Heart Valve Repair Devices

Abstract

A valve repair device for repairing a native valve of a patient, the valve repair device including a paddle, a gripping member, and an indicator, the paddle and / or the gripping member being movable to form an opening or capture area between the gripping member and the paddle, the indicator being configured to indicate whether a leaflet of the native valve is inserted to at least a minimum insertion depth into the opening or capture area between the paddle and the gripping member.

Description

[Background technology]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 225,387, entitled "Heart Valve Repair Devices and Delivery Devices Therefor," filed July 23, 2021, and U.S. Provisional Patent Application No. 63 / 307,589, entitled "Heart Valve Repair Devices and Delivery Devices Therefor," filed February 7, 2022, each of which is incorporated by reference in its entirety.

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring the forward flow of blood to be properly delivered through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc., and therefore can become less effective. Such damage to the valves can lead to severe cardiovascular failure or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and complications can occur. Transvascular techniques can be used to introduce and implant prosthetic devices in a much less invasive manner than open-heart surgery. As an example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting 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. A similar transvascular technique may be used, beginning as the transseptal technique, but not going as far as puncturing the septum, and instead rotating the delivery catheter toward the tricuspid valve in the right atrium to implant the prosthetic 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 and includes a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure than other native heart valves. The mitral valve includes an annulus portion, which is a circular portion of native valve tissue that surrounds the mitral valve opening, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle. The mitral valve annulus may form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape with major and minor axes. The anterior leaflet may be larger than the posterior leaflet, and when closed together, form a generally "C" shaped boundary between the abutting sides of the leaflets.

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve that allows blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygen-rich blood that is collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), the rising blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve, so that blood cannot flow back into the left atrium, but instead is ejected out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous chordae, called chordae tendineae, anchor the leaflets to papillary muscles in the left ventricle.

[0005] 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 left ventricular dilation, or a combination of these. Mitral regurgitation in the central portion of the leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the commissures of the leaflets (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, and therefore the valve does not close and regurgitation is present. Tricuspid regurgitation can be similar, except on the right side of the heart. Summary of the Invention [Problem to be solved by the invention]

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

[0007] Disclosed is a device for repairing and / or treating a patient's native valve. The device may be a valve repair device, an implantable device, a valve treatment device, an implant, etc. Similar configurations may be used with other devices, such as valve repair devices, that are not necessarily implanted and may be removed following treatment, although they may be described as implantable devices in various embodiments herein for illustrative purposes. [Means for solving the problem]

[0008] The device may include an indicator (which may be the same as or similar to other indicators described herein) and a gripping member or clasp (which may be the same as or similar to other gripping members, gripper arms, clasps, and clasp arms described herein). The device may also include a paddle (which may be the same as or similar to other paddles described herein). The paddle and / or gripping member / clasp (e.g., clasp arms of a clasp, gripper arms, etc.) are movable to form an opening or capture area for receiving the leaflet. In some implementations, the opening or capture area is formed between the gripper member / clasp (e.g., clasp arms of a clasp, etc.) and the paddle (e.g., a portion of a paddle, etc.). The indicator is configured to indicate whether the leaflet of the native valve is inserted into the opening or capture area to at least a minimum insertion or engagement depth. The minimum insertion or engagement depth may be preselected and / or configured to a particular depth, as desired.

[0009] The indicators herein may be configured in a variety of shapes, sizes, and materials, in some implementations, the indicators may include undulating shapes, S-shapes, C-shapes, U-shapes, V-shapes, hook shapes, checkmark shapes, swoosh shapes, and the like.

[0010] In some implementations, the valve repair device (or valve therapy device, etc.) includes a clasp and / or clasp arm and an indicator (e.g., leaflet depth indicator, indicator arm, marker, sensor, electrode, etc.). The device may also include a paddle. The indicator may be configured as an indicator arm and / or configured such that it is movable (e.g., through the clasp, paddle, and / or another portion of the device) to indicate whether the leaflet of the native valve is inserted into the opening or capture area to at least a minimum insertion depth. The minimum insertion depth may be preselected and / or configured to a particular depth, as desired.

[0011] In some implementations, the indicator may include an indicator arm that may be coupled to the valve repair device at a first end of the indicator arm and a second end of the indicator arm. The indicator arm may be coupled to an optional coaptation element of the valve repair device. The indicator arm may be compressible and configured to engage the leaflets of the native valve. The indicator arm may include one or more protrusions extending from the indicator arm. The clasp and indicator arm may each include a marker including a radiopaque material. The capture area may be formed between a portion of the paddle and the arm of the clasp. The paddle may include an outer paddle and an inner paddle.

[0012] In some implementations, the indicator or indicator arm can be configured to pass through a channel, slot, gap, and / or opening in the clasp. In some implementations, the indicator or indicator arm can be configured to pass through a channel, slot, gap, and / or opening in the paddle. In some implementations, the indicator or indicator arm can be configured to pass through a channel, slot, gap, and / or opening in the movable arm of the clasp.

[0013] In some implementations, the clasp can optionally include a fixed arm, hi some implementations, the fixed arm of the clasp can include a first beam, a second beam, and / or an engagement member between the first beam and the second beam.

[0014] In some implementations, the indicator marker may be attached to an indicator arm. The indicator arm may include a fixed end and a moving end. The fixed end of the indicator arm may be coupled to the clasp. The fixed end of the indicator arm may be coupled to the movable arm of the clasp. The moving end may include an indicator marker including a radiopaque material. The fixed end and the moving end may be disposed on a first side of the movable arm of the clasp.

[0015] In some implementations, the indicator or indicator arm includes a leaflet engagement member (e.g., an extension, protrusion, arm, edge, bump, dip, swoosh, U-shaped portion, V-shaped portion, triangular portion, curved portion, circular portion, rectangular portion, etc.) between the fixed end and the moving end. The leaflet engagement member can be configured to pass through at least one of the movable arm and paddle of the clasp.

[0016] In some implementations, the leaflet engagement member is disposed on a second side of the movable arm of the catch, hi some implementations, the leaflet engagement member can include one or more protrusions extending therefrom.

[0017] In some implementations, the indicator can include a first arm and a second arm that can be coupled with a moving end and connected at a connection point at a fixed end.

[0018] In some implementations, the indicator arm is formed from a portion of the clasp. The indicator arm may be formed between the outer beams of the movable arms of the clasp and / or external to the outer beams of the clasp (or clasp arms of the clasp).

[0019] In some implementations, the indicator arm can include a twisted portion. The twisted portion can include one or more twists from 0 degrees to 180 degrees.

[0020] In some implementations, the indicator arm may include a first arm portion and a second arm portion. At least one of the first arm portion and the second arm portion may be formed between and / or external to the outer beams of the clasp. At least one of the first arm portion and the second arm portion may be formed from a portion of the first beam of the clasp. In some implementations, the first arm portion may include a twist portion. The twist portion of the first arm portion may include one or more twists from 0 degrees to 180 degrees clockwise.

[0021] In some implementations, the second arm portion can include a twisted portion. The twisted portion of the second arm portion can include one or more twists from 0 degrees to 180 degrees counterclockwise.

[0022] In some implementations, the first arm portion and the second arm portion are coupled with the moving end at a connection point, which may include an indicator marker including a radiopaque material pressed into at least one of the first arm portion and the second arm portion.

[0023] In some implementations, a valve repair system for repairing a patient's native valve includes a delivery system and a valve repair device coupled to the delivery system. The valve repair device may include a paddle, an indicator (e.g., a leaflet depth indicator, an indicator arm, a sensor, etc.), and a gripping member or clasp. The gripping member / clasp and / or the paddle may be movable to form an opening or a capture area to receive a leaflet of the native valve. The indicator is coupled to the valve repair device. In some implementations, the indicator is configured as an indicator arm and / or is movable to indicate whether the leaflet of the native valve is inserted into the opening or capture area to at least a minimum insertion depth. The device may be configured to have different minimum insertion depths (e.g., one or more of a minimum depth of 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, etc.) as desired. The indicator or indicator arm may be configured to pass through one or more of the paddle and the gripping member / clasp.

[0024] In some implementations, the valve repair device includes a gripping member or clasp (e.g., clasp arms, gripper arms, etc.) and a leaflet depth indicator. The leaflet depth indicator includes at least a first electrode and a second electrode. The first electrode and the second electrode provide an electrical signal to indicate whether the leaflets of the native valve are inserted into the opening or capture area to at least a minimum insertion depth. The minimum insertion depth may be preselected and / or configured to a particular depth as desired. The device may also include a paddle.

[0025] In some implementations, a valve repair device for repairing a native heart valve includes a gripping member or clasp (e.g., clasp arm, gripper arm, etc.) and a leaflet depth indicator. The clasp (or clasp arm / gripper arm of the clasp) may be movable to form an opening or capture area for receiving a native leaflet of the native valve. The leaflet depth indicator may include a first electrode and a second electrode. The first electrode and the second electrode may provide an electrical signal to indicate whether the leaflet of the native valve is inserted to a particular insertion depth into the opening.

[0026] In some implementations, the electrical signal includes an intracardiac electrocardiogram signal or a bioimpedance signal. The first electrode and the second electrode may be coupled to a gripping member / clasp (or clasp arm, gripper arm, etc.). In some implementations, the gripping member / clasp includes a movable arm, and the first electrode and the second electrode are coupled to the movable arm. In some implementations, the first electrode and the second electrode are coupled to an indicator arm. The indicator arm may be coupled to the valve repair device and is moveable within the opening or capture region.

[0027] In some implementations, a valve repair system for repairing a native heart valve includes a delivery system and a valve repair device. The valve repair device is removably coupled to the delivery system. The valve repair device includes a gripping member or clasp (e.g., a clasp arm, a gripper arm, etc.) and a leaflet depth indicator. The gripping member / clasp (e.g., a portion thereof, a clasp arm, a gripper arm, etc.) is movable to form an opening or a capture area for receiving a native leaflet of the native valve. The leaflet depth indicator includes a first electrode and a second electrode. The first electrode and the second electrode provide an electrical signal to indicate whether the leaflet of the native valve is inserted into the opening or capture area to at least a minimum insertion depth. The minimum insertion depth may be preselected and / or configured to a particular depth as desired.

[0028] In some implementations, the leaflet depth indicator may be integrally formed with the gripping member / clasp. For example, the leaflet depth indicator may be formed from the same material as the gripping member / clasp. In some implementations, the gripping member / clasp and leaflet depth indicator may be cut from a single piece of sheet material.

[0029] In some implementations, the material of the leaflet depth indicator can be bent, twisted, and / or shaped relative to the material of the gripping member / clasp such that the leaflet depth indicator is positioned in a plane to contact the native leaflet and determine whether the gripping member / clasp has properly engaged the native leaflet. The leaflet depth indicator can extend from a moveable arm of the clasp, a hinged portion of the clasp, and / or a fixed arm of the clasp.

[0030] In some implementations, the valve repair device includes a gripping member or clasp (and / or its clasp arms, gripper arms, etc.) and an indicator. The device may also include a paddle. The valve repair device may also include an insulator disposed between at least a portion of the gripping member / clasp / clasp arms and the indicator. The indicator includes one or more conductive indicator contacts that may be connected to a sensor to indicate whether the leaflets of the native valve are inserted into the opening or capture area to at least a minimum insertion depth. The minimum insertion depth may be preselected and / or configured to a particular depth, as desired.

[0031] In some implementations, the signal may be transmitted to the sensor by electrical wiring from the valve repair device to the sensor. The signal may be transmitted to the sensor by electrical conductance from the indicator through a portion of the valve repair device. In some implementations, the signal is transmitted to the sensor by electrical conductance from the indicator through at least one of a conductive fixation arm, a conductive interface element, a conductive collar, a conductive catheter coupler, and a conductive working line.

[0032] In some implementations, the gripping member or catch can include a movable arm and a fixed arm, as well as a first indicator plate coupled to the fixed arm and a second indicator plate coupled to the movable arm.

[0033] In some implementations, the valve repair device can include a bar coupled to the clasp, the bar including a leaflet-engaging portion and a device-engaging portion. The leaflet-engaging portion can reinforce the paddle and can prevent or inhibit the leaflets from bunching around or between portions of the indicator.

[0034] In some implementations, a valve repair device for repairing a patient's native valve includes a gripping member or clasp (and / or clasp arm, gripper arm, etc.) and an indicator. The gripping member / clasp (or a portion of the gripping member / clasp, arm, etc.) is movable to form an opening or capture area for capturing a leaflet of the native valve. The indicator is coupled to the valve repair device. The indicator may include one or more conductive indicator contacts. The indicator may indicate whether the leaflet of the native valve is inserted into the opening or capture area to at least a minimum insertion depth.

[0035] In some implementations, the indicator may include two conductive indicator contacts. The two conductive indicator contacts may be bridged when the gripping member / clasp is in the closed position and the leaflet tissue is not inserted to the minimum insertion depth. Alternatively, the two conductive indicator contacts may be electrically isolated when the gripping member / clasp is in the closed position and the leaflet tissue is inserted to the minimum insertion depth. The one or more conductive indicator contacts may be disposed on a paddle of the valve repair device.

[0036] In some implementations, a valve repair device for repairing a native heart valve includes a conductive clasp (or other gripping member), a conductive paddle, and an insulator. The insulator is disposed between a portion of the conductive clasp and the conductive paddle. The conductive clasp is configured to move to form a capture area for capturing a leaflet of the native valve. The conductive clasp contacts the conductive paddle when the clasp is in a closed position and the leaflet tissue is not inserted to a minimum insertion depth.

[0037] In some implementations, the clasp is electrically isolated from the conductive paddle when the clasp is in a closed position and the leaflet tissue is inserted to a minimum insertion depth.

[0038] In some implementations, the conductive paddle is coupled to the conductive collar. The conductive paddle may be coupled to the conductive collar by a conductive interface element.

[0039] In some implementations, the valve repair system includes a valve repair device and a delivery device. The valve repair device includes a conductive clasp (or other gripping member), a conductive paddle, an insulator, and a conductive collar. The insulator is disposed between a portion of the conductive clasp and the conductive paddle. The conductive collar is electrically coupled to the conductive paddle. The delivery device includes a catheter, a conductive coupler, and a conductive actuation line. The conductive coupler is removably coupled to the conductive collar. The conductive actuation line is connected to the conductive clasp configured to move the clasp to form a capture area for capturing the leaflets of the native valve. The conductive clasp contacts the conductive paddle when the clasp is in a closed position and the leaflet tissue is not inserted to a minimum insertion depth.

[0040] In some implementations, the conductive paddle is coupled to the conductive collar by a conductive interface element, and the clasp can be electrically isolated from the conductive paddle when the clasp is in a closed position and the leaflet tissue is inserted to a minimum insertion depth.

[0041] In some implementations, a valve repair device for repairing a native heart valve includes a conductive clasp (or other gripping member), a conductive leaflet depth indicator, and an insulator. The insulator is disposed between a portion of the conductive clasp and the conductive leaflet depth indicator. The conductive clasp (or clasp arm) is configured to move to form a capture area for capturing a leaflet of the native valve.

[0042] In some implementations, the conductive leaflet depth indicator contacts the conductive clasp when the clasp is in the closed position and the leaflet tissue is not inserted to the minimum insertion depth.

[0043] In some implementations, the clasp is electrically isolated from the conductive leaflet depth indicator when the clasp is in a closed position and the leaflet tissue is inserted to a minimum insertion depth.

[0044] In some implementations, the conductive leaflet depth indicator moves relative to the clasp (or clasp arm) when the clasp is in the closed position and the leaflet tissue is inserted to a minimum insertion depth.

[0045] In some implementations, the valve repair device includes a clasp (or clasp arm), an indicator, and a sensor. The clasp includes a movable arm and a fixed arm. The clasp (or its movable arm) is movable to form an opening or capture area for capturing a leaflet of the native valve. The indicator includes a first indicator plate coupled to the fixed arm and a second indicator plate coupled to the movable arm. The indicator is configured to detect one or more electrical properties of blood or tissue. The sensor is coupled to the indicator.

[0046] In some implementations, the sensor is configured to measure one or more of resistance, inductance, capacitance, voltage, current, and impedance. The sensor may be configured to measure impedance. The sensor may be configured to compare the sensed electrical properties to previously measured electrical properties corresponding to known tissue and blood samples. The sensor may be configured to determine whether tissue is engaged. The sensor is configured to distinguish between leaflet tissue and chordae tendineae tissue.

[0047] In some implementations, a first impedance value is measured in a manner that identifies a clasp state (or a state of the gripper members). The first impedance value is compared to a previously measured impedance value. One or more of the underlying clasp state or position is determined or estimated based on the comparison. The method may be performed in a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a body part being simulated, a heart, a valve leaflet, tissue, etc.), etc.

[0048] In some implementations, a valve repair device for repairing a patient's native valve includes a paddle, an indicator, a bar, and a gripping member or clasp. The gripping member / clasp (or a portion or movable arm thereof) is movable to form a capture area for capturing a leaflet of the native valve. In some implementations, an indicator is coupled to the gripping member / clasp. The indicator may be configured as an indicator arm and / or may be configured to be movable to indicate whether the leaflet of the native valve is inserted into the opening or capture area to at least a minimum insertion depth. The minimum insertion depth may be preselected and / or configured to a particular depth as desired. The bar is coupled to the paddle. The bar strengthens the paddle and reduces the space in the capture area.

[0049] In some implementations, the bar can include a leaflet-engaging portion and a device-engaging portion. The leaflet-engaging portion can include one or more apices positioned to contact the leaflet. The apices can overlap the indicator when viewed from the side.

[0050] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference characters and in which:

[0051] To further clarify various aspects of the embodiments of the present disclosure, a more particular description of certain embodiments and implementations will be made by reference to various aspects of the accompanying drawings. It will be understood that these drawings depict only exemplary implementations of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Moreover, while some embodiments may be shown to scale, not all embodiments are necessarily shown to scale. The embodiments of the present disclosure and other features and advantages will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0052] [Figure 1] FIG. 1 shows a cross-section of a human heart in diastole. [Diagram 2] FIG. 2 shows a cross-section of a human heart during systole. [Diagram 3] FIG. 3 shows a cross-section of a human heart during systole, showing valvular regurgitation. [Figure 4] FIG. 4 is a cross-sectional view of FIG. 3, annotated to show the natural shape of the mitral valve leaflets during systole. [Diagram 5] FIG. 5 shows a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Figure 6] FIG. 6 shows an incompetent mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] FIG. 8 shows one embodiment of an implantable device or implant at various stages of deployment. [Figure 9]FIG. 9 shows one embodiment of an implantable device or implant at various stages of deployment. [Figure 10] FIG. 10 illustrates one embodiment of an implantable device or implant at various stages of deployment. [Figure 11] FIG. 11 shows one embodiment of an implantable device or implant at various stages of deployment. [Figure 12] FIG. 12 shows one embodiment of an implantable device or implant at various stages of deployment. [Figure 13] FIG. 13 shows one embodiment of an implantable device or implant at various stages of deployment. [Figure 14] FIG. 14 shows one embodiment of an implantable device or implant at various stages of deployment. [Figure 15] FIG. 15 shows one embodiment of an implantable device or implant similar to the device shown in FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16] FIG. 16 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 17] FIG. 17 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 18] FIG. 18 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 19] FIG. 19 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 20] FIG. 20 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 21] FIG. 21 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 22] FIG. 22 shows a perspective view of an exemplary implantable device or implant in a closed position. [Diagram 23] FIG. 23 shows a front view of the implantable device or implant of FIG. [Figure 24] FIG. 24 shows a side view of the implantable device or implant of FIG. [Diagram 25] FIG. 25 shows a front view of the implantable device or implant of FIG. 22 with a cover over the paddles and the coaptation elements or spacers. [Figure 26] FIG. 26 shows a top perspective view of the implantable device or implant of FIG. 22 in the open position. [Figure 27] FIG. 27 shows a bottom perspective view of the implantable device or implant of FIG. 22 in the open position. [Figure 28] FIG. 28 shows a clasp for use in an implantable device or implant. [Figure 29] FIG. 29 shows a portion of native valve tissue grasped by a clasp. [Diagram 30] FIG. 30 shows a side view of an exemplary implantable device or implant in a partially open position, with the clasp in a closed position. [Diagram 31] FIG. 31 shows a side view of an exemplary implantable device or implant in a partially open position, with the clasp in the open position. [Diagram 32] FIG. 32 shows a side view of an exemplary implantable device or implant in a semi-open position, with the clasp in a closed position. [Diagram 33] FIG. 33 shows a side view of an exemplary implantable device or implant in a semi-open position, with the clasp in the open position. [Diagram 34] FIG. 34 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in the closed position. [Diagram 35] FIG. 35 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasps in the open position. [Diagram 36] FIG. 36 shows a side view of an exemplary implantable device in a fully open or fully bailed out position with the clasp in the closed position. [Figure 37] FIG. 37 shows a side view of an exemplary implantable device in a fully open or fully bailed out position with the clasp in the open position. [Figure 38] FIG. 38 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within the native valve. [Figure 39] FIG. 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a covering, delivered and implanted within a native valve. [Diagram 40] FIG. 40 shows the exemplary implantable device or implant of FIGS. 30-38, including a covering, delivered and implanted within a native valve. [Diagram 41] FIG. 41 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 42] FIG. 42 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within the native valve. [Diagram 43] FIG. 43 shows the exemplary implantable device or implant of FIGS. 30-38, including a covering, delivered and implanted within a native valve. [Diagram 44] FIG. 44 shows the exemplary implantable device or implant of FIGS. 30-38, including a covering, delivered and implanted within a native valve. [Diagram 45] FIG. 45 shows the exemplary implantable device or implant of FIGS. 30-38, including a covering, delivered and implanted within a native valve. [Diagram 46] FIG. 46 shows the exemplary implantable device or implant of FIGS. 30-38, including a covering, delivered and implanted within a native valve. [Figure 47] FIG. 47 shows the exemplary implantable device or implant of FIGS. 30-38, including a covering, delivered and implanted within a native valve. [Figure 48] FIG. 48 shows the exemplary implantable device or implant of FIGS. 30-38, including a covering, delivered and implanted within a native valve. [Figure 49] FIG. 49 shows the exemplary implantable device or implant of FIGS. 30-38, including a covering, delivered and implanted within a native valve. [Figure 50] FIG. 50 shows a schematic diagram illustrating the path of the native valve leaflets along each side of a coaptation element or spacer of an exemplary valve repair device or implant. [Figure 51] FIG. 51 is a top schematic view showing the trajectory of the leaflets of a native valve around a coaptation element or spacer of an exemplary valve repair device or implant. [Figure 52] FIG. 52 shows the coaptation element or spacer within the native valve gap as viewed from the atrial side of the native valve. [Figure 53] FIG. 53 shows a valve repair device or implant attached to the leaflets of a native valve with the coaptation elements or spacers within the native valve gap as viewed from the ventricular side of the native valve. [Figure 54] FIG. 54 shows a perspective view of a valve repair device or implant attached to the leaflets of a native valve with a coaptation element or spacer within the native valve gap as viewed from the ventricular side of the native valve. [Figure 55] FIG. 55 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 56] FIG. 56 shows a perspective view of an exemplary clasp of an exemplary implantable device or implant in a closed position. [Figure 57] FIG. 57 shows the valve repair device with the paddles in the open position. [Figure 58] FIG. 58 shows the valve repair device of FIG. 57 with the paddle in an open position and the gripping members (e.g., gripping arms, clasp arms, etc.) moved to create a wider gap between the gripping members and the paddle. [Figure 59] FIG. 59 shows the valve repair device of FIG. 57 in the position shown in FIG. 57 with the valve tissue disposed between the grasping members and the paddles. [Figure 60] FIG. 60 illustrates the valve repair device of FIG. 57 with the gripping members moved to reduce the gap between the gripping members and the paddles. [Figure 61A] FIG. 61A shows the paddles of the valve repair device of FIG. 57 moving from an open position to a closed position. [Figure 61B] FIG. 61B illustrates the paddles of the valve repair device of FIG. 57 moving from an open position to a closed position. [Figure 62] FIG. 62 illustrates the valve repair device of FIG. 57 in a closed position, with the gripping members engaging valve tissue. [Figure 63] FIG. 63 shows the valve repair device of FIG. 57 after being detached from the delivery device and attached to the valve tissue, with the valve repair device in a closed and locked state. [Figure 64] FIG. 64 illustrates an exemplary clasp or leaflet capture portion deployed to engage the leaflets of the native valve. [Figure 65] FIG. 65 illustrates an exemplary clasp or leaflet capture portion deployed to engage the leaflets of the native valve. [Figure 66] FIG. 66 illustrates an exemplary clasp or leaflet capture portion deployed to engage the leaflets of the native valve. [Figure 67] FIG. 67 illustrates an exemplary clasp or leaflet capture portion deployed to engage the leaflets of the native valve. [Figure 68] FIG. 68 shows a device having a clasp with indicator arms being delivered and deployed within a native valve. [Figure 69] FIG. 69 shows a device having a clasp with indicator arms being delivered and deployed within a native valve. [Figure 70] FIG. 70 shows a device having a clasp with indicator arms being delivered and deployed within a native valve. [Figure 71] FIG. 71 shows a device having a clasp with indicator arms being delivered and deployed within a native valve. [Figure 72] FIG. 72 shows a device having a clasp with indicator arms being delivered and deployed within a native valve. [Figure 73]FIG. 73 shows a device having a clasp with indicator arms being delivered and deployed within a native valve. [Figure 74] FIG. 74 shows a device having a clasp with indicator arms being delivered and deployed within a native valve. [Figure 75] FIG. 75 shows a device having a clasp with indicator arms being delivered and deployed within a native valve. [Figure 76] FIG. 76 shows a device having a clasp with indicator arms being delivered and deployed within a native valve. [Figure 77] FIG. 77 shows a device having a clasp with indicator arms being delivered and deployed within a native valve. [Figure 78] FIG. 78 illustrates an exemplary valve repair device with the paddles in the open position. [Figure 79] FIG. 79 illustrates an exemplary valve repair device with the paddles in the open position. [Figure 80] FIG. 80 illustrates an exemplary valve repair device with the paddles in the open position. [Figure 81] FIG. 81 illustrates an exemplary valve repair device with the paddles in the open position. [Figure 82] FIG. 82 illustrates an exemplary valve repair device with the paddles in the open position. [Figure 83] FIG. 83 illustrates an exemplary valve repair device with the paddles in the open position. [Figure 84] FIG. 84 illustrates an exemplary valve repair device with the paddles in the open position. [Figure 85] FIG. 85 shows a device having a clasp with an indicator arm. [Figure 86] FIG. 86 shows a device having a clasp with an indicator arm. [Figure 87] FIG. 87 shows a device having a clasp with an indicator arm. [Figure 88] FIG. 88 shows an embodiment of a clasp having an indicator arm with a shaped end. [Figure 89]FIG. 89 shows an embodiment of a clasp having an indicator arm with a shaped end. [Figure 90] FIG. 90 shows an embodiment of a clasp having an indicator arm with a shaped end. [Figure 91] FIG. 91 shows an embodiment of a clasp having an indicator arm with a shaped end. [Figure 92] FIG. 92 shows an embodiment of a clasp having an indicator arm with a shaped end. [Figure 93] FIG. 93 shows an embodiment of a clasp having an indicator arm with a shaped end. [Figure 94] FIG. 94 shows an embodiment of a clasp having an indicator arm with the molded portion in a closed position. [Figure 95A] FIG. 95A shows an embodiment of a clasp having an indicator arm with the molded portion in a closed position. [Figure 95B] FIG. 95B shows an embodiment of a clasp having an indicator arm with the molded portion in a closed position. [Figure 95C] FIG. 95C shows an embodiment of a clasp having an indicator arm with the molded portion in a closed position. [Fig. 95D] FIG. 95D shows an embodiment of a clasp having an indicator arm with the molded portion in a closed position. [Figure 95E] FIG. 95E shows an embodiment of a clasp having an indicator arm with the molded portion in a closed position. [Fig. 95F] FIG. 95F shows an embodiment of a clasp having an indicator arm with the molded portion in a closed position. [Figure 95G] FIG. 95G shows an embodiment of a clasp having an indicator arm with the molded portion in a closed position. [Figure 96A] FIG. 96A shows the clasp with indicator arm of FIG. 94 with the molded portion in the open position. [Figure 96B]FIG. 96B shows the clasp with the indicator arm of FIG. 94 with the molded portion in the open position. [Figure 97] FIG. 97 illustrates an exemplary valve repair device having a clasp with a leaflet depth indicator. [Figure 98] FIG. 98 illustrates an exemplary valve repair device having a clasp with a leaflet depth indicator. [Figure 99] FIG. 99 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 100] FIG. 100 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 101] FIG. 101 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 102A] FIG. 102A shows a valve repair device having a clasp with a leaflet depth indicator. [Figure 102B] FIG. 102B shows a valve repair device having a clasp with a leaflet depth indicator. [Figure 103] FIG. 103 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 104] FIG. 104 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 105] FIG. 105 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 106] FIG. 106 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 107] FIG. 107 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 108] FIG. 108 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 109] FIG. 109 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 110] FIG. 110 shows the fixed end of the leaflet depth indicator. [Figure 111] FIG. 111 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 112]FIG. 112 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 113] FIG. 113 illustrates an exemplary clasp having a leaflet depth indicator. [Fig. 114] FIG. 114 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 115] FIG. 115 shows a device having a clasp with a leaflet depth indicator. [Fig. 116] FIG. 116 shows a device having a clasp with a leaflet depth indicator. [Figure 117] FIG. 117 illustrates an exemplary leaflet pathway between the clasp and the leaflet depth indicator. [Fig. 118] FIG. 118 illustrates an exemplary leaflet pathway between the clasp and the leaflet depth indicator. [Figure 119] FIG. 119 illustrates an exemplary leaflet depth indicator for a clasp and / or capture device. [Figure 120] FIG. 120 illustrates an exemplary leaflet depth indicator for a clasp and / or capture device. [Figure 121] FIG. 121 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 122] FIG. 122 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 123] FIG. 123 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 124] FIG. 124 illustrates an exemplary clasp having a leaflet depth indicator. [Fig. 125] FIG. 125 illustrates an exemplary clasp having a leaflet depth indicator. [Fig. 126] FIG. 126 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 127] FIG. 127 illustrates an exemplary implantable device with a clasp having a leaflet depth indicator. [Figure 128] FIG. 128 illustrates an exemplary implantable device with a clasp having a leaflet depth indicator. [Figure 129] FIG. 129 illustrates an exemplary clasp having a leaflet depth indicator. [Fig. 130] FIG. 130 illustrates an exemplary device with a clasp having a leaflet depth indicator. [Fig. 131] FIG. 131 illustrates an exemplary clasp having a leaflet depth indicator. [Fig. 132] FIG. 132 illustrates an exemplary implantable device with a clasp having a leaflet depth indicator. [Fig. 133] FIG. 133 illustrates an exemplary clasp having a leaflet depth indicator. [Fig. 134] FIG. 134 illustrates an exemplary implantable device with a clasp having a leaflet depth indicator. [Fig. 135] FIG. 135 illustrates an exemplary clasp having a leaflet depth indicator. [Fig. 136] FIG. 136 shows an intracardiac electrocardiogram (IECG) signal measured by electrodes of an exemplary leaflet depth indicator. [Fig. 137A] FIG. 137A shows an intracardiac electrocardiogram (IECG) signal measured by electrodes of an exemplary valve impingement depth indicator. [Fig. 137B] FIG. 137A shows an intracardiac electrocardiogram (IECG) signal measured by electrodes of an exemplary valve impingement depth indicator. [Fig. 137C] FIG. 137C shows a bipolar IECG signal measured from electrodes of an exemplary leaflet depth indicator. [Fig. 137D] FIG. 137D shows the IECG signal measured from the electrodes of an exemplary valve thrust depth indicator. [Figure 137E] FIG. 137E shows the IECG signal measured from the electrodes of an exemplary valve thrust depth indicator. [Fig. 137F] FIG. 137F shows the IECG signal measured from the electrodes of an exemplary valve thrust depth indicator. [Figure 138] FIG. 138 illustrates an exemplary clasp having a leaflet depth indicator. [Figure 139] FIG. 139 illustrates an exemplary clasp having an integral leaflet depth indicator. [Fig. 140A] FIG. 140A shows an exemplary clasp having arms that may be formed into an integrated leaflet depth indicator. [Fig. 140B] FIG. 140B illustrates an exemplary clasp with an integrated leaflet depth indicator made from the arms shown in FIG. 140A. [Fig. 140C] FIG. 140C illustrates an exemplary clasp with an integrated leaflet depth indicator made from the arms shown in FIG. 140A. [Fig. 141A] FIG. 141A shows an exemplary clasp having an arm that may be formed on the movable arm of the clasp and an arm that may be formed on the integrated leaflet depth indicator. [Fig. 141B] FIG. 141B illustrates an exemplary clasp having an arm that may be formed into a working arm of the clasp and an arm that may be formed into an integral valve impact depth indicator. [Fig. 141C] FIG. 141C shows an exemplary clasp having a movable arm and an integrated leaflet depth indicator made from the arm shown in FIG. 141A or FIG. 141B. [Fig. 141D] FIG. 141B illustrates an exemplary clasp having an arm that may be formed into a working arm of the clasp and an arm that may be formed into an integral valve impact depth indicator. [Fig. 142A] FIG. 142A illustrates an exemplary clasp having an integrated leaflet depth indicator, where the leaflets of the valve are not inserted to a depth that would cause displacement of the leaflet depth indicator. [Fig. 142B] FIG. 142B illustrates an exemplary clasp having an integrated leaflet depth indicator, where the leaflets of the valve are inserted to a depth that causes displacement of the leaflet depth indicator. [Fig. 143A] FIG. 143A illustrates an exemplary clasp having an integrated leaflet depth indicator, where the leaflets of the valve are not inserted to a depth that would cause displacement of the leaflet depth indicator. [Fig. 143B]FIG. 143A illustrates an exemplary clasp having an integrated leaflet depth indicator, where the leaflets of the valve are inserted to a depth that causes displacement of the leaflet depth indicator. [Fig. 144] FIG. 144 illustrates an exemplary device with a clasp having an electronic leaflet depth indicator. [Fig. 145] FIG. 145 illustrates an exemplary device with a clasp having an electronic leaflet depth indicator. [Fig. 146] FIG. 146 illustrates an exemplary device with a clasp having an electronic leaflet depth indicator. [Fig. 147] FIG. 147 illustrates an exemplary device with a clasp having an electronic leaflet depth indicator. [Fig. 148] FIG. 148 illustrates an exemplary clasp with leaflet depth indicators configured to provide visual and electrical indication of leaflet insertion. [Figure 149] FIG. 149 illustrates an exemplary clasp with leaflet depth indicators configured to provide visual and electrical indication of leaflet insertion. [Fig. 150] FIG. 150 illustrates an exemplary clasp with leaflet depth indicators configured to provide visual and electrical indication of leaflet insertion. [Fig. 151] FIG. 151 illustrates an exemplary clasp with leaflet depth indicators configured to provide visual and electrical indication of leaflet insertion. [Fig. 152] FIG. 152 illustrates an exemplary clasp with leaflet depth indicators configured to provide visual and electrical indication of leaflet insertion. [Fig. 153] FIG. 153 illustrates an exemplary clasp with leaflet depth indicators configured to provide visual and electrical indication of leaflet insertion. [Fig. 154] FIG. 154 illustrates an exemplary clasp with leaflet depth indicators configured to provide visual and electrical indication of leaflet insertion. [Fig. 155] FIG. 155 illustrates an exemplary clasp with leaflet depth indicators configured to provide visual and electrical indication of leaflet insertion. [Fig. 156] FIG. 156 shows a clasp having a different sensing plate configuration. [Fig. 156A] FIG. 156A shows a clasp with a different sensing plate configuration. [Fig. 156B] FIG. 156B shows a clasp with a different sensing plate configuration. [Fig. 156C] FIG. 156C shows a clasp with a different sensing plate configuration. [Fig. 156D] FIG. 156D shows a clasp with a different sensing plate configuration. [Fig. 157] FIG. 157 illustrates an exemplary clasp having an electronic leaflet depth indicator. [Fig. 158] FIG. 158 illustrates an exemplary clasp having an electronic leaflet depth indicator. [Fig. 159] FIG. 159 illustrates an exemplary clasp having a blood sensing electronic leaflet depth indicator of one of FIGS. 157 and 158. [Fig. 160] FIG. 160 illustrates an exemplary clasp having an electronic leaflet depth indicator of one of FIGS. 157 and 158 that senses the leaflets of the valve. [Fig. 161] FIG. 161 illustrates an exemplary clasp having one of the electronic leaflet depth indicators of FIGS. 157 and 158 that senses the chordae tendineae. [Fig. 162] FIG. 162 shows the circuit used to measure impedance for some implementations of a clasp with an electrical indicator. [Fig. 163] FIG. 163 shows an example of the calculation of impedance components. [Fig. 164] FIG. 164 shows an example implementation of a method for identifying the state of a clasp based on electrical measurements. [Fig. 165] FIG. 165 illustrates an exemplary device and / or portion of a device with a clasp having a leaflet depth indicator. [Fig. 166]FIG. 166 illustrates an exemplary device and / or portion of a device with a clasp having a leaflet depth indicator. [Fig. 167] FIG. 167 illustrates an exemplary device and / or portion of a device with a clasp having a leaflet depth indicator. [Fig. 168] FIG. 168 illustrates an exemplary device and / or portion of a device with a clasp having a leaflet depth indicator. [Fig. 169] FIG. 169 illustrates an exemplary device and / or portion of a device with a clasp having a leaflet depth indicator. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0053] 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.

[0054] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, various implementations of valve repair devices, implantable devices, implants, and systems (including systems for delivering 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 can be performed on simulations, such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0055] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection may be direct, such as between the components, or may be indirect, such as through the use of one or more intermediate components. Also, references to a "member," "component," or "portion" described herein are not limited to a single structural member, component, or element, but may include an assembly of components, members, or elements. Also, the terms "substantially" and "about" described herein are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%). Although the terms "clasp" and "clasp arm" are often used herein with respect to specific embodiments, the terms "gripping member" and / or "gripper arm" may be substituted and function in the same or similar manner, even if not configured in the same manner as a typical clasp.

[0056] 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 valve openings, which come together or "coapt" in flow to form a unidirectional fluid occlusion surface. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the 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.

[0057] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase, or diastole, seen in FIG. 1, blood already collected in the left atrium LA (during the contraction phase) moves through the mitral valve MV into the left ventricle LV due to the expansion of the left ventricle LV. During the contraction phase, or systole, seen in FIG. 2, the left ventricle LV contracts to pump blood 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 around a coaptation element or spacer that beneficially acts as a filler in the regurgitant opening to prevent or reduce backflow or regurgitation during systole, although this is not required.

[0058] Now, referring to FIGS. 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense fibrous ring of tissue that surrounds the leaflets 20, 22. Referring to FIGS. 3 and 4, 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 required to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular tissue, which function to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in Figure 3, the anatomy of the leaflets 20, 22 is such that the inner surfaces of the leaflets 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.

[0059] 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.

[0060] 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, thereby causing blood to leak back into the previous heart chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0061] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier's Type I, II, and III insufficiencies. Carpentier's Type I insufficiency involves dilatation of the valve annulus, so that normally functioning leaflets move apart and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in the insufficiency of the Type I mechanism is leaflet perforation, as occurs in endocarditis. Carpentier's Type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier's Type III insufficiency involves 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 (Ma) or ventricular dilatation (IIIb).

[0062] With reference to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflets 20 and posterior leaflets 22 coapt, thereby preventing blood from leaking from the left ventricle LV into the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflets 20 and / or posterior leaflets 22 of the mitral valve MV are displaced into the left atrium LA during systole, such that the edges of the leaflets 20, 22 do not contact each other. This failure to coapt creates a gap 26 between the anterior leaflets 20 and posterior leaflets 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. 3. With reference to FIG. 6, the gap 26 may have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 may have a width W of greater than 15 mm. As discussed above, there are a number of different ways in which a valve leaflet (eg, the leaflets 20, 22 of the mitral valve MV) may become incompetent, causing valve regurgitation.

[0063] In any of the above situations, a valve repair device or implant that can engage the anterior leaflets 20 and posterior leaflets 22 and close the gap 26 to prevent or inhibit backflow of blood through the mitral valve MV is desirable. As can be seen from FIG. 4, an abstract representation of a valve repair device, implantable device, or implant 10 is shown implanted between the leaflets 20, 22 such that backflow does not occur during systole (compare FIG. 3 to FIG. 4). In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) of the device 10 have a generally tapered or triangular shape that naturally matches the shape of the native valve and its tendency to expand (towards the annulus). In this application, terms such as spacers, coaptation elements, and gap fillers are used interchangeably to refer to elements that are configured to fill a portion of the space between the leaflets of the native valve and / or to engage or "coapt" the leaflets of the native valve (e.g., to coapt not only to each other but also to the coaptation elements, spacers, etc.).

[0064] 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. 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 pressures are substantially higher in the left side of the heart, insufficiency of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening.

[0065] Dysfunctional native heart valves can be either repaired or replaced. Repair typically involves maintaining and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Since the stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or pulmonary valve can be 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).

[0066] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it is understood that the devices and concepts provided herein can be used to repair any native valve, as well as to repair any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit backflow of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the 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.

[0067] An exemplary implantable device (e.g., an implantable prosthetic device, etc.) or implant may optionally have a coaptation element (e.g., a spacer, coaptation element, gap filler, etc.) and at least one anchor (e.g., one, two, three or more). In some implementations, an implantable device or implant may have any combination or subcombination of the features disclosed herein without a coaptation element. The coaptation element (e.g., coaptation element, spacer, etc.), when included, is configured to be positioned within the native heart valve opening to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting the above-mentioned backflow. The coaptation element may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the native leaflets to close around the coaptation element during ventricular systole, thereby blocking backflow of blood from the left or right ventricle into the left or right atrium, respectively. The device or implant can be configured to seal against two or three native leaflets, i.e., the device can be used with native mitral (bicuspid) and native tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill the space between native leaflets (e.g., mitral valves 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely or function properly.

[0068] The optional coaptation element (e.g., spacer, coaptation element, etc.) can have a variety of shapes. In some implementations, the coaptation element can have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation element can have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation element can have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the native leaflets. In some implementations configured for use with a tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid leaflets.

[0069] In some implementations, the anchors can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between two native leaflets. In some implementations configured for use with a tricuspid valve, the anchors can be configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between three native leaflets. In some implementations, the anchors can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchors can be attached to an actuating element, such as a shaft or actuating wire, to which the coaptation element is also attached. In some implementations, the anchors and coaptation elements can be independently positioned relative to one another by separately moving each of the anchors and coaptation elements along a longitudinal axis of the actuating element (e.g., actuating shaft, actuating rod, actuating tube, actuating wire, etc.). In some implementations, the anchors and coaptation elements can be simultaneously positioned by moving the anchors and coaptation elements together along a longitudinal axis of the actuating element, such as a shaft, actuating wire, etc. The anchors can be configured to be positioned behind the native leaflets when implanted such that the leaflets are gripped by the anchors.

[0070] The device or implant may be configured to be implanted via a delivery system or other delivery means. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The coaptation element and anchor may be compressible to a radially compressed state and may be self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured such that the anchor is expanded radially away from the initially still compressed coaptation element to create a gap between the coaptation element and the anchor. The native leaflet may then be positioned within the gap. The coaptation element may be expanded radially to close the gap between the coaptation element and the anchor to capture the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to be self-expanding. The implantation methods for various implementations may vary and are described more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, which are incorporated by reference in their entirety for all purposes. These methods can be performed, mutatis mutandis, on live animals or can be performed on simulations, such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0071] 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 that are gripped by the anchors.

[0072] 8-15, a schematic representation of a device or implant 100 (e.g., an artificial spacer device, a valve repair device, etc.) is shown in various stages of deployment. The device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated by reference in their entireties. The device 100 may include any other features of another device or implant described in this application or the applications cited above, and the device 100 may be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above).

[0073] The device or implant 100 is deployed from a delivery system or other delivery means 102. The delivery system 102 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, etc. The device or implant 100 includes a joint portion 104 and an anchor portion 106.

[0074] In some implementations, the interface portion 104 of the device or implant 100 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes an interface element 110 (e.g., a spacer, plug, filler, foam, sheet, membrane, interface element, etc.) slidably attached to an actuation element 112 (e.g., an actuation wire, shaft, tube, hypotube, line, suture, braid, etc.). The anchor portion 106 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, a paddle, a gripping member, or the like. Actuation of the actuation means or element 112 causes the anchor portion 106 of the device 100 to open and close and grip the leaflets of the native valve during implantation. The actuation means or element 112 (as well as other actuation means and elements herein) may take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), may be made from a variety of different materials, and may have a variety of configurations. As one example, the actuation element may be threaded such that rotational actuation of the actuation element moves the anchor portion 106 relative to the interface portion 104. Alternatively, the actuation element may be unthreaded such that pushing or pulling actuation of the actuation element 112 moves the anchor portion 106 relative to the interface portion 104.

[0075] The anchor portion 106 and / or anchor of the device 100, in some implementations, includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the interface element 110 by portions 124, 126, 128. The portions 124, 126, 128 may be articulated and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, interface element 110, and cap 114 by portions 124, 126, 128 may constrain the device to the positions and movements shown herein.

[0076] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuation means or element 112 (e.g., actuation wire, actuation shaft, 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 112 extends through the delivery catheter and the interface element 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the spacing between the interface element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. 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 110 to the delivery system 102 such that an actuation means or element 112 slides through the collar or other attachment member, and in some implementations, through the interface element 110 during actuation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0077] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member. The illustrated gripping member may include a catch 130 including a base or fixed arm 132, a movable arm 134, optional barbs, friction enhancing elements or other fastening means 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and an interface portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the interface portion 138 disposed proximate to the interface element 110. In some implementations, the catch (e.g., a barbed catch, a barbed gripping member, etc.) has a flat surface and does not fit within a recess of the inner paddle. Rather, the flat portion of the catch is disposed against a surface of the inner paddle 122. The interface portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the catch 130. Interface 138 can be any suitable interface, such as a flexible interface, a spring interface, a pivot interface, or the like. In some implementations, interface 138 is a flexible piece of material integrally formed with fixed arm 132 and movable arm 134. Fixed arm 132 is attached to inner paddle 122 and remains stationary or substantially stationary relative to inner paddle 122 when movable arm 134 is opened, opening clasp 130 and exposing optional barbs, friction enhancing members, or fastening means 136.

[0078] In some implementations, the clasp 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend or pivot on a joint 138. The actuation line 116 extends through the delivery system 102 (e.g., through the steerable catheter and / or the implant catheter). Other actuation mechanisms are also possible.

[0079] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be spring loaded so that in the closed position, the clasp 130 continues to provide a clamping force against the grasped native leaflet. This clamping force remains constant regardless of the position of the inner paddle 122. Optional barbs, friction enhancing members, or other securing means 136 of the clasp 130 can grasp, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0080] The paddles 120, 122 may be opened and closed during implantation, for example, to grip a native leaflet (such as a leaflet of a native mitral valve) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element 110. The clasps 130 may be used to grip and / or further secure the native leaflet by engaging the leaflet with optional barbs, frictional enhancements or fixation means 136 and clamping the leaflet between the movable arm 134 and the fixed arm 132. The optional barbs, frictional enhancements or other fixation means 136 of the clasps 130 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) may increase friction with the leaflet or partially or completely puncture the leaflet. The actuation lines 116 may be actuated separately such that each clasp 130 may be opened and closed separately. Acting separately allows one leaflet to be grasped at a time, or the clasp 130 to be repositioned on a leaflet that was not adequately grasped without changing the good grip on the other leaflets. The clasp 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), allowing the leaflets to be grasped in various positions as the particular situation requires.

[0081] 8, the device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of a delivery system 102. The device 100 is positioned at the end of the catheter in the fully open position because it takes up the least amount of space, allowing the smallest catheter to be used (or the largest device for a given catheter size). In the extended state, the cap 114 is spaced from the interface element 110 such that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 is maintained in a closed state during deployment through the delivery system 102 such that the optional barbs, friction enhancing members or other fastening means 136 (FIG. 9) do not catch or damage tissue within the delivery system 102 or the patient's heart.

[0082] 9, the device 100 is shown in an extended, unravelled state similar to that of FIG. 8, but with the clasp 130 in a fully open position at a range of about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees between the fixed portion 132 and the movable portion 134 of the clasp 130. Full opening of the paddles 120, 122 and clasp 130 has been found to improve ease of unravelling or detachment from the patient's anatomical structures, such as the chordae tendineae CT, during implantation of the device 100.

[0083] Referring now to FIG. 10, the device 100 is shown in a shortened or fully closed state. The compact size of the device 100 in the shortened state may make it easier to manipulate and place inside the heart. To move the device 100 from the extended state to the shortened state, the actuation means or element 112 is retracted, pulling the cap 114 towards the coaptation element 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained from moving, such that the compressive force acting on the outer paddle 120 from the cap 114 retracting towards the coaptation element 110 moves the paddle or gripping member radially outward. The outer paddle 120 maintains an acute angle with the actuation means or element 112 during movement from the open position to the closed position. The outer paddle 120 may optionally be biased towards the closed position. Because the inner paddle 122 is oriented away from the open interface element 110 during the same movement, it moves through a much larger angle and collapses along the side of the closed interface element 110. In some implementations, the inner paddle 122 may be thinner and / or narrower than the outer paddle 120, and the connecting portions 126, 128 (e.g., joints, flexible connections, etc.) connected to the inner paddle 122 may be thinner and / or more flexible. For example, this increased flexibility may allow for greater movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the outer paddle 120 is narrower than the inner paddle 122. The connecting portions 126, 128 connected to the inner paddle 122 may be more flexible to allow for greater movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114, for example. In some implementations, the inner paddle 122 may be the same width or substantially the same width as the outer paddle.

[0084] 11-13, the device 100 is shown in a partially open, ready to grasp state. To move from the fully closed state to the partially open state, an actuation means or element (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor or anchor portion 106 to partially unfold. The actuation line 116 is also retracted to open the clasp 130, which allows the leaflets to be grasped. In some implementations, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation means or single actuation element 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 will close the clasp. In some implementations, the paddles 120, 122 may be independently controllable. For example, the device 100 may have two actuation elements and two independent caps (or other mounting parts), such that one independent actuation element (e.g., a wire, shaft, etc.) and cap (or other mounting part) is used to control one paddle, and the other independent actuation element and cap (or other mounting part) is used to control the other paddle.

[0085] 12, one of the actuation lines 116 can be extended to close one of the clasps 130. Now, referring to FIGURE 13, the other actuation line 116 can be extended to close the other clasp 130. One or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0086] 14, the device 100 is shown in a fully closed and deployed state. The delivery system or delivery means 102 and actuation means or actuation element 112 are retracted and the paddles 120, 122 and clasp 130 remain in a fully closed position. Once deployed, the device 100 may be maintained in the fully closed position by a mechanical latch or may be biased to remain closed by the use of a spring material such as steel, other metals, plastics, composites, or a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from a metal such as steel or from a shape memory alloy such as Nitinol, fabricated into a wire, sheet, tube, or laser sintered powder, and biased to hold the outer paddle 120 closed around the interface element 110 and the clasp 130 in a clamped state around the native leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the valve leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0087] Figure 15 shows an embodiment in which the paddles 120, 122 are independently controllable. The device 101 shown in Figure 15 is similar to the device 100 shown in Figure 11, except that the device 101 in Figure 15 includes an actuation element configured as two independent actuation elements 111, 113 coupled to two independent caps 115, 117. The actuation means or actuation element 111 is extended to push the cap 115 away from the interface element 110 to transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor 108 to partially expand. An actuation means or element 113 is extended to push the cap 115 away from the mating element 110 to move the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially expand. The independent paddle control shown in Figure 15 can be implemented in any of the devices disclosed in this application. For comparison, in the embodiment shown in Figure 11, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation means or element 112.

[0088] 16-21, the apparatus 100 of FIGS. 8-14 is shown delivered and deployed within the native mitral valve MV of the heart H. With reference to FIG. 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as shown in FIG. 16. The actuation means or element 112 is then retracted, moving the implant / apparatus to a fully closed state as shown in FIG. 17.

[0089] As can be seen from Figure 18, the implant / device is moved into a position within the mitral valve MV and into the ventricle LV in a partially open state so that the leaflets 20, 22 can be grasped. For example, a steerable catheter can be advanced to steer or bend the steerable catheter to position it as shown in Figure 18. An implant catheter connected to the implant / device can be advanced from within the steerable catheter to position the implant as shown in Figure 18.

[0090] 19, the implant catheter may be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasps 130. The actuating line 116 is extended to close one of the clasps 130, capturing the leaflet 20. FIG. 20 shows the other actuating line 116 then being extended to close the other clasp 130, capturing the remaining leaflet 22. Finally, as can be seen from FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuating means or element 112, and actuating line 116 are then retracted and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0091] 22-27, one embodiment of an implantable device or implant or implants 200 is shown. The implantable device 200 is one of many different configurations that the device 100, shown generally in FIGS. 8-14, may take. The device 200 may include any of the other features of an implantable device or implant described herein, and the device 200 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system, such as any of the valve repair systems disclosed herein. The device / implant 200 may be an artificial spacer device, a valve repair device, or another type of implant that attaches to the leaflets of a native valve.

[0092] In some implementations, the implantable device or implant 200 includes an interface portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the interface portion 204 of the device optionally includes an interface element 210 (e.g., a spacer, interface element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some implementations, the anchor portion 206 includes multiple anchors 208. The anchors may be configured in a variety of ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism 213 (FIGS. 43-49) of the delivery system 202 (FIGS. 38-42 and 49). The delivery system 202 may be the same as or similar to the delivery system 102 described elsewhere and may comprise one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, etc. The capture mechanism may be configured in a variety of ways and in some implementations may comprise one or more of a clamp, clip, pin, suture, line, lasso, noose, snare, buckle, lock, latch, etc.

[0093] In some implementations, the joint elements 210 and paddles 220, 222 are formed from a flexible material, which may be a metal fabric formed as a mesh, woven fabric, braided fabric, or in any other suitable manner, or a flexible material that is laser cut or otherwise cut. The material may be a fabric, a shape memory alloy wire such as Nitinol to provide shape setting capabilities, or any other flexible material suitable for implantation in the human body.

[0094] An actuating element 212 (e.g., an actuating shaft, actuating rod, actuating tube, actuating wire, actuating line, etc.) extends from the delivery system 202 to engage and enable actuation of the implantable device or implant 200. In some implementations, the actuating element 212 extends through the capture mechanism 213, the proximal collar 211, and the interface element 210 to engage a cap 214 on the distal portion 207. The actuating element 212 may be configured to releasably engage the cap 214, such as with a threaded connection, such that the actuating element 212 may be disengaged and removed from the device 200 after implantation.

[0095] The coaptation element 210 extends from a proximal collar 211 (or other attachment member) to an inner paddle 222. In some implementations, the coaptation element 210 has a generally elongated, circular shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above (e.g., FIG. 51), a tapered shape or cross-section when viewed from the front (e.g., FIG. 23), or a circular shape or cross-section when viewed from the side (e.g., FIG. 24). A mixture of these three geometries may result in the illustrated three-dimensional shape of the coaptation element 210 that achieves the advantages described herein. It may be seen that the circular shape of the coaptation element 210 also substantially follows or approximates the shape of the paddle frame 224 when viewed from above.

[0096] The size and / or shape of the coaptation element 210 may be selected to minimize the number of implants required per patient (preferably one) while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation element is about 5 mm, and the medial-lateral distance at the widest point of the coaptation element is about 10 mm. In some implementations, the overall geometry of the device 200 may be based on these two dimensions and the overall shape plan described above. Using other anterior-posterior and medial-lateral distances as a starting point for the device, it will be readily apparent that the device will have different dimensions. Additionally, using other dimensions and the shape plan described above will also result in the device having different dimensions.

[0097] In some implementations, the outer paddle 220 is joinably attached to the cap 214 of the distal portion 207 by connecting portion 221 and to the inner paddle 222 by connecting portion 223. The inner paddle 222 is joinably attached to the joint element by connecting portion 225. In this manner, the anchor 208 is configured similar to a leg, in that the inner paddle 222 is like an upper portion of a leg, the outer paddle 220 is like a lower portion of a leg, and the connecting portion 223 is like a knee portion of a leg.

[0098] In some implementations, the inner paddle 222 is rigid, relatively rigid, stiff, has a stiff portion, and / or is stiffened by a stiffening member or fixed portion 232 of the clasp 230. The stiffening of the inner paddle allows the device to move to a variety of different positions as described herein. The inner paddle 222, outer paddle 220, and interface elements may all be interconnected as described herein such that the device 200 is constrained to the movements and positions as described herein.

[0099] In some implementations, the paddle frame 224 is attached to the cap 214 of the distal portion 207 and extends to a connection 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a material that is stiffer and harder than the material forming the paddles 222, 220 such that the paddle frame 224 provides support for the paddles 222, 220.

[0100] The paddle frame 224 provides additional clamping force between the inner paddle 222 and the coaptation element 210, as can be seen in FIG. 51, and helps wrap the leaflets around the sides of the coaptation element 210 for a better seal between the coaptation element 210 and the leaflets. That is, the paddle frame 224 may be configured with a rounded three-dimensional shape that extends from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer and inner paddles 220 and 222, the cap 214, and the coaptation element 210 may constrain each of these members to the movements and positions described herein. In particular, the connecting portion 223 is constrained by its connections between the outer and inner paddles 220 and 222, and by its connections to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus the inner paddle 222 and the outer paddle 220 ) and by its attachment to the cap 214 .

[0101] Configuring the paddle frame 224 in this manner provides an increased surface area compared to the outer paddle 220 alone, which may, for example, allow easier grasping and fixation of the native leaflets. The increased surface area may also distribute the clamping force of the paddles 220 and paddle frame 224 against the native leaflets over a larger surface area of ​​the native leaflets to further protect the native leaflet tissue. Referring again to FIG. 51, the increased surface area of ​​the paddle frame 224 may also clamp the native leaflets to the implantable device or implant 200 such that the native leaflets are generally coapted against the periphery of the coaptation member or element 210. This may, for example, improve sealing of the native leaflets 20, 22, thereby preventing or further reducing mitral regurgitation.

[0102] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 230 includes a base or fixed arm 232, a movable arm 234, an optional barb 236, and an interface portion 238. The fixed arm 232 is attached to the inner paddle 222 with the interface portion 238 disposed proximate to the interface element 210. The interface portion 238 is spring loaded such that the fixed arm 232 and the movable arm 234 are biased toward each other when the clasp 230 is in a closed state. In some implementations, the clasp 230 includes optional friction enhancing members or fastening means, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0103] In some implementations, the fixed arm 232 is attached to the inner paddle 222 through a hole or slot 231 by a suture (not shown). The fixed arm 232 may be attached to the inner paddle 222 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, a clamp, a latch, or the like. The fixed arm 232 remains substantially stationary relative to the inner paddle 222 when the movable arm 234 is opened to open the clasp 230 and expose the optional barb or other friction enhancing member 236. The clasp 230 is opened by applying tension to an actuation line 216 (e.g., as shown in FIGS. 43-48 ) attached to a hole 235 in the movable arm 234, thereby allowing the movable arm 234 to articulate, pivot, and / or bend over an interface 238.

[0104] 29, a close-up view of one of the leaflets 20, 22 grasped by a clasp, such as clasp 230, is shown. The leaflets 20, 22 are grasped between a movable arm 234 and a fixed arm 232 of the clasp 230. The tissue of the leaflets 20, 22 is not pierced by the optional barbs or frictional enhancement members 236, although in some implementations the optional barbs 236 may partially or fully pierce the leaflets 20, 22. The angle and height of the optional barbs or frictional enhancement members 236 relative to the movable arms 234 helps secure the leaflets 20, 22 within the clasp 230. In particular, the force pulling the implant away from the native leaflets 20, 22 encourages the optional barbs or frictional enhancement members 236 to further engage the tissue, thereby ensuring a better hold. Retention of the leaflets 20, 22 within the catch 230 is further improved by the location of the fixed arms 232 near the optional barbs / frictional enhancements 236 when the catch 230 is closed. In this arrangement, the tissue is forced by the fixed and movable arms 232, 234 and the optional barbs / frictional enhancements 236 into an S-shaped, tortuous path. Thus, the force pulling the leaflets 20, 22 away from the catch 230 encourages the tissue to further engage the optional barbs / frictional enhancements 236 before the leaflets 20, 22 may prolapse. For example, tension on the leaflets during diastole may encourage the optional barbs 236 to pull towards the ends of the leaflets 20, 22. Thus, the S-shaped path may take advantage of the tension on the leaflets during diastole to more tightly engage the leaflets 20, 22 with the optional barbs / frictional enhancements 236.

[0105] 25, the device or implant 200 may also include a cover 240. In some implementations, the cover 240 may be disposed on the interface elements 210, the outer and inner paddles 220 and 222, and / or the paddle frame 224. The cover 240 may be configured to prevent or reduce blood flow through the device or implant 200 and / or to promote natural tissue ingrowth. In some implementations, the cover 240 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 cover 240 may include a coating (e.g., a polymer) applied to the implantable device or implant 200.

[0106] During implantation, the paddles 220, 222 of the anchor 208 are opened and closed to grip the native valve leaflets 20, 22 between the paddles 220, 222 and the coaptation element 210. The anchor 208 is moved between a closed position (FIGS. 22-25) and various open positions (FIGS. 26-37) by extending and retracting the actuation element 212. The extension and retraction of the actuation element 212 increases and decreases the spacing between the coaptation element 210 and the cap 214, respectively. The proximal collar 211 (or other attachment member) and coaptation element 210 slide along the actuation element 212 during operation, thereby changing the spacing between the coaptation element 210 and the cap 214 to move the paddles 220, 220 between different positions to grip the mitral valve leaflets 20, 22 during implantation.

[0107] To open and close the device 200, the pair of inner and outer paddles 222, 220 are moved together, not independently, by a single actuation element 212. Additionally, the position of the clasp 230 depends on the position of the paddles 222, 220. For example, the clasp 230 is positioned such that closure of the anchor 208 causes the clasp 230 to close simultaneously. In some implementations, the device 200 can be made to allow the paddles 220, 222 to be independently controllable in the same manner (e.g., device 101 shown in FIG. 15).

[0108] In some implementations, the clasp 230 further secures the native leaflets 20, 22 by engaging the leaflets 20, 22 with optional barbs and / or other friction enhancing members 236 and / or by sandwiching the leaflets 20, 22 between the movable arm 234 and the fixed arm 232. In some implementations, the clasp 230 is a barbed clasp that includes barbs that can increase friction with the leaflets 20, 22 and / or partially or fully pierce the leaflets 20, 22. The actuation lines 216 (FIGS. 43-48) can be actuated separately such that each clasp 230 can be opened and closed separately. By acting separately, one leaflet 20, 22 can be gripped at a time, or the clasp 230 can be repositioned over a leaflet 20, 22 that was not adequately gripped without changing the good grip on the other leaflets 20, 22. The clasp 230 can be fully opened or closed when the inner paddle 222 is not closed, thereby allowing the leaflets 20, 22 to be grasped in various positions as the particular situation requires.

[0109] 22-25, the device 200 is shown in a closed position. The inner paddle 222 is disposed between the outer paddle 220 and the coaptation element 210 when closed. The clasp 230 is disposed between the inner paddle 222 and the coaptation element 210. Upon successful capture of the native leaflets 20, 22, the device 200 is moved and held in a closed position such that the leaflets 20, 22 are secured within the device 200 by the clasp 230 and pressed against the coaptation element 210 by the paddles 220, 222. The outer paddle 220 may have a wider curved shape that fits around the curved shape of the coaptation element 210 to more firmly grip the leaflets 20, 22 when the device 200 is closed (e.g., as can be seen in FIG. 51). The curved shape and rounded edges of the outer paddle 220 also prevent or inhibit tearing of the leaflet tissue.

[0110] 30-37, the implantable device or implant 200 described above is shown in various positions and configurations ranging from partially open to fully open. The paddles 220, 222 of the device 200 transition between each of the positions shown in FIGS. 30-37, from the closed position shown in FIGS. 22-25, to the extension of the actuating element 212 from a fully retracted position to a fully extended position.

[0111] 30 and 31, the device 200 is shown in a partially open position. The device 200 is moved to the partially open position by extending the actuation element 212. The extension of the actuation element 212 pulls down the bottom of the outer paddle 220 and paddle frame 224. The outer paddle 220 and paddle frame 224 pull down the inner paddle 222, which is connected to the outer paddle 220 and paddle frame 224. With the proximal collar 211 (or other attachment member) and joint element 210 held in place by the capture mechanism 213, the inner paddle 222 is caused to articulate, rotate, and / or bend in an open direction. The inner paddle 222, outer paddle 220, and paddle frame all bend to the positions shown in FIGS. 30 and 31. Opening the paddles 222, 220 and frame 224 creates a gap between the coaptation element 210 and the inner paddle 222 that may receive and grasp the native leaflets 20, 22. This movement exposes the clasp 230, which may be moved between a closed position (FIG. 30) and an open position (FIG. 31) to form a second gap for grasping the native leaflets 20, 22. The extent of the gap between the fixed arm 232 and the movable arm 234 of the clasp 230 is limited to the extent that the inner paddle 222 extends away from the coaptation element 210.

[0112] 32 and 33, the device 200 is shown in a laterally extended or laterally open position. The device 200 is moved to the laterally extended or laterally open position by continuing the extension of the actuating element 212 as described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207. Continuing the extension of the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the coaptation element 210. In the laterally extended or laterally open position, the inner paddle 222 extends more horizontally than in other positions of the device 200, forming an angle of approximately 90 degrees with the coaptation element 210. Similarly, the paddle frame 224 are in their maximum spread position when the device 200 is in the laterally extended or laterally open position. The increased gap between the interface element 210 and the inner paddle 222 formed in the laterally extended or laterally open position allows the catch 230 to open further before engaging the interface element 210 (FIG. 33), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0113] 34 and 35, the exemplary device 200 is shown in a three-quarters extended position. The device 200 is moved to the three-quarters extended position by continuing the extension of the actuating element 212 as described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207. Continuing the extension of the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the coaptation element 210. In the three-quarters extended position, the inner paddle 222 opens to an angle of more than 90 degrees to about 135 degrees with the coaptation element 210. The paddle frame 224 spreads less than in the laterally extended or laterally open positions and begins to move inwardly toward the actuating element 212 as the actuating element 212 extends further. The outer paddle 220 also bends backwards toward the actuating element 212. Similar to the laterally extended or laterally open position, the increased gap between the joint element 210 and the inner paddle 222 formed in the laterally extended or laterally open position may allow the clasp 230 to open even further (FIG. 35), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0114] 36 and 37, an exemplary device 200 is shown in a fully extended position. The device 200 is moved to the fully extended position by continuing the extension of the actuating element 212 as described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207 to the maximum distance allowable by the device 200. Continuing the extension of the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the coaptation element 210. The outer paddle 220 and the paddle frame 224 move to a position where they are closer to the actuating element. In the fully extended position, the inner paddle 222 is opened to an angle of about 180 degrees with the coaptation element 210. In the fully extended position, the inner and outer paddles 222, 220 are linearly extended to form an angle of about 180 degrees between the paddles 222, 220. The fully extended position of the device 200 provides the largest size gap between the coaptation element 210 and the inner paddle 222, and in some implementations also allows the clasp 230 to fully open to approximately 180 degrees between the fixed arm 232 and the movable arm 234 of the clasp 230 ( FIG. 37 ). The position of the device 200 is its longest and narrowest configuration. Thus, the fully extended position of the device 200 may be a desired position for extrication of the device 200 from an attempted implantation, or may be in a desired position for placement of the device into a delivery catheter or the like.

[0115] Configuring the device or implant 200 such that the anchors 208 may extend into a straight or nearly straight configuration (e.g., about 120 degrees to 180 degrees relative to the coaptation element 210) may provide several advantages. For example, this configuration may reduce the radial crimp profile of the device or implant 200. The configuration may make it easier to grasp the native leaflets 20, 22 by providing a larger opening between the coaptation element 210 and the inner paddle 222 for grasping the native leaflets 20, 22. Additionally, the relatively narrow and straight configuration may prevent or reduce the likelihood of the device or implant 200 becoming entangled in natural anatomy (e.g., the chordae tendineae CT shown in FIGS. 3 and 4) when positioning and / or retrieving the device or implant 200 within the delivery system 202.

[0116] 38-49, an exemplary implantable device 200 is shown being delivered and deployed within a native mitral valve MV of a heart H. As discussed above, the device 200 shown in FIGS. 38-49 includes an optional cover 240 (e.g., FIG. 25) over the coaptation member 210, the clasp 230, the inner paddle 222 and / or the outer paddle 220. The device 200 is deployed from a delivery system 202 (which may include, e.g., a steerable catheter 241 and / or an implant catheter extendable from a guide sheath) and is held by a capture mechanism 213 (see, e.g., FIGS. 43 and 48) and actuated by extending and retracting an actuating element 212. Fingers of the capture mechanism 213 releasably attach the collar 211 to the delivery system 202. In some implementations, the capture mechanism 213 is held in a closed state around the collar 211 by the actuating element 212, such that after the device 200 is successfully implanted, removal of the actuating element 212 can cause the fingers of the capture mechanism 213 to open and release the collar 211, disengaging the capture mechanism 213 from the device 200.

[0117] Now referring to FIG. 38, the delivery system 202 (e.g., its delivery catheter / sheath) is inserted through the septum into the left atrium LA, and the device / implant 200 is deployed from the delivery system 202 in a fully open state for the reasons described above with respect to the device 100 (e.g., the implant catheter holding the device / implant may be extended to deploy the device / implant out of the steerable catheter). The actuating element 212 is then retracted, moving the device 200 through a partially closed state (FIG. 39) to a fully closed state as shown in FIGS. 40 and 41. The delivery system or catheter then steers the device / implant 200 towards the mitral valve MV, as shown in FIG. 41. Now referring to FIG. 42, when the device 200 is aligned with the mitral valve MV, the actuating element 212 is extended to open the paddles 220, 222 to a partially open position, and the actuating line 216 (FIGS. 43-48) is retracted, opening the clasp 230 to prepare for grasping the valve leaflets. Next, as shown in Figures 43 and 44, the partially open device 200 is inserted through the native valve (e.g., by advancing the implant catheter from the steerable catheter) until the leaflets 20, 22 are properly positioned between the inner paddle 222 and the coaptation element 210 and within the open clasp 230.

[0118] FIG. 45 shows the device 200 with both clasps 230 in a closed position, but with the optional barb 236 of one clasp 230 not engaged with one of the leaflets 22. As can be seen from FIGS. 45-47, the misaligned clasp 230 is again opened and closed to properly grasp the unengaged leaflet 22. When both leaflets 20, 22 are properly grasped, the actuating element 212 is retracted, moving the device 200 to a fully closed position, shown in FIG. 48. With the device 200 fully closed and implanted within the native valve, the actuating element 212 is disengaged and withdrawn from the cap 214, releasing the capture mechanism 213 from the proximal collar 211 (or other attachment member), so that the capture mechanism 213 may be withdrawn into the delivery system 202 (e.g., into a catheter / sheath), as shown in FIG. 49. Once deployed, the device 200 may be maintained in a fully closed position by mechanical means such as a latch, or may be biased to remain closed through the use of a spring material such as steel, and / or a shape memory alloy such as Nitinol. For example, the paddles 220, 222 may be formed from steel or Nitinol shape memory alloy fabricated into a wire, sheet, tube, or laser sintered powder and biased to hold the outer paddle 220 in a closed position around the inner paddle 222, the coaptation element 210, and / or the clasp 230 in a clamped position around the native leaflets 20, 22.

[0119] 50-54, once the device 200 is implanted within a native valve, the coaptation element 210 functions as a gap filler within a valve regurgitation opening, such as the gap 26 in the mitral valve MV shown in FIG. 6 or a gap in another native valve. In some implementations, when the device 200 is deployed between two opposing leaflets 20, 22, the leaflets 20, 22 no longer coapt against each other in the region of the coaptation element 210, but instead coapt against the coaptation element 210. This reduces the distance that the leaflets 20, 22 must approach to close the mitral valve MV during systole, thereby facilitating the repair of functional valve disease that may cause mitral regurgitation. The reduction in leaflet approach distance may provide several other benefits as well. For example, the stresses experienced by the native valve are reduced or minimized by the reduction in the approach distance required of the leaflets 20, 22. A closer approximation of the leaflets 20, 22 may require a reduced approximation force, which may result in less tension on the leaflets 20, 22 and less reduction in the diameter of the valve annulus. Less or no reduction in the valve annulus may result in less reduction in valve opening area compared to a device without a coaptation element or spacer. In this manner, the coaptation element 210 may reduce the transvalvular gradient.

[0120] In order to adequately fill the gap 26 between the leaflets 20, 22, the device 200 and its components can have a wide variety of different shapes and sizes. For example, the outer paddle 220 and paddle frame 224 can be configured to match the shape or geometry of the coaptation element 210, as shown in FIGS. 50-54. As a result, the outer paddle 220 and paddle frame 224 can mate with both the coaptation element 210 and the native valve leaflets 20, 22. In some implementations, when the leaflets 20, 22 are coapted against the coaptation element 210, the leaflets 20, 22 completely surround or "hugge" the coaptation element 210 with their entirety, and thus small leaks at the outer and inner surfaces 201, 203 of the coaptation element 210 can be prevented or inhibited. The interaction of the leaflets 20, 22 with the device 200 is made clear in Fig. 51, which shows a schematic atrial or surgeon's eye view showing a paddle frame 224 (which would not actually be visible from a true atrial view, e.g., from Fig. 52) that conforms to the geometry of the coaptation element 210. The opposing leaflets 20, 22 (whose ends also would not be visible from a true atrial view, e.g., from Fig. 52) are approximated by the paddle frame 224 to completely surround or "hug" the coaptation element 210.

[0121] This coaptation of the leaflets 20, 22 against the lateral and medial surfaces 201, 203 of the coaptation element 210 (shown from the atrial side in FIG. 52 and from the ventricular side in FIG. 53) would seem to contradict the statement above that the presence of the coaptation element 210 minimizes the distance the leaflets must approximate. However, the distance the leaflets 20, 22 must approximate is still minimized if the coaptation element 210 is positioned precisely in the regurgitation gap 26, and the regurgitation gap 26 is smaller than the width (medial minus lateral) of the coaptation element 210.

[0122] FIG. 50 shows the geometry of the coaptation element 210 and paddle frame 224 from the perspective of the LVOT. As can be seen from this figure, the coaptation element 210 has a tapered shape with smaller dimensions in the area near where the inner surfaces of the leaflets 20, 22 coapt and are desired to increase in size as the coaptation element 210 extends toward the atrium. Thus, the illustrated native valve geometry is accommodated by the tapered coaptation element geometry. Still referring to FIG. 50, the tapered coaptation element geometry, in conjunction with the illustrated expanding paddle frame shape (towards the annulus), can help achieve coaptation at the bottom of the leaflets, reduce stress, and minimize transvalvular gradients.

[0123] 54, the shapes of the coaptation element 210 and the paddle frame 224 may be defined based on the inner commissure diagram of the native valve and the device 200. Two factors in these shapes are the coaptation of the leaflets against the coaptation element 210 and the reduction of stress on the leaflets due to coaptation. With reference to FIG. 54 and FIG. 24, the coaptation element 210 may have a circular or round shape and the paddle frame 224 may have a full radius that spans almost the entirety of the paddle frame 224 to both coapt the leaflets 20, 22 against the coaptation element 210 and reduce the stress that the coaptation element 210 and / or paddle frame 224 apply to the leaflets 20, 22. The round shape of the coaptation element 210 and / or the fully round shape of the paddle frame 224 shown distributes the stress on the leaflets 20, 22 over a large curved engagement region 209. For example, in FIG. 54, the force on the leaflets 20, 22 by the paddle frame is spread along the entire rounded length of the paddle frame 224 as the leaflets 20 attempt to open during diastole.

[0124] 55, there is shown one embodiment of an implantable device or implant 300. The implantable device 300 is one of many different configurations that the device 100 may assume, as shown generally in Figures 8-14. The device 300 may include any of the other features of an implantable device or implant described herein, and the device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0125] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a coaptation portion 304, which optionally includes a coaptation element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors can also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment member) for engaging with a capture mechanism (e.g., a capture mechanism such as capture mechanism 213 shown in Figures 43-49, or another capture mechanism described herein or otherwise known) of a delivery system (e.g., a delivery system such as the systems shown in Figures 38-42 and 49).

[0126] The anchors 308 may be attached to other portions of the device and / or to each other in a variety of different manners (e.g., directly, indirectly, by welding, by sutures, by adhesive, by links, by latches, by integral formation, by any or all combinations thereof, etc.) In some implementations, the anchors 308 are attached to the joining member or joining element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0127] The anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. The connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached to the cap 314 or to another mounting portion. In this manner, the anchor 308 is configured similar to a leg in that the inner paddle 322 is like an upper portion of a leg, the outer paddle 320 is like a lower portion of a leg, and the connecting portion 323 is like a knee portion of a leg.

[0128] In implementations that include a joining member or element 310, the joining member or element 310 and the anchor 308 may be coupled together in a variety of ways. For example, as shown in the illustrated embodiment, the joining element 310 and the anchor 308 may be coupled together by integrally forming the joining element 310 and the anchor 308 as a single, unitary component. This may be accomplished, for example, by forming the joining element 310 and the anchor 308 from a continuous piece 301 of braided or woven material, such as braided or interwoven Nitinol wire. In the illustrated embodiment, the joining element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous piece of fabric 301.

[0129] Similar to the anchor 208 of the implantable device or implant 200 described above, the anchor 308 may be configured to transition between various configurations by axially moving a distal end of the device (e.g., cap 314, etc.) relative to a proximal end of the device (e.g., proximal collar 311 or other attachment member, etc.), which causes the anchor 308 to move relative to a midpoint of the device. This movement may occur along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device. For example, the anchor 308 may be positioned in a fully extended or straight configuration (e.g., similar to the configuration of the device 200 shown in FIG. 36) by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device.

[0130] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the joint element 310 (e.g., similar to the configuration of the device 200 shown in FIG. 36). From the straight configuration, the anchor 308 can be moved to a fully folded configuration (e.g., FIG. 55), for example, by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device. Initially, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and / or midpoint or center of the device, the anchor 308 bends at the connecting portions 321, 323, 325, and the connecting portion 323 moves radially outward relative to the longitudinal axis of the device 300 and axially toward the midpoint and / or proximal end of the device (e.g., similar to the configuration of the device 200 shown in FIG. 34). As cap 314 continues to move toward the midpoint and / or toward the proximal end of the device, connecting portion 323 moves radially inward relative to the longitudinal axis of device 300 and axially toward the proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 30).

[0131] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 330 (detailed in FIG. 56 ) includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing member 336, and an interface portion 338. The fixed arm 332 is attached to the inner paddle 322 with the interface portion 338 disposed proximate to the interface element 310. The interface portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is in a closed state.

[0132] The fixed arm 332 is attached to the inner paddle 322 by sutures (not shown) through holes or slots 331. The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened to open the clasp 330 and expose the optional barb 336. The clasp 330 is opened by applying tension to an actuation line (e.g., actuation line 216 shown in FIGS. 43-48 ) attached to a hole 335 in the movable arm 334, thereby allowing the movable arm 334 to articulate, pivot, and / or bend over an interface 338.

[0133] In summary, the implantable device or implant 300 is similar in construction and operation to the implantable device or implant 200 described above, except that the joint element 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed from a single piece of material 301. In some implementations, the piece of material 301 is attached to the proximal collar 311, the cap 314, and the paddle frame 324 by weaving or inserting through openings in the proximal collar 311, in the cap 314, and in the paddle frame 324 that are configured to receive the continuous piece of material 301. The continuous piece 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of material 301, and other portions are formed from multiple overlapping or overlapping layers of the piece of material 301.

[0134] For example, Figure 55 shows a joining element 310 and inner paddle 322 formed from multiple overlapping layers of the piece of material 301. The single continuous piece of material 301 may start and end at various locations on the apparatus 300. The ends of the piece of material 301 may be at the same location or at different locations on the apparatus 300. For example, in the embodiment shown in Figure 55, the piece of material 301 starts and ends at the location of the inner paddle 322.

[0135] As with the implantable device or implant 200 described above, the size of the coaptation element 310 may be selected to minimize the number of implants required per patient (preferably one), while at the same time maintaining a low transvalvular gradient. Notably, by forming many of the components of the device 300 from a single piece of material 301, the device 300 may be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance at the widest point of the device 300 (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is about 5 mm.

[0136] 57-63 show another embodiment of a valve repair system 400, one of many, for repairing a patient's native valve to which the concepts of the present application may be applied. The valve repair system 400 includes a delivery device 401 and a valve repair device 402.

[0137] The valve repair device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408 (e.g., clasps, clasp arms, grippers, gripping arms, latches, etc.). In some implementations, the paddles 406 may be integrally formed with the base assembly. For example, the paddles 406 may be formed as an extension of a link of the base assembly. In the illustrated example, the base assembly 404 of the valve repair device 402 includes a shaft 403, a coupler 405 configured to move along the shaft, and a lock 407 configured to lock the coupler in a stationary position on the shaft. The coupler 405 is mechanically connected to the paddles 406 such that moving the coupler 405 along the shaft 403 moves the paddles between an open position and a closed position. In this manner, coupler 405 serves as a means for mechanically coupling paddles 406 to shaft 403 and for moving paddles 406 between their open and closed positions as they move along shaft 403.

[0138] In some implementations, the gripping member 408 is pivotally connected to the base assembly 404 (e.g., the gripping member 408 may be pivotally connected to the shaft 403 or any other suitable member of the base assembly) such that the gripping member can be moved to adjust the width of the opening 414 between the paddle 406 and the gripping member 408. The gripping member 408 may include an optional barbed portion 409 for attaching the gripping member to the valve tissue when the valve repair device 402 is attached to the valve tissue. The gripping member 408 forms a means for gripping the valve tissue (particularly the tissue of the valve leaflets) by an anchoring means or portion such as the optional barbed portion 409. When the paddle 406 is in the closed position, the paddle engages the gripping member 408 such that, when the valve tissue is attached to the optional barbed portion 409 of the gripping member, the paddle acts as a retention or fixation means to hold the valve tissue to the gripping member and secure the valve repair device 402 to the valve tissue. In some implementations, the gripping member 408 is configured to engage the paddle 406 such that the optional barbed portion 409 engages the valve tissue member and the paddle 406 to secure the valve repair device 402 to the valve tissue member. For example, in certain circumstances it may be advantageous to have the paddle 406 maintain an open position and have the gripping member 408 move outwardly toward the paddle 406 to engage the valve tissue and the paddle 406.

[0139] Although the embodiment shown in FIGS. 57-63 shows a pair of paddles 406 and a pair of gripping members 408, it will be understood that the valve repair device 402 can include any suitable number of paddles and gripping members.

[0140] In some implementations, the valve repair system 400 includes a deployment shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the valve repair device 402. The deployment shaft 413 is detached from the shaft 403 after the valve repair device 402 is secured to the valve tissue, removing the valve repair device 402 from the rest of the valve repair system 400 such that the valve repair device 402 can remain attached to the valve tissue and the delivery device 401 can be removed from the patient's body.

[0141] The valve repair system 400 may also include a paddle control mechanism 410, a gripper control mechanism 411, and a lock control mechanism 412. The paddle control mechanism 410 is mechanically attached to the coupler 405 and moves the coupler along the shaft, thereby moving the paddle 406 between the open and closed positions. The paddle control mechanism 410 may take any suitable form and may include, for example, a shaft, wire, tube, hypotube, rod, suture, line, etc. For example, the paddle control mechanism may comprise a hollow shaft and a catheter tube or sleeve that fits over the deployment shaft 413 and shaft 403 and connects to the coupler 405.

[0142] Gripper control mechanism 411 is configured to move gripping member 408 such that the width of opening 414 between the gripping member and paddle 406 may be altered. Gripper control mechanism 411 may take any suitable form, such as, for example, a line, suture, wire, rod, catheter, tube, hypotube, etc.

[0143] The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 serves as a locking means for locking the coupler 405 in a stationary position relative to the shaft 403 and can take a wide variety of different forms, and the type of lock control mechanism 412 can be dictated by the type of lock used. In some implementations, the lock 407 includes a pivotable plate having a hole, and the shaft 403 of the valve restoration device 402 is disposed within the hole of the pivotable plate. In this example, when the pivotable plate is in a tilted position, the pivotable plate engages the shaft 403 and maintains its position on the shaft 403, but when the pivotable plate is in a substantially non-tilted position, the pivotable plate can be moved along the shaft (which allows the coupler 405 to move along the shaft 403). In other words, the coupler 405 is prevented or inhibited from moving in direction Y (as shown in FIG. 61A ) along the shaft 403 when the pivotable plate of the lock 407 is in the tilted position (or locked position), and the coupler is allowed to move in direction Y along the shaft 403 when the pivotable plate is in the substantially non-tilted position (or unlocked position). In embodiments in which the lock 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage the pivotable plate to move the plate between the tilted position and the substantially non-tilted position. The lock control mechanism 412 can be, for example, a rod, a suture, a wire, or any other member that can move the pivotable plate of the lock 407 between the tilted position and the substantially non-tilted position. In some implementations, the pivotable plate of the lock 407 is biased to the tilted position (or locked position), and the plate is moved from the tilted position to the substantially non-tilted position (or unlocked position) using the lock control mechanism 412. In some implementations, the rotatable plate of the lock 407 is biased to a substantially non-tilted position (or unlocked position), and the plate is moved from the substantially non-tilted position to the tilted position (or locked position) using the lock control mechanism 412.

[0144] 61A and 61B show the valve repair device 402 moving from an open position (shown in FIG. 61A) to a closed position (shown in FIG. 61B). The base assembly 404 includes a first link 1021 extending from point A to point B, a second link 1022 extending from point A to point C, a third link 1023 extending from point B to point D, a fourth link 1024 extending from point C to point E, and a fifth link 1025 extending from point D to point E. The coupler 405 is movably attached to the shaft 403, which is fixed to the fifth link 1025. The first link 1021 and the second link 1022 are pivotally attached to the coupler 405 at point A, such that moving the coupler 405 along the shaft 403 moves the location of point A, which in turn moves the first link 1021 and the second link 1022. The first link 1021 and the third link 1023 are pivotally attached to one another at point B, and the second link 1022 and the fourth link 1024 are pivotally attached to one another at point C. One paddle 406a is attached to the first link 1021, such that moving the first link 1021 moves the paddle 406a, and the other paddle 406b is attached to the second link 1022, such that moving the second link 1022 moves the paddle 406b. In some implementations, the paddles 406a, 406b may be connected to the links 1023, 1024 or may be extensions of the links 1023, 1024.

[0145] To move the valve repair device from an open position (shown in FIG. 61A ) to a closed position (shown in FIG. 61B ), the coupler 405 is moved in direction Y along the shaft 403, thereby moving the pivot point A for the first link 1021 and the second link 1022 to a new position. Moving the coupler 405 (and pivot point A) in direction Y moves the position of the first link 1021 near point A in direction H and moves the position of the first link 1021 near point B in direction J. The paddle 406a is attached to the first link 1021 such that moving the coupler 405 in direction Y moves the paddle 406a in direction Z. Additionally, the third link 1023 is pivotally attached to the first link 1021 at point B such that moving the coupler 405 in direction Y moves the third link 1023 in direction K. Similarly, moving the coupler 405 (and pivot point A) in direction Y causes the position of the second link 1022 near point A to move in direction L and the position of the second link 1022 near point C to move in direction M. The paddle 406b is attached to the second link 1022 such that moving the coupler 405 in direction Y causes the paddle 406b to move in direction V. In addition, the fourth link 1024 is pivotally attached to the second link 1022 at point C such that moving the coupler 405 in direction Y causes the fourth link 1024 to move in direction N. FIG. 61B shows the final position of the valve repair device 402 after the coupler 405 has been moved as shown in FIG. 61A.

[0146] 58, the valve repair device 402 is shown in an open position (similar to the position shown in FIG. 61A) and the gripper control mechanism 411 is shown moving the gripping members 408 to provide a wider gap at the opening 414 between the gripping members and the paddle 406. In the illustrated embodiment, the gripper control mechanism 411 includes a line, such as a suture, wire, or the like, that is threaded through an opening in the end of the gripper member 408. Both ends of the line extend through a delivery opening 516 of the delivery device 401. When the line is pulled in direction Y through the delivery opening 516, the gripping members 408 move inward in direction X, causing the opening 414 between the gripping members and the paddle 406 to become wider.

[0147] 59, the valve repair device 402 is shown with the valve tissue 20, 22 positioned within the opening 414 between the gripping member 408 and the paddle 406. With reference to FIG. 60, after the valve tissue 20, 22 is positioned between the gripping member 408 and the paddle 406, the gripper control mechanism 411 is used to narrow the opening 414 between the gripping member and the paddle. That is, in the illustrated embodiment, the line of the gripper control mechanism 411 is released or pushed out of the delivery member opening 516 in direction H such that the gripping member 408 can be moved in direction D to narrow the opening 414. Although the gripper control mechanism 411 is shown moving the gripping member 408 to widen the opening 414 between the gripping member and the paddle 406 (FIG. 59), it will be understood that the gripping member may not need to be moved to position the valve tissue within the opening 414. However, in certain circumstances, the opening 414 between the paddle 406 and the gripping member 408 may be wider to receive the valve tissue.

[0148] 62, the valve repair device 402 is in a closed position and secured to the valve tissue 20, 22. The valve repair device 402 is secured to the valve tissue 20 by the paddles 406a, 406b and the gripping members 408a, 408b. In particular, the valve tissue 20, 22 is attached to the valve repair device 402 by the optional barbed portions 409 of the gripping members 408a, 408b, and the paddles 406a, 406b engage the gripping members 408, securing the valve repair device 402 to the valve tissue 20, 22.

[0149] To move the valve repair device 402 from an open position to a closed position, the lock 407 is moved to an unlocked state (as shown in FIG. 62 ) by the lock control mechanism 412. Once the lock 407 is in the unlocked state, the coupler 405 may be moved along the shaft 403 by the paddle control mechanism 410. In the illustrated embodiment, the paddle control mechanism 410 moves the coupler 405 along the shaft in direction Y, thereby moving one paddle 406a in direction X and the other paddle 406b in direction Z. Moving the paddles 406a, 406b in directions X and Z causes the paddles to engage the gripping members 408a, 408b and secure the valve repair device 402 to the valve tissue 20, 22.

[0150] 63, after the paddle 406 is moved to the closed position to secure the valve repair device 402 to the valve tissue 20, 22 (as shown in FIG. 62), the lock 407 is moved to a locked state by the lock control mechanism 412 (FIG. 62) to maintain the valve repair device 402 in the closed position. After the valve repair device 402 is maintained in the locked state by the lock 407, the valve repair device 402 is removed from the delivery device 401 by decoupling the shaft 403 from the deployment shaft 413 (FIG. 62). In addition, the valve repair device 402 is removed from the paddle control mechanism 410 (FIG. 62), the gripper control mechanism 411 (FIG. 62), and the lock control mechanism 412. Removing the valve repair device 402 from the delivery device 401 allows the valve repair device to remain secured to the valve tissue 20, 22 while the delivery device 401 is removed from the patient.

[0151] The concepts disclosed herein may be used in a wide variety of different valve repair devices. For example, the concepts disclosed herein may be used in a wide variety of different valve repair devices disclosed herein. The concepts disclosed herein may be used in valve repair devices having paddles, spacers, and other components that can be narrowed and widened, such as the valve repair devices disclosed by U.S. Provisional Patent Application No. 63 / 278,037, the entirety of which is incorporated herein by reference.

[0152] In many of the embodiments disclosed herein, the leaflets of the native valve are positioned in a gap between components such as the movable and fixed arms of the clasp, or between the clasp arms and the paddles, which are secured to the leaflets. Once the leaflets are positioned in the gap, the components are actuated to pinch the leaflet tissue, thereby securing the leaflets. If the device includes a clasp, actuating the movable arm to further position the leaflet in the opening between the arms of the clasp before pinching the leaflet allows the movable arm to engage more leaflet tissue. Not only is more tissue then engaged by the clasp, but any optional barbs or other securing members located at the distal end of the movable or fixed arms are positioned to engage thicker portions of the native leaflet tissue as the tissue is further positioned in the gap. Having more and thicker tissue engaged by the clasp ensures a more secure grip of the clasp on the native leaflet.

[0153] Determining the depth of engagement of the native leaflets within the gap between the movable and fixed arms is a challenge even using current imaging technology. In particular, leaflet tissue moves with each beat of the heart and may be translucent or otherwise visually difficult to distinguish from the surrounding tissue. In contrast, clasps formed from materials such as metal (e.g., optional barbed clasps, etc.) are more easily visible to imaging devices. Thus, the surgeon can verify the position of the movable arm and one or more indicators to determine whether the clasp has properly engaged the native leaflets.

[0154] An exemplary valve repair device may include an indicator that is used to determine whether the native leaflets are sufficiently engaged by or within the clasp or optional barbed clasp during implantation, deployment, or other use of the valve repair device. In some implementations, the indicator is visible via an imaging device during implantation. In some implementations, the indicator generates an electrical signal indicative of leaflet insertion or capture. The indicator may be configured to indicate or otherwise indicate to a user that the leaflet is inserted into the opening to a desired capture depth and / or that the leaflet does not reach the desired capture depth. Using the indicator, a user may observe the indicator and / or a signal therefrom to determine that the leaflets are properly engaged.

[0155] The various indicators herein may be configured in a variety of shapes, sizes, and materials, and in some implementations, the indicators may include curved shapes, contoured shapes, S-shapes, C-shapes, U-shapes, V-shapes, hook shapes, checkmark shapes, swoosh shapes, straight shapes, flat shapes, circular shapes, rectangular shapes, triangular shapes, and the like.

[0156] 64-67, an exemplary clasp 500 (which may be a barbed clasp or include other friction or gripping enhancement mechanisms) is shown deployed within a native valve 40, such as a mitral, tricuspid, molar or pulmonary valve, to couple a device (not shown), such as a device described herein, a valve repair device, a valve therapy device, an implantable device, an implant, or the like, to one of the native valve leaflets 42, 44. The leaflets 42, 44 may be the leaflets 20, 22 of the mitral valve or the leaflets of the tricuspid, aortic or pulmonary valve. Referring now to FIG. 64, the clasp 500 is shown in an open state with the native leaflets 42, 44 partially inserted into the opening of the clasp 500 formed between the fixed arm 510 and the movable arm 530. To determine whether the leaflets 42, 44 have reached a desired engagement depth, the indicator arm 550 may be actuated via an actuation line (not shown), such as an actuation element, an actuation suture, an actuation wire, or the like. The indicator arm has optional barbs 555 to further secure the leaflets in position. Referring now to Figure 65, the clasp is shown in a closed configuration closed on the leaflets 42, 44. The indicator arm 550 has not yet been actuated.

[0157] 66, the indicator arm 550 is shown in an actuated state. The illustrated optional barb 540 on the movable arm 530 punctures the native leaflet. If the leaflet 42, 44 is inserted into the opening of the clasp 500 halfway or less than halfway between the optional barbed portion 540 and the joined, flexible or hinged portion 520 and / or is not inserted far enough into the clasp to overlap the length of the indicator arm 550, the indicator arm 550 will not engage the leaflet 42, 44. Instead, the indicator arm pivots towards the fixed arm 510. The position of the indicator arm is visible via the imaging device used to monitor the implantation and deployment of the device.

[0158] Referring now to FIG. 67, the clasp is closed over the leaflets 42, 44 and the leaflets are positioned deep enough into the clasp 500 to overlap the indicator arm 550. An optional barb 540 on the movable arm 530 pierces the native leaflet. The indicator arm rests on the leaflet tissue, which prevents or inhibits the indicator arm from moving all the way towards the fixed arm 510 of the clasp. The indicator arm shown in FIG. 67 has an optional barb 540 to further secure the leaflet in place. In an embodiment where the indicator arm does not have a barb, the indicator arm may bounce off with the pulse of the heartbeat, pulsing the leaflet. This pulsing is visible by the imaging techniques described above and can be used to indicate to the operator that the leaflet is positioned deep enough within the clasp. Any of the indicators disclosed herein may be configured to pulse or bounce off the leaflet as the heart beats.

[0159] 68-77, an exemplary clasp 500 is shown attached to a paddle of a device, such as any of the devices disclosed herein, valve repair devices, valve therapy devices, implantable devices, implants, etc., and deployed within the native valve 40 and coupled to one or more of the native leaflets 42, 44. The clasp 500 is attached to the paddle 122 of the device 100, which can be moved between open and closed positions to capture and secure the native leaflets 42, 44 within the device 100, as described above.

[0160] 69, the device 100 is shown with the native valve 40 with the paddle 122 open. The clasp 500 is then opened by tensioning the actuation lines 502, 504 attached to the ends of the movable arm 530 and the indicator arm 550, respectively. The indicator arms disclosed herein can be active (e.g., opened and closed by an active step, such as pulling the line 504) or passive (e.g., no additional action is required in addition to opening and closing the clasp for operation of the indicator arm). As shown in FIG. 69, by opening the clasp 500 and the paddle 122, the device 100 can be operated such that the leaflets 42, 44 are at least partially disposed within the opening 506 formed between the fixed arm 510 and the movable arm 530 of the clasp, facilitating capture of the leaflets 42, 44 by the clasp 500.

[0161] 69, the paddle 122 and clasp 500 are partially closed to position the leaflets for detection by the indexing arm 550 and eventual capture by the clasp 500. The partially closed position of the paddle 122 and clasp 500 allows the optional barbed portion 540 of the movable arm 530 to pinch the leaflets 42, 44 against the fixed arm 510 without stretching or moving the leaflets 42, 44 such that the leaflets 42, 44 are pushed out by the movable arm 530 or slip off the optional barbed portion 540 during attempted leaflet capture.

[0162] 70, both indicator arms 550 are actuated by releasing tension on an actuation line 504 (e.g., an actuation wire, an actuation suture, etc.), which may be the same as or similar to other actuation lines described elsewhere herein. Both indicator arms 550 disengage or slide off the leaflets 42, 44 and move to a fully actuated position beyond the fixation arms 510 of the clasp 500. The indicator arms 550 crossing the fixation arms 510 form an X-shape that is visible via imaging equipment used to monitor the implantation and deployment of the device.

[0163] 71, the indicator arms 550 are retracted by tensioning the actuation lines 504 (e.g., actuation wires, actuation sutures, etc.) and the device 100 is repositioned such that the leaflets 42, 44 are inserted deeper into the openings 506 of the clasp 500. One of the indicator arms 550 is then allowed to close by releasing tension on one of the actuation lines 504, as can be seen in FIG. 72. The indicator arm 550 engages the leaflet 42, pinching it against the fixation arm 510 and paddle 122. FIG. 73 shows that the other indicator arm 550 is actuated, engaging the other leaflet 44, pinching it against the other fixation arm 510 and paddle 122. The engagement with the leaflets 42, 44 prevents or inhibits the indicator arm 550 from moving past the fixation arm 510 of the clasp 500 to form the X-shape shown in FIG. Thus, the indicator arm 550 indicates to an observer viewing the installation via an imaging device that the leaflets 42, 44 are inserted into the opening 506 beyond a minimum engagement or insertion depth determined by the length of the indicator arm 550.

[0164] The terms minimum engagement depth or minimum insertion depth are often used in this disclosure, although other similar terms such as insertion depth, engagement depth, selected insertion depth, selected engagement depth, preselected insertion depth, preselected engagement depth, predetermined insertion depth, predetermined engagement depth, etc. may be used in their place.

[0165] 74-77, once the indicator arm 550 indicates that the leaflets 42, 44 are fully inserted within the opening 506, the movable arm 530 is actuated by releasing tension on the actuation line 502 such that the leaflets 42, 44 are sandwiched between the optional barbed portion 540 of each clasp 500 and the fixation arm 510. The paddle 122 is then moved to the fully closed position shown in FIG. 76, firmly securing the leaflets within the device 100. The indicator 550 may be monitored in any of the positions shown in FIGS. 72-76. For example, the indicator 550 pulses or jumps as the heart beats. This pulsing or jumping may be visualized to confirm that the valve repair device is correctly positioned. For indicator 550 to be flexible enough to bend or jump as the heart beats, movable arm 530 may be made stiff and / or may close with a high enough force that closed movable arm 530 does not pulse or jump as the heart beats. Any of the indicators disclosed herein may be flexible enough to bend or jump as the heart beats.

[0166] 77, one of the leaflets 44 is shown partially withdrawn from the device 100, which may occur due to movement of the leaflets 42, 44 during beating of the heart. As can be seen in FIG. 77, the leaflet 44 remains partially secured by the optional barbed portion 540. However, the leaflet 44 is no longer secured beyond a minimum engagement depth, determined by the length of the indicator arm 550. The withdrawal of the leaflet 44 allows the indicator arm 550 to move beyond the securing arm 510, thereby forming an X-shape visible to an observer using an imaging device. Additionally or alternatively, the indicator arm 550 that does not contact the leaflets of the valve does not pulse or jump as the heart beats. Thus, insufficient retention or slippage of the leaflets 42, 44 from the device 100 can be detected before the device 100 is removed from the delivery device (not shown). Once a slipped leaflet is detected, the clasp 500 and paddle 122 can be opened and repositioned to better secure the slipped leaflet. Any of the indicator arms disclosed herein can be configured to detect a slipped leaflet. In some implementations, a single actuation line can be used to raise or lower a movable arm of the clasp, allowing the indicator to move to a leaflet detection position.

[0167] Any of the features of any of the leaflet depth indicators disclosed in PCT Patent Application Publication No. 2020 / 168,081 are incorporated herein by reference in their entirety and may be combined with the leaflet depth indicators disclosed herein. The leaflet depth indicators may be used with a variety of devices that also grip the leaflets. For example, the leaflet depth indicators may be used with valve repair devices, implants, etc. described and illustrated in U.S. Patent No. 2019 / 0290260, WO2018167388, as well as chordae repair devices that require gripping the ends of the leaflets (see, e.g., U.S. Patent No. 2019 / 0290260, WO2018167388).

[0168] 78-87, an exemplary device 600 (which may be the same as or similar to other devices, valve repair devices, valve therapy devices, implants, etc., described herein) is shown in various positions and configurations ranging from partially open to closed.

[0169] As shown in FIG. 78 , an exemplary device 600 includes an interface portion 604, a proximal or attachment portion 605, an anchor portion 606, and a distal portion 607. In some implementations, the interface portion 604 of the device optionally includes an interface element 610 (e.g., a spacer, an interface element, a plug, a membrane, a sheet, etc.) for implantation between the leaflets of a native valve. In some implementations, the anchor portion 606 includes a plurality of anchors 608. The anchors may be configured in a variety of ways. In some implementations, each anchor 608 includes an outer paddle 620, an inner paddle 622, a paddle extension member or paddle frame (not shown), and a clasp 630. In some implementations, the clasp 630 includes a base or fixed arm 632, a movable arm 634, an optional barb 636, and an interface portion 638. In some implementations, the attachment portion 605 includes a first or proximal collar 611.

[0170] 78, the device 600 is shown in a laterally extended or open position. The device 600 is moved to the laterally extended or open position by continuing the extension of the actuation element 612 as described above, thereby increasing the distance between the coaptation element 610 and the cap 614 of the distal portion 607. In the laterally extended or open position, the inner paddle 622 extends more horizontally than in other positions of the device 600 and forms an angle of approximately 90 degrees with the coaptation element 610. Similarly, the paddle frames (not shown) are in their maximum spread position when the device 600 is in the laterally extended or open position. The increased gap between the coaptation element 610 and the inner paddle 622 formed in the laterally extended or open position allows the catch 630 to open further before engaging the coaptation element 610, thereby increasing the size of the gap between the fixed arm 632 and the movable arm 634.

[0171] To determine whether the leaflets have reached the engagement depth, the device 600 may include an indicator arm 650. The indicator arm 650 may be of various shapes and sizes and may be made of various materials. In some implementations, the indicator arm 650 is a wire. The indicator arm 650 may be attached to the device 600 in a variety of locations. In some implementations, a first end 652 of the indicator arm 650 is fixedly attached to the coaptation element 610.

[0172] 79, according to some implementations, the fixed arm 632, the movable arm 634, the outer paddle 620, the inner paddle 622, and the paddle frame (not shown) may each include one or more channels or slots through which the indicator arm 650 may be disposed. For example, as shown in FIG. 79, the indicator arm 650 may be disposed through a movable arm channel or slot 660 of the movable arm 634, a fixed arm channel or slot 662 of the fixed arm 632, an inner paddle channel or slot 664 of the inner paddle 622, and an outer paddle channel or slot 666 of the outer paddle 620.

[0173] The second end 654 of the indicator arm 650 may terminate in a variety of locations. In some implementations, the second end 654 of the indicator arm 650 may terminate distal to the outer paddle 620, while in other implementations, the second end 654 of the indicator arm 650 may terminate between the outer paddle 620 and the inner paddle 622, or between the fixed arm 632 and the movable arm 634. The second end 654 of the indicator arm 650 may also terminate within any of the movable arm channel or slot 660, the fixed arm channel or slot 662, the inner paddle channel or slot 664, or the outer paddle channel or slot 666. As the device 600 moves and goes from an open state to a closed state, the second end 654 of the indicator arm 650 also moves. For example, the indicator arm 650 is flattened, aligned, and / or pressed against the device 600 when the device is closed. As a result, indicator arm 650 does not increase or significantly increase the size of device 600 .

[0174] In some implementations, the indicator arm 650 may include any number of loops, turns, bends, or twists between the first end 652 and the second end 654. With reference to FIG. 80 , the indicator arm 650 may include a bend 658 between the first end 652 and the second end 654. Although the bend 658 shown in FIG. 80 is located distal to the outer paddle 620, the bend may also be located between the movable arm 634 and the fixed arm 632, or between the fixed arm 632 and the outer paddle 620. Distal to the bend 658, the second end 654 of the indicator arm 650 may be positioned toward or attached to the interface element 610.

[0175] 81 and 82, indicator arm 650 is attached to opposing indicator arms 650 of device 600. For example, the two indicator arms may be formed from a single wire. The single wire may be thin and flexible such that the wire is compressed within device 600 when the device is closed. As a result, indicator arm 650 does not increase or significantly increase the size of device 600. In the embodiment shown in FIG. 81, the portion connecting the indicator arms is located inside the paddle. In the embodiment shown in FIG. 82, the portion connecting indicator arms 650 extends through and / or past the paddle.

[0176] The indicator arm 650 may include an indicator marker 656, and / or the indicator arm itself may act as a marker or may include a portion that acts as a marker. The indicator marker 656 may be a radiopaque material that may be printed or attached as a separate piece of material to the indicator marker 656. For example, the radiopaque material may be a coil made of platinum or another radiopaque material. The indicator marker 656 may be visible under fluoroscopy and / or other imaging techniques to help a user determine if the leaflet is properly positioned within the clasp 630. The indicator marker need not be a separate component. For example, in some implementations, the indicator marker is integral with the indicator arm, e.g., the indicator marker may be part of an indicator arm that includes a radiopaque material and / or has a thicker or larger surface area (which may help increase visibility).

[0177] The indicator arm 650 may be moved separately relative to the movable arm 634 to facilitate detection of the depth of engagement of the native leaflet between the movable arm 634 and the fixed arm 632 of the clasp 630. In one embodiment, the indicator arm 650 is more elastic and / or flexible than the movable arm 634. This increased elasticity and / or flexibility allows the indicator arm to bounce, pulse or jump while the movable arm 634 provides a firm grip on the leaflet tissue and does not bounce, pulse or jump. The bouncing, pulsing or jumping of the indicator arm 650 may be viewed using standard imaging equipment to determine when the clasp is properly engaged with the leaflet tissue.

[0178] When viewed by fluoroscopy and / or other imaging techniques, the distance that the indicator arm 650 and indicator marker 656 travel can help a user determine if the leaflets are properly positioned within the clasp 630. When the leaflets 42, 44 positioned within the clasp 630 engage or otherwise actuate the indicator arm 650, the indicator arm 650 and indicator marker 656 travel a distance that can be measured using a variety of techniques. A sufficient distance to indicate proper alignment of the leaflets 42, 44 within the clasp 630 can be predetermined by the user. On the other hand, if the leaflets 42, 44 positioned within the clasp 630 do not engage or otherwise actuate the indicator arm 650 a sufficient distance, adjustments to the device 600 may be necessary until proper alignment is achieved.

[0179] The relative positioning of the indicator arm 650 and the indicator marker 656 may aid in determining when a minimum engagement depth of the leaflets 42, 44 has been achieved as measured from the end of the moveable arm 634 of the clasp 630. Positioning the indicator marker 656 closer to or further from the first end 652 of the indicator arm 650 may alter the distance that the indicator marker 656 travels when engaged by the leaflets 42, 44. For example, an indicator marker 656 positioned closer to the first end 652 of the indicator arm 650 will not travel as great a distance when engaged by the leaflets 42, 44 as an indicator marker 656 positioned further from the first end 652 of the indicator arm 650.

[0180] 83 and 84, the clasp 630 is shown in an open configuration with the leaflets 42, 44 engaging the indicator arm 650. The leaflets 42, 44 push the marker 656 on the indicator arm near the movable arm 634 of the clasp and near the coaptation element 610. This movement indicates that the leaflets are positioned at an acceptable depth. Once the user has determined that the leaflets are positioned at an acceptable depth, the movable arm 634 and / or the inner and outer paddles 622, 620 are closed, capturing the leaflets.

[0181] 85-87, an exemplary clasp 700 is shown attached to a paddle of an exemplary device 702, which is similar in many respects to other devices, valve repair devices, valve therapy devices, implantable devices, implants, etc. disclosed herein, that is deployed within the native valve 40 to secure the device to the native valve leaflets 42, 44. Additionally, the device illustrated in Figures 85-87 is similar to the device illustrated in Figures 75-84, except that an indicator arm 750 is connected to a movable arm instead of a spacer. As such, any of the features of the device illustrated in Figures 85-87 may be used with the device illustrated in Figures 49-64.

[0182] 85, the device 702 is shown with the paddle 722 open on the native valve 40. The clasp 700 is then opened by applying tension to the actuation line 704 attached to the end of the movable arm 730. The tension bends the hinged portion 720 of the clasp, opening the clasp. As shown in FIG. 85, opening the clasp 700 and paddle 722 manipulates the device 702 so that the leaflets 42, 44 are at least partially positioned within the opening 706 formed between the fixed arm 710 and the movable arm 730 of the clasp, facilitating capture of the leaflets 42, 44 by the clasp 700.

[0183] 86 , the paddle 722 and clasp 700 are partially closed to position the leaflets for detection by the indicator arm 750 and eventual capture by the clasp 700. The partially closed position of the paddle 722 and clasp 700 allows the optional barbed portion 740 of the movable arm 730 to pinch the leaflets 42, 44 against the fixed arm 710 without stretching or moving the leaflets 42, 44 such that the leaflets 42, 44 slip off the optional barbed portion 740 during laterally pushed or attempted leaflet capture by the movable arm 730.

[0184] Once the indicator arm 750 indicates that the leaflets 42, 44 are fully inserted within the opening 706, the movable arm 730 is actuated by releasing the tension on the actuation line 704 such that the leaflets 42, 44 are sandwiched between the optional barbed portion 740 of each clasp 700 and the fixation arm 710. The paddle 722 is moved to the fully closed position shown in FIG.

[0185] 87, one of the leaflets 44 is shown partially pulled out of the device 702, which may occur for a variety of reasons, including due to movement of the leaflets 42, 44 during heartbeat. The leaflet 44 remains partially secured by the optional barbed portion 740. However, the leaflet 44 is no longer secured beyond a minimum engagement depth, as determined by the position of the indicator arm 750 and indicator marker 756. Insufficient retention or slippage of the leaflet 42, 44 from the device 702 can be detected before the device 702 is removed from the delivery device (not shown). Once a slipped leaflet is detected, the clasp 700 and paddle 722 can be opened and repositioned to better secure the slipped leaflet.

[0186] Referring to FIG. 88, a clasp 830 of a valve repair device includes an indicator arm 850 with a shaped portion 852 that can be used in a valve repair device (see, for example, the valve repair device disclosed by WO2020 / 168081). The clasp 830 includes a fixed arm 832, a movable arm 834 having a bent or hinged portion 838, an optional barbed portion 836, and an indicator 850 connected to the movable arm 834 via an indicator bent or hinged portion 854. The indicator 850 is used to indicate whether the leaflet has reached a minimum depth. The movable arm 834 may have at least one opening 860 therein through which the indicator passes. Thus, the shaped portion 852 of the indicator arm 850 indicates that the native leaflet has reached a minimum engagement depth only when the leaflet is inserted at or beyond the position of the shaped portion 852. Once the leaflets 42, 44 have reached the desired engagement depth, the indicator arm 850 is pressed by the leaflets 42, 44 towards the movable arm 834, causing the shaped portion 852 of the indicator arm to pass through an opening 860 in the movable arm 834. This is visible under fluoroscopy since the shaped portion is on the atrial side of the valve. Thus, the shaped portion 852 positioned on the exterior of the movable arm, as opposed to the interior space between the movable arm 834 and the fixed arm 832 of the clasp, indicates that the leaflets 42, 44 have reached sufficient depth. The shaped portion may be configured in a variety of shapes, such as, for example, a circle, a square, a triangle, a rectangle, a D-shape, a P-shape, an S-shape, an ellipse, an oval, a coiled shape, etc.

[0187] 89 and 90 show the clasp 830 in an open position with the indicator 850 having a shaped portion 852 in a normal or unengaged configuration. FIGS. 91-93 show the clasp 830 deployed within a native valve to secure at least one of the leaflets 42, 44. In FIG. 91, the clasp 830 is shown in an open position with the native leaflets 42, 44 partially inserted into an opening in the clasp 830 formed between the fixed arm 832 and the movable arm 834. To determine if the leaflets 42, 44 have reached a desired engagement depth, the movable arm 834 is actuated to close the clasp, causing the movable arm and the fixed arm to move closer together. The indicator arm is free to bend, move or pivot about the indicator bend or hinge portion 854 when pressure is applied to the indicator arm by either the leaflets 42, 44 or the fixed arm 832.

[0188] 92, when the movable arm 834 is actuated to close the clasp on the leaflets 42, 44, the indicator arm is not pushed out of its rest configuration if the leaflet is not deep enough within the clasp. That is, if the leaflet is not positioned deep enough within the clasp, the indicator arm and shaped portion 852 remain in its rest configuration between the movable arm and the fixed arm.

[0189] In Fig. 93, the movable arm 834 has been actuated to close the clasp on the leaflets 42, 44 when the leaflets are positioned deep enough within the clasp. The indicator arm 850 and its shaped portion 852 indicate to the operator that the leaflets 42, 44 are deep enough. When the leaflets are deep enough and the movable arm 834 is actuated, the leaflets press against the indicator arm. This pressure causes the indicator arm 850 to move toward the movable arm such that the shaped portion 852 of the indicator arm 850 passes through an opening 860 in the movable arm to the side of the movable arm that faces away from the fixed arm (i.e., into the open space on the atrial side of the leaflets of the valve).

[0190] 94-98, the clasp 930 includes a fixed arm 932, a movable arm 934 having a bend or hinge portion 938, an optional barbed portion 936, and an indicator arm 950 connected to the movable arm 934. The movable arm 934 may have at least one opening 960 (e.g., an aperture, channel, slot, etc.) therein through which the indicator arm 950 passes. In some implementations, instead of an opening, the indicator arm moves adjacent to or through a notch on a side of the movable arm. The indicator arm 950 may include an optional indicator marker 956 and / or the movable clasp arm 934 may include an optional indicator marker 957. Any of the implementations disclosed herein may include the optional indicator marker 956 and / or the optional indicator marker 957. In some implementations, the indicator marker 956 and / or the indicator marker 957 include a radiopaque material that may be printed or attached to the indicator marker 956 and / or the indicator marker 957 as a separate piece of material. For example, the radiopaque material may be a coil made of platinum or another radiopaque material. The indicator marker is not necessarily a separate component. For example, in some implementations, the indicator marker 956 is integral with the indicator arm, e.g., the indicator marker 956 may be a portion of the indicator arm that includes a radiopaque material and / or has a thicker or larger surface area (which may help increase visibility), and / or the indicator marker 957 is integral with the movable clasp arm, e.g., the indicator marker 957 may be a portion of the clasp arm that includes a radiopaque material and / or has a thicker or larger surface area (which may help increase visibility).

[0191] Indicator marker 956 and / or indicator marker 957 may be visible under fluoroscopy and / or other imaging techniques to aid a user in determining whether the leaflet is properly positioned within clasp 930. Indicator arm 950 may be used with any suitable valve therapy or repair device (see, for example, devices disclosed by WO2020 / 168081, which is incorporated herein by reference). Although some valve repair or repair devices may be described or illustrated herein as implantable devices for illustrative purposes, the concepts and configurations described herein (e.g., indicator portion, etc.) may be adapted for use with a variety of devices that are not necessarily implanted and may be removed following treatment.

[0192] The indicator arm 950 includes a fixed end 954 and a moving end 952. The fixed end 954 of the indicator arm 950 may be coupled to the movable arm 934 in a variety of ways and at a variety of locations along the movable arm 934. The indicator arm 950 may be coupled to the movable arm 934 at any point between the hinge portion 938 and the optional barbed portion 936.

[0193] As shown in FIGS. 94-98 , the indicator arm 950 is coupled to the movable arm 934 of the clasp 930 at a first side F of the clasp 930. The indicator arm 950 may pass around or through the movable arm 934 of the clasp 930 such that a portion of the indicator arm 950 is disposed in a second side G of the clasp 930 (opposite the first side F). In some implementations, the indicator arm 950 includes a shaped leaflet engagement member or portion 958 located at least partially on the second side G that may contact the native leaflets when inserted into the clasp 930. Optionally, the leaflet engagement member or portion 958 extends into a space between a portion of the fixation arm or a cutout in the fixation arm. This extra extension of the leaflet engaging member or leaflet engaging portion 958 facilitates greater movement of the marker and / or end than would be possible if the leaflet engaging member or leaflet engaging portion 958 stopped at the surface of the fixation arm.

[0194] The indicator arm includes one or more arms extending from a moving end to a fixed end. In some implementations, as shown in FIGS. 95A-95G and 96A-B, the indicator arm 950 can include a first arm 972 and a second arm 974 extending from a moving end 952 to a fixed end 954 of the indicator arm 950. The first arm 972 and the second arm 974 are connected to the moving end 952 on a first side F of the clasp 930. In some implementations, between the moving end 952 of the indicator arm 950 and the leaflet engagement member or portion 958, the first arm 972 extends through a first opening 962 disposed in a surface of the movable arm 934 and the second arm 974 extends through a second opening 964 disposed in a surface of the movable arm 934 (although other arrangements are possible, e.g., adjacent to or through a side notch). The movable arm 934 of the catch includes a first beam 990 and a second beam 992 that extend perpendicular to one another and define a first opening 962 and a second opening 964. The beams 990, 992 define the size of the openings 962, 964 and the path of travel of the indicator arm 950. The beam 990 prevents or inhibits twisting of the indicator. The beam 992 causes the indicator to move substantially orthogonally into space F when the indicator engages leaflet tissue.

[0195] Between the leaflet engaging member or portion 958 of the indicator arm 950 and the fixed end, a first arm 972 and a second arm 974 of the indicator arm are wrapped around the movable arm 934 of the clasp 130, back to a first side F of the clasp 130. At the fixed end 954, the first arm 972 and the second arm 974 may be connected to one another at a connection point 976 (see also FIG. 110 ). At the fixed end 954, the indicator arm 950 is also connected to the movable arm 934 of the clasp 130.

[0196] The indicator arm 950 is used to indicate whether the leaflet has reached the desired depth of the catch 930. Once the leaflet has reached the desired engagement depth of the catch 930, the leaflet engages the indicator arm 950 on the second side G of the catch 930. For example, the leaflet may engage one or more of the first arm 972 and the second arm 974 at a leaflet engagement portion 958 of the indicator arm 950. The leaflet engagement member or leaflet engagement portion 958 is pressed toward the movable arm 934 of the catch 930, which causes the moving end 952 and any indicator marker 956 (if included) to move away from the movable arm 934 of the catch 930 and any indicator marker 957 (if included). The movement of the indicator marker 956 away from the movable arm 934 of the catch 930 can be seen and / or measured under fluoroscopy to determine whether the leaflet has been engaged in the proper position of the catch 930.

[0197] In implementations where both indicator markers 956, 957 are included, an image (e.g., a fluoroscopic image) showing only a single marker (i.e., the two markers 956, 957 are adjacent or abutting one another and only a single mass is visible on the image) indicates that tissue, such as valve leaflet tissue, has not been positioned sufficiently deep within the clasp 930. Conversely, when both indicator markers 956, 957 are included, an image (e.g., a fluoroscopic image) showing two separate markers (i.e., the two markers 956, 957 are spaced apart) indicates that tissue, such as valve leaflet tissue, has been positioned sufficiently deep within the clasp 930.

[0198] 95A-95G and 96A-96B, the indicator arm 950 can be pushed such that the moving end 952 is moved vertically away from the movable arm 934 (FIGS. 95F and 95G) or parallel to the movable arm 934 toward any barbed portion 936. For example, when the device is partially open and the indicator arm 950 is engaged by the valve leaflets 42, 44, the indicator arm assumes the position shown in FIG. 95F and FIG. 95G, clearly indicating that the leaflet tissue is at a sufficient depth. With reference to FIG. 96A and FIG. 96B, when the device is fully closed, the indicator is pressed against the spacer, central component, and / or actuating element, etc., and pressed into a flattened state (see FIG. 101). As a result, a device with the indicator 950 occupies no or little additional space compared to an identical device without the indicator. Optionally, a line or suture can be connected to the indicator 950 to move the indicator into a flattened configuration during the process of capturing the valve leaflets 42, 44. As a result, the indicator does not occupy the space between the fixed arm 932 and the movable arm 934 during the leaflet capture process.

[0199] 97 and 98 show a valve repair device 900 including the clasp 930 shown in FIGS. 95A-95G and 96A-96B. The valve repair device is in a closed configuration in FIGS. 97 and 98. The valve repair device 900 can be operated in substantially the same manner as the valve repair device 200 described above. The valve repair device 900 can optionally include an adjustable width paddle frame assembly 924 in place of the paddle frame 224 of the valve repair device 200. The adjustable width paddle frame assembly 924 allows the width of the device 900 to be narrowed and widened during deployment of the valve repair device 900. The adjustable width paddle frame assembly 924 can take a wide variety of different forms. In the illustrated embodiment, the adjustable width paddle frame assembly 924 includes a rigid inner paddle frame 925 and a flexible outer paddle frame 927. The rigid inner paddle frame 925 has a fixed width. The flexible outer paddle frame 927 has an adjustable width that is controllable and / or settable during deployment of the valve repair device 900.

[0200] 95F and 95G, the movable arm 934 may include a crossbar 980. The indicator arm 950 may contact the crossbar 980. When the indicator arm 950 is in the engaged position, the indicator arm 950 contacts the movable arm 934 of the clasp 930 to limit the movement of the indicator arm 950. Thus, the crossbar 980 acts as a stop for the indicator arm 950 in the engaged position. When the indicator arm 950 is in the disengaged position (FIGS. 95C-95E), the moving end 952 of the indicator arm 950 contacts the movable arm 934 of the clasp 930 to set or limit the position of the indicator arm 950. Thus, the rear and moving end 952 of the movable arm 934 act as a stop for the indicator arm 950 in the disengaged position.

[0201] 99-101 show an embodiment of a clasp 1030 that operates in a similar manner to clasp 930. FIG. 99 shows clasp 1030 in a disengaged position. In some implementations, referring to FIGS. 99-101, between a fixed end 1054 and a moving end 1052, indicator arm 1050 extends through a single opening (e.g., opening 1060) in a movable arm 1034 of clasp 1030. In this embodiment, fixed arm 1032 has a fork configuration, so that in the disengaged position (FIG. 99), moving end 1052 of indicator arm 1050 may be aligned parallel to or partially angled to a second opening 1062 of movable arm 1034. The clasps herein may be used with a variety of valve repair or treatment devices, whether implanted or removed after treatment.

[0202] The indicator arm 1050 may include one or more protrusions 1080 extending outwardly from the indicator arm 1050. The protrusions 1080 may be located on the leaflet engagement member or portion 1058 of the indicator arm 1050 such that when the indicator arm 1050 is in the engaged position (FIGS. 100 and 101), the protrusions 1080 engage the movable arm 1034 of the catch 1030 to prevent or inhibit the leaflet engagement member or portion 1058 from moving through the opening 1060 to the first side F. The indicator arm may be pushed such that the movable end 1052 is moved vertically away from the movable arm 1034 (FIG. 100) or parallel to the movable arm 1034 toward the optional barbed portion 1064 (FIG. 101). For example, when the device is partially open and the indicator 1050 is engaged by the valve leaflets 42, 44, the indicator arm assumes the position shown in FIG. 100, clearly indicating that the leaflet tissue is at sufficient depth. When the device is fully closed, the indicator is pressed against the spacer and pressed into the flat state shown in FIG. 101. As a result, a device with the indicator 1050 occupies no or little additional space compared to an identical device without the indicator. Optionally, during the process of capturing the valve leaflets 42, 44, a line or suture can be connected to the indicator 1050, moving the indicator to the configuration shown in FIG. 101. As a result, the indicator does not occupy space between the fixed arm 1032 and the movable arm 1034 during the leaflet capturing process.

[0203] 102A and 102B, a device 1100 with two clasps is shown. FIG. 102A shows the device as viewed in open space. FIG. 102B shows the device as viewed under fluoroscopy. The first clasp 1130 is engaged with the leaflet and the second clasp 1230 is not engaged with the leaflet. The leaflet 42 engages the indicator arm 1150, for example at the leaflet engagement member or portion 1158, such that the leaflet engagement member or portion 1158 is forced toward the movable arm 1134 of the clasp 1130, thereby causing the moving end 1152 and indicator marker (not shown) to move or extend away from the movable arm 1134 of the clasp 1130. As seen in FIG. 102A and 102B, a clear indication of the capture of the leaflet is provided.

[0204] 102A and 102B, the second catch 1230 is not engaged with the leaflet, and thus the moving end 1252 of the second indicator arm 1250 is adjacent and / or coupled to the movable arm 1234. The first and second indicator arms 1150, 1250 can be any of the indicators or indicator arms disclosed herein. For example, the indicator arms 1150, 1250 can have any of the features or combinations of features of the indicator arms shown in FIGS. 94, 95A-95G, 96A and 96B, 99-101, and 103-118.

[0205] 103-105 show additional examples of indicator arm configurations. The indicator arm may be positioned along the clasp in a variety of ways. For example, with reference to FIG. 103, the moving end 1352 of the indicator arm 1350 may be oriented such that in the disengaged position it lies on a first side F of the movable arm 1334 of the clasp 1330 and bends toward the movable arm 1334. With reference to FIG. 104, the moving end 1352 of the indicator arm 1350 may be oriented such that in the disengaged position it lies on a second side G of the movable arm 1334 of the clasp 1330 and bends toward the movable arm 1334. With reference to FIG. 105, the moving end 1352 of the indicator arm 1350 may be oriented such that in the disengaged position it lies within an opening in the movable arm 1334 of the clasp 1330 and extends along a plane AA of the movable arm 1334.

[0206] 106, the movable arm 1434 of the catch 1430 may include a bar 1490 that extends through an opening along axis AA along the movable arm 1434. The bar 1490 prevents or reduces twisting of the indicator arm 1450 by providing a path for the legs of the indicator arm 1450 to slide along. In the disengaged position, the travel end 1452 of the indicator arm 1450 is positioned on a first side F of the catch 1430 adjacent the bar 1490.

[0207] 107, the movable arm 1434 of the clasp 1430 may include one or more protrusions 1492 extending from the movable arm 1434. In addition to or instead of the bar 1490, the protrusions 1492 prevent or reduce twisting of the indicator arm 1450 by providing a path for the legs of the indicator arm 1450 to slide along.

[0208] 108 and 109 show the catch 1530 in a closed position. With reference to FIG. 108, the leaflets are positioned within the catch 1530, but are not positioned far enough into the catch 1530 to engage the indicator arm 1550. Thus, the indicator marker 1556 does not move from the movable arm 1534 of the catch 1530. The location of the indicator marker 1556, visible under fluoroscopy and / or other imaging techniques, may help a user determine that the leaflets 42, 44 are not properly positioned within the catch 1530. In the implementation of FIG. 108, the indicator marker 1556 rests against the back of the movable arm 1534 when the leaflets 42, 44 are not engaged with the indicator arm 1550. Thus, the back of the movable arm 1534 acts as a stop for the indicator arm 1550 in the "unengaged" state.

[0209] 109, the leaflet is positioned far enough into the clasp 1530 to engage the indicator arm 1550. As the indicator arm 1550 moves, an indicator marker 1556 moves from the movable arm 1534 of the clasp 1530. The location of the indicator marker 1556, visible under fluoroscopy and / or other imaging techniques, can help the user determine that the leaflet 42, 44 is properly positioned within the clasp 1530. In the implementation of FIG. 109, the indicator arm 1550 presses against a cross beam 1560 (see also the similar cross beam in the implementation shown in FIGS. 106 and 107) on the front of the movable arm 1534 when the leaflet 42, 44 engages the indicator arm 1550. Thus, the cross beam 1560 of the movable arm 1534 acts as a stop for the indicator arm 1550 in the "engaged" state. Therefore, the "unengaged" stops of FIG. 108 and the "engaged" stops of FIG. 109 serve to provide a clear indication of whether the leaflets 42, 44 have been inserted deep enough into the clasp.

[0210] 110, at the fixed end 1654 of the indicator arm 1650, the first arm 1672 and the second arm 1674 may be connected to each other at a connection point 1676. The connection of the first arm 1672 and the second arm 1674 at the connection point 1676 may be made in various ways, for example, by welding, hinge, gluing, linking, interconnecting, etc. At the fixed end 1654, the indicator arm 1650 may also be connected to the movable arm of a clasp (see FIG. 96). This split connection point 1676 allows the indicator arm to be made from a single piece and routed as shown in any of FIGS. 95A-95G, 96A and 96B, 97 and 98, 103-109. That is, the split connection point 1676 may be spread apart and routed through an opening and / or around a bar of the movable arm to position the indicator arm relative to the movable arm, bring it back together, and secure it to the movable arm.

[0211] 111-113, the movable arm 1732 of the clasp 1730 may include one or more markers 1790 in addition to the markers on the indicator 1750. The markers 1790 may be of a material similar to the indicator markers 1756 on the indicator arm 1750. The markers 1790 may be a radiopaque material that may be printed or attached as a separate piece of material to the markers 1756. For example, the radiopaque material may be a coil made of platinum or another radiopaque material. The indicator marker need not be a separate component. For example, in some implementations, the indicator marker is integral with the indicator arm, e.g., the indicator marker may be part of an indicator arm that includes a radiopaque material and / or has a thicker or larger surface area (which may help increase visibility).

[0212] The marker 1756 may be visible under fluoroscopy and / or other imaging techniques to help a user determine whether the leaflets are properly positioned within the clasp 1730. For example, when the indicator arm 1750 engages a leaflet, it is pushed, causing the indicator marker 1756 to move away from a marker 1790 on the movable arm 1732 of the clasp 1730. The distance between the indicator marker 1756 and the marker 1790 on the movable arm 1732 may both be visible under fluoroscopy and / or other imaging techniques to help a user determine whether the leaflets 42, 44 are properly positioned within the clasp 1730 or are not properly positioned within the clasp 1730.

[0213] In some implementations, various indicator arms herein can be pulled, stretched, and / or moved to open up more capture space. For example, FIG. 114 shows that during the process of capturing the valve leaflets 42, 44 between the fixed arm 1832 and the movable arm 1834 of the clasp 1830, the end 1852 of the indicator arm 1850 and / or the marker 1856 can be pulled, as indicated by arrow 1851. For example, the end 1852 of the indicator arm 1850 can be pulled by a line or suture when the clasp is open. As a result, the indicator arm does not block the space between the fixed arm 1832 and the movable arm 1834 or takes up less of the space between the fixed arm and the movable arm. In the illustrated embodiment, the indicator arm 1850 has a curved path when pulled, as indicated by arrow 1851. For example, the indicator arm may bend into space G from the attachment between the movable arm and the indicator arm, as indicated by reference character 1858, but not all the way to the fixed arm. The indicator arm 1850 then bends back through the movable arm to space F, but not to the extent that the indicator arm would extend if engaged by a leaflet of the valve. The indicator arm 1850 then extends back towards the free end of the movable arm 1834. Once the leaflet is positioned in space G (or the user deems it to be in space G), the indicator arm may be released, indicating whether the leaflet is located in space G and that closing the clasp 1830 would result in the leaflet being captured.

[0214] 115 and 116, according to some implementations, one or more of the fixed arm 1932, the movable arm 1934, the outer paddle 1920, the inner paddle 1922, and / or the paddle frame (not shown) of the device 1900 may include an opening, channel, cutout, notch, etc. through which the leaflet engagement member or leaflet engagement portion 1958 of the indicator arm 1950 may pass. Otherwise, the fixed arm 1932, the movable arm 1934, the outer paddle 1920, the inner paddle 1922, and the paddle frame (not shown) of the device 1900 may be the same or similar to and / or operate in the same or similar manner as the fixed arm, the movable arm, the outer paddle, the inner paddle, and the paddle frame of the device 200 described above or other devices herein. In some implementations, the fixed arm 1932, the movable arm 1934, the outer paddle 1920, and the inner paddle 1922 may be formed from a single sheet or ribbon of material. 115 and 116, the leaflet engagement member or portion 1958 of the indicator arm 1950 may be positioned through the movable arm channel 1960 of the movable arm 1934, the fixed arm channel 1962 of the fixed arm 1932, and the inner paddle channel 1964 of the inner paddle 1922. By allowing the leaflet engagement portion 1958 to extend through the fixed arm channel 1962 and the inner paddle channel 1964, the free end of the indicator arm 1950 may extend further from the movable arm 1934, providing a clearer indication of leaflet engagement.

[0215] The indicator arms of the devices, clasps, and various devices herein (including, for example, devices 900, 1100, 1900, and clasps 930, 1030, 1130, 1330, 1430, 1530, 1730, 1830, 2030, etc.) may be configured such that, even when the device is in a closed configuration (e.g., as shown in Figs. 97, 98, 115, and 116), the indicator arms remain extended in an extended position away from the movable arms if leaflet tissue is captured within the clasp. Thus, the device can provide an indication of proper capture of the leaflet upon capture when the device is in a partially open or ready to capture configuration, and when the device is transitioned from the partially open to the closed configuration, the device can still provide an indication that the leaflet remains properly captured and has not slipped or torn in any way from the clasp. This may give the user confidence that the device has been properly implanted, even in the closed configuration.

[0216] Additionally, the indicator arms of the devices, clasps, and various devices herein (including, for example, devices 900, 1100, 1900, and clasps 930, 1030, 1130, 1330, 1430, 1530, 1730, 1830, 2030, etc.) may be configured such that the indicator arms may bounce, pulse, or jump in a manner that is visible using standard imaging equipment to aid in determining correct placement and engagement with leaflet tissue. For example, the devices, clasps, and indicator arms may be configured such that the indicator arms bounce, pulse, or jump while the leaflet tissue is within the capture region of the clasp before the movable arms of the clasp are closed. This may provide confidence to the end user that the leaflet tissue is deep enough to engage the leaflet engagement portion and is properly captured before releasing the movable arms to the fully closed position (and thus before penetrating or deeply penetrating the tissue with any optional barbs that may be used on the movable arms of the clasp).

[0217] 117, the clasp 2030 includes an engagement member 2090 between a first beam 2092 and a second beam 2094 of the fixation arm 2034. The engagement member 2090 may assist in further stabilizing the leaflets 42, 44 when the leaflets 42, 44 are engaged to the clasp 2030 by the indicator arm 2050. Specifically, the leaflets 42, 44 are pressed against the two legs of the indicator arm 2050, the first beam 2092 of the fixation arm 2034, the second beam 2094 of the fixation arm, and the engagement member 2090, leading to further stabilization of the leaflets 42, 44. FIG. 117 illustrates the undulating path of the leaflets 42, 44 when the engagement member is included. FIG. 118 illustrates the resulting path of the clasp 2030 and leaflets without the engagement member 2090.

[0218] In some implementations, the indicator arm may be coupled to the inner paddle and / or the fixation arm of the clasp of the valve repair device or valve therapy device. The valve repair device may have any configuration of the valve repair device disclosed herein, such as the valve repair device 200. With reference to FIGS. 119-123, the indicator arm 2150 is configured to attach to the inner paddle 2122 (see FIG. 121). This configuration may allow the indicator arm 2150 to remain positioned between the inner and outer paddles at all times. As such, the indicator arm 2150 is contained within the envelope of the valve repair device 2100. The indicator arm 2150 may include a leaflet engagement member or leaflet engagement portion 2158 (e.g., an extension, protrusion, arm, edge, bump, dip, swoosh, U-shaped portion, V-shaped portion, triangular portion, curved portion, circular portion, rectangular portion, etc.) for engaging the leaflet, and an indicator marker 2156 to assist the user in determining whether the leaflet is properly positioned within the clasp. The indicator arm 2150 may also include a coupling member 2190 for coupling the indicator arm 2150 to the inner paddle. The coupling member 2190 may be of various shapes and sizes and may include a pin 2192 (FIG. 119) and / or a curve 2194 (FIG. 120) to aid in coupling. In some implementations, the coupling member 2190 may comprise one or more of a joint, a pivot, a hinge, a pin, a clip, a clamp, a flexible connection, a suture, a ribbon, a bridge, a sheet, and the like. The indicators (e.g., indicator arms, markers, sensors, electrodes, and the like) herein may be used with a variety of valve repair or treatment devices, whether implanted or removed after treatment.

[0219] 121-123, the device 2100 with the catch 2130 includes a movable arm 2134, a fixed arm 2132, and an indicator arm 2150 coupled to the inner paddle 2122 via a coupling member 2190. When the leaflets 42, 44 are not positioned far enough into the catch 2130 to engage the indicator arm 2150 (see FIG. 122), the indicator marker 2156 is placed against the inner paddle 2122. When the leaflets 42, 44 are positioned far enough into the catch 2130 to engage the indicator arm 2150, the indicator marker 2156 moves away from the inner paddle 2122 (FIG. 123). The position of the indicator marker 2156, visible under fluoroscopy and / or other imaging techniques, can aid the user in determining that the leaflets 42, 44 are properly positioned within the catch 2130.

[0220] In some implementations, the device may include multiple indicators coupled to the clasp. Any of the clasps disclosed herein may include two or more indicators. For example, with reference to FIGS. 124-126, the device 2200 includes a first indicator arm 2202 and a second indicator arm 2204. The first indicator arm 2202 and the second indicator arm 2204 may be substantially similar to the indicator arm 2150 of FIGS. 121-123. However, any of the indicator configurations disclosed herein may be used and / or the indicators disclosed herein may be broken in half or have a portion broken in half to provide two indicating portions. Having multiple indicators next to each other (e.g., leaflet engaging portions having similar depths or distances from the clasp hinge and / or optional clasp barb / friction enhancing features) allows the user to determine whether the leaflet is properly oriented within the clasp (e.g., not significantly angled) or whether the leaflet is positioned too far away from one side or the other of the clasp. For example, referring to FIG. 125, the leaflets 42, 44 are positioned within the clasp 2230 such that they engage the second indicator arm 2204 but not the first indicator arm 2202. This may be determined by locating the indicator markers via fluoroscopy and / or other imaging techniques. This may be due to the device being tilted relative to the leaflets of the valve. Referring to FIG. 126, the device 2200 may be realigned such that the leaflets engage both the first indicator arm 2202 and the second indicator arm 2204, indicating secure fit of the leaflets 42, 44 within the device 2200 with an acceptable orientation of the clasp on the leaflets. In some implementations, the multiple indicators may provide leaflet engagement at different depths (or different distances from the clasp hinge or optional clasp barb / friction enhancement mechanism) to indicate whether the leaflets are partially engaged or fully engaged in depth.

[0221] 127-135, the depth of the leaflets can be determined by analyzing electrical signals from electrodes placed on the valve repair device. The electrodes can be placed on a wide variety of different locations on the valve repair device. For example, the electrodes can be placed on a portion of the device, such as a visual indicator, such as any of the indicators disclosed herein, on a clasp, on a paddle, on a spacer, etc. If the electrodes (or other electrical measurement components) are placed on the visual indicator, the depth of the leaflets can be determined by both imaging and analysis of the electrical signals.

[0222] The measured signal can take a wide variety of different forms. For example, the signal can include an intracardiac electrocardiogram (IECG) signal and a bioimpedance signal. The signal measures the electrical activity of the heart during contraction. Surprisingly, it has been found that when the electrical signal is measured during leaflet capture, the amplitude and shape of the electrical signal differs in cases where the electrode contacts the leaflet or other parts of the heart valve (e.g., the chordae tendineae). The electrical signal can distinguish the type of tissue in contact and the degree of contact with the electrode (i.e., when the electrode is at the edge of the leaflet or near the root). Thus, by placing the electrode on the device, the electrical signal can help the user determine whether the leaflet is captured or partially captured within the device, whether there is no tissue captured by the device, and / or whether the device is contacting the chordae tendineae or other parts of the heart valve instead of the leaflet.

[0223] In the example shown in FIG. 127, an exemplary implantable valve repair or treatment device includes a plurality of anchors 2308. The anchors can be configured in a variety of ways. In some implementations, each anchor 2308 includes an outer paddle 2320, an inner paddle 2322, a paddle extension or frame (not shown), and a clasp 2330 having a fixed arm 2332 and a movable arm 2334. The device can take a variety of different forms. In some implementations, the device 2300 is the same as or similar to the device 200 described herein. While the example shown in FIG. 127 is an implantable device, similar configurations and concepts described in connection with FIG. 127 can be used with other devices that are not necessarily implanted and may be removed after treatment, such as valve repair devices.

[0224] In some implementations, to determine if the leaflets have reached a particular engagement depth, the device 2300 may include an indicator arm 2350. The indicator arm may include one or more electrodes that may measure an electrical signal to help the user determine if the leaflets are captured or partially captured within the device. For example, the indicator arm 2350 may include a first electrode 2356 and a second electrode 2358. The first electrode 2356 and the second electrode 2358 each provide a signal in and / or in contact with material within the heart at two different locations. For example, the electrodes may provide a signal based on being positioned in the blood of the atrium (and not in contact with tissue), based on being positioned in the blood of the ventricle (and not in contact with tissue), based on being in contact with valve leaflet tissue, and / or based on being in contact with chordae tendineae tissue. In some implementations, three, four, five, or more electrodes are included. Any number of electrodes may be included for each clasp.

[0225] The electrical signal can take a wide variety of different forms and can be processed in a wide variety of different ways to determine the location of the device within the heart and / or the location of the valve leaflets relative to the heart. In some implementations, the IECG signal is measured on the first and second electrodes 2356, 2358. A bipolar signal can be calculated as the signal from the first electrode 2356 subtracted from the signal from the second electrode 2358. The resulting bipolar signal and / or the original signal can provide an indication of the first and / or second electrodes 2356, 2358 being in the atrium (and not in contact with tissue), positioned in the blood of the ventricle (and not in contact with tissue), in contact with valve leaflet tissue, and / or in contact with chordae tendineae tissue.

[0226] When measuring the bioimpedance signal, different signal readings are seen for leaflets contacting one or both electrodes. For example, if the leaflet contacts only the first electrode, a higher magnitude signal reading may result. However, if the leaflet fully contacts both the first electrode 2356 and the second electrode 2358, a lower magnitude signal reading may result, indicating that the device is correctly positioned.

[0227] 128 and 129, the clasp 2330 of the device 2300 may be partially closed (FIG. 128) or fully closed (FIG. 129) so that the position of the leaflets 42, 44 may be detected by the indicator arm 2350 for eventual capture by the clasp 2330. The leaflet 42 is partially secured within the clasp 2330 and contacts only the first electrode 2356. The leaflet 44 is partially secured within the clasp 2330 but does not contact either the first electrode 2356 or the second electrode 2358. FIG. 129 illustrates partial capture of the leaflet 42 within the clasp 2330. Electrical signals from the first electrode 2356 and the second electrode 2358 may indicate to the user that the leaflets 42, 44 are in an insufficient position and that repositioning of the clasp 2330 is necessary. The device 2300 can be removed and reattached so that the leaflets can be recaptured within the clasps 2330.

[0228] 130 and 131, the leaflets 42, 44 are repositioned within the clasp 2330 so that they contact both the first electrode 2356 and the second electrode 2358. Electrical signals from the first electrode 2356 and the second electrode 2358 can indicate to the user that the leaflets 42, 44 are in an acceptable position and that repositioning of the clasp 2330 is not required.

[0229] 132 and 133, the clasp 2430 of the device 2400 includes electrodes on a movable arm 2434. Specifically, a first electrode 2456 and a second electrode 2458 may be coupled at different positions along the movable arm 2434. Alternatively or additionally, the electrodes 2456, 2458 may be positioned on the fixed arm 2432 of the clasp 2430 and / or on the inner paddle portion of the device. When the clasp is closed, the leaflets engage the electrodes and an electrical signal from the electrodes may indicate to the user whether the leaflets are in a sufficient position or that repositioning of the clasp is required. In some implementations, the IECG signal is measured on the first and second electrodes 2456, 2458. A bipolar signal may be calculated as the signal from the first electrode 2456 subtracted from the signal from the second electrode 2458. The resulting bipolar signal and / or the original signal can provide an indication of the first and / or second electrodes 2456, 2458 being within the atrium (and not in contact with tissue), positioned in the blood of the ventricle (and not in contact with tissue), in contact with valve leaflet tissue, and / or in contact with chordae tendineae tissue.

[0230] The device may also include multiple indicator arms, each with an electrode to indicate whether the leaflets are in a sufficient position. Referring now to FIG. 134 and FIG. 135, the device 2500 has a pair of clasps 2530, each including a first indicator arm 2550 and a second indicator arm 2252. The first indicator arm 2550 includes a first electrode 2556 and the second indicator arm 2252 includes a second electrode 2558. In this case, when the clasps are closed, the leaflets engage the first electrode 2556 of the first indicator arm 2550 as well as the second electrode 2558 of the second indicator arm 2252, and an electrical signal from the electrodes may indicate to the user whether the leaflets are in a sufficient position or that repositioning of the clasp is required.

[0231] Figure 136 shows the reading of the IECG signal. The P wave is a small deflection wave representing atrial depolarization, the Q wave corresponds to the depolarization of the interventricular septum, the R wave represents the depolarization of the main mass of the ventricle, and the S wave signifies the final depolarization of the ventricle at the base of the heart.

[0232] IECG readings from electrodes on a leaflet fixed at an appropriate depth within the device (e.g., leaflet 42 shown in Fig. 130 and Fig. 131 or 133) are shown in Figs. 137A-137C. Fig. 137A shows the waveform signal of electrode 2358 (or 2458) alone. Fig. 137B shows the waveform signal of first electrode 2356 (or 2456) alone. Fig. 137C shows the bipolar waveform signal (the waveform signal of Fig. 137A minus the waveform signal of Fig. 137B).

[0233] FIG. 137D shows a bipolar waveform signal of a leaflet contacting only the first electrode 2356 (or 2456). For example, this may be the signal provided by the embodiment shown in FIG. 128 and FIG. 129. The signal from the first electrode will be significantly lower than the signal shown in FIG. 137B because a smaller leaflet is inserted into the clasp. This reduced insertion causes a thinner portion of the leaflet to be contacted by the electrode resulting in a lower amplitude signal. The lack of contact with the leaflet by the electrode 2358 (2458) results in a very low amplitude signal such as the signal shown in FIG. 137F. The bipolar signal shown in FIG. 137D and / or the individual signals from the two electrodes may be used to determine that the leaflet is inserted into the first electrode 2356 (or 2456) but not as far as the second electrode 2358 (2458). 137E may correspond to an expected waveform when the leaflets are inserted into the first electrode 2356 (or 2456) but not as inserted into the second electrode 2358 (2458). Or, the set of bipolar signals and individual signals from the electrodes may correspond to an expected set of waveforms when the leaflets are inserted into the first electrode 2356 (2456) but not into the second electrode 2358 (2458).

[0234] FIG. 137E illustrates a bipolar waveform signal with a portion of the chordae in contact with the first electrode 2356 (or 2456). The signal from the first electrode is different when it is in contact with the tendon diaphragm than when it is in contact with the leaflet tissue. For example, the signal illustrated in FIG. 137E may have a higher amplitude and / or a longer wavelength (i.e., when the electrode is in contact with the chordae) than the signal illustrated in FIG. 137C (i.e., when the electrode is in contact with the leaflet tissue). The bipolar signal illustrated in FIG. 137E and / or the individual signals from the two electrodes may be used to determine when one or both of the electrodes are in contact with the biliary tendon. For example, the waveform illustrated in FIG. 137E may correspond to an expected waveform when the chordae are inserted into the first electrode 2356 (or 2456) and the second electrode 2358 (2458) is not in contact with tissue. Alternatively, the set of bipolar signals and individual signals from the electrodes may correspond to a set of expected waveforms when the chordae contact the first electrode 2356 (or 2456) but the chordae do not contact the second electrode 2358 (2458).

[0235] FIG. 137F illustrates a bipolar waveform signal when there is no cardiac tissue in contact with the electrodes. The signal is substantially flat and / or zero because both sensors are in contact only with the blood in the heart. The signal may have the shape illustrated in FIG. 137F when the second electrode 2358 (2458) is deeper in the device (e.g., further into the clasp) and therefore more shielded than the first electrode 2356 (or 2456). The signal from the electrode is different when it is not in contact with tissue (e.g., only in contact with cardiac blood) than when it is in contact with leaflet tissue. For example, the signal illustrated in FIG. 137F may have a lower amplitude and / or may be flat or substantially flat. The bipolar signal illustrated in FIG. 137F and / or the individual signals from the two electrodes may be used to determine that one or both of the electrodes are in the blood in the heart. The signal from the electrode is different when the electrode (and therefore the device) is in the atrium than when the electrode is placed in the ventricle. For example, the signal from each electrode may have a higher magnitude in the ventricle than in the atrium.

[0236] Signals from the electrodes may be used to determine various different states of the device, for example, the electrodes may be used to determine and / or confirm whether the device is positioned within the atrium, whether it is positioned within the ventricle, whether the device is contacting the leaflets, whether the leaflets are deep enough within the clasps, whether the chordae tendineae are positioned within the device, such as within the clasps, etc.

[0237] In some implementations, a portion of the indicator may be formed from the clasp. For example, the indicator may be formed by cutting a portion of the movable arm and shaping and / or twisting the cut portion. The indicator may be positioned in a plane such that it can contact the native leaflets and determine whether the clasp has properly engaged the native leaflets.

[0238] 138, a flat piece of material 2630 is shown that can be bent to form a clasp and indicator arm for a valve repair device. The flat clasp material 2630 includes a fixed arm 2632, a bent or hinged portion 2638, a movable arm 2634 having a gripping portion 2636 (such as the optional barbed end shown), and an indicator arm 2650. The movable arm 2634 can have at least one opening 2661 (e.g., aperture, channel, slot, etc.) therein configured for the indicator arm 2650 to pass through. The entire flat clasp material 2630 can be formed from a single flat piece of material.

[0239] The indicator arm 2650 is formed from a portion of the movable arm 2634 of the flat clasp material 2630. The indicator arm 2650 may be cut into a portion of the movable arm 2634 by a variety of methods, including laser cutting, etc. The indicator arm 2650 includes a moving end 2652 and a fixed end 2654. The fixed end 2654 of the indicator arm 2650 may be coupled to the movable arm 2634 in a variety of ways and at a variety of locations along the movable arm 2634. In the illustrated embodiment, the movable arm and indicator arm are cut into the flat clasp material such that the indicator arm remains attached to the movable arm at a joint 2660. The indicator arm 2650 may be coupled to the movable arm 2634 at any point between the hinge portion 2638 and the gripping portion 2636.

[0240] The indicator arm 2650 may include an optional indicator marker 2656. In some implementations, the indicator marker 2656 includes a radiopaque material that may be printed or attached to the indicator marker 2656 as a separate piece of material. For example, the radiopaque material may be a coil made of platinum or another radiopaque material. The indicator marker is not necessarily a separate component. For example, in some implementations, the indicator marker 2656 is integral with the indicator arm, e.g., the indicator marker 2656 may be part of an indicator arm that includes a radiopaque material and / or has a thicker or larger surface area (which may help increase visibility).

[0241] The indicator marker 2656 is visible under fluoroscopy and / or other imaging techniques and may aid a user in determining whether the leaflet is properly positioned within the clasp 2630. The indicator arm 2650 may be used with any suitable valve repair device, such as any of the valve repair devices disclosed herein (see also, for example, the valve repair devices disclosed by Published PCT Application No. WO2020 / 168081, which is incorporated herein by reference in its entirety).

[0242] The indicator arm 2650 intersects with the movable arm 2634 at a joint 2660 on the movable arm 2634. The joint 2660 can be located at various locations along the movable arm 2634. For example, the joint 2660 can be located at a base 2662 on the movable arm 2634, at a location near the hinge portion 2638. The joint 2660 can also be located along the side of the inner edge (see FIGS. 139 and 141A and 141B) or outer edge (see FIGS. 140A-140C) of the movable arm, at any point between the hinge portion 2638 and the gripping portion 2636. In another implementation, the joint 2660 can be at the gripping portion 2636 end of the movable arm and extend toward the base 2662.

[0243] The indicator arm 2650 can be of various lengths. In some implementations, the indicator arm 2650 is cut along the length of the movable arm 2634 from the hinge portion 2638 to the gripping portion 2636. In other implementations, the indicator arm 2650 extends along only a portion of the movable arm 2634 between the hinge portion 2638 and the gripping portion 2636. In some implementations, the length of the indicator arm is between 2.0 mm and 15.0 mm, including any subrange including 5.0 mm to 10.0 mm, and 6.0 mm to 8.0 mm.

[0244] The indicator arm 2650 can have a range of thicknesses. In some implementations, the indicator arm has a thickness between 0.100 mm and 0.500 mm, including between 0.250 mm and 0.400 mm, and between 0.320 mm and 0.380 mm. In some implementations, the indicator arm has a thickness of 0.380 mm. The indicator arm can have a thickness within any subrange of these ranges.

[0245] The indicator arm 2650 can have a range of widths. In some implementations, the indicator arm width is 0.025 mm to 0.250 mm, including 0.040 mm to 0.120 mm, and 0.075 mm to 0.100 mm. In some implementations, the indicator arm thickness is 0.050 mm. The indicator arm can have a width in any subrange of these ranges. In an example implementation, by cutting both the movable arm and the indicator arm from a single thickness of material, the relative flexibility of the indicator arm and the movable arm can be controlled by selecting the relative widths of the portion of material forming the movable arm and the portion of material forming the indicator arm.

[0246] In some implementations, the indicator arm may be bent to include one or more twisted sections between the moving end and the fixed end of the indicator arm. With reference to FIG. 138, the indicator arm 2650 may include a twisted section 2658 between the moving end 2652 and the fixed end 2654. The twisted section may include one or more twists, each twist ranging from 0 degrees to 180 degrees relative to the untwisted section of the indicator arm. In some implementations, the twisted section may be twisted 5 degrees to 170 degrees, 15 degrees to 145 degrees, 30 degrees to 120 degrees, or 60 degrees to 90 degrees. In some implementations, the twisted section is twisted 90 degrees relative to the untwisted section. The twist may be clockwise or counterclockwise relative to the untwisted section. Twisting of the twisting portion may position the moving end of the indicator arm between the movable arm 2634 and the fixed arm 2632 of the clasp 2630 (e.g., at the second side G, as shown in FIGS. 139, 140B, 140C, and 141C). The twisting may position the moving end 2652 such that it may contact the native valve leaflets when the indicator arm 2650 is inserted into the clasp 2630.

[0247] In some implementations, twisting the indicator arm is configured to make it bend more easily (or less easily). For example, if the indicator arm is narrower than the thickness of the indicator arm, an indicator arm that is bent 90 degrees will bend more easily when engaged by leaflet tissue than an indicator arm that is not bent. As a result, the flexibility or responsiveness of the indicator arm can be controlled with the width of the indicator arm and by twisting the indicator arm.

[0248] FIG. 139 shows an example implementation of a clasp 2730 with an indicator arm 2750 that may be made from a single flat piece of material. The indicator arm 2750 of the clasp 2730 may include a first arm portion 2770 and a second arm portion 2780. Both the first arm portion 2770 and the second arm portion 2780 may be similar in various respects (including length, width, and thickness) to the indicator arm 2650 of FIG. 138. In some implementations, the movable arm 2734 includes a central beam 2790 and two outer beams 2735 (such as optional barbed ends as shown) disposed between the hinge portion 2738 and the gripping portion 2736. The central beam 2790 and the two outer beams define the size of the openings 2762, 2764.

[0249] The first arm portion 2770 and the second arm portion 2780 are each cut from the material between the central beam 2790 and the two outer beams 2735 of the movable arm 2734. The material between the central beam 2790 and the two outer beams 2735 may be straightened, stretched, bent or otherwise treated or processed to create the indicator arms 2735. For example, the material between the central beam 2790 and the two outer beams 2735 of the indicator arm portions 2770, 2780 may be cut in a serpentine path, extending the length of material forming the indicator arm portions and straightening, bending or otherwise treating the material to form the indicator arm portions 2770, 2780 shown in FIG. 139. The first arm portion 2770 includes a bent portion 2772 adjacent the fixed end 2754 of the first arm portion 2770. The second arm portion 2780 also includes a bent portion 2782 adjacent the fixed end 2755 of the second arm portion 2780 .

[0250] The bent portions 2772, 2782 extend the first and second arm portions 2770, 2780 to a second side G of the clasp 2730, where the indicator arm 2650 may contact the native leaflets when inserted into the clasp 2730. The first arm portion 2770 and the second arm portion 2780 may be connected at a connection point 2792 on the first side F of the clasp 2830. The first arm portion 2770 and the second arm portion 2780 may be connected by various means including welding, press fitting, and the like. In some implementations, the indicator arm 2750 includes an indicator marker 2756 similar in material aspects to the indicator marker 2656. In some implementations, the first arm portion 2770 is secured to the second arm portion 2780 by the indicator marker 2756, where the indicator marker 2756 is press fit into both the first arm portion 2770 and the second arm portion 2780. The axis of the indicator marker 2756 may be press fit into the first arm portion 2770 and the second arm portion 2780 in a space formed by the connection of the ends of the indicator arms, a stacked configuration, or a mirrored configuration. A stacked configuration may position the axis of the indicator marker 2756 perpendicular to the plane of the indicator arm 2750, while a mirrored configuration places the axis of the indicator marker 2756 in the plane of the indicator arm 2750. Depending on the dimensions of the indicator marker 2756 used, different orientations may be more visible to the available fluoroscopy angles.

[0251] 140A-140C show an example implementation of a clasp with an integral indicator arm 2850, where the indicator arm is formed from a material external to the outer beam 2835. In these examples, the first arm portion 2870 and the second arm portion 2880 of the indicator arm 2850 are formed from a flat material that is disposed transversely to the flat material from which the outer beam 2835 of the movable arm 2834 is made. Both the first arm portion 2870 and the second arm portion 2880 can be similar in various respects (including length, width, and thickness) to the indicator arm 2650 of FIG. 138, except that the arm portions 2870, 2880 are made from a material external to the clasp.

[0252] 140A-140C, the first arm portion 2870 can meet the movable clasp arm 2834 at a first joint 2860 on the movable arm 2834. The second arm portion 2880 can meet the movable arm 2834 at a second joint 2861 on the movable arm 2834. The joints 2860, 2861 can be located at various positions along the movable arm 2834. For example, the joints 2860, 2861 can be located on the movable arm 2834 at a position near the hinge portion 2838. The joints 2860, 2861 can also be located along the outer beam 2835 of the movable arm 2834 at any point between the hinge portion 2838 and the grip portion 2836 (such as the optional barbed end shown). FIG. 140A shows the first arm portion 2870 and the second arm portion 2880 of the indicator arm 2850 after they have been formed from material adjacent the outer beam 2835 of the movable arm 2834, but before they have been molded to form the indicator arm 2850.

[0253] 140B and 140C, the first arm portion 2870 and the second arm portion 2880 may be configured in a variety of ways. With reference to FIG. 140B, the first arm portion 2870 includes a twisted and / or bent portion 2872 adjacent the fixed end 2854 of the first arm portion 2870. The second arm portion 2880 also includes a twisted and / or bent portion 2882 adjacent the fixed end 2855 of the second arm portion 2880. In the implementation of FIG. 140B, the twisted and / or bent portion 2872 and / or bent portion 2882 are configured such that the first and second indicator arm portions 2870, 2880 extend across the outer beam 2835 on side F. The first and second indicator arm portions 2870, 2880 then extend through the space 2862, 2864 between the outer beam 2835 and the central beam 2890 to the second side G of the clasp 2830 where the indicator arm 2850 may contact the native leaflet when inserted into the clasp 2830. The first and second indicator arm portions may include additional twists and / or bends to allow the first arm portion 2870 and the second arm portion 2880 to connect at a connection point 2892 on the first side F of the clasp 2830. The first arm portion 2870 and the second arm portion 2880 may be connected by various means including welding, etc. In some implementations, the indicator arm 2850 may include an indicator marker 2856 similar in material aspects to the indicator markers 2656, 2756.

[0254] 140C, the first arm portion 2870 includes a twisted and / or bent portion 2872 adjacent the fixed end 2854 of the first arm portion 2870. The second arm portion 2880 also includes a twisted and / or bent portion 2882 adjacent the fixed end 2855 of the second arm portion 2880. In the implementation of FIG. 140C, the twisted and / or bent portion 2882 are configured such that the first and second indicator arm portions 2870, 2880 extend across the outer beam 2835 on the medial G. The first and second indicator arm portions 2870, 2880 are bent in a configuration that may contact the native valve leaflets when the indicator arm 2850 is inserted into the clasp 2830. The first and second indicator arm portions may include an additional twist and / or bend 2880 to extend through the spaces 2862, 2864 between the outer beams 2835 and the central beam 2890 to the side F of the clasp 2830 and may be connected at a connection point 2892. The first arm portion 2870 and the second arm portion 2880 may be connected by various means including welding, etc. In some implementations, the indicator arm 2850 may include an indicator marker 2856 similar in material aspects to the indicator markers 2656, 2756.

[0255] The clasp with integrated leaflet depth indicator can be made from a single flat piece of material in a variety of different ways. With reference to FIGS. 141A and 141B, in some implementations, the gripping portion 2936 of the clasp 2930 can include a first gripping member 2910, a second gripping member 2912, and a third gripping member 2914. The gripping members can be the same as or similar to other gripping members, clasps, clasp arms, etc. described elsewhere herein). The first gripping member 2910 and the second gripping member 2912 can each be connected to the third gripping member 2914 by a connecting member 2916. The connecting member 2916 can take a variety of different forms. For example, the connecting member 2916 can include a suture, a fastener, a pin, a snap, a magnet, etc. In some implementations, the connecting member can extend through an opening in one or more of the first gripping member 2910, the second gripping member 2912, and the third gripping member 2914.

[0256] Configuring the first gripping member 2910, the second gripping member 2912, the third gripping member 2914, the first indicator arm portion 2970, and / or the second indicator arm portion 2980 in the manner shown in Figures 141A and 141B may facilitate easier manufacturing of the clasp 2930 with an integrated leaflet depth indicator. For example, in the implementation shown in Figures 141A and 141B, the first indicator arm portion 2970 and the second indicator arm portion 2980 extend beyond the first gripping member 2910, the second gripping member 2912, and the third gripping member 2914. This allows the leaflet depth indicator to be longer than would be possible if the arms were formed solely from the material in the window of the movable arm.

[0257] The clasp 2930 shown in FIGS. 141A and 141B is similar, except that the indicator arm portions 2970, 2980 in FIG. 141A do not include a connecting member, and the indicator arm portion in FIG. 141B includes a connecting member 2918. In the implementation of FIG. 141A, the indicator arm portions 2970, 2980 are not attached to one another and may form two independent, movable leaflet depth indicators. By including two side-by-side leaflet depth indicators, additional information regarding the position of the leaflet relative to the clasp may be provided. For example, two side-by-side leaflet depth indicators may provide an indication of the rotation and / or offset of the clasp relative to the leaflet in addition to the depth of the leaflet within the clasp. Two independent leaflet depth indicator arms may be used in any of the implementations disclosed herein.

[0258] In the implementation of FIG. 141B, the first indicator arm portion 2970 may be connected to the second indicator arm portion 2980 by a connecting member or mechanism 2918. The connecting member or mechanism 2918 may take a wide variety of different forms. For example, the connecting member or mechanism 2918 may include complementary sutures, fasteners, pins, snaps, magnets, and the like. In some implementations, the connecting member may extend through one or more openings in the first indicator arm portion 2970 and the second indicator arm portion 2980. In some implementations, the first indicator arm portion 2970 may be connected to the second indicator arm portion 2980 by other means. For example, referring to FIG. 141C, the first indicator arm portion 2970 may be connected to a second indicator arm portion similar to the first indicator arm portion and the second indicator arm portion of FIG. 140C.

[0259] 141A and 141B, gripping portion 2936 (such as the optional illustrated barbed end) is shown in a preliminary configuration whereby first gripping member 2910 and second gripping member 2912 are not yet connected to third gripping member 2914. With reference to FIG. 141C, gripping portion 2936 is shown in a formed or assembled configuration whereby first gripping member 2910 and second gripping member 2912 are connected to third gripping member 2914 by corresponding connecting members 2916.

[0260] 141C, the first arm portion 2970 includes a twist and / or bend portion 2972 ​​adjacent the fixed end 2954 of the first arm portion 2970. The second arm portion 2980 also includes a twist and / or bend portion 2982 adjacent the fixed end 2955 of the second arm portion 2980. The first and second indicator arm portions 2970, 2980 extend on a second side G of the space 2962, 2964 between the outer beam 2835 and the central beam 2990, and the indicator arm 2950 may contact the native leaflet when inserted into the clasp 2930. The first and second indicator arm portions may include an additional twist and / or bend to allow the first arm portion 2970 and the second arm portion 2980 to be connectable at a connection point 2992 on the first side F of the clasp 2930. The first arm portion 2970 and the second arm portion 2980 may be connected by various means including welding, etc. In some implementations, the indicator arm 2950 may include an indicator marker 2956.

[0261] 141D, the first arm portion 2970 can have a bent portion 2972 ​​adjacent the fixed end 2954 of the first arm portion 2970. The second arm portion 2980 can also include a bent portion 2982 adjacent the fixed end 2955 of the second arm portion 2980. The first and second indicator arm portions 2970, 2980 when bent can extend onto a second side G of the space 2962, 2964 between the outer beam 2934 and the central beam 2990, and the indicator arm 2950 can contact the native leaflet when inserted into the clasp 2930. The first and second indicator arm portions 2970, 2980 are integrally formed with the transition portion 2920. The first and second indicator arm portions 2970, 2980 can include an additional twist and / or bend so that the transition portion 2920 can be positioned onto the first side F of the clasp 2930. In some implementations, the transition portion 2920 can include an indicator marker.

[0262] 142A and 142B, the clasp 3030 is shown in a closed position. In some implementations, the clasp 3030 is the same as or substantially similar to any of the clasps 2630, 2730, 2830, or 2930. With reference to FIG. 142A, the leaflets are positioned within the clasp 3030, but are not positioned far enough within the clasp 3030 to engage the indicator arm 3050. Thus, the optional indicator marker 3056 (if included) does not move away from the movable arm 3034 of the clasp 3030 or the optional indicator marker 3057 (if included). The position of the indicator marker 3056 and / or indicator marker 3057 visible under fluoroscopy and / or other imaging techniques may aid the user in determining that the leaflets 42, 44 are not properly positioned within the clasp 3030. For example, when both indicator markers 3056, 3057 are included, an image (e.g., a fluoroscopy image) that shows only a single marker (i.e., the two markers 3056, 3057 are adjacent to or abutting each other and only a single mass is visible on the image) indicates that tissue, such as valve leaflet tissue, has not been positioned deep enough within the retainer 3030.

[0263] 142B, the leaflet is positioned far enough into the clasp 3030 to engage the indicator arm 3050. As the indicator arm 3050 moves, the indicator marker 3056 moves from the movable arm 3034 of the clasp 3030. The location of the indicator marker 3056, visible under fluoroscopy and / or other imaging techniques, may aid a user in determining that the leaflet 42, 44 is properly positioned within the clasp 3030. For example, if both indicator markers 3056, 3057 are included, an image (e.g., a fluoroscopic image) showing two separate markers (i.e., the two markers 3056, 3057 are spaced apart) indicates that tissue, such as leaflet tissue, is positioned sufficiently deep within the clasp 3030.

[0264] In the implementations shown in FIGS. 138, 139, 140A-140C, 141A-141D, 142A, and 142B, the leaflet depth indicators 2650, 2750, 2850, 2950 extend from the movable arms of the clasp. However, in other implementations, the leaflet depth indicators may extend from the hinged or fixed arm portions of the clasp. For example, in the implementation shown in FIGS. 143A and 143B, the clasp 3130, the leaflet depth indicator 3150 extends from the fixed arm 3132 of the clasp. The leaflet depth indicator 3150 may be integrally formed with the clasp 3130. In the implementation shown in FIGS. 143A and 143B, the leaflet depth indicator 3150 originates from the fixed arm 3132. 143A and 143B, the leaflet depth indicator 3150 includes a curved portion 3160 that extends along the hinge portion 3138. The leaflet depth indicator then extends along the movable arm 3134 of the clasp 3130.

[0265] 143A, the leaflet is positioned within the catch 3030, but is not positioned far enough into the catch 3130 to engage the indicator arm 3150. Thus, the indicator marker 3156 does not move from the movable arm 3134 of the catch 3130. The location of the indicator marker 3156, visible under fluoroscopy and / or other imaging techniques, may aid a user in determining that the leaflet 42, 44 is not properly positioned within the catch 3030. For example, when both indicator markers 3156, 3157 are included, an image (e.g., a fluoroscopic image) showing only a single marker (i.e., the two markers 3156, 3157 are adjacent or abutting each other and only a single mass is visible on the image) indicates that tissue, such as leaflet tissue, is not positioned deep enough within the catch 3130.

[0266] 143B, the leaflet is positioned far enough into the catch 3130 to engage the indicator arm 3150. As the indicator arm 3150 moves, the indicator marker 3156 moves from the movable arm 3134 of the catch 3130. The location of the indicator marker 3156, visible under fluoroscopy and / or other imaging techniques, may aid a user in determining that the leaflet 42, 44 is properly positioned within the catch 3030. For example, if both indicator markers 3156, 3157 are included, an image (e.g., a fluoroscopic image) showing two separate markers (i.e., the two markers 3156, 3157 spaced apart) indicates that tissue, such as leaflet tissue, is positioned sufficiently deep within the catch 3130.

[0267] 144 and 145 show an example implementation of a device 3200 with a leaflet indicator 3250. The leaflet indicator 3250 may be used with a variety of different devices 3200. For example, the leaflet indicator 3250 may be used with any of the valve repair devices disclosed herein or any other valve repair devices. In the illustrated example, the device 3200 includes an inner paddle 3222 and an outer paddle 3220, and a clasp 3230 with a movable arm 3234 and a fixed arm 3232. The leaflet indicator 3250 may be coupled to various components on the device, such as the inner paddle 3222, the fixed arm of the clasp 3232, and / or the movable arm 3234 of the clasp 3230. In the illustrated example, the leaflet indicator 3250 is disposed on the inner paddle 3222.

[0268] The indicator 3250 can take a wide variety of different forms. For example, the indicator 3250 can comprise one or more components capable of sensing electrical properties of a material, such as blood or tissue, which may be valve leaflets, chordae tendineae, papillary muscles, heart wall tissue, etc., and / or contact by a valve repair device component, such as a clasp arm, a paddle portion, a coaptation element, etc. In the illustrated embodiment, the indicator 3250 can include one or more conductive contacts, such as a first contact 3252 and a second contact 3254. Although two indicator contacts are shown in FIGS. 144 and 145, any number of indicator contacts can be used in the indicator. The indicator contacts can be electrically coupled to one or more sensors. The sensors can be coupled to the indicator contacts through a number of methods, including conductive wiring. The sensors can include electrical sensors capable of measuring one or more of resistance, inductance, capacitance, voltage, current, and impedance.

[0269] 144, no leaflets are positioned within the clasp 3230. If the clasp 3230 closes without a leaflet positioned between the movable arm 3234 and the fixed arm 3232, the movable arm 3234 may move and contact the indicator 3250, creating a bridge between the first indicator contact 3252 and the second indicator contact 3254. In this case, the sensor 3260 senses the lack of resistance (e.g., a circuit is closed by the movable clasp arm). This information may be used to determine that a leaflet is not present within the clasp 3230.

[0270] 145, the leaflets 42, 44 are positioned within the clasp 3230. When the clasp 3230 is closed with the leaflets 42, 44 positioned between the movable arm 3234 and the fixed arm 3232, the movable arm 3234 may not contact the indicator 3250 when bent to the closed position. In this case, the sensor 3260 may observe or otherwise indicate that there is a measurable resistance between the contacts 3252, 3254, which may be used to determine that the leaflets are present within the clasp 3230.

[0271] 146 and 147, an implementation of a system 3301 having a leaflet indicator 3350 is shown. In this implementation, components of the valve repair system itself are used as the indicator 3350. A wide variety of different configurations of valve repair system components can be used as leaflet depth indicators. The illustrated device 3300 includes an inner paddle 3322 and an outer paddle 3320, and a clasp 3330 with a movable arm 3334 and a fixed arm 3332. In the illustrated example, an insulator 3356 is positioned between the inner pedal 3322 and the fixed arm 3332. The device 3300 can include any device disclosed herein, as well as any other valve repair device. The leaflet indicator 3350 can include various components on the device that can be electrically coupled to a proximal control handle (not shown). In the illustrated example, a first electrical pathway is defined by a control line 3362 and the clasp 3330. A second electrical pathway is defined by the inner panel 3322, the coupling element 3372, and the coupler 3376. The electrical pathway may be formed in a variety of different ways. For example, the component, a portion of the component, or a subcomponent extending along the component may be formed from a conductive material.

[0272] The indicator 3350 may be electrically coupled to one or more sensors 3360. The sensors may include electrical sensors capable of measuring one or more of resistance, inductance, capacitance, voltage, current, impedance, and the like. The sensors 3360 may be coupled to the indicator 3350 in a number of ways. The indicator 3350 may be electrically coupled to the sensor 3360 through a first path defined by the control line 3362 and the clasp 3330, and a second path defined by the inner panel 3322, the interface element 3372, and the coupler 3376. In some implementations, the device is made from conductive components. For example, the movable arm, the interface element 3372, the collar 3374, the catheter coupler 3376, and / or the actuation line 3378 may be conductive.

[0273] 146, no leaflets are positioned within the clasp 3330. If the clasp 3330 were to close without a leaflet positioned between the movable arm 3334 and the fixed arm 3332, the movable arm 3334 would move and contact the indicator 3350, thereby closing the circuit between the first pathway, the sensor 3360, and the second pathway. In this instance, the sensor 3360 would indicate a lack of resistance (e.g., a circuit is closed by the movable clasp arm), which could be used to determine that a leaflet is not present within the clasp 3330.

[0274] 147, the leaflets 42, 44 are positioned within the catch 3330. When the catch 3330 is closed with the leaflets 42, 44 positioned between the movable arm 3334 and the fixed arm 3332, the movable arm 3334 does not contact the inner paddle 3322. In this case, the circuit between the sensor 3360, the first pathway, and the second pathway is interrupted (open state) and the sensor 3360 can determine that the leaflets are present within the catch 3330.

[0275] 148-155, in some implementations, the visual indicator 3450 is coupled to the movable arm 3434 of the clasp 3430, and the visual indicator 3450 and the clasp 3430 act as electrical indicators. The visual indicator 3450 and the clasp 3430 can take a variety of different forms. For example, the indicator 3450 and the clasp 3430 can be any of the clasps and indicators disclosed in this patent application. In the implementation shown in FIGS. 148-155, the visual indicator 3450 can be according to FIGS. 94-98. A circuit can be formed by the sensor 3460, the clasp 3430, and the visual indicator 3450 via wiring connecting the clasp 3430 and the visual indicator 3450 to the sensor 3460.

[0276] 148-151, in some implementations, the insulator 3480 insulates one or more portions of the indicator 3450 from the clasp 3430. The insulator 3480 can take a variety of forms. In the embodiments of FIGS. 148-151, the portions of the indicator 3450 and the clasp 3430 that are electrically isolated from one another are indicated generally by dashed region 3480. The generally indicated insulator 3480 can be achieved in a variety of different ways. With reference to FIGS. 152-155, the indicator 3450 and the clasp 3430 are electrically isolated from one another through one or more insulating components, for example, a first insulator 3482 and a second insulator 3484. The first insulator 3482 insulates the visual indicator 3450 and the clasp 3430 at the connection between the clasp and the indicator. A second insulator 3484 insulates the crossbar of the clasp 3430 from the curved portion of the visual indicator 3450 when the visual indicator is in the leaflet engaging position.

[0277] 148-155, by being insulated in region 3480, such as by one or more insulating components, an electrical signal indicative of the presence or absence of a leaflet disposed within the clasp may be determined by sensor 3460. If a leaflet does not engage indicator 3450 within clasp 3430, visual indicator 3450 is in electrical contact with clasp 3430 and the circuit is closed (see FIGS. 148, 149, 152, and 153). If a leaflet engages indicator 3450 within clasp 3430, visual indicator 3450 is not in electrical contact with clasp 3430 and the circuit is open (see FIGS. 150, 151, 154, and 155).

[0278] 148 and 149, and 152 and 153, the indicator 3450 is in an unengaged position, which may be the case when no leaflet is positioned within the clasp 3430. In the unengaged position, an indication of the absence of a leaflet may be visually confirmed through the location of the indicator marker 3456, which does not move from the movable arm 3434 of the clasp 3430, and through a closed circuit comprising the sensor 3460, the clasp 3430, the indicator 3450, and wiring connecting the clasp 3430 and the indicator 3450 to the sensor 3460. However, in other implementations, an insulator may be configured such that the circuit is open when the visual indicator is in the unengaged position. For example, an insulator may be positioned on the marker 3456 and the crossbar of the clasp to insulate the visual indicator from the clasp in the unengaged position.

[0279] 150 and 151 and 154 and 155, the indicator 3450 is in an engaged position, which may be the case when a leaflet is positioned within the clasp 3430. In the engaged position, an indication that a leaflet is present may be visually confirmed through the location of the indicator marker 3456 that has moved a measurable distance from the movable arm 3434 of the clasp 3430, as well as through an open circuit comprising the sensor 3460, the clasp 3430, the indicator 3450, and wiring connecting the clasp 3430 and the indicator 3450 to the sensor 3460. However, in other implementations, the insulators may be configured such that when the visual indicator is in the engaged position, a circuit is closed. For example, the insulators may be configured such that the crossbar of the clasp is not insulated from the curved portion of the visual indicator, such that the curved portion of the indicator directly engages the crossbar of the clasp in the engaged position.

[0280] 156-158, an implementation of a clasp 3530 having an electrical indicator 3550 is shown. The electrical indicator 3550 can take a variety of different forms. For example, the indicator 3550 can include one or more plates. With reference to FIG. 156, the exemplary indicator 3550 includes a first indicator plate 3552 and a second indicator plate 3554. According to some implementations, the first indicator plate 3552 is coupled to a fixed arm 3532 of the clasp 3530, and the second indicator plate 3554 is coupled to a movable arm 3534 of the clasp 3530. With reference to FIG. 158, the indicator plates can be made of one or more separate plates. The indicator plates can be made of a conductive material.

[0281] 156A-156D show additional indicator plate configurations. The implementations shown in Fig. 156, Fig. 156A-156D, and Fig. 158 are some examples of many configurations that may be used. In the implementation shown in Fig. 156A, the first and second plates 3552, 3554 are positioned near the hinge portion of the clasp 3530. In other implementations, the plates are positioned only on the movable arm 3534 of the clasp or only on the fixed arm of the clasp. The plates 3552, 3554 may be positioned at or near the minimum allowable leaflet insertion depth.

[0282] 156B illustrates an implementation in which the first and second plates 3552, 3554 are positioned on the fixed arm 3532 of the clasp 3530. In other implementations, the first and second plates 3552, 3554 are positioned on the movable arm 3534 of the clasp. In other implementations, a pair of plates are positioned on the fixed arm 3532 of the clasp and a pair of plates are positioned on the movable arm of the clasp. In the implementation shown in FIG. 156B, the indicator plate 3554 can correspond to a minimum leaflet insertion depth and the indicator plate 3552 can correspond to a maximum leaflet insertion depth.

[0283] In an implementation shown in FIG. 156C, the first and second plates 3552, 3554 are positioned on the fixed arm 3532 of the clasp 3530. In other implementations, the first and second plates 3552, 3554 are positioned on the movable arm 3534 of the clasp. In an implementation shown in FIG. 156C, the first and second plates 3552, 3554 extend along the length of the clasp arm. The first plate 3552 and the second plate 3554 are separated by a gap. With the implementation shown in FIG. 156C, the indicator 3550 can detect the presence or change in depth of tissue, such as leaflet tissue, across the width of the clasp. For example, the configuration shown in FIG. 156C can sense that a leaflet is cracked or bent, or is otherwise improperly gripped by the clasp. The implementation shown in FIG. 156D is the same as the implementation shown in FIG. 156C, except that a pair of plates is disposed on a fixed clasp arm 3532 and a pair of plates is disposed on a movable clasp arm 3534.

[0284] 157 and 158, in some implementations, an AC voltage is applied across the electrical indicator and one or more impedance measurements are obtained and / or derived. The applied AC voltage may be varied. Different materials may have different impedance characteristics for different applied AC voltages. Thus, applying a varying AC voltage may allow for improved differentiation between different biological materials disposed within the clasp. Any of the electrical indicators disclosed herein may be used with one or more AC voltages applied and one or more impedance measurements obtained.

[0285] In some implementations, an AC voltage is applied and one or more impedance characteristics are measured while the clasp is closed. In other implementations, an AC voltage is applied and one or more impedance characteristics are measured while the clasp is not open, partially open, or fully closed. Obtaining impedance measurements while the clasp is not open, partially open, or fully closed can have the advantage of ensuring that leaflet tissue is properly positioned within the clasp and / or that other undesirable tissue, such as chordae tendineae, is not positioned within the clasp before the clasp is closed. The clasp can take a variety of different forms. For example, the clasp can be any of the clasps disclosed in this patent application. The clasp can include optional barbs or other friction enhancing or fixation elements. Obtaining impedance measurements while the clasp is not open, partially open, or fully closed can prevent or inhibit the optional barbs from puncturing or penetrating the leaflet until it is confirmed that the leaflet is properly positioned within the clasp. Obtaining impedance measurements while the clasp is not open, partially open, or fully closed can prevent or inhibit the chordae tendineae from closing within the clasp.

[0286] 157-162, the indicator 3550 may be included in a circuit with an AC power source, an electrical sensor 3560, and wiring. The sensor 3560 and the AC power source may be a single device or separate devices. The wiring connects the first indicator plate 3552 and the second indicator plate 3554 to the AC power source and the electrical sensor 3560 to measure, among other things, resistance, inductance, capacitance, voltage, current, and / or impedance, components of impedance, and the like. The sensor 3560 may measure electrical properties in a variety of locations and situations, including when the indicator 3550 is in contact with blood 3590 (FIG. 159), the leaflets 42, 44 (FIG. 160), and chordae tendineae 3592 or other portions of the heart valve in place of the leaflets (FIG. 161). The resistance, inductance, capacitance, voltage, impedance, and / or current readings obtained by the sensor may vary based on the anatomical structure with which the indicator 3550 contacts. Thus, the electrical properties measured by the electrical sensors 3560 may be used to determine the location of the clasp and / or the anatomical structures that the clasp contacts based on the resistance, inductance, capacitance, voltage, impedance, and / or current readings obtained by the sensors.

[0287] Referring to FIG. 162, impedance can be measured using a sensor 3560. The sensor can take a variety of different forms, including an impedance meter. Impedance is a quantity that represents the resistance to the flow of AC current. The magnitude of the impedance Z is equal to the maximum value of the potential difference or voltage V (volts) across the circuit divided by the maximum value of the current I (amperes) flowing through the circuit. Thus, for any given situation, the impedance can be calculated by controlling the AC voltage and measuring the current.

[0288] Referring to Figure 163, the impedance of an ideal resistor is the real part only, the resistance impedance Z RIt is called the impedance of a coil and can be measured by dividing the voltage (V) by the current (I). Ideal coils and capacitors have reactive impedances that are only imaginary. The impedance of a coil increases as frequency increases and can be calculated as jwL, the product of frequency and inductance times an imaginary number. The impedance of a capacitor decreases as frequency increases and can be calculated as 1 / (jwC), the inverse of the product of frequency and capacitance times an imaginary number.

[0289] Referring to FIG. 164, a method 3600 for identifying a clasp status is shown. The method 3600 includes measuring a first impedance value 3610. The impedance may be measured in a variety of different ways. The resistive component of the impedance R, the inductive component of the impedance L, and / or the capacitive component of the impedance C may be measured or derived from the measurements. The impedance may be measured by a sensor used in the circuits according to FIGS. 144-161 or according to the measurements described in FIGS. 162-163. For example, the impedance between the plates of the indicator 3550 shown in FIGS. 156-161 may be measured. In other implementations, the impedance between any of the components of the indicators disclosed herein may be measured.

[0290] The method 3600 also includes a step 3620 of comparing the impedance Z value to a set of previously collected measurements. The previously collected impedance values ​​may correspond to known conditions. For example, each of the previously collected impedance values ​​may be for a type of tissue in the clasp, such as leaflet tissue or chordae tendineae, an amount of tissue in the clasp, a fluid, such as blood, in the clasp and / or surrounding the tissue, etc. The previously measured impedance values ​​and associated conditions may be collected, analyzed, and / or processed to predict or estimate conditions associated with future measurements. For example, lookup tables, predictive algorithms, and / or machine learning schemes may be formed using the previously measured impedance values ​​and corresponding conditions. These lookup tables, predictive algorithms, and / or machine learning schemes may then be used to identify, estimate, and / or predict conditions corresponding to future measured impedance values, such as the impedance values ​​measured in step 3610.

[0291] Method 3600 also includes a step 3630 of identifying or estimating a state and / or position of the clasp. The state of the clasp may be determined by comparing the measured impedance value to a state associated with a corresponding value of a previously measured impedance value. The state of the clasp may include determining where the clasp is located, what the clasp is attached to, etc. Method 3600 may determine, for example, whether the clasp is coupled to the leaflet and, if so, the amount of insertion of the leaflet into the clasp.

[0292] When the leaflets are captured by the valve repair device, they may be pressed between the indicator and the clasp. In some cases, small or thin leaflets may be at least partially bunched between a particular portion of the indicator or between the indicator and the clasp such that the distance the indicator is pressed is reduced. With reference to FIGS. 165-169, in some implementations, the device 3700 may include a bar coupled to at least one of the fixation arm 3732 of the clasp 3730 and the inner paddle 3722. The bar may reinforce the inner paddle 3722 and prevent or inhibit the leaflets from bunching around or between portions of the indicator 3750. Thus, when the leaflets are captured within the clasp of the device, contact between the leaflets and the bar may ensure that contact between the leaflets and the indicator is adequately identified by the user. The bar may be included in any device disclosed herein, as well as any other valve repair device.

[0293] 165, the bar 3760 may include a leaflet engaging portion 3762 and a device engaging portion 3764. The bar 3760 may be disposed in a gap between the leaflet engaging portions 3758 of the indicator 3750 (see FIG. 166). The leaflet engaging portion 3762 may have a variety of shapes and sizes. For example, the leaflet engaging portion 3762 of the bar 3760 may contact the fixation arm 3732 of the clasp 3730 and / or may be flush with a surface of the fixation arm of the clasp 3730 from a first end 3766 of the leaflet engaging portion 3762 to a second end 3768 of the leaflet engaging portion. The bar 3760 may be disposed through or around the anchoring arm 3732 of the clasp 3730 and the inner paddle 3722 such that the device engaging portion 3764 is hooked onto or otherwise secured to the inner paddle 3722 at a location between the inner paddle 3722 and the outer paddle 3720. The bar 3760 may assist in further stabilizing the leaflets 42, 44 when the leaflets 42, 44 are engaged to the clasp 3730 by the indicator arm 3750. Specifically, the leaflets 42, 44 are pressed against the indicator arm 2050 and the two legs of the bar 3760, leading to further stabilization of the leaflets 42, 44. The bar 3760 creates an undulating path for the leaflets 42, 44.

[0294] The bar can have a variety of different contours. For example, the contour can be selected to optimize or improve visualization of the indicator 3750 and / or to optimize or improve engagement or gripping of the leaflets by the clasp 3730. In the implementation shown in FIG. 166, the bar 3770 can include one or more ridges 3774 on or adjacent to the leaflet engagement portion 3772. The bar 3767 extends substantially into the gap between the leaflet engagement portions 3758 of the indicator 3750. As such, the bar 3770 increases the travel of the indicator 3750 when the leaflets are placed in the clasp and / or the leaflets are more securely gripped by the closure clasp.

[0295] 167, the bar 3780 may be positioned such that the surface 3788 does not contact and / or is spaced apart from the fixed arms 3732 of the clasp 3730. The device engaging portion 3784 may include a clasp area 3786 that may be positioned about the inner paddle 3722 to secure the bar 3780 to the device 3700.

[0296] 168 and 169, the leaflet engaging portion 3792 of the bar 3790 can include one or more apices 3796. The apices 3796 of the bar 3790 can be configured to substantially move the indicator 3750 to provide a visual indication as soon as the leaflet reaches a minimum insertion depth. The apices can be configured to substantially move the indicator 3750 as soon as the leaflet reaches a minimum insertion depth in a variety of different ways. In the illustrated embodiment, the apices 3796 abut the movable arm 3734 and / or are in close proximity to the movable arm 3734. Also, when viewed from the side, the profile of the apices 3796 overlaps the leaflet engaging portion of the indicator 3750, as shown in FIG. 168. As a result, the indicator 3750 substantially moves as soon as the leaflet reaches the overlap between the apices 3796 and the leaflet engaging portion of the indicator 3750. In some implementations, the overlap is selected to coincide with the minimum leaflet insertion depth.

[0297] In some implementations, the apex 3796 may be configured to cause the clasp 3730 to engage the portion of the leaflet more firmly at the proximal end of the clasp 3730 (towards the open end) than the portion of the leaflet at the distal end of the clasp (towards the closed end). The apex 3796 may be configured to cause the clasp 3730 to engage the portion of the leaflet more firmly at the proximal end of the clasp 3730 than the portion of the leaflet at the distal end of the clasp in a variety of different ways. In the implementation shown in FIG. 168 and FIG. 169, the apex 3796 is included near the proximal end of the clasp, but there is no apex included at the distal end of the clasp. Thus, the portion of the leaflet closer to the proximal end of the clasp is engaged more firmly than the portion of the leaflet closer to the distal end of the clasp. In other implementations, the apex 3796 may be included in multiple locations, such as both the proximal end of the clasp and the distal end of the clasp.

[0298] Any of the various systems, devices, apparatus, 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 herein may include sterilization of associated systems, devices, equipment, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0299] Various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in the embodiments herein, and these various aspects, concepts, and features may be used individually or in various combinations and subcombinations thereof in many alternative implementations. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Still further, although various alternative implementations of the various aspects, concepts, and features of the present disclosure may be described herein, e.g., 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 implementations, 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 implementations and applications, even if such implementations are not expressly disclosed herein.

[0300] Furthermore, although some features, concepts, or aspects of the present disclosure may be described herein as being preferred arrangements or methods, such description is not intended to imply that such features are essential or required, unless expressly so described. Furthermore, although exemplary or representative values ​​and 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 expressly so described.

[0301] 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 fully described herein without being expressly identified as such or as part of a particular disclosure, which disclosure is instead defined in the appended claims. Descriptions of exemplary methods or processes are not limited to including all steps as essential in all cases, and the order in which steps are presented is not to be construed as essential or essential unless expressly stated. Furthermore, the techniques, methods, operations, steps, etc., as described or suggested herein, may be performed on live animals, or may be performed on non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., where body parts, tissues, etc. are simulated), etc. 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 implementations herein.

Claims

1. A valve repair device for repairing a patient's native valve, comprising: a gripping member; a paddle, wherein the gripping member is movable to form a capture region for capturing the leaflet tip of the native valve, and the paddle; an indicator coupled to the valve repair device and movable to indicate whether the leaflet tip of the native valve is inserted into the capture region to at least a minimum insertion depth; the indicator is configured to pass through one or more of the paddle and the gripping member; the indicator is configured as an indicator arm having a fixed end and a movable end; the fixed end of the indicator arm is coupled to the movable arm of the gripping member; the fixed end and the movable end are disposed on a first side surface of the movable arm of the gripping member; the indicator arm includes a leaflet engagement member between the fixed end and the movable end; the leaflet engagement member is disposed on a second side surface of the movable arm of the gripping member; the leaflet capture region is disposed on the second side surface of the movable arm. A valve repair device.

2. The valve repair device according to claim 1, wherein the capture region is formed between a portion of the paddle and an arm of the gripping member.

3. The valve repair device according to claim 2, wherein the paddle includes an outer paddle portion and an inner paddle portion.

4. The valve repair device according to any one of claims 1 to 3, wherein the indicator is configured to pass through at least one of a channel of the gripping member and a channel of the paddle.

5. The valve repair device according to any one of claims 1 to 3, wherein the fixed arm of the gripping member includes a first beam, a second beam, and an engagement member between the first beam and the second beam.

6. The valve repair device according to any one of claims 1 to 5, further comprising an indicator marker attached to the indicator.

7. The valve repair device according to any one of claims 1 to 6, wherein the movable end includes an indicator marker including a radiopaque material.

8. The valve repair device according to any one of claims 1 to 7, wherein the leaflet engagement member is the only part of the indicator configured to pass through at least one of the gripping member and the paddle.

9. The valve tip engagement member includes one or more protrusions extending from the valve tip engagement member, and the valve repair device according to any one of claims 1 to 7.

10. The indicator arm includes a first arm and a second arm, and the first arm and the second arm are coupled to the moving end and connected at a connection point of the fixed end, and the valve repair device according to any one of claims 1 to 9.

11. The indicator is formed from a portion of the gripping member, and the valve repair device according to any one of claims 1 to 10.

12. The indicator includes a first arm portion and a second arm portion, and the valve repair device according to any one of claims 1 to 11.

13. The first arm portion includes a twisted portion, the twisted portion of the first arm portion includes one or more twists between 0 degrees and 180 degrees in a first direction, the second arm portion includes a twisted portion, and the twisted portion of the second arm portion includes one or more twists between 0 degrees and 180 degrees in a second direction opposite to the first direction, and the valve repair device according to claim 12.

14. The first arm portion and the second arm portion are coupled to the moving end at a connection point, and the valve repair device according to claim 12 or 13.

15. The connection point includes an indicator marker including a radiopaque material press-fitted into at least one of the first arm member and the second arm member, and the valve repair device according to claim 14.

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