Methods and Apparatus for Removing Valve Repair Devices - Patent application

Abstract

The implantable device or implant is configured to be positioned inside the native heart valve so that the native heart valve may form a more effective seal. The implantable device may be removed using one or more of the cutting device and the stabilizing component. The stabilizing component may control the position of the implantable device while the cutting device resects one or more of the leaflets with which the implantable device engages.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 399,360, filed August 19, 2022, and U.S. Provisional Patent Application No. 63 / 331,762, filed April 15, 2022, which are incorporated by reference herein in their entireties. [Background technology]

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring the forward flow of blood to be properly delivered through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc., and therefore can become less effective. Such damage to the valves can lead to severe cardiovascular disability or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and complications can occur. Transvascular techniques can be used to introduce and implant prosthetic devices in a much less invasive manner than open-heart surgery. As an example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, ascending the inferior vena cava, and into the right atrium). The septum is then punctured and the catheter is passed into the left atrium. A similar transvascular technique may be used, beginning as the transseptal technique, but not going as far as puncturing the septum, instead pivoting the delivery catheter toward the tricuspid valve in the right atrium to implant the device inside the tricuspid valve.

[0003] A healthy heart has a generally conical shape that tapers toward the apex and base. The heart is a four-chambered structure, including the left atrium, the right atrium, the left ventricle, and the 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 a very different anatomical structure than other native heart valves. The mitral valve includes an annulus portion, which is a ring-shaped portion of native valve tissue that surrounds the mitral valve opening, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle. The mitral valve annulus may form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape with major and minor axes. The anterior leaflet may be larger than the posterior leaflet, and when closed together, form a generally "C" shaped boundary between the abutting sides of the leaflets.

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve that can only allow blood to flow from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygen-rich blood that is collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), the rising blood pressure in the left ventricle urges 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 ejected out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous chordae, called chordae tendineae, anchor the leaflets to papillary muscles in the left ventricle.

[0005] Valvular regurgitation involves a valve inappropriately allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of heart contraction, allowing blood to flow from the left ventricle to the left atrium. 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 insufficiency, stretching of the mitral annulus from left ventricular dilation, or a combination of these. Mitral regurgitation in the central portion of the leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the commissures of the leaflets (i.e., where the leaflets meet) can 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 can be similar, except on the right side of the heart. Summary of the Invention

[0006] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples of this summary is not required by the claims unless the claims explicitly recite that feature. Also, features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure can be included in the examples outlined herein.

[0007] Disclosed is a device 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. Similar configurations may be used with other devices, such as valve repair devices, that are not necessarily implanted and may be removed following treatment, although they may be described as implantable devices in various embodiments herein for illustrative purposes.

[0008] In some implementations, an implantable device or implant (such as, for example, an implantable device) is provided that is configured to be positioned within the native heart valve so that the native heart valve can form a more effective seal.

[0009] In some implementations, the implantable device or implant includes an anchor portion, each anchor including a plurality of paddles each movable between an open position and a closed position.

[0010] Certain conditions or situations may require removal of an implantable device from a native heart valve. In some implementations, the implantable device can be removed using a retrieval catheter through which a cutting device and / or optional stabilization component are delivered to the device. The optional stabilization component can control the position of the implantable device while the cutting device resects one or more of the leaflets with which the implantable device engages. In some implementations, the stabilization component stores the implantable device within the retrieval catheter. In some implementations, the same element functions as the stabilization method and the cutting device. In some implementations, the retrieval catheter can also optionally deploy indicators and / or gauges to guide the cutting device.

[0011] In some implementations, the device for ablating the natural lobe includes 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 or ablating the natural lobe. The stabilizing component comprises an element for gripping the implantable device.

[0012] In some implementations, the cutting device may be formed of an electrode that may be comprised of a metal element that allows an electric current to flow. The cutting device may be made of Nitinol. The cutting device may include a surface that allows the radio frequency energy to ablate the natural lobe. The cutting device may function as a stabilizing component. The element for gripping the implantable device may be a snare. The element for gripping the implantable device may be a pincer, a grasper, or a vacuum suction device. The second cutting device may include a second snare that may cut or ablate the natural lobe.

[0013] In some implementations, the device for excising the natural lobe includes a catheter, a cutting device, and a stabilizing component. The cutting device includes at least one coring element disposed proximate to the catheter. The at least one coring element includes features capable of cutting or excising the natural lobe. The stabilizing component has an element for gripping the implantable device.

[0014] In some implementations, the at least one coring element is disposed along the outer surface of the catheter. The single coring element can surround the outer surface of the catheter. The device includes a first coring element and a second coring element. The at least one coring element can be arc-shaped. The feature capable of cutting or ablating the natural leaflet can be a blade, a cutting tip formed from an electrode that can be made of a metal element that allows electrical current to flow, and / or a surface that conducts radio frequency energy. The at least one coring element can be made of Nitinol. The element for grasping the implantable device can be a snare, pincer, grasper, or vacuum suction device.

[0015] In some implementations, the device for ablating the natural lobe includes a catheter, a cutting device, and an indicator or gauge. The cutting device includes at least one electrosurgical element. The stabilizing component is configured to grip the implantable device.

[0016] In some implementations, 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, pincer, grasper, or vacuum suction device. The device can include a second cutting device. The indicator or gauge can include a radiopaque feature. The indicator or gauge can be a depth gauge. The indicator or gauge can be a long, conformable positioning wire or rod. The indicator or gauge can be configured to guide the cutting device and engage the tissue to be cut prior to the cutting device.

[0017] In some implementations, a method of excising a native leaflet includes placing a catheter on an implantable device secured to at least one leaflet of a native heart valve. A cutting device is deployed from the catheter onto 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. A natural leaflet is excised with the cutting device. A second natural leaflet is excised with the cutting device. The implantable device is detached from the native heart valve using at least one of the cutting device and the stabilizing component via the catheter.

[0018] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0019] In some implementations, the device for ablating the natural lobe comprises a catheter and a clamp, the clamp comprising a first gripping arm and a second gripping arm, the clamp comprising an element configured to cut, sever, or ablate the natural lobe.

[0020] In some implementations, upon closure of the first and second gripping arms of the clamp, the first and second gripping arms form a complete encapsulation with a gap in its center to secure the implantable device. The first and second gripping arms may each include a serrated edge or blade and / or an electrocautery element.

[0021] In some implementations, the device for ablating the natural lobe includes a catheter, a cutting device, and a stabilizing component. The cutting device includes a central wire, a first prong, and a second prong. The first and second prongs are configured to cut, sever, and / or ablate the natural lobe. The stabilizing component is configured to grip the implantable device.

[0022] In some implementations, the first and second prongs comprise a sharp blade and / or an electrocautery element. The cutting device can be connected to an infrared generator so that heat can be used to sever the natural leaflet. The first and second prongs can comprise a surface that allows radio frequency energy to ablate the natural leaflet. The cutting apparatus can be made of Nitinol. The device can comprise a balloon. The balloon can include a cutting structure that can cut, sever, and / or ablate the natural leaflet, such as through the use of electrocautery, vibration, blades, or heat.

[0023] In some implementations, the device for cutting the natural leaf may include a hook and loop joined around the natural leaf and configured to cut the natural leaf.

[0024] In some implementations, the hook may extend from a first catheter and the loop may extend from a second catheter. The device may include a stabilizing component configured to grip the implantable device. The hook and loop may cut, sever, and / or ablate the natural leaflet, such as through the use of friction, heat, electrocautery, vibration, blades, and / or saws. The hook and loop may be formed with an electrode, which may be made of a metal element that allows an electric current to flow. The hook and loop may be connected to an infrared generator so that heat can be used to cut the natural leaflet. The hook and loop may be made of nitinol or spring wire. The loop may be aligned perpendicular to the loop when deployed. The hook may be aligned to enter the loop to create a lasso that can be used to cut the natural leaflet.

[0025] In some implementations, the apparatus for removing the natural leaflets includes a catheter and a retrieval device. The retrieval device may 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 natural leaflets, such as through the use of friction, heat, electrocautery, vibration, blades, saws, etc. In some implementations, a bag is connected to the snare and configured to contain and retrieve the valve repair device and the cut leaflet portions.

[0026] In some implementations, the retrieval device (e.g., snare, etc.) may be comprised of an electrocautery element. The retrieval device (e.g., snare, etc.) may be connected to an infrared generator so that heat can be used to sever the natural lobe. The retrieval apparatus, snare, and / or bag may be made of Nitinol or spring wire to allow for shape memory properties. The retrieval device (e.g., snare, etc.) may be comprised of a surface that allows radio frequency energy to ablate the natural lobe.

[0027] In some implementations, the device for ablating the natural lobes includes a catheter, a cap, a cutting element, and / or an actuating element. The cap is attached to the catheter such that the cap is movable between an open position and a closed position relative to the catheter. The actuating element can be configured to move the cap between the open position and the closed position. The cutting element has the ability to cut, sever, or ablate the natural lobes. The cutting element can be attached to the cap and / or the catheter. The cap is configured to capture the valve repair device.

[0028] In some implementations, the cutting element may be comprised of an electrocautery element. The cutting element may be connected to an infrared generator so that heat can be used to cut the natural lobe. The cutting element and / or cap may be made of Nitinol or spring wire to allow for shape memory properties. The cutting element may be comprised of a surface that allows radio frequency energy to ablate the natural lobe.

[0029] In some implementations, the cap is biased in a closed position and an actuating element is used to move the cap from the closed position to the open position. In some implementations, the cap is biased in an open position and an actuating element is used to move the cap from the open position to the closed position.

[0030] In some implementations, a method for excising one or more natural leaflets of a native valve and implanting a replacement valve within the native valve includes deploying a cutting device such that the cutting device is positioned adjacent to the native valve. The method may further include cutting the one or more natural leaflets with the cutting device such that the valve repair device is removed from the one or more natural leaflets, the valve repair device remaining connected to at least one other natural leaflet of the native valve. The method may further include positioning a replacement valve such that the replacement valve is positioned adjacent to the native valve, the replacement valve having a body and one or more anchors. The method may further include attaching the replacement valve to at least a portion of the one or more natural leaflets and at least one other natural leaflet such that the valve repair device is captured by the replacement valve between the body and the one or more anchors.

[0031] In some implementations, the one or more natural leaves are engaged with the cutting device prior to cutting the one or more natural leaves, and the cutting device is repositioned relative to the one or more natural leaves if tenting of the one or more natural leaves is not detected.

[0032] In some implementations, cutting includes the use of at least one of friction, electrocautery, vibration, and sawing.

[0033] In some implementations, the cutting device comprises one or more blades.

[0034] In some implementations, the cutting device comprises an electrosurgical tip formed with an electrode including a metallic element configured to allow an electrical current to flow therethrough.

[0035] In some implementations, the cutting device comprises an electrosurgical tip formed with an electrode including a metallic element configured to allow an electrical current to flow therethrough.

[0036] In some implementations, the cutting device is connected to an infrared generator so that heat can be used to cut one or more natural leaves.

[0037] In some implementations, the cutting device comprises one or more surfaces that enable radio frequency energy to ablate one or more natural lobes.

[0038] In some implementations, a delivery system is positioned proximate to the native valve, the delivery system configured to deploy the cutting device and the replacement valve.

[0039] In some implementations, the stabilization component connects the valve repair device to the delivery system prior to cutting one or more natural leaflets.

[0040] In some implementations, 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.

[0041] In some implementations, the body comprises an outer body or frame and an inner body or frame.

[0042] In some implementations, a system for resecting a natural lobe includes a catheter having a first lumen and a second lumen, a first cutter delivery catheter configured to be delivered through the first lumen, a second cutter delivery catheter configured to be delivered through the second lumen, and a cutting element configured to extend through the third lumen.

[0043] In some implementations, a first distal tip of the first cutter delivery catheter includes a first coupling element configured to connect to a second coupling element on a second distal tip of the second cutter delivery catheter such that the cutting element is advanceable through the second lumen.

[0044] In some implementations, the first coupling element is configured to magnetically couple to the second coupling element. In some implementations, the second cutter delivery catheter includes a fourth lumen, and when the first distal tip is connected to the second distal tip, the third lumen aligns with the fourth lumen. In some implementations, the cutting element is advanceable through the second lumen via the fourth lumen.

[0045] In some implementations, the first coupling element and / or the second coupling element are magnets, hi some implementations, the first coupling element is a first annular magnet and the second coupling element is a second annular magnet.

[0046] In some implementations, the first coupling element is configured to mechanically couple to the second coupling element. In some implementations, the first coupling element is configured as a female connector and the second coupling element is configured as a male connector. In some implementations, the first coupling element is configured to be received within the third lumen at the first distal tip. In some implementations, the first coupling element has a first exterior surface having a complementary shape to an interior surface of the first distal tip.

[0047] In some implementations, the first coupling element includes a distal end and a proximal end, and the cutting element is attached to the proximal end. In some implementations, the distal end is configured to receive the second coupling element. In some implementations, the second coupling element includes one or more radially outwardly extending protrusions.

[0048] In some implementations, the first coupling element includes one or more radially inwardly extending protrusions configured to engage with the one or more radially outwardly extending protrusions to resist separation of the second coupling element from the first coupling element, hi some implementations, the first coupling element is configured to be detached from the first cutter delivery catheter when coupled to the second coupling element.

[0049] In some implementations, the cutting element is a conductive wire. In some implementations, the actuation source is configured to energize the cutting element. In some implementations, the actuation source is a radio frequency generator.

[0050] In some implementations, the first cutter delivery catheter has a steerable distal end portion.In some implementations, the first cutter delivery catheter has a distal end portion having shape memory properties.

[0051] In some implementations, the inflatable balloon is attached to an outer surface of the first cutter delivery catheter adjacent the first distal tip, hi some implementations, the inflatable balloon is attached to an outer surface of the second cutter delivery catheter adjacent the second distal tip.

[0052] In some implementations, the system for ablating a natural lobe includes a delivery catheter and a cutting device configured to deliver through the delivery catheter. In some implementations, the cutting element includes 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 extending between the first distal end and the second distal end.

[0053] In some implementations, the cutting element is a conductive wire. In some implementations, the conductive wire is in a slack state between a first distal end and a second distal end. In some embodiments, the first arm and the second arm form a V-shape.

[0054] In some implementations, the first arm and the second arm are insulated conductive wires and the cutting element is an uninsulated conductive wire. In some implementations, the actuation source is configured to energize the cutting element. In some implementations, the actuation source is a radio frequency generator.

[0055] In some implementations, a method of resecting a native valve leaflet captured by an implantable device includes extending a first cutter delivery catheter from an atrial side of the native valve leaflet to a ventricular side on a first side of the implantable device, extending a second cutter delivery catheter from the atrial side of the native valve leaflet to the ventricular side of a second side of the implantable device opposite 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.

[0056] In some implementations, the method further includes extending a cutting element through a first lumen of the first cutter delivery catheter and a second lumen of the second cutter delivery catheter, withdrawing the first cutter delivery catheter to expose the cutting element adjacent to a leaflet of the native valve, and / or moving the cutting element through the leaflet of the native valve from the ventricular side to the atrial side to detach the leaflet of the native valve from the implantable device.

[0057] In some implementations, connecting the first cutter delivery catheter to the second cutter delivery catheter further includes magnetically coupling the first cutter delivery catheter to the second cutter delivery catheter.

[0058] In some implementations, connecting the first cutter delivery catheter to the second cutter delivery catheter further includes aligning a first lumen in the first cutter delivery catheter with a second lumen in the second cutter delivery catheter. In some implementations, the method includes steering 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.

[0059] In some implementations, the method includes connecting the cutting element to an actuation source. In some implementations, the actuation source is a radio frequency generator. In some implementations, the method includes activating the cutting element with radio frequency energy. In some implementations, the cutting element is a conductive wire.

[0060] In some implementations, extending the first cutter delivery catheter from the atrial side to the ventricular side of the leaflets of the native valve further includes inflating a balloon on an outer surface of the first cutter delivery catheter.

[0061] In some implementations, extending the second cutter delivery catheter from the atrial side to the ventricular side of the leaflet of the native valve further includes inflating a second balloon on an outer surface of the second cutter delivery catheter.

[0062] In some implementations, a method of resecting a native valve leaflet captured by an implantable device includes extending a first cutter delivery catheter from an atrial side of the native valve leaflet to a ventricular side on a first side of the implantable device, extending a second cutter delivery catheter from the atrial side of the native valve leaflet to a ventricular side on a second side of the implantable device opposite 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.

[0063] In some implementations, the cutting element is connected to a first coupling element associated with the first cutter delivery catheter. In some implementations, the method further includes withdrawing the first cutter delivery catheter to expose the cutting element adjacent to the native valve leaflet and moving the cutting element through the native valve leaflet from the ventricular side to the atrial side to detach the native valve leaflet from the implantable device.

[0064] In some implementations, 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 implementations, mechanically coupling the first cutter delivery catheter to the second cutter delivery catheter further comprises receiving a male connector within a female connector.

[0065] In some implementations, withdrawing the first cutter delivery catheter further comprises detaching the female connector from the first cutter delivery catheter, hi some implementations, withdrawing the female connector from the first cutter delivery catheter further comprises applying a pulling force to one or both of the first cutter delivery catheter and the second cutter delivery catheter.

[0066] In some implementations, the method includes connecting the cutting element to an actuation source. In some implementations, the actuation source is a radio frequency generator. In some implementations, the method includes activating the cutting element with radio frequency energy. In some implementations, the cutting element is a conductive wire.

[0067] In some implementations, extending the first cutter delivery catheter from the atrial side to the ventricular side of the leaflets of the native valve further includes inflating a balloon on an outer surface of the first cutter delivery catheter.

[0068] In some implementations, connecting the first cutter delivery catheter to the second cutter delivery catheter on the ventricular side of the native valve leaflet further includes steering a distal end portion of the first cutter delivery catheter toward the second cutter delivery catheter.

[0069] In some implementations, a method of ablating a native valve leaflet captured by an implantable device includes delivering a distal tip of a delivery catheter to an atrial side of the native valve leaflet, supporting a cutting element adjacent to the atrial side of the native valve leaflet, and moving the cutting element through the native valve leaflet from the atrial side to the ventricular side to detach the native valve leaflet from the implantable device. In some implementations, the cutting element is supported adjacent to the atrial side of the native valve leaflet in a relaxed state.

[0070] In some implementations, the method further includes connecting the cutting element to an actuation source. In some implementations, the actuation source is a radio frequency generator. In some implementations, the method further includes activating the cutting element with radio frequency energy. In some implementations, the cutting element is a conductive wire.

[0071] In some implementations, supporting the cutting element adjacent 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. In some implementations, the method further includes extending the first arm and the second arm from a distal tip of the delivery catheter.

[0072] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, a virtual person, a simulator, etc.). In a simulation, the body parts may optionally be referred to as "simulations" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, computerized and / or physical representations.

[0073] Any of the above systems, assemblies, devices, equipment, components, etc. may be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for patient use, and the above methods may include (or additional methods may include or consist of) sterilization (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, equipment, components, etc. herein.

[0074] 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 elements bear like reference numerals and in which:

[0075] To further clarify various aspects of the embodiments of the present disclosure, a more particular description of certain embodiments and implementations will be made by reference to various aspects of the accompanying drawings. These drawings depict only exemplary implementations of the present disclosure and are therefore not to be considered as limiting the scope of the present disclosure. Moreover, while the drawings may be drawn to scale for some embodiments, the drawings are not necessarily drawn to scale for all embodiments. The embodiments of the present disclosure and other features and advantages will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0076] [Figure 1] FIG. 1 shows a cross-section of a human heart in diastole. [Diagram 2] FIG. 2 shows a cross-section of a human heart during systole. [Diagram 3] FIG. 3 shows a cross-section of a human heart during systole, showing valvular regurgitation. [Figure 4] FIG. 4 is a cross-sectional view of FIG. 3, annotated to show the natural shape of the mitral valve leaflets during systole. [Diagram 5] FIG. 5 shows a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Figure 6] FIG. 6 shows an incompetent mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 9] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 10] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 11] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 12] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 13] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 14] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 15] FIG. 15 illustrates one embodiment of an implantable device or implant similar to the device illustrated in FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16]16-21 show the exemplary device or implant of FIGS. 8-14 delivered and placed within the native valve. [Figure 17] 16-21 show the exemplary device or implant of FIGS. 8-14 delivered and placed within the native valve. [Figure 18] 16-21 show the exemplary device or implant of FIGS. 8-14 delivered and placed within the native valve. [Figure 19] 16-21 show the exemplary device or implant of FIGS. 8-14 delivered and placed within the native valve. [Figure 20] 16-21 show the exemplary device or implant of FIGS. 8-14 delivered and placed within the native valve. [Figure 21] 16-21 show the exemplary device or implant of FIGS. 8-14 delivered and placed within the native valve. [Figure 22] FIG. 22 shows a perspective view of an exemplary device or implant in a closed position. [Diagram 23] FIG. 23 illustrates a perspective view of an exemplary device or implant in a closed position. [Figure 24] FIG. 24 illustrates an exemplary valve repair device with the paddle in an open position. [Figure 25A] FIG. 25A shows another exemplary valve repair device with the paddles in a closed position. [Figure 25B] FIG. 25B shows a top view of an exemplary valve repair device. [Figure 26] FIG. 26 shows a perspective view of an exemplary device having a paddle with adjustable width. [Figure 27] FIG. 27 is a cross-section of the implantable device of FIG. 26, dividing the implantable device in two halves. [Figure 28] 28 is another cross-section of the implantable device of FIG. 26, bisecting the implantable device along a plane perpendicular to the plane shown in FIG. [Figure 29]FIG. 29 is a schematic diagram of an exemplary implant catheter assembly coupled to an implantable device, where the actuation element is coupled to a paddle actuation control and a driver head of the implantable device. [Diagram 30] FIG. 30 is a view of the assembly of FIG. 29 with the implantable device rotated 90 degrees to show a paddle width adjustment element coupled to the inner end of the implantable device's connector and coupled to the paddle width control device. [Diagram 31] FIG. 31 shows a front view of an exemplary implantable device in a closed position engaging the anterior and posterior leaflets of the mitral valve. [Diagram 32] FIG. 32 shows a front view of an exemplary retrieval catheter, cutting device, and optional stabilizing components. [Diagram 33] FIG. 33 shows a side view of the exemplary retrieval catheter, cutting device, and optional stabilizing components of FIG. [Diagram 34] FIG. 34 shows a front view of the exemplary removal catheter, cutting device, and optional stabilization components of FIG. 32 with the cutting device partially retracted and the removal catheter proximal to the anterior and posterior leaflets. [Diagram 35] FIG. 35 illustrates a side view of the exemplary retrieval catheter, cutting device, and optional stabilization components shown in FIG. [Diagram 36] FIG. 36 shows a front view of an exemplary retrieval catheter, two cutting devices, and optional stabilizing components. [Figure 37] FIG. 37 shows a side view of the exemplary retrieval catheter, two cutting devices, and optional stabilization components of FIG. [Figure 38] FIG. 38 illustrates a front view of the exemplary retrieval catheter, two cutting devices, and optional stabilization components of FIG. 36 with the cutting devices partially retracted and the retrieval catheter proximal to the anterior and posterior leaflets. [Figure 39] FIG. 39 illustrates a side view of the exemplary retrieval catheter, cutting device, and optional stabilization components shown in FIG. [Diagram 40]FIG. 40 shows an exemplary retrieval catheter, cutting device, and stabilization components. [Diagram 41] FIG. 41 illustrates the exemplary removal catheter, cutting device, and stabilization components of FIG. 40 with the cutting device and catheter advanced into the leaflets. [Diagram 42] FIG. 42 illustrates the exemplary retrieval catheter, cutting device, and stabilizing component of FIG. 40 with the cutting device cutting the leaflets. [Diagram 43] FIG. 43 illustrates the exemplary retrieval catheter, cutting device, and stabilizing component of FIG. 40, with the leaflets and valve repair device being retracted into the retrieval catheter by the stabilizing component. [Diagram 44] 44 illustrates a top view of an exemplary retrieval catheter, stabilization component, cutting device, and indicator or gauge. The retrieval catheter is shown off-center so that all features of the drawing are visible. [Diagram 45] 45 is a front view of the exemplary retrieval catheter, stabilizing component, cutting device, and indicator or gauge of FIG. 44. [Diagram 46] FIG. 46 is a front view of an exemplary retrieval catheter, stabilization component, and two cutting devices. [Figure 47] FIG. 47 is a top view of the exemplary retrieval catheter, stabilization components, and two cutting devices of FIG. [Figure 48] FIG. 48 is a front view of an exemplary retrieval catheter, stabilization component, and cutting device. [Figure 49] 49 is a top view of the exemplary retrieval catheter, stabilization components, and cutting device of FIG. 48. [Figure 50A] 50A-50B illustrate a method of removing an exemplary implantable device using an exemplary cutting device. [Figure 50B] 50A-50B illustrate a method of removing an exemplary implantable device using an exemplary cutting device. [Figure 51A]51A-51C illustrate a method of removing an exemplary implantable device using an exemplary cutting device. [Figure 51B] 51A-51C illustrate a method of removing an exemplary implantable device using an exemplary cutting device. [Figure 51C] 51A-51C illustrate a method of removing an exemplary implantable device using an exemplary cutting device. [Figure 52] FIG. 52 is a front view of an exemplary cutting device. [Diagram 53] FIG. 53 illustrates the exemplary retrieval catheter and cutting device of FIG. [Figure 54A] 54A-54C show example locations of the retrieval catheter and cutting device of FIG. [Figure 54B] 54A-54C show example locations of the retrieval catheter and cutting device of FIG. [Figure 54C] 54A-54C show example locations of the retrieval catheter and cutting device of FIG. [Fig. 54D] 54D-54F illustrate a method of severing leaflets attached to an exemplary implantable device using the retrieval catheter and cutting device of FIG. 52. [Figure 54E] 54D-54F illustrate a method of severing leaflets attached to an exemplary implantable device using the retrieval catheter and cutting device of FIG. 52. [Fig. 54F] 54D-54F illustrate a method of severing leaflets attached to an exemplary implantable device using the retrieval catheter and cutting device of FIG. 52. [Figure 55A] 55A-55B illustrate a method of storing an exemplary cutting device within the retrieval catheter of FIG. [Figure 55B] 55A-55B illustrate a method of storing an exemplary cutting device within the retrieval catheter of FIG. [Figure 56A]56A-B illustrate a method of removing an exemplary implantable device from a valve leaflet using the retrieval catheter and cutting device of FIG. 52. [Figure 56B] 56A-B illustrate a method of removing an exemplary implantable device from a valve leaflet using the retrieval catheter and cutting device of FIG. 52. [Figure 57A] 57A-57B illustrate a method of obtaining an exemplary implantable device using a first retrieval catheter, a second retrieval catheter, and two cutting devices. [Figure 57B] 57A-57B illustrate a method of obtaining an exemplary implantable device using a first retrieval catheter, a second retrieval catheter, and two cutting devices. [Figure 58A] 58A-B illustrate a method of obtaining an exemplary implantable device using a retrieval catheter, cutting device, and stabilizing component. [Figure 58B] 58A-B illustrate a method of obtaining an exemplary implantable device using a retrieval catheter, cutting device, and stabilizing component. [Figure 59A] 59A-59B illustrate a method of storing the cutting device and stabilizing components of FIGS. 58A-58B into a retrieval catheter. [Figure 59B] 59A-59B illustrate a method of storing the cutting device and stabilizing components of FIGS. 58A-58B into a retrieval catheter. [Figure 60A] 60A-60B show an example of a retrieval catheter and cutting device. [Figure 60B] 60A-60B show an example of a retrieval catheter and cutting device. [Figure 61A] 61A-61C illustrate a method of retrieving an exemplary implantable device using the retrieval catheter and cutting device of FIGS. 60A-60B. [Figure 61B] 61A-61C illustrate a method of retrieving an exemplary implantable device using the retrieval catheter and cutting device of FIGS. 60A-60B. [Figure 62A] 62A-62H illustrate a method of detaching an exemplary implantable device from at least one leaflet of a native heart valve using an exemplary cutting device. [Figure 62B] 62A-62H illustrate a method of detaching an exemplary implantable device from at least one leaflet of a native heart valve using an exemplary cutting device. [Figure 63A] 63A-63D show a method of implanting a replacement valve into a native valve such that the replacement valve captures an implantable device attached to the native valve. [Figure 63B] 63A-63D show a method of implanting a replacement valve into a native valve such that the replacement valve captures an implantable device attached to the native valve. [Figure 64] FIG. 64 illustrates an exemplary replacement valve. [Figure 65A] 65A-65E illustrate a method of implanting the replacement valve of FIG. 64 over the native valve so that the replacement valve captures the implantable device attached to the native valve. [Figure 65B] 65A-65E illustrate a method of implanting the replacement valve of FIG. 64 over the native valve so that the replacement valve captures the implantable device attached to the native valve. [Figure 65C] 65A-65E illustrate a method of implanting the replacement valve of FIG. 64 over the native valve so that the replacement valve captures the implantable device attached to the native valve. [Fig. 65D] 65A-65E illustrate a method of implanting the replacement valve of FIG. 64 over the native valve so that the replacement valve captures the implantable device attached to the native valve. [Figure 65E] 65A-65E illustrate a method of implanting the replacement valve of FIG. 64 over the native valve so that the replacement valve captures the implantable device attached to the native valve. [Figure 66] 66-71 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 67]66-71 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 68] 66-71 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 69] 66-71 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 70] 66-71 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 71] 66-71 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 72] FIG. 72 illustrates an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 73] 73-77 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 74] 73-77 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 75] 73-77 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 76] 73-77 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 77] 73-77 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 78] 78-83 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 79] 78-83 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 80] 78-83 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 81]78-83 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 82] 78-83 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 83] 78-83 show an exemplary cutting device for detaching the implantable device from the valve leaflets. [Figure 84] FIG. 84 illustrates an exemplary cutting device for detaching the implantable device from the valve leaflets. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0077] In the following description, reference is made to the accompanying drawings which illustrate example implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0078] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, various implementations of valve repair devices, implantable devices, implants, and systems (including systems for delivering the same) are disclosed herein, and unless specifically excluded, any combination of these options can be made. In other words, individual components of the disclosed devices and systems can be combined unless they are mutually exclusive or otherwise physically impossible.

[0079] The treatment techniques, methods, operations, steps, etc. described or suggested in this specification or the references incorporated herein may be performed on living subjects (e.g., humans, other animals, etc.) or on non-living simulations such as cadavers, cadaver hearts, simulators, virtual persons, etc. When performed in a simulation, the body parts, e.g., hearts, tissues, valves, etc., may optionally be referred to as "simulations" (e.g., simulated hearts, simulated tissues, simulated valves, etc.) and may include, for example, computerized and / or physical representations of the body parts, tissues, etc.

[0080] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection may be direct, such as between the components, or may be indirect, such as through the use of one or more intermediate components. Also, references to a "member," "component," or "portion" described herein are not limited to a single structural member, component, or element, but may include an assembly of components, members, or elements. Also, the terms "substantially" and "about" described herein are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%). Although the terms "clasp" and "clasp arm" are often used herein with respect to specific embodiments, the terms "gripping member" and / or "gripping arm" may be substituted and function in the same or similar manner, even if not configured in the same manner as a typical clasp.

[0081] 1 and 2 are cross-sectional views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., 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., leaflets 20, 22 shown in Figs. 3-6 and leaflets 30, 32, 34 shown in Fig. 7) that extend inwardly across their respective valve openings, which come together or "coapt" in flow to form a unidirectional fluid occlusion surface. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomical structures of the left atrium LA and the left ventricle LV are described in more detail. However, the devices described herein may also be used in the repair of other native valves, for example, the devices may be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0082] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase, or diastole, seen in FIG. 1, blood already collected in the left atrium LA (during the contraction phase) moves through the mitral valve MV into the left ventricle LV due to the expansion of the left ventricle LV. During the contraction phase, or systole, seen in FIG. 2, the left ventricle LV contracts to pump blood through the aortic valve AV and the ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close, preventing blood from flowing back from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described in this application is used to restore the function of a defective mitral valve MV. That is, the device is configured to assist in the closure of the leaflets of the mitral valve to prevent, inhibit, or reduce blood from flowing back from the left ventricle LV into the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation element or spacer that beneficially acts as a filler in the regurgitant opening to prevent or reduce backflow or regurgitation during systole, although this is not required.

[0083] Referring now to Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see Figure 5), which is a variably dense fibrous ring of tissue that surrounds the leaflets 20, 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located in the wall of the left ventricle LV at the base of the chordae tendineae CT) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from everting. 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. Rather, the papillary muscles PM support or brace the leaflets 20, 22 against the high pressures required to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular tissue, which function to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in Figure 3, the anatomy of the leaflets 20, 22 is such that the inner surfaces of the leaflets meet at their free ends and the leaflets 20, 22 begin to retract or spread apart from one another. The leaflets 20, 22 spread apart toward the atrium until each leaflet contacts the mitral valve annulus.

[0084] Various disease processes can impair the proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber deficiency, 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 disease (e.g., cardiomyopathies, etc.) can distort the geometry of the native valve, which can cause the native valve to malfunction. However, the majority of patients who undergo valve surgery, such as mitral valve MV surgery, suffer from a degenerative disease that causes malfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0085] In general, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely, thereby causing impaired blood flow. Typically, valve stenosis is due to the accumulation of calcified material on the leaflets of the valve, which thickens the leaflets and impairs the ability of the valve to open completely and allow forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely, causing blood to leak back into the previous heart chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0086] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier's Type I, II, and III insufficiencies. Carpentier's Type I insufficiency involves dilatation of the valve annulus, so that normally functioning leaflets move apart and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in the insufficiency of the Type I mechanism is leaflet perforation, as occurs in endocarditis. Carpentier's Type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier's Type III insufficiency involves restricted movement of one or more leaflets of the native valve, so that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or ventricular dilatation.

[0087] With reference to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 are coapted, thereby preventing blood from leaking from the left ventricle LV into the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA during systole, so that the edges of the leaflets 20, 22 do not contact each other. Such malcoaptation 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 systole, as shown by the mitral regurgitation MR flow path in FIG. 3. With reference to FIG. 6, the gap 26 may have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 may have a width W of greater than 15 mm or even greater than 17.5 mm. As discussed above, there are several different ways in which a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) may become incompetent, causing valve regurgitation.

[0088] In any of the above situations, a valve repair device or implant that can engage the anterior leaflets 20 and posterior leaflets 22 and close the gap 26 to prevent or inhibit backflow of blood through the mitral valve MV is desirable. As can be seen from FIG. 4, an abstract representation of a valve repair device, implantable device, or implant 10 is shown implanted between the leaflets 20, 22 such that backflow does not occur during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) of the device 10 have a generally tapered or triangular shape that naturally matches the shape of the native valve and its tendency to expand (towards the annulus). In this application, the terms spacer, coaptation element, gap filler, plug, etc. are used interchangeably and refer to elements that are configured to fill a portion of the space between the leaflets of the native valve and / or to cause the leaflets of the native valve to engage or "coapt" (e.g., so that the native leaflets coapt not only to each other but also to the coaptation element, spacer, etc.).

[0089] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve AV or the pulmonary valve PV, and regurgitation has been found to primarily affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the burden on the heart H and, if left untreated, can lead to extremely serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. This is because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating blood flow throughout the body. Thus, since pressures are substantially higher in the left side of the heart, insufficiency of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening.

[0090] Dysfunctional native heart valves can be either repaired or replaced. Repair typically involves maintaining and correcting 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 pulmonary valve PV are more prone to stenosis. Since the stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or pulmonary valve can be to remove the valve and replace it with a surgically implanted heart valve, or to replace it with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to deformation of the leaflets and / or surrounding tissue, which can prevent the mitral valve MV or tricuspid valve TV from closing properly, as described above, and can cause regurgitation or backflow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV can cause regurgitation or backflow from the left ventricle LV into the left atrium LA, as shown in FIG. 3). Regurgitation or backflow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. In addition, regurgitation can occur due to incompetence of the chordae tendineae CT (e.g., the chordae tendineae CT can stretch or rupture), allowing the anterior leaflet 20 and posterior leaflet 22 to evertate so that blood flows back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be ameliorated by repairing the structure of the chordae tendineae CT or mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0091] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it is understood that the devices and concepts provided herein can be used to repair any native valve, as well as to repair 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 backflow of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or inhibit backflow of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used together on all three of the leaflets 30, 32, 34 to prevent or inhibit backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein can be centrally located between the three leaflets 30, 32, 34.

[0092] An exemplary device or implant may optionally have a coaptation element (e.g., a spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) and at least one anchor (e.g., one, two, three or more). In some implementations, an implantable device or implant may have any combination or subcombination of the features disclosed herein without a coaptation element. The coaptation element (e.g., a spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.), when included, is configured to be positioned within the native heart valve opening to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or blocking the backflow described above. The coaptation element may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the native valve leaflets to close around the coaptation element during ventricular systole, thereby blocking backflow of blood from the left or right ventricle into the left or right atrium, respectively. The device or implant can be configured to seal against two or three native leaflets, i.e., the device can be used with native mitral (bicuspid) and native tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill the space between dysfunctional native leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely.

[0093] The optional coaptation elements (e.g., spacers, coaptation elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) may have a variety of shapes. In some implementations, the coaptation elements may have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation elements 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 implementations, the coaptation elements may have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the native leaflets. In some implementations configured for use with a tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid leaflets.

[0094] In some implementations, the anchors can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between two native leaflets. In some implementations configured for use with a tricuspid valve, the anchors are configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between three native leaflets. In some implementations, the anchors can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchors can be attached to an actuation element (e.g., actuation shaft, actuation tube, actuation wire, etc.) to which the coaptation element is also attached. In some implementations, the anchors and coaptation elements can be independently positioned relative to one another by separately moving each of the anchors and coaptation elements along a longitudinal axis of the actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some implementations, the anchors and coaptation elements can be simultaneously positioned by moving the anchors and coaptation elements together along a longitudinal axis of the actuation element (e.g., shaft, actuation wire, etc.). The anchors may be configured to be positioned behind the native valve leaflets when implanted such that the leaflets are grasped by the anchors.

[0095] The device or implant may be configured to be implanted via a delivery system or other delivery means. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The coaptation element and anchor may be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured such that the anchor is radially expanded away from the initially still compressed coaptation element to create a gap between the coaptation element and the anchor. The native leaflet may then be positioned within the gap. The coaptation element may be radially expanded to close the gap between the coaptation element and the anchor to capture the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. The implantation methods for various implementations may vary and are described more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 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 simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where body parts, hearts, tissues, etc. are simulated), etc.

[0096] The disclosed device or implant may be configured such that anchors are connected to the leaflets and utilize tension from the natural chordae tendineae to resist high systolic pressures that urge the device toward the left atrium. During diastole, the device may rely on compressive and retaining forces exerted on the leaflets that are gripped by the anchors.

[0097] 8-15, a schematic representation of a 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, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated by reference in their entireties. The device 100 may include any other features of another device or implant described in this application or the applications cited above, and the device 100 may be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above).

[0098] 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 thereof, etc. The device or implant 100 includes a joint portion 104 and an anchor portion 106.

[0099] In some implementations, the interface portion 104 of the device or implant 100 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes an interface element 110 that is slidably attached to an actuation element 112 (e.g., an actuation wire, shaft, tube, hypotube, line, suture, blade, etc.). The anchor portion 106 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, a paddle, a gripping element, or the like. When the actuation element 112 is actuated, the anchor portion 106 of the device 100 opens and closes to grip the native leaflets during implantation. The actuation element 112 (as well as other actuation elements disclosed herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As one example, the actuation element can be threaded such that rotating the actuation element causes the anchor portion 106 to move relative to the interface portion 104. Alternatively, the actuation element can be unthreaded such that pushing or pulling on the actuation element 112 causes the anchor portion 106 to move relative to the interface portion 104.

[0100] The anchor portion 106 and / or anchor of the device 100, in some implementations, includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the interface element 110 by portions 124, 126, 128. The portions 124, 126, 128 may be interfaced and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, interface element 110, and cap 114 by portions 124, 126, 128 may constrain the device to the positions and movements shown herein.

[0101] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuating element 112 (e.g., an actuating wire, shaft, tube, hypotube, line, suture, blade, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuating element 112 extends through the delivery catheter and the interface element 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuating element 112 increases and decreases, respectively, the spacing between the interface element 110 and the distal end of the device (e.g., a cap 114 or other attachment portion). In some implementations, a collar or other attachment element (e.g., a clamp, clip, lock, suture, friction fit, buckle, snap fit, lasso, etc.) removably attaches, either directly or indirectly, the interface element 110 to the delivery system 102 such that the actuation element 112 slides through the collar or other attachment element, and in some implementations, through the interface element 110 during actuation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0102] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member (e.g., a gripping arm, a clasp arm, etc.). The illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, optional friction enhancing elements, other securing structures 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and an interface portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the interface portion 138 disposed proximate to the interface element 110. The interface portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the clasp 130. The interface portion 138 may be any suitable interface, such as a flexible interface, a spring interface, a pivot interface, or the like. In some implementations, interface 138 is a flexible piece of material integrally formed with fixed arm 132 and movable arm 134. Fixed arm 132 is attached to inner paddle 122 and remains stationary or substantially stationary relative to inner paddle 122 when movable arm 134 is in an open state, opening clasp 130 and exposing optional barbs or other friction enhancing elements 136.

[0103] In some implementations, the clasp 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend or pivot on a joint 138. The actuation line 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible.

[0104] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be spring loaded so that the clasp 130 continues to provide a clamping force against the grasped native leaflet in the closed position. Optional barbs or other frictional enhancing elements 136 of the clasp 130 can grasp, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0105] During implantation, the paddles 120, 122 may be opened and closed, for example, to grip the native leaflets (e.g., leaflets of a native mitral valve, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element 110 (e.g., spacer, plug, membrane, etc.). The clasps 130 may be used to grip 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 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) of the clasps 130 may increase friction with the leaflets or partially or completely puncture the leaflets. The actuation lines 116 may be actuated separately such that each clasp 130 may be opened and closed separately. Acting separately allows one leaflet to be grasped at a time, or the clasp 130 to be repositioned on a leaflet that was not adequately grasped without changing the good grip on the other leaflets. The clasp 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), allowing the leaflets to be grasped in various positions as the particular situation requires.

[0106] 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 placed on the end of the catheter of the delivery system 102 in the fully open position. In the extended state, the cap 114 is spaced apart from the coaptation element 110 such that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 can be held closed during deployment through the delivery system. The actuation line 116 can extend to and be attached to a movable arm 134.

[0107] 9, device 100 is shown in an extended state similar to FIG. 8, but with clasp 130 in a range of about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or in a fully open position of about 180 degrees between fixed arm 132 and movable portion 134 of clasp 130.

[0108] 10, the device 100 is shown in a contracted or fully closed state. To move the device 100 from the extended state to the contracted state, the actuation element 112 is retracted, pulling the cap 114 towards the interface element 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained from moving, so that the compressive force acting on the outer paddle 120 from the cap 114 retracting towards the interface element 110 moves the paddle or gripping element radially outward. The outer paddle 120 maintains an acute angle with the actuation element 112 during movement from the open position to the closed position. The outer paddle 120 can optionally be biased towards the closed position. The inner paddle 122 moves through a much larger angle during the same movement, as it is oriented away from the open interface element 110, and crushes along the side of the closed interface element 110.

[0109] 11-13, the device 100 is shown in a partially open, ready to grasp state. To move from a fully closed state to a partially open state, an actuation element (e.g., actuation wire, shaft, tube, hypotube, line, suture, blade, etc.) is extended to push the cap 114 away from the coaptation element 110, thereby pulling the outer paddle 120 and then the inner paddle 122, causing the anchor or anchor portion 106 to partially unfold. The actuation line 116 is also retracted, opening the clasp 130 so that the leaflets can be grasped. In some implementations, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation element 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 also closes the clasp. In some implementations, the paddles 120, 122 may be independently controllable. In the example shown in FIG. 15, the device 100 may have two actuating elements 111, 113 and two independent caps 115, 117 (or other attachments), such that one independent actuating element (e.g., actuation wires, shafts, tubes, hypotubes, lines, sutures, blades, etc.) and cap (or other attachment) is used to control one paddle, and the other independent actuating element and cap (or other attachment) is used to control the other paddle.

[0110] 12, one of the actuation lines 116 can be extended to close one of the clasps 130. Now, referring to FIGURE 13, the other actuation line 116 can be extended to close the other clasp 130. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0111] 14, the device 100 is shown in a fully closed and deployed state. The delivery system 102 and actuation element 112 are retracted and the paddles 120, 122 and clasp 130 remain in the fully closed position. Once deployed, the device 100 may be maintained in the fully closed position by a mechanical latch or may be biased to remain closed by the use of a spring material such as steel, other metals, plastics, composites, or a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from a metal such as steel or from a shape memory alloy such as Nitinol that is fabricated into a wire, sheet, tube, or laser sintered powder and biased to hold the outer paddle 120 closed around the interface element 110 and the clasp 130 in a clamped state around the native leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the valve leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0112] Figure 15 shows an embodiment in which the paddles 120, 122 are independently controllable. The device 101 shown in Figure 15 is similar to the device shown in Figure 11, except that the device 100 of Figure 15 includes an actuation element configured as two independent actuation elements 111, 113 coupled to two independent caps 115, 117. The actuation element 111 is extended to push the cap 115 away from the interface element 110 to transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor 108 to partially expand. The actuation element 113 is extended to push the cap 115 away from the spacer or mating element 110 to transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially expand. The independent paddle control shown in Figure 15 can be implemented in any of the devices disclosed in this application. For comparison, in the embodiment shown in Figure 11, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation element 112.

[0113] 16-21, the device 100 of Figures 8-14 is shown being delivered and deployed within the native mitral valve MV of the heart H. With reference to Figure 16, a 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 in Figure 16. The actuating element 112 is then retracted, moving the implant / device to a fully closed state as shown in Figure 17.

[0114] As can be seen from Figure 18, the implant / device can be moved into position within the mitral valve MV and into the ventricle LV and partially opened to grasp the leaflets 20, 22. For example, the steerable catheter can be advanced and steered or bent to position the steerable catheter as Figure 18 shows. An implant catheter connected to the implant / device can be advanced from within the steerable catheter to position the implant as Figure 18 shows.

[0115] 19, the implant catheter may be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasps 130. The actuating line 116 is extended to close one of the clasps 130, capturing the leaflet 20. FIG. 20 shows the other actuating line 116 then being extended to close the other clasp 130, capturing the remaining leaflet 22. Finally, as can be seen from FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuating element 112, and actuating line 116 are then retracted and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0116] Any of the features disclosed herein may be used in a wide variety of different valve repair devices. Figures 22-24 show examples of valve repair devices that may be modified to include any of the features disclosed herein. Any combination or subcombination of the features disclosed herein may be combined with, substituted for, and / or added to any combination or subcombination of the features of the valve repair devices shown in Figures 8-24.

[0117] 22, one embodiment of an implantable device or implant 200 is shown. Device 200 is one of many different configurations that device 100, shown generally in FIGS. 8-14, may take. Device 200 may include any other features of an implantable device or implant described herein, and device 200 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system, such as any of the valve repair systems disclosed herein. Device / implant 200 may be an artificial spacer device, a valve repair device, or another type of implant that is attached to the leaflets of a native valve.

[0118] In some implementations, the implantable device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) for implantation between the leaflets of the native valve. In some implementations, the anchor portion 206 includes multiple anchors 208. The anchors may be configured in a variety of ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension or frame 224, and a clasp 230. In some implementations, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism of a delivery system. The delivery system for device 200 may be the same as or similar to delivery system 102 described above and may comprise 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 pathway, combinations thereof, etc. The capture mechanism may be configured in a variety of ways and in some implementations may include one or more of a clamp, clip, pin, suture, line, lasso, noose, snare, buckle, lock, latch, etc.

[0119] In some implementations, the joint elements 210 and paddles 220, 222 are formed from a flexible material, which may be a metal fabric formed as a mesh, woven fabric, braided fabric, or the like, or in any other suitable manner, or a flexible material that is laser cut or otherwise cut. The material may be a fabric, a shape memory alloy wire, such as Nitinol, to provide shape setting capabilities, or any other flexible material suitable for implantation within the human body.

[0120] An actuating element (e.g., an actuating wire, shaft, tube, hypotube, line, suture, blade, etc.) may extend from a delivery system (not shown) and engage the device or implant 200 to enable actuation thereof. In some implementations, the actuating element extends through the proximal collar 211 and spacer or interface element 210 and engages a cap 214 on the distal portion 207. The actuating element may be configured to releasably engage the cap 214 with a threaded connection, or the like, such that the actuating element may be disengaged and removed from the device 200 after implantation.

[0121] The coaptation element 210 extends from a proximal collar 211 (or other attachment element) to an inner paddle 222. In some implementations, the coaptation element 210 has a generally elongated and circular shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an oval shape or cross-section when viewed from above, a tapered shape or cross-section when viewed from the front, and a circular shape or cross-section when viewed from the side. A mixture of these three geometries may result in the illustrated three-dimensional shape of the coaptation element 210 that achieves the benefits described herein. The round shape of the coaptation element 210 may also be seen to substantially follow or approximate the shape of the paddle frame 224 when viewed from above.

[0122] The size and / or shape of the coaptation element 210 may be selected to minimize the number of implants required per patient (preferably one) while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation element is about 5 mm, and the medial-lateral distance at the widest point of the coaptation element is about 10 mm. In some implementations, the overall geometry of the device 200 may be based on these two dimensions and the overall shape plan described above. It will be readily apparent that using other anterior-posterior and medial-lateral distances as a starting point for the device will result in a device with different dimensions. Additionally, using other dimensions and the shape plan described above will also result in a device with different dimensions.

[0123] In some implementations, the outer paddle 220 is joinably attached to the cap 214 of the distal portion 207 by connecting portion 221 and to the inner paddle 222 by connecting portion 223. The inner paddle 222 is joinably attached to the joint element by connecting portion 225. In this manner, the anchor 208 is configured similar to a leg, in that the inner paddle 222 is like an upper portion of a leg, the outer paddle 220 is like a lower portion of a leg, and the connecting portion 223 is like a knee portion of a leg.

[0124] In some implementations, the inner paddle 222 is hard, relatively hard, rigid, has a rigid portion, and / or is rigidified by a reinforcing member or fastening portion of the clasp 230. The inner paddle 222, the outer paddle 220, and the interface elements may all be interconnected as described herein.

[0125] In some implementations, the paddle frame 224 is attached to the cap 214 of the distal portion 207 and extends to a connection 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a material that is stiffer and harder than the material forming the paddles 222, 220 such that the paddle frame 224 provides support for the paddles 222, 220.

[0126] The paddle frame 224 may provide additional clamping force between the inner paddle 222 and the coaptation element 210 and may help wrap the leaflets around the sides of the coaptation element 210. That is, the paddle frame 224 may be configured with a rounded three-dimensional shape that extends from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer and inner paddles 220 and 222, the cap 214, and the coaptation element 210 may constrain each of these components to the movements and positions described herein. In particular, the connecting portion 223 is constrained by its connections between the outer and inner paddles 220 and 222, and by its connections to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus the inner and outer paddles 222 and 220) and by its attachment to the cap 214.

[0127] The wider configuration of the paddle frame 224 increases the surface area as compared to just the inner paddle 222. The increased surface area allows the clamping force of the paddles 220 and paddle frame 224 against the native leaflets to be distributed over a larger area of ​​the native leaflets to further protect the native leaflet tissue.

[0128] 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 in Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215). Any combination or subcombination of features disclosed by this 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. WO2018 / 195215). Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) is incorporated herein by reference in its entirety.

[0129] 23, there is shown an embodiment of a device or implant 300. Device 300 is one of many different configurations that device 100 may assume, as shown generally in Figures 8-14. Device 300 may include any other features of a device or implant discussed herein, and device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0130] The device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes an interface portion 304, which can optionally include an interface element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, such as an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors can also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging a capture mechanism of a delivery system.

[0131] The anchors 308 may be attached to other portions of the device and / or to each other in a variety of different manners (e.g., directly, indirectly, by welding, by sutures, by adhesive, by links, by latches, by integral formation, by combinations of any or all of these, etc.) In some implementations, the anchors 308 are attached to the interface element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0132] The 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. The connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached to the cap 314 or other mounting portion. In this manner, the anchor 308 is configured similar to a leg, in that the inner paddle 322 is like an upper portion of a leg, the outer paddle 320 is like a lower portion of a leg, and the connecting portion 323 is like a knee portion of a leg.

[0133] In implementations including interface element 310, interface element 310 and anchor 308 may be coupled together in a variety of ways. As shown in the illustrated embodiment, interface element 310 and anchor 308 may be coupled together by integrally forming interface element 310 and anchor 308 as a single, unitary component. This may be accomplished, for example, by forming interface element 310 and anchor 308 from a continuous piece 301 of braided or woven material, such as braided or woven Nitinol wire. In the illustrated embodiment, interface element 310, outer paddle portion 320, inner paddle portion 322, and connecting portions 321, 323, 325 are formed from a continuous piece of fabric 301.

[0134] Similar to the anchors 208 of the device or implant 200 described above, the anchors 308 may be configured to transition between various configurations by axially moving a distal end of the device (e.g., cap 314, etc.) relative to a proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement may occur along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device.

[0135] In some implementations, 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 implementations, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the spacer or coaptation element 310. From the straight configuration, the anchor 308 can be moved to a fully collapsed configuration (e.g., FIG. 23), for example, by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device.

[0136] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 330 includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and an interface portion 338. The fixed arm 332 is attached to the inner paddle 322 with the interface portion 338 disposed proximate to the interface element 310. The interface portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward one another when the clasp 330 is in a closed state.

[0137] The fixed arm 332 is attached to the inner paddle 322 by sutures through holes or slots. The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened, thereby opening the clasp 330 to expose the optional barb 336. The clasp 330 is opened by applying tension to an actuation line attached to the movable arm 334, thereby allowing the movable arm 334 to articulate, pivot, and / or bend on the interface 338.

[0138] In summary, the device or implant 300 is similar in construction and operation to the device or implant 200 described above, except that the joint element 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed from a single piece of material 301. In some implementations, the piece of material 301 is attached to the proximal collar 311, the cap 314, and the paddle frame 324 by weaving or inserting through openings in the proximal collar 311, in the cap 314, and in the paddle frame 324 that are configured to receive the continuous piece of material 301. The continuous piece 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of material 301, and other portions are formed from multiple overlapping or overlapping layers of the piece of material 301.

[0139] For example, Figure 23 shows a joining element 310 and inner paddle 322 formed from multiple overlapping layers of material strips 301. The single continuous piece of material 301 may begin and end at various locations on the apparatus 300. The ends of the piece of material 301 may be at the same location or at different locations on the apparatus 300. For example, in the illustrated embodiment of Figure 23, the piece of material 301 begins and ends at the location of the inner paddle 322.

[0140] As with the device or implant 200 described above, the size of the coaptation element 310 may be selected to minimize the number of implants required per patient (preferably one), while at the same time maintaining a low transvalvular gradient. Notably, by forming many of the components of the device 300 from a single piece of material 301, the device 300 may be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance at the device 300's widest point (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is approximately 5 mm.

[0141] 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 this 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.

[0142] 24 illustrates one embodiment of one of many valve repair systems 40056 for repairing a patient's native valve to which the concepts of the present application may be applied. The valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0143] The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656, and a pair of gripping members 40856 (e.g., clasps, clasp arms, grippers, gripping arms, latches, etc.). In one embodiment, the paddles 40656 may be formed integrally with the base assembly. For example, the paddles 40656 may be formed as an extension of a link of the base assembly. In the illustrated embodiment, the base assembly 40456 of the valve repair device 40256 includes a shaft 40356, a coupler 40556 configured to move along the shaft, and a lock 40756 configured to lock the coupler in a stationary position on the shaft. The coupler 40556 is mechanically connected to the paddles 40656 such that movement of the coupler 40556 along the shaft 40356 moves the paddles between an open position and a closed position. In this manner, the couplers 40556 function as a means for mechanically coupling the paddles 40656 to the shaft 40356 and for moving the paddles 40656 between their open and closed positions as they move along the shaft 40356.

[0144] In some implementations, the gripping member 40856 is pivotally connected to the base assembly 40456 (e.g., the gripping member 40856 can be pivotally connected to the shaft 40356, or any other suitable member of the base assembly) such that the gripping member can be moved to adjust the width of the opening 41456 between the paddle 40656 and the gripping member 40856. The gripping member 40856 can include an optional barbed portion 40956 for attaching the gripping member to the valve tissue when the valve repair device 40256 is attached to the valve tissue. When the paddle 40656 is in a closed position, the paddle engages the gripping member 40856 such that when the valve tissue is attached to the barbed portion 40956 of the gripping member, the paddle secures the valve repair device 40256 to the valve tissue. In some implementations, the gripping member 40856 is configured to engage the paddle 40656 such that the optional barbed portion 40956 engages the valve tissue member and the paddle 40656 to secure the valve repair device 40256 to the valve tissue member. For example, in certain circumstances it may be advantageous to have the paddle 40656 maintain an open position and move the gripping member 40856 outwardly toward the paddle 40656 to engage the valve tissue and the paddle 40656.

[0145] Although the embodiment depicted in FIG. 24 shows a pair of paddles 40656 and a pair of gripping members 40856, it will be understood that the valve repair device 40256 can include any suitable number of paddles and gripping members.

[0146] In some implementations, 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. The placement shaft 41356 is detached from the shaft 40356 after the valve repair device 40256 is secured to the valve tissue, removing the valve repair device 40256 from the remainder 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's body.

[0147] The valve repair system 40056 can also include a paddle control mechanism 41056, a gripper control mechanism 41156, and a lock control mechanism 41256. The paddle control mechanism 41056 is mechanically attached to the coupler 40556 to drive the paddle 40656 between open and closed positions by driving the coupler along the shaft. The paddle control mechanism 41056 can take any suitable form and can include, for example, a shaft, wire, tube, hypotube, rod, suture, line, etc. For example, the paddle control mechanism can include a hollow shaft and a catheter tube or sleeve that fits over the mounting shaft 41356 and the shaft 40356 and connects to the coupler 40556.

[0148] The gripper control mechanism 41156 is configured to move the gripping member 40856 such that the width of the opening 41456 between the gripping member and the paddle 40656 can be altered. The gripper control mechanism 41156 can take any suitable form, such as, for example, a line, suture, wire, rod, catheter, tube, hypotube, etc.

[0149] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 locks the coupler 40556 in a stationary position relative to the shaft 40356 and can take a wide variety of different forms, and the type of lock control mechanism 41256 can be determined by the type of lock used. In embodiments in which the lock 40756 includes a pivotable plate, the lock control mechanism 41256 is configured to engage the pivotable plate to move the plate between the tilted position and the substantially non-tilted position. The lock control mechanism 41256 can be, for example, a rod, suture, wire, or any other member that can move the pivotable plate of the lock 40756 between the tilted position and the substantially non-tilted position.

[0150] The valve restoration device 40256 is movable from an open position to a closed position. The base assembly 40456 includes a link that is moved by a coupler 40556. The coupler 40556 is movably attached to a shaft 40356. To move the valve restoration device from the open position to the closed position, the coupler 40556 is moved along the shaft 40356, thereby moving the link.

[0151] The gripper control mechanism 41156 moves the gripping members 40856 to provide a wider or narrower gap at the opening 41456 between the gripping members and the paddle 40656. In the illustrated embodiment, the gripper control mechanism 41156 includes a line, such as a suture, wire, or the like, that is connected to an opening in the end of the gripping members 40856. When the line is pulled, the gripping members 40856 move inward, causing the opening 41456 between the gripping members and the paddle 40656 to become wider.

[0152] To move the valve restoration device 40256 from an open position to a closed position, the lock 40756 is moved to an unlocked state by the lock control mechanism 41256. Once the lock 40756 is in the unlocked state, the coupler 40556 may be moved along the shaft 40356 by the paddle control mechanism 41056.

[0153] After the paddle 40656 is moved to the closed position, the lock 40756 is moved to a locked state by the lock control mechanism 41256 to maintain the valve repair device 40256 in the closed position. After the valve repair device 40256 is maintained in the locked state by the lock 40756, the valve repair device 40256 is removed from the delivery device 40156 by decoupling the shaft 40356 from the deployment shaft 41356. In addition, the valve repair device 40256 is disengaged from the paddle control mechanism 41056, the gripper control mechanism 41156, and the lock control mechanism 41256.

[0154] Additional features of the device 40256, 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 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of features disclosed by this 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.

[0155] The clasp or leaflet grasping device disclosed herein can take a wide variety of different forms. An example of a clasp is disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Any combination or subcombination of features disclosed by this application can be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201) is incorporated herein by reference in its entirety.

[0156] 25A and 25B, an exemplary implementation of the valve repair device 40256 includes a coaptation element 3800. The valve repair device 40256 may have the same configuration as the valve repair device shown in FIG. 24 with the addition of the coaptation element. The coaptation element 3800 may take a wide variety of different shapes. The coaptation element 3800 may be compressible and / or expandable. For example, the coaptation element may be compressed to fit within one or more catheters of a delivery system, may expand when moved out of the one or more catheters, and / or may be compressed by a paddle 40656 to adjust the size of the coaptation element. In the embodiment shown in FIG. 25A and 25B, the size of the coaptation element 3800 may be decreased by squeezing the coaptation element with the paddle 40656 and increased by moving the paddle 40656 away from each other. The coaptation element 3800 may extend beyond the outer edge 4001 of the gripping member or clasp 40856 as illustrated to provide additional surface area for closing the mitral valve gap.

[0157] The coaptation element 3800 may be coupled to the valve repair device 40256 in a variety of different ways. For example, the coaptation element 3800 may be fixed to the shaft 40356, slidably disposed about the shaft, connected to the coupler 40556, connected to the lock 40755, and / or connected to a central portion of the catch or gripping member 40856. In some implementations, the coupler 40656 405 may take the form of the coaptation element 3800. That is, a single element may be used as the coupler 40556 that moves the paddle 40656 between the open and closed positions and the coaptation element 3800 that closes the gap between the leaflets 20, 22 when the valve repair device 40256 is attached to the leaflets.

[0158] The interface element 3800 can be disposed about one or more of the shaft or other control elements of the valve repair system 40056. For example, the interface element 3800 can be disposed about the shaft 40356, the shaft 41356, the paddle control mechanism 41056, and / or the lock control mechanism 41256.

[0159] The valve repair device 40256 may include any other features for the valve repair device discussed in this 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 this application). Additional features of the device 40256, 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 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of features disclosed by this 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).

[0160] 26-30 show one embodiment of one of many valve repair systems for repairing a patient's native valve to which the concepts of the present application may be applied. With reference to FIGS. 29 and 30, the valve repair system includes an implant catheter assembly 1611 and an implantable valve repair device 8200. With reference to FIGS. 26-28, the 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 may be configured in a variety of ways.

[0161] 26, the paddle frame 8224 may be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 8224 is not symmetrical about the axis YY. Further, with reference to FIG. 26, the paddle frame 8224 includes an outer frame portion 8256 and an inner frame portion 8260.

[0162] In some implementations, the connector 8266 (e.g., a shaped metal component, a shaped plastic component, a tether, a wire, a post, a line, a cord, a suture, etc.) is attached to the outer frame portion 8256 at an outer end of the connector 8266 and to the coupler 8972 at an inner end 8968 of the connector 8266 (see FIG. 28 ). Between the connector 8266 and the attachment portion 8205, the outer frame portion 8256 forms a curved shape. For example, in the illustrated embodiment, the shape of the outer frame portion 8256 resembles an apple shape, where the outer frame portion 8256 is wider toward the attachment portion 8205 and narrower toward the distal portion 8207. However, in some implementations, the outer frame portion 8256 may be shaped in other ways.

[0163] The inner frame portion 8260 extends from the mounting 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 cap 8214. The retaining portion 8272 and the actuation cap 8214 can be configured to be attached in any suitable manner.

[0164] In some implementations, the inner frame portion 8260 is a rigid frame portion while the outer frame portion 8256 is a flexible frame portion. As shown in FIG. 26 , a proximal end of the outer frame portion 8256 connects to a proximal end of the inner frame portion 8260.

[0165] A width adjustment element 8211 (e.g., a width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt, etc.) is configured to move the outer frame portion 8256 from an expanded position to a constricted position by pulling the inner end 8968 ( FIG. 28 ) and a portion of the connector 8266 on the actuation cap 8214. The actuation element 8102 is configured to move the inner frame portion 8260 to open and close the paddles according to some implementations disclosed herein.

[0166] As shown in FIGS. 27 and 28 , the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211 such that a user can move the inner end 8968 inside the receiver 8912 (e.g., an internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a cylinder, a raceway, etc.) to move the outer frame portion 8256 between a constricted position and an expanded position. In the illustrated embodiment, the inner end 8968 includes a post 8970 that is attached to the outer frame portion 8256 and a coupler 8972 that extends from the post 8970. The coupler 8972 is configured to be attached to and detached from both the width adjustment element 8211 and the receiver 8912. The coupler 8972 can take a wide variety of different forms. For example, the coupler 8972 may include one or more of a threaded connection, a mechanism that mates with a thread, an outwardly biased arm, a detent connection such as a wall, or other portion. 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 removed from the width adjustment element 8211, the coupler is secured to the receiver. However, the inner end 8968 of the connector may be configured in a variety of ways. Any configuration may be used that can suitably attach the outer frame portion 8256 to the coupler so that the width adjustment element 8211 can move the outer frame portion 8256 between a constricted position and an expanded position. The coupler may be similarly configured in a variety of ways and may be a separate component or may be integrated with another portion of the device, such as the connector or another portion of the inner end of the connector.

[0167] The width adjustment element 8211 allows a user to expand or contract the outer frame portion 8256 of the device 8200. In the embodiment shown in FIGS. 27 and 28, the width adjustment element 8211 includes a male threaded end that screws into the coupler 8972. The width adjustment element 8211 moves the coupler into 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.

[0168] In some implementations, the receiver 8912 may be integrally formed with the distal cap 8214. Moving the cap 8214 relative to the body of the mounting portion 8205 opens and closes the paddle. In the illustrated embodiment, the receiver 8912 slides inside the body of the mounting portion. When the coupler 8972 is removed from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to the body of the mounting portion 8205. Moving the cap may open and close the device in the same manner as other implementations disclosed above.

[0169] In the illustrated embodiment, the driver head 8916 is disposed at a proximal end of the actuating element 8102. The driver head 8916 removably couples the actuating element 8102 to the receiver 8912. In the illustrated embodiment, the width adjustment element 8211 extends through the actuating element 8102. The actuating element is advanced axially in the opposite direction to the Y direction to move the distal cap 8214. As shown by the arrows in FIG. 27, movement of the distal cap 8214 relative to the mounting portion 8205 is effective to open and close the paddle. That is, when the distal cap 8214 is moved in the Y direction, the device is closed, and when the distal cap is moved in the opposite direction to the Y direction, the device is opened.

[0170] 27 and 28, the width adjustment element 8211 extends through the actuation element 8102, the driver head 8916, and the receiver 8912 and engages a coupler 8972 attached to the inner end 8968. When the outer frame portion 8256 is moved to the stenotic position, the device or implant 8200 may be more easily maneuvered into position for implantation into the heart by reducing contact and / or friction between the native structures of the heart (e.g., chordae tendineae) and the device 8200. When the outer frame portion 8256 is moved to the expanded position, the anchor portions of the device or implant 8200 are provided with a larger surface area to engage and capture the leaflets of the native heart valve.

[0171] 29 and 30, an implementation of an implant catheter assembly 1611 is shown in which the clasp actuation line 624 extends through the handle 1616, the actuation element 8102 is coupled to a paddle actuation control 1626, and the width adjustment element 8211 is coupled to a paddle width control 1628. A proximal end portion 1622a of the 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 the delivery shaft or catheter of the implant catheter assembly 1611, and through the proximal end of the device 8200, where the actuation element couples with a driver head 8916. The actuation element 8102 may be axially movable relative to the outer shaft of the implant catheter assembly 1611 and handle 1616 to open and close the device.

[0172] The width adjustment element 8211 may extend distally from the paddle width control 1628, through the paddle actuation control 1626, through the actuation element 8102 (and consequently through the handle 1616, the outer shaft of the implant catheter assembly 1611, and the device 8200), where the width adjustment element couples with the movable coupler 8972. The width adjustment element 8211 may be axially movable relative to the actuation element 8102, the outer shaft of the implant catheter assembly 1611, and the handle 1616. The clasp actuation line 624 may extend through and be axially movable relative to the handle 1616 and the outer shaft of the implant catheter assembly 1611. The clasp actuation line 624 may also be axially movable relative to the actuation element 8102.

[0173] 29 and 30, the width adjustment element 8211 can be removably coupled to the coupler 8972 of the device 8200. The width adjustment element 8211 is advanced and retracted via the paddle width control 1628 to increase or decrease the width of the paddle. The actuation element 8102 is advanced and retracted via the paddle actuation control 1626 to open and close the paddle of the device.

[0174] 29 and 30, the catheter or shaft of the implant catheter assembly 1611 is an elongate shaft extending axially between a proximal end portion 1622a that is coupled to the handle 1616 and a distal end portion 1622b that is 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.

[0175] 31-59B, various devices and methods are shown that are used to retrieve an implantable device from a native heart valve. Occasionally, it may be necessary to excise a native leaflet (e.g., mitral leaflet 20, 22, or tricuspid leaflet 30, 32, 34) and remove the implantable device from the patient's body. Existing solutions for removing an implantable device often require surgical intervention. Therefore, it is advantageous to utilize a minimally invasive transcatheter-based method for retrieval of the implantable device. As shown in FIG. 31-59B, the devices and methods described below can be used to retrieve any of the implantable devices described herein from the patient's body or any other type of implantable valve repair device. Although the anterior and posterior leaflets 20, 22 of the mitral valve are shown and described in the following exemplary implementations, the use of the devices and methods of FIG. 31-59B is not limited to the mitral leaflets 20, 22 and may be employed with any of the native heart valves described herein. In each of the implementations described below, the various devices may be deployed using a transfemoral, transapical, or transaortic approach, such as from either the atrial or ventricular side of the patient's heart. Additionally, these methods may be performed in live animals or in simulations, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., simulated body parts, hearts, tissues), etc.

[0176] 31-39 show an exemplary apparatus and method for obtaining an implantable apparatus 3100 using at least one cutting apparatus 3140 (see FIG. 32), which includes a snare or lasso 3141. FIG. 31 shows a front view of an implantable device 3100 attached to a natural leaflet (e.g., the anterior and posterior leaflets 20, 22 of the mitral valve as shown). In some implementations, the implantable apparatus 3100 has a collar 3111 at the proximal end of the implantable apparatus 3100 and a cap 3114 at the distal end. FIG. 32 shows a front view of an exemplary retrieval catheter 3160, cutting apparatus 3140, and optional stabilization component 3150.

[0177] The exemplary retrieval catheter 3160 provides a conduit through which the cutting device 3140 and stabilizing component 3150 are delivered to the implantable device 3100. In some implementations, the implantable device 3100 is removed from the native heart valve via the retrieval catheter 3160. In some implementations, the distal end of the retrieval catheter 3160 may also be used to provide a downward force to 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 implementations, the stabilizing component 3150 and the cutting device 3140 are each deployed via separate catheters or stabilizing component 3150, and the cutting device 3140 may be deployed by a single catheter as shown by FIG. The inner diameter of the retrieval catheter 3160 may have an increased inner diameter so that the implantable device 3100 and portions of the excised anterior and posterior leaflets 20, 22 may be retracted therethrough.

[0178] In some implementations, the cutting apparatus 3140 comprises a snare or lasso 3141. The cutting device 3140 may have a first end 3142 and a second end 3144, with at least one end, and in some implementations, both ends 3142, 3144 extending upwardly through the distal end of the retrieval catheter 3160 and 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 implementations, the snare or lasso 3141 comprises features for cutting, severing, or resecting the anterior and posterior lobes 20, 22, such as through the use of friction, electrocautery, vibration, saw teeth, sharp edges, or the like. In some implementations, the cutting device 3140 comprises an electrocautery snare or lasso 3141, which is formed of an electrode that may be comprised of metal elements that allow electrical current to flow. In some implementations, the cutting device 3140 is made of Nitinol to allow for shape memory properties. In some implementations, the snare or lasso 3141 may be comprised of a surface that allows radio frequency energy to ablate tissue around the implantable device 3100.

[0179] The snare or lasso 3141 may also function as the cutting device 3140 and the stabilizing component. In some implementations, a separate stabilizing component 3150 may be used. In some implementations, the stabilizing component 3150 may be deployed through the retrieval catheter 3160 or a separate catheter (not shown). In some implementations, the stabilizing component 3150 comprises an element for gripping and stabilizing the implantable device 3100, such as a stabilizing snare 3152. The stabilizing snare 3152 may be secured around a portion of the implantable device 3100, such as the collar 3111 or the cap 3114. In some implementations, the portion of the implantable device 3100 to which the stabilizing snare 3152 is attached, such as the cap 3114 or the collar 3111, may be configured (e.g., a radiopaque material) to be visible under imaging (e.g., fluoroscopy, x-ray, etc.) to allow a user to more easily secure the stabilizing component 3150 to the implantable device 3100. In some implementations, the stabilizing component 3150 may include pincers, graspers, vacuum suction devices, or any other means of connecting or docking. In some implementations, the stabilizing component 3150 stabilizes the implantable device 3100 and also allows the implantable device 3100 to be withdrawn into the retrieval catheter 3160, partially into the retrieval catheter, or into abutment with the retrieval catheter.

[0180] As shown in Figures 32-33, in some implementations, the cutting device 3140 is deployed by a harvesting catheter 3160 and extends along the implantable device, through the native heart valve between the anterior and posterior leaflets 20, 22, until a snare or lasso 3141 is positioned under the distal end of the implantable device 3100. Optionally, a stabilizing component 3150 may 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 additionally, the cutting device 3140 may be used to stabilize the implantable device 3100 by first securing a snare or lasso 3141 around a portion of the implantable device 3100, such as the cap 3114.

[0181] As shown in FIGS. 34 and 35, in some implementations, the implantable device 3100 can be retracted upward toward the distal end of the retrieval catheter 3160 using at least one of the cutting device 3140 and the stabilizing component 3150, 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 component 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 implementations, 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 proximate to the distal end of the retrieval catheter 3160. In some implementations, the snare or lasso 3141 is retracted upward to surround the implantable device 3100. As the snare or lasso 3141 continues to be retracted around the implantable device 3100, the snare or lasso 3141 contacts tissue of the anterior and posterior lobes 20, 22 on either side of 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 severs the anterior and posterior lobes 20, 22 proximate the implantable device 3100 such that the portions of the anterior and posterior lobes 20, 22 grasped by the implantable device 3100 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 component 3150.

[0182] 36 and 37, in some implementations, two cutting devices 3140A, 3140B are deployed by a retrieval catheter 3160 and extend under the distal end of the implantable device 3100 through the native heart valve between the anterior leaflet 20 and the posterior leaflet 22. In some implementations, the cutting devices 3140A, 3140B each comprise 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, with at least one end, and in some implementations, all of the ends 3142A, 3142B, 3144A, 3144B extending proximally through the distal end of the retrieval catheter 3160 and secured to a retrieval component or device at the proximal end of the retrieval catheter 3160 so as to enable a user to extend or retract the cutting devices 3140A, 3140B within the retrieval catheter 3160.

[0183] In some implementations, the cutting devices 3140A, 3140B are disposed on opposite sides of the implantable device 3100. Optionally, the stabilizing component 3150 may 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 additionally, at least one of the cutting devices 3140A, 3140B may be used to first 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, such as the cap 3114.

[0184] 38 and 39, in some implementations, at least one of the cutting device 3140A, 3140B and stabilizing component 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 stabilizing component 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 implementations, 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 proximate the distal end of the retrieval catheter 3160.

[0185] In some implementations, at least one of the snares or lassos 3141A, 3141B are retracted upwardly 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 contact tissue of the anterior and posterior lobes 20, 22 on either side of the implantable device 3100. In some implementations, the first snare or lasso 3141A resects the anterior lobe 20 and the second snare or lasso 3141B resects the posterior lobe 22. Using any of the cutting or resection methods described above, such as electrocautery, the snare or lasso 3141A, 3141B severs the anterior and posterior lobes 20, 22 proximal to the implantable device 3100 such that the portions of the anterior and posterior lobes 20, 22 grasped by the implantable device 3100 remain attached thereto. The implantable device 3100 can then be retracted proximally towards the distal end of the retrieval catheter 3160 by at least one of the cutting devices 3140A, 3140B or the stabilizing component 3150.

[0186] 40-43 show an exemplary apparatus and method for obtaining the implantable device 3100 using at least one cutting device 3140, the cutting device 3140 including at least one of the coring elements 3170A, 3170B. FIG. 40 shows a side view of an exemplary retrieval catheter 3160, the cutting device 3140 including at least one of the coring elements 3170A, 3170B, and the stabilizing component 3150. As shown in FIG. 40, in some implementations, the implantable device 3100 may include a cap 3114 at a distal end and a collar 3111 at a proximal end of the implantable device 3100. The exemplary retrieval catheter 3160 provides a conduit through which the cutting device 3140 and the stabilizing component 3150 are delivered to the implantable device 3100. In some implementations, the implantable device 3100 is removed from the native heart valve via the retrieval catheter 3160.

[0187] In some implementations, the distal end of the retrieval catheter 3160 may also be used to provide a downward force on the proximal side of the anterior and posterior leaflets 20, 22 and / or 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 resected anterior and posterior leaflets 20, 22 may be retracted therethrough.

[0188] In some implementations, at least one coring element 3170A, 3170B is disposed along an outer surface of the recovery catheter 3160. In some implementations, at least one coring element 3170A, 3170B is deployed from an inner surface of the recovery catheter 3160. In some implementations, the cutting device comprises two coring elements 3170A, 3170B deployed on opposite sides of the removal catheter 3160. In some implementations, the cutting device 3140 comprises a single coring element (reference numbers 3170A, 3170B represent two portions of a single coring element in this implementation) that entirely surrounds the removal catheter 3160. For example, the coring element(s) 3170A, 3170B may be annular or semi-annular, or may include annular or semi-annular cutting portions. In some implementations, the coring elements 3170A, 3170B comprise features for cutting, severing, or ablating the anterior and posterior leaflets 20, 22, such as through the use of friction, electrocautery, vibration, sawing, etc. In some implementations, at least one coring element 3170A, 3170B may be circular, arc-shaped, or annular. In some implementations, at least one coring element 3170A, 3170B may enter tissue of the anterior and posterior leaflets 20, 22 and cut the tissue as it rotates. In some implementations, at least one coring element 3170A, 3170B may comprise a blade or sawing portion for cutting tissue of the anterior and posterior leaflets 20, 22. In some implementations, the coring elements 3170A, 3170B comprise an electrosurgical tip or blade formed from an electrode, which may be comprised of a metal element that allows an electric current to flow. In some implementations, the coring elements 3170A, 3170B are made of Nitinol to allow for shape memory properties. In some implementations, the coring elements 3170A, 3170B may be comprised of a surface that allows radio frequency energy to ablate tissue around the implantable device 3100.

[0189] In some implementations, the stabilizing component 3150 may be deployed through the retrieval catheter 3160 or a separate catheter (not shown). In some implementations, the stabilizing component 3150 comprises an element for gripping and stabilizing the implantable device 3100, such as a stabilizing snare 3152. The stabilizing snare 3152 may be secured around a portion of the implantable device 3100, such as the collar 3111 or the cap 3114. In some implementations, the portion of the implantable device 3100 to which the stabilizing snare 3152 is attached, such as the cap 3114 or the collar 3111, may be configured to enhance imaging so that a user can more easily secure the stabilizing component 3150 to the implantable device 3100. In some implementations, the stabilizing component 3150 may include a pincer, a grasper, a vacuum suction device, or any other docking means. In some implementations, the stabilizing component 3150 stabilizes the implantable device 3100 and also allows the implantable device 3100 to be retracted into the retrieval catheter 3160.

[0190] As shown in FIG. 40, in some implementations, the stabilizing component 3150 is secured around a portion of the implantable device 3100, such as by placing a stabilizing snare 3152 around the collar 3111. As shown in FIG. 41, the stabilizing component 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 implementations, prior to resection, the implantable device 3100 is initially retracted such that the anterior and posterior leaflets 20, 22 are proximal to the distal end of the retrieval catheter 3160. As the stabilization component 3150 continues to retract the implantable device 3100 upwardly into the retrieval catheter 3160 and / or the distal end of the retrieval catheter 3160, and the coring elements 3170A, 3170B are further advanced, the coring elements 3170A, 3170B sever the anterior and posterior leaflets 20, 22 proximate to the implantable device using any of the cutting or cutting methods described above, such as a sharp blade. The portions of the anterior and posterior leaflets 20, 22 grasped by the implantable device 3100 remain attached to it. As shown in FIG. 43, in some implementations, the coring elements 3170A, 3170B may be deployed further distally to allow for complete severing of the anterior and posterior leaflets 20, 22. In some implementations, the coring elements 3170A, 3170B can move in several directions, such as longitudinally, laterally, transversally, or radially, for example, in a radial path around the entire implantable device 3100 to completely sever the implantable device 3100 from the anterior and posterior leaflets 20, 22.The implantable device 3100 can then be retracted by the stabilizing component 3150 upwardly towards the distal end of the retrieval catheter 3160.

[0191] 44-47 show an exemplary apparatus and method for obtaining an implantable device 3100 using at least one cutting device 3140 comprising a movable cutting tip 3143, such as a blade or electrosurgical tip. The retrieval catheter is shown as being offset from the central axis of the implantable device 3100 for illustrative purposes. In some implementations, the retrieval catheter 3160 may be aligned directly over the proximal end of the implantable device 3100. As shown in FIG. 44, in some implementations, the implantable device 3100 may comprise a collar 3111 at the proximal end of the implantable device 3100.

[0192] FIG. 44 shows a top view of an exemplary retrieval catheter 3160, a cutting device 3140 including a cutting tip 3143, a stabilization component 3150, and an optional indicator or gauge 3180. The indicator or gauge 3180 may be configured to be in the same path as the movable cutting tip, but guides the movable cutting tip 3143 to engage the tissue to be cut before the cutting tip 3143. Engagement of the tissue with the indicator or gauge 3180 can provide an indication to the user that tissue is about to be cut. In some implementations, the indicator or gauge 3180 may be configured to distinguish between different types of tissue. For example, the indicator or gauge 3180 may be configured to distinguish valve leaflet tissue from other types of tissue, such as chordae tendineae.

[0193] In some implementations, the retrieval catheter 3160 provides a conduit through which the cutting device 3140, stabilizing component 3150, and indicator or gauge 3180 are delivered to the implantable device 3100. In some other implementations, each of the cutting device 3140, stabilizing component 3150, and / or indicator or gauge 3180 may be deployed via a separate catheter. In some implementations, the implantable device 3100 is removed from the native heart valve via the retrieval catheter 3160. In some implementations, the distal end of the retrieval catheter 3160 may also be used to provide a downward force to 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. The inner diameter of the retrieval catheter 3160 may have an increased inner diameter so that the implantable device 3100 and portions of the excised anterior and posterior leaflets 20, 22 may be retracted therethrough.

[0194] As shown in FIG. 45, in some implementations, the cutting device 3140 comprises a single cutting tip 3143 formed from an electrode that may be comprised of a metal element that allows for electrical current to flow. In some implementations, the cutting device 3140 is made of Nitinol to allow for shape memory properties. In some implementations, the stabilization component 3150 and the indicator or gauge 3180 may be deployed through the retrieval catheter 3160 or a separate catheter (not shown). In some implementations, the stabilization component 3150 comprises an element for gripping and stabilizing the implantable device 3100, such as a stabilization snare 3152. The stabilization snare 3152 may be secured around a portion of the implantable device 3100, such as the collar 3111. In some implementations, the portion of the implantable device 3100 to which the stabilization snare 3152 is attached, such as the collar 3111, may be configured to enhance imaging so that a user can more easily secure the stabilization component 3150 to the implantable device 3100. In some implementations, the stabilizing component 3150 may include pincers, graspers, vacuum suction devices, or any other docking means. In some implementations, the stabilizing component 3150 stabilizes the implantable device 3100 and also allows the implantable device 3100 to be retracted into the retrieval catheter 3160.

[0195] The indicator or gauge 3180 may be used prior to or simultaneously with the cutting device 3140 to indicate the location of the anterior and posterior leaflets 20, 22, particularly any portions of the anterior and posterior leaflets 20, 22 that remain uncut. For example, the indicator or gauge 3180 may include a radiopaque feature. In some implementations, the indicator or gauge 3180 may be a radiopaque feature and / or a depth gauge. In some implementations, the indicator or gauge may be made of a long conforming wire or rod. In some implementations, the indicator or gauge 3180 contacts tissue within the ventricle, including the anterior and posterior leaflets 20, 22. This indicator or gauge 3180 may be used in any of the embodiments of the device and method for obtaining an implantable device shown and described in Figures 31-59B. The indicator or gauge 3180 may be deployed from the same or a separate catheter as the cutting device 3140 and / or the stabilization component 3150.

[0196] In some implementations, the cutting tip 3143 of the cutting device 3140 is positioned between the anterior and posterior leaflets 20, 22 parallel to the implantable device 3100. The cutting tip 3143 then rotates around the implantable device 3100 and severs the anterior and posterior leaflets 20, 22 proximate to the implantable device. An indicator or gauge 3180 can move with the cutting tip 3143 to guide the cutting process. The portions of the anterior and posterior leaflets 20, 22 gripped by the implantable device 3100 remain attached to it. In some implementations, the cutting tip 3143 can move in several directions, such as longitudinally, laterally, transversally, or radially, for example, in an arcuate 360 ​​degree path around the entirety of the implantable device 3100 to completely sever the implantable device 3100 from the anterior and posterior leaflets 20, 22. The implantable device 3100 can then be retracted upwardly by the stabilizing component 3150 towards the distal end of the retrieval catheter 3160. In some implementations, the cutting tip 3143 can move an arcuate 180 degrees or similar path around the implantable device 3100 enough to sever the implantable device 3100 from one of the leaflets while leaving the device attached to the other leaflet. Any of the implementations disclosed herein can be configured to sever the implantable device 3100 from one of the leaflets while leaving it attached to the other leaflet.

[0197] Two cutting devices 3140A, 3140B each having a cutting tip 3143A, 3143B may also be used. FIG. 47 shows a top view of an exemplary retrieval catheter 3160 and two cutting devices 3140A, 3140B each with a cutting tip 3143A, 3143B and a stabilizing component 3150. In some implementations, the cutting tips 3143A, 3143B are attached such that the cutting devices 3140A, 3140B form a loop or snare. Any of the indicators or gauges (not shown) described above may also be used. The retrieval catheter is shown as offset from the central axis of the implantable device 3100 for illustrative purposes. In some implementations, the retrieval catheter 3160 may be aligned directly over the proximal end of the implantable device 3100. As shown in FIGS. 46-47, in some implementations, the implantable device 3100 may include a collar 3111 at the proximal end of the implantable device 3100.

[0198] In some implementations, the exemplary retrieval catheter 3160 provides a conduit through which the cutting devices 3140A, 3140B, the stabilizing component 3150, and any indicators or gauges are delivered to the implantable device 3100. In some other implementations, each of the cutting devices 3140A, 3140B and the stabilizing component 3150 may be deployed via a separate catheter, such as the second catheter 3162. In some implementations, the implantable device 3100 is removed from the native heart valve via the retrieval catheter 3160. In some implementations, the distal end of the retrieval catheter 3160 may also be used to provide a downward force to the 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. The inner diameter of the retrieval catheter 3160 may have an increased inner diameter so that the implantable device 3100 and portions of the excised anterior and posterior leaflets 20, 22 may be retracted therethrough.

[0199] As shown in FIG. 46, in some implementations, the cutting devices 3140A, 3140B each include a single cutting tip 3143A, 3143B formed with an electrode that may be made of a metal element that allows for electrical current to flow. In some implementations, the cutting devices 3140A, 3140B are made of Nitinol to allow for shape memory properties. In some implementations, the stabilization component 3150 may be deployed through the retrieval catheter 3160 or a separate catheter 3162. In some implementations, the stabilization component 3150 includes an element for gripping and stabilizing the implantable device 3100, such as a stabilization snare 3152. The stabilization snare 3152 may be secured around a portion of the implantable device 3100, such as a collar 3111. In some implementations, the portion of the implantable device 3100 to which the stabilization snare 3152 is attached, such as the collar 3111, may be configured to enhance imaging so that a user can more easily secure the stabilization component 3150 to the implantable device 3100. In some implementations, the stabilizing component 3150 may include pincers, graspers, vacuum suction devices, or any other docking means. In some implementations, the stabilizing component 3150 stabilizes the implantable device 3100 and also allows the implantable device 3100 to be retracted into the retrieval catheter 3160.

[0200] In some implementations, a first cutting tip 3143A of the first cutting device 3140A is deployed from the acquisition catheter 3160 into the space between the anterior leaf 20 and the posterior leaf 22 below the center of the anterior leaf 20 and / or above the clasp of the valve repair device attached to the anterior leaf. Then (or simultaneously), a second cutting tip 3143B of the second cutting device 3140B is deployed from the second catheter 3162 into a second space between the anterior leaf 20 and the posterior leaf 22 below the center of the anterior leaf 20 and / or above the clasp of the valve repair device attached to the anterior leaf. Then, in some implementations, the cutting tips 3143A, 3143B cut against each other toward the outer edge of the anterior leaflet 20, each cutting the anterior leaflet 20 proximate the implantable device. In some implementations, the cutting tips 3143A, 3143B are attached to each other before or after deployment to form a snare or loop, and the cutting device 3140A, 3140B is looped around the anterior leaflet 20 using the snare formed by the cutting tips 3143A, 3143B.

[0201] In some implementations, the implantable device 3100 may remain attached to a second leaflet, such as the posterior leaflet 22, or the above process can optionally be repeated on a second leaflet, such as the posterior leaflet 22, to completely sever the implantable device 3100 from the anterior and posterior leaflets 20, 22. To sever the posterior leaflet 22, each of the cutting tips 3143A, 3143B can be retracted upward into the ventricle and then deployed on the posterior leaflet 22. In some implementations, the cutting devices 3140A, 3140B remain attached via the cutting tips 3143A, 3143B and thus can be looped around and down the posterior leaflet 22, which is severed by moving the cutting tips 3143A, 3143B upward toward the distal end of the retrieval catheter 3160. The portions of the anterior and posterior leaflets 20, 22 grasped by the implantable device 3100 remain attached thereto. In some implementations, the cutting tips 3143A, 3143B can move in several directions, such as longitudinally, laterally, transversally, and / or radially, to cut the implantable device 3100 from one or both of the leaflets. When cut from both leaflets, the implantable device 3100 can be retracted upwards towards the distal end of the retrieval catheter 3160 by the stabilizing component 3150.

[0202] FIG. 49 shows a top view of an exemplary retrieval catheter 3160, a cutting device 3140 including an electrosurgical ring 3145, a stabilizing component 3150, and any indicators or gauges (not shown). The retrieval catheter is shown as being offset from the central axis of the implantable device 3100 for illustrative purposes. In some implementations, the retrieval catheter 3160 may be aligned directly over the proximal end of the implantable device 3100. As shown in FIGS. 48-49, in some implementations, the implantable device 3100 may include a collar 3111 at the proximal end of the implantable device 3100. In some implementations, the exemplary retrieval catheter 3160 provides a conduit through which the cutting device 3140, the stabilizing component 3150, and the indicators or gauges are delivered to the implantable device 3100. In some other implementations, each of the cutting device 3140, the stabilizing component 3150, and the indicators or gauges may be deployed via a separate catheter, such as a second catheter 3162. In some implementations, the implantable device 3100 is removed from the native heart valve via a retrieval catheter 3160. In some implementations, the distal end of the retrieval catheter 3160 may also be used to provide a downward force on the proximal side of the leaflets 20, 22 and / or 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 resected anterior and posterior leaflets 20, 22 may be retracted therethrough.

[0203] As shown in FIG. 48, in some implementations, the cutting device 3140 comprises an electrosurgical ring 3145 formed from one or more electrodes, which may be comprised of metallic elements that allow electrical current to flow. In some implementations, the cutting device 3140 is made of Nitinol to allow for shape memory properties. In some implementations, the stabilization component 3150 and indicator or gauge can be deployed through a retrieval catheter 3160, and the electrosurgical ring 3145 can be deployed using an optional second catheter 3162. In some implementations, the stabilization component 3150 comprises an element for gripping and stabilizing the implantable device 3100, such as a stabilization snare 3152. The stabilization snare 3152 can be secured around a portion of the implantable device 3100, such as a collar 3111. In some implementations, the portion of the implantable device 3100 to which the stabilization snare 3152 is attached, such as the collar 3111, can be enhanced for imaging to allow a user to more easily secure the stabilization component 3150 to the implantable device 3100. In some implementations, the stabilizing component 3150 may include pincers, graspers, vacuum suction devices, or any other docking means. In some implementations, the stabilizing component 3150 stabilizes the implantable device 3100 and also allows the implantable device 3100 to be retracted into the retrieval catheter 3160.

[0204] In some implementations, the electrosurgical ring 3145 of the cutting apparatus 3140 is deployed distally toward the anterior and posterior leaflets 20, 22 just above the implantable apparatus 3100. Once the electrosurgical ring 3145 contacts the anterior and posterior leaflets 20, 22, the electrosurgical ring 3145 can be made to cut the anterior and posterior leaflets 20, 22 radially around the implantable device 3100. The portion of the anterior and posterior leaflets 20, 22 grasped by the implantable apparatus 3100 remains attached to it. In some implementations, the electrosurgical ring 3145 can move in several directions, such as longitudinally, laterally, transversally, or radially, to completely cut the implantable device 3100 from the anterior and posterior leaflets 20, 22. The implantable device 3100 can then be retracted by the stabilizing component 3150 upwardly towards the distal end of the retrieval catheter 3160.

[0205] 50A-C show an exemplary device and method for obtaining an implantable device 3200 using a clamp 3148 having a first gripping arm 3146 and a second gripping arm 3147. FIG. 50A shows the implantable device 3200 secured to the first and second gripping arms 3146, 3147 of the clamp 3148 and the anterior and posterior leaflets 20, 22. In some implementations, each gripping 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 gripping arms 3146, 3147 form a complete encapsulation with a void in its center to secure the implantable device 3200 during removal. The clamp 3148 may include various features for cutting, severing, and / or ablating the anterior and posterior leaflets 20, 22, such as a serrated edge, blade, electrocautery, ultrasound, mechanical vibration, or friction. In some implementations, the gripping arms 3146, 3147 include a serrated edge or blade for cutting the anterior and posterior leaflets 20, 22 like scissors. In some implementations, the gripping arms 3146, 3147 are each formed at least in part from an electrode that may be comprised of a metallic element that allows an electric current to flow such that the gripping arms 3146, 3147 form an electrocautery tool that removes tissue of the anterior and posterior leaflets 20, 22 as the gripping arms 3146, 3147 close around the implantable device 3200.

[0206] As shown in Figures 50A and 50B, the first and second gripping arms 3146, 3147 each extend into the space formed by the anterior and posterior leaflets 20, 22 on either side of the implantable device 3200. In some implementations, the clamp 3148 can be guided into position using various methods, such as the indicators or gauges described above, or an echocardiogram. In some implementations, the gripping arms 3146, 3147 are aligned to the implantable device 3200 using fluoroscopy to ensure that the implantable device 3200 is positioned between the gripping arms 3146, 3147 prior to cutting the anterior and posterior leaflets 20, 22. As shown in Figures 50B-50C, once the gripping arms 3146, 3147 are in position around the implantable device 3200, the gripping arms 3146, 3147 move towards each other and simultaneously cut the tissue of the anterior and posterior leaflets 20, 22 using one of the methods described above. When the clamp 3148 is closed and the gripping arms 3146, 3147 contact each other, the implantable device 3200 can be fully enclosed within the clamp 3148 such that the implantable device 3200 is securely stored after being fully severed from the anterior and posterior leaflets 20, 22. In some implementations, the gripping arms 3146, 3147 move in a medial-lateral direction, each cutting both the anterior and posterior leaflets 20, 22 as the clamp 3148 moves to the closed position.

[0207] In some implementations, the bladed gripping arms 3146, 3147 also include a blade guard or sheath that can cover the blade while the gripping arms 3146, 3147 are in place to prevent or stop any inadvertent cutting from occurring. Once the gripping arms 3146, 3147 are correctly positioned, the sheath (not shown) can be removed and the gripping arms 3146, 3147 can close around the implantable device 3200 and cut the anterior and posterior leaflets 20, 22. The sheath can cover the entire clamp 3148 or each gripping arm 3146, 3147 individually.

[0208] FIG. 51A shows a front view of the clamp 3148, first gripping arm 3146, and second gripping arm 3147, with the implantable device 3200 positioned in the void space between the gripping arms 3146, 3147. FIG. 51B shows a top view along section A-A' of the implantable device 3200 secured to the anterior and posterior leaflets 20, 22, with the gripping arms 3146, 3147 positioned in the space between the anterior and posterior leaflets 20, 22. FIG. 51C shows a side view of the gripping arm 3146 along section B-B' showing the implantable device 3200 enclosed within the gripping arm 3146. FIGS. 52-56 show an exemplary apparatus and method for obtaining an implantable device using a cutting apparatus 3340 shaped like a tuning fork. FIG. 52 shows a cutting device 3340 comprising a central wire 3346, a first prong 3342 and a second prong 3344. In some implementations, the first and second prongs 3342, 3344 comprise features for cutting, severing, or ablating the anterior and posterior leaflets 20, 22, such as through the use of friction, heat, electrocautery, vibration, blades, saws, and the like. In some implementations, the first and second prongs 3342, 3344 are formed with very sharp blades. In some implementations, the first and second prongs 3342, 3344 are formed with electrodes that may be made of metal elements that allow electrical current to flow. In some implementations, the cutting device 3340 is connected to an infrared generator so that heat can be used to cut the natural leaf. In some implementations, the cutting device 3340 is made of Nitinol or spring wire to allow for shape memory properties. In some implementations, the cutting device 3340 can be comprised of a surface that allows radiofrequency energy to ablate tissue around the implantable device 3300. The gripping arms 3146, 3147 are closed to cut the leaflets and retain the detached implantable device.

[0209] 52 and 53 show a system for removing a valve repair device 3300 from one or more leaflets 20, 22 of a native heart valve. In the implementation illustrated by FIG. 53, 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, orient the catheter, advance the cutting device 3340 relative to the catheter, and / or control the cutting device 3340. In some implementations, the cutting device 3340 is deployed to the heart valve via the retrieval catheter 3360. In some implementations, the stabilization components described above may also be deployed through 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 any stabilization components (not shown) are delivered to the implantable device.

[0210] 54A-54F illustrate the operation of the catheter 3360 and / or cutting device 3340 with the control handle. FIG. 54A is a side view of the cutting device 3340 in an extended position where the first and second prongs 3342, 3344 are outside of the recovery catheter 3360, but at least a portion of the central wire 3346 remains within the recovery catheter 3360. FIG. 54B is a side view of the cutting device 3340 in a closed position where the recovery catheter 3360 extends distally toward the confluence of the central wire 3346, and the first and second prongs 3342, 3344 and / or cutting device 3340 are retracted within the recovery catheter 3360 such that the first and second prongs 3342, 3344 are forced closer together by the wall of the recovery catheter 3360. FIG. 54C is a side view of the cutting device 3340 in a scissored position with the removal catheter 3360 extending further distally over a portion of the first and second prongs 3342, 3344 and / or the cutting device 3340 being further retracted within the removal catheter 3360 such that the first and second prongs 3342, 3344 are crossed, transverse, or pushed into a scissored position.

[0211] 54D-54F show how the position of the cutting device 3340 shown in FIGS. 54A-54C functions to sever the implantable device 3300 from the anterior and posterior leaflets 20, 22. FIG. 54D shows a top view of the implantable device 3300 secured to the anterior and posterior leaflets 20, 22. The cutting device 3340 may be positioned such that the first prong 3342 and the second prong 3344 each enter one of the openings formed by the anterior and posterior leaflets 20, 22 on either side of the implantable device 3300. As shown in FIG. 54E, when the cutting device 3340 enters the closed position, the first and second prongs 3342, 3344 move inwardly from the opening toward one of the anterior leaflets 20, such as the anterior leaflet 20 and the posterior leaflet 22. Once the first and second prongs 3342, 3344 contact the sides of the anterior leaflet 20, the cutting device 3340 begins to cut the tissue using any one of the methods for cutting tissue described above, such as via electrocautery, infrared, or radio frequency ablation. As the retrieval catheter 3360 continues to advance over the cutting device 3340, the first and second prongs 3342, 3344 traverse one another and completely cut the anterior leaflet 20, as shown in FIG.

[0212] The process shown in Figures 54D-54E can then be repeated on the posterior leaflet 22. In some implementations, the implantable device 3300 is removed from the native heart valve via a retrieval catheter 3360. In some implementations, 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. The inner diameter of the retrieval catheter 3160 can have an increased inner diameter so that the implantable device 3100 and the portions of the resected anterior and posterior leaflets 20, 22 can be retracted therethrough.

[0213] 55A-B, in some implementations, the cutting device 3340 can sever the anterior and posterior leaflets 20, 22 by moving the first and second prongs 3342, 3344 away from each other rather than towards each other. FIG. 55A is a side view of the cutting device 3340 in a closed position, with the retrieval catheter 3360 extending distally toward the confluence of the central wire 3346, and the first and second prongs 3342, 3344 and / or the cutting device 3340 retracted within the retrieval catheter 3360 such that the first and second prongs 3342, 3344 are forced closer together by the walls of the retrieval catheter 3360. FIG. 55B is a side view of the cutting device 3340 in an extended position with the first and second prongs 3342 , 3344 outside the retrieval catheter 3360 , but with at least a portion of the central wire 3346 remaining within the retrieval catheter 3360 .

[0214] 56A and 56B show how the position of the cutting apparatus 3340 shown in FIGS. 55A-B functions to sever the implantable device 3300 from the anterior and posterior leaflets 20, 22. FIG. 56A shows a top view of the implantable device 3300 secured to the anterior and posterior leaflets 20, 22. The cutting apparatus 3340 may be positioned such that the first prong 3342 and the second prong 3344 each enter into the center of one of the anterior leaf 20 and the posterior leaf 22 in the closed position such as the anterior leaf 20. A space is shown between the first prong 3342 and the second prong 3344 to illustrate the presence of two prongs. However, in some implementations, the two prongs may contact each other, cross each other, and / or form a single hole in the leaflet tissue such that there is no tissue bridge or only a small / steerable tissue bridge between the prongs.

[0215] As shown in Figure 56B, when the cutting device 3340 is moved to the extended position, the first prong 3342 and the second prong 3344 move outward from the center of the anterior leaflet 20 toward the edge of the anterior leaflet 20. When the first and second prongs 3342, 3344 contact the side of the anterior leaflet 20, the cutting device 3340 has cut the tissue using any one of the methods for cutting tissue described above, such as via electrocautery, infrared, or radio frequency ablation.

[0216] In some implementations, a balloon (not shown) can be inserted into the perforation in the anterior and posterior leaflets 20, 22 caused by the first and second prongs 3342, 3344. The balloon can be inflated within the perforation, passively tearing the anterior and posterior leaflets 20, 22 as it inflates. The balloon (not shown) can also include features for cutting, severing, or ablating tissue, such as through the use of electrocautery, vibration, blades, heat, or the like.

[0217] The process shown in Figures 56A-56B can then be repeated on the posterior leaflet 22. In some implementations, the implantable device 3300 is removed from the native heart valve via a retrieval catheter 3360. In some implementations, 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. The inner diameter of the retrieval catheter 3160 can have an increased inner diameter so that the implantable device 3100 and the portions of the resected anterior and posterior leaflets 20, 22 can be retracted therethrough.

[0218] 57A-B illustrate an exemplary device and method for removing an implantable device using hooks 3350 and loops 3352. As shown in FIG. 57A, the exemplary device includes a retrieval catheter 3360. Disposed within the retrieval catheter are a first catheter 3362 in which the hooks 3350 are deployed and a second catheter 3364 in which the loops are deployed. In some implementations, the hooks 3350 and loops 3352 include features for cutting, severing, or ablating the anterior and posterior leaflets 20, 22 through the use of friction, heat, electrocautery, vibration, blades, saws, and the like. In some implementations, the hooks 3350 and loops 3352 are formed from electrodes that may be comprised of metallic elements that allow electrical current to flow. In some implementations, at least one of the hooks 3350 and loops 3352 is connected to an infrared generator such that heat can be used to sever the anterior and posterior leaflets 20, 22. In some implementations, at least one of the hooks 3350 and loops 3352 are made of Nitinol or spring wire to allow for shape memory properties. In some implementations, at least one of the hooks 3350 and loops 3352 may be comprised of a surface that allows radio frequency energy to ablate tissue around the implantable device 3300. In some implementations, the shape memory properties of the hooks 3350 and loops 3352 are such that when the hooks 3350 are deployed from the first catheter, they are aligned perpendicular to the loops 3352 when it is deployed from the second catheter 3364, and the hooks 3350 are aligned to enter the loops 3352, creating a loop or lasso that can be used to cut the anterior and posterior leaflets 20, 22.

[0219] 57B shows the implantable device 3300 secured to the anterior and posterior leaflets 20 and 22. In some implementations, the hook 3350 is first deployed from a first catheter 3362 disposed from or within the removal catheter 3360 into the opening between the anterior and posterior leaflets 20 and 22. The loop 3352 is then deployed from a second catheter 3364 disposed from or within the removal catheter 3360 through the opposing opening between the anterior and posterior leaflets 20 and 22. The hook 3350 then enters the loop 3352 under the anterior and posterior leaflets 20, 22 and the implantable device 3300 to form a loop or lasso around one of the natural leaflets, such as the anterior leaflet 20. The hooks 3350 and loops 3352 may then be simultaneously retracted within their respective catheters 3360, 3362, 3364, and the loop or lasso formed by the hooks 3350 and loops 3352 contact the side of the anterior leaflet 20. The hooks 3350 and loops 3352 cut the tissue using any one of the methods described above, such as via electrocautery, infrared, or radio frequency ablation. The process can then be repeated on the posterior leaflet 22.

[0220] In some implementations, the implantable device 3300 is removed from the native heart valve via a retrieval catheter 3360. In some implementations, the distal end of the retrieval catheter 3360 may also be used to provide a downward force to 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.

[0221] 58A-59B illustrate an exemplary apparatus and method for removing an implantable device using a snare bag. FIG. 58A shows a retrieval catheter 3460 and a retrieval device 3450 disposed therethrough. The retrieval device 3450 may include a positioning element 3451 (e.g., a wire, rod, line, pusher, tether, etc.), a snare 3452, and / or a bag 3453. In some implementations, the bag 3453 may be a mesh, net, or a solid material.

[0222] In some implementations, the acquisition device (e.g., snare 3452, etc.) comprises features for cutting, severing, or ablating the anterior and posterior leaflets 20, 22 through the use of friction, heat, electrocautery, vibration, blades, saws, etc. In some implementations, the retrieval device (e.g., snare 3452, etc.) is formed from an electrode that may be made of a metal element that allows an electric current to flow. In some implementations, the acquisition device (e.g., snare 3452, etc.) is connected to an infrared generator so that heat can be used to sever the anterior and posterior leaflets 20, 22. In some implementations, at least one of the snare 3452 and bag 3453 of the retrieval apparatus is made of Nitinol or spring wire to allow for shape memory properties. In some implementations, the acquisition device (e.g., snare 3452, etc.) may be comprised of a surface that allows radio frequency energy to ablate tissue around the implantable device. As shown in FIG. 58B, the acquisition device (eg, snare 3452, etc.) can be moved from an open position to a closed position by retracting the positioning element 3451 and / or extending the acquisition catheter 3460.

[0223] 59A and 59B show an exemplary method of using a retrieval device 3450 to remove an implantable device 3400 secured to natural leaflets (e.g., anterior and posterior leaflets 20, 22, etc.). As shown in FIG. 59A, the retrieval device 3450 can be deployed into one of the openings between the leaflets (e.g., between the anterior and posterior leaflets 20, 22) via a retrieval catheter 3460 such that a snare 3452 and bag 3453 can be positioned beneath the distal end of the implantable device 3400.

[0224] In some implementations, the positioning element 3451 is made of Nitinol so that it can have shape memory properties to properly position the removal device 3450 when the removal catheter 3460 is retracted and / or the positioning element 3451 extends therefrom.

[0225] 59B, once the retrieval device 3450 is in place, the retrieval catheter 3460 can then be extended distally towards the retrieval device 3450 and / or the positioning element 3451 can be retracted into the retrieval catheter 3460 such that the retrieval device 3450 moves upward to contain the implantable device 3400 within the bag 3453. Once the implantable device 3400 is fully within the bag 3453, the positioning element 3451 can be further retracted into the retrieval catheter 3460 and the snare 3452 can be tightened into a closed position. As the snare 3452 closes, it contacts the anterior and posterior leaflets 20, 22 and cuts that tissue using any one of the methods described above, such as via electrocautery, infrared, or radio frequency ablation. Once the anterior and posterior leaflets 20, 22 are completely severed and the snare 3452 is completely closed, the implantable device 3400 is tightly enclosed within the retrieval device 3450 and may then be removed from the native heart valve via the retrieval catheter 3460. In some implementations, the distal end of the retrieval catheter 3360 may also be used to provide a downward force on the proximal side of the anterior and posterior leaflets 20, 22 and / or 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 may have an increased inner diameter so that the implantable device 3100 and portions of the resected anterior and posterior leaflets 20, 22 may be retracted therethrough.

[0226] 60A-61C show exemplary systems, devices, and methods for removing an implantable device using a retrieval catheter 3560, a retrieval apparatus 3550, and an actuating element 3551. The retrieval device 3550 can be attached to the retrieval catheter 3560 such that the retrieval device 3550 can be moved between an open position (as shown in FIG. 60A) and a closed position (as shown in FIG. 60B) relative to the retrieval catheter 3560 by the actuating element 3551. In implementations, the retrieval apparatus 3550 is attached to the retrieval catheter 3560 by a hinge connection, such as 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 apparatus 3550 to an open position and / or a closed position.

[0227] In some implementations, the acquisition device 3550 can be biased in a closed position and the actuating element 3551 can be used to move the acquisition device to an open position. In some implementations, the acquisition device 3550 can be biased in an open position and the actuating element 3551 can be used to move the acquisition device to a closed position. In some implementations, the retrieval device 3550 can be further attached to a retrieval catheter 3560 to maintain the retrieval device 3550 in a closed position. That is, the retrieval device 3550 can be attached to the retrieval catheter 3560 with a cap-like connection, such as a friction fit connection, a tongue and groove connection, a latch type connection, a threaded connection, or any other suitable type of connection. The actuating element 3551 can be used to move the retrieval device 3550 from an open position to a closed position and / or between the closed and open positions.

[0228] The removal device 3550 may include a cutting element 3552 and a cap 3553. In some implementations, the cap 3553 may be a solid material, a mesh material, a net material, etc. In some implementations, the cutting element 3552 is configured to cut, sever, and / or ablate one or more leaflets L of the native heart valve (e.g., the anterior and / or posterior leaflets of the mitral valve, or the anterior, posterior, and / or septal leaflets of the tricuspid valve) through the use of friction, heat, electrocautery, vibration, blades, saws, cold cutting, etc. In some implementations, the cutting element 3552 is formed from an electrode that may be made of a metal element that allows an electric current to flow. In some implementations, the cutting element 3552 is connected to an infrared generator so that heat can be used to cut the leaflets L of the native heart valve. In some implementations, at least one of the cutting element 3552 and the cap 3553 is made of Nitinol or spring wire to allow for shape memory properties. In some implementations, the cutting element 3552 may include a surface that allows radio frequency energy to ablate tissue around the implantable device. In some implementations, the cutting element 3552 may include cryogenic cutting features that may be used to cut the leaflets L of the native heart valve.

[0229] In some implementations, the cutting element 3552 may be disposed on the cap 3553 as shown, may be disposed on or at the distal end 3557 of the acquisition catheter 3560, or may be disposed on both the cap 3553 and the distal end 3557 of the acquisition catheter 3560. If included in both the cap 3553 and the distal end 3557 of the acquisition catheter 3560, the same or different types of cutting mechanisms may be used on the cap 3553 and the distal end 3557 of the catheter 3560. The cutting element 3552 on the distal end 3557 of the retrieval catheter may be configured to cut, sever, or ablate the leaflets L of the native heart valve through the use of friction, heat, electrocautery, vibration, blades, saws, cold cutting, etc. In some implementations, the cutting element on the distal end 3557 is formed from an electrode that may be comprised of a metallic element that allows an electric current to flow. In some implementations, the cutting element on the distal end 3557 is connected to an infrared generator so that heat can be used to cut the native heart valve leaflets L. In some implementations, the cutting element on the distal end 3557 can include a surface that allows radio frequency energy to ablate tissue around the implantable device. In some implementations, the cutting element on the distal end 3557 can include cryogenic cutting features that can be used to cut the native heart valve leaflets L.

[0230] In some implementations, only one of the distal end 3557 of the retrieval catheter 3560 and the cap 3553 of the retrieval device 3550 has cutting elements 3552 for severing the native heart valve leaflets L. In some implementations, both the distal end 3557 of the retrieval catheter 3560 and the cap 3553 of the retrieval device 3550 have cutting elements 3552 for severing the native heart valve leaflets L.

[0231] 61A-61C illustrate a method of using a retrieval device 3550 to remove an implantable device 3500 secured to one or more leaflets L of a native heart valve. The implantable device 3500 can take any suitable form, such as any of the forms described herein. As shown in FIG. 61A, a retrieval catheter 3560 can be positioned (e.g., by any means described herein) through the native heart valve such that the implantable device 3500 is positioned between a distal end 3557 of the retrieval catheter 3560 and the retrieval device 3550 when the retrieval device 3550 is in an open position. When in this position, the implantable device may be below the distal end 3557 of the retrieval catheter 3560 (as shown in the illustrated embodiment) and / or a portion of the implantable device may extend within the retrieval catheter 3560.

[0232] 61B, the retrieval device 3550 is then moved to a closed position such that the implantable device 3500 is enclosed by the retrieval device 3550 and retrieval catheter 3560. Once the implantable device 3500 is enclosed by the retrieval device 3550 and retrieval catheter 3560, a cutting element 3552 on at least one of the retrieval device 3550 and retrieval catheter 3560 can be used to cut the leaflets L of the native heart valve.

[0233] Referring to FIG. 61C, after the leaflet(s) L have been cut, 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 a portion of the leaflet(s) L may be removed from the patient's heart.

[0234] 62A-H illustrate methods, systems, and apparatus for detaching an implantable device 3600 from at least one leaflet L of a native heart valve using an exemplary cutting device 3640 (see FIG. 62C). 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 sever the leaflets L, for example, through the use of friction, electrocautery, vibration, sawing, cold cutting, or the like. In some implementations, the cutting device 3640 includes an electrosurgical tip or blade formed from an electrode, which may be comprised of a metallic element that allows an electric current to flow. In some implementations, 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 implementations, the cutting apparatus 3640 may include a surface that allows radio frequency energy to ablate tissue around the implantable device. In some implementations, at least a portion of the cutting apparatus 3640 may be made of Nitinol to allow for shape memory properties. In some implementations, the cutting device 3640 may include cryogenic cutting features that may be used to cut the leaflets L of a native heart valve. The implantable device 3600 may take any suitable form, such as, for example, any of the forms described in this application.

[0235] 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 implementations, the distal end of the retrieval catheter 3660 can also be used to provide a downward force on the proximal side of the lobe(s) L and / or implantable device 3600 to keep the lobe(s) taut and / or the implantable device 3600 stable during the resection process. In some implementations, the inner diameter of the retrieval catheter 3660 can have an inner diameter that allows the implantable device 3600 and portions of the resected lobe(s) L to be retracted therethrough.

[0236] An optional stabilizing component 3650 can be used to secure and hold the implantable apparatus 3600 during cutting of one or more leaflets L. The stabilizing component 3650 can be deployed through the catheter 3660 or a separate catheter (not shown). In some implementations, the stabilizing component 3650 has an element for gripping and stabilizing the implantable device 3600, such as a stabilizing snare 3652 (or a lasso, tether, latch, clasp, 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 cap 3614 (e.g., any cap described herein).

[0237] In some implementations, a portion of the implantable device 3600 to which the stabilizing snare 3652 is attached, such as the cap 3614 or collar 3611, may be configured to enhance imaging so that a user can more easily secure the stabilizing component 3650 to the implantable device 3600. In some implementations, the stabilizing component 3650 may include a pincer, grasper, vacuum suction device, or any other docking means. In some implementations, the stabilizing component 3650 stabilizes the implantable device 3600 so that the cutting device 3640 may be more easily positioned to cut one or more leaflets L of the native heart valve.

[0238] In some implementations, when the implantable device has been completely detached from the native heart valve, the stabilizing component 3650 can be used to retract the implantable device 3600 into the catheter 3660 so that the implantable device 3600 can be removed from the patient's heart. In some implementations, a separate retrieval device (e.g., any of the retrieval devices described in this application) can be used in conjunction with the catheter 3660 and / or stabilizing component 3650 to remove the implantable device 3600 from the patient's heart.

[0239] With reference to Fig. 62A, the catheter 3660 is shown being delivered adjacent to the tricuspid valve TV of the heart H. The catheter 3660 may be inserted into the right atrium RA by any suitable means, such as, for example, any of the means described herein. With reference to Fig. 62B, an optional stabilization component 3650 is shown attached to a collar 3611 of the implantable device 3600 to secure and retain the implantable device 3600.

[0240] With reference to FIGS. 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 may be positioned within the coaptation region of the tricuspid valve TV. With reference to FIGS. 62E and 62F, in some implementations, the leaflets L may be tented to ensure proper placement of the cutting device 3640 prior to the resection process. For example, with reference to FIG. 62E, the cutting device 3640 is shown engaged with the leaflets L, but the leaflets L are not deformed or tented due to this engagement because the implantable device 3600 is positioned on the other side of the leaflets L. With reference to FIG. 62F, in one implementation, moving the cutting device 3640 in an outward direction D allows the engagement between the cutting device 3640 and the leaflets L to cause a deformation or tenting 3641 indicating that the cutting device 3640 is in proper position for the resection process. That is, the implantable device 3600 is no longer in a position relative to the cutting device 3640 that affects severing of the leaflets L by the cutting device 3640. Although the illustrated implementation shows an implantable device preventing or inhibiting tenting 3641 of the leaflets L, it should be understood that other objects may be positioned to prevent or inhibit tenting 3641 and proper severing of the leaflets L, such as, for example, the chordae tendineae of the left ventricle LV of the heart H.

[0241] With reference to Figures 62G and 62H, the cutting device 3640 is shown moving in an outward direction D such that the cutting device 3640 is positioned away from the implantable device 3600. With reference to Figure 62H, the cutting device 3640 is shown cutting the leaflets L in direction C such that the implantable device 3600 and the cut portion of the leaflet L are removed from one of the leaflets, while the implantable device 3600 remains connected to the other leaflet L. In some implementations, the implantable device 3600 may be removed from more than one leaflet L of a native heart valve.

[0242] Although the method illustrated in Figures 62A-62H is described with reference to the tricuspid valve TV, it should be understood that the method may 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.

[0243] 63A-63D show a method of implanting a replacement valve 3701 onto a native valve such that the valve captures the implantable device 3700 attached to the native valve. For example, the implantable device 3700 may be attached to at least one leaflet, but not all leaflets, of a native heart valve because the implantable device 3700 has been severed from one or more leaflets, such as by using a cutting device 3640 described with reference to FIGS. 62A-62H, or any other cutting apparatus or method disclosed herein. The implantable device 3700 may take any suitable form, such as any of the forms described herein.

[0244] The replacement heart valve 3701 may be configured to be implanted via a delivery system or other delivery means. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The replacement heart valve 3701 may be removably coupled to the delivery catheter 3760. The replacement heart valve 3701 may be coupled to the catheter 3760 in a variety of ways, including a removable coupler, a removable press fit, a friction fit, a magnetic fit, a threaded connection, and the like. In implementations where the implantable device is cut from one of the leaflets using the cutting device 3640 and catheter 3660 of FIGS. 62A-H, the same catheter can optionally be used to deliver both the cutting device 3640 and the replacement heart valve 3701. In some implementations, different catheters can be used to deliver the cutting device 3640 and the replacement heart valve 3701.

[0245] The replacement heart valve 3701 may be positioned within the native heart valve between the opposing leaflets L. The replacement heart valve 3701 may take any suitable form, such as, for example, any of the forms described herein, as well as any of the forms described in U.S. Published Patent Application Publication Nos. 2020 / 0368015 and 2020 / 0297481, which are incorporated herein by reference in their entireties, and U.S. Patent Nos. 10,799,938, 10,758,348, and 10,166,097. In some implementations, the replacement heart valve may include an inner body 3730, an outer body 3740, and an anchor 3732, or the replacement heart valve 3701 may include a body 3740 attached to an anchor 3732, and the inner body may be omitted. If included, the inner body 3730 may 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 implementations 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.

[0246] The inner body or frame 3730 and the outer body or frame 3740 may include various shapes and may be made from various materials or substances. For example, the inner body or frame 3730 and / or the outer body or frame 3740 may be made from a flexible and / or expandable material. The inner body or frame 3730 and the outer body or frame 3740 may be configured to expand and contract. For example, the inner body or frame 3730 and the outer body or frame 3740 may contract or compress to fit within the cavity 3712 of the capsule 3710. In some implementations, the inner body or frame 3730 and the outer body or frame 3740 are configured to expand 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. For example, the inner body or frame 3730 and / or the outer body or frame 3740 may have a stent or stent-like configuration with struts that allow for expansion and contraction.

[0247] 63B-63D, the anchor 3732 can take a wide variety of forms, such as, for example, a hook, a paddle, a gripping element, or the like. The anchor can be bonded and / or flexible. The anchor 3732 can be curved or rounded so that the leaflets can fit into the curve and be secured between the anchor 3732 and the outer body 3740. In some implementations, the anchor 3732 can include an attachment portion or gripping member. The gripping member can include a clasp, optional barbs, friction enhancing elements, or other means for securing (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.).

[0248] One or more actuating elements may be used during deployment of the replacement heart valve 3701. In the illustrated example, the outer body or frame 3740 is removably coupled to the outer actuating element 3750. In some implementations, 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 inward of the catheter 3760. The outer actuating element 3750 may be slidable relative to the catheter 3760. In some examples, the outer actuating element 3750 may be attached to the outer body or frame 23740 at an outer collar 3744.

[0249] The optional inner body or frame 3730 may be removably coupled to the optional inner operating element 3752, or the inner body or frame 3730 may 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 operating element 3752 may be omitted. The optional inner operating element 3752 may be disposed radially inward of the outer operating element 3750. The inner operating element 3752 may be slidable relative to the outer operating element 3750. In some examples, the inner operating element 3752 may be attached to the inner body or frame 3730 at an inner collar 3734. The optional inner operating element 3752, the outer operating element 3750, and the catheter 3760 may all move simultaneously and independently of one another.

[0250] The outer actuating element 3750 and the optional inner actuating element 3752 can take a wide variety of different forms, including wires, rods, shafts, tubes, threads, sutures, lines, 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 can have a variety of configurations. As an example, the actuating element can be threaded such 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 unthreaded and pushing or pulling the actuating element can move the valve 3701 or one or more portions of the valve relative to the capsule.

[0251] With reference to FIGS. 63A-63D, the device 3701 can be positioned within the heart valve between the opposing leaflets L. With reference to FIG. 63B, the device 3701 can be configured to move the inner body or frame 3730 along a longitudinal axis of the inner actuating element 3752 away from the capsule 3710 to create a gap between the capsule 3710 and the anchor 3732. In the illustrated example, the inner body or frame 3730 is pushed out of the outer body or frame 3740 and the capsule 3710. The movement of the inner actuating element 3752 can push the anchor 3732 out of the capsule 3710 and into a ventricle or lower portion of the heart. In some implementations, the optional inner body or frame 3730, outer body or frame 3740, and anchor 3732 are configured to self-expand when moved distally from the capsule 3710. For example, the anchor body or frame 3730 can have a self-expanding stent or stent-like configuration.

[0252] 63C, the device 3701 can be configured to move the outer body or frame 3740 along a longitudinal axis of the outer actuating element 3750 away from the capsule 3710. Movement of the outer actuating element 3750 can push the outer body or frame 3740 out of the capsule 3710 and towards 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 extend radially outwardly more than the outer body or frame 3740 such that the anchors 3732 are disposed on the lateral or ventricular side of the leaflets L and the outer body or frame 3740 is disposed on the medial or atrial side of the leaflets L. In some implementations, the outer body or frame 3740 is configured to self-expand when it moves distally from the capsule 3710 or when the capsule 3710 is retracted from the outer body or frame 3740.

[0253] 63C, as the possible device 3700 becomes attached to one of the leaflets L (e.g., due to the excision process described with reference to FIGS. 62A-62H), the implantable device 3700 is also positioned between the outer body or frame 3740 and the anchor 3732. In some implementations, the capsule 3710 is retracted proximally from the optional inner actuating element 3752 and / or the outer actuating element 3750. The outer body or frame 3740 expands radially outward as the outer body or frame extends further out from the capsule 3710 to secure the leaflet L and the device 3700 between the outer body or frame 3740 and the anchor.

[0254] 63D, when the outer body or frame 3740 is advanced completely out of the capsule, the leaflets L, and consequently the implantable device 3700, are fixed relative to the outer body or frame 3740 and the anchors 3732. In implementations, the expanded outer body or frame 3740 and / or anchors may fit around the device 3700. The actuation element(s) 3750, 3752 and the delivery system or catheter 3760 may be separated from the device 3701, leaving the device 3701 attached to the leaflets L of the native valve. When the device 3701 is implanted onto the leaflets L of the native valve, the implantable device 3700 attached to one or more of the leaflets L is fixed in position relative to the leaflets L, the anchors 3732 and / or the outer body or frame 3734 such that the device is prevented or inhibited from being cut off. 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.

[0255] In some embodiments configured for use in a tricuspid valve, the replacement heart valve 3701 is configured to be secured to three tricuspid valves such that the one-way valve 3735 of the replacement valve 3701 is disposed between all three native leaflets. In some implementations configured for use in a mitral valve, the replacement heart valve 3701 is configured to be secured to two mitral leaflets such that the one-way valve of the replacement valve 3701 is positioned between both native leaflets.

[0256] FIG. 64 shows an exemplary valve 3801, and FIGS. 65A-E show a method of implanting the valve 3801 onto a native valve such that the valve 3801 captures the implantable device 3800 attached to the native valve. In some implementations, the valve 3801 can optionally be an EVOQUE™ valve from Edwards Lifesciences.

[0257] In some implementations, as shown in Figure 64, the valve 3801 can have an anchor 3832 and a body or frame 3840. One or more leaflets of an implantable device (e.g., implantable device 3800 shown in Figures 65A-E) attached to a native heart valve and leaflet(s) can be secured between the anchor 3832 and the body or frame 3840 when the valve is implanted onto the native heart valve (e.g., mitral or tricuspid).

[0258] Further details and design examples of valves such as the valve 3801 shown in Fig. 64 are described in U.S. Patent Nos. 8,403,983, 8,414,644, 8,652,203, 10,813,757, and U.S. Patent Application Publication Nos. 2011 / 0313515, 2012 / 0215303, 2014 / 0277390, 2014 / 0277422, 2014 / 0277427, 2018 / 0021129, and 2018 / 0055629, which are incorporated by reference in their entirety and made a part hereof. The implantable device 3800 can take any suitable form, such as any of the forms described in this application.

[0259] Now referring to Figures 65A-65E, in some embodiments, the valve 3801 can be delivered to the native tricuspid valve TV of the heart H to secure the valve 3801 to the leaflets L, such that after the excision process (e.g., the excision process shown in Figures 62A-62H), the implantable device 3800 remains connected to one or more leaflets, thereby securing the implantable device 3800 to the leaflet(s).

[0260] The heart valve 3801 may be configured to be implanted via a delivery system or other delivery means. The delivery system may include one or more of a guidewire, a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The heart valve 3801 may be removably coupled to a delivery catheter 3860. The replacement heart valve 3801 may be coupled to the catheter 3860 in a variety of ways, including a removable coupler, a removable press fit, a friction fit, a magnetic fit, a threaded connection, and the like. In implementations where the implantable device is cut using the cutting device 3640 and catheter 3660 of FIGS. 62A-H, the same catheter can optionally be used to deliver both the cutting device 3640 and the replacement heart valve 3801. In some implementations, different catheters can be used to deliver the cutting device 3640 and the replacement heart valve 3801.

[0261] Referring 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 over the optional guidewire 3865 into the right atrium RA. Referring to FIG. 65B, the catheter 3860 is moved into position within the tricuspid valve TV and into the right ventricle RV. The anchors 3832 are partially extended from the catheter 3860, thereby partially opened so that the leaflets L can be captured. For example, the delivery catheter 3860 can be advanced and steered or bent to position the valve 3801, as FIG. 65B shows. An actuating element (not shown) can be advanced from inside the steerable catheter 3860 to engage the valve 3801, and / or the catheter 3860 can be retracted to extend the valve anchors 3832 from the catheter 3860. The operating element may take any suitable form, such as, for example, any of the forms described in this application.

[0262] 65C, the valve 3801 can be further advanced (via retraction of the actuating elements and / or catheter) from the catheter 3860 such that the body or frame 3840 and anchors 3832 are positioned to capture the leaflets L and attached device 3800. Referring to FIG. 65D, the valve 3801 is fully deployed from the catheter 3860 such 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 the implantable device 3800 between the body or frame 3840 and the anchors 3832. In implementations, a portion of the body or frame 3840 and / or a portion of the anchors 3832 conform to the shape of the device 3800. Referring to FIG. 65E, after the valve is secured to the leaflets L, the catheter 3860 is removed from the heart H, leaving the valve 3801 secured to the leaflets L, capturing the implantable device 3800.

[0263] Although the method shown in Figures 65A-65E is described with reference to the tricuspid valve TV, it should be understood that the method may also be used to secure the valve 3801 to the mitral valve such that the replacement valve captures an implantable device connected to the leaflets of the mitral valve.

[0264] Certain conditions or circumstances may require the detachment of an implantable device from one or more leaflets of a native heart valve. In some implementations, devices and methods are provided for detaching the implantable device from a first leaflet while the device remains attached to the second leaflet. In some implementations, devices and methods are provided for detaching the implantable device from both the first and second leaflets so that the device may be removed using a retrieval catheter.

[0265] In some implementations, the device is configured to ablate the leaflets of the native valve to detach the leaflets from the implantable device. In some implementations, the device is a cutting device. The cutting device may be formed with electrodes that may be made of metal elements that allow an electric current to flow. The cutting device may be made of Nitinol. The cutting device may include a surface that allows radio frequency energy, ultrasound, or another type of energy to ablate and / or cut the native leaflets.

[0266] 80 illustrates an exemplary implantable device (e.g., implantable device 3100) deployed between the anterior and posterior leaflets 20, 22 of the mitral valve MV. The implantable device 3100 is illustrated capturing both the anterior and posterior leaflets 20, 22 and is generally located in the center of the valve such that a dual orifice valve is formed (i.e., a first or lateral orifice 40 on a first side of the implantable device 3100, and a second or medial orifice 42 on a second side of the implantable device 3100 opposite the first orifice 40).

[0267] 66-72 show an exemplary cutting device 4000 for resecting a natural leaflet. The cutting device 4000 may be delivered to the valve by any suitable delivery system, such as any of the delivery systems disclosed herein. The cutting device 4000 may be configured in a variety of ways. In the illustrated implementation, the cutting device 4000 may be delivered via a catheter 4002 (e.g., a steerable catheter or a non-steerable catheter passing through one or more steerable catheters) having a first lumen 4004 and a second lumen 4006 separated from the first lumen 4004, with an opening shown to a distal end 4007 of the catheter 4002.

[0268] In the illustrated example, the cutting device 4000 includes a first cutter delivery catheter 4008 having a third lumen 4010 and configured to be delivered through a first lumen 4004, and a second cutter delivery catheter 4012 having a fourth lumen 4014 and configured to be delivered through a second lumen 4006. The first cutter delivery catheter 4008 includes a bendable and / or flexible first distal end portion 4016, and the second cutter delivery catheter 4012 includes a bendable and / or flexible second distal end portion 4018. In some implementations, 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 may be orientable by any suitable means. In some implementations, the first distal end portion 4016 and / or the second distal end portion 4018 include a shape memory alloy, such as, for example, Nitinol, to enable shape memory properties. Thus, the first distal end portion 4016 and / or the second distal end portion 4018 can be shape set to a desired position. For example, the first distal end portion 4016 and the second distal end portion 4018 can be shape set to the positions illustrated by FIGS. 68 and 69 such that the first distal end portion 4016 and the second distal end portion 4018 do not need to be steerable.

[0269] 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 implementations, the first distal tip 4020 is configured to removably couple to the second distal tip 4022 such that the third lumen 4010 is aligned (e.g., operatively connected) with the fourth lumen 4014. In some implementations, the first distal tip 4020 may include a first coupling element 4024 and the second distal tip 4022 may include a second coupling element 4026. The first coupling element 4024 and the second coupling element 4026 may be configured in a variety of ways, such as male / female connectors, magnets, hook-and-loop fasteners, detents, threaded couplings, clasps, grippers, or other suitable couplers.

[0270] In the illustrated implementation, 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 disposed on the first distal tip 4020 and the second distal tip 4022, respectively, and attract each other (i.e., with different poles facing distally) such that they couple to each other when the first distal tip 4020 and the second distal tip 4022 are in close proximity to each other.

[0271] 66, a first cutter delivery catheter 4008 is shown extending from a first lumen 4004 of the catheter 4002. The first cutter delivery catheter 4008 may extend from the first lumen 4004 through a first or lateral orifice 40 to the ventricular side of the valve, and the second cutter delivery catheter 4012 may extend from the second lumen 4006 through a second or medial orifice 42 to the ventricular side of the valve (see FIG. 80). In some implementations, 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, a first cutter delivery catheter 4008 can extend from the first lumen 4004 through a first or lateral orifice 40 to the ventricular side of the valve, and through a second or medial orifice 42 to the atrial side of the valve, and connect to a second cutter delivery catheter 4012.

[0272] 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 mated to one another such that the third lumen 4010 and the fourth lumen 4014 are aligned or operatively connected. In some implementations, the first distal end portion 4016 and the second distal end portion 4018 are steerable and thus may be steered to bring the first distal tip 4020 and the second distal tip 4022 into proximity with one another such that the first coupling element 4024 and the second coupling element 4026 are coupled together. In some implementations, the first and second distal end portions 4016, 4018 are shaped to bend into a position that brings the first and second distal tips 4020, 4022 into proximity with one another as the first and second coupling elements 4024, 4026 couple together as they extend from the catheter 4002. In some implementations, the flexibility of the first and second distal end portions 4016, 4018, which are not shaped or steerable, results in the first and second distal tips 4020, 4022 being movable into proximity with one another as the first and second coupling elements 4024, 4026 couple together.

[0273] 69, once 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 posterior leaflet 22 may advance through the third lumen 4010 and return through the fourth lumen 4014, or vice versa. The cutting element 4030 may be configured to cut, sever, or ablate the leaflets in a variety of ways, such as through the use of friction, heat, electrocautery, vibration, blades, saws, etc. (shown in dashed lines in FIG. 69). In the illustrated implementation, the cutting element 4030 is a conductive wire (e.g., made of metal or has a metallic element that allows an electric current to flow).

[0274] 70 , as the cutting element advances through the third lumen 4010 and returns through the fourth lumen 4014, or vice versa, the first cutter delivery catheter 4008 and the second cutter delivery catheter 4012 may 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 may be separated 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).

[0275] 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 implementation may be connected to an activation source 4032 configured to energize, heat, vibrate, or otherwise activate the cutting element 4030. In an exemplary implementation, the cutting element 4030 configured as a conductive wire, the activation source 4032 is a radio frequency generator connected to the cutting element 4030 to deliver 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 may then be pulled through a portion of the anterior leaflet 20 or posterior leaflet 22 adjacent where the implantable device 3100 grips the anterior leaflet 20 or posterior leaflet 22. As a result, the cut and / or excised anterior leaflet 20, or the cut and / or excised posterior leaflet 22, is removed from the implantable device 3100.

[0276] 72, in some implementations, the first cutter delivery catheter 4008 includes a first inflatable balloon 4034 at or adjacent to a first distal tip 4020, and the second cutter delivery catheter 4012 includes a second inflatable balloon 4036 at or adjacent to a second distal tip 4022. The first inflatable balloon 4034 may be inflated as the first distal tip 4020 extends through the first or lateral orifice 40 and past the chordae tendineae CT (e.g., FIG. 3). Upon inflation, the first inflatable balloon 4034 may displace the chordae tendineae CT away from the implantable device 3100 such that the first distal tip 4020 does not extend between the individual chordae tendineae CT or minimizes the number of individual chordae tendineae CT between the first distal end portion 4016 of the first cutter delivery catheter 4008 and the implantable device 3100. In doing so, few or no chordae CT are severed when the cutting element 4030 detaches the leaflets 20, 22 from the implantable device 3100. Similarly, upon inflation, the second inflatable balloon 4036 can displace the chordae CT away from the implantable device 3100 such that the second distal tip 4022 does not extend between individual chordae CT or minimize 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.

[0277] 73-77 show an exemplary cutting device 4100 for resecting a natural leaflet. The cutting device 4100 may be delivered to the valve by any suitable delivery system, such as any of the delivery systems disclosed herein. The cutting device 4100 may be configured in a variety of ways. In the illustrated implementation, the cutting device 4100 may be delivered via a catheter 4002 having a first lumen 4004 and a second lumen 4006.

[0278] 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, pusher, shaft, rod, etc.) configured to be delivered through the second lumen 4006. The first cutter delivery catheter 4108 includes a bendable and / or flexible first distal end portion 4116. In some implementations, the first distal end portion 4116 is steerable. The first distal end portion 4116 may be orientable by any suitable means. In some implementations, the first distal end portion 4116 may include a shape memory alloy, such as, for example, Nitinol, to enable shape memory properties. Thus, the first distal end portion 4116 may be shape set to a desired position. In some implementations, the second cutter delivery element 4112 may be configured similarly to the first cutter delivery catheter 4108. For example, the second cutter delivery element 4112 may have a bendable or flexible portion, or a steerable portion, or a shape-setting portion.

[0279] 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 implementations, the first distal tip 4120 is configured to couple to the second distal tip 4122. In some implementations, 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, clasps, grippers, or other suitable couplers.

[0280] In the illustrated implementation, the first coupling element 4124 is a female connector removably coupled to the first cutter delivery catheter 4108. The first coupling element 4124 may be removably coupled to the first cutter delivery catheter 4108 in a variety of ways. In an exemplary implementation, the first coupling element 4124 is received within the third lumen 4110 at or adjacent to the first distal tip 4120. In some implementations, the first coupling element 4124 is received within the third lumen 4110 via a friction fit and / or a detent and is releasable from the third lumen 4110 by application of an axial force sufficient to separate the first coupling element 4124 from the first cutter delivery catheter 4108. In some implementations, the outer surface of the first coupling element 4124 and the inner surface of the third lumen 4110 may have complementary shapes that act as detents. Any suitable complementary shapes may be used. In the illustrated example, the first coupling element 4124 and the inner surface of the third lumen 4110 have complementary shapes, such as a wavy or hourglass shape.

[0281] 75-76, the first coupling element 4124 includes a distal end 4128 and a proximal end 4131 opposite the distal end 4128 (FIGS. 75-76). In the illustrated implementation, the second coupling element 4126 is a male connector secured to the second cutter delivery element 4112 to form the 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, which, when received, is configured to hold the second coupling element 4126 within the distal end 4128. The second coupling element 4126 and the distal end 4128 of the first coupling element 4124 can be configured in a variety of ways. In the illustrated implementation, the second coupling element 4126 includes one or more radially outwardly extending protrusions 4132 (e.g., barbs) and the distal end 4128 includes one or more radially inwardly extending protrusions 4134.

[0282] In the illustrated embodiment, 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 may be configured to cut, sever, or ablate the leaflets in a variety of ways (shown in dashed lines in FIGS. 73 and 74), such as using friction, heat, electrocautery, vibration, blades, saw teeth, etc. In the illustrated implementation, the cutting element 4130 is a conductive wire (e.g., made of metal or having a metallic element that allows an electric current to flow) having an end attached to the first coupling element 4124.

[0283] 73-74, a first cutter delivery catheter 4108 is shown extending from a 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 a heart valve (e.g., the mitral valve MV). As 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 may bend (e.g., orient or shape set) around the implanted device 3100 and return through the other of the first orifice 40 or the second orifice 42. FIG. 74 shows the second cutter delivery element 4112 extending through the second lumen 4006 such that the second coupling element 4126 extends from the second lumen 4006 and is connected to the first coupling element 4124 .

[0284] 75-76, to 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 onto the second coupling element 4126. When 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. As the radially outwardly extending protrusion 4132 moves axially past the radially inwardly extending protrusion 4134, the radially inwardly extending protrusion 4134 bends to its original position, as shown in FIG. 76, capturing the second coupling element 4126 and connecting the first cutter delivery catheter 4108 to the second cutter delivery element 4112.

[0285] Once the first coupling element 4124 and the second coupling element 4126 are connected, the first coupling element 4124 may be detached from the first cutter delivery catheter 4108. For example, sufficient tension may 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 over 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 separated from the first coupling element 4124, the first cutter delivery catheter 4108 may be withdrawn through the first lumen 4004 exposing the cutting element 4130.

[0286] Additionally, when the first cutter delivery catheter 4108 is separated from the first coupling element 4124, the second cutter delivery element 4112 can be pulled back through the second lumen 4006 pulling the first coupling element 4124 and the cutting element 4130 with it. As a result, the cutting element 4130 can loop through the first and second lumens 4004, 4006 as shown in FIG. 77. Similar to the cutting device 4100 illustrated in FIG. 71, the cutting element 4130 can be connected to an actuation source (e.g., actuation source 4032) configured to energize, heat, vibrate, or otherwise activate the cutting element 4130. In an exemplary implementation, the cutting element 4130 is configured as a conductive wire, and the actuation source is a radio frequency generator connected to the cutting element 4130 to deliver radio frequency energy through the cutting element 4130. The radio frequency energy activates (i.e., heats) the cutting element 4130.

[0287] The actuated cutting element 4130 may then be pulled through a portion of the anterior leaflet 20 or posterior leaflet 22 adjacent where the implantable device 3100 grasps the anterior leaflet 20 or posterior leaflet 22. As a result, the cut and / or excised anterior leaflet 20, or the cut and / or excised posterior leaflet 22, is detached from the implantable device 3100.

[0288] In some implementations, the second cutter delivery element 4112 may include or be a conductive element, and the first coupling element 4124 and the second coupling element 4126 may electrically couple the cutting element 4130 to the conductive element. In some implementations, the first coupling element 4124 and the second coupling element 4126 may be conductive such that when coupled together they form an electrical connection between the second cutter delivery element and the cutting element 4130. Thus, in some implementations, the first coupling element 4124 does not need to be pulled back through the second lumen 4006 by the second cutter delivery element 4112 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 coupled.

[0289] 78-84 show an exemplary cutting device 4200 for resecting a natural leaflet. The cutting device 4200 may be delivered to the valve by any suitable delivery system, such as any of the delivery systems disclosed herein. The cutting device 4200 may be configured in a variety of ways. In the illustrated implementation, the cutting device 4200 may be delivered via a catheter 4202 having one or more lumens 4204 and a distal tip 4206.

[0290] In the illustrated embodiment, the cutting device 4200 is formed as a fork or V-shape having a first arm or prong 4220 having a first distal end 4222 and a second arm or prong 4224 having a second distal end 4226 spaced from the first distal end 4222. Extending between the first distal end 4222 and the second distal end 4226 is a cutting element 4230 for cutting, severing, or ablating the anterior leaflet 20 and / or the posterior leaflet 22. The cutting element 4230 may be configured to cut, sever, or ablate the leaflets in a variety of ways, such as using friction, heat, electrocautery, vibration, blades, saws, etc. In the illustrated implementation, the cutting element 4230 is a conductive wire (e.g., made of metal or has a metallic element that allows an electric current to flow therethrough). In some implementations, the cutting element 4230 extending between the first distal end 4222 and the second distal end 4226 is in a relaxed state (ie, untensioned).

[0291] The first arm 4220 and the second arm 4224 may be configured in a variety of ways. For example, the first arm 4220 and the second arm 4224 may be a tube or catheter through which the cutting element 4230 extends. In some implementations, the first arm 4220 and the second arm 4224 may include a shape memory alloy (e.g., Nitinol) or spring wire to enable shape memory properties. In some implementations, the first arm 4220 and the second arm 4224 may be an insulated wire, while the cutting element is formed from the same wire with the insulation removed.

[0292] 79-81, the cutting device 4200 can be delivered to the left atrium LA via a catheter 4202. When extended from the catheter 4202, the first arm 4220 and the second arm 4224 spread apart, as shown in FIG 78. The cutting device 4200 can be positioned over one of the leaflets 20, 22 adjacent to the installed implantable device 3100 such that the cutting element 4230 extends across the atrial side of the leaflets 20, 22 (shown in FIG 80 as the anterior leaflet 20 of the mitral valve MV).

[0293] 84, the cutting element 4230 can be connected to an actuation source (e.g., actuation source 4032) configured to energize, heat, vibrate, or otherwise activate the cutting element 4230. In an exemplary implementation, for a cutting element 4230 configured as a conductive wire, the actuation source is a radio frequency generator connected to the cutting element 4230 to deliver radio frequency energy through the cutting element 4230. The radio frequency energy activates (i.e., heats) the cutting element 4230.

[0294] 82-83, once the cutting element 4320 is positioned over the atrial side of the leaflets 20, 22 adjacent to the attached implantable device 3100, the activated cutting element 4230 may then be moved downward toward the left ventricle LV through a portion of the leaflet adjacent to where the implantable device 3100 grasps the anterior leaflet 20 (e.g., the anterior leaflet 20 in FIGS. 82-83). As a result, the cut and / or excised anterior leaflet 20 is detached from the implantable device 3100.

[0295] Although many of the implementations herein are in the context of removing implants, the systems, apparatus, devices, methods, etc. herein may be adapted to cut or remove natural tissue even when no implant is present.

[0296] Examples (some non-limiting examples are disclosed below):

[0297] Example 1. A device for cutting natural leaves, comprising: A catheter; a cutting device disposed within the catheter, the cutting device comprising a snare capable of cutting or ablating the natural lobe; and a stabilization component including an element for gripping the implantable device.

[0298] Example 2. A device as described in example 1, wherein the cutting device is formed with an electrode, which may consist of a metallic element that allows an electric current to flow.

[0299] Example 3. The device of example 1 or 2, wherein the cutting device is made of Nitinol.

[0300] Example 4. A device according to any one of Examples 1-3, wherein the cutting device comprises a surface that allows radio frequency energy to ablate the natural leaf.

[0301] Example 5. The device of any one of Examples 1-4, wherein the stabilization component is configured to be attached to a collar of the implantable device.

[0302] Example 6. A device according to any one of Examples 1 to 5, wherein the element for gripping the implantable device is a snare.

[0303] Example 7. A device according to any one of Examples 1-5, wherein the element for grasping the implantable device is any one of a pincer, a grasper, or a vacuum suction device.

[0304] Example 8. The apparatus of any one of Examples 1-7, further comprising a second cutting device comprising a second snare capable of cutting or ablating the natural leaf.

[0305] Example 9. The device according to example 8, wherein the second cutting device is formed with an electrode, which may consist of a metallic element that allows an electric current to flow.

[0306] Example 10. The apparatus of any one of Examples 8-9, wherein the second cutting device comprises a surface that allows the radio frequency energy to ablate the natural leaf.

[0307] Example 11. The device of any one of Examples 8-10, wherein the second cutting device functions as a stabilizing component.

[0308] Example 12. A device for cutting natural leaves, comprising: A catheter; a cutting device including at least one coring element disposed adjacent to said catheter, said at least one coring element including features capable of cutting or ablating said natural lobe; and a stabilization component including an element for gripping the implantable device.

[0309] Example 13. The device of example 12, wherein at least one coring element is disposed along the outer surface of the catheter.

[0310] Example 14 The device of example 13, wherein the device comprises a single coring element that surrounds the outer surface of the catheter.

[0311] Example 15. An apparatus described in any one of Examples 12-13, wherein the apparatus comprises a first coring element and a second coring element.

[0312] Example 16. An apparatus described in any one of Examples 12-15, wherein at least one coring element is arc-shaped.

[0313] Example 17. A device according to any one of Examples 12-16, wherein the feature capable of cutting or ablating a natural leaf is a blade.

[0314] Example 18. A device described in any one of Examples 12 to 16, wherein the feature capable of cutting or ablating a natural leaf is a cutting tip formed from an electrode, which may be comprised of a metallic element that allows an electric current to flow.

[0315] Example 19. A device described in any one of Examples 12 to 18, wherein at least one coring element is made of Nitinol.

[0316] Example 20. A device described in any one of Examples 12 to 16, wherein the feature capable of cutting or ablating a natural leaf is a cutting tip formed from an electrode, which may be comprised of a metallic element that allows an electric current to flow.

[0317] Example 21. A device described in any one of Examples 12 to 18, wherein at least one coring element further comprises a surface that is conductive to radio frequency energy.

[0318] Example 22. A device described in any one of Examples 12 to 21, wherein the element for gripping the implantable device is a snare.

[0319] Example 23. A device described in any one of Examples 12 to 21, wherein the element for grasping the implantable device is any one of a pincer, a grasper, or a vacuum suction device.

[0320] Example 24. A device for cutting natural leaves, comprising: A catheter; a cutting device including at least one electrosurgical element; a stabilization component including elements for gripping the implantable device; and an indicator or gauge.

[0321] Example 25 The device of example 24, wherein the cutting device is made of Nitinol.

[0322] Example 26. A device described in any one of Examples 24 to 25, wherein at least one electrosurgical element is a cutting tip or blade.

[0323] Example 27. A device described in any one of Examples 24 to 25, wherein at least one electrosurgical element is an electrosurgical ring.

[0324] Example 28. A device described in any one of Examples 24 to 27, wherein the element for grasping the implantable device is a snare.

[0325] Example 29. A device described in any one of Examples 24 to 27, wherein the element for grasping the implantable device is any one of a pincer, a grasper, or a vacuum suction device.

[0326] Example 30. The device of any one of Examples 25-29, further comprising a second cutting device having a second cutting tip.

[0327] Example 31. A device described in any one of Examples 25 to 30, wherein the indicator or gauge is a radiopaque feature.

[0328] Example 32. A device described in any one of Examples 25 to 31, wherein the indicator or gauge is a depth gauge.

[0329] Example 33. A device described in any one of Examples 25 to 31, wherein the indicator or gauge is a long, conformable positioning wire or rod.

[0330] Example 34. A device described in any one of Examples 25 to 31, wherein the indicator or gauge is configured to guide the cutting device and engage the tissue to be cut prior to the cutting device.

[0331] Example 35. A method for excising a natural leaf, comprising: placing a catheter into an implantable device secured to at least one leaflet of the native heart valve; deploying a cutting device disposed within the catheter onto the at least one leaflet; securing at least one of the cutting device and stabilization component to a portion of the implantable device; cutting the natural leaf with the cutting device; cutting a second natural leaf with the cutting device; and detaching the implantable device from the native heart valve using at least one of the cutting device and the stabilizing component via the catheter.

[0332] Example 36. An apparatus for removing an implantable device from a natural leaflet, comprising: A catheter; a clamp having a first gripping arm and a second gripping arm disposed within the catheter; The apparatus, wherein the clamp further comprises an element capable of cutting, severing, or excising the natural leaf.

[0333] Example 37. The device of example 36, wherein upon closure of the first and second gripping arms of the clamp, the first and second gripping arms encircle the implantable device.

[0334] Example 38. A device described in any of Examples 36-37, wherein the first gripping arm and the second gripping arm each further comprise a serrated edge or blade.

[0335] Example 39. A device described in any of Examples 36 to 38, wherein the first gripping arm and the second gripping arm each further comprise an electrocautery element.

[0336] Example 40. A device for cutting natural leaves, comprising: A catheter; a cutting device comprising a central wire, a first prong, and a second prong, the cutting device being capable of cutting, severing, or ablating the natural leaf; and a stabilization component including an element configured to grip the implantable device.

[0337] Example 41 The device of example 40, wherein the first prong and the second prong comprise sharp blades.

[0338] Example 42 The device of example 40, wherein the first prong and the second prong comprise an electrocautery element.

[0339] Example 43. The device of example 40, wherein the cutting device is connected to an infrared generator such that heat can be used to cut natural leaves.

[0340] Example 44 The device of example 40, wherein the first prong and the second prong comprise a surface that enables radiofrequency energy to ablate the natural lobe.

[0341] Example 45. A device described in any of Examples 40 to 44, wherein the cutting device is made of Nitinol.

[0342] Example 46. The device of any of Examples 40 to 45, further comprising a balloon coupled to the cutting device.

[0343] Example 47. The device of example 46, wherein the balloon is configured to cut, sever, or ablate the natural lobe.

[0344] Example 48. A device for cutting natural leaves, comprising: A first catheter; a first cutting device including a hook disposed within the first catheter; A second catheter; a second cutting device including a loop disposed within the second catheter; and a stabilization component including an element for gripping the implantable device.

[0345] Example 49. The device of example 48, wherein the hooks and loops are capable of cutting, severing, or ablating the natural leaf, such as through the use of friction, heat, electrocautery, vibration, blades, or saws.

[0346] Example 50. A device described in any of Examples 48-49, wherein the hooks and loops are formed from electrodes that may be comprised of metallic elements that allow electrical current to flow.

[0347] Example 51. The device of any of Examples 48-50, wherein the hook and loop are connected to an infrared generator such that heat is generated to cut the natural leaf.

[0348] Example 52. A device described in any of Examples 48 to 51, wherein the hooks and loops are made of Nitinol or spring wire.

[0349] Example 53. A device according to any of Examples 48-52, wherein the hooks and loops comprise a surface that allows radio frequency energy to ablate the natural lobe.

[0350] Example 54. A device described in any of Examples 48-53, wherein the hooks align perpendicular to the loops when deployed from the second catheter, such that the hooks align and enter the loops, creating a lasso that can be used to sever the natural lobe.

[0351] Example 55. A device for cutting natural leaves, comprising: A catheter; a retrieval device comprising a positioning element, a snare, and / or a bag, capable of cutting, severing, or excising the natural lobe, such as through the use of friction, heat, electrocautery, vibration, blades, saws, etc.; The apparatus, wherein the retrieval device is configured to capture a valve repair device.

[0352] Example 56. The device described in Example 55, wherein the snare comprises an electrocautery element.

[0353] Example 57. The device of example 55, wherein the snare is connected to an infrared generator such that heat can be used to cut natural leaves.

[0354] Example 58. A device described in any of Examples 55 to 57, wherein at least one of the snare and bag is made of Nitinol or spring wire to enable shape memory properties.

[0355] Example 59. The device of example 55 or 58, wherein the snare comprises a surface that enables radio frequency energy to ablate the natural lobe.

[0356] Example 60. A device for cutting natural leaves, comprising: a catheter having a distal end; a cap attached to the catheter such that the cap is movable relative to the catheter 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 actuation element configured to move the cap between an open position and a closed position; the one or more cutting elements are configured to cut, sever, or ablate the natural leaf; The device, wherein the cap is configured to capture a valve repair device.

[0357] Example 61. The device described in Example 60, wherein the one or more cutting elements are configured to cut, sever, or ablate natural leaves by the use of at least one of friction, heat, electrocautery, vibration, blades, and sawtooth.

[0358] Example 62. The device described in example 60 or 61, wherein the one or more cutting elements comprises a single cutting element on the cap.

[0359] Example 63. The device described in Example 62, wherein the cutting element comprises an electrocautery element.

[0360] Example 64. The device described in example 62, wherein the cutting element is connected to an infrared generator, such that heat can be used to cut natural leaves.

[0361] Example 65. The device of example 62, wherein the cutting element comprises a surface that enables radiofrequency energy to ablate the natural leaf.

[0362] Example 66. A device described in any of Examples 60 to 65, wherein the one or more cutting elements include a single cutting element disposed on the distal end of the catheter.

[0363] Example 67. The device described in Example 66, wherein the cutting element comprises an electrocautery element.

[0364] Example 68. The device described in example 66, wherein the cutting element is connected to an infrared generator, such that heat can be used to cut natural leaves.

[0365] Example 69. The device described in Example 66, wherein the cutting element comprises one or more surfaces configured to apply radio frequency energy to ablate the natural leaf.

[0366] Example 70. A device described in any of Examples 60 to 69, wherein at least one of the cutting element and the cap is made of Nitinol or spring wire to provide shape memory properties.

[0367] Example 71. A device described in any of Examples 60 to 70, wherein the cap is connected to the catheter by a hinge connector.

[0368] Example 72. The device of any of Examples 60-71, wherein the cap is biased in a closed position and an actuation element is used to move the cap from the closed position to the open position.

[0369] Example 73. A device described in any of Examples 60 to 72, wherein the actuation element comprises a wire.

[0370] Example 74. A method for removing one or more native leaflets of a native valve and implanting a replacement valve into said native valve, comprising: deploying a cutting device such that the cutting device is positioned adjacent to the native valve; cutting the one or more natural leaflets with the cutting device such that a valve repair device is removed from the one or more natural leaflets, the valve repair device remaining connected to at least one other natural leaflet of the native valve; positioning the replacement valve such that the replacement valve is positioned adjacent to the native valve, the replacement valve having a body and one or more anchors; and attaching the replacement valve to the one or more natural lobes and at least a portion of the at least one other natural lobe 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.

[0371] Example 75. The method of Example 74, further comprising engaging the one or more natural leaves with a cutting device prior to cutting the one or more natural leaves, and repositioning the cutting device relative to the one or more natural leaves if tenting of the one or more natural leaves is not detected.

[0372] Example 76. The method of any of Examples 74-75, wherein cutting comprises the use of at least one of friction, electrocautery, vibration, and sawing.

[0373] Example 77. The method of any of Examples 74-76, wherein the cutting device comprises one or more blades.

[0374] Example 78. The method of any of Examples 74-76, wherein the cutting device comprises an electrosurgical tip formed with an electrode including a metallic element configured to allow an electric current to flow therethrough.

[0375] Example 79. The method of any of Examples 74-76, wherein the cutting device comprises an electrosurgical tip formed with an electrode including a metallic element configured to allow an electric current to flow therethrough.

[0376] Example 80. The method of any of Examples 74-76, wherein the cutting device is connected to an infrared generator such that the cutting device can use heat to cut one or more natural leaves.

[0377] Example 81. The method of any of Examples 74-76, wherein the cutting device comprises one or more surfaces that enable radiofrequency energy to ablate one or more natural lobes.

[0378] Example 82. The method of any of Examples 74-81, further comprising positioning a delivery system adjacent to the native valve, the delivery system being configured to position the cutting device and the replacement valve.

[0379] Example 83 The method of Example 82, further comprising deploying a stabilizing component to connect the valve repair device to a delivery system prior to cutting one or more natural leaflets.

[0380] Example 84. The method of any of Examples 82-83, 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.

[0381] Example 85. The method of any of Examples 74-84, wherein the body comprises an inner body and an outer body.

[0382] Example 86. A system for ablating a natural leaf, 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, The system, wherein the first distal tip includes a first coupling element configured to connect to a second coupling element on the second distal tip such that the cutting element is advanceable through the second lumen.

[0383] Example 87. The system of example 86, wherein the first coupling element is configured to magnetically couple to the second coupling element.

[0384] Example 88. The system described in Example 86 or 87, wherein the second cutter delivery catheter includes 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.

[0385] Example 89. The system of example 88, wherein the cutting element is advanceable through the second lumen via the fourth lumen.

[0386] 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.

[0387] Example 91. The system of example 86, wherein the first coupling element is configured to mechanically couple to the second coupling element.

[0388] Example 92. The system described in Example 91, wherein the first coupling element is configured as a female connector and the second coupling element is configured as a male connector.

[0389] Example 93. The system described in Example 92, wherein the first coupling element is configured to be received within the third lumen at the first distal tip.

[0390] Example 94. The system described in Example 93, wherein the first coupling element has a first outer surface having a shape complementary to the inner surface of the first distal tip.

[0391] Example 95. A system described in any of Examples 92 to 94, wherein the first coupling element includes a distal end and a proximal end, and the cutting element is attached to the proximal end.

[0392] Example 96. The system described in Example 95, wherein the distal end is configured to receive a second coupling element.

[0393] Example 97. A system described in any of Examples 92 to 96, wherein the second coupling element includes one or more radially outward extending protrusions.

[0394] Example 98. The system described in Example 97, wherein the first coupling element includes one or more radially inwardly extending protrusions configured to engage with the one or more radially outwardly extending protrusions to resist separation of the second coupling element from the first coupling element.

[0395] Example 99. A system described in any of Examples 92 to 98, wherein the first coupling element is configured to be detached from the first cutter delivery catheter when coupled to the second coupling element.

[0396] Example 100. A system described in any of Examples 86 to 99, wherein the cutting element is a conductive wire.

[0397] Example 101. The system described in Example 100, further comprising an actuation source configured to energize the cutting element.

[0398] Example 102. The system described in Example 101, wherein the activation source is a radio frequency generator.

[0399] Example 103. A system described in any of Examples 86 to 102, wherein the first cutter delivery catheter has a steerable distal end portion.

[0400] Example 104. A system described in any of Examples 86 to 102, wherein the first cutter delivery catheter has a distal end portion having shape memory properties.

[0401] Example 105. A system described in any of Examples 86 to 104, further comprising an inflatable balloon attached to the outer surface of the first cutter delivery catheter adjacent the first distal tip.

[0402] Example 106. A system for ablating a natural leaf, comprising: A delivery catheter; a cutting device configured for delivery through the delivery catheter, a first arm having a first distal end; a second arm having a second distal end spaced from the first distal end; a cutting device comprising a cutting element extending between the first distal end and the second distal end.

[0403] Example 107. The system described in Example 106, wherein the cutting element is a conductive wire.

[0404] Example 108. The system described in Example 107, wherein the conductive wire is in a slack state between the first distal end and the second distal end.

[0405] Example 109. A system described in any of Examples 106 to 108, wherein the first arm and the second arm form a V-shape.

[0406] Example 110. A system described in 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.

[0407] Example 111. The system described in Example 106, further comprising an actuation source configured to energize the cutting element.

[0408] Example 112. The system described in Example 111, wherein the activation source is a radio frequency generator.

[0409] Example 113. A method of ablating a leaflet of a native valve captured by an implantable device, comprising: extending a first cutter delivery catheter from an atrial side of a leaflet of the native valve to a ventricular side of a first side of the implantable device; extending a second cutter delivery catheter from the atrial side of a leaflet of the native valve to the ventricular side of 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 a leaflet of the native valve; extending a cutting element through a first lumen of the first cutter delivery catheter and a second lumen of the second cutter delivery catheter; withdrawing the first cutter delivery catheter to expose the cutting element adjacent a leaflet of the native valve; and moving a cutting element through a leaflet of the native valve from the ventricular side to the atrial side to detach the leaflet of the native valve from the implantable device.

[0410] 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.

[0411] Example 115. The method of Example 114, wherein 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.

[0412] Example 116. The method of any of Examples 113-115, further comprising steering the first distal tip of the first cutter delivery catheter toward the second distal tip of the second cutter delivery catheter on the ventricular side.

[0413] Example 117. The method of any of Examples 113-116, further comprising connecting the cutting element to a power source.

[0414] Example 118. The method described in Example 117, wherein the activation source is a radio frequency generator.

[0415] Example 119. The method of any of Examples 113-118, further comprising activating the cutting element with radio frequency energy.

[0416] Example 120. The method of any of Examples 113-119, wherein the cutting element is a conductive wire.

[0417] Example 121. The method of any of Examples 113-120, wherein extending the first cutter delivery catheter from the atrial side to the ventricular side of the leaflet of the native valve further comprises inflating a balloon on the exterior surface of the first cutter delivery catheter.

[0418] Example 122. A method of ablating a leaflet of a native valve captured by an implantable device, comprising: extending a first cutter delivery catheter from an atrial side of a leaflet of the native valve to a ventricular side on a first side of the implantable device, a cutting element being connected to a first coupling element associated with the first cutter delivery catheter; extending a second cutter delivery catheter from the atrial side of a leaflet of the native valve to the ventricular side of 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 a leaflet of the native valve; withdrawing the first cutter delivery catheter to expose the cutting element adjacent a leaflet of the native valve; and moving a cutting element through a leaflet of the native valve from the ventricular side to the atrial side to detach the leaflet of the native valve from the implantable device.

[0419] 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.

[0420] 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 within a female connector.

[0421] 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.

[0422] Example 126. The method of example 125, wherein removing the female connector from the first cutter delivery catheter further comprises applying a pulling force to one or both of the first cutter delivery catheter and the second cutter delivery catheter.

[0423] Example 127. The method of any of Examples 122-126, further comprising connecting the cutting element to a power source.

[0424] Example 128. The method described in Example 127, wherein the activation source is a radio frequency generator.

[0425] Example 129. The method of any of Examples 122-128, further comprising activating the cutting element with radio frequency energy.

[0426] Example 130. The method of any of Examples 122-129, wherein the cutting element is a conductive wire.

[0427] Example 131. The method of any of Examples 122-130, wherein extending the first cutter delivery catheter from the atrial side to the ventricular side of the leaflet of the native valve further comprises inflating a balloon on the exterior surface of the first cutter delivery catheter.

[0428] Example 132. The method of any of Examples 122-131, wherein connecting the first cutter delivery catheter to a second cutter delivery catheter on the ventricular side of the native valve leaflet further comprises steering a distal end portion of the first cutter delivery catheter toward the second cutter delivery catheter.

[0429] Example 133. A method of ablating a leaflet of a native valve captured by an implantable device, comprising: delivering a distal tip of a delivery catheter to an atrial side of a leaflet of the native valve; supporting a cutting element adjacent the atrial side of a leaflet of the native valve; and moving a cutting element through the leaflets of the native valve from the atrial side to the ventricular side to detach the leaflets of the native valve from the implantable device.

[0430] Example 134. The method according to example 133, wherein the cutting element is supported in a relaxed state adjacent to the atrial side of the leaflets of the native valve.

[0431] Example 135. The method of example 133 or 134, further comprising connecting the cutting element to a power source.

[0432] Example 136. The method of example 135, wherein the activation source is a radio frequency generator.

[0433] Example 137. The method of any of Examples 133-136, further comprising activating the cutting element with radio frequency energy.

[0434] Example 138. The method of any of Examples 133-137, wherein the cutting element is a conductive wire.

[0435] Example 139. The method of any of Examples 133-138, wherein supporting the cutting element adjacent the atrial side of the leaflet of the native valve further comprises extending the cutting element between the first distal end of the first arm and the second distal end of the second arm.

[0436] Example 140 The method of example 139, further comprising extending a first arm and a second arm from a distal tip of the delivery catheter.

[0437] Any of the various systems, assemblies, devices, equipment, etc. in this disclosure (including the examples above) may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on a patient, and the methods described herein may include (or additional methods may include or consist of) sterilization of the associated systems, devices, equipment, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0438] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in the examples herein, these various aspects, concepts, and features may be used in many alternatives, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Still further, although various alternatives for various aspects, concepts, and features of the present disclosure may be described herein, such as alternative materials, alternative structures, alternative configurations, alternative methods, alternative devices, alternative components, alternatives in form, alternatives in fit, alternatives in function, and the like, such descriptions are not intended to be a complete or exhaustive list of available alternatives, whether currently known or later developed. Those skilled in the art may readily incorporate one or more of the aspects, concepts, or features of the present invention into additional examples and uses within the scope of the present application, even if such examples are not expressly disclosed herein.

[0439] Additionally, although some features, concepts, or aspects of the present disclosure may be described herein as being preferred configurations or methods, such description is not intended to imply that such features are essential or essential unless expressly stated.Furthermore, while exemplary or representative values, and even exemplary or representative ranges, may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be critical values ​​or ranges only if so expressly stated.

[0440] Moreover, although various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the disclosure, such identification is not intended to be exclusive; rather, there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a particular disclosure, the disclosure being instead defined in the appended claims. Descriptions of exemplary methods or processes are not limited to the inclusion of every step as essential in all cases, nor is the order in which steps are presented construed as essential or essential unless expressly stated. The terms used in the claims are to be given their full ordinary meaning and are not to be limited in any way by the description of the examples herein.

Claims

1. An apparatus for removing natural leaflets, Catheter and, A recovery device is provided which can cut, slice, or excavate the natural leaflets by means of friction, heat, electrocautery, vibration, blades, saw teeth, etc. An apparatus in which the recovery device is configured to capture a valve repair device.

2. The apparatus according to claim 1, wherein the recovery device comprises a positioning element, a snare, and a bag, the bag being configured to capture the valve repair device.

3. The device according to claim 1, wherein the recovery device comprises a cap, which is attached to the catheter such that the cap is movable between an open position and a closed position relative to the catheter, and an actuation element configured to move the cap between the open position and the closed position, wherein the cap is configured to capture the valve repair device.

4. The apparatus according to claim 1, wherein the recovery device comprises a clamp having a first gripping arm and a second gripping arm disposed within the catheter.

5. The apparatus according to claim 4, wherein when the first gripping arm and the second gripping arm of the clamp are closed, the first gripping arm and the second gripping arm surround the valve repair device.

6. The apparatus according to claim 5, wherein the first gripping arm and the second gripping arm each further comprises a serrated edge or blade.

7. A method for removing one or more simulation leaflets from a simulation valve and transplanting a replacement valve to the simulation valve, The cutting device is deployed so that it is positioned close to the simulation valve. Cutting one or more simulation leaflets using the cutting device so that the valve repair device is removed from one or more simulation leaflets, wherein the valve repair device remains connected to at least one other simulation leaflet of the simulation valve. The arrangement of the replacement valve such that the replacement valve is positioned in close proximity to the simulation valve, wherein the replacement valve has a body and one or more anchors. A method comprising attaching the replacement valve to one or more simulation leaflets and at least one other simulation leaflet of the simulation valve such that the valve repair device is captured by the replacement valve between the body and one or more anchors.

8. The method according to claim 7, further comprising engaging the one or more simulation leaflets with the cutting device before cutting the one or more simulation leaflets, and repositioning the cutting device with respect to the one or more simulation leaflets if tenting of the one or more simulation leaflets is not detected.

9. The method according to claim 7, wherein the cutting device comprises a first cutter delivery catheter and a second cutter delivery catheter, and the method further comprises magnetically connecting the first cutter delivery catheter to the second cutter delivery catheter.

10. The method according to claim 7, wherein the cutting device comprises a central wire, a first prong, and a second prong, and the cutting device has the ability to cut, slice, or excavate the simulation leaflet.

11. The apparatus according to claim 10, wherein the first prong and the second prong each comprise an electrocautery element.

12. The method according to claim 7, wherein the cutting device includes at least one coring element positioned in close proximity to the catheter, the at least one coring element having the ability to cut or excise the simulation leaflet.

13. The method according to claim 7, wherein the cutting device comprises a first snare capable of cutting or cutting the simulation leaflet, and a second snare capable of cutting or cutting the simulation leaflet.

14. The method according to claim 7, further comprising guiding the cutting device using the indicator or gauge, and engaging the indicator or gauge with the tissue to be cut in front of the cutting device.

15. The method according to claim 7, wherein the cutting comprises the use of at least one of friction, electrocautery, vibration, and a saw.

16. The method according to claim 7, wherein the cutting device includes an electrosurgical tip formed of an electrode containing a metal element configured to allow an electric current to flow.

17. The method according to claim 7, wherein the cutting device is connected to an infrared generator so that heat can be used to cut the one or more simulation leaflets.

18. The method according to claim 7, further comprising locating a delivery system in proximity to the simulation valve, wherein the delivery system is configured to house the cutting device and the replacement valve.

19. The method according to claim 7, further comprising unfolding the stabilization components and connecting the valve repair device to the replacement valve delivery system before cutting the one or more simulation leaflets.

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