Heart Valve Repair Devices

Abstract

The implantable device includes one or more anchors. The anchors are configured to capture one or more leaflets of a native heart valve. The one or more anchors are configured to retract the leaflets of the native valve into the device. The anchor portions can be extendable and retractable. The one or more anchors can be closed to secure the implantable device to the leaflets of the native valve.

Description

[Background technology]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 281,587, entitled “HEART VALVE REPAIR DEVICES AND DELIVERY DEVICES THEREFOR,” filed November 19, 2021, which is incorporated by reference in its entirety herein.

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring forward flow for adequate blood supply 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 disorders 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 devices to treat the heart 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 a catheter into the right femoral vein, ascending the inferior vena cava, and into the right atrium). The septum is then punctured and the catheter passed into the left atrium. Using a similar transvascular technique, beginning as the transseptal technique but not going as far as puncturing the septum, the delivery catheter is instead rotated 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-chamber 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 natural 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 natural heart valves. The mitral valve includes an annulus, which is a circular portion of natural valve tissue that surrounds the mitral valve opening, and a pair of leaflets or cusps 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 they are 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 relaxes (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 expelled from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus into the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.

[0005] Valve 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 dilation of the left ventricle, or a combination of these. Mitral regurgitation in the center of the leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the leaflets' commissures (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the leaflet edges do not meet in the middle, so the valve does not close and regurgitation is present. Tricuspid regurgitation is similar but can be on the right side of the heart. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Publication No. 2018 / 195201 Brochure [Patent Document 2] International Publication No. 2018 / 195215 Brochure [Patent Document 3] International Publication No. 2018 / 209021 Brochure [Patent Document 4] International Publication No. 2019 / 051180 Brochure [Patent Document 5] International Publication No. 2019 / 139904 Brochure [Patent Document 6] International Publication No. 2019 / 204559 Brochure [Patent Document 7] International Publication No. 2020 / 076898 Brochure [Patent Document 8] International Publication No. 2020 / 168081 Brochure [Patent Document 9] U.S. Pat. No. 8,403,983 [Patent Document 10] U.S. Pat. No. 8,414,644 [Patent Document 11] U.S. Pat. No. 8,449,599 [Patent Document 12] U.S. Pat. No. 8,652,203 [Patent Document 13] U.S. Pat. No. 10,517,726 [Patent Document 14] U.S. Pat. No. 10,813,757 [Patent Document 15] US Patent Application Publication No. 2011 / 0313515 [Patent Document 16] US Patent Application Publication No. 2012 / 0215303 [Patent Document 17] US Patent Application Publication No. 2014 / 0067052 [Patent Document 18] US Patent Application Publication No. 2014 / 0222136 [Patent Document 19] US Patent Application Publication No. 2014 / 0277390 [Patent Document 20] US Patent Application Publication No. 2014 / 0277422 [Patent Document 21] US Patent Application Publication No. 2014 / 0277427 [Patent Document 22] US Patent Application Publication No. 2016 / 0331523 [Patent Document 23] US Patent Application Publication No. 2018 / 0021129 [Patent Document 24] US Patent Application Publication No. 2018 / 0055629 [Patent Document 25] US Patent Application Publication No. 2020 / 0113676 Summary of the Invention

[0007] This summary is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any features included in an example of this summary are not required by the claims unless the claims explicitly recite those features. 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 summarized herein.

[0008] An implantable device or implant (eg, an implantable prosthetic device, etc.) is configured to be positioned within the native heart valve such that the native heart valve forms a more effective seal.

[0009] In some implementations, the implantable device includes one or more anchors. The anchors are configured to capture one or more leaflets of a native heart valve. The one or more anchors may be configured to retract the leaflets of the native valve into the device. The anchor portions may be extendable and retractable. The one or more anchors may be closed to secure the implantable device to the leaflets of the native valve.

[0010] In some implementations, the implantable device includes a capture element and an anchor portion. The anchor portion includes one or more anchors. The anchor portion is at least partially disposed within the capture element. The anchor is configured to capture one or more leaflets of a native heart valve. The anchor portion is extendable from and retractable within the capture element. The capture element and anchor portion are configured to draw leaflet tissue of the native valve into the capture element when the anchor portion is retracted within the capture element.

[0011] In some implementations, the capture element includes an inner cavity through which the anchor portion can extend and into which the native valve leaflet tissue can be drawn.

[0012] In some implementations, the implantable device or implant includes an anchor portion having an inner anchor body and an outer anchor body, The inner anchor body can include one or more anchors configured to attach to one or more leaflets of a native heart valve.

[0013] In some implementations, the capture element is cylindrical in shape and / or round in cross-section, hi some implementations, the inner cavity extends from a first end of the capture element to a second end of the capture element.

[0014] In some implementations, in the closed position, the anchor portion is contained completely within the inner cavity, and in some implementations, in the open position, the anchor portion is contained at least partially outside the inner cavity.

[0015] In some implementations, the capture element is impermeable to blood, hi some implementations, the capture device inhibits or reduces blood flow.

[0016] In some implementations, the capture element comprises an opening in an end wall at a first end of the capture element. In some implementations, the second end of the capture element is open to allow the anchor portion to move in and out of the capture element from the second end. In some implementations, the capture element comprises a one-way valve.

[0017] In some implementations, the one or more anchors are made from a flexible or expandable material. In some implementations, the anchor portion comprises a body coupled to the one or more anchors. In some implementations, the anchor portion is expandable.

[0018] In some implementations, the capture element is removably attached to the delivery catheter. In some implementations, the anchor portion is removably attached to the working element. In some implementations, the working element is disposed radially inward of the delivery catheter.

[0019] In some implementations, the actuation element is attached to a collar of the anchor portion.

[0020] In some implementations, movement of the actuation element can move the anchor portion between a closed position and an open position.

[0021] In some implementations, the actuating element is connected to the anchor portion such that a user can apply tension to the actuating element to move the anchor portion from an expanded position having an expanded width to a constricted position having a constricted width, the expanded width being greater than the constricted width.

[0022] In some implementations, the implantable device includes a capture element and an anchor portion, hi some implementations, the anchor portion includes an inner anchor body and an outer anchor body.

[0023] In some implementations, the anchor portion is at least partially disposed within the capture element, the capture element including an interior cavity.

[0024] In some implementations, the outer anchor body can extend from and be retracted within the inner cavity. In some implementations, the inner anchor body can extend from and be retracted within the outer anchor body.

[0025] In some implementations, the inner anchor body and the outer anchor body are configured to capture native valve leaflet tissue therebetween.

[0026] In some implementations, the capture element and anchor portion are configured to draw native valve leaflet tissue into the inner cavity when the anchor portion is retracted within the inner cavity of the capture element.

[0027] In some implementations, the capture element is cylindrical in shape and / or round in cross-section, hi some implementations, the inner cavity extends from a first end of the capture element to a second end of the capture element.

[0028] In some implementations, in the closed position, the anchor portion is contained completely within the inner cavity, and in some implementations, in the open position, the anchor portion is contained at least partially outside the inner cavity.

[0029] In some implementations, the capture element is impermeable to blood, hi some implementations, the capture element inhibits or reduces blood flow.

[0030] In some implementations, the capture element comprises an opening at a first end of the capture element. In some implementations, the second end of the capture element is open to allow the anchor portion to move in and out of the capture element from the second end. In some implementations, the capture element comprises a one-way valve.

[0031] In some implementations, the anchor portion is made from a flexible or expandable material. In some implementations, the anchor portion is expandable.

[0032] In some implementations, the capture element is removably attached to the delivery catheter. In some implementations, the anchor portion is removably attached to one or more actuation elements.

[0033] In some implementations, the inner anchor body is removably attached to the inner working element. In some implementations, the outer anchor body is removably attached to the outer working element.

[0034] In some implementations, the one or more working elements are disposed radially inward of the delivery catheter, hi some implementations, movement of the inner working element can move the inner anchor body between the closed and open positions.

[0035] In some implementations, movement of the outer actuating element can move the outer anchor body between a closed position and an open position.

[0036] In some implementations, one or more actuating elements are connected to the anchor portion such that a user can apply tension to the one or more actuating elements to move the anchor portion from an expanded position having an expanded width to a constricted position having a constricted width, the expanded width being greater than the constricted width.

[0037] In some implementations, a method of repairing a native valve includes positioning an anchor portion such that leaflets of a native heart valve are disposed within the anchor portion and drawing the anchor portion and the leaflet portion into an open end of a capture element. In some implementations, the capture element has a first end, a second end, and a cavity between the first and second ends.

[0038] In some implementations, the anchor portion can extend from and be retracted within a cavity of the capture element.

[0039] In some implementations, the method includes blocking blood flow with a capture element. In some implementations, the method further includes detaching the anchor portion and the capture element from the delivery catheter.

[0040] The above methods can be performed on live animals or can be performed on simulations such as cadavers, cadaver hearts, humanoid ghosts, simulators (e.g., simulated using body parts, hearts, tissues, etc.).

[0041] In some implementations, the implantable device includes an anchor portion and a rotating member. In some implementations, the anchor portion includes one or more anchors. In some implementations, the anchor portion is coupled with a capture element.

[0042] In some implementations, the rotating member is coupled with the one or more anchors and configured to draw native valve leaflet tissue into the one or more anchors.

[0043] In some implementations, the rotating member is cylindrical, hi some implementations, the rotating member includes one or more protrusions, notches, or other gripping members spaced throughout the rotating member for engaging with the leaflets.

[0044] In some implementations, the rotating member includes threaded ridges along a surface of the rotating member, hi some implementations, the rotating member is removably attached to the actuation element.

[0045] In some implementations, in response to the rotating member rotating in a first direction, the rotating member draws the leaflets into the one or more anchors, and in response to the rotating member rotating in a second direction, the rotating member displaces the leaflets from the one or more anchors.

[0046] In some implementations, a device (e.g., a valve repair device, an implant, etc.) is adapted to be implanted between the leaflets of a native heart valve. The device includes a grasping member and a leaflet repositioning device.

[0047] In some implementations, the gripping member includes a base arm and a movable arm and is configured to move between an open position and a closed position, in which the gripping member is configured to grip a leaflet of the native heart valve between the base arm and the movable arm.

[0048] In some implementations, the leaflet repositioning device is configured to reposition the leaflets relative to the base arms while the gripping members are in the closed position.

[0049] In some implementations, the leaflet repositioning device is configured to move the movable arm relative to the base arm toward a centerline of the device while the gripping members are in the closed position.

[0050] In some implementations, the movable arm has a proximal end and a distal end, and the leaflet repositioning device includes a retraction element attached to the proximal end, and pulling the retraction element while the gripping member is in a closed position moves the distal end toward a centerline of the device.

[0051] In some implementations, the device further includes an interface element positioned along a centerline of the device, and pulling the retraction element retracts the movable arm into the interface element.

[0052] In some implementations, the device further includes a lock configured to secure the movable arm in position after it has been moved by the leaflet repositioning device.

[0053] In some implementations, the device further includes a fixation element disposed on the movable arm for engaging the leaflet. In some implementations, the fixation element includes one or more barbs. In some implementations, the device further includes a second fixation element disposed on the base arm for engaging the leaflet.

[0054] In some implementations, the leaflet repositioning device is configured to move the fixation element relative to the moveable arm toward a centerline of the device while the gripping members are in the closed position.

[0055] In some implementations, the movable arm has a proximal end and a distal end, and the leaflet repositioning device includes a retraction element attached to the fixation element end. Pulling the retraction element while the gripping member is in the closed position moves the fixation element toward a centerline of the device.

[0056] In some implementations, the device further includes a joint element positioned along a centerline of the device.

[0057] In some implementations, the device further includes a lock configured to secure the fixation element in a fixed position relative to the movable arm after being moved by the leaflet repositioning device.

[0058] In some implementations, the fixation element includes one or more barbs, hi some implementations, the fixation element has a distal position and a proximal position that is inward from the distal position.

[0059] In some implementations, the leaflet repositioning device can be configured to repeatedly move the fixation elements between distal and proximal positions to incrementally move the leaflets toward the centerline of the device.

[0060] In some implementations, the leaflet repositioning device includes a ratchet device operable to repeatedly move the fixation element between the distal and proximal positions.

[0061] In some implementations, the device includes a second fixation element disposed on the base arm for engaging the leaflet, hi some implementations, the fixation element disposed on the movable arm can be moved from a proximal position to a distal position while the second fixation element holds the leaflet in place relative to the movable arm.

[0062] In some implementations, the leaflet repositioning device is configured to rotate the movable arm relative to the base arm about a longitudinal axis of the movable arm while the gripping member is in the closed position, hi some implementations, rotating the movable arm moves the leaflet relative to the base arm.

[0063] In some implementations, the device includes a lock configured to lock the movable arm in a rotated position after it has been moved by the leaflet repositioning device.

[0064] In some implementations, the device includes an anchoring element disposed on the moveable arm for engaging the leaflets, hi some implementations, the anchoring element includes one or more barbs.

[0065] In some implementations, the device further includes a second gripping member including a second base arm and a second movable arm. In some implementations, the second gripping member is configured to move between an open position and a closed position. In the closed position, the second gripping member is configured to grip a second leaflet of the native heart valve between the second base arm and the second movable arm.

[0066] In some implementations, the leaflet repositioning device is configured to rotate the second movable arm relative to the second base arm about a second longitudinal axis of the second movable arm while the second gripping member is in the closed position.

[0067] In some implementations, the device includes a second leaflet repositioning device. In some implementations, the second repositioning device is configured to rotate the second movable arm relative to the second base arm about a second longitudinal axis of the second movable arm while the second gripping member is in the closed position. In some implementations, the second movable arm and the movable arm are configured to simultaneously rotate in opposite directions.

[0068] In some implementations, a method of repairing a native valve includes delivering an implantable device to the native valve, positioning the implantable device at an annulus of the native valve, closing grasping members of the implantable device to grasp the native leaflets, and repositioning the leaflets relative to the base arms while the grasping members remain closed.

[0069] In some implementations, the gripping member has a base arm and a movable arm. In some implementations, repositioning the leaflet includes moving the movable arm relative to the base arm toward a centerline of the device.

[0070] In some implementations, moving the movable arm includes applying tension to a retraction element coupled to the movable arm, hi some implementations, applying tension to the retraction element includes retracting the movable arm into a mating element of the device.

[0071] In some implementations, the method includes locking the movable arm in position after repositioning the leaflets.

[0072] In some implementations, closing the gripping members includes engaging the leaflets with a fixation element disposed on the movable arm, hi some implementations, the fixation element includes one or more barbs.

[0073] In some implementations, closing the gripping members includes engaging the leaflets with a second fixation element disposed on the base arm.

[0074] In some implementations, the fixation element is disposed on the movable arm, and repositioning the leaflet includes moving the fixation element relative to the movable arm toward a centerline of the device while the gripping member is in the closed position.

[0075] In some implementations, moving the fixation element includes applying tension to a retraction element coupled to the fixation element.

[0076] In some implementations, the method includes locking the fixation element in position relative to the moveable arm after being moved by the leaflet repositioning device, hi some implementations, the fixation element includes one or more barbs.

[0077] In some implementations, the fixation element has a distal position and a proximal position that is inward from the distal position.

[0078] In some implementations, repositioning the leaflets includes repeatedly moving the fixation elements between distal and proximal positions to incrementally move the leaflets toward a centerline of the device.

[0079] In some implementations, a second fixation element is disposed on the base arm for engaging the leaflet.

[0080] In some implementations, repeatedly moving the fixation element between the distal and proximal positions includes holding the leaflet in a fixed position relative to a movable arm having a second fixation element as the fixation element disposed on the movable arm moves from the proximal position to the distal position.

[0081] In some implementations, repositioning the leaflets includes rotating the movable arm relative to the base arm about a longitudinal axis of the movable arm while the gripping members are in the closed position.

[0082] In some implementations, rotating the movable arm moves the leaflets relative to the base arm, hi some implementations, the method includes locking the movable arm in the rotated position after repositioning the leaflets.

[0083] In some implementations, closing the gripping members includes engaging the leaflets with a fixation element disposed on the movable arm, hi some implementations, the fixation element includes one or more barbs.

[0084] In some implementations, the method includes closing a second gripping member of the implantable device to grip a second leaflet of the native valve.

[0085] In some implementations, the second gripping member includes a second base arm and a second movable arm, hi some implementations, the method includes repositioning the second leaflet relative to the second base arm while the second gripping member remains closed.

[0086] In some implementations, repositioning the second leaflet includes rotating the second movable arm relative to the second base arm about a second longitudinal axis of the second movable arm while the second gripping member is in the closed position.

[0087] In some implementations, the steps of rotating the second movable arm and rotating the first movable arm occur simultaneously in opposite directions.

[0088] The above methods can be performed on live animals or can be performed on simulations such as cadavers, cadaver hearts, humanoid ghosts, simulators (e.g., simulated using body parts, hearts, tissues, etc.).

[0089] Any of the above-mentioned systems, devices, instruments, components, etc. may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on a patient, and the above-mentioned methods described herein may include sterilization of one or more systems, devices, instruments, components, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0090] 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 characters and in which:

[0091] To further clarify various aspects of the implementation of the present disclosure, certain examples and implementations will be described in more detail by reference to various aspects of the accompanying drawings. These drawings show only exemplary implementations of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Furthermore, the drawings may be drawn to scale for some examples, but are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0092] [Figure 1] FIG. 1 illustrates a cross-section of a human heart in diastole. [Diagram 2] FIG. 2 illustrates a cross-section of a human heart during systole. [Diagram 3] FIG. 3 illustrates a cross-sectional view of a human heart during systole, demonstrating mitral regurgitation. [Figure 4]FIG. 4 shows a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Diagram 5] FIG. 5 shows a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 6] FIG. 6 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 7] FIG. 7 shows an exploded view of the device or implant. [Figure 8] FIG. 8 shows an example of a device or implant. [Figure 9] FIG. 9 shows an example of a device or implant. [Figure 10] FIG. 10 shows an example of a device or implant at various stages of deployment. [Figure 11] FIG. 11 shows an example of a device or implant at various stages of deployment. [Figure 12] FIG. 12 shows an example of a device or implant at various stages of deployment. [Figure 13] FIG. 13 shows an example of a device or implant at various stages of deployment. [Figure 14] FIG. 14 shows an example of a device or implant at various stages of deployment. [Figure 15] FIG. 15 shows a top view of a mitral valve with the device or implant in use. [Figure 16] FIG. 16 shows an example of a device or implant. [Figure 17] FIG. 17 shows an exploded view of the device or implant of FIG. [Figure 18] FIG. 18 illustrates the device or implant of FIG. 16 coupled to a delivery system. [Figure 19] FIG. 19 shows an example of the device or implant of FIG. 16 in various stages of deployment. [Figure 20] FIG. 20 shows an example of the device or implant of FIG. 16 in various stages of deployment. [Figure 21]FIG. 21 shows an example of the device or implant of FIG. 16 in various stages of deployment. [Figure 22] FIG. 22 shows an example of the device or implant of FIG. 16 in various stages of deployment. [Diagram 23] FIG. 23 shows an example of the device or implant of FIG. 16 in various stages of deployment. [Figure 24] FIG. 24 shows the exemplary device or implant of FIGS. 7-14 delivered and implanted within a native valve. [Diagram 25] FIG. 25 shows the exemplary device or implant of FIGS. 7-14 delivered and implanted inside a native valve. [Figure 26] FIG. 26 shows the exemplary device or implant of FIGS. 7-14 delivered and implanted within a native valve. [Figure 27] FIG. 27 shows the exemplary device or implant of FIGS. 7-14 delivered and implanted within a native valve. [Figure 28] FIG. 28 shows the exemplary device or implant of FIGS. 7-14 delivered and implanted inside a native valve. [Figure 29] FIG. 29 shows the exemplary device or implant of FIGS. 7-14 delivered and implanted inside a native valve. [Diagram 30] FIG. 30 illustrates an exemplary delivery system for delivering components of a prosthetic valve. [Diagram 31] FIG. 31 illustrates an example of a prosthetic valve in an expanded configuration. [Diagram 32] FIG. 32 shows an example of a device or implant. [Diagram 33] FIG. 33 shows an example of a device or implant. [Diagram 34] FIG. 34 shows an example of a device or implant. [Diagram 35] FIG. 35 shows an example of a device or implant. [Diagram 36]FIG. 36 shows the exemplary device or implant of FIG. 35, including a cover, at various stages of deployment within a native valve. [Figure 37] FIG. 37 shows the exemplary device or implant of FIG. 35, including a cover, at various stages of deployment within a native valve. [Figure 38] FIG. 38 shows the exemplary device or implant of FIG. 35, including a cover, at various stages of deployment within a native valve. [Figure 39] FIG. 39 shows an example of a device or implant. [Diagram 40] FIG. 40 illustrates the exemplary device or implant of FIG. 39 at various stages of deployment within a native valve. [Diagram 41] FIG. 41 illustrates the exemplary device or implant of FIG. 39 at various stages of deployment within a native valve. [Diagram 42] FIG. 42 illustrates the exemplary device or implant of FIG. 39 at various stages of deployment within a native valve. [Diagram 43] FIG. 43 shows an example of a device or implant. [Diagram 44] FIG. 44 illustrates adjustment of the position of the exemplary device or implant of FIG. 43 within the native valve. [Diagram 45] FIG. 45 illustrates adjustment of the position of the exemplary device or implant of FIG. 43 within the native valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0093] In the following description, reference is made to the accompanying drawings which illustrate exemplary implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0094] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, various implementations of devices, valve repair devices, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or physically impossible. Furthermore, the techniques and methods herein can be performed on live animals or on simulations such as cadavers, cadaver hearts, humanoid ghosts, simulators (e.g., where body parts, hearts, tissues, etc. are simulated), etc.

[0095] 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, as used herein, the terms "substantially" and "about" 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%).

[0096] Additionally, the therapeutic techniques, methods, processes, etc. described or suggested herein, or references incorporated herein, may be performed on live animals or on non-living body simulations, such as cadavers, cadaver hearts, simulators (e.g., simulating body parts, tissues, etc.). Any of the various systems, devices, equipment, etc. in this disclosure may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and the methods described herein may include sterilization of the associated systems, devices, equipment, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0097] 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 inward across their respective 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 anatomy of the left atrium LA and the left ventricle LV will be 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.

[0098] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase, or diastole, as 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, as seen in FIG. 2, the left ventricle LV contracts to pump blood into the body through the aortic valve AV and the ascending aorta AA. During systole, the leaflets of the mitral valve MV close to prevent 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 the present application is used to restore the function of a defective mitral valve MV. That is, the device is configured to assist in the closing of the leaflets of the mitral valve to prevent or inhibit 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 to prevent or inhibit backflow or regurgitation during systole, although this is not required.

[0099] Now, referring to FIG. 1-FIG. 6, 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, which is a variably dense fibrous ring of tissue that surrounds the leaflets 20, 22. Referring to FIG. 3, the mitral valve MV is fixed 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 necessary to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular tissue, which functions 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 coapt 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.

[0100] 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 shape 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 the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV) to malfunction, resulting in prolapse and regurgitation.

[0101] 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 to 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).

[0102] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier Type I, Type II, and Type III insufficiency. Carpentier 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). Type I mechanism insufficiency includes leaflet perforation, such as occurs in endocarditis. Carpentier Type II insufficiency involves deviation of one or more leaflets of the native valve above the plane of coaptation. Carpentier Type III insufficiency involves restriction of the 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.

[0103] With reference to FIG. 4, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV into the left atrium LA. With reference to FIGS. 3 and 4, 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. This failure to coapt creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow regurgitantly from the left ventricle LV into the left atrium LA during systole, as shown by the mitral regurgitation MR flow path in FIG. 4. With reference to FIG. 5, the gap 26 can 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.

[0104] In any of the above situations, a valve repair device or implant capable of engaging the anterior and posterior leaflets 20, 22 to close the gap 26 and prevent or inhibit the backflow of blood through the mitral valve MV is desirable.

[0105] 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 very 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. Therefore, since the pressure on the left side of the heart is substantially higher, insufficiency of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening.

[0106] Malfunctioning native heart valves can be either repaired or replaced. Repair typically involves preserving 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 removal of the valve and replacing it with a surgically implanted heart valve, or replacing 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, as described above, prevents the mitral valve MV or tricuspid valve TV from closing properly and allows regurgitation or backflow of blood from the ventricle into the atrium (e.g., deformation of the mitral valve MV can allow 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 the posterior leaflet 22 to evertate, resulting in blood flowing back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be repaired by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0107] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it will be 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. 6), 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 on all three of the leaflets 30, 32, 34 together 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.

[0108] 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 the large systolic pressures that urge the device toward the left atrium. During diastole, the device may rely on compressive and retaining forces exerted against the leaflets gripped by the anchors.

[0109] 7-9, an implantable device 100 (e.g., an implant, prosthetic device, prosthetic spacer device, valve repair device, etc.) is illustrated. Other similar devices / implants are described in more detail in WO 2018 / 195215, WO 2020 / 076898, and WO 2019 / 139904, which are incorporated by reference in their entireties. Device 100 may include any other features of an implantable device or implant described in this application or the applications cited above, and 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).

[0110] 7, device 100 is illustrated and includes a capture portion 102 and an anchor portion 104. Device 100 is configured to be positioned within a natural heart valve opening between the leaflets, thereby reducing or preventing regurgitation as described above. Device 100 may be configured to attach and / or seal to two or three native valve leaflets. Device 100 may be used with native mitral (bicuspid) and tricuspid valves.

[0111] The capture portion 102 includes a capture element 110. In some implementations, the capture element 110 is adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and is attached to an actuation element (e.g., an actuation wire, an actuation shaft, an actuation tube, an actuation rod, etc.) or delivery system 120. The delivery system may comprise one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. With reference to FIG. 9 , the capture element 110 may be removably coupled to a catheter of the delivery system 120.

[0112] 7, the capture element 110 can have a variety of shapes. In some implementations, the capture element can have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the capture element can have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or a variety of other non-cylindrical shapes. The capture element includes an inner cavity 112 that extends from a wall at the first end 114 of the capture element 110 to an open second end 116 of the capture element 110. In some implementations, the wall at the first end 114 of the capture element 110 includes an opening 124 at the first end of the capture element 110. In some implementations, the opening at the second end 116 of the capture element 110 is configured to allow the anchor portion 104 to move in and out of the capture element 110.

[0113] The capture element 110 may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the natural valve leaflets to close around the capture element during ventricular systole to block the backflow of blood from the left or right ventricle into the left or right atrium, respectively. In some implementations, the capture element 110 may optionally include a one-way valve through the inner cavity 112 and out of the opening 124 such that fluid (e.g., blood) can move out of the opening 124 of the cavity 112 but cannot move from the opening 124 into the cavity.

[0114] The anchor portion 104 includes a body 106 and one or more anchors 108. The body 106 and the anchors 108 can include a variety of shapes and can be made from a variety of materials or substances. For example, the body 106 and / or the anchors 108 can be made from a flexible or expandable material.

[0115] The anchors 108 can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. The anchors can be bonded and / or flexible. The anchors 108 can be curved or rounded so that the leaflets can conform to the curvature and be secured by the anchors 108. In some implementations, the anchors can include attachment portions or gripping members. The illustrated gripping members can include clasps, optional barbs, friction enhancing elements, or other means for securing (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.).

[0116] 8, anchor portion 104 may be fully received within inner cavity 112 of capture element 110 such that anchor body 106 and anchor 108 are disposed between first end 114 and second end 116 of capture element 110. Anchor portion 104 is in a closed position when received within inner cavity 112 of capture element 110. When device 100 is in the closed position (with and / or without leaflet tissue), anchor portion 104 may be secured within inner cavity 112 of capture element 110, for example, by a friction fit.

[0117] 9 illustrates device 100 coupled to a delivery system. Device 100 may be configured to be implanted via the delivery system or other delivery means. Capture element 110 may be coupled to the catheter of delivery system 120 in a variety of ways, including selectively detachable couplings, press fit, friction fit, magnetic fit, mating threads, etc.

[0118] The anchor portion 104 may be coupled to an actuating element 122. The actuating element 122 may take a wide variety of different forms, including a wire, a rod, a shaft, a tube, a screw, a suture, a line, a strip, or a combination thereof. The actuating element 122 may be made of a variety of different materials and may have a variety of configurations. As an example, the actuating element may be threaded such that rotational actuation of the actuating element moves the anchor portion relative to the capture element. Alternatively, the actuating element may be unthreaded such that pushing or pulling actuation of the actuating element moves the anchor portion relative to the capture element 110. The actuating element 122 may be disposed through an opening 124 in the first end 114 of the capture element 110 and attached to the anchor portion 104. In some implementations, the actuating element 122 may be attached to the body 106 or to a collar 134 of the body 106. The actuating element 122 can be connected to the anchor portion 104 such that a user can provide a force to the actuating element 122 to move the anchor portion 104 from an expanded position having an expanded width W (FIG. 11) to a constricted position having a constricted width W' (FIG. 13), where the expanded width W is greater than the constricted width W'.

[0119] 10-14, the device 100 can be positioned within the heart valve between the opposing leaflets. In some implementations, the anchor 108 and the capture element 110 can be positioned simultaneously by moving the anchor 108 and the capture element 110 together along a longitudinal axis of the actuation element 122. The anchor 108 can be configured to be positioned behind the native leaflets when implanted such that the leaflets are grasped by the anchor 108.

[0120] 11 , device 100 can be configured such that anchor portion 104 moves along a longitudinal axis of actuating element 122 away from capture element 110 to create a gap between capture element 110 and anchor 108. Movement of actuating element 122 can push anchor 108 out of capture element 110 and into a ventricle or lower portion of the heart. In some implementations, body 106 is configured to self-expand upon moving distally from capture element 110.

[0121] 12, the device 100 can be moved such that the native leaflets (e.g., mitral leaflets 20, 22) are positioned in the gap between the anchor 108 and the capture element 110. In some implementations, the actuating element 122 is moved proximally and the anchor 108 is pulled toward the capture element 110 to secure the leaflets 20, 22 within the anchor 108. Once the anchor 108 secures the leaflets 20, 22, the actuating element 122 and anchor portion 104 are pulled further toward the capture element 110 until the leaflets 20, 22 are secured relative to the capture element 110 and anchor 108 (FIG. 13). In the example illustrated by FIG. 13, portions of the leaflets 20, 22 are pulled inwardly of the capture element. A portion of the leaflets can be pressed between an inner surface of the capture element and the anchor, between an end surface of the capture element and the anchor, and / or between an outer surface of the capture element and the anchor. 13 and 14, a portion of the leaflets are compressed between all of the inner surfaces of the capture elements and the anchors, between an end face of the capture elements and the anchors, and between an outer surface of the capture elements and the anchors. Once the leaflets 20, 22 are compressed between the capture elements and the anchors 108, the actuation element 122 and delivery system 120 can be separated from the device 100, as shown in FIG.

[0122] In some implementations, the capture element 110 can move toward the anchor 108, thereby closing the gap between the capture element 110 and the anchor 108 and capturing the leaflets 20, 22 between the capture element 110 and the anchor 108.

[0123] 15 , the anchors can be configured to secure the device to one or both of the leaflets 20, 22 such that the capture element 110 is positioned between the leaflets 20, 22. 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 capture element is positioned between two or all three native leaflets.

[0124] 16-17, an exemplary device 200 is illustrated. The device 200 includes a capture element 210 and an anchor portion 204. The capture element 210 may be the same or similar in all material aspects to the capture element 110 (FIGS. 7-14). The capture element 110 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and is attached to an actuation element (e.g., actuation wire, actuation shaft, actuation tube, actuation rod, etc.) or catheter 220 of a delivery system (FIGS. 18-22). The capture element 210 may have an elongated cylindrical shape with a round cross-sectional shape or another cross-sectional shape. In some implementations, the shape of the capture element has the same shape as the annulus of the native mitral valve, but reduced in size. The capture element includes an inner cavity 212 extending from a first end 214 of the capture element 210 to a second end 216 of the capture element 210.

[0125] The capture element 210 is impermeable to blood (or resists blood flow therethrough) and may have a structure that allows the natural valve leaflets to close around the capture element during ventricular systole to block the backflow of blood from the left or right ventricle into the left or right atrium, respectively. The capture element may include a check valve that allows blood to flow from the first end 214 to the second end 216, but blocks blood flow in a direction from the second end 216 to the first end. In some implementations, an optional check is disposed in the opening 224.

[0126] The anchor portion 204 of the device 200 includes an inner anchor body 230 and an outer anchor body 240. The inner anchor body 230 and the outer anchor body 240 can include a variety of shapes and can be made from a variety of materials or substances. For example, the inner anchor body 230 and / or the outer anchor body 240 can be made from a flexible and / or expandable material.

[0127] The inner anchor body 230 and the outer anchor body 240 can be configured to expand and contract. For example, the inner anchor body 230 and the outer anchor body 240 can be contracted or compressed to fit within the cavity 212 of the capture element 210. In various implementations, the inner anchor body 230 and the outer anchor body 240 are configured to expand when the inner anchor body 230 and the outer anchor body 240 are removed from the cavity 212 of the capture element 210. For example, the inner anchor body 230 and / or the outer anchor body 240 can have a stent or stent-like configuration with struts that allow for expansion and contraction.

[0128] 17, the inner anchor body 230 can include one or more anchors 232. The anchors 232 can take a wide variety of forms, such as, for example, hooks, paddles, gripping elements, or the like. The anchors can be bonded and / or flexible. The anchors 232 can be curved or rounded such that the leaflets can fit into the curve and be secured by the anchors 232. In some implementations, the anchors can include attachment portions or gripping members. The illustrated gripping members can include clasps, optional barbs, friction enhancing elements, or other means for securing (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.).

[0129] 16 , the anchor portion 204 can be fully received within the inner cavity 212 of the capture element 210 such that the inner anchor body 230 and the outer anchor body 240 are disposed between the first end 214 and the second end 216 of the capture element 210. The anchor portion 204 is in a closed position when received within the inner cavity 212 of the capture element 110.

[0130] With reference to Figure 18, device 200 may be configured to be implanted via a delivery system or other delivery means. The delivery system may comprise one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. With reference to Figures 18-22, capture element 210 may be removably coupled to catheter 220. Capture element 210 may be coupled to catheter 220 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.

[0131] The anchor portion 204 may be coupled to one or more actuating elements. In the illustrated example, the outer anchor body 240 is removably coupled to an outer actuating element 250. The outer actuating element 250 may be disposed radially inward of the catheter 220. The outer actuating element 250 may be slidable relative to the catheter 220. In some implementations, the outer actuating element 250 may be attached to the outer anchor body 240 at an outer collar 244.

[0132] The inner anchor body 230 is removably coupled to the inner operating element 252. The inner operating element 252 may be disposed radially inward of the outer operating element 250. The inner operating element 252 may be slidable relative to the outer operating element 250. In some implementations, the inner operating element 252 may be attached to the inner anchor body 230 at the inner collar 234. The inner operating element 252, the outer operating element 250, and the catheter 220 may all move simultaneously and independently of one another.

[0133] The outer actuating element 250 and the inner actuating element 252 can take a wide variety of different forms, including wires, rods, shafts, tubes, threads, sutures, lines, strips, or combinations thereof. The outer actuating element 250 and the inner actuating element 252 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 rotational actuation of the actuating element moves the anchor portion relative to the capture element. Alternatively, the actuating element can be unthreaded such that pushing or pulling actuation of the actuating element moves the anchor portion relative to the capture element. The outer actuating element 250 and the inner actuating element 252 can be disposed through the opening 224 in the first end 214 of the capture element 210.

[0134] 19-23, device 200 can be positioned within a heart valve between opposing leaflets. In some implementations, anchor portion 204 and capture element 210 can be positioned simultaneously by moving anchor portion 204 and capture element 210 together along a longitudinal axis of catheter 220. Anchor portion 204 can be configured to be positioned behind one or more native leaflets (e.g., mitral leaflets 260, 262) when implanted such that the native leaflets are grasped by anchor portion 204.

[0135] 20, the device 200 can be configured to move the inner anchor body 230 away from the capture element 210 along a longitudinal axis of the inner working element 252 to create a gap between the capture element 210 and the anchor 232. In the illustrated example, the inner anchor body 230 is pushed away from the outer anchor body 240 and the capture element 210. The movement of the inner working element 252 can push the anchor 232 out of the capture element 210 and into a ventricle or lower portion of the heart. In some implementations, the inner anchor body 230 and the anchor 232 are configured to self-expand upon moving distally from the capture element 210. For example, the anchor body 230 can have a self-expanding stent or stent-like configuration.

[0136] 21 , the device 200 can be configured such that the outer anchor body 240 moves along a longitudinal axis of the outer actuating element 250 away from the capture element 210. Movement of the outer actuating element 250 can push the outer anchor body 240 out of the capture element 210 and towards the leaflets 260, 262. As a result, the leaflets 260, 262 can be captured between the outer anchor body 240 and the inner anchor body 230. In the illustrated example, the anchor 232 expands radially outwardly beyond the outer anchor body 240 such that the anchor 232 is disposed on the outer or ventricular side of the leaflets 260, 262 and the outer anchor body 240 is disposed on the inner or atrial side of the leaflets 260, 262. In some implementations, the outer anchor body 240 is configured to self-expand upon moving distally from the capture element 210.

[0137] 21 , the leaflets 260, 262 may then be positioned between the outer anchor body 240 and the anchor 232. In some implementations, the inner actuating element 252 and the outer actuating element 250 are moved proximally toward the capture element 210. The outer anchor body 240 and the anchor 232 are pulled toward the capture element 210 to secure the leaflets 260, 262. As the inner actuating element 252 and the outer actuating element 250 are pulled further proximally, the leaflets 260, 262 are secured relative to the outer anchor body 240, the capture element 210, and the anchor 232 ( FIG. 22 ). With reference to FIG. 23 , the actuating elements 250, 252 and the delivery system or catheter 220 may be separated from the device 200, which remains attached to the leaflets 260, 262 of the native valve.

[0138] In some implementations, the capture element 210 can move toward the anchor 232, thereby closing the gap between the capture element 210 and the anchor 232. Portions of the leaflets 260, 262 can be captured between the outer anchor body 240 and the inner anchor body 230, and / or between the capture element 210 and the anchor 232. Portions of the leaflets 260, 262 can be captured between an inner surface of the capture element 210 and the anchor 232, between an end surface of the capture element 210 and the anchor 232, between an outer surface of the capture element 210 and the anchor 232, and / or between the outer anchor body 240 and the anchor 232. In the example illustrated by FIG. 22 , leaflet portions are captured between the outer anchor body 240 and the anchor 232, between an end face of the capture element 210 and the anchor 232, and between an outer surface of the capture element 210 and the anchor 232. 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 valve leaflets, such that the capture element is positioned between two native leaflets, or between all three native leaflets.

[0139] 24-29, implantable device 100 of Figures 7-15 is shown delivered and implanted within the native mitral valve MV of heart H. The implantable device of Figures 16-23 may be delivered in the same manner, except that inner anchor body 230 and outer anchor body 240 are deployed as shown in Figures 20 and 21. With reference to Figures 24-25, the delivery sheath and / or catheter of delivery system 120 is inserted through the septum into the left atrium LA and into the left ventricle.

[0140] As can be seen from Fig. 26, the implantable device or implant 100 is moved into a position within the mitral valve MV and into the ventricle LV in a partially open state so that it can grasp the leaflets 20, 22. For example, the catheter of the delivery system 120 can be advanced and steered or bent to position the device 100 as shown in Fig. 26. An actuating element 122 can be advanced from inside the catheter of the delivery system 120 to position the implant outside of the capture element 110 as shown in Fig. 26.

[0141] 27, the catheter of the delivery system 120 can be retracted to position the leaflets 20, 22 of the mitral valve within the anchor 108. Once the leaflets are inside the anchor 108, the actuating element 122 is retracted and / or the catheter of the delivery system 120 is advanced to retract the anchor 108 and the leaflets 20, 22 into the capture element 110, capturing the leaflet 20. The actuating element 122 is further retracted to move the device to a fully closed state, shown in FIG.

[0142] Finally, as can be seen from Figures 28 and 29, the delivery system 120 (e.g., a steerable catheter, an implant catheter, etc.) and the working element 122 are separated and retracted, and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0143] 30-31, the devices and components described herein can take a variety of different forms for implantation in a variety of different delivery systems. For example, the prosthesis shown in FIG. 31 having anchors 408 can be used in the methods described herein with the system 300 shown in FIG. Further details and design examples for prostheses such as the prosthesis shown in FIG. 31 are described in U.S. Pat. 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, each of which patents and publications is incorporated by reference in its entirety and made a part of this specification.

[0144] Figures 32-34 show examples of valve repair systems 500, 600, and 700 configured to retract the leaflets 20, 22 into the anchors. The valve repair systems 500, 600, and 700 can take a wide variety of different forms. For example, the system can have any of the features of any of the systems disclosed herein and / or any of the features of the valve repair systems disclosed by WO 2018 / 195201, WO 2019 / 204559, WO 2019 / 051180, WO 2018 / 209021, WO 2018 / 195215, WO 2019 / 139904, WO 2020 / 168081, U.S. Patent Application Publication No. 2020 / 0113676, and U.S. Patent No. 10,517,726, which are incorporated by reference in their entireties. In the example illustrated by Figures 32-34, the valve repair device includes anchors or arms for capturing the leaflets 20, 22 and one or more rotating members for retracting or adjusting the position of the leaflets of the native valve relative to the anchors or arms. The rotating member can take a wide variety of different forms. Any rotating member or device that uses a rotational motion to retract or adjust the position of the leaflets of the native valve relative to the anchors or arms can be used. Any of the devices disclosed in WO 2018 / 195201, WO 2019 / 204559, WO 2019 / 051180, WO 2018 / 209021, WO 2018 / 195215, WO 2019 / 139904, WO 2020 / 168081, US 2020 / 0113676, and US 10,517,726 can be modified to include the features disclosed herein that retract or adjust the position of the leaflets of the native valve relative to the anchors or arms.

[0145] 32 , the system 500 includes a delivery device 502 and an anchor 504. The delivery device 502 may include a catheter 510 and an actuating element 554 or shaft. The illustrated anchor 504 includes a body or base 506 and one or more arms 508. The anchor 504 further includes a rotating member 550 coupled to the actuating element 554 or shaft of the delivery device 502.

[0146] The rotating member 550 can take a wide variety of different forms. The rotating member can be a variety of shapes and sizes. In some implementations, the rotating member can be cylindrical, but the rotating member can also be rectangular, circular, or a variety of other shapes. The rotating member can have a screw-like configuration with threads, protrusions, notches, or other gripping members spaced along the rotating member to adjust the position of the leaflets 20, 22 relative to the arms 508. In the example illustrated by FIG. 32, the rotating member 550 includes an external thread extending along a surface of the rotating member 550.

[0147] The rotating member 550 may be coupled to an actuating element 554 or shaft. The actuating element 554 may take a wide variety of different forms, including a wire, a rod, a shaft, a tube, a screw, a suture, a line, a strip, or a combination thereof. The actuating element 554 may be connected to the rotating member 550 such that a user can provide a force to the rotating member 550 to rotate the rotating member 550 in a first direction D. As the rotating member 550 rotates in the first direction D, the rotating member 550 contacts the leaflets 20, 22 and pulls the leaflets 20, 22 further into the arms 508. The leaflets may then be secured between the rotating member 550 and the arms 508 of the anchor portion 504.

[0148] If repositioning of the leaflets relative to the arms 508 and rotating member 550 is required (e.g., if the leaflets are tightly retracted within the anchor portion 604), the rotating member 550 can be rotated in a second direction opposite the first direction D. Rotation of the rotating member 550 in the second direction moves the leaflets out of the arms 508 of the anchor portion 504 until a more desired fit is achieved.

[0149] 33 illustrates an example of a system 600 including a delivery device 602 and an anchor 604. The delivery device 602 may include a catheter 610 and two independent actuating elements 654, 664. The illustrated anchor 604 includes a body or base 606 and one or more arms or anchors 608. The anchor 604 further includes a first rotation / translation member or belt member 650 and a second rotation / translation member or belt member 660. For example, the anchor portion 604 may include a first rotation / translation member 650 and a second rotation / translation member 660 disposed along a surface of the arm or anchor 608. The rotation / translation members 650, 660 may include protrusions, notches, or other friction enhancing elements for engaging with the valve leaflets.

[0150] The rotation / translation members 650, 660 may be coupled to actuation elements 654, 664, respectively, such that a user can provide a force to the rotation / translation members 650, 660. A force applied to the actuation elements 654, 664 can move the rotation / translation members 650, 660 in a first direction D into the arms 608 of the anchor 604. The actuation elements 654, 664 may be independent of one another such that they can be simultaneously engaged at different times, speeds and / or amounts. As a result, different lengths or amounts of the first and second leaflets 20, 22 can be retracted into the arms 608 of the anchor 604. Once the leaflets 20, 22 are positioned, the leaflets 20, 22 can be secured between the rotation / translation members 650, 660 and the base 606 of the anchor portion 604.

[0151] If repositioning of one or both of the leaflets within the arms 608 of the anchor portion 604 is required (e.g., if one or more of the leaflets are tightly retracted within the anchor portion 604), the rotation / translation members 650 and / or 660 may be moved in a second direction opposite the first direction D. As the rotation / translation members 650 and / or 660 move in the second direction, the leaflets are moved out of the arms 608 of the anchor portion 604. The amount of movement of the rotation / translation members 650 and / or 660 is controlled by the actuation elements 654, 664 to control how far the leaflets 20, 22 are from the arms 608 of the anchor portion 604.

[0152] FIG. 34 illustrates an example of a system 700 similar to the system 600 of the example of FIG. 34, except that the system 700 includes wheels 750, 760 that draw the leaflets into the arms 708 of the anchor portion 704. The system 700 of FIG. 34 includes a delivery device 702 and an anchor 704. The delivery device 702 may include a catheter 710 and two independent actuating elements 754, 764. The illustrated anchor 704 includes a body or base 706 and one or more arms or anchors 708. The anchor 704 further includes a first rotating member or wheel 750 and a second rotating member or wheel 760. For example, the anchor portion 704 may include a first rotating member or wheel 750 and a second rotating member or wheel 760 disposed at the ends of the arms or anchors 708. The rotating members or wheels 750, 760 may include protrusions, notches, or other friction enhancing elements 752, 762 for engaging the leaflets 20, 22.

[0153] The rotating members or wheels 750, 760 may be coupled to actuating elements 754, 764. The actuating elements may take a variety of different forms. For example, the actuating elements 754, 764 may be lines, belts, chains, etc. that may be used to translate linear motion imparted to the actuating elements 754, 764 into rotation of the rotating members or wheels 750, 760. A force applied to the actuating elements 754, 764 may rotate the rotating members or wheels 750, 760 in a first direction D to pull the leaflets 20, 22 into the arms 708 of the anchor 704. The actuating elements 754, 764 may be independent of one another such that the rotating members or wheels 750, 760 may simultaneously engage leaflet tissue at different times, speeds and / or amounts. As a result, different lengths or amounts of the first leaflet 20 and the second leaflet 22 may be drawn into the arms 708 of the anchor 704. Once the leaflets 20 , 22 are positioned, the leaflets 20 , 22 may be secured between the rotating members 750 , 760 and the base 706 of the anchor portion 704 .

[0154] If repositioning of one or both of the leaflets within the arms 708 of the anchor portion 704 is required (e.g., if the leaflets are tightly retracted within the anchor portion 704), the rotating members or wheels 750 and / or 760 can be moved in a second direction opposite the first direction D. As the rotating members or wheels 750 and / or 760 rotate in the second direction, the leaflets are moved out of the arms 708 of the anchor portion 604. The amount of movement of the rotating members or wheels 750 and / or 760 is controlled by the actuating elements 754, 764 to control how far the leaflets 20, 22 are from the arms 708 of the anchor portion 704.

[0155] Additional information regarding methods of delivery of valve repair and replacement devices 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 WO 2020 / 076898, each of which is incorporated by reference in its entirety for all purposes. These methods may, mutatis mutandis, be performed on live animals or on simulations, such as cadavers, cadaveric hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated).

[0156] 35, a schematic representation of an implantable device or implant 1100 (e.g., an implantable prosthetic device, an artificial spacer device, a valve repair device, etc.) is shown. The implantable device or implant 1100, as well as other similar devices / implants, are described in more detail in International Publication Nos. WO 2018 / 195215, WO 2020 / 076898, and WO 2019 / 139904, which are incorporated by reference in their entireties. The device 1100 may include any other features of any other implantable device or implant described in this application or the applications cited above, and the device 1100 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).

[0157] The device or implant 1100 is deployed from a delivery system or other delivery means 1102. The delivery system 1102 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 passageway, combinations thereof, etc. The device or implant 1100 may include an optional interface portion 1104 and an anchor portion 1106.

[0158] In some implementations, the interface portion 1104 of the device or implant 1100 is adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and includes an interface element 1110 (e.g., a spacer, plug, filler, foam, sheet, membrane, interface element, etc.) that is slidably attached to an actuating element 1112 (e.g., an actuating wire, shaft, tube, hypotube, line, suture, braid, etc.).

[0159] In some implementations, the anchor portion 1106 includes one or more anchors 1108 that are actuable between an open and a closed state and can take a wide variety of forms, such as, for example, paddles, grasping elements, or the like. Actuation of an actuation means or element 1112 causes the anchor portion 1106 of the device 1100 to open and close and grasp the leaflets of the native valve during implantation.

[0160] The actuation means or element 1112 (as well as other actuation means and elements disclosed herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, threads, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As an example, the actuation element can be threaded such that rotational actuation of the actuation element moves the anchor portion 1106 relative to the interface portion 1104. Alternatively, the actuation element can be unthreaded such that pushing or pulling actuation of the actuation element 1112 moves the anchor portion 1106 relative to the interface portion 1104.

[0161] The anchor portion 1106 and / or the anchor can take a variety of different forms. For example, the anchor portion 1106 and / or the anchor can take the form of any of the anchors or components of anchors disclosed in the present application, or any anchor of a known mitral or tricuspid valve repair device. Furthermore, the anchor portion 1106 and / or the anchor can take any form that allows the device 1100 to be attached to the leaflets of a mitral or tricuspid valve.

[0162] In some implementations, the anchor portion 1106 and / or anchor of the device 1100 includes an outer paddle 1120 and an inner paddle 1122 that, in some implementations, are connected between the cap 1114 and the interface element 1110 by portions 1124, 1126, 1128. In some implementations, the device 1100 does not include both the outer paddle 1120 and the inner paddle 1122. For example, each inner paddle 1120 and outer paddle 1122 combination can be replaced with a single paddle that can be opened and closed. The portions 1124, 1126, 1128 can be interfaced and / or flexible to move between various positions. The interconnection of the outer paddle 1120, the inner paddle 1122, the coaptation element 1110, and the cap 1114 by portions 1124, 1126, and 1128 can restrict the device to various positions and movements required to deliver the device to the native valve, open the device, and close the device to secure it to the native valve leaflets.

[0163] In some implementations, the delivery system 1102 includes a steerable catheter, an implant catheter, and an actuation means or element 1112 (e.g., actuation wire, actuation shaft, actuation tube, actuation rod, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation means or element 1112 extends through the delivery catheter and the interface element 1110 to a distal end (e.g., a cap 1114 or other attachment portion at the distal connection of the anchor portion 1106). In some implementations, extending and retracting the actuation element 1112 increases and decreases the spacing between the interface element 1110 and the distal end of the device (e.g., a cap 1114 or other attachment portion), respectively.

[0164] In some implementations, a collar or other attachment element (e.g., clamp, clip, lock, suture, friction fit, buckle, snap fit, lasso) removably attaches, either directly or indirectly, the interface element 1110 to the delivery system 1102 such that an actuation means or element 1112 slides through the collar or other attachment element, and in some implementations, through the interface element 1110 during actuation, to open and close the paddles 1120, 1122 of the anchor portion 1106 and / or anchor 1108.

[0165] In some implementations, the anchor portion 1106 and / or the anchor 1108 may include an attachment portion or gripping member 1130 (e.g., an arm, clamp, clasp, hook, etc.). The illustrated gripping member may include an optional fixed arm 1132, a movable arm 1134, and optional fixation elements, friction enhancing elements or other fastening means 1136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.). In some implementations, the device 1100 includes a pair of gripping members 1130, each having an optional base or fixation arm 1132, a movable arm 1134, and one or more optional barbs 1136. In some implementations, the fixation arm 1132 is omitted and the movable arm 1134 and inner paddle 1122 are configured to capture and secure the native valve leaflets.

[0166] The movable arm 1134 is configured to move between an open position where the movable arm 1134 extends along the coaptation element 1110 and a closed position where the movable arm 1134 extends along the fixed arm 1132 (if included) and the inner paddle 1122, as shown in FIG. 35. In some implementations, the movable arm 1134 is configured to articulate, bend, or pivot to move between the open and closed positions. In some implementations, the movable arm 1134 articulates, bends, or pivots at a position adjacent the distal end of the coaptation element or adjacent the portion 1128, as shown in FIG. 35. The optional fixed arm 1132 is attached to the inner paddle 1122 and remains stationary or substantially stationary relative to the inner paddle 1122 when opening the movable arm 1134 opens the gripping member 1130 to expose the optional barb 1136.

[0167] In some implementations, the movable arm 1134 can be biased to the closed position. The movable arm 1134 can be biased to the closed position in a variety of ways. For example, the movable arm 1134 can be formed of a shape memory alloy such as Nitinol that is shape set in the closed position, or the movable arm 1134 can be biased to the closed position through the use of a spring material such as steel, other metals, plastics, composites, etc. In some implementations, the gripping member 1130 is opened by tensioning an actuation line 1116 attached to the movable arm 1134, thereby causing the movable arm 1134 to articulate, bend, or pivot. The actuation line 1116 extends through the delivery system 1102 (e.g., through the steerable catheter and / or the implant catheter). Other actuation mechanisms are also possible.

[0168] The actuation line 1116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The gripping member 1130 can be biased such that in the closed position the gripping member 1130 continues to provide a clamping force on the gripped native leaflet. Optional barbs 1136 of the gripping member 1130 can grasp, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0169] The paddles 1120, 1122 can be opened and closed during implantation to, for example, grip a native leaflet (e.g., a leaflet of a native mitral valve, etc.) between the paddles 1120, 1122 and / or between the paddles 1120, 1122 and the coaptation element 1110 (e.g., a spacer, plug, membrane, gap filler, etc.). The gripping member 1130 can be used to clamp and / or further secure the native leaflet by engaging the leaflet with optional barbs 1136 and clamping the leaflet between the movable arm 1134 and the fixed arm 1132 and / or between the movable arm 1134 and the inner paddle 1122. The optional fixation element 1136 or fixation means of the gripping member 1130 (e.g., barbs, friction enhancing elements, protrusions, ridges, grooves, textured surfaces, adhesives, etc.) can increase friction with the leaflet or partially and / or completely pierce the leaflet.

[0170] In some implementations, the actuation lines 1116 may be actuated separately such that each gripping member 1130 may be opened and closed separately. Actuating separately may allow gripping one leaflet at a time, or may allow the gripping members 1130 to be repositioned over leaflets that were not adequately gripped without changing the good grip on the other leaflets. In some implementations, the actuation lines 1116 may be actuated simultaneously such that the gripping members 1130 may be opened and closed together (e.g., to capture two or more leaflets simultaneously).

[0171] In some implementations, the gripping member 1130 can be opened and closed relative to the position of the inner paddle 1122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing the leaflets to be gripped in various positions as required by a particular situation.

[0172] In some implementations, the device 1100 includes a leaflet repositioning device 1139 configured to reposition the captured leaflets 20, 22 relative to the device 1100. By repositioning the captured leaflets 20, 22, the device 1100 can reposition the poorly grasped leaflets to an improved captured position without having to release and reposition the grasping members 1130.

[0173] The leaflet repositioning device can be configured in a variety of ways. In some implementations, the leaflet repositioning device 1139 allows each of the movable arms 1134 to be separately retracted (i.e., moved inward toward the centerline CL of the device 1100) while in the closed position. Thus, the effective length (e.g., exposed length) of the movable arms 1134 can be customized to reposition a captured leaflet relative to any of the fixed arms 1132 and / or inner paddle 1122.

[0174] As shown in FIG. 35 , each movable arm 1134 has a proximal end 1140 and a distal end 1142. Each of the movable arms 1134 can be separately retracted while in the closed position such that the distal end 1142 of the movable arm 1134 moves inward toward the joint element 1110 or centerline CL of the device. The implantable device 1100 can be configured in a variety of ways to enable retraction of the movable arms 1134. In some implementations, the proximal end 1140 of each movable arm 1134 is connected to a corresponding retraction element 1144. The retraction element 1144 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, tube, catheter or the like. The retraction element 1144 can be connected to the proximal end 1140 of each movable arm 1134 in any suitable manner or with any type of connection device, lock, fastener, or the like.

[0175] Retraction of the movable arms 1134 allows leaflets that were not adequately grasped to be pulled inwardly towards the coaptation element 1110 to improve capture of the leaflets. With reference to FIG. 36, the implantable device 1100 is shown positioned at the annulus of the mitral valve with the movable arms 1134 in the closed position and the leaflets 20, 22 captured by the grasping members 1130.

[0176] In some implementations, the implantable device 1100 may also include an optional covering 1150. In some implementations, the covering 1150 may be disposed on the interface elements 1110 and / or the outer paddle 1120 and the inner paddle 1122. The covering 1150 may be configured to prevent, inhibit or reduce blood flow through the device or implant 1100 and / or to promote natural tissue ingrowth. In some implementations, the covering 1150 may be a cloth or fabric, such as PET, velour, or other suitable fabric. In some implementations, instead of or in addition to a fabric, the covering 1150 may include a coating (e.g., a polymer) applied to the implantable device or implant 1100.

[0177] As shown in FIG. 36 , one leaflet 20 is fully captured (e.g., deep enough within the gripping member 1130), while the other leaflet 22 is not fully captured (e.g., insufficiently deep within the gripping member 1130). In particular, the insufficiently captured leaflet 22 is captured only by the distal end 1142 of the movable arm 1134. To improve capture of this leaflet 22 when the paddle 1122 is closed, the movable arm 1134 can be retracted, as shown in FIG. 37 . As shown by arrow A, tension can be applied to the retracting element 1144 to pull the retracting element 1144 proximally such that the proximal end 1140 of the movable arm 1134 is pulled into any coaptation element 1110. As a result, the movable arm 1134 moves inwardly (i.e., moves to a retracted position) relative to the fixed arm 1132 and / or the paddle 1122 while remaining in the closed position. The leaflets 22 are connected to the movable arms 1134 via anchoring elements 1136 on the movable arms 1134 so that as the movable arms 1134 move inward, they pull the leaflets 22 inward with them.

[0178] In some implementations, one or more locking elements 1152 may be operatively associated with each of the retraction elements 1144 and / or each of the movable arms 1134. For example, one locking element 1152 may be configured to lock one of the movable arms 1134 in place after the movable arms 1134 are retracted (i.e., fixing the effective length of the movable arms 1134). Similarly, another locking element 1152 may be configured to lock the other of the movable arms 1134 in place after the other movable arm 1134 is retracted. Thus, movement of the movable arms 1134 may pull the leaflets 22 inwardly to a sufficient depth to lock them in place against the inner paddle 1122 such that when the paddles 1120, 1122 are closed, the leaflets 20, 22 are secured by the implantable device 1100, as shown in FIG.

[0179] 39-42, an exemplary device or implant 1200 (e.g., a repair device, an implantable device, an implantable prosthetic device, an artificial spacer device, a valve repair device, etc.) is shown, shown in schematic form. The device or implant 1200 corresponds to the previously disclosed device or implant illustrated in FIGS. 35-38, and the description of the device or implant 1100 applies equally to the device or implant 1200, with reference numbers of similar elements kept the same. The device or implant 1200 may include any of the features of any of the devices or implants 1200 described in this application or the applications cited above. The device 1200 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 of the valve repair systems disclosed in this application or the applications cited above).

[0180] In some implementations, the device 1200 includes an interface portion 1104 and an anchor portion 1106. The interface portion 1104 is adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and includes an interface element 1110 (e.g., a spacer, plug, filler, foam, sheet, membrane, interface element, etc.) that is slidably attached to an actuating element 1112 (e.g., an actuating wire, shaft, tube, hypotube, line, suture, braid, etc.).

[0181] In some implementations, the anchor portion 1106 includes one or more anchors 1108 that are actuable between open and closed states and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation means or elements 1112 causes the anchor portion 1106 of the device 1100 to open and close, gripping the leaflets of the native valve during implantation. The actuation means or elements 1112 (as well as other actuation means and elements disclosed herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, threads, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a wide variety of configurations.

[0182] The anchor portion 1106 and / or the anchor can take a variety of different forms. For example, the anchor portion 1106 and / or the anchor can take the form of any of the anchors or components of anchors disclosed in the present application, or any anchor of a known mitral or tricuspid valve repair device. Furthermore, the anchor portion 1106 and / or the anchor can take any form that allows the device 1100 to be attached to the leaflets of a mitral or tricuspid valve.

[0183] In some implementations, the anchor portion 1106 and / or anchor of the device 1200 includes an outer paddle 1120 and an inner paddle 1122 that, in some implementations, are connected between the cap 1114 and the interface element 1110 by portions 1124, 1126, 1128. However, in some implementations, the device 1100 does not include both the outer paddle 1120 and the inner paddle 1122. For example, each inner paddle 1120 and outer paddle 1122 combination can be replaced with a single paddle that can be opened and closed.

[0184] In some implementations, the anchor portion 1106 and / or the anchor 1108 may include an attachment portion or gripping member. The illustrated gripping member may comprise a gripping member 1130 including an optional base or fixed arm 1132, a movable arm 1134, an optional fixing element or fixing means 1136 (e.g., barbs, friction enhancing elements, protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and a joint portion 1138. If included, the optional fixed arm 1132 may be attached to the inner paddle 1122. In some implementations, the fixed arm 1132 is attached to the inner paddle 1122 with the joint portion 1138 disposed proximate to the optional joining element 1110.

[0185] In some implementations, the joint portion 1138 provides a spring force between the fixed arm 1132 and the movable arm 1134 of the gripping member 1130 and / or between the movable arm 1134 and the inner paddle 1120. The joint portion 1138 can be any suitable joint, such as a flexible joint, a spring joint, a pivoting joint, or the like. In some implementations, the joint portion 1138 is a flexible piece of material integrally formed with the fixed arm 1132 and the movable arm 1134. The fixed arm 1132 is attached to the inner paddle 1122 and remains stationary or substantially stationary relative to the inner paddle 1122 when the movable arm 1134 is in an open state, opening the gripping member 1130 and exposing the optional fixed element 1136.

[0186] The movable arm 1134 is configured to move between an open position in which the movable arm 1134 extends along the interface element 1110 and a closed position in which the movable arm 1134 extends along the optional fixed arm 1132 and / or inner paddle 1122, as shown in Figure 39. The fixed arm 1132 is attached to the inner paddle 1122 and remains stationary or substantially stationary relative to the inner paddle 1122 when the movable arm 1134 is in the open state, opening the gripping member 1130 and exposing the optional fixing element or fixing means 1136.

[0187] In some implementations, the gripping member 1130 is opened by tensioning an actuation line 1116 attached to the movable arm 1134, thereby causing the movable arm 1134 to articulate, bend or pivot on a joint portion 1138. The actuation line 1116 extends through the delivery system 1102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible. The actuation line 1116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter or the like. The gripping member 1130 can be biased such that in the closed position the gripping member 1130 continues to provide a clamping force to the gripped native leaflet. This clamping force remains constant regardless of the position of the inner paddle 1122. An optional fixation element or fixation means 1136 of the gripping member 1130 can grip, pinch and / or pierce the native leaflet to further secure the native leaflet.

[0188] In some implementations, the paddles 1120, 1122 can be opened and closed during implantation to, for example, grip a native leaflet (such as a leaflet of a native mitral valve) between the paddles 1120, 1122 and / or between the paddles 1120, 1122 and the coaptation element 1110 (spacer, plug, membrane, gap filler, etc.). The gripping member 1130 can be used to grip and / or further secure the native leaflet by engaging the leaflet with an optional fixation element 1136 and clamping the leaflet between the movable arm 1134 and the fixation arm 1132. The optional fixation element 1136 of the gripping member 1130 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) can increase friction with the leaflet or partially or fully puncture the leaflet.

[0189] In some implementations, the actuation lines 1116 may be actuated separately such that each gripping member 1130 may be opened and closed separately. Acting separately allows one leaflet to be gripped at a time, or the gripping members 1130 may be repositioned on leaflets that were not adequately gripped without changing the good grip on the other leaflets. In some implementations, the gripping members 1130 may be opened and closed relative to the position of the inner paddle 1122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing the leaflets to be gripped in various positions as the particular situation requires.

[0190] In some implementations, the device 1200 includes a leaflet repositioning device 1139 configured to reposition the captured leaflets 20, 22 relative to the device 1200. By repositioning the captured leaflets 20, 22, the device 1200 can reposition an insufficiently grasped leaflet to a safer captured position without having to release and reposition the grasping member 1130. The leaflet repositioning device can be configured in a variety of ways. In some implementations, the leaflet repositioning device 1139 allows the movable arm 1134 and attached fixation element 1136 to be retracted inward (i.e., toward the centerline CL of the device 1200) and / or outward (i.e., away from the centerline CL of the device 1200) to reposition the captured leaflets relative to the fixation arm 1132 and / or inner paddle 1122. In some implementations, the leaflet repositioning device 1139 allows the fixation element 1136 to be moved inward (i.e., toward the centerline CL of the device 1200) and outward (i.e., away from the centerline CL of the device 1200) along the movable arm 1134 to reposition a captured leaflet relative to the fixation arm 1132 and / or inner paddle 1122.

[0191] 39, each movable arm 1134 has a proximal end 1140 and a distal end 1142. In some implementations, each of the movable arms 1134 and attached fixing elements 1136 can be separately retracted inward and released outward while in the closed position. In some implementations, the fixing elements 1136 on each of the movable arms 1134 can be separately moved along the movable arm 1134 toward and away from the proximal end 1140 while in the closed position. For example, the fixing elements 1136 on each of the movable arms 1134 can be moved back and forth between a distal position on the movable arm 1134 and a proximal position that is closer to the proximal end 1140 than the distal position.

[0192] The implantable device 1200 may be configured in a variety of ways to permit movement of the fixation element 1136 along the movable arms 1134. In some implementations, the fixation element 1136 of each movable arm 1134 is connected to a corresponding retraction element 1144. The retraction element 1144 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The retraction element 1144 can be connected to the fixation element 1136 of each movable arm 1134 in any suitable manner or by any connection device. For example, the fixation element may be disposed on or include a ring, collar, or the like that is slidably disposed on the movable arm 1134.

[0193] The inward movement of the fixation elements 1136 toward the centerline CL of the device 1200 allows for improved capture of the leaflets by pulling inwardly any leaflets that are not adequately gripped toward the coaptation element 1110 or the centerline CL of the device 1200. In some implementations, one or more locking elements 1152 may be operatively associated with each of the retraction elements 1144, each of the movable arms 1134, and / or each fixation element 1136. For example, the one or more locking elements 1152 may be configured to lock the fixation element 1136 in position after the fixation element 1136 moves inwardly. Thus, any leaflets that are not adequately gripped may be pulled inwardly to a sufficient depth by the movement of the fixation element 1136 and locked in position against the inner paddle 1122 such that the leaflets 20, 22 are securely held by the implantable device 1200 when the paddles 1120, 1122 are closed.

[0194] In some implementations, the leaflet repositioning device 1139 is configured as a ratchet mechanism, or similar device or mechanism. That is, after the fixation element 1136 is pulled inward toward the centerline CL of the device 1200, the fixation element 1136 on the movable arm 1134 can be released from the leaflet and returned to a distal position on the movable arm 1134, if desired. The fixation element 1136 can then be re-engaged with the leaflet and pulled inward toward the centerline CL of the device 1200 again to a proximal position. In this manner, the leaflet can be gradually pulled inward toward the centerline CL of the device 1200 until it is deemed sufficiently gripped, and the inward movement can be repeated, so that the total length of movement of the fixation element 1136 can be shortened.

[0195] In some implementations, the leaflet repositioning device 1139 may be configured as a ratchet mechanism by including a second fixation element 1137 (e.g., a protrusion, a ridge, a groove, a textured surface, an adhesive, etc.). That is, after the fixation element 1136 is pulled inward toward the centerline CL of the device 1200, the second fixation element 1137 holds the position of the leaflets 20, 22. The fixation element 1136 may then slide over the leaflets and move back to a distal position. The fixation element 1136 may then re-engage with the leaflets, pulling the leaflets inward toward the centerline CL on the second fixation element 1137 back to a proximal position, and the second fixation element 1137 may again hold the leaflets' position. In this manner, the leaflets may be pulled incrementally inward toward the centerline CL of the device 1200 until they are deemed sufficiently gripped. In some implementations, the total length of movement of the fixation element 1136 may be short, as the inward movement may be repeated.

[0196] 40, the implantable device 1200 is shown positioned at the annulus of the mitral valve with the movable arms 1134 in a closed position and the leaflets 20, 22 captured by the gripping members 1130. In the illustrated implementation, one leaflet 20 is fully captured (e.g., sufficiently deep within the gripping members 1130) while the other leaflet 22 is not fully captured (e.g., not deep enough within the gripping members 1130). In particular, the leaflet 22 that is not fully anchored is captured only at the distal end 1142 of the movable arms 1134. In some implementations, such as the illustrated implementation, both the movable arms 1134 and the fixed arms 1132 have fixation elements 1136, 1137 for engaging the leaflets 20, 22.

[0197] To improve this capture of the leaflets 22, the fixation element 1136 on the movable arm 1134 can be retracted inwardly from a distal position (as shown in FIG. 40) to a proximal position, as shown in FIG 41. Tension can be applied to the retraction element 1144 to pull it proximally such that the fixation element 1136 on the movable arm 1134 is pulled inwardly relative to the movable arm 1134, toward the centerline CL of the device 1200, as shown by the arrows in FIG 41. Because the leaflets 22 are connected to the movable arm 1134 via the fixation element 1136 on the movable arm 1134, the leaflets 22 are retracted inwardly by the fixation element 1136.

[0198] The fixation elements 1137 on the fixation arms 1132 can be configured to provide minimal or no resistance to movement of the leaflets 22 in the inward direction so as not to damage or impede the inward movement of the leaflets 22. For example, the fixation arms 1132 can include barbs that are angled inwardly to allow the leaflets 22 to slide over the barbs when moving in the inward direction.

[0199] 42, after the leaflets 22 have been retracted inwardly, the fixation element 1136 on the movable arm 1134 can move outwardly to release the leaflets 22 and return to a distal position while the fixation element 1137 holds the position of the leaflets 22 relative to the movable arm 1134. For example, the movable arm 1134 can include barbs angled inwardly to allow the leaflets 22 to slide over the barbs as they move outwardly. The fixation element 1136 on the movable arm 1134 can move outwardly in a variety of ways. For example, the fixation element 1136 can be biased outwardly to a distal position using a spring material or pushed outwardly by a retraction element 1144 or another pusher.

[0200] As the fixation element 1136 on the movable arm 1134 moves outward to a distal position, the leaflets 22 are held in place by the fixation element 1137 on the fixation arm 1132. From the distal position, the fixation element 1136 on the movable arm 1134 can re-engage the leaflets 22 again pulling them inward to a proximal position to further retract the leaflets inward. This ratcheting action can be configured to allow the fixation element 1136 on the movable arm 1134 to repeatedly move between the distal and proximal positions to progressively retract the leaflets inward until they are sufficiently gripped against the inner paddle 1122 and locked in place such that the leaflets 20, 22 are securely held by the implantable device 1200 when the paddles 1120, 1122 are closed.

[0201] 43-45, a schematic representation of a device or implant 1300 (e.g., a repair device, an implantable device, an implantable prosthetic device, an artificial spacer device, a valve repair device, etc.) is shown. The device or implant 1300 corresponds to the previously disclosed device or implant illustrated in FIGS. 39-42, and the description of the device or implant 1100 applies equally to the device or implant 1300, with reference numbers of similar elements kept the same. The device or implant 1300 may include any of the features of any of the devices or implants 1100 described in this application or the applications cited above. The device 1300 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 of the valve repair systems disclosed in this application or the applications cited above).

[0202] In some implementations, the device 1300 includes a coaptation portion 1104 and an optional anchor portion 1106. In some implementations, the coaptation portion 1104 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes a coaptation element 1110 (e.g., a spacer, plug, filler, foam, sheet, membrane, coaptation element, etc.) that is slidably attached to an actuation element 1112 (e.g., an actuation wire, shaft, tube, hypotube, line, suture, braid, etc.). The anchor portion 1106 includes one or more anchors 1108 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 grasping element, or the like.

[0203] In some implementations, actuation of the actuation means or elements 1112 causes the anchor portion 1106 of the device 1100 to open and close and grip the leaflets of the native valve during implantation. The actuation means or elements 1112 (as well as other actuation means and elements disclosed herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, threads, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations.

[0204] The anchor portion 1106 and / or the anchor can take a variety of different forms. For example, the anchor portion 1106 and / or the anchor can take the form of any of the anchors or components of anchors disclosed in the present application, or any anchor of a known mitral or tricuspid valve repair device. Furthermore, the anchor portion 1106 and / or the anchor can take any form that allows the device 1100 to be attached to the leaflets of a mitral or tricuspid valve.

[0205] In some implementations, the anchor portion 1106 and / or anchor of the device 1300 includes an outer paddle 1120 and an inner paddle 1122, which in some implementations are connected between the cap 1114 and the interface element 1110 by portions 1124, 1126, 1128. However, in some implementations, the device 1100 does not include both the outer paddle 1120 and the inner paddle 1122. For example, each inner paddle 1120 and outer paddle 1122 combination can be replaced with a single paddle that can be opened and closed. In some implementations, the anchor portion 1106 and / or anchor 1108 can include an attachment portion or gripping member. In some implementations, as shown, the gripping member 1130 includes a base or movable arm 1134 and / or an optional fixing element 1136 (e.g., barbs, friction enhancing elements, protrusions, ridges, grooves, textured surfaces, adhesives, etc.).

[0206] The movable arm 1134 is configured to move between an open position in which the movable arm 1134 extends along the interface element 1110, as shown in FIG. 39, and a closed position in which the movable arm 1134 extends along the inner paddle 1122. The movable arm 1134 is opened to open the gripping member 1130 and expose the optional locking element 1136. In some implementations, the movable arm 1134 may be biased to the closed position. The movable arm 1134 may be biased to the closed position in a variety of ways. For example, the movable arm 1134 may be formed of a shape memory alloy, such as Nitinol, that is shape set in the closed position, or the movable arm 1134 may be biased to the closed position through the use of a spring material, such as steel, other metals, plastics, composites, etc.

[0207] In some implementations, the gripping member 1130 is opened by tensioning an actuation line 1116 attached to the movable arm 1134, thereby causing the movable arm 1134 to articulate, bend or rotate. The actuation line 1116 extends through the delivery system 1102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible. The actuation line 1116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter or the like. The gripping member 1130 can be biased such that in the closed position the gripping member 1130 continues to provide a clamping force to the gripped native leaflet. This clamping force remains constant regardless of the position of the inner paddle 1122. The fixation element 1136 of the optional gripping member 1130 can grip, pinch and / or pierce the native leaflet to further secure the native leaflet.

[0208] In some implementations, the paddles 1120, 1122 can be opened and closed during implantation to, for example, grip a native leaflet (such as a leaflet of a native mitral valve) between the paddles 1120, 1122 and / or between the paddles 1120, 1122 and the coaptation element 1110 (spacer, plug, membrane, gap filler, etc.). In some implementations, the gripping member 1130 can be used to grip and / or further secure the native leaflet by engaging the leaflet with an optional fixation element 1136. The optional fixation element of the gripping member 1130 may increase friction with the leaflet or partially or fully puncture the leaflet.

[0209] In some implementations, the actuation lines 1116 may be actuated separately such that each gripping member 1130 may be opened and closed separately. Acting separately allows one leaflet to be gripped at a time, or the gripping members 1130 may be repositioned on leaflets that were not adequately gripped without changing the good grip on the other leaflets. The gripping members 1130 may be opened and closed relative to the position of the inner paddle 1122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing the leaflets to be gripped in various positions as the particular situation requires.

[0210] In some implementations, the device 1300 includes a leaflet repositioning device 1139 configured to reposition the device 1300 over one or more of the captured leaflets 20, 22. Repositioning the device 1300 over the leaflets 20, 22 may allow the device 1300 to be repositioned relative to one or both of the grasped leaflets 20, 22 by translating the device 1300 along one or more of the leaflets without releasing the device 1300. The leaflet repositioning device 1139 may be configured in a variety of ways. In some implementations, the leaflet repositioning device 1139 may include one or more movable arms 1134 rotatable about a longitudinal axis L of the movable arms 1134. In some implementations, the leaflet repositioning device 1139 may be configured to rotate one of the movable arms 1134. In some implementations, the leaflet repositioning device 1139 may be configured to rotate both of the movable arms 1134 separately or simultaneously, such as with a geared system. In some implementations, the leaflet repositioning device 1139 is configured to rotate one movable arm 1134 clockwise and the other movable arm 1134 counterclockwise. In some implementations, the movable arm 1134 is shaped as a cylindrical rod or tube with an optional fixation element 1136 disposed circumferentially around the outer surface of the movable arm 1134.

[0211] As shown in Figures 44-45, with the device 1300 closed and the leaflets 20, 22 captured between the movable arms 1134 and the inner paddle 1122, one or both of the movable arms 1134 can be rotated. By rotating one of the movable arms 1134 clockwise and the other counterclockwise at the same rotational speed, as shown in Figure 45, the device 1300 can be translated laterally along the leaflets 20, 22 (e.g., along the coaptation plane of the leaflets) (only a single rotatable movable arm 1134 is shown for simplicity). In this way, if mitral regurgitation is noted in the lateral direction in which the device 1300 is deployed, the device 1300 can be moved laterally to the location of the mitral regurgitation to address the problem.

[0212] In some implementations, one or more locking elements (e.g., clamps, locks, clasps, set screws, etc.) may be operatively associated with each of the movable arms 1134. For example, one locking element (not shown) may be configured to lock one of the movable arms 1134 in a rotated position after the movable arms 1134 are rotated. Similarly, another locking element (not shown) may be configured to lock the other of the movable arms 1134 in a rotated position after the other movable arm 1134 is rotated. Thus, the leaflets 20, 22 may be repositioned relative to the device 1300 and locked in position relative to the inner paddle 1122 such that the leaflets 20, 22 are securely held by the implantable device 1100 when the paddles 1120, 1122 are closed.

[0213] Any of the various systems, devices, equipment, components, etc. in this disclosure (including any of the examples below) may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use on patients, and the methods described herein may include sterilization of the associated systems, devices, equipment, components, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.). [Example]

[0214] EXAMPLES (Some non-limiting examples of the concepts herein are listed below).

[0215] Example 1. 1. An implantable device comprising: (i) a capture element having a first end, a second end, and a cavity between the first end and the second end; and (ii) an anchor portion comprising one or more anchors, the anchor portion being at least partially disposed within the capture element, the anchors configured to capture one or more leaflets of a native heart valve, the anchor portion being extendable from and retractable within the cavity of the capture element, the capture element and the anchor portion being configured to draw leaflet tissue of the native valve into the cavity when the anchor portion is retracted within the cavity of the capture element.

[0216] Example 2. The implantable device of Example 1, wherein the capture element is cylindrical in shape.

[0217] Example 3. The implantable device of Example 1 or 2, wherein the capture element is round in cross-section.

[0218] Example 4. The implantable device of any one of Examples 1-3, wherein the internal cavity extends from the first end of the capture element to the second end of the capture element.

[0219] Example 5. The implantable device of Example 4, wherein in the closed position, the anchor portion is contained entirely within the inner cavity.

[0220] Example 6. The implantable device of Example 4, wherein in the open position, the anchor portion is at least partially contained outside the inner cavity.

[0221] Example 7. The implantable device of Example 4, wherein the capture element is impermeable to blood.

[0222] Example 8. The implantable device of any one of Examples 1-7, wherein the capture element comprises an opening in an end wall at the first end of the capture element.

[0223] Example 9. The implantable device of any one of Examples 1-8, wherein the second end of the capture element is open such that the anchor portion can move in and out of the capture element from the second end.

[0224] Example 10. The implantable device of Example 4, wherein the capture element comprises a one-way valve.

[0225] Example 11. The implantable device of any one of Examples 1-10, wherein the anchor is made of a flexible or expandable material.

[0226] Example 12. The implantable device of any one of Examples 1-11, wherein the anchor portion comprises a body coupled to the anchor.

[0227] Example 13. The implantable device of any one of Examples 1-12, wherein the anchor portion is expandable.

[0228] Example 14. The implantable device of any one of Examples 1-13, wherein the capture element is removably attached to the delivery catheter.

[0229] Example 15. The implantable device of Example 14, wherein the anchor portion is removably attached to the actuation element.

[0230] Example 16. The implantable device of Example 15, wherein the actuating element is disposed radially inward of the delivery catheter.

[0231] Example 17. The implantable device of Example 15, wherein the actuating element is attached to a collar of the anchor portion.

[0232] Example 18. The implantable device of Example 15, wherein movement of the actuation element can move the anchor portion between a closed position and an open position.

[0233] Example 19. An implantable device as described in Example 15, wherein the actuating element is connected to the anchor portion such that a user can apply tension to the actuating element to move the anchor portion from an expanded position having an expanded width to a constricted position having a constricted width, the expanded width being greater than the constricted width.

[0234] Example 20. 1. An implantable device comprising: (i) a capture element having a first end, a second end, and a cavity between the first and second ends; and (ii) an anchor portion including an inner anchor body and an outer anchor body, the anchor portion being at least partially disposed within the capture element, the outer anchor body being extendable from and retractable within the cavity of the capture element, the inner anchor body being extendable from and retractable within the outer anchor body, the inner anchor body and the outer anchor body being configured to capture native valve leaflet tissue therebetween, and the capture element and anchor portion being configured to draw the native valve leaflet tissue into the cavity when the anchor portion is retracted within the cavity of the capture element.

[0235] Example 21. The implantable device of Example 20, wherein the capture element is cylindrical in shape.

[0236] Example 22. The implantable device of Example 20 or 21, wherein the capture element is round in cross-section.

[0237] Example 23. The implantable device of any one of Examples 20-22, wherein the internal cavity extends from the first end of the capture element to the second end of the capture element.

[0238] Example 24. The implantable device of Example 23, wherein in the closed position, the anchor portion is contained entirely within the inner cavity.

[0239] Example 25. 24. The implantable device of Example 23, wherein in the open position, the anchor portion is at least partially contained outside the inner cavity.

[0240] Example 26. The implantable device of Example 23, wherein the capture element is impermeable to blood.

[0241] Example 27. The implantable device of any one of Examples 20-26, wherein the capture element comprises an opening at a first end of the capture element.

[0242] Example 28. The implantable device of any one of Examples 20-27, wherein the second end of the capture element is open so that the anchor portion can enter and exit the capture element from the second end.

[0243] Example 29. The implantable device of Example 23, wherein the capture element comprises a one-way valve.

[0244] Example 30. The implantable device of any one of Examples 20-29, wherein the anchor is made from a flexible or expandable material.

[0245] Example 31. The implantable device of any one of Examples 20 to 30, wherein the anchor portion is expandable.

[0246] Example 32. The implantable device of any one of Examples 20-31, wherein the capture element is removably attached to the delivery catheter.

[0247] Example 33. The implantable device of Example 32, wherein the anchor portion is removably attached to one or more actuating elements.

[0248] Example 34. The implantable device of Example 32, wherein the inner anchor body is removably attached to the inner working element.

[0249] Example 35. The implantable device of Example 34, wherein the outer anchor body is removably attached to the outer actuating element.

[0250] Example 36. The implantable device of Example 32, wherein the actuating element is disposed radially inward of the delivery catheter.

[0251] Example 37. The implantable device of Example 35, wherein movement of the inner actuating element can move the inner anchor body between a closed position and an open position.

[0252] Example 38. The implantable device of Example 35, wherein movement of the outer actuating element can move the outer anchor body between a closed position and an open position.

[0253] Example 39. An implantable device described in any one of Examples 20 to 38, wherein an actuating element is connected to the anchor portion such that a user can apply tension to the actuating element to move the anchor portion from an expanded position having an expanded width to a constricted position having a constricted width, the expanded width being greater than the constricted width.

[0254] Example 40. 1. A method of repairing a native valve, comprising: positioning an anchor portion such that leaflets of a native heart valve are disposed within the anchor; and retracting the anchor and portion of the leaflet into an open end of a capture element having a first end, a second end, and a cavity between the first and second ends.

[0255] Example 41. The method of example 40, further comprising an anchor portion extendable from and retractable within the cavity of the capture element.

[0256] Example 42. The method of example 40 or 41, further comprising blocking blood flow with a capture element.

[0257] Example 43. The method of example 40 or 41, further comprising separating the anchor and capture element from the delivery catheter.

[0258] Example 44. An implantable device comprising: (i) an anchor portion including one or more anchors, the anchor portion coupled to a capture element; and (ii) a rotating member coupled to the one or more anchors, the rotating member configured to draw native valve leaflet tissue into the one or more anchors.

[0259] Example 45. The implantable device of Example 44, wherein the rotating member is cylindrical.

[0260] Example 46. An implantable device as described in Example 44 or 45, wherein the rotating member has one or more protrusions, notches, or other gripping members spaced throughout the rotating member for engaging with the valve leaflets.

[0261] Example 47. An implantable device described in any one of Examples 44 to 46, wherein the rotating member has threaded ridges along a surface of the rotating member.

[0262] Example 48. An implantable device described in any one of Examples 44 to 47, wherein in response to the rotating member rotating in a first direction, the rotating member retracts the valve leaflets into one or more anchors and in response to the rotating member rotating in a second direction, the rotating member displaces the valve leaflets from the one or more anchors.

[0263] Example 49. The implantable device of any one of Examples 44-48, wherein the rotating member is removably attached to the actuation element.

[0264] Example 50. 1. A device adapted to be implanted between leaflets of a native heart valve, the device comprising: (i) a gripping member including a base arm and a movable arm, the gripping member configured to move between an open position and a closed position, wherein in the closed position the gripping member is configured to grip a leaflet of the native heart valve between the base arm and the movable arm; and (ii) a leaflet repositioning device configured to reposition the leaflet relative to the base arm while the gripping member is in the closed position.

[0265] Example 51. The device of Example 50, wherein the leaflet repositioning device is configured to move the movable arm relative to the base arm toward a centerline of the device while the gripping member is in a closed position.

[0266] Example 52. 52. The device of claim 51 , wherein the movable arm has a proximal end and a distal end, and the exemplary leaflet repositioning device includes a retraction element attached to the proximal end, and wherein pulling the retraction element while the gripping member is in a closed position moves the distal end toward a centerline of the device.

[0267] Example 53. The device of Example 52, wherein the device further comprises a joint element positioned along a centerline of the device, and pulling the retraction element causes the movable arm to retract into the joint element.

[0268] Example 54. A device described in any one of Examples 51 to 53, further comprising a lock configured to fix the movable arm in a fixed position after it has been moved by the leaflet repositioning device.

[0269] Example 55. A device described in any one of Examples 50 to 54, further comprising a fixation element disposed on the movable arm for engaging the valve leaflet.

[0270] Example 56. The device of example 55, wherein the fixation element comprises one or more barbs.

[0271] Example 57. The device of Example 55, further comprising a second fixation element disposed on the base arm for engaging the valve leaflet.

[0272] Example 58. The device of Example 50, further comprising a fixation element disposed on the movable arm for engaging the valve leaflet, wherein the leaflet repositioning device is configured to move the fixation element relative to the movable arm toward a centerline of the device while the gripping member is in a closed position.

[0273] Example 59. The device of Example 58, wherein the movable arm has a proximal end and a distal end, and the leaflet repositioning device includes a retraction element attached to the fixation element end, and pulling the retraction element while the gripping member is in a closed position moves the fixation element toward the centerline of the device.

[0274] Example 60. The device of Example 59, wherein the device further comprises a joining element positioned along the centerline of the device.

[0275] Example 61. A device described in any one of Examples 58 to 60, further comprising a lock configured to fix the fixation element in a fixed position relative to the movable arm after it has been moved by the leaflet repositioning device.

[0276] Example 62. The device described in any one of Examples 58 to 61, wherein the fixation element comprises one or more barbs.

[0277] Example 63. A device described in any one of Examples 58 to 62, wherein the fixation element has a distal position and a proximal position that is inside the distal position, and the leaflet repositioning device is configured to repeatedly move the fixation element between the distal and proximal positions to progressively move the leaflets toward the centerline of the device.

[0278] Example 64. The device of Example 63, wherein the leaflet repositioning device comprises a ratchet device operable to repeatedly move the fixation element between the distal and proximal positions.

[0279] Example 65. The device described in Example 63 or 64, further comprising a second fixation element disposed on the base arm to engage with the valve leaflet, wherein when the fixation element disposed on the movable arm moves from a proximal position to a distal position, the second fixation element holds the valve leaflet in a fixed position relative to the movable arm.

[0280] Example 66. The device of Example 50, wherein the leaflet repositioning device is configured to rotate the movable arm relative to the base arm about a longitudinal axis of the movable arm while the gripping member is in a closed position.

[0281] Example 67. The device of Example 66, wherein rotating the movable arm moves the valve leaflets relative to the base arm.

[0282] Example 68. The device of Example 66 or 67, further comprising a lock configured to secure the movable arm in a rotated position after being moved by the leaflet repositioning device.

[0283] Example 69. A device described in any one of Examples 66 to 68, further comprising a fixation element disposed on the movable arm for engaging with the valve leaflet.

[0284] Example 70. The device of Example 69, wherein the fixation element comprises one or more barbs.

[0285] Example 71. The device described in Example 66, further comprising a second gripping member including a second base arm and a second movable arm, the second gripping member configured to move between an open position and a closed position, and in the closed position, the second gripping member configured to grip a second leaflet of the native heart valve between the second base arm and the second movable arm.

[0286] Example 72. The device of Example 71, wherein the leaflet repositioning device is configured to rotate the second movable arm relative to the second base arm about a second longitudinal axis of the second movable arm while the second gripping member is in a closed position.

[0287] Example 73. The device of Example 71, further comprising a second leaflet repositioning device, the second repositioning device configured to rotate the second movable arm relative to the second base arm about a second longitudinal axis of the second movable arm while the second gripping member is in the closed position.

[0288] Example 74. A device described in any one of Examples 71 to 73, wherein the second movable arm and the movable arm are configured to rotate simultaneously in opposite directions.

[0289] Example 75. A delivery system for a device adapted to be implanted between the leaflets of a native heart valve, comprising: (i) an implant catheter assembly having a sheath having a distal end portion comprising a capture mechanism for removably attaching the sheath to the device; and (ii) an implantable device described in any one of Examples 50-57.

[0290] Example 76. 1. A method of repairing a native valve, the method comprising: (i) delivering an implantable device to the native valve; (ii) positioning the implantable device at an annulus of the native valve; (iii) closing a grasping member of the implantable device to grasp a leaflet of the native valve, the grasping member having a base arm and a movable arm; and (iv) repositioning the leaflet relative to the base arm while the grasping member remains closed.

[0291] Example 77. 77. The method of example 76, wherein the step of repositioning the leaflets further comprises the step of moving the movable arm toward the centerline of the device relative to the base arm.

[0292] Example 78. 78. The method of example 77, wherein the step of moving the movable arm further comprises the step of applying tension to a retraction element coupled to the movable arm.

[0293] Example 79. 79. The method of example 78, wherein the step of applying tension to the retraction element further comprises the step of retracting the movable arm into the joining element of the device.

[0294] Example 80. The method of any one of Examples 76-79, further comprising the step of locking the movable arm in position after repositioning the valve leaflet.

[0295] Example 81. The method of any one of Examples 76 to 80, wherein closing the gripping member further comprises engaging the valve leaflet with a fixation element disposed on the movable arm.

[0296] Example 82. The method of example 81, wherein the fixation element comprises one or more barbs.

[0297] Example 83. The method of example 81 or 82, wherein closing the gripping member further comprises engaging the leaflet with a second fixation element disposed on the base arm.

[0298] Example 84. The method of example 76, wherein the fixation element is disposed on the movable arm, and the step of repositioning the valve leaflet further comprises the step of moving the fixation element toward the centerline of the device relative to the movable arm while the gripping member is in the closed position.

[0299] Example 85. 85. The method of example 84, wherein the step of moving the fixation element further comprises the step of applying tension to a retraction element coupled to the fixation element.

[0300] Example 86. The method of example 84 or 85, further comprising the step of locking the fixation element in a fixed position relative to the movable arm after being moved by the leaflet repositioning device.

[0301] Example 87. The method of any one of Examples 84-86, wherein the fixation element comprises one or more barbs.

[0302] Example 88. The method of any one of Examples 84 to 87, wherein the fixation element has a distal position and a proximal position that is inside the distal position, and the step of repositioning the leaflet further includes the step of repeatedly moving the fixation element between the distal position and the proximal position to progressively move the leaflet toward the centerline of the device.

[0303] Example 89. The method of example 88, wherein a second fixation element is disposed on the base arm for engaging the valve leaflet, and repeatedly moving the fixation element between the distal position and the proximal position further comprises holding the valve leaflet in a fixed position relative to the movable arm having the second fixation element when the fixation element disposed on the movable arm moves from the proximal position to the distal position.

[0304] Example 90. 77. The method of example 76, wherein the step of repositioning the valve leaflet further comprises the step of rotating the movable arm relative to the base arm about a longitudinal axis of the movable arm while the gripping member is in the closed position.

[0305] Example 91. 91. The method of example 90, wherein the step of rotating the movable arm moves the valve leaflets relative to the base arm.

[0306] Example 92. The method of example 90 or 91, further comprising the step of locking the movable arm in a rotated position after repositioning the leaflet.

[0307] Example 93. The method of example 90 or 91, wherein closing the gripping member further comprises engaging the valve leaflet with a fixation element disposed on the movable arm.

[0308] Example 94. The method of example 93, wherein the fixation element comprises one or more barbs.

[0309] Example 95. The method of example 76, further comprising the steps of closing a second gripping member of the implantable device to grip a second leaflet of the native valve, the second gripping member having a second base arm and a second movable arm, and repositioning the second leaflet relative to the second base arm while the second gripping member remains closed.

[0310] Example 96. The method of example 95, wherein the step of repositioning the second leaflet further includes the step of rotating the second movable arm relative to the second base arm about a second longitudinal axis of the second movable arm while the second gripping member is in the closed position.

[0311] Example 97. 97. The method of embodiment 96, wherein the steps of rotating the second movable arm and rotating the first movable arm are performed simultaneously in opposite directions.

[0312] Example 98. The method according to any one of Examples 76 to 97, further comprising the step of sterilizing the implantable device.

[0313] 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, for example, 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, even if such examples are not expressly disclosed herein.

[0314] 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.

[0315] 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 being essential in all cases, nor is the order in which the 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. a capture element having a first end, a second end, and an interior cavity between the first end and the second end; an anchor portion comprising one or more anchors, the anchor portion being at least partially disposed within the capture element, the one or more anchors being configured to capture one or more leaflets of a native heart valve; the anchor portion is extendable from and retractable within the inner cavity of the capture element; An implantable device, wherein the capture element and the anchor portion are configured to draw native valve leaflet tissue into the inner cavity when the anchor portion is retracted within the inner cavity of the capture element.

2. The implantable device of claim 1 , wherein the capture element is cylindrical in shape.

3. The implantable device of claim 1 , wherein the internal cavity extends from the first end of the capture element to the second end of the capture element.

4. The implantable device of claim 3 , wherein in the closed position, the anchor portion is completely contained within the inner cavity.

5. The implantable device of claim 3 , wherein in the open position, the anchor portion is housed at least partially outside the inner cavity.

6. The implantable device of any one of claims 1 to 5, wherein the capture element comprises an opening in an end wall at the first end of the capture element.

7. The implantable device of any one of claims 1 to 5, wherein the second end of the capture element is open so that the anchor portion can move in and out of the capture element from the second end.

8. The implantable device of any one of claims 1 to 5, wherein the capture element comprises a one-way valve.

9. The implantable device of any one of claims 1 to 5, wherein the anchor portion comprises a body coupled to the one or more anchors.

10. The implantable device of any one of claims 1 to 5, wherein the anchor portion is expandable.

11. The implantable device of any one of claims 1 to 5, wherein the capture element is removably attached to a delivery catheter.

12. The implantable device of claim 11 , wherein the anchor portion is removably attached to an actuation element.

13. The implantable device of claim 12 , wherein the actuation element is disposed radially inward of the delivery catheter.

14. The implantable device of claim 12 , wherein the actuation element is attached to a collar of the anchor portion.

15. The implantable device of claim 12 , wherein movement of the actuation element can move the anchor portion between a closed position and an open position.

16. 13. The implantable device of claim 12, wherein the actuating element is connected to the anchor portion such that a user can apply tension to the actuating element to move the anchor portion from an expanded position having an expanded width to a constricted position having a constricted width, the expanded width being greater than the constricted width.

17. a capture element having a first end, a second end, and an interior cavity between the first end and the second end; an anchor portion comprising an inner anchor body and an outer anchor body, the anchor portion being at least partially disposed within the capture element; the outer anchor body is extendable from and retractable within the inner cavity of the capture element; the inner anchor body is extendable from and retractable within the outer anchor body; the inner anchor body and the outer anchor body are configured to capture native valve leaflet tissue therebetween; An implantable device, wherein the capture element and the anchor portion are configured to draw leaflet tissue of the native valve into the inner cavity when the anchor portion is retracted within the inner cavity of the capture element.

18. The implantable device of claim 17, wherein the inner anchor body is removably coupled to the inner actuating element such that movement of the inner actuating element moves the inner anchor body between a closed position and an open position.

19. The implantable device of claim 17, wherein the outer anchor body is removably coupled to the outer actuating element such that movement of the outer actuating element moves the outer anchor body between a closed position and an open position.

20. 20. The implantable device of claim 18 or 19, wherein at least one of the inner actuating element and the outer actuating element is connected to the anchor portion such that a user can apply tension to the at least one of the inner actuating element and the outer actuating element to move the anchor portion from an expanded position having an expanded width to a constricted position having a constricted width, the expanded width being greater than the constricted width.

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