrared or radiofrequency ablation. This process can then be repeated on the posterior leaflet 22.

[0281] In some embodiments, the implantable device 3300 is removed from the native heart valve via a retrieval catheter 3360. In some embodiments, the distal end of the retrieval catheter 3360 can also be used to provide a downward force on the anterior and posterior leaflets 20, 22 and / or the proximal side of the implantable device 3300 to keep the anterior and posterior leaflets 20, 22 taut and / or the implantable device 3300 stable during the resection process.

[0282] Figures 58A-59B Exemplary devices and methods for removing an implantable device using a snare bag are shown. Fig.58A A retrieval catheter 3460 and a retrieval device 3450 disposed therethrough are shown. The retrieval device 3450 can include a positioning element 3451 (e.g., a wire, rod, line, pusher, tether, etc.), a snare 3452, and / or a bag 3453. In some embodiments, the bag 3453 can be a mesh, netting, or solid material.

[0283] In some embodiments, the retrieval device (e.g., snare 3452, etc.) is equipped with features for cutting, severing, or ablating the anterior leaflet 20 and the posterior leaflet 22, such as by using friction, heat, electrocautery, vibration, blades, saw teeth, etc. In some embodiments, the retrieval device (e.g., snare 3452, etc.) is formed by electrodes, which can be composed of metal elements that allow electric current to flow. In some embodiments, the retrieval device (e.g., snare 3452, etc.) is connected to an infrared generator so that heat can be used to sever the anterior leaflet 20 and the posterior leaflet 22. In some embodiments, at least one of the snare 3452 and the bag 3453 of the retrieval device is made of nitinol or spring wire to achieve shape memory properties. In some embodiments, the retrieval device (e.g., snare 3452, etc.) can be composed of a surface that enables radio frequency energy to ablate tissue surrounding the implantable device. As Fig.58B As shown in , a retrieval device (e.g., snare 3452, etc.) can be moved from an open position to a closed position by retracting the positioning element 3451 and / or extending the retrieval catheter 3460.

[0284] Fig.59A and 59B An exemplary method of removing an implantable device 3400 secured to a native valve leaflet (eg, anterior leaflet 20 and posterior leaflet 22, etc.) using a retrieval device 3450 is shown. Fig.59A As shown in , the retrieval device 3450 can be deployed via a retrieval catheter 3460 into an opening between the leaflets (e.g., between the anterior leaflet 20 and the posterior leaflet 22) so that the snare 3452 and the bag 3453 can be positioned directly below the distal end of the implantable device 3400.

[0285] In some embodiments, the positioning element 3451 is made of Nitinol so that it can have shape memory properties so that the positioning element properly positions the retrieval device 3450 once the retrieval catheter 3460 is retracted and / or the positioning element 3451 is extended from the retrieval catheter.

[0286] In some embodiments, such as Fig.59B As shown in , once the retrieval device 3450 is in place, the retrieval catheter 3460 can then be extended distally toward the retrieval device 3450 and / or the positioning element 3451 can be retracted into the retrieval catheter 3460, so that the retrieval device 3450 moves upward to enclose the implantable device 3400 in the bag 3453. Once the implantable device 3400 is completely in the bag 3453, the positioning element 3451 can be further retracted in the retrieval catheter 3460, so that the snare 3452 is tightened to a closed position. When the snare 3452 is closed, it contacts the front leaflet 20 and the rear leaflet 22, and uses any of the above methods to cut off its tissue, such as via electrical cautery, infrared or radiofrequency ablation. Once the front leaflet 20 and the rear leaflet 22 are completely cut off and the snare 3452 is completely closed, the implantable device 3400 is securely enclosed in the retrieval device 3450 and can then be removed from the native heart valve via the retrieval catheter 3460. In some embodiments, the distal end of the retrieval catheter 3360 can also be used to provide a downward force on the proximal side of the anterior and posterior leaflets 20, 22 and / or the implantable device 3400 to keep the anterior and posterior leaflets 20, 22 taut and / or the implantable device 3400 stable during the resection process. The inner diameter of the retrieval catheter 3160 can have an increased inner diameter so that the implantable device 3100 and the dissected portions of the anterior and posterior leaflets 20, 22 can be retracted therefrom.

[0287] Figures 60A-61C Exemplary systems, devices, and methods for removing an implantable device using a retrieval catheter 3560, a retrieval device 3550, and an actuation element 3551 are shown. The retrieval device 3550 can be attached to the retrieval catheter 3560 so that the retrieval device 3550 can be moved relative to the retrieval catheter 3560 in an open position (e.g., Fig.60A ) and the closed position (as shown in Fig.60B In an embodiment, the retrieval device 3550 is attached to the retrieval conduit 3560 by an articulated connection (e.g., by a hinge connector 3555). The actuating element 3551 can be, for example, a suture, a wire, a rod, a line, and / or any other suitable element capable of moving the retrieval device 3550 to an open and / or closed position.

[0288] In some embodiments, the retrieving device 3550 can be biased in a closed position, and the actuating element 3551 can be used to move the retrieving device to an open position. In some embodiments, the retrieving device 3550 can be biased in an open position, and the actuating element 3551 can be used to move the retrieving device to a closed position. In some embodiments, the retrieving device 3550 can be further attached to the retrieving conduit 3560 to maintain the retrieving device 3550 in a closed position. That is, the retrieving device 3550 can be attached to the retrieving conduit 3560 by a cap-shaped connector, such as a friction fit connector, a tongue and groove connector, a latch-type connector, a threaded connector, or any other suitable type of connector. The actuating element 3551 can be used to move the retrieving device 3550 from an open position to a closed position and / or between a closed position and an open position.

[0289] The retrieval device 3550 may include a cutting element 3552 and a cover 3553. In some embodiments, the cover 3553 may be a solid material, a mesh material, a netting material, etc. In some embodiments, the cutting element 3552 is configured to cut, cut off and / or ablate one or more leaflets L of a native heart valve (e.g., the anterior leaflet and / or posterior leaflet of a mitral valve, or the anterior leaflet, posterior leaflet and / or septal leaflet of a tricuspid valve), for example by using friction, heat, electrocautery, vibration, a blade, a sawtooth, cold cutting, etc. In some embodiments, the cutting element 3552 is formed by an electrode, which may be composed of a metal element that allows current to flow. In some embodiments, the cutting element 3552 is connected to an infrared generator so that heat can be used to cut off the leaflets L of the native heart valve. In some embodiments, at least one of the cutting element 3552 and the cover 3553 is made of nitinol or a spring wire to achieve shape memory properties. In some embodiments, the cutting element 3552 may include a surface that enables radio frequency energy to ablate tissue surrounding the implantable device. In some embodiments, the cutting element 3552 can include a cryogenic cutting feature that can be used to cut the leaflets L of a native heart valve.

[0290] In some embodiments, the cutting element 3552 can be provided on the cover 3553 as shown, on or at the distal end 3557 of the retrieval catheter 3560, or on both the cover 3553 and the distal end of the retrieval catheter 3560. When included on both the cover 3553 and the distal end 3557 of the retrieval catheter 3560, the same or different types of cutting mechanisms can be used on the cover 3553 and the distal end 3557 of the catheter 3560. The cutting element 3552 on the distal end 3557 of the retrieval catheter can be configured to cut, sever or ablate the leaflets L of the native heart valve, for example, by using friction, heat, electric cauterization, vibration, blades, saw teeth, cold cutting, etc. In some embodiments, the cutting element on the distal end 3557 is formed by an electrode, which can be composed of a metal element that allows current to flow. In some embodiments, the cutting element on the distal end 3557 is connected to an infrared generator so that the leaflets L of the native heart valve can be cut using heat. In some embodiments, the cutting element on the distal end 3557 can include a surface that enables radiofrequency energy to ablate tissue surrounding the implantable device. In some embodiments, the cutting element on the distal end 3557 can include a cryogenic cutting feature that can be used to cut the leaflets L of a native heart valve.

[0291] In some embodiments, only one of the distal end 3557 of the retrieval catheter 3560 and the cap 3553 of the retrieval device 3550 has a cutting element 3552 for cutting off the leaflets L of the native heart valve. In some embodiments, both the distal end 3557 of the retrieval catheter 3560 and the cap 3553 of the retrieval device 3550 have a cutting element 3552 for cutting off the leaflets L of the native heart valve.

[0292] Figures 61A-61C A method of removing an implantable device 3500 secured to one or more leaflets L of a native heart valve using a retrieval device 3550 is shown. The implantable device 3500 may take any suitable form, such as any form described in the present application. Fig.61A , a retrieval catheter 3560 can be placed through a native heart valve (e.g., by any of the tools described herein) such that when the retrieval device 3550 is in an open position, the implantable device 3500 is positioned between the distal end 3557 of the retrieval catheter 3560 and the retrieval device 3550. When in this position, the implantable device can be below the distal end 3557 of the retrieval catheter 3560 (as shown in the illustrated example), and / or a portion of the implantable device can extend into the retrieval catheter 3560.

[0293] refer to Fig.61B, then, the retrieval device 3550 is moved to a closed position so that the implantable device 3500 is enclosed by the retrieval device 3550 and the retrieval catheter 3560. Once the implantable device 3500 is enclosed by the retrieval device 3550 and the retrieval catheter 3560, the cutting element 3552 on at least one of the retrieval device 3550 and the retrieval catheter 3560 can be used to cut off the leaflets L of the native heart valve.

[0294] refer to Fig.61C , after the leaflets L are severed, the retrieval catheter 3560 is removed from the native heart valve (in the illustrated example in direction Y) so that the implantable device 3500 and portions of the leaflets L can be removed from the patient's heart.

[0295] Figures 62A-62H An exemplary cutting device 3640 (see Fig.62C ) Methods, systems and apparatus for removing an implantable device 3600 from at least one leaflet L of a native heart valve. The cutting device 3640 may include, for example, a wire, a blade, a razor, an energy-based cutting device, scissors, any other suitable member for cutting, severing or ablating one or more leaflets L of a native heart valve, or any combination thereof. The cutting device 3640 may cut the leaflets L, for example, by using friction, electrocautery, vibration, saw teeth, cold cutting, etc. In some embodiments, the cutting device 3640 includes an electrosurgical tip or blade formed by an electrode, which may be composed of a metal element that allows current to flow. In some embodiments, the cutting device 3640 is connected to an infrared generator so that heat can be used to sever the leaflets L of the native heart valve. In some embodiments, the cutting device 3640 may include a surface that enables radiofrequency energy to ablate tissue surrounding the implantable device. In some embodiments, at least a portion of the cutting device 3640 may be made of nitinol to achieve shape memory properties. In some embodiments, the cutting device 3640 can include a cryogenic cutting feature that can be used to cut the leaflets L of a native heart valve. The implantable device 3600 can take any suitable form, such as any form described herein.

[0296] The catheter 3660 can be used to provide a conduit through which the cutting device 3640 is delivered to the implantable device 3100. In some embodiments, the distal end of the retrieval catheter 3660 can also be used to provide a downward force on the proximal side of the leaflets L and / or the implantable device 3600 to keep the leaflets taut and / or the implantable device 3600 stable during the resection process. In some embodiments, the inner diameter of the retrieval catheter 3660 can have an inner diameter that allows the implantable device 3600 and the portion of the dissected leaflets L to be retracted therefrom.

[0297] An optional stabilizing member 3650 can be used to secure and hold the implantable device 3600 during cutting of one or more leaflets L. The stabilizing member 3650 can be deployed by the catheter 3660 or a separate catheter (not shown). In some embodiments, the stabilizing member 3650 has an element for grasping and stabilizing the implantable device 3600, such as a stabilizing snare 3652 (or a lasso, tether, latch, fastener, or other element). The stabilizing snare 3652 can be secured around a portion of the implantable device 3600, such as a collar 3611 (e.g., any collar described herein) or a cover 3614 (e.g., any cover described herein).

[0298] In some embodiments, the portion of the implantable device 3600 to which the stabilizing snare 3652 is attached, such as the cap 3614 or the collar 3611, can be configured to enhance imaging so that a user can more easily secure the stabilizing member 3650 to the implantable device 3600. In some embodiments, the stabilizing member 3650 can include a clamp, a gripper, a vacuum suction device, or any other docking tool. In some embodiments, the stabilizing member 3650 stabilizes the implantable device 3600 so that the cutting device 3640 can be more easily positioned to cut one or more leaflets L of the native heart valve.

[0299] In some embodiments, when the implantable device is completely removed from the native heart valve, stabilizing member 3650 can be used to aspirate implantable device 3600 into catheter 3660 so that implantable device 3600 can be removed from the patient's heart. In some embodiments, a separate retrieval device (e.g., any retrieval device described herein) can be used with catheter 3660 and / or stabilizing member 3650 to remove implantable device 3600 from the patient's heart.

[0300] refer to Fig.62A , catheter 3660 is shown being delivered near the tricuspid valve TV of the heart H. The catheter 3660 may be inserted into the right atrium RA by any suitable tool, such as any tool described in this application. Fig.62B , an optional stabilization feature 3650 is shown attached to a collar 3611 of the implantable device 3600 to secure and hold the implantable device 3600.

[0301] refer to Fig.62C and 62D , the cutting device 3640 is shown deployed from the catheter 3660 and engaging the leaflets L of the tricuspid valve TV. The cutting device 3640 can be positioned in the coaptation region of the tricuspid valve TV. Fig.62E and 62F In some embodiments, the leaflet L can be propped up to ensure proper placement of the cutting device 3640 prior to the resection process. Fig.62E , the cutting device 3640 is shown as engaging the leaflet L, but because the implantable device 3600 is positioned on the other side of the leaflet L, the leaflet L is not deformed or stretched due to such engagement. Fig.62F , in one embodiment, moving the cutting device 3640 in the outward direction D effects engagement between the cutting device 3640 and the leaflets L to cause a deformation or propping 3641 that indicates that the cutting device 3640 is properly positioned for the resection process. That is, the implantable device 3600 is no longer in a position relative to the cutting device 3640 that could affect the cutting of the leaflets L by the cutting device 3640. While the illustrated embodiment shows that the implantable device prevents or inhibits propping 3641 of the leaflets L, it should be understood that other objects may be positioned to prevent or inhibit propping 3641 and proper cutting of the leaflets L, such as chordae tendineae in the left ventricle LV of the heart H.

[0302] refer to Figure 62G and 62H , the cutting device 3640 is shown as being moved in an outward direction D such that the cutting device 3640 is positioned away from the implantable device 3600. Figure 62H , the cutting device 3640 is shown cutting through the leaflet L in direction C, so that the implantable device 3600 and the cut portion of the leaflet L are removed from one leaflet, while the implantable device 3600 remains connected to the other leaflet L. In some embodiments, the implantable device 3600 can be removed from two or more leaflets L of a native heart valve.

[0303] Although the reference tricuspid valve TV describes Figures 62A-62H , but it should be understood that the method can also be used to remove the implantable device 3600 from at least one leaflet L of the mitral valve using the exemplary cutting device 3640.

[0304] Figures 63A-63D A method of implanting a replacement valve 3701 onto a native valve is shown such that the valve captures an implantable device 3700 attached to the native valve. For example, the implantable device 3700 can be attached to at least one leaflet of the native heart valve, but not all leaflets, because the implantable device 3700 is cut off from one or more leaflets, for example, by using a reference Figures 62A-62H The described cutting device 3640 or any other cutting device or method disclosed in this application. The implantable device 3700 can take any suitable form, such as any form described in this application.

[0305] The replacement heart valve 3701 can be configured to be implanted via a delivery system or other means for delivery. The delivery system can include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations of these, and the like. The replacement heart valve 3701 can be removably coupled to the delivery catheter 3760. The replacement heart valve 3701 can be coupled to the catheter 3760 in a variety of ways, including releasable couplings, releasable press fits, friction fits, magnetic fits, threaded connectors, and the like. In which the implantable device is used Figures 62A-62H In embodiments where the cutting device 3640 and catheter 3660 are severed from one leaflet, the same catheter may optionally be used to deliver both the cutting device 3640 and the replacement heart valve 3701. In some embodiments, different catheters may be used to deliver the cutting device 3640 and the replacement heart valve 3701.

[0306] The replacement heart valve 3701 can be positioned in the native heart valve between the opposing leaflets L. The replacement heart valve 3701 can take any suitable form, such as any form described in the present application, and any form described in U.S. Published Patent Application Publication Nos. 2020 / 0368015 and 2020 / 0297481 and U.S. Patent Nos. 10,799,938, 10,758,348, and 10,166,097, which are incorporated herein by reference in their entireties. In some embodiments, the replacement heart valve can include an inner body 3730, an outer body 3740, and an anchor 3732, or the replacement heart valve 3701 can include a body 3740 attached to an anchor 3732 and the inner body can be omitted. When the inner body 3730 is included, the inner body can include a one-way valve 3735 (see Fig.63D ). The optional inner body 3730 may be movable relative to the outer body 3740, or the optional inner body 3730 may be fixed to the outer body 3740. In embodiments that do not include the optional inner body 3730, the outer body 3740 may include a one-way valve 3735. The replacement heart valve 3701 may be delivered from an optional capsule 3710 attached to the distal end of the catheter 3760 or from the catheter itself.

[0307] The inner body or frame 3730 and the outer body or frame 3740 can include various shapes and be made of various materials or substances. For example, the inner body or frame 3730 and / or the outer body or frame 3740 can be made of flexible and / or expandable materials. The inner body or frame 3730 and the outer body or frame 3740 can be configured to expand and contract. For example, the inner body or frame 3730 and the outer body or frame 3740 can contract or be compressed to fit in the cavity 3712 of the capsule 3710. In some embodiments, when the inner body or frame 3730 and / or the outer body or frame 3740 are removed from the cavity 3712 of the capsule 210, the inner body or frame 3730 and the outer body or frame 3740 are configured to expand. For example, the inner body or frame 3730 and / or the outer body or frame 3740 can have a stent or stent-like structure, and the stent or stent-like structure has a support that allows expansion and contraction.

[0308] refer to Figures 63B-63D , the anchor 3732 can take a variety of forms, such as a hook, a paddle, a clamping element, etc. The anchor can be engaged and / or flexible. The anchor 3732 can be curved or rounded so that the leaflet can be bent to fit and be fixed between the anchor 3732 and the outer body 3740. In some embodiments, the anchor 3732 can include an attachment portion or a clamping member. The clamping member can include a fastener, an optional barb, a friction enhancing element, or other means for fixing (e.g., a protrusion, a ridge, a groove, a textured surface, an adhesive, etc.).

[0309] One or more actuating elements may be used during deployment of the replacement heart valve 3701. In the example shown, the outer body or frame 3740 is removably coupled to the outer actuating element 3750. In some embodiments, the outer body or frame 3740 may be covered by a removable or retractable retaining sleeve. The outer actuating element 3750 may be disposed radially inwardly of the catheter 3760. The outer actuating element 3750 may slide relative to the catheter 3760. In some examples, the outer actuating element 3750 may be attached to the outer body or frame 23740 at the outer collar 3744.

[0310] The optional inner body or frame 3730 can be removably coupled to the optional inner actuation element 3752, or the inner body or frame 3730 can be fixed to the outer body or frame 3740. When the inner body or frame 3730 is fixed to the outer body or frame 3740, the inner actuation element 3752 can be omitted. The optional inner actuation element 3752 can be disposed radially inward of the outer actuation element 3750. The inner actuation element 3752 can slide relative to the outer actuation element 3750. In some examples, the inner actuation element 3752 can be attached to the inner body or frame 3730 at the inner collar 3734. The optional inner actuation element 3752, the outer actuation element 3750, and the catheter 3760 can all move simultaneously and independently of each other.

[0311] The outer actuating element 3750 and the optional inner actuating element 3752 can take a variety of different forms, including wires, rods, shafts, tubes, screws, sutures, threads, strips, or combinations thereof. The outer actuating element 3750 and the optional inner actuating element 3752 can be made of a variety of different materials and have a variety of configurations. As an example, the actuating element can be threaded so that rotation of the actuating element moves the valve 3701 or one or more portions of the valve relative to the capsule. Alternatively, the actuating element can be threadless so that pushing or pulling the actuating element moves the valve 3701 or one or more portions of the valve relative to the capsule.

[0312] refer to Figures 63A-63D , the device 3701 can be positioned in a heart valve between opposing leaflets L. Fig.63B , the device 3701 can be configured to move the inner body or frame 3730 away from the capsule 3710 along the longitudinal axis of the inner actuating element 3752 so as to form a gap between the capsule 3710 and the anchor 3732. In the illustrated example, the inner body or frame 3730 is pushed away from the outer body or frame 3740 and the capsule 3710. The movement of the inner actuating element 3752 can push the anchor 3732 away from the capsule 3710 and into the ventricle or lower portion of the heart. In some embodiments, the optional inner body or frame 3730, the outer body or frame 3740 and the anchor 3732 are configured to self-expand when they are moved distally from the capsule 3710. For example, the body or frame 3730 can have a self-expanding stent or stent-like structure.

[0313] refer to Fig.63C, the device 3701 can be configured to move the outer body or frame 3740 away from the capsule 3710 along the longitudinal axis of the outer actuating element 3750. The movement of the outer actuating element 3750 can push the outer body or frame 3740 away from the capsule 3710 and toward the leaflets L. As a result, the leaflets L can be captured between the outer body or frame 3740 and the anchors 3732. In the illustrated example, the anchors 3732 expand radially outward farther than the outer body or frame 3740, so that the anchors 3732 are disposed on the outer side or ventricular side of the leaflets L and the outer body or frame 3740 is disposed on the inner side or atrial side of the leaflets L. In some embodiments, the outer body or frame 3740 is configured to self-expand when it is moved distally from the capsule 3710 or the capsule 3710 is retracted from the outer body or frame 3740.

[0314] Still refer to Fig.63C , since the implantable device 3700 is attached to one leaflet L (e.g., due to reference Figures 62A-62H 3732). In some embodiments, the capsule 3710 is proximally retracted from the optional inner actuation element 3752 and / or the outer actuation element 3750. As the outer body or frame 3740 further extends out of the capsule 3710, the outer body or frame expands radially outward to secure the leaflets L and the device 3700 between the outer body or frame 3740 and the anchor.

[0315] refer to Fig.63D , when the outer body or frame 3740 is fully advanced out of the capsule, the leaflets L and therefore the implantable device 3700 are fixed against the outer body or frame 3740 and the anchors 3732. In an embodiment, the expanded outer body or frame 3740 and / or the anchors can conform to the shape around the device 3700. The actuating elements 3750, 3752 and the delivery system or catheter 3760 can be disconnected from the device 3701, thereby attaching the device 3701 to the native valve leaflets L. Once the device 3701 is implanted on the native valve leaflets L, the implantable device 3700 attached to one or more leaflets L is fixed in a position against the leaflets L, the anchors 3732 and / or the outer body or frame 3734, so that the device is prevented or inhibited from being disconnected. The one-way valve 3735 replaces the function of the native valve. That is, the replacement valve allows normal flow through the native valve and prevents or inhibits retrograde flow through the native valve.

[0316] In some embodiments configured for use with a tricuspid valve, the replacement heart valve 3701 is configured to be secured to three tricuspid valve leaflets such that the one-way valve 3735 of the replacement valve 3701 is positioned between all three native leaflets. In some embodiments configured for use with a mitral valve, the replacement heart valve 3701 is configured to be secured to two mitral valve leaflets such that the one-way valve of the replacement valve 3701 is positioned between the two native leaflets.

[0317] Fig.64 An exemplary valve 3801 is shown, and Figures 65A-65E A method of implanting a valve 3801 onto a native valve is shown such that the valve 3801 captures an implantable device 3800 attached to the native valve. In some embodiments, the valve 3801 may optionally be an EVOQUE® from Edwards Lifesciences. TM valve.

[0318] In some embodiments, such as Fig.64 As shown in , valve 3801 can have an anchor 3832 and a body or frame 3840. When the valve is implanted on a native heart valve (e.g., a mitral valve or a tricuspid valve), one or more leaflets of the native heart valve and an implantable device attached to the leaflets (e.g., Figures 65A-65E The implantable device 3800 shown in FIG. 38 can be secured between an anchor 3832 and a body or frame 3840 .

[0319] Used for Fig.64 Additional details and exemplary designs of valves such as valve 3801 shown in are described in U.S. Patent Nos. 8,403,983, 8,414,644, 8,652,203, 10,813,757, and U.S. Patent Publication Nos. 2011 / 0313515, 2012 / 0215303, 2014 / 0277390, 2014 / 0277422, 2014 / 0277427, 2018 / 0021129, and 2018 / 0055629, which are hereby incorporated by reference in their entirety and constitute a part of this specification. Implantable device 3800 can take any suitable form, such as any form described in this application.

[0320] Reference now Figures 65A-65E In some embodiments, valve 3801 can be delivered to the native tricuspid valve TV of heart H so that valve 3801 can be secured to leaflets L and implantable device 3800 can be secured to leaflets because implantable device 3800 is removed during the resection process (e.g., Figures 62A-62H ) after remaining connected to one or more leaflets.

[0321] The heart valve 3801 can be configured to be implanted via a delivery system or other means for delivery. The delivery system can include one or more of a guidewire, a guide / delivery sheath, a delivery catheter, a steerable catheter, an implantation catheter, a tube, a combination of these, and the like. The heart valve 3801 can be removably coupled to the delivery catheter 3860. The replacement heart valve 3801 can be coupled to the catheter 3860 in a variety of ways, including releasable couplings, releasable press fits, friction fits, magnetic fits, threaded connectors, and the like. In which the implantable device is used Figures 62A-62H In embodiments where the cutting device 3640 and the catheter 3660 are cut off, the same catheter can optionally be used to deliver both the cutting device 3640 and the replacement heart valve 3801. In some embodiments, different catheters can be used to deliver the cutting device 3640 and the replacement heart valve 3801.

[0322] refer to Fig.65A , an optional guidewire 3865 is inserted through the right atrium RA, through the tricuspid valve TV and into the right ventricle RV. A delivery sheath and / or catheter 3860 is inserted into the right atrium RA over the optional guidewire 3865. Reference Fig.65B , the catheter 3860 is moved to an appropriate position within the tricuspid valve TV and into the right ventricle RV. The anchor 3832 partially extends from the catheter 3860 and is thereby partially opened so that the leaflet L can be captured. For example, the delivery catheter 3860 can be advanced and turned or flexed to position such as Fig.65B The valve 3801 is shown. An actuation element (not shown) can be advanced from within the steerable catheter 3860 to engage the valve 3801, and / or the catheter 3860 can be retracted to extend the valve's anchor 3832 from the catheter 3860. The actuation element can take any suitable form, such as any of the forms described herein.

[0323] Reference now Fig.65C , the valve 3801 can be further advanced from the catheter 3860 (via retraction of the actuating element and / or the catheter) such that the body or frame 3840 and anchors 3832 are positioned to capture the leaflets L and the attached device 3800. Fig.65D , the valve 3801 is fully deployed from the catheter 3860, so that the body or frame 3840 moves to an expanded position causing engagement with the anchors 3832. This engagement between the body or frame 3840 and the anchors 3832 captures the leaflets L, and thus captures the implantable device 3800 between the body or frame 3840 and the anchors 3832. In an embodiment, a portion of the body or frame 3840 and / or some of the anchors 3832 conform to the shape of the device 3800. Reference Fig.65E, after the valve is secured to the leaflets L, the catheter 3860 is removed from the heart H, with the valve 3801 remaining secured to the leaflets L and the implantable device 3800 captured.

[0324] Although the reference tricuspid valve TV describes Figures 65A-65E , but it will be appreciated that the method may also be used to secure valve 3801 to the mitral valve such that the replacement valve captures an implantable device connected to the leaflets of the mitral valve.

[0325] Certain conditions or circumstances may require detaching an implantable device from one or more leaflets of a native heart valve. In some embodiments, a device and method are provided for detaching an implantable device from a first leaflet while the device remains attached to a second leaflet. In some embodiments, a device and method are provided for detaching an implantable device from both a first leaflet and a second leaflet so that the device can be removed using a retrieval catheter.

[0326] In some embodiments, the device is configured to excise the native valve leaflets to detach the leaflets from the implantable device. In some embodiments, the device is a cutting device. The cutting device can be formed by electrodes, which can be composed of metal elements that allow current to flow. The cutting device can be made of nitinol. The cutting device can include a surface that allows radiofrequency energy, ultrasound, or another type of energy to ablate and / or cut the native valve leaflets.

[0327] Fig.80 An exemplary implantable device (e.g., implantable device 3100) is shown deployed between the anterior leaflet 20 and the posterior leaflet 22 of a mitral valve MV. Implantable device 3100 is shown as having captured both the anterior leaflet 20 and the posterior leaflet 22 and positioned generally in the middle of the valve such that a double-orifice valve is formed (i.e., a first or outer orifice 40 on a first side of the implantable device 3100 and a second or inner orifice 42 on a second side of the implantable device 3100 opposite the first orifice 40).

[0328] Figures 66-72 An exemplary cutting device 4000 for resecting an autologous valve leaflet is shown. The cutting device 4000 can be delivered to the valve by any suitable delivery system, such as any delivery system disclosed herein. The cutting device 4000 can be constructed in various ways. In the illustrated embodiment, the cutting device 4000 can be delivered via a catheter 4002 (e.g., a steerable catheter or a non-steerable catheter through one or more steerable catheters) having a first lumen 4004 and a second lumen 4006 separated from the first lumen 4004, the second lumen being shown as leading to a distal end 4007 of the catheter 4002.

[0329] In the illustrated example, the cutting device 4000 comprises a first cutter delivery catheter 4008 having a third lumen 4010 and configured to be delivered through the first lumen 4004 and a second cutter delivery catheter 4012 having a fourth lumen 4014 and configured to be delivered through the second lumen 4006. The first cutter delivery catheter 4008 comprises a bendable and / or flexible first distal end portion 4016, and the second cutter delivery catheter 4012 comprises a bendable and / or flexible second distal end portion 4018. In some embodiments, the first distal end portion 4016 and / or the second distal end portion 4018 are steerable. The first distal end portion 4016 and / or the second distal end portion 4018 can be steered by any suitable tool. In some embodiments, the first distal end portion 4016 and / or the second distal end portion 4018 comprises a shape memory alloy such as nitinol to achieve shape memory properties. Thus, the first distal end portion 4016 and / or the second distal end portion 4018 can be shaped to a desired position. For example, the first distal end portion 4016 and the second distal end portion 4018 can be shaped to Fig.68 and 69 As shown in the position, the first distal end portion 4016 and the second distal end portion 4018 do not need to be steerable.

[0330] The first cutter delivery catheter 4008 includes a first distal tip 4020, and the second cutter delivery catheter 4012 includes a second distal tip 4022. In some embodiments, the first distal tip 4020 is configured to be releasably coupled to the second distal tip 4022 such that the third lumen 4010 is aligned (e.g., operably connected) with the fourth lumen 4014. In some embodiments, the first distal tip 4020 can include a first coupling element 4024, and the second distal tip 4022 can include a second coupling element 4026. The first coupling element 4024 and the second coupling element 4026 can be configured in a variety of ways, such as male / female connectors, magnets, hook and loop fasteners, ratchets, threaded couplings, fasteners, clamps, or other suitable couplings.

[0331] In the illustrated embodiment, the first coupling element 4024 is a first annular magnet and the second coupling element 4026 is a second annular magnet. The first coupling element 4024 and the second coupling element 4026 are respectively arranged on the first distal tip 4020 and the second distal tip 4022 to attract each other (i.e., with different magnetic poles facing the distal side), so that the first distal tip 4020 and the second distal tip 4022 are coupled to each other when approaching each other.

[0332] refer to Fig.66, showing a first cutter delivery catheter 4008 extending from a first lumen 4004 of catheter 4002. The first cutter delivery catheter 4008 can extend from the first lumen 4004 through the first or outer orifice 40 to the ventricular side of the valve, and a second cutter delivery catheter 4012 can extend from the second lumen 4006 through the second or inner orifice 42 to the ventricular side of the valve (see Fig.80 In some embodiments, instead of both the first cutter delivery catheter 4008 and the second cutter delivery catheter 4012 extending to the ventricular side of the valve, one of the first cutter delivery catheter 4008 or the second cutter delivery catheter 4012 can remain on the atrial side of the valve, and the other of the first cutter delivery catheter 4008 or the second cutter delivery catheter 4012 can extend from the atrial side to the ventricular side and back to the atrial side. For example, the first cutter delivery catheter 4008 can extend from the first lumen 4004 through the first or outer orifice 40 to the ventricular side of the valve, and through the second or inner orifice 42 to the atrial side of the valve to connect to the second cutter delivery catheter 4012.

[0333] refer to Figures 67-68 Once the first distal end portion 4016 of the first cutter delivery catheter 4008 and the second distal end portion 4018 of the second cutter delivery catheter 4012 are on the ventricular side of the valve, the first distal tip 4020 and the second distal tip 4022 are coupled to each other so that the third lumen 4010 and the fourth lumen 4014 are aligned or operably connected. In some embodiments, the first distal end portion 4016 and the second distal end portion 4018 are steerable and can therefore be steered to bring the first distal tip 4020 and the second distal tip 4022 into proximity with each other, thereby allowing the first coupling element 4024 and the second coupling element 4026 to be coupled together. In some embodiments, the first distal end portion 4016 and the second distal end portion 4018 are shaped so that when extended from the catheter 4002, they bend to a position where the first distal tip 4020 and the second distal tip 4022 are in proximity with each other, thereby allowing the first coupling element 4024 and the second coupling element 4026 to be coupled together. In some embodiments, the flexibility of the first distal end portion 4016 and the second distal end portion 4018 enables the first distal tip 4020 and the second distal tip 4022 to move closer to each other without being shaped or deflectable, thereby connecting the first connecting element 4024 and the second connecting element 4026 together.

[0334] refer to Fig.69Once the first distal tip 4020 and the second distal tip 4022 are connected, a cutting element 4030 for cutting, severing or ablating the anterior leaflet 20 and / or the posterior leaflet 22 can be advanced through the third lumen 4010 and returned through the fourth lumen 4014, or advanced through the fourth lumen and returned through the third lumen. The cutting element 4030 can be configured to cut, sever or ablate the leaflets in a variety of ways, such as by using friction, heat, electrical cautery, vibration, blades, saw teeth, etc. (In Fig.69 In the illustrated embodiment, the cutting element 4030 is a conductive wire (eg, made of metal, or having a metal element, thereby allowing electrical current to flow).

[0335] refer to Fig.70 Once the cutting element is advanced through the third lumen 4010 and back through the fourth lumen 4014, or advanced through the fourth lumen and back through the third lumen, the first cutter delivery catheter 4008 and the second cutter delivery catheter 4012 can be withdrawn through the first lumen 4004 and the second lumen 4006 of the catheter 4002, respectively, over the cutting element 4030. The first coupling element 4024 and the second coupling element 4026 can be decoupled by pulling the first cutter delivery catheter 4008 and the second cutter delivery catheter 4012 apart (e.g., applying tension to one or both of the first cutter delivery catheter 4008 and the second cutter delivery catheter 4012).

[0336] refer to Fig.71 , before or after the first cutter delivery catheter 4008 and the second cutter delivery catheter 4012 are withdrawn through the catheter 4002, the cutting element 4030 of the illustrated embodiment can be connected to an activation source 4032, which is configured to energize, heat, vibrate, or otherwise activate the cutting element 4030. In the illustrative embodiment, the cutting element 4030 is configured as a conductive wire, and the activation source 4032 is a radio frequency generator connected to the cutting element 4030 to supply radio frequency energy through the cutting element 4030. The radio frequency energy activates (i.e., heats) the cutting element 4030. The activated cutting element 4030 can then be pulled through a portion of the anterior leaflet 20 or the posterior leaflet 22 adjacent to the location where the implantable device 3100 grasps the anterior leaflet 20 or the posterior leaflet 22. As a result, the cut and / or ablated anterior leaflet 20 or the cut and / or ablated posterior leaflet 22 is detached from the implantable device 3100.

[0337] refer to Fig.72In some embodiments, the first cutter delivery catheter 4008 includes a first inflatable balloon 4034 at or near the first distal tip 4020, and the second cutter delivery catheter 4012 includes a second inflatable balloon 4036 at or near the second distal tip 4022. When the first distal tip 4020 extends through the first or outer orifice 40 and past the chordae tendineae CT, the first inflatable balloon 4034 can be inflated (e.g., Figure 3 ). When inflated, the first inflatable balloon 4034 can displace the chordae CT away from the implantable device 3100, so that the first distal tip 4020 does not extend between individual chordae CT or minimizes the number of individual chordae CT between the first distal end portion 4016 of the first cutter delivery catheter 4008 and the implantable device 3100. In doing so, when the cutting element 4030 detaches the leaflets 20, 22 from the implantable device 3100, few or no chordae CT are cut. Similarly, when inflated, the second inflatable balloon 4036 can displace the chordae CT away from the implantable device 3100, so that the second distal tip 4022 does not extend between individual chordae CT or minimizes the number of individual chordae CT between the second distal end portion 4018 of the second cutter delivery catheter 4012 and the implantable device 3100.

[0338] Figures 73-77 An exemplary cutting device 4100 for resecting a native valve leaflet is shown. The cutting device 4100 can be delivered to the valve by any suitable delivery system, such as any delivery system disclosed herein. The cutting device 4100 can be configured in various ways. In the illustrated embodiment, the cutting device 4100 can be delivered via a catheter 4002 having a first lumen 4004 and a second lumen 4006.

[0339] In the illustrated example, the cutting device 4100 includes a first cutter delivery catheter 4108 having a third lumen 4110 and configured to be delivered through the first lumen 4004 and a second cutter delivery element 4112 (e.g., a catheter, a pusher, a shaft, a rod, etc.) configured to be delivered through the second lumen 4006. The first cutter delivery catheter 4108 includes a first distal end portion 4116 that is bendable and / or flexible. In some embodiments, the first distal end portion 4116 is steerable. The first distal end portion 4116 can be steered by any suitable tool. In some embodiments, the first distal end portion 4116 can include a shape memory alloy such as nitinol to achieve shape memory properties. Therefore, the first distal end portion 4116 can be shaped to a desired position. In some embodiments, the second cutter delivery element 4112 can be configured to be similar to the first cutter delivery catheter 4108. For example, the second cutter delivery element 4112 can have a bendable or flexible portion, or a steerable portion, or a shaped portion.

[0340] The first cutter delivery catheter 4108 includes a first distal tip 4120, and the second cutter delivery element 4112 includes a second distal tip 4122. In some embodiments, the first distal tip 4120 is configured to couple to the second distal tip 4122. In some embodiments, the first distal tip 4120 may include a first coupling element 4124, and the second distal tip 4122 may include a second coupling element 4126. The first coupling element 4124 and the second coupling element 4126 may be configured in a variety of ways, such as male / female connectors, magnets, hook and loop fasteners, detents, threaded couplings, fasteners, clamps, or other suitable couplings.

[0341] In the illustrated embodiment, the first coupling element 4124 is a female connector that is releasably coupled to the first cutter delivery catheter 4108. The first coupling element 4124 can be releasably coupled to the first cutter delivery catheter 4108 in various ways. In the illustrative embodiment, the first coupling element 4124 is received in the third lumen 4110 at or near the first distal tip 4120. In some embodiments, the first coupling element 4124 is received in the third lumen 4110 via friction fit and / or a detent, and can be released from the third lumen 4110 when sufficient axial force is applied to separate the first coupling element 4124 from the first cutter delivery catheter 4108. In some embodiments, the outer surface of the first coupling element 4124 and the inner surface of the third lumen 4110 can have a complementary shape that acts as a detent. Any suitable complementary shape can be used. In the illustrated example, the inner surface of the first coupling element 4124 and the third lumen 4110 have a complementary shape of a wave shape or an hourglass shape.

[0342] refer to Figures 75-76 The first coupling element 4124 includes a distal end 4128 and a proximal end 4131 ( Figures 75-76 ). In the illustrated embodiment, the second coupling element 4126 is a male connector that is fixed to the second cutter delivery element 4112 to form a second distal tip 4122. The second coupling element 4126 is configured to be received within the distal end 4128 of the first coupling element 4124, and the distal end 4128 of the first coupling element 4124 is configured to be retained within the distal end 4128 once the second coupling element 4126 is received. The distal ends 4128 of the second coupling element 4126 and the first coupling element 4124 can be configured in a variety of ways. In the illustrated embodiment, the second coupling element 4126 includes one or more radially outwardly extending projections 4132 (e.g., barbs), and the distal end 4128 includes one or more radially inwardly extending projections 4134.

[0343] In the illustrated example, the cutting device 4100 includes a cutting element 4130 for cutting, severing, or ablating the anterior leaflet 20 and / or the posterior leaflet 22. The cutting element 4130 can be configured to cut, sever, or ablate the leaflets in a variety of ways, such as using friction, heat, electrical cautery, vibration, blades, saw teeth, etc. (in the example of FIG. Fig.73 and Fig.74 In the illustrated embodiment, the cutting element 4130 is a conductive wire (eg, made of metal, or having a metal element to allow current to flow) attached at one end to the first coupling element 4124.

[0344] refer to Figure 73-74 , showing a first cutter delivery catheter 4108 extending from the first lumen 4004 of the catheter 4002. The first cutter delivery catheter 4108 may extend from the first lumen 4004 through one of the first orifice 40 or the second orifice 42 (see Fig.80 ) to the ventricular side of the heart valve (e.g., mitral valve MV). Once the first distal end portion 4116 of the first cutter delivery catheter 4108 extends through one of the first orifice 40 or the second orifice 42, the first distal end portion 4116 can be bent (e.g., turned or shaped) around the implant device 3100 and returned through the other of the first orifice 40 or the second orifice 42. Fig.74 The second cutter delivery element 4112 is shown extending through the second lumen 4006 such that the second coupling element 4126 extends out of the second lumen 4006 to connect to the first coupling element 4124.

[0345] refer to Figures 75-76To connect the first coupling element 4124 and the second coupling element 4126, the second coupling element 4126 is pressed into the distal end 4128 of the first coupling element 4124, or the distal end 4128 of the first coupling element 4124 is pressed over the second coupling element 4126. As the second coupling element 4126 extends into the distal end 4128, the radially inwardly extending protrusion 4134 is displaced (e.g., flexed or bent) to allow the radially outwardly extending protrusion 4132 to pass through. Once the radially outwardly extending protrusion 4132 has moved axially past the radially inwardly extending protrusion 4134, the radially inwardly extending protrusion 4134 is flexed back to the original position, as shown in FIG. Fig.76 , to capture the second coupling element 4126 and connect the first cutter delivery catheter 4108 to the second cutter delivery element 4112.

[0346] Once the first coupling element 4124 and the second coupling element 4126 are connected, the first coupling element 4124 can be detached from the first cutter delivery catheter 4108. For example, sufficient tension can be applied to the first cutter delivery catheter 4108 (e.g., pulled back through the first lumen 4004) to pull the first distal tip 4120 above the first coupling element 4124, which is held in place by the second cutter delivery element 4112 via the connection between the first coupling element 4124 and the second coupling element 4126. Once the first cutter delivery catheter 4108 is detached from the first coupling element 4124, the first cutter delivery catheter 4108 can be withdrawn through the first lumen 4004, thereby exposing the cutting element 4130.

[0347] Furthermore, once the first cutter delivery catheter 4108 is detached from the first coupling element 4124, the second cutter delivery element 4112 can be pulled back through the second lumen 4006, thereby pulling the first coupling element 4124 and the cutting element 4130 therewith. Thus, the cutting element 4130 can be looped through the first lumen 4004 and the second lumen 4006, as shown in FIG. Fig.77 As shown in Fig.71 , the cutting element 4130 can be connected to an activation source (e.g., activation source 4032) that is configured to energize, heat, vibrate, or otherwise activate the cutting element 4130. In the illustrative embodiment, the cutting element 4130 is configured as an electrically conductive wire and the activation source is an RF generator connected to the cutting element 4130 to supply RF energy through the cutting element 4130. The RF energy activates (i.e., heats) the cutting element 4130.

[0348] The activated cutting element 4130 can then be pulled through the portion of the anterior leaflet 20 or the posterior leaflet 22 adjacent to where the implantable device 3100 grasps the anterior leaflet 20 or the posterior leaflet 22. Thus, the cut and / or ablated anterior leaflet 20 or the cut and / or ablated posterior leaflet 22 is detached from the implantable device 3100.

[0349] In some embodiments, the second cutter delivery element 4112 can include or be a conductive element, and the first coupling element 4124 and the second coupling element 4126 can electrically couple the cutting element 4130 to the conductive element. In some embodiments, the first coupling element 4124 and the second coupling element 4126 can be electrically conductive such that when coupled together, an electrical connection is formed between the second cutter delivery element and the cutting element 4130. Thus, in some embodiments, the first coupling element 4124 does not need to be pulled back through the second lumen 4006 by the second cutter delivery element 4112 in order to connect to the activation source 4032 because an electrical circuit is formed when the first coupling element 4124 and the second coupling element 4126 are engaged.

[0350] Figures 78-84 An exemplary cutting device 4200 for resecting a native valve leaflet is shown. The cutting device 4200 can be delivered to the valve by any suitable delivery system, such as any delivery system disclosed herein. The cutting device 4200 can be configured in various ways. In the illustrated embodiment, the cutting device 4200 can be delivered via a catheter 4202 having one or more lumens 4204 and a distal tip 4206.

[0351] In the example shown, the cutting device 4200 is formed in a fork or V-shape, having a first arm or fork 4220 with a first distal end 4222 and a second arm or fork 4224 with a second distal end 4226 spaced apart from the first distal end 4222. A cutting element 4230 for cutting, severing or ablating the anterior leaflet 20 and / or the posterior leaflet 22 extends between the first distal end 4222 and the second distal end 4226. The cutting element 4230 can be configured to cut, sever or ablate the leaflet in various ways, such as using friction, heat, electrical cauterization, vibration, a blade, saw teeth, etc. In the embodiment shown, the cutting element 4230 is a conductive wire (e.g., made of metal, or having a metal element, thereby allowing current to flow). In some embodiments, the cutting element 4230 extending between the first distal end 4222 and the second distal end 4226 is in a relaxed state (i.e., not tensioned).

[0352] The first arm 4220 and the second arm 4224 can be configured in a variety of ways. For example, the first arm 4220 and the second arm 4224 can be a tube or conduit through which the cutting element 4230 extends. In some embodiments, the first arm 4220 and the second arm 4224 can include a shape memory alloy (e.g., Nitinol) or a spring wire to achieve shape memory properties. In some embodiments, the first arm 4220 and the second arm 4224 can be an insulated wire, and the cutting element is formed from the same wire with the insulation capability removed.

[0353] refer to Figures 79-81 , the cutting device 4200 can be delivered to the left atrium LA via the catheter 4202. Once extended out of the catheter 4202, the first arm 4220 and the second arm 4224 diverge, such as Fig.78 The cutting device 4200 can be positioned above one of the leaflets 20, 22 at a location adjacent to the installed implantable device 3100, such that the cutting element 4230 extends across the atrial side of the leaflet 20, 22 (at Fig.80 Shown in FIG. 2 is the anterior leaflet 20 of the mitral valve MV).

[0354] like Fig.84 , the cutting element 4230 can be connected to an activation source (e.g., activation source 4032) that is configured to energize, heat, vibrate, or otherwise activate the cutting element 4230. In the illustrative embodiment, for the cutting element 4230 configured as a conductive wire, the activation source is an RF generator connected to the cutting element 4230 to supply RF energy through the cutting element 4230. The RF energy activates (i.e., heats) the cutting element 4230.

[0355] refer to Figures 82-83 Once the cutting element 4320 is positioned above the atrial side of the leaflets 20, 22 adjacent to the mounted implantable device 3100, the activated cutting element 4230 may then be moved downward toward the left ventricle LV, through the leaflets (e.g., Figures 82-83 The portion of the anterior leaflet 20 in the implantable device 3100) adjacent to the position where the implantable device 3100 grasps the anterior leaflet 20. Therefore, the cut and / or ablated anterior leaflet 20 is detached from the implantable device 3100.

[0356] While many of the embodiments herein are in the context of removing an implant, the systems, devices, apparatuses, methods, etc. herein can be adapted for cutting or removing autologous tissue even when no implant is present.

[0357] Examples (some non-limiting examples are disclosed below):

[0358] Example 1. A device for removing a native valve leaflet, comprising:

[0359] catheter;

[0360] a cutting device disposed within the catheter, wherein the cutting device comprises a snare capable of severing or ablating the native valve leaflets; and

[0361] A stabilization member includes elements for grasping an implantable device.

[0362] Example 2. The device of Example 1, wherein the cutting device is formed by an electrode, which may be composed of a metal element that allows the flow of electric current.

[0363] Example 3. The device of example 1 or 2, wherein the cutting device is made of nitinol.

[0364] Example 4. A device according to any of Examples 1 to 3, wherein the cutting device includes a device that enables radiofrequency energy to ablate the surface of the native leaflet.

[0365] Example 5. The device of any of Examples 1 to 4, wherein the stabilization feature is configured to be attached to a collar of the implantable device.

[0366] Example 6. The device of any one of Examples 1 to 5, wherein the element for grasping the implantable device is a snare.

[0367] Example 7. The device of any one of Examples 1 to 5, wherein the element for grasping the implantable device is any one of a clamp, a grasper, or a vacuum suction device.

[0368] Example 8. The device according to any one of Examples 1 to 7 further comprises a second cutting device, wherein the second cutting device comprises a second snare capable of severing or ablating the native leaflet.

[0369] Example 9. The device according to Example 8, wherein the second cutting device is formed by an electrode, which can be composed of a metal element that allows the flow of electric current.

[0370] Example 10. The device of any of Examples 8 to 9, wherein the second cutting device comprises a device that enables radiofrequency energy to ablate the surface of the native leaflet.

[0371] Example 11. The device of any one of Examples 8 to 10, wherein the second cutting device serves as the stabilizing member.

[0372] Example 12. A device for resecting a native valve leaflet, comprising:

[0373] catheter;

[0374] a cutting device comprising at least one coring element disposed proximate to the catheter, wherein the at least one coring element comprises features capable of severing or ablating the native leaflet; and

[0375] A stabilization member includes elements for grasping an implantable device.

[0376] Example 13. The device of Example 12, wherein the at least one coring element is disposed along an outer surface of the catheter.

[0377] Example 14. The device of Example 13, wherein the device comprises a single coring element surrounding the outer surface of the catheter.

[0378] Example 15. The device of any of Examples 12-13, wherein the device comprises a first coring element and a second coring element.

[0379] Example 16. The device of any one of Examples 12 to 15, wherein the at least one coring element is arcuate.

[0380] Example 17. A device according to any of Examples 12 to 16, wherein the feature capable of severing or ablating the native leaflet is a blade.

[0381] Example 18. A device according to any of Examples 12 to 16, wherein the feature capable of severing or ablating the native leaflet is a cutting tip formed by an electrode, which may be composed of a metal element that allows electric current to flow.

[0382] Example 19. The device of any of Examples 12 to 18, wherein the at least one coring element is made of nitinol.

[0383] Example 20. A device according to any of Examples 12 to 16, wherein the feature capable of severing or ablating the native leaflet is a cutting tip formed by an electrode, which may be composed of a metal element that allows electric current to flow.

[0384] Example 21. The device of any of Examples 12 to 18, wherein the at least one coring element further comprises a surface that conducts radio frequency energy.

[0385] Example 22. The device of any of Examples 12 to 21, wherein the element for grasping the implantable device is a snare.

[0386] Example 23. The device of any one of Examples 12 to 21, wherein the element for grasping the implantable device is any one of a clamp, a grasper, or a vacuum suction device.

[0387] Example 24. A device for resecting a native valve leaflet, comprising:

[0388] catheter;

[0389] a cutting device comprising at least one electrosurgical element;

[0390] a stabilization member including elements for grasping the implantable device; and

[0391] Indicator or meter.

[0392] Example 25. The device of Example 24, wherein the cutting device is made of Nitinol.

[0393] Example 26. A device according to any of Examples 24 to 25, wherein at least one electrosurgical element is a cutting tip or blade.

[0394] Example 27. A device according to any of Examples 24 to 25, wherein the at least one electrosurgical element is an electrosurgical ring.

[0395] Example 28. The device of any of Examples 24 to 27, wherein the element for grasping the implantable device is a snare.

[0396] Example 29. The device of any one of Examples 24 to 27, wherein the element for grasping the implantable device is any one of a clamp, a grasper, or a vacuum suction device.

[0397] Example 30. The device of any one of Examples 25 to 29, further comprising a second cutting device comprising a second cutting tip.

[0398] Example 31. A device according to any of Examples 25 to 30, wherein the indicator or instrument is a radiopaque feature.

[0399] Example 32. A device according to any one of Examples 25 to 31, wherein the indicator or meter is a depth gauge.

[0400] Example 33. A device according to any one of Examples 25 to 31, wherein the indicator or meter is a long flexible positioning wire or rod.

[0401] Example 34. The device of any one of Examples 25 to 31, wherein the indicator or meter is configured to guide the cutting device and engage the tissue to be cut before the cutting device.

[0402] Example 35. A method for resecting a native valve leaflet, comprising:

[0403] deploying a catheter to an implantable device secured to at least one leaflet of a native heart valve;

[0404] deploying a cutting device disposed within the catheter to the at least one leaflet;

[0405] securing at least one of the cutting device and the stabilizing component to a portion of the implantable device;

[0406] Removing the autologous valve leaflet with the cutting device;

[0407] Resecting the second native valve leaflet with the cutting device; and

[0408] The implantable device is removed from the native heart valve via the catheter using at least one of the cutting device and the stabilizing component.

[0409] Example 36. A device for resecting an implantable device from a native valve leaflet, comprising:

[0410] catheter;

[0411] a clamp comprising a first grasping arm and a second grasping arm disposed within the catheter, and

[0412] The clamp further comprises an element capable of cutting, severing or resecting the native valve leaflet.

[0413] Example 37. The device of Example 36, wherein when the first grasping arm and the second grasping arm of the clamp are closed, the first grasping arm and the second grasping arm surround the implantable device.

[0414] Example 38. The device of any one of Examples 36 to 37, wherein the first grasping arm and the second grasping arm each further comprise a serrated edge or blade.

[0415] Example 39. The device of any one of Examples 36 to 38, wherein the first grasping arm and the second grasping arm each further comprise an electrocautery element.

[0416] Example 40. A device for resecting a native valve leaflet, comprising:

[0417] catheter;

[0418] a cutting device comprising a central wire, a first prong, and a second prong, wherein the cutting device is capable of cutting, severing, or ablating the native valve leaflet; and

[0419] A stabilization component includes elements configured to grasp an implantable device.

[0420] Example 41. A device according to Example 40, wherein the first prong and the second prong include sharp blades.

[0421] Example 42. The device of Example 40, wherein the first prong and the second prong comprise an electrocautery element.

[0422] Example 43. A device according to Example 40, wherein the cutting device is connected to an infrared generator so that heat can be used to sever the native leaflets.

[0423] Example 44. The device of Example 40 wherein the first prong and the second prong include surfaces that enable RF energy to ablate the native leaflets.

[0424] Example 45. A device according to any of Examples 40 to 44, wherein the cutting device is made of nitinol.

[0425] Example 46. The device of any one of Examples 40 to 45, further comprising a balloon connected to the cutting device.

[0426] Example 47. The device of Example 46, wherein the balloon is configured to cut, sever, or ablate the native leaflet.

[0427] Example 48. A device for resecting a native valve leaflet, comprising:

[0428] First catheter;

[0429] a first cutting device comprising a hook disposed within the first conduit;

[0430] Second catheter;

[0431] a second cutting device comprising a ring disposed within the second conduit; and

[0432] A stabilization member includes elements for grasping an implantable device.

[0433] Example 49. A device according to Example 48, wherein the hook and the loop are capable of cutting, severing or ablating the native leaflet, such as by using friction, heat, electrocautery, vibration, blades or saw teeth.

[0434] Example 50. The device of any one of Examples 48 to 49, wherein the hook and the loop are formed by electrodes, which may be composed of metal elements that allow the flow of electric current.

[0435] Example 51. The device of any one of Examples 48 to 50, wherein the hook and the loop are connected to an infrared generator to generate heat to sever the native leaflets.

[0436] Example 52. The device of any of Examples 48 to 51, wherein the hook and the loop are made of nitinol or spring wire.

[0437] Example 53. The device of any of Examples 48 to 52, wherein the hooks and the loops are constructed to enable radiofrequency energy to ablate the surface of the native leaflet.

[0438] Example 54. A device according to any of Examples 48 to 53, wherein the hook is vertically aligned with the ring when the ring is deployed from the second catheter, and wherein the hook is aligned to enter the ring to form a lasso that can be used to sever the native leaflet.

[0439] Example 55. A device for resecting a native valve leaflet, comprising:

[0440] catheter;

[0441] a retrieval device comprising a positioning element, a snare and / or a bag, wherein the retrieval device is capable of cutting, severing or ablating the native leaflet, such as by using friction, heat, electrocautery, vibration, a blade, saw teeth; and

[0442] The retrieval device is configured to capture the valve repair device.

[0443] Example 56. A device according to Example 55, wherein the snare is comprised of an electrocautery element.

[0444] Example 57. A device according to Example 55, wherein the snare is connected to an infrared generator so that heat can be used to sever the native leaflets.

[0445] Example 58. The device of any of Examples 55 to 57, wherein at least one of the snare and the bag is made of nitinol or spring wire to achieve shape memory properties.

[0446] Example 59. The device of Example 55 or 58, wherein the snare is comprised of a surface that enables radiofrequency energy to ablate the native leaflet.

[0447] Example 60. A device for resecting a native valve leaflet, comprising:

[0448] a catheter having a distal end;

[0449] a cover attached to the conduit such that the cover is movable relative to the conduit between an open position and a closed position;

[0450] one or more cutting elements connected to one or more of the distal end of the catheter and the cap;

[0451] an actuating element configured to move the cover between the open position and the closed position;

[0452] wherein the one or more cutting elements are configured to cut, sever or ablate the native leaflet; and

[0453] Wherein the cover is configured to capture a valve repair device.

[0454] Example 61. A device according to Example 60, wherein the one or more cutting elements are configured to cut, sever, or ablate the native leaflet by using at least one of friction, heat, electrocautery, vibration, blades, and saw teeth.

[0455] Example 62. A device according to Example 60 or 61, wherein the one or more cutting elements include a single cutting element on the cover.

[0456] Example 63. A device according to Example 62, wherein the cutting element is composed of an electrocautery element.

[0457] Example 64. A device according to Example 62, wherein the cutting element is connected to an infrared generator so that heat can be used to sever the native leaflet.

[0458] Example 65. The device of Example 62 wherein the cutting element comprises a surface enabling radiofrequency energy to ablate the native leaflet.

[0459] Example 66. The device of any of Examples 60 to 65, wherein the one or more cutting elements comprises a single cutting element disposed on the distal end of the catheter.

[0460] Example 67. A device according to Example 66, wherein the cutting element is composed of an electrocautery element.

[0461] Example 68. The device of Example 66, wherein the cutting element is connected to an infrared generator so that heat can be used to sever the native leaflets.

[0462] Example 69. The device of Example 66 wherein the cutting element comprises a device configured to apply radiofrequency energy to ablate one or more surfaces of the native leaflet.

[0463] Example 70. The device of any of Examples 60 to 69, wherein at least one of the cutting element and the cover is made of nitinol or spring wire to provide shape memory properties.

[0464] Example 71. A device as described in any of Examples 60 to 70, wherein the cover is connected to the conduit via a hinge connector.

[0465] Example 72. A device according to any of Examples 60 to 71, wherein the lid is biased in the closed position, and wherein the actuation element is used to move the lid from the closed position to the open position.

[0466] Example 73. A device according to any one of Examples 60 to 72, wherein the actuating element comprises a wire.

[0467] Example 74. A method for resecting one or more native leaflets of a native valve and implanting a replacement valve into the native valve, comprising:

[0468] deploying a cutting device such that the cutting device is positioned proximate to the native valve;

[0469] cutting the one or more native leaflets with the cutting device such that a valve repair device is removed from the one or more native leaflets, wherein the valve repair device remains connected to at least one other native leaflet of the native valve;

[0470] deploying the replacement valve so that the replacement valve is positioned proximate to the native valve, the replacement valve having a body and one or more anchors; and

[0471] The replacement valve is attached to the one or more native leaflets and at least a portion of the at least one other native leaflet of the native valve such that the valve repair device is captured by the replacement valve between the body and the one or more anchors.

[0472] Example 75. The method according to Example 74 further includes engaging the one or more autologous leaflets with the cutting device before cutting the one or more autologous leaflets, and repositioning the cutting device relative to the one or more autologous leaflets if propping up of the one or more autologous leaflets is not detected.

[0473] Example 76. A method according to any one of Examples 74 to 75, wherein the cutting includes using at least one of friction, electrocautery, vibration and saw teeth.

[0474] Example 77. A method according to any one of Examples 74 to 76, wherein the cutting device includes one or more blades.

[0475] Example 78. A method according to any of Examples 74 to 76, wherein the cutting device comprises an electrosurgical tip formed by an electrode, wherein the electrode comprises a metallic element configured to allow the flow of electric current.

[0476] Example 79. A method according to any of Examples 74 to 76, wherein the cutting device comprises an electrosurgical tip formed by an electrode, wherein the electrode comprises a metallic element configured to allow the flow of electric current.

[0477] Example 80. A method according to any one of Examples 74 to 76, wherein the cutting device is connected to an infrared generator so that heat can be used to sever the one or more native leaflets.

[0478] Example 81. A method according to any of Examples 74 to 76, wherein the cutting device includes a device that enables radiofrequency energy to ablate one or more surfaces of the one or more native leaflets.

[0479] Example 82. The method of any one of Examples 74 to 81, further comprising positioning a delivery system proximate to the native valve, the delivery system configured to deploy the cutting device and the replacement valve.

[0480] Example 83. The method of Example 82 further comprises deploying a stabilization member to connect the valve repair device to the delivery system prior to cutting the one or more native leaflets.

[0481] Example 84. A method according to any of Examples 82 to 83, wherein the cutting device is deployed from a first catheter of the delivery system and the replacement valve is deployed from a second catheter of the delivery system.

[0482] Example 85. A method according to any one of Examples 74 to 84, wherein the body comprises an inner body and an outer body.

[0483] Example 86. A system for resecting a native valve leaflet, comprising:

[0484] a catheter having a first lumen and a second lumen;

[0485] a first cutter delivery catheter configured to be delivered through the first lumen, the first cutter delivery catheter having a third lumen and a first distal tip;

[0486] a second cutter delivery catheter configured to be delivered through the second lumen, the second cutter delivery catheter having a second distal tip; and

[0487] a cutting element configured to extend through the third lumen;

[0488] Wherein the first distal tip includes a first coupling element configured to be connected to a second coupling element on the second distal tip so that the cutting element can be advanced through the second lumen.

[0489] Example 87. A system according to Example 86, wherein the first coupling element is configured to magnetically couple to the second coupling element.

[0490] Example 88. The system of Examples 86 or 87 wherein the second cutter delivery catheter comprises a fourth lumen, and wherein the third lumen is aligned with the fourth lumen when the first distal tip is connected to the second distal tip.

[0491] Example 89. The system of Example 88 wherein the cutting element is advanceable through the second lumen via the fourth lumen.

[0492] Example 90. The system of Example 89, wherein the first coupling element is a first annular magnet and the second coupling element is a second annular magnet.

[0493] Example 91. A system as described in Example 86, wherein the first coupling element is configured to be mechanically coupled to the second coupling element.

[0494] Example 92. A system according to Example 91, wherein the first connecting element is configured as a female connector and the second connecting element is configured as a male connector.

[0495] Example 93. The system of Example 92 wherein the first coupling element is configured to be received in the third lumen at the first distal tip.

[0496] Example 94. The system of Example 93 wherein the first coupling element has a first outer surface having a shape complementary to an inner surface of the first distal tip.

[0497] Example 95. The system of any of Examples 92 to 94, wherein the first coupling element comprises a distal end and a proximal end, wherein the cutting element is attached to the proximal end.

[0498] Example 96. The system of Example 95, wherein the distal end is configured to receive the second coupling element.

[0499] Example 97. A system according to any of Examples 92 to 96, wherein the second coupling element includes one or more radially outwardly extending protrusions.

[0500] Example 98. A system according to Example 97, wherein the first coupling element includes one or more radially inwardly extending protrusions that are configured to engage the one or more radially outwardly extending protrusions to prevent the second coupling element from separating from the first coupling element.

[0501] Example 99. The system of any of Examples 92-98 wherein the first coupling element is configured to be removed from the first cutter delivery catheter once coupled to the second coupling element.

[0502] Example 100 The system of any of Examples 86 to 99, wherein the cutting element is a conductive wire.

[0503] Example 101. The system of Example 100, further comprising an activation source configured to energize the cutting element.

[0504] Example 102. A system according to Example 101, wherein the activation source is a radio frequency generator.

[0505] Example 103. A system according to any of Examples 86 to 102, wherein the first cutter delivery catheter has a steerable distal end portion.

[0506] Example 104. A system according to any of Examples 86 to 102, wherein the first cutter delivery catheter comprises a distal end portion having shape memory properties.

[0507] Example 105. The system of any of Examples 86 to 104, further comprising an inflatable balloon attached to an outer surface of the first cutter delivery catheter adjacent to the first distal tip.

[0508] Example 106. A system for resecting a native valve leaflet, comprising:

[0509] delivery catheter;

[0510] a cutting device configured to be delivered through the delivery catheter, the cutting device comprising:

[0511] a first arm having a first distal end;

[0512] a second arm having a second distal end spaced from the first distal end; and

[0513] A cutting element extends between the first distal end and the second distal end.

[0514] Example 107. The system of Example 106, wherein the cutting element is a conductive wire.

[0515] Example 108. The system of Example 107, wherein the conductive wire is in a relaxed state between the first distal end and the second distal end.

[0516] Example 109. A system according to any one of Examples 106 to 108, wherein the first arm and the second arm form a V-shape.

[0517] Example 110 The system of any of Examples 106 to 108, wherein the first arm and the second arm are insulated conductive wires and the cutting element is an uninsulated conductive wire.

[0518] Example 111. The system of Example 106, further comprising an activation source configured to energize the cutting element.

[0519] Example 112. A system according to Example 111, wherein the activation source is a radio frequency generator.

[0520] Example 113. A method of resecting a native valve leaflet captured by an implantable device, the method comprising:

[0521] extending a first cutter delivery catheter on a first side of the implantable device from an atrial side to a ventricular side of the native valve leaflets;

[0522] extending a second cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflets on a second side of the implantable device opposite the first side;

[0523] connecting the first cutter delivery catheter to the second cutter delivery catheter on the ventricular side of the native valve leaflets;

[0524] extending a cutting element through a first lumen in the first cutter delivery catheter and a second lumen in the second cutter delivery catheter;

[0525] withdrawing the first cutter delivery catheter to expose the cutting element adjacent to the native valve leaflets; and

[0526] A cutting element is moved from the ventricular side through the native valve leaflets to the atrial side to detach the native valve leaflets from the implantable device.

[0527] Example 114. The method of Example 113, wherein connecting the first cutter delivery catheter to the second cutter delivery catheter further comprises magnetically coupling the first cutter delivery catheter to the second cutter delivery catheter.

[0528] Example 115. The method of Example 114, wherein connecting the first cutter delivery catheter to the second cutter delivery catheter further comprises aligning the first lumen in the first cutter delivery catheter with the second lumen in the second cutter delivery catheter.

[0529] Example 116. The method of any of Examples 113 to 115 further comprises turning a first distal tip of the first cutter delivery catheter toward a second distal tip of the second cutter delivery catheter on the ventricle side.

[0530] Example 117. The method of any one of Examples 113 to 116, further comprising connecting the cutting element to an activation source.

[0531] Example 118. A method according to Example 117, wherein the activation source is a radio frequency generator.

[0532] Example 119. The method of any one of Examples 113 to 118, further comprising activating the cutting element with radiofrequency energy.

[0533] Example 120 The method of any one of Examples 113 to 119, wherein the cutting element is a conductive wire.

[0534] Example 121. A method according to any one of Examples 113 to 120, wherein extending the first cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflets further includes inflating a balloon on an outer surface of the first cutter delivery catheter.

[0535] Example 122. A method of resecting a native valve leaflet captured by an implantable device, the method comprising:

[0536] extending a first cutter delivery catheter from an atrial side to a ventricular side of the native valve leaflets on a first side of the implantable device, wherein a cutting element is connected to a first coupling element associated with the first cutter delivery catheter;

[0537] extending a second cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflets on a second side of the implantable device opposite the first side;

[0538] connecting the first cutter delivery catheter to the second cutter delivery catheter on the ventricular side of the native valve leaflets;

[0539] withdrawing the first cutter delivery catheter to expose the cutting element adjacent to the native valve leaflets; and

[0540] A cutting element is moved from the ventricular side through the native valve leaflets to the atrial side to detach the native valve leaflets from the implantable device.

[0541] Example 123. The method of Example 122, wherein connecting the first cutter delivery catheter to the second cutter delivery catheter further comprises mechanically coupling the first cutter delivery catheter to the second cutter delivery catheter.

[0542] Example 124. The method of Example 123, wherein mechanically coupling the first cutter delivery catheter to the second cutter delivery catheter further comprises receiving a male connector into a female connector.

[0543] Example 125. The method of Example 124, wherein withdrawing the first cutter delivery catheter further comprises detaching the female connector from the first cutter delivery catheter.

[0544] Example 126. The method of Example 125, wherein detaching the female connector from the first cutter delivery catheter further comprises applying tension to one or both of the first cutter delivery catheter and the second cutter delivery catheter.

[0545] Example 127. The method of any one of Examples 122 to 126, further comprising connecting the cutting element to an activation source.

[0546] Example 128. A method according to Example 127, wherein the activation source is a radio frequency generator.

[0547] Example 129. The method of any one of Examples 122 to 128, further comprising activating the cutting element with radiofrequency energy.

[0548] Example 130 The method of any one of Examples 122 to 129, wherein the cutting element is a conductive wire.

[0549] Example 131. A method according to any of Examples 122 to 130, wherein extending the first cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflets further includes inflating a balloon on an outer surface of the first cutter delivery catheter.

[0550] Example 132. A method according to any one of Examples 122 to 131, wherein connecting the first cutter delivery catheter to the second cutter delivery catheter on the ventricular side of the native valve leaflet further includes turning the distal end portion of the first cutter delivery catheter toward the second cutter delivery catheter.

[0551] Example 133. A method of resecting a native valve leaflet captured by an implantable device, the method comprising:

[0552] delivering a distal tip of a delivery catheter to the atrial side of the native valve leaflets;

[0553] supporting a cutting element adjacent the atrial side of the native valve leaflets; and

[0554] A cutting element is moved from the atrial side through the native valve leaflets to the ventricular side to detach the native valve leaflets from the implantable device.

[0555] Example 134. A method according to Example 133, wherein the cutting element is supported in a relaxed state near the atrial side of the native valve leaflets.

[0556] Example 135. The method of Example 133 or 134 further includes connecting the cutting element to an activation source.

[0557] Example 136. A method according to Example 135, wherein the activation source is a radio frequency generator.

[0558] Example 137. The method of any one of Examples 133 to 136 further comprises activating the cutting element with radiofrequency energy.

[0559] Example 138 The method of any one of Examples 133 to 137, wherein the cutting element is a conductive wire.

[0560] Example 139. A method according to any of Examples 133 to 138, wherein supporting the cutting element near the atrial side of the native valve leaflet further includes extending the cutting element between a first distal end of the first arm and a second distal end of the second arm.

[0561] Example 140. The method of Example 139 further includes extending the first arm and the second arm from the distal tip of the delivery catheter.

[0562] Any of the various systems, components, devices, equipment, etc. in the present disclosure (including those in the above examples) may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and the methods herein may include sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) the associated systems, devices, equipment, etc. (or the additional methods include or consist of such sterilization).

[0563] Although various inventive aspects, concepts and features of the present disclosure may be described and illustrated herein as being combined and embodied in the examples herein, these various aspects, concepts and features may be used in many alternative examples individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein, all such combinations and sub-combinations are intended to be within the scope of the present application. In addition, although various alternative examples of various aspects, concepts and features of the present disclosure may be described herein, such as alternative materials, structures, constructions, methods, devices and components, alternatives to form, coordination and function, etc., these descriptions are not intended to be complete or exhaustive lists of available alternative examples currently known or developed later. Those skilled in the art may easily use one or more of these inventive aspects, concepts or features for additional examples and uses within the scope of the present application, even if these examples are not explicitly disclosed herein.

[0564] In addition, although some features, concepts or aspects of the present disclosure may be described herein as preferred arrangements or methods, such description is not intended to imply that such features are required or essential unless explicitly stated. In addition, examples or representative values ​​and ranges may be included to assist in understanding the present application, however, such values ​​and ranges should not be interpreted as limiting and are considered critical values ​​or ranges only when so explicitly stated.

[0565] Furthermore, while various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the present disclosure, such identification is not intended to be exclusive, and there may be inventive aspects, concepts, and features that are fully described herein but are not expressly identified as such or as part of the specific disclosure, rather, such disclosure is set forth in the appended claims. Descriptions of exemplary methods or processes are not limited to including all steps that are required in all cases, nor is the order of steps presented to be construed as required or necessary unless expressly so stated. Words used in the claims have their full ordinary meaning and are not limited in any way by the description of the examples in the specification.

Claims

1. A device for removing an autologous valve leaflet, comprising: catheter; a cutting device disposed within the catheter, wherein the cutting device comprises a snare capable of severing or ablating the native valve leaflet; as well as A stabilization member includes elements for grasping an implantable device.

2. Device according to claim 1, wherein the cutting device is formed by an electrode which can be constituted by a metal element allowing the flow of electric current.

3. The device according to any one of claims 1 to 2, wherein the cutting device comprises a device that enables radiofrequency energy to ablate the surface of the native leaflet.

4. The device of any one of claims 1 to 3, wherein the stabilization component is configured to be attached to a collar of the implantable device.

5. The device according to any one of claims 1 to 4, wherein the element for grasping the implantable device is a snare.

6. The device according to any one of claims 1 to 4, wherein the element for grasping the implantable device is any one of a clamp, a grasper or a vacuum suction device.

7. The device according to any one of claims 1 to 6, further comprising a second cutting device, the second cutting device comprising a second snare capable of cutting off or ablating the native leaflet.

8. Device according to claim 7, wherein the second cutting means is formed by an electrode which can be constituted by a metal element allowing the flow of electric current.

9. The device according to any one of claims 7 to 8, wherein the second cutting device comprises a device enabling radiofrequency energy to ablate the surface of the native leaflet.

10. A device for removing an autologous valve leaflet, comprising: catheter; a cutting device comprising at least one coring element disposed proximate to the catheter, wherein the at least one coring element comprises features capable of severing or ablating the native leaflet; as well as A stabilization member includes elements for grasping an implantable device.

11. The device of claim 10, wherein the at least one coring element is disposed along an outer surface of the conduit.

12. The device of claim 11, wherein the device comprises a single coring element surrounding the outer surface of the conduit.

13. The device according to any one of claims 10 to 12, wherein the device comprises a first coring element and a second coring element.

14. The device according to any one of claims 10 to 13, wherein the at least one coring element is arcuate.

15. The device according to any one of claims 10 to 14, wherein the feature capable of severing or ablating the native leaflet is a cutting tip formed by an electrode, which can be composed of a metal element that allows the flow of electric current.

16. The apparatus of any one of claims 10 to 15, wherein the at least one coring element further comprises a surface that conducts radio frequency energy.

17. The device according to any one of claims 10 to 16, wherein the element for grasping the implantable device is a snare.

18. The device according to any one of claims 10 to 16, wherein the element for grasping the implantable device is any one of a clamp, a grasper or a vacuum suction device.

19. A device for removing an autologous valve leaflet, comprising: catheter; a cutting device comprising at least one electrosurgical element; a stabilizing member including elements for grasping the implantable device; as well as Indicator or meter.

20. The device of claim 19, wherein the at least one electrosurgical element is an electrosurgical ring.

21. The device according to any one of claims 19 to 20, wherein the element for grasping the implantable device is a snare.

22. The device according to any one of claims 19 to 21, wherein the element for grasping the implantable device is any one of a clamp, a grasper or a vacuum suction device.

23. The device according to any one of claims 20 to 22, further comprising a second cutting device, the second cutting device comprising a second cutting tip.

24. The device of any one of claims 20 to 23, wherein the indicator or gauge is a radiopaque feature.

25. Apparatus according to any one of claims 20 to 24, wherein the indicator or gauge is a depth gauge.

26. The device of any one of claims 20 to 24, wherein the indicator or meter is configured to guide the cutting device and engage tissue to be cut before the cutting device.

27. A method for resecting an autologous valve leaflet, comprising: deploying a catheter to an implantable device secured to at least one leaflet of a native heart valve; deploying a cutting device disposed within the catheter to the at least one leaflet; securing at least one of the cutting device and the stabilizing component to a portion of the implantable device; Removing the autologous valve leaflet with the cutting device; Removing the second autologous valve leaflet with the cutting device; as well as The implantable device is removed from the native heart valve via the catheter using at least one of the cutting device and the stabilizing component.

28. A device for resecting an implantable device from a native valve leaflet, comprising: catheter; a clamp comprising a first grasping arm and a second grasping arm disposed within the catheter, and The clamp further comprises an element capable of cutting, severing or resecting the native valve leaflet.

29. The device of claim 28, wherein when the first and second grasping arms of the clamp are closed, the first and second grasping arms surround the implantable device.

30. The device of any one of claims 28 to 29, wherein the first gripping arm and the second gripping arm each further comprise a serrated edge or blade.

31. The device of any one of claims 28 to 29, wherein the first grasping arm and the second grasping arm each further comprise an electrocautery element.

32. A device for removing a native valve leaflet, comprising: catheter; a cutting device comprising a central wire, a first prong, and a second prong, wherein the cutting device is capable of cutting, severing, or ablating the native valve leaflet; as well as A stabilization component includes elements configured to grasp an implantable device.

33. The device of claim 32, wherein the first prong and the second prong comprise electrocautery elements.

34. The device of claim 32, wherein the cutting device is connected to an infrared generator so that heat can be used to sever the native leaflets.

35. The device of claim 32, wherein the first and second prongs include surfaces that enable radiofrequency energy to ablate the native leaflets.

36. The device of any one of claims 32 to 35, further comprising a balloon coupled to the cutting device.

37. The device of claim 36, wherein the balloon is configured to cut, sever or ablate the native leaflet.

38. A device for removing a native valve leaflet, comprising: First catheter; a first cutting device comprising a hook disposed within the first conduit; Second catheter; a second cutting device comprising a ring disposed within the second conduit; as well as A stabilization member includes elements for grasping an implantable device.

39. The device of claim 38, wherein the hooks and the loops are capable of cutting, severing or ablating the native leaflets, for example by using friction, heat, electrocautery, vibration, blades or saw teeth.

40. A device according to any one of claims 38 to 39, wherein the hook and the loop are formed by electrodes which may be constituted by metal elements allowing the flow of electric current.

41. The device according to any one of claims 38 to 40, wherein the hook and the loop are connected to an infrared generator so as to generate heat to sever the native leaflets.

42. The device of any one of claims 38 to 41, wherein the hook is vertically aligned with the ring when the ring is deployed from the second catheter, and wherein the hook is aligned to enter the ring to form a lasso that can be used to sever the native leaflet.

43. A device for removing an autologous valve leaflet, comprising: catheter; a retrieval device comprising a positioning element, a snare and / or a bag, wherein the retrieval device is capable of cutting, severing or ablating the native leaflet, such as by using friction, heat, electrocautery, vibration, a blade, saw teeth; and The retrieval device is configured to capture the valve repair device.

44. The device of claim 43, wherein the snare is comprised of an electrocautery element.

45. The device of claim 43, wherein the snare is connected to an infrared generator so that heat can be used to sever the native leaflets.

46. ​​A device for removing an autologous valve leaflet, comprising: a catheter having a distal end; a cover attached to the conduit such that the cover is movable relative to the conduit between an open position and a closed position; one or more cutting elements connected to one or more of the distal end of the catheter and the cap; an actuating element configured to move the cover between the open position and the closed position; wherein the one or more cutting elements are configured to cut, sever or ablate the native valve leaflets; and Wherein the cover is configured to capture a valve repair device.

47. The device of claim 46, wherein the one or more cutting elements are configured to cut, sever or ablate the native leaflet using at least one of friction, heat, electrocautery, vibration, blades and saw teeth.

48. The device of claim 46, wherein the one or more cutting elements consist of an electrocautery element.

49. The device of claim 46, wherein the one or more cutting elements are connected to an infrared generator so that heat can be used to sever the native leaflets.

50. The device of any one of claims 46 to 49, wherein the cover is connected to the conduit by a hinged connector.

51. A device according to any one of claims 46 to 50, wherein the cover is biased in the closed position, and wherein the actuation element is used to move the cover from the closed position to the open position.

52. A method for resecting one or more native leaflets of a native valve and implanting a replacement valve into the native valve, comprising: deploying a cutting device such that the cutting device is positioned proximate to the native valve; cutting the one or more native leaflets with the cutting device such that a valve repair device is removed from the one or more native leaflets, wherein the valve repair device remains connected to at least one other native leaflet of the native valve; deploying the replacement valve so that the replacement valve is positioned proximate to the native valve, the replacement valve having a body and one or more anchors; as well as The replacement valve is attached to the one or more native leaflets and at least a portion of the at least one other native leaflet of the native valve such that the valve repair device is captured by the replacement valve between the body and the one or more anchors.

53. The method according to claim 52 further includes engaging the one or more autologous leaflets with the cutting device before cutting the one or more autologous leaflets, and repositioning the cutting device relative to the one or more autologous leaflets if propping up of the one or more autologous leaflets is not detected.

54. The method of any one of claims 52 to 53, wherein the cutting comprises using at least one of friction, electrocautery, vibration, and saw teeth.

55. A method according to any one of claims 52 to 54, wherein the cutting means comprises one or more blades.

56. A method according to any one of claims 52 to 55, wherein the cutting device comprises an electrosurgical tip formed by an electrode comprising a metallic element configured to allow the flow of electric current.

57. A method according to any one of claims 52 to 54, wherein the cutting device comprises an electrosurgical tip formed by an electrode comprising a metallic element configured to allow the flow of electric current.

58. A method according to any one of claims 52 to 54, wherein the cutting device is connected to an infrared generator so that heat can be used to sever the one or more native leaflets.

59. The method of any one of claims 52 to 58, further comprising positioning a delivery system proximate to the native valve, the delivery system configured to deploy the cutting device and the replacement valve.

60. The method of claim 59, further comprising deploying a stabilization member to connect the valve repair device to the delivery system prior to cutting the one or more native leaflets.

61. The method of any one of claims 59 to 60, wherein the cutting device is deployed from a first catheter of the delivery system and the replacement valve is deployed from a second catheter of the delivery system.

62. A system for resecting a native valve leaflet, comprising: a catheter having a first lumen and a second lumen; a first cutter delivery catheter configured to be delivered through the first lumen, the first cutter delivery catheter having a third lumen and a first distal tip; a second cutter delivery catheter configured to be delivered through the second lumen, the second cutter delivery catheter having a second distal tip; a cutting element configured to extend through the third lumen; and Wherein the first distal tip includes a first coupling element configured to be connected to a second coupling element on the second distal tip so that the cutting element can be advanced through the second lumen.

63. The system of claim 62, wherein the first coupling element is configured to magnetically couple to the second coupling element.

64. The system of claim 62 or 63, wherein the second cutter delivery catheter comprises a fourth lumen, and wherein the third lumen is aligned with the fourth lumen when the first distal tip is connected to the second distal tip.

65. The system of claim 64, wherein the cutting element is advanceable through the second lumen via the fourth lumen.

66. The system of claim 65, wherein the first coupling element is a first annular magnet and the second coupling element is a second annular magnet.

67. The system of claim 65, wherein the first coupling element is configured to be mechanically coupled to the second coupling element.

68. The system of claim 67, wherein the first coupling element is configured as a female connector and the second coupling element is configured as a male connector.

69. The system of claim 68, wherein the first coupling element is configured to be received in the third lumen at the first distal tip.

70. The system of claim 69, wherein the first coupling element has a first outer surface having a shape complementary to an inner surface of the first distal tip.

71. The system of any one of claims 68 to 70, wherein the first coupling element comprises a distal end and a proximal end, wherein the cutting element is attached to the proximal end.

72. The system of any one of claims 62 to 71, wherein the first cutter delivery catheter has a steerable distal end portion.

73. The system of any one of claims 62 to 71, wherein the first cutter delivery catheter comprises a distal end portion having shape memory properties.

74. The system of any one of claims 62 to 73, further comprising an inflatable balloon attached to an outer surface of the first cutter delivery catheter adjacent the first distal tip.

75. A system for resecting a native valve leaflet, comprising: delivery catheter; a cutting device configured to be delivered through the delivery catheter, the cutting device comprising: a first arm having a first distal end; a second arm having a second distal end spaced from the first distal end; and A cutting element extends between the first distal end and the second distal end.

76. The system of claim 75, wherein the cutting element is in a relaxed state between the first distal end and the second distal end.

77. The system of any one of claims 75 to 76, wherein the first arm and the second arm form a V-shape.

78. The system of any one of claims 75 to 77, wherein the first arm and the second arm are insulated conductive wires and the cutting element is an uninsulated conductive wire.

79. A method of resecting a native valve leaflet captured by an implantable device, the method comprising: extending a first cutter delivery catheter on a first side of the implantable device from an atrial side to a ventricular side of the native valve leaflets; extending a second cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflets on a second side of the implantable device opposite the first side; connecting the first cutter delivery catheter to the second cutter delivery catheter on the ventricular side of the native valve leaflets; extending a cutting element through a first lumen in the first cutter delivery catheter and a second lumen in the second cutter delivery catheter; withdrawing the first cutter delivery catheter to expose the cutting element adjacent to the native valve leaflets; as well as The cutting element is moved from the ventricular side through the native valve leaflets to the atrial side to detach the native valve leaflets from the implantable device.

80. The method of claim 79, wherein connecting the first cutter delivery catheter to the second cutter delivery catheter further comprises magnetically coupling the first cutter delivery catheter to the second cutter delivery catheter.

81. A method of resecting a native valve leaflet captured by an implantable device, the method comprising: extending a first cutter delivery catheter from an atrial side to a ventricular side of the native valve leaflets on a first side of the implantable device, wherein a cutting element is connected to a first coupling element associated with the first cutter delivery catheter; extending a second cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflets on a second side of the implantable device opposite the first side; connecting the first cutter delivery catheter to the second cutter delivery catheter on the ventricular side of the native valve leaflets; withdrawing the first cutter delivery catheter to expose the cutting element adjacent to the native valve leaflets; as well as The cutting element is moved from the ventricular side through the native valve leaflets to the atrial side to detach the native valve leaflets from the implantable device.

82. The method of claim 81 , wherein connecting the first cutter delivery catheter to the second cutter delivery catheter further comprises mechanically coupling the first cutter delivery catheter to the second cutter delivery catheter.

83. The method of any one of claims 81 to 82, wherein extending the first cutter delivery catheter from the atrial side to the ventricular side of the native valve leaflets further comprises inflating a balloon on an outer surface of the first cutter delivery catheter.

84. The method of any one of claims 81 to 83, wherein connecting the first cutter delivery catheter to the second cutter delivery catheter on the ventricular side of the native valve leaflet further comprises turning a distal end portion of the first cutter delivery catheter toward the second cutter delivery catheter.

85. A method of resecting a native valve leaflet captured by an implantable device, the method comprising: delivering a distal tip of a delivery catheter to the atrial side of the native valve leaflets; supporting a cutting element adjacent the atrial side of the native valve leaflets; as well as The cutting element is moved from the atrial side through the native valve leaflets to the ventricular side to detach the native valve leaflets from the implantable device.

86. The method of claim 85, wherein the cutting element is supported in a relaxed state adjacent the atrial side of the native valve leaflets.

87. The method of any one of claims 82 to 83, wherein supporting the cutting element near the atrial side of the native valve leaflet further comprises extending the cutting element between a first distal end of a first arm and a second distal end of a second arm.

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