Valve repair implant with leaflet tension indication - Patent Application 20070122997

Abstract

The implantable device or implant includes an anchor portion including one or more anchors coupled to an actuation element. The anchors are configured to attach to one or more leaflets of a native heart valve. The anchors are configured to move between an open position and a closed position. The device or implant includes an indicator feature that is movable between an acceptable tension position and an excessive tension position. When the anchors are attached to the leaflets of the native heart valve, the indicator feature indicates to a user when the amount of force applied to the anchor portion by the leaflets of the native heart valve exceeds a preset or predetermined amount of force.

Description

[Technical Field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 066,097, filed August 14, 2020, which is incorporated herein by reference in its entirety for all purposes. [Background technology]

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring proper forward flow of blood supply throughout the cardiovascular system. These heart valves can be damaged and therefore less effective due to, for example, congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such valve damage can cause serious cardiovascular disability or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and can result in complications. 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., threading the catheter into the right femoral vein, ascending the inferior vena cava, and into the right atrium). The septum is then punctured, and the catheter is advanced into the left atrium. A similar transvascular technique can be used to implant a prosthetic device within the tricuspid valve, beginning similarly to the transseptal technique but stopping short of puncturing the septum and instead directing the delivery catheter toward the tricuspid valve in the right atrium.

[0003] A healthy heart has a generally conical shape that tapers to the lower apex. The heart is divided into four chambers, including the left atrium, right atrium, left ventricle, and 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 in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different biological structure from other native heart valves. The mitral valve includes an annulus, which is a circular portion of native valve tissue surrounding the mitral orifice, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle. The mitral valve annulus can form a "D"-shaped, elliptical, or otherwise non-circular cross-sectional shape with major and minor axes. The anterior leaflet is larger than the posterior leaflet, and when they close together, they can form a generally "C"-shaped boundary between adjacent leaflets.

[0004] When functioning properly, the anterior and posterior leaflets function together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), oxygenated blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricular muscle contracts (also called "ventricular systole" or "systole"), increased blood pressure in the left ventricle closes the one-way mitral valve by drawing the two leaflets together. This prevents blood from flowing back into the left atrium and instead expels blood from the left ventricle through the aortic valve. To prevent the leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae connect the leaflets to the papillary muscles of the left ventricle.

[0005] Valve regurgitation involves a valve inadequacy that allows some blood to flow in the wrong direction through the valve. For example, during the systolic phase of cardiac contraction, the native mitral valve fails to close properly, causing blood to flow from the left ventricle into 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, dysfunctional papillary muscles, stretching of the mitral annulus due to left ventricular dilation, or two or more of these. Mitral regurgitation in the central portion of the valve leaflets can be called central-jet mitral regurgitation, while mitral regurgitation closer to one commissure of the leaflets (i.e., where the leaflets meet) can be called eccentric-jet mitral regurgitation. Central-jet regurgitation occurs when the edges of the leaflets do not meet in the middle, thus preventing the valve from closing and resulting in regurgitation. Tricuspid regurgitation is similar but can occur on the right side of the heart. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 8,449,599 [Patent Document 2] US Patent Application Publication No. 2014 / 0222136 [Patent Document 3] US Patent Application Publication No. 2014 / 0067052 [Patent Document 4] US Patent Application Publication No. 2016 / 0331523 [Patent Document 5] International Publication No. 2020 / 076898 Brochure [Patent Document 6] International Publication No. 2018 / 195215 Brochure [Patent Document 7] International Publication No. 2020 / 076898 Brochure [Patent Document 8] International Publication No. 2019 / 139904 Brochure Summary of the Invention [Problem to be solved by the invention]

[0007] This Summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in an example of this Summary are not required by a claim unless the claim explicitly recites those features. Also, features, components, steps, concepts, etc. described in examples in this Summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure can be included in the examples summarized herein. [Means for solving the problem]

[0008] In some embodiments, the implantable device or implant includes an anchor portion having one or more anchors configured to attach to one or more leaflets of a native heart valve. The anchors are movable between an open position and a closed position. The implantable device or implant has an indication feature movable between an acceptable tension position and an excessive tension position. When the anchors are attached to the leaflets of the native heart valve, the indication feature indicates to a user that the amount of force applied by the leaflets of the native heart valve to the implantable device or implant (and vice versa) exceeds a preset or predetermined amount of force, with the indication feature in the excessive tension position. The indication feature may provide this tension indication when the device is in a partially open position and / or when the device is in a closed position.

[0009] In some embodiments, the implantable device or implant includes an anchor portion including one or more anchors coupled to an actuating element. The anchors are configured to attach to one or more leaflets of the native heart valve. The anchors are configured to move between an open position and a closed position with movement of the actuating element. At least one of the actuating element and the anchor portion has an indicating feature that is movable between an acceptable tension position and an excessive tension position. When the anchors are attached to the leaflets of the native heart valve, the indicating feature indicates to a user when the amount of force applied to the anchor portion by the leaflets of the native heart valve exceeds a preset or predetermined amount of force.

[0010] In some embodiments, the implantable device or implant includes a coaptation portion having a coaptation element, a distal portion having a cap movable relative to the coaptation element, and an anchor portion having one or more anchors coupled to the coaptation element and the cap. The anchors are configured to attach to one or more leaflets of the native heart valve and move between an open position and a closed position by movement of the cap relative to the coaptation element. At least one of the coaptation portion, distal portion, and anchor portion has an indicating feature movable between an acceptable tension position and an excessive tension position. When the anchors are attached to the leaflets of the native heart valve and in the closed position, the indicating feature indicates to a user that the amount of force applied to the implantable device or implant by the leaflets of the native heart valve exceeds a preset or predetermined amount of force by the indicating feature being in the excessive tension position.

[0011] In some embodiments, the valve repair device comprises an anchor portion and an indicator feature (e.g., a tension indicator feature). The anchor portion may comprise one or more anchors configured to attach to one or more leaflets of the native heart valve. The anchors may be configured to move between an open position and a closed position. When the anchors are attached to the leaflets of the native heart valve, the indicator feature may be configured to indicate when the amount of force applied to the device and / or anchor portion by the leaflets of the native heart valve exceeds a preset or predetermined amount of force and / or to indicate when a predetermined tension on the device and / or anchor portion is exceeded.

[0012] The valve repair device may include any of the features or components of any of the devices or implants described anywhere herein.

[0013] The valve repair device may include a variety of different mechanisms or combinations of mechanisms for transitioning the anchor between the open and closed positions. For example, in some embodiments, the device includes an actuation element that may be the same as or similar to any of the actuation elements described elsewhere herein. In some embodiments, the device may include a gear mechanism, a cam mechanism, a worm screw, an articulation joint, a scissor-like mechanism, a combination of more than one of these, or the like, that assists in transitioning the anchor between the open and closed positions.

[0014] In some embodiments, the anchor portion and / or anchor includes one or more clasps. The clasps may also be configured to move or transition between an open configuration and a closed configuration, such as using an actuation line. The clasps may be the same as or similar to other clasps described herein.

[0015] In some embodiments, one or more of the clasps include an indicating feature.

[0016] In some embodiments, at least a portion of the one or more clasps comprises a fixed arm attached to the anchor and a movable arm pivotally connected to the fixed arm, and the indicator feature comprises a flexible material of the movable arm that allows the movable arm to be in an unextended position when the indicator feature is in a first tension position and in an extended position when the indicator feature is in a second tension position, the second tension position indicating to a user when the amount of force exceeds a predetermined amount of force and / or a predetermined tension.

[0017] In some embodiments, one or more clasps comprise a first portion including a first visible marking of the indication feature and a second portion including a second visible marking of the indication feature, and the second portion of the clasp is movable relative to the first portion such that movement of the second portion moves the second visible marking relative to the first visible marking, causing the indication feature to indicate to a user that the amount of force applied to the anchor portion by the leaflets of the native heart valve exceeds a predetermined amount of force and / or a predetermined tension.

[0018] In some embodiments, the indicator feature comprises components, configurations, and / or designs of the device and / or anchor that enable the anchor to be in a non-extended position when the indicator feature is in a first tension position (e.g., an acceptable tension position, or a position where a predetermined amount of force and / or a predetermined tension limit or an optimal force / tension range has not been exceeded), and in an extended position when the indicator feature is in a second tension position (e.g., an exceeded tension position, or a position where a predetermined amount of force and / or a predetermined tension limit or an optimal force / tension range has been exceeded).

[0019] In some embodiments, at least a portion of one or more clasps comprises a fixed arm attached to the anchor at a connection point and a movable arm pivotally connected to the fixed arm at a pivot connection point, the connection point being spaced from the pivot connection point.

[0020] In some embodiments, the indicator feature comprises an attachment between the fixation arms at the connection point that allows at least a portion of the fixation arms to bend relative to the connection point when the indicator feature is in a second tension position, the second tension position indicating that a predetermined amount of force or predetermined tension has been exceeded.

[0021] In some embodiments, the indicator feature comprises a flexible material of the anchor, and the indicator feature is in a second tensioned position when the flexible material of the anchor bends the anchor away from the center of the device (e.g., the central axis, the coaptation elements, and / or some other central component) when the anchor is connected to the leaflets of the native heart valve and in a closed position.

[0022] In some embodiments, an actuation element for transitioning the anchor between the open and closed positions extends through the catheter, and the indicator feature includes a viewable portion of the actuation element extending proximally of the proximal end of the catheter, hi some embodiments, the viewable portion can be inside a catheter handle at the proximal end of the catheter.

[0023] In some embodiments, the indicator feature comprises a flexible portion of the actuation element that allows the actuation element to flex.

[0024] In some embodiments, the device further comprises a connecting element movable from an unlocked state to a locked state, the connecting element attaching to the anchor when the connecting element is in the locked state to lock the anchor in the closed position. The connecting element may be the same as or similar to other connecting elements described herein or otherwise known.

[0025] A further understanding of the nature and advantages of the present invention can be found in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals and in which:

[0026] To further clarify various aspects of embodiments of the present disclosure, a more particular description of certain examples and embodiments will be made by reference to various aspects of the accompanying drawings. These drawings depict only exemplary embodiments of the present disclosure and therefore should not be considered to limit the scope of the disclosure. Moreover, while the figures may be to scale for some examples, the figures are not necessarily to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0027] [Figure 1] 1 illustrates a cutaway view of a human heart in diastole. [Figure 2] 1 illustrates a cutaway view of a human heart during systole. [Figure 3] 1 illustrates a cutaway view of a human heart during systole showing mitral regurgitation. [Figure 4] FIG. 4 is a cutaway view of FIG. 3 annotated to show the natural shape of the mitral valve leaflets during systole. [Figure 5] 1 illustrates a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Figure 6] 1 illustrates a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] 1 illustrates the tricuspid valve as seen from the atrial side of the tricuspid valve. [Figure 8] 1 shows an embodiment of an implantable device or implant in various stages of deployment. [Figure 9] 1 shows an embodiment of an implantable device or implant in various stages of deployment. [Figure 10] 1 shows an embodiment of an implantable device or implant in various stages of deployment. [Figure 11] 1 shows an embodiment of an implantable device or implant in various stages of deployment. [Figure 12]1 shows an embodiment of an implantable device or implant in various stages of deployment. [Figure 13] 1 shows an embodiment of an implantable device or implant in various stages of deployment. [Figure 14] 1 shows an embodiment of an implantable device or implant in various stages of deployment. [Figure 15] 10 shows an embodiment of an implantable device or implant similar to the device illustrated by FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16] 15 shows an embodiment of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 17] 15 shows an embodiment of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 18] 15 shows an embodiment of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 19] 15 shows an embodiment of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 20] 15 shows an embodiment of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 21] 15 shows an embodiment of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 22] 1 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 23] 23 shows a front view of the implantable device or implant of FIG. 22. [Figure 24] 23 shows a side view of the implantable device or implant of FIG. 22. [Figure 25] 23 shows a front view of the implantable device or implant of FIG. 22 with a cover over the paddle and coaptation element or spacer. [Figure 26]23 shows a top perspective view of the implantable device or implant of FIG. 22 in an open position. [Figure 27] 23 shows a bottom perspective view of the implantable device or implant of FIG. 22 in the open position. [Figure 28] 1 shows a clasp for use in an implantable device or implant. [Figure 29] 1 shows a portion of native valve tissue grasped by a clasp. [Figure 30] 1 shows a side view of an exemplary implantable device or implant with the clasp in a closed position and in a partially open position. [Figure 31] 1A-1C show side views of an exemplary implantable device or implant with the clasp in an open and partially open position. [Figure 32] 1 shows a side view of an exemplary implantable device or implant in a semi-open position with the clasp in a closed position. [Figure 33] 1 shows a side view of an exemplary implantable device or implant in a semi-open position with the clasp in the open position. [Figure 34] 1 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in a closed position. [Figure 35] 1 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in the open position. [Figure 36] 1A-1C show side views of an exemplary implantable device in a fully open or fully bailed out position with the clasp in a closed position. [Figure 37] 1A-1C show side views of an exemplary implantable device in a fully open or fully bailed out position with the clasp in an open position. [Figure 38] 30-38, including a cover, is shown delivered and implanted within a native valve. [Figure 39] 30-38 are shown delivered and implanted within the autologous valve, including the cover. [Figure 40] 30-38 are shown delivered and implanted within the autologous valve, including the cover. [Figure 41] 30-38 are shown delivered and implanted within the autologous valve, including the cover. [Figure 42] 30-38 are shown delivered and implanted within the autologous valve, including the cover. [Figure 43] 30-38 are shown delivered and implanted within the autologous valve, including the cover. [Figure 44] 30-38 are shown delivered and implanted within the autologous valve, including the cover. [Figure 45] 30-38 are shown delivered and implanted within the autologous valve, including the cover. [Figure 46] 30-38 are shown delivered and implanted within the autologous valve, including the cover. [Figure 47] 30-38 are shown delivered and implanted within the autologous valve, including the cover. [Figure 48] 30-38 are shown delivered and implanted within the autologous valve, including the cover. [Figure 49] 30-38 are shown delivered and implanted within the autologous valve, including the cover. [Figure 50] 1A-1C are schematic diagrams illustrating the paths of the leaflets of a native valve along each side of a coaptation element or spacer of an exemplary valve repair device or implant. [Figure 51] 1A-1C are top schematic views illustrating the path of the leaflets of a native valve around a coaptation element or spacer of an exemplary valve repair device or implant. [Figure 52]1 illustrates a coaptation element or spacer in the gap of the native valve as viewed from the atrial side of the native valve. [Figure 53] 1 illustrates a valve repair device or implant attached to the leaflets of a native valve, with coaptation elements or spacers in the gaps between the native valve when viewed from the ventricular side of the native valve. [Figure 54] 1 is a perspective view of a valve repair device or implant attached to the leaflets of a native valve, with coaptation elements or spacers in the gaps of the native valve as viewed from the ventricular side of the native valve. FIG. [Figure 55] 1 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 56] 1 illustrates a perspective view of an exemplary clasp of an exemplary implantable device or implant in a closed position. [Figure 57] 1 shows an exemplary implantable device or implant attached to the leaflets of a dysfunctional mitral valve as viewed from the atrial side of the mitral valve, with the implantable device or implant inducing a tension force on the leaflets. [Figure 58] As shown in FIG. 57, an example of an implantable device or implant that can be used to induce tension forces on the valve leaflets is shown. [Figure 59] 59 shows the implantable device or implant of FIG. 58 attached to the leaflets of a native valve and providing a tension force to the leaflets. [Figure 60] An example of an implantable device or implant is shown that includes an indicator feature to allow a user to determine whether a tension force applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicator feature being movable between an acceptable tension position and an exceeded tension position. [Figure 61]FIG. 1 shows a partial view of an example of an implantable device or implant that includes an indicator feature to allow a user to determine whether the tension applied to the implantable device or implant has exceeded a preset or predetermined tension, the indicator feature being included on one or more clasps of the implantable device or implant and indicating an acceptable tension position. [Figure 62] 62 shows a partial view of the implantable device or implant of FIG. 61 with the indicator feature shown in an over-tension position. [Figure 63] An example of an implantable device or implant is shown that includes an indicating feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicating feature being movable between an acceptable tension position and an exceeded tension position. [Figure 64] An example of an implantable device or implant is shown that includes an indicating feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicating feature being movable between an acceptable tension position and an exceeded tension position. [Figure 65] An example of an implantable device or implant is shown that includes an indicating feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicating feature being movable between an acceptable tension position and an exceeded tension position. [Figure 66] An example of an implantable device or implant is shown that includes an indicating feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicating feature being movable between an acceptable tension position and an exceeded tension position. [Figure 67]An example of an implantable device or implant is shown that includes an indicating feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicating feature being movable between an acceptable tension position and an exceeded tension position. [Figure 68] An example of an implantable device or implant is shown that includes an indicating feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicating feature being movable between an acceptable tension position and an exceeded tension position. [Figure 69] An example of an implantable device or implant is shown that includes an indicating feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicating feature being movable between an acceptable tension position and an exceeded tension position. [Figure 70] An example of an implantable device or implant is shown that includes an indicating feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicating feature being movable between an acceptable tension position and an exceeded tension position. [Figure 70A] An example of an implantable device or implant is shown that includes an indicator feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicator feature being movable between an acceptable tension position and an exceeded tension position, and the implantable device or implant has a connecting element to lock the implantable device or implant in a closed position. [Figure 71] 71 shows the implantable device or implant of FIG. 70 with the indicator feature in an over-tensioned position. [Figure 71A]70B shows the implantable device or implant of FIG. 70A with the indicator feature in an over-tensioned position. [Figure 72] An example of an implantable device or implant is shown that includes an indicating feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicating feature being movable between an acceptable tension position and an exceeded tension position. [Figure 72A] An example of an implantable device or implant is shown that includes an indicator feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicator feature being movable between an acceptable tension position and an exceeded tension position, and the implantable device or implant has a connecting element to lock the implantable device or implant in a closed position. [Figure 73] 73 shows the implantable device or implant of FIG. 72 with the indicator feature in an over-tensioned position. [Figure 73A] 72B shows the implantable device or implant of FIG. 72A with the indicator feature in an over-tensioned position. [Figure 74] An example of a clasp for an implantable device or implant is shown, the clasp including an indicator feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicator feature being movable between an acceptable tension position and an exceeded tension position. [Figure 75] 75 shows the clasp of FIG. 74 with the indicator feature in an over-tension position. [Figure 76] 75 shows the clasp of FIG. 74 attached to the leaflets of a native heart valve, with the indicator feature in an acceptable tension position. [Figure 77] 75 shows the clasp of FIG. 74 attached to the leaflets of a native heart valve, with the indicator feature in an over-tension position. [Figure 78] An example of a clasp for an implantable device or implant attached to the leaflets of a native heart valve is shown, the clasp including an indicator feature to allow a user to determine whether tension applied to the implantable device or implant has reached or exceeded a preset or predetermined tension, the indicator feature being movable between an acceptable tension position and an exceeded tension position. [Figure 79] 79 shows the clasp of FIG. 78 with the indicator feature in an over-tension position. [Figure 80] An example of a clasp is shown that includes an indicator feature to allow a user to determine whether the tension applied to an implantable device or implant has reached or exceeded a preset or predetermined tension, the indicator feature being movable between an acceptable tension position and an exceeded tension position. [Figure 81] An example of a clasp is shown that includes an indicator feature to allow a user to determine whether the tension applied to an implantable device or implant has reached or exceeded a preset or predetermined tension, the indicator feature being movable between an acceptable tension position and an exceeded tension position. DETAILED DESCRIPTION OF THE INVENTION

[0028] The following description refers to the accompanying drawings that illustrate exemplary embodiments of the present disclosure. Some embodiments having different structure and operation do not depart from the scope of the present disclosure.

[0029] Exemplary embodiments of the present disclosure are directed to systems, devices, methods, etc. for repairing defective heart valves. For example, various embodiments of implantable devices, valve repair devices, implants, and systems (including systems for their delivery) are disclosed herein, and any combination of these options may be made unless specifically excluded. In other words, individual components of the disclosed devices and systems may be combined unless mutually exclusive or otherwise physically impossible. Furthermore, the techniques and methods herein may be performed on live animals or simulations, such as, for example, cadavers, cadaver hearts, simulators (e.g., simulated body parts, hearts, tissues, etc.).

[0030] As used herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection may be direct between the components or may be indirect, such as through the use of one or more intermediate components. Also, as used herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but can include a collection of components, members, or elements. Also, as used herein, the terms "substantially" and "about" are defined as at least near (and including) a given value or condition (preferably, within 10%, more preferably, within 1%, and most preferably, within 0.1%).

[0031] 1 and 2 are cutaway 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. Furthermore, an aortic valve AV separates the left ventricle LV from the ascending aorta AA, and a 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 ) extending inward across their respective orifices that come together or "coapt" in flow to form a one-way fluid-occluding surface. The autologous valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomical structures of the left atrium LA and 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.

[0032] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, shown in FIG. 1, blood already collected in the left atrium LA (during systole) moves into the left ventricle LV through the mitral valve MV due to the expansion of the left ventricle LV. During the systolic phase, or systole, shown in FIG. 2, the left ventricle LV contracts, pumping 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 returning from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some embodiments, the device described by the present application is used to restore the function of a defective mitral valve MV. That is, the device is configured to close the leaflets of the mitral valve to help prevent blood from returning 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, which beneficially acts as a filler for the regurgitant orifice to prevent or inhibit backflow or regurgitation during systole, although this is not required.

[0033] Referring now 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, a variably dense ring of fibrous tissue surrounding the leaflets 20, 22. Referring to FIGS. 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located at the base of the chordae tendineae CT and within the wall of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM limit the movement of the leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from retracting. 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 valve 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 functions to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed. When viewed from the left ventricular outflow tract (LVOT) view shown in FIG. 3, the anatomy of the valve leaflets 20, 22 is such that the medial sides of the leaflets coapt at their free ends and the leaflets 20, 22 begin to retract or splay away from each other. The leaflets 20, 22 splay apart toward the atrium until each leaflet contacts the mitral annulus.

[0034] Various disease processes can impair the proper function of one or more of the heart's native valves. 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.). Furthermore, 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 cardiac diseases (e.g., cardiomyopathies, etc.) can deform the shape of the native valve, which can lead to malfunction of the native valve. However, the majority of patients undergoing valve surgery, such as mitral valve (MV) surgery, suffer from degenerative disease that causes malfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve (MV)), resulting in prolapse and regurgitation.

[0035] Generally, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when the native valve does not open completely, thereby causing obstruction to blood flow. Typically, valve stenosis results from the accumulation of calcified material on the valve leaflets, which thickens the leaflets and impairs the valve's ability to open completely and allow forward blood flow. Valve regurgitation occurs when the valve leaflets do not close completely, causing blood to leak back into the previous ventricle (e.g., blood leaking from the left ventricle into the left atrium).

[0036] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier Type I, Type II, and Type III insufficiency. Carpentier Type I insufficiency involves annular dilation, such that the normally functioning leaflets are deflected from one another and are unable to form a tight seal (i.e., the leaflets do not coapt properly). Type I mechanism dysfunctions include leaflet perforation, such as occurs in endocarditis. Carpentier Type II insufficiency involves prolapse of one or more native valve leaflets above the plane of coaptation. Carpentier Type III insufficiency involves restriction of one or more native valve leaflets, such that the leaflets are abnormally constricted below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0037] Referring to FIG. 5, when a healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV into the left atrium LA. Referring to FIGS. 3 and 6, during systole, mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV are translated into the left atrium LA, so that the edges of the leaflets 20, 22 do not contact each other. This lack of coaptation causes a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow regurgitantly from the left ventricle LV into the left atrium LA during systole, as exemplified by the mitral regurgitation MR flow path shown in FIG. 3. Referring to FIG. 6, the gap 26 can have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 can have a width W greater than 15 mm. As noted above, there are several different ways in which a valve leaflet (eg, the leaflets 20, 22 of the mitral valve MV) can be dysfunctional, thereby causing valve regurgitation.

[0038] In any of the above situations, a valve repair device or implant capable of engaging the anterior and posterior leaflets 20, 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV is desirable. As seen in FIG. 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the valve leaflets 20, 22 so that backflow does not occur during systole (compare FIG. 3 to FIG. 4). In some embodiments, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, etc.) of device 10 have a generally tapered or triangular shape that naturally conforms to the geometry of the native valve and its propensity to expand (toward the annulus). In this application, the terms spacer, coaptation element, coaptation element, and gap filler are used interchangeably and refer to elements that are configured to fill a portion of the space between the leaflets of the native valve and / or to cause the leaflets of the native valve to engage or "coapt" (e.g., so that the native valve leaflets coapt against the coaptation element, coaptation element, spacer, etc. instead of only against each other).

[0039] While stenosis or regurgitation can affect any valve, stenosis is known to primarily affect either the aortic valve (AV) or the pulmonary valve (PV), while regurgitation is known to primarily affect either the mitral valve (MV) or the tricuspid valve (TV). Both valve stenosis and valve regurgitation increase the workload of the heart (H) and, if left untreated, can lead to very serious conditions, including endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for circulating blood throughout the body. Therefore, because pressures on the left side of the heart are substantially higher, malfunction of the mitral valve (MV) or aortic valve (AV) is particularly problematic and often life-threatening.

[0040] Dysfunction of a native heart valve can be either repaired or replaced. Repair typically involves preserving and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic or pulmonary valve can involve removal of the valve and replacement with a surgically implanted heart valve or 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, can prevent the mitral valve (MV) or tricuspid valve (TV) from closing properly and allow regurgitation or backflow of blood from the ventricle into the atrium (e.g., a deformed mitral valve (MV) may 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 into the atrium results in valvular insufficiency. Deformities in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. Additionally, regurgitation can occur because the chordae tendineae CT become incompetent (e.g., the chordae tendineae CT may stretch or rupture), allowing the anterior and posterior leaflets 20, 22 to back out, thus allowing blood to flow back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be corrected by repairing the structure of the chordae tendineae CT or mitral valve MV (e.g., by fixating the leaflets 20, 22 in the affected portion of the mitral valve).

[0041] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve and any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit the backflow of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or inhibit the backflow of blood from the right ventricle into the right atrium. Furthermore, any of the devices and concepts provided herein can be used on all three leaflets 30, 32, and 34 together to prevent or inhibit the backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein can be centrally positioned between the three leaflets 30, 32, and 34.

[0042] Exemplary implantable devices (e.g., implantable devices, etc.) or implants may optionally include a coaptation element (e.g., a spacer, coaptation element, void filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some embodiments, an implantable device or implant may include any combination or subcombination of the features disclosed herein without a coaptation element. When included, the coaptation element (e.g., a coaptation element, spacer, etc.) is configured to be positioned within the native heart valve orifice to help fill the space between the valve leaflets and form a more effective seal, thereby reducing or preventing regurgitation. The coaptation element may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the native valve leaflets to close around the coaptation element during ventricular systole, preventing blood from flowing 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 valve leaflets, i.e., the device can be used with native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because it can fill the space between improperly functioning native valve leaflets (e.g., mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) that do not close completely.

[0043] The optional coaptation element (e.g., spacer, coaption element, etc.) can have a variety of shapes. In some embodiments, the coaptation element can have an elongated cylindrical shape with a circular cross-sectional shape. In some embodiments, the coaptation element can have an elliptical, oval, crescent, rectangular cross-sectional shape, or various other non-cylindrical shapes. In some embodiments, the coaptation element can have an atrial portion positioned in or adjacent to the atrium, a ventricular or inferior portion positioned in or adjacent to the ventricle, and lateral sides extending between the native valve leaflets. In some embodiments configured for use with a tricuspid valve, the atrial or superior portion is positioned in or adjacent to the right atrium, and the ventricular or inferior portion is positioned in or adjacent to the right ventricle, with lateral sides extending between the native tricuspid valve leaflets.

[0044] In some embodiments, the anchors can be configured to secure the device to one or both of the native valve leaflets so that the coaptation element is positioned between two native leaflets. In some embodiments configured for use with a tricuspid valve, the anchors can be configured to secure the device to one, two, or three of the tricuspid valve so that the coaptation element is positioned between three native leaflets. In some embodiments, the anchors can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some embodiments, the anchors can be attached to an actuating element, such as a shaft or actuation wire, to which the coaptation element is also attached. In some embodiments, the anchors and coaptation element can be positioned independently relative to each other by separately moving each of the anchor and coaptation element along the longitudinal axis of the actuating element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some embodiments, the anchors and coaptation element can be positioned simultaneously by moving the anchor and coaptation element together along the longitudinal axis of the actuating element (e.g., shaft, actuation wire, etc.). The anchors can be configured to be positioned behind the native valve leaflets when implanted so that the leaflets are grasped by the anchors.

[0045] 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 elements and anchors may be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured so that the anchors first expand radially away from the still-compressed coaptation elements to create a gap between the coaptation elements and the anchors. The native leaflets may then be positioned within the gap. The coaptation elements may be radially expanded to close the gap between the coaptation elements and the anchors and capture the leaflets between them. In some embodiments, the anchors and coaptation elements are optionally configured to self-expand. Implantation methods for various embodiments may vary and are discussed more fully below with respect to each embodiment. Additional information regarding these and other delivery methods may be found in U.S. Patent Nos. 6,279,249; 6,279,280; 6,279,290; 6,279,290; and 6,279,290, each of which is incorporated herein by reference in its entirety and for all purposes. These methods may, mutatis mutandis, be performed on live animals or on simulations such as, for example, cadavers, cadaver hearts, simulators (e.g., simulated body parts, hearts, tissues), etc.

[0046] The disclosed device or implant can be configured with anchors connected to the valve leaflets and utilizing tension from the natural chordae tendineae to resist high systolic pressures that pull the device toward the left atrium. During diastole, the device can rely on compressive and retaining forces exerted on the leaflets that are gripped by the anchors.

[0047] 8-15, a schematic illustration of an implantable device or implant 100 (e.g., a prosthetic spacer device, a valve repair device, etc.) is shown in various stages of deployment. Device or implant 100 and other similar devices / implants are described in more detail in U.S. Patent Nos. 6,275,929, 6,282,975, 6,297,097, and 6,297,097, which are incorporated herein by reference in their entireties. Device 100 may include any other features of implantable devices or implants discussed in this or the above-listed applications, and device 100 may be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this or the above-listed applications).

[0048] 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 coaption or interface portion 104 and an anchor portion 106.

[0049] In some embodiments, the coaptation portion 104 of the device or implant 100 includes a coaptation element or coaptation means 110 (e.g., a spacer, plug, filter, foam, sheet, membrane, coaption element, etc.) adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and slidably attached to an actuation element 112 (e.g., an actuation wire, an actuation shaft, an actuation tube, 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, paddles, grasping elements, etc. Actuation of the actuation means or actuation means 112 opens and closes the anchor portion 106 of the device 100 to grasp the leaflets of the native valve during implantation. The actuation means or actuation elements 112 (as well as other actuation means and elements herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), be made from a variety of different materials, and have a variety of configurations. As an example, the actuation element may be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the interface portion 104. Alternatively, the actuation element may be non-threaded such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the interface portion 104.

[0050] The anchor portion 106 and / or anchor of the device 100, in some embodiments, includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the mating means or mating element 110 by portions 124, 126, and 128. The portions 124, 126, and 128 may be coupled and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, mating element 110, and cap 114 by portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.

[0051] In some embodiments, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuation means or element 112 (e.g., an actuation wire, an actuation shaft, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some embodiments, the actuation means or element 112 extends through the delivery catheter and the attachment means or 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 attachment element 110 and the distal end (e.g., a cap 114 or other attachment portion) of the device, respectively. In some embodiments, a collar or other attachment element removably attaches, either directly or indirectly, the joint element 110 to the delivery system 102 such that the actuation means or element 112 slides through the collar or other attachment element, and in some embodiments, through the joint means or element 110 during actuation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0052] In some embodiments, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member. The illustrated gripping member may include a clasp 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, adhesive, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122. In some embodiments, the fixed arm 132 is attached to the inner paddle 122 using the joint portion 138 located proximate to the joining means or joining element 110. In some embodiments, the clasp (e.g., a barbed clasp, etc.) has a flat surface and does not fit into a recess in the inner paddle. Rather, the flat portion of the clasp is positioned against the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed arm and the movable arms 132, 134 of the clasp 130. Joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, etc. In some embodiments, joint portion 138 is a single piece of flexible material integrally formed with fixed and movable arms 132, 134. Fixed arm 132 is attached to inner paddle 122 and remains fixed or substantially fixed relative to inner paddle 122 when movable arm 134 is opened to open clasp 130 and expose flip, friction-enhancing element, or securing means 136.

[0053] In some embodiments, 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 portion 138. The actuation line 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible.

[0054] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, etc. The clasp 130 can be spring-loaded so that in the closed position, the clasp 130 continues to provide a clamping force on the grasped native valve leaflet. This clamping force remains constant regardless of the position of the inner paddle 122. Optional barbs, friction-enhancing elements, or other fixation means 136 of the clasp 130 can grasp, pinch, and / or pierce the native valve leaflet to further secure it.

[0055] During implantation, the paddles 120, 122 can be opened and closed to grasp native valve leaflets (e.g., native mitral valve leaflets) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation means or coaptation element 110, for example. The clasps 130 can be used to grasp and / or further secure the native valve leaflets by engaging the leaflets with barbs, friction-enhancing elements, or fixation means 136 and clamping the leaflets between the movable arms 134 and fixation arms 132. The barbs, friction-enhancing elements, or other fixation means 136 (e.g., barbs, projections, ridges, grooves, textured surfaces, adhesives, etc.) of the clasp or barbed clasp 130 can increase friction with the leaflets or partially or fully pierce the leaflets. The actuation wires 116 can be separately actuated to allow each clasp 130 to be opened and closed separately. Separate manipulations allow for grasping one leaflet at a time or repositioning of the clasp 130 on a poorly grasped leaflet without altering the good grip of the other leaflet. 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), thereby allowing for grasping of the leaflets in various positions as a particular situation requires.

[0056] Referring now to FIG. 8 , device 100 is shown in an elongated or fully open state for deployment from an implant delivery catheter of a delivery system 102. Because the fully open position takes up minimal space, allowing the smallest catheter to be used (or the largest device 100 to be used for a given catheter size), device 100 is positioned at the end of the catheter of delivery system 102 in the fully open position. In the elongated state, cap 114 is spaced from the attachment means or attachment element 110 so that paddles 120, 122 are fully extended. In some embodiments, the angle formed between the interior of outer and inner paddles 120, 122 is approximately 180 degrees. Clasp 130 is held closed during deployment through delivery system 102 so that barbs, friction-enhancing elements, or other securing means 136 ( FIG. 9 ) do not catch or damage tissue within delivery system 102 or the patient's heart. Actuation wire 116 may extend from and be attached to a movable arm 134.

[0057] 9, the device 100 is shown in an elongated, uncoiled state similar to that of FIG. 8, but with the clasp 130 in a fully open position at an angle ranging from 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. Allowing the paddles 120, 122 and the clasp 130 to be fully open has been found to improve the ease of uncoil or detachment of the device 100 from the patient's anatomy, such as the chordae tendineae CT, during implantation.

[0058] Referring now to FIG. 10 , the device 100 is shown in a contracted or fully closed state. The compact size of the device 100 in the contracted state allows for easier manipulation and placement within the heart. To move the device 100 from the elongated state to the contracted state, the actuation means or element 112 is retracted, pulling the cap 114 toward the attachment means or element 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained such that a compressive force acting on the retracted outer paddle 120 from the cap 114 toward the attachment means or element 110 moves the paddle or gripping element radially outward. During movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with the actuation means or element 112. The outer paddle 120 may optionally be biased toward the closed position. During the same movement, the inner paddles 122 move through a significantly larger angle because they are oriented away from the joining means or joining element 110 in the open state and folded along both sides of the joining means or joining element 110 in the closed state. In some embodiments, the inner paddle 122 is 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 more movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some embodiments, 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, for example, to allow for more movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some embodiments, the inner paddle 122 may be the same or substantially the same width as the outer paddle.

[0059] 11-13, device 100 is shown in a partially open, ready-to-grasp state. To transition 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 cap 114 away from coaptation means or element 110, thereby pulling outer paddle 120, which in turn pulls inner paddle 122, causing anchor or anchor portion 106 to partially unfold. Actuation wire 116 is also retracted to open clasp 130, which may then grasp the valve leaflets. In some embodiments, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single actuation means or element 112. Additionally, the position of clasp 130 depends on the position of paddles 122, 120. For example, referring to FIG. 10, closing paddles 122, 120 also closes the clasp. In some embodiments, paddles 120, 122 may be independently controllable. For example, device 100 may have two actuation elements and two independent caps (or other mounting portions), whereby one independent actuation element (e.g., a wire, shaft, etc.) and cap (or other mounting portion) is used to control one paddle, and the other independent actuation element and cap (or other mounting portion) is used to control the other paddle.

[0060] 12, one of the actuation lines 116 extends to allow one of the clasps 130 to close. Referring now to FIG. 13, the other actuation line 116 extends to allow the other clasp 130 to close. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0061] 14 , the device 100 is shown in a fully closed and deployed state. The delivery system or delivery means 102 and actuation means or element 112 are retracted, with the paddles 120, 122 and clasp 130 still in the fully closed position. Once deployed, the device 100 may be maintained in the fully closed position by a mechanical latch, or may be biased to remain closed through 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, joint 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 a shape-memory alloy, such as Nitinol, fabricated from a wire, sheet, tube, or laser-sintered powder, and biased to hold the outer paddle 120 closed around the coaptation means or element 110, and the clasp 130 clamped around the native valve leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the valve leaflets. In some embodiments, the attachment or connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 closed after implantation.

[0062] Figure 15 illustrates an embodiment in which the paddles 120, 122 are independently controllable. The device 101 illustrated by Figure 15 is similar to the device illustrated by Figure 11, except that the device 100 of Figure 15 includes actuation elements configured as two independent actuation elements or actuation wires 111, 113 coupled to two independent caps 115, 117. To transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, the actuation means or actuation element 111 extends to push the cap 115 away from the joining means or joining element 110, thereby pulling the outer paddle 120, which pulls the inner paddle 122 and causes the first anchor 108 to partially unfold. To transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, the actuation means or element 113 extends to push the cap 115 away from the mating means or element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially unfold. The independent paddle control illustrated by FIG. 15 can be implemented in any of the devices disclosed herein. For comparison, in the embodiment illustrated by FIG. 11, the pair of inner and outer paddles 122, 120 move in unison, rather than independently, by a single actuation means or element 112.

[0063] 16-21, the implantable device 100 of Figures 8-14 is shown delivered and implanted within the native mitral valve MV of the heart H. Referring now to Figure 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA, and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as illustrated in Figure 16. The actuation means or element 112 is then retracted to move the implant / device to a fully closed state shown in Figure 17.

[0064] As can be seen in Figure 18, the implant / device is moved into position within the ventricle LV and into the mitral valve MV and partially opened so that the leaflets 20, 22 can be grasped. For example, the steerable catheter can be advanced and steered or bent to position the steerable catheter as illustrated by Figure 18. An implant catheter connected to the implant / device can be advanced from inside the steerable catheter to position the implant as illustrated by Figure 18.

[0065] 19, the implant catheter may be retracted into the steerable catheter to position the valve leaflets 20, 22 within the clasps 130. The actuating wire 116 is extended to close one of the clasps 130 and capture the leaflet 20. FIG. 20 shows that the other actuating wire 116 is then extended to close the other clasp 130, capturing the remaining leaflet 22. Finally, as seen in FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuating means or element 112, and actuating wire 116 are then retracted, and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0066] 22-27, an example 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, illustrated generally in FIGS. 8-14, can assume. The device 200 can include any other features of an implantable device or implant discussed herein, and the device 200 can 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). The device / implant 200 can be a prosthetic spacer device, a valve repair device, or another type of implant that attaches to the leaflets of a native valve.

[0067] In some embodiments, implantable device or implant 200 includes a coaptation or coaptation portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some embodiments, device coaptation or coaptation portion 204 optionally includes a coaptation element 210 (e.g., a spacer, coaptation element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some embodiments, anchor portion 206 includes multiple anchors 208. The anchors may be configured in various ways. In some embodiments, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some embodiments, attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism 213 ( FIGS. 43-49 ) of delivery system 202 ( FIGS. 38-42 and 49 ). Delivery system 202 may be the same as or similar to delivery system 102 described elsewhere and 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, and the like.

[0068] In some embodiments, the joint elements 210 and paddles 220, 222 may be formed from a flexible material, which may be a metal fiber, such as mesh, woven, knitted, or formed in any other suitable manner, or a laser cut or otherwise cut flexible material. The material may also be cloth, wire such as Nitinol to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0069] An actuation element 212 (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from the delivery system 202 to engage and enable actuation of the implantable device or implant 200. In some embodiments, the actuation 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 actuation element 212 may be configured to releasably engage the cap 214, such as with a threaded connection, so that the actuation element 212 can be disengaged and removed from the device 200 after implantation.

[0070] The coaptation element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddle 222. In some embodiments, the coaptation element 210 has a generally elongated, round shape, although other shapes and configurations are possible. In some embodiments, the coaptation element 210 has an oval 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 round shape or cross-section when viewed from the side (e.g., FIG. 24). A blend of these three geometries can result in the three-dimensional shape of the illustrated coaptation element 210 achieving the benefits described herein. The round shape of the coaptation element 210 can also be seen to substantially follow or approximate the shape of the paddle frame 224 when viewed from above.

[0071] The size and / or shape of the coaptation element 210 can be selected to minimize the number of implants (preferably one) required by a single patient while simultaneously maintaining a low transvalvular gradient. In some embodiments, the anterior-posterior distance at the top of the coaptation element is approximately 5 mm, and the medial-lateral distance of the coaptation element at its widest portion is approximately 10 mm. In some embodiments, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It is readily apparent that using other anterior-posterior distances and medial-lateral distances as a starting point for the device will result in a device with different dimensions. Furthermore, using other size and shape strategies described above will also result in a device with different dimensions.

[0072] In some embodiments, outer paddle 220 is articulably attached to cap 214 of distal portion 207 by connecting portion 221 and to inner paddle 222 by connecting portion 223. Inner paddle 222 is articulably attached to the articulating element by connecting portion 225. In this manner, anchor 208 is configured similar to a leg in that inner paddle 222 is like the upper part of the leg, outer paddle 220 is like the lower part of the leg, and connecting portion 223 is like the knee part of the leg.

[0073] In some embodiments, the inner paddle 222 is hard, relatively hard, rigid, has a rigid portion, and / or is reinforced by a reinforcing member or fixed portion 232 of the clasp 230. The reinforcement of the inner paddle allows the device to move to a variety of different positions as shown and described herein. The inner paddle 222, outer paddle 220, and joints may all be interconnected as described herein, thereby constraining the device 200 to the movements and positions as shown and described herein.

[0074] In some embodiments, the paddle frame 224 is attached to the cap 214 at the distal portion 207 and extends to a connection portion 223 between the inner and outer paddles 222, 220. In some embodiments, the paddle frame 224 is formed of 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.

[0075] The paddle frame 224, as can be seen in FIG. 51 , provides additional clamping force between the inner paddle 222 and the coaptation element 210 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 extending 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, 222, the cap 214, and the coaptation element 210 can limit each of these portions to the movements and positions described herein. In particular, the connecting portion 223 is limited by its connection between the outer and inner paddles 220, 222 and by its connection to the paddle frame 224. Similarly, the paddle frame 224 is limited by its attachment to the connecting portion 223 (and thus the inner and outer paddles 222, 220) and the cap 214.

[0076] Configuring the paddle frame 224 in this manner provides an increased surface area compared to the outer paddle 220 alone, which can facilitate, for example, grasping and securing the native valve leaflets. The increased surface area can also distribute the clamping force of the paddles 220 and paddle frame 224 against the native valve leaflets over a larger surface area of ​​the native valve leaflets to further protect the native leaflet tissue. Referring again to FIG. 51 , the increased surface area of ​​the paddle frame 224 can also enable the native valve leaflets to be secured to the implantable device or implant 200 such that the native leaflets are fully coapted around the coaptation member or element 210. This can, for example, improve the sealing of the native valve leaflets 20, 22 and thus prevent or further reduce mitral regurgitation.

[0077] In some embodiments, the clasp includes a movable arm connected to the anchor. In some embodiments, the clasp 230 includes a base or fixed arm 232, a movable arm 234, a barb 236, and a joint portion 238. The fixed arm 232 is attached to the inner paddle 222, and the joint portion 238 is positioned proximate to the joining element 210. The joint portion 238 is spring loaded so that the fixed and movable arms 232, 234 are biased toward each other when the clasp 230 is in the closed state. In some embodiments, the clasp 230 includes friction-enhancing elements or means for fastening, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0078] In some embodiments, the locking arm 232 is attached to the inner paddle 222 with a suture (not shown) through a hole or slot 231. The locking 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, welding, an adhesive, etc. The locking arm 232 remains substantially fixed relative to the inner paddle 222 when the movable arm 234 opens, opening the clasp 230 and exposing the barb or other friction-enhancing element 236. The clasp 230 is opened by applying tension to an actuation line 216 (shown, for example, in FIGS. 43-48 ) attached to a hole 235 in the movable arm 234, thereby causing the movable arm 234 to articulate, pivot, and / or bend on a joint portion 238.

[0079] 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 the movable and locking arms 234 of the clasp 230. The tissue of the leaflets 20, 22 is not pierced by the barbs or friction-enhancing elements 236, although in some embodiments, the barbs 236 may partially or completely pierce the leaflets 20, 22. The angle and height of the barbs or friction-enhancing elements 236 relative to the movable arms 234 help 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 barbs or friction-enhancing elements 236 to further engage the tissue, thereby ensuring better retention. Retention of the leaflets 20, 22 in the clasp 230 is further improved by the location of the locking arms 232 near the barbs / friction-enhancing elements 236 when the clasp 230 is closed. In this arrangement, the tissue is forced into an S-shaped, tortuous path by the fixed and movable arms 232, 234 and the barbs / frictional enhancement elements 236. Thus, the force pulling the leaflets 20, 22 away from the clasp 230 will encourage the tissue to further engage the barbs / frictional enhancement elements 236 before the leaflets 20, 22 can prolapse. For example, tension on the leaflets during diastole can urge the barbs 236 to pull toward the end portions of the leaflets 20, 22. Thus, the S-shaped path can take advantage of leaflet tension during diastole to more tightly engage the leaflets 20, 22 with the barbs / frictional enhancement elements 236.

[0080] 25 , the prosthetic device or implant 200 may also include a cover 240. In some embodiments, the cover 240 may be disposed on the joint element 210, the outer and inner paddles 220, 222, and / or the paddle frame 224. The cover 240 may be configured to prevent or reduce blood flow through the prosthetic device or implant 200 and / or to promote autologous tissue ingrowth. In some embodiments, the cover 240 may be a cloth or fabric, such as PET, velour, or other suitable fabric. In some embodiments, 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.

[0081] 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. Extending and retracting 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 element) and the coaptation element 210 slide along the actuation element 212 during actuation, and as a result, changing the spacing between the coaptation element 210 and the cap 214 moves the paddles 220, 220 between different positions to grip the mitral valve leaflets 20, 22 during implantation.

[0082] As device 200 opens and closes, the pair of inner and outer paddles 222, 220 are moved in unison by a single actuation element 212, rather than independently. Also, the position of clasp 230 depends on the position of paddles 222, 220. For example, clasp 230 is positioned such that closure of anchor 208 simultaneously closes clasp 230. In some embodiments, device 200 can be fabricated with paddles 220, 222 that are independently controllable in the same manner (e.g., device 100 illustrated in FIG. 15).

[0083] In some embodiments, the clasps 230 further secure the native leaflets 20, 22 by engaging the leaflets 20, 22 with barbs and / or other friction-enhancing elements 236 and sandwiching the leaflets 20, 22 between the movable and fixed arms 234, 232. In some embodiments, the clasps 230 are barbed clasps that include barbs that increase friction with the leaflets 20, 22 and / or can partially or fully pierce the leaflets 20, 22. The actuation lines 216 (FIGS. 43-48) can be separately actuated such that each clasp 230 can be opened and closed separately. Separate actuation allows for gripping one leaflet 20, 22 at a time or allows for repositioning of the clasp 230 on a poorly gripped leaflet 20, 22 without altering the good grip of the other leaflet 20, 22. The clasps 230 can be fully opened and closed when the inner paddles 222 are not closed, thereby allowing the leaflets 20, 22 to be grasped in various positions as the particular situation requires.

[0084] 22-25, the device 200 is shown in the closed position. When closed, the inner paddle 222 is positioned between the outer paddle 220 and the coaptation element 210. The clasp 230 is positioned between the inner paddle 222 and the coaptation element 210. Upon successful capture of the native leaflets 20, 22, the device 200 is moved to and held in the 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 seen in FIG. 51). The curved shape and rounded edges of the outer paddle 220 also prevent or inhibit tearing of the leaflet tissue.

[0085] 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 of the actuating element 212 to a fully retracted position to a fully extended position.

[0086] 30-31 , device 200 is shown in a partially open position. Device 200 is moved to the partially open position by extending actuation element 212. The extension of actuation element 212 pulls down the bottom portions of outer paddle 220 and paddle frame 224. Outer paddle 220 and paddle frame 224 pull down inner paddle 222, which is connected to outer paddle 220 and paddle frame 224. Because proximal collar 211 (or other attachment element) and interface element 210 are held in place by capture mechanism 213, inner paddle 222 is forced to articulate, pivot, and / or bend toward the opening. Inner paddle 222, outer paddle 220, and paddle frame all bend to the positions shown in FIGS. 30 and 31 . The opening of the paddles 222, 220 and frame 224 creates a gap between the coaptation element 210 and the inner paddle 222 that can receive and grasp the native leaflets 20, 22. This movement also exposes the clasp 230, which can move between closed ( FIG. 30 ) and open ( FIG. 31 ) positions to create a second gap for grasping the native leaflets 20, 22. The extent of the gap between the fixed and movable arms 232, 234 of the clasp 230 is limited to the extent that the inner paddle 222 extends away from the coaptation element 210.

[0087] 32 and 33, the device 200 is shown in a laterally extended or open position. The device 200 moves to the laterally extended or open position by continuing to extend the actuation element 212, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207. Continuing to extend the actuation element 212 pulls down the outer paddle 220 and paddle frame 224, thereby causing the inner paddle 222 to spread further away from the coaptation element 210. In the laterally extended or open position, the inner paddle 222 extends more horizontally than in other positions of the device 200, forming an approximately 90-degree angle with the coaptation element 210. Similarly, the paddle frame 224 is in its most spread position when the device 200 is in the laterally extended or open position. The increased gap between the joining element 210 and the inner paddle 222 formed in the laterally extended or open position allows the clasp 230 to open further (FIG. 33) before engaging the joining element 210, thereby increasing the size of the gap between the fixed and movable arms 232, 234.

[0088] 34 and 35 , the exemplary device 200 is shown in a three-quarters extended position. The device 200 moves to the three-quarters extended position by continuing to extend the actuation element 212, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207. Continuing to extend the actuation element 212 pulls down on the outer paddle 220 and paddle frame 224, thereby causing the inner paddle 222 to spread 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 approximately 135 degrees from the coaptation element 210. The paddle frame 224 spreads less than in the laterally extended or open position and begins to move inward toward the actuation element 212 as the actuation element 212 extends further. The outer paddle 220 also bends backward toward the actuation element 212. Similar to the laterally extended or open position, the increased gap between the joint element 210 and the inner paddle 222 formed in the laterally extended or open position allows the clasp 230 to open even further (FIG. 35), thereby increasing the size of the gap between the fixed and movable arms 232, 234.

[0089] 36 and 37 , the exemplary device 200 is shown in a fully extended position. The device 200 moves to the fully extended position by continuing to extend the actuation element 212, 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 to extend the actuation element 212 pulls down the outer paddle 220 and paddle frame 224, thereby causing the inner paddle 222 to spread further away from the coaptation element 210. The outer paddle 220 and paddle frame 224 are moved to a position where they are closer to the actuation element. In the fully extended position, the inner paddle 222 opens approximately 180 degrees from the coaptation element 210. The inner and outer paddles 222, 220 are straightened in the fully extended position, forming an approximately 180-degree angle between the paddles 222, 220. The fully extended position of device 200 provides the largest size of gap between coaptation element 210 and inner paddle 222 and, in some embodiments, also allows clasp 230 to fully open to approximately 180 degrees between fixed and movable arms 232, 234 of clasp 230 ( FIG. 37 ). The position of device 200 is its longest and narrowest configuration. Thus, the fully extended position of device 200 may be the desired position for bailout of device 200 from an attempted implantation, or for placement of the device into a delivery catheter, etc.

[0090] Configuring the prosthetic device or implant 200 so that the anchors 208 can extend to a straight or nearly straight configuration (e.g., approximately 120-180 degrees relative to the coaptation element 210) can provide several advantages. For example, this configuration can reduce the radial wave profile of the prosthetic device or implant 200. It can also 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. Furthermore, the relatively narrow straight configuration can prevent or reduce the likelihood of the prosthetic device or implant 200 becoming entangled within native anatomical structures (e.g., the chordae tendineae CT shown in FIGS. 3 and 4 ) when positioning and / or removing the prosthetic device or implant 200 from the delivery system 202.

[0091] 38-49 , an exemplary implantable device 200 is shown delivered and implanted within a native mitral valve MV of a heart H. As described above, the device 200 shown in FIGS. 38-49 includes a coaptation element 210, a clasp 230, an inner paddle 222, and / or an optional cover 240 (e.g., FIG. 25 ) over the outer paddle 220. The device 200 is deployed from a delivery system 202 (which may comprise, for example, a steerable catheter and / or an implant catheter extendable from a guide sheath), held by a capture mechanism 213 (see, for example, FIGS. 43 and 48 ), and actuated by extending or retracting an actuation element 212. Fingers of the capture mechanism 213 removably attach a collar 211 to the delivery sheath 202. In some embodiments, the capture mechanism 213 is held closed around the collar 211 by the actuating element 212 such that removal of the actuating element 212 allows the fingers of the capture mechanism 213 to open and release the collar 211 to decouple the capture mechanism 213 from the device 200 after the device 200 is successfully implanted.

[0092] 38, a 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 for device 100 (e.g., an implant catheter holding the device / implant can be extended to deploy the device / implant out of the steerable catheter). The actuating element 212 is then retracted to move the device 200 through a partially closed state (FIG. 39) to the fully closed state shown in FIGS. 40 and 41. The delivery system or catheter then steers the device / implant 200 toward the mitral valve MV, as shown in FIG. 41. 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 to open the clasp 230 and prepare to grasp the valve leaflets. Next, as shown in FIGS. 43 and 44, the partial opening device 200 is inserted through the native valve (e.g., by advancing an 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 inside the open clasp 230.

[0093] FIG. 45 shows the device 200 with both clasps 230 closed, but the barb 236 of one clasp 230 has missed one leaflet 22. As can be seen in FIGS. 45-47, the out-of-position clasp 230 is again opened and closed to properly grasp the missed leaflet 22. Once both leaflets 20, 22 are properly grasped, the actuating element 212 is retracted to move the device 200 to the 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 from the cap 214 and retracted to release the capture mechanism 213 from the proximal collar 211 (or other attachment element) so that the capture mechanism 213 may be withdrawn into the delivery system 202, as shown in FIG. Once deployed, the device 200 may be maintained in a fully closed position using mechanical means such as a latch, or may 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 wire, sheet, tube, or laser-sintered powder-produced steel or Nitinol shape memory alloy and are biased to hold the outer paddle 220 closed around the inner paddle 222, the coaptation element 210, and / or the clasp 230 clamped around the native leaflets 20, 22.

[0094] 50-54, when device 200 is implanted in a native valve, coaptation element 210 functions as a gap filler for a valve regurgitation orifice, such as gap 26 in the mitral valve MV illustrated by FIG. 6 or a gap in another native valve. In some embodiments, when device 200 is deployed between two opposing valve leaflets 20, 22, the leaflets 20, 22 no longer coapt against each other in the region of coaptation element 210, but instead coapt against coaptation element 210. This reduces the distance that the leaflets 20, 22 must approximate to close the mitral valve MV, thereby facilitating repair of functional valve disease that can cause mitral regurgitation. The reduction in leaflet proximity may result in several other benefits as well. For example, the reduced proximity required for the leaflets 20, 22 reduces or minimizes stress experienced by the native valve. The shorter approximation distance of the leaflets 20, 22 may also require less approximation force, which may result in less tension experienced by the leaflets 20, 22 and a smaller diameter reduction of the annulus. The smaller, or no, reduction of the annulus may result in a smaller reduction in valve orifice area compared to a device without a coaptation element or spacer. In this manner, the coaptation element 210 may reduce transvalvular gradients.

[0095] 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 leaflets 20, 22 of the native valve. Thus, when the leaflets 20, 22 are coapted against the coaptation element 210, the entire leaflets 20, 22 completely surround or "hugge" the coaptation element 210, thereby preventing small leaks at the lateral and medial surfaces 201, 203 of the coaptation element 210. The interaction of the leaflets 20, 22 and device 200 is made clear in Figure 51, which shows a schematic atrial view or surgeon's perspective showing a paddle frame 224 (not actually visible from a true atrial view, e.g., Figure 52) that conforms to the geometry of the coaptation element 210. The opposing leaflets 20, 22 (both ends of which are also not visible in a true atrial view, e.g., Figure 52) are approximated by the paddle frame 224 to completely surround or "hug" the coaptation element 210.

[0096] 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 the ventricular side in FIG. 53) seems to contradict the statement above that the presence of the coaptation element 210 minimizes the distance the leaflets need to be approximated. However, if the coaptation element 210 is precisely positioned in the regurgitation gap 26, and the regurgitation gap 26 is smaller than the width (medial surface minus lateral surface) of the coaptation element 210, the distance the leaflets 20, 22 need to approximate is still minimized.

[0097] FIG. 50 illustrates the geometry of the coaptation element 210 and paddle frame 224 from the perspective of the LVOT. As can be seen in this figure, the coaptation element 210 has a tapered shape, with smaller dimensions in regions closer to where the inner surfaces of the leaflets 20, 22 need to coapt and increasing dimensions as the coaptation element 210 extends toward the atrium. Thus, the illustrated geometry of the native valve is accommodated by the tapered coaptation element geometry. Further referring to FIG. 50, the tapered coaptation element geometry, in conjunction with the illustrated expanded (toward the annulus) shape of the paddle frame 224, can help achieve coaptation at the inferior ends of the leaflets, reduce stress, and minimize transvalvular gradients.

[0098] 54 , the shapes of the coaptation elements 210 and paddle frame 224 can be defined based on a view of the native valve and the inner commissure of the device 200. Two factors contribute to these shapes: leaflet coaptation against the coaptation elements 210 and reducing stress on the leaflets due to coaptation. With reference to FIGS. 54 and 24 , the coaptation elements 210 can have a round or rounded shape, and the paddle frame 224 can have a full radius that spans nearly the entire length of the paddle frame 224, both to coapt the leaflets 20, 22 against the coaptation elements 210 and to reduce stress applied to the leaflets 20, 22 of the valve by the coaptation elements 210 and / or paddles 224. The round shape of the coaptation elements 210 and / or the illustrated fully rounded shape of the paddle frame 224 distributes 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.

[0099] 55, an embodiment of an implantable device or implant 300 is shown. The implantable device 300 is one of many different configurations that the device 100, illustrated generally in FIGS. 8-14, can assume. The device 300 can include any other features of an implantable device or implant discussed herein, and the device 300 can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0100] Implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some embodiments, device / implant 300 includes a coaptation portion 304, which may optionally include 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 embodiments, anchor portion 306 includes multiple anchors 308. In some embodiments, each anchor 308 may include one or more paddles, such as an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors may also include and / or be coupled to clasps 330. In some embodiments, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging a capture mechanism (such as capture mechanism 213 shown in Figures 43-49) of a delivery system (such as the systems shown in Figures 38-42 and 49).

[0101] Anchors 308 may be attached to other portions of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, by welding, stitching, adhesive, linking, latching, integrally formed, combinations of some or all of these, etc.) In some embodiments, anchors 308 are attached to joining member or joining element 310 by connecting portion 325 and to cap 314 by connecting portion 321.

[0102] Anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a joint portion 323. Connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached to cap 314 or other attachment portion. In this manner, anchor 308 is configured similar to a leg in that inner paddle 322 is like the top portion of the leg, outer paddle 320 is like the bottom portion of the leg, and joint portion 323 is like the knee portion of the leg.

[0103] In embodiments using a joining member or element 310, the joining member or element 310 and the anchor 308 can be connected together in a variety of ways. For example, as shown in the illustrated embodiment, the joining element 310 and the anchor 308 can be connected together by integrally forming the joining element 310 and the anchor 308 as a single, unitary component. This can be accomplished, for example, by forming the joining element 310 and the anchor 308 from a continuous strip 301 of knitted or woven material, such as knitted or woven nitinol wire. In the illustrated embodiment, the joining element 310, outer paddle portion 320, inner paddle portion 322, and connecting portions 321, 323, 325 are formed from a continuous strip 301 of fabric.

[0104] Similar to the anchor 208 of the implantable device or implant 200 described above, the anchor 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.), such that the anchor 308 moves relative to the midpoint of the device. This movement can 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 can 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.

[0105] In some embodiments, in the straight configuration, paddle portions 320, 322 are aligned or linear with respect to the longitudinal axis of the device. In some embodiments, connecting portion 323 of anchor 308 is adjacent to the longitudinal axis of connecting element 310 (e.g., similar to the configuration of device 200 shown in FIG. 36). From the straight configuration, anchor 308 can be moved to a fully collapsed 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, anchor 308 bends at connecting portions 321, 323, 325, and connecting portion 323 moves radially outward relative to the longitudinal axis of device 300 and axially toward the midpoint and / or proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 34). As cap 314 continues to move toward the midpoint and / or 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).

[0106] In some embodiments, the clasp includes a movable arm connected to an anchor. In some embodiments, the clasp 330 includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and a joint portion 338. The fixed arm 332 is attached to the inner paddle 322, and the joint portion 338 is positioned adjacent to the joining element 310. The joint portion 338 is spring loaded such that the fixed and movable arms 332, 334 are biased toward each other when the clasp 330 is in the closed state.

[0107] The locking arm 332 is attached to the inner paddle 322 with sutures (not shown) through holes or slots 331. The locking 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, etc. The locking arm 332 remains substantially fixed relative to the inner paddle 322 when the movable arm 334 opens, releasing the barbed clasp 330 and exposing the barbs 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 the hole 335 in the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or bend on the joint portion 338.

[0108] In summary, implantable device or implant 300 is similar in construction and operation to implantable device or implant 200 described above, except that joint element 310, outer paddle 320, inner paddle 322, and connecting portions 321, 323, 325 are formed from a single strip of material 301. In some embodiments, the strip of material 301 is attached to proximal collar 311, cap 314, and paddle frame 324 by weaving or inserting it through openings in proximal collar 311, cap 314, and paddle frame 324 that are configured to receive the continuous strip of material 301. The continuous strip 301 may be a single layer of material or may include two or more layers. In some embodiments, some portions of device 300 have a single layer of strip of material 301, while other portions are formed from multiple overlapping or overlapping layers of strip of material 301.

[0109] For example, Figure 55 shows a joining member 310 and inner paddle 322 formed from multiple overlapping layers of strip of material 301. The single continuous strip of material 301 can start and end at various locations on the device 300. The ends of the strip of material 301 can be at the same location or at different locations on the device 300. For example, in the illustrated embodiment of Figure 55, the strip of material 301 starts and ends at the location of the inner paddle 322.

[0110] According to the implantable device or implant 200 described above, the size of the coaptation element 310 can be selected to minimize the number of implants (preferably one) required for a single patient while simultaneously maintaining a low transvalvular gradient. In particular, forming many components of device 300 from strips of material 301 allows device 300 to be made smaller than device 200. For example, in some embodiments, the anterior-posterior distance at the top of coaptation element 310 is less than 2 mm, and the medial-lateral distance of device 300 at its widest portion (i.e., the width of paddle frame 324, which is wider than coaptation element 310) is approximately 5 mm.

[0111] After implantation of an implantable device or implant, such as the devices / implants disclosed herein, into a native heart valve, a force can be applied to the valve leaflets through a connection with the implantable device or implant that induces tension on the leaflets, and / or tension can be applied to the implantable device or implant through its connection with the valve leaflets. For example, with reference to FIG. 57 , an implantable device or implant 400 can be connected to the leaflets 20, 22 of the mitral valve MV to close the gap 26 between the leaflets 20, 22 and prevent backflow of blood through the mitral valve during the systolic phase of cardiac contraction. This connection between the device 400 and the leaflets 20, 22 induces a tension force F that pulls the leaflets 20, 22 away from the annulus 24 of the mitral valve MV. This connection between the device 400 and the leaflets 20, 22 can also induce a tension force T on the device 400.

[0112] The implantable device or implant 400 can take any suitable form that can connect to the leaflets 20, 22 of the mitral valve MV and prevent backflow of blood through the mitral valve MV, such as, for example, any of the forms described in this application or any of the forms described in U.S. Patent Nos. 6,279,999, 6,279,999, 6,279,999, and 6,279,999, which are incorporated herein by reference in their entireties.

[0113] 58 and 59, device 400 can include an optional spacer, coaption, or coaptation portion 404, a proximal or attachment portion (e.g., attachment portion 205 shown in FIGS. 22-37), an anchor portion 406, and a distal portion 407. In some embodiments, optional spacer, coaption, or coaptation portion 404 is not included (see, e.g., FIG. 57). In some embodiments, optional coaptation portion 404 of the device optionally includes a coaptation element 410 (e.g., a spacer, coaption element, plug, etc.) for implantation between the leaflets of the native valve. Optional coaptation element 410 can take any suitable form, such as, for example, any of the forms described herein.

[0114] In some embodiments, the anchor portion 406 includes multiple anchors 408. The anchors 408 can be configured in various ways, such as any of the ways described herein. In some embodiments, each anchor 408 includes an outer paddle 420, an inner paddle 422, a paddle extension or paddle frame (e.g., paddle frame 224 shown in FIGS. 22-37), and a clasp 430. The clasp 430 can have a base or fixed arm 432, a movable arm 434, and a barb 436. The fixed arm 432 can be attached to the inner paddle 422, and the joint portion 438 can be disposed proximate to the joining element 410. The fixed arm 432 and the movable arm 434 can be biased toward each other when the clasp 430 is in the closed state. In some embodiments, the clasp 430 includes friction-enhancing elements or means for securing, such as barbs 436, protrusions, ridges, grooves, textured surfaces, adhesives, etc. In some embodiments, clasp 430 is opened by applying tension to actuation line 416 attached to movable arm 434, thereby causing movable arm 434 to articulate, bend, or pivot on joint portion 438. Actuation line 416 can take a wide variety of forms, such as, for example, any of the forms described herein. Paddles 420, 422 and clasp 430 can take any suitable form, such as, for example, any of the forms described herein.

[0115] The attachment portion can include a first or proximal collar (e.g., proximal collar 211 shown in FIGS. 22-37) for engaging a capture mechanism of a delivery system (e.g., capture mechanism 213 shown in FIGS. 43-49). The attachment portion can take any suitable form, such as, for example, any of the forms described herein. In some embodiments, an actuation element 412 (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from the implant catheter (e.g., implant catheter 202 shown in FIG. 43) to engage and enable actuation of the implantable device or implant 400. For example, the actuation element 412 can extend through the capture mechanism, the proximal collar, and the joint element 410 to engage with a cap 414 of the distal portion 407. Actuating element 412 may be configured to releasably engage cap 414, such as with a threaded connection, such that actuating element 412 moves device 400 between open and closed positions, and such that actuating element 412 may be disengaged and removed from device 400 after implantation. Actuating element 412 and cap 414 may take any suitable form, such as, for example, any of the forms described herein.

[0116] 59, an implantable device or implant 400 is shown attached to the leaflets 20, 22 of a native valve (see, for example, FIG. 57). The connection between the device 400 and the leaflets 20, 22 induces a tension force F on the leaflets, and also induces a tension force T on the device 400.

[0117] FIG. 60 illustrates an example of an implantable device or implant 500 that includes an indicator feature 501 that allows a user to determine whether the tension force applied to the implantable device or implant has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. That is, the indicator feature 501 provides a visual indication to the user when the user is viewing the connection between the device 500 and the valve leaflets 20, 22 directly, through echocardiogram, or fluoroscopic imaging. The predetermined tension may be set to the maximum allowable tension for the valve leaflets 20, 22. When the indicator feature 501 indicates to the user that the tension force applied to the device 500 has reached or exceeded the predetermined tension or optimal tension range, the user can release the device 500, detach it from the valve leaflets 20, 22, and reconnect the device in a position where the indicator feature 501 has not reached or exceeded the predetermined tension or optimal tension range.

[0118] Device 500 may include features of any suitable implantable device or implant, such as, for example, features of device 400 shown in FIGS. 58 and 59 or any other device described herein. For example, device 500 may include a coaptation portion 504, a proximal or attachment portion (e.g., attachment portion 205 shown in FIGS. 22-37), an anchor portion 506, and a distal portion 507. In some embodiments, device coaptation portion 504 optionally includes a coaptation element 510 (e.g., a spacer, coaptation element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some embodiments, anchor portion 506 includes multiple anchors 508. Anchors 508 may be configured in a variety of ways, such as, for example, any of the ways described herein. In some embodiments, each anchor 508 includes an outer paddle 520, an inner paddle 522, a paddle extension member or paddle frame (e.g., paddle frame 224 shown in FIGS. 22-37), and a clasp 530. The clasp 530 may have a base or fixed arm 532 and a movable arm 534. The fixed arm 532 may be attached to the inner paddle 522, with a joint portion 538 disposed proximate to the joining element 510. In some embodiments, the clasp 530 includes friction-enhancing elements or means for securing, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc. In some embodiments, the clasp 530 is opened by applying tension to an actuation line 516 attached to the movable arm 534, thereby allowing the movable arm 534 to articulate, bend, or pivot on the joint portion 538. The actuation line 516 may take a wide variety of forms, such as any of those described herein. Paddles 520, 522 and clasp 530 can take any suitable form, such as, for example, any of the forms described in this application.

[0119] In some embodiments, an actuation element 512 (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from an implant catheter (e.g., implant catheter 202 shown in FIG. 43 ) to engage and enable actuation of the implantable device or implant 500. For example, the actuation element 512 can extend through and move relative to the capture mechanism, proximal collar, and coaptation element 510 to engage a cap 514 on the distal portion 507. The actuation element 512 can be configured to releasably engage the cap 514 with a threaded connection, etc., such that the actuation element 512 moves the device 500 between open and closed positions and such that the actuation element can be disengaged and removed from the device 500 after implantation. The actuation element 512 and cap 514 can take any suitable form, such as, for example, any of the forms described herein.

[0120] 60 , the clasps 530 include indicating features 501 that allow a user to determine whether the tension force applied to the implantable device or implant 500 has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. For example, at least a portion of the clasps 530 may be made from a flexible or elastic material that allows at least a portion of the clasps 530 to stretch or extend in the X direction when a tension force T is applied to the device 500 via its connection with the valve leaflets 20, 22. In some embodiments, when one or more of the clasps 530 extend in the direction X to or beyond a predetermined length, the indicating feature 501 indicates that the tension force applied to the device 500 has reached or exceeded the predetermined tension or optimal tension range, in an over-tension position. If the clasp 530 does not extend to or beyond the predetermined length, the indicating feature 501 is in an acceptable tension position, where the tension force applied to the device 500 is below the predetermined tension or within an optimal tension range. A user may determine the amount of extension of the clasp 530, for example, by comparing the outer end of the clasp 530 to other components of the device 500 (e.g., paddles 520, 522, coaptation element 510, etc.), or the imaging software may be configured to measure the length of the clasp 530 to determine whether the clasp has extended to or beyond the predetermined length. In some embodiments, pulling the outer end 535 of the movable arm 534 of the clasp 530 past the outer end 537 of the paddles 520, 522 indicates that the tension force applied to the clasp has reached or exceeded a predetermined acceptable or preset tension. In some embodiments, the indicator feature 501 may include a visible marking (e.g., a dot, an X mark, a radiopaque marker, etc.) that allows a user to more easily determine the extension of the clasp 530 relative to other components of the device 500, such as the paddles 520, 522.

[0121] Figures 61 and 62 illustrate device 600, which is a more specific embodiment of device 500 shown in Figure 60. Figure 61 illustrates device 600 when indicator feature 501 is in an acceptable tension position, and Figure 62 illustrates device 600 when indicator feature 501 is in an excessive tension position. Device 600 includes optional coaptation element 510, inner paddle 520, outer paddle 522, and clasp 530. A fixed arm 532 of clasp 530 is attached to inner paddle 520, and a movable arm 534 of clasp 530 includes barbs 536 (or other friction-enhancing elements or means) that secure device 600 to the leaflets 22 of the native valve. In this example, at least the movable arms 534 of the clasp 530 are made of a flexible or elastic material such that a tension force T ( FIG. 62 ) applied to the device 600 causes the movable arms 534 of the clasp 530 to move in an outward direction X. In some embodiments, the indicator feature 501 may include a visible marking (e.g., a dot, an X mark, etc.) that allows a user to more easily determine the extension of the clasp 530 relative to other components of the device 500.

[0122] 61 , the outer end 535 of the movable arm 534 of the clasp 530 does not extend beyond the outer end 537 of the outer paddle 520, indicating acceptable tension. Referring to FIG. 62 , the outer end 535 of the movable arm 534 of the clasp 530 extends beyond the outer end 537 of the outer paddle 520, indicating excessive tension. The ability of the movable arm 534 to stretch is advantageous because the barbs 536 of the clasp 530, which engage the leaflets 22, move with the movable arm 534, and this stretching of the movable arm 534 reduces the stress applied to the leaflets 22 caused by the barbs 536. While the indication feature 501 of the clasp 530 is shown in conjunction with the devices 500, 600 shown in Figures 60-62, it should be understood that the clasp 530 may be used with any suitable implantable device or implant when the tension applied to the implantable device or implant reaches or exceeds a predetermined tension or optimal tension range.

[0123] FIG. 63 shows an example of an implantable device or implant 700 that includes an indicator feature 701 that allows a user to determine whether the tension force applied to the implantable device or implant has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. In some embodiments, pulling the outer ends 737 of the paddles 720, 722 beyond a predetermined distance indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. For example, a marker 739 may be applied to the inner paddle. Movement of the marker 739 past the outer end 735 of the clasp 730 (or any other portion of the device) indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. That is, the indicator feature 701 provides a visual indication to the user when the user is viewing the connection between the device 700 and the valve leaflets 20, 22, either directly, through echocardiogram, or fluoroscopic imaging. When the indicator feature 701 indicates to the user that the tension force applied to the device 700 has reached or exceeded a predetermined tension or optimal tension range, the user can release the device 700, remove it from the valve leaflets 20, 22, and reconnect the device in a position where the indicator feature 701 has not reached or exceeded the predetermined tension or optimal tension range.

[0124] Device 700 may include features of any suitable implantable device or implant, such as, for example, features of device 400 shown in Figures 58 and 59, or any other device described herein. For example, device 700 may include a coaptation portion 704, a proximal or attachment portion (e.g., attachment portion 205 shown in Figures 22-37), an anchor portion 706, and a distal portion 707. In some embodiments, device coaptation portion 704 optionally includes a coaptation element 710 (e.g., a spacer, coaptation element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some embodiments, anchor portion 706 includes multiple anchors 708. Anchors 708 may be configured in a variety of ways, such as, for example, any of the ways described herein. In some embodiments, each anchor 708 includes an outer paddle 720, an inner paddle 722, a paddle extension member or paddle frame (e.g., paddle frame 224 shown in FIGS. 22-37), and a clasp 730. The clasp 730 may have a base or fixed arm 732 and a movable arm 734. The fixed arm 732 may be attached to the inner paddle 722, with a joint portion 738 disposed proximate to the joining element 710. In some embodiments, the clasp 730 includes friction-enhancing elements or means for securing, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc. In some embodiments, the clasp 730 is opened by applying tension to an actuation line 716 attached to the movable arm 734, thereby allowing the movable arm 734 to articulate, bend, or pivot on the joint portion 738. The actuation line 716 can take a wide variety of forms, such as, for example, any of the forms described herein. Paddles 720, 722 and clasp 730 can take any suitable form, such as, for example, any of the forms described in this application.

[0125] In some embodiments, an actuation element 712 (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from an implant catheter (e.g., implant catheter 202 shown in FIG. 43 ) to engage and enable actuation of the implantable device or implant 700. For example, the actuation element 712 can extend through and move relative to the capture mechanism, proximal collar, and coaptation element 710 to engage a cap 714 on the distal portion 707. The actuation element 712 can be configured to releasably engage the cap 714 with a threaded connection, etc., such that the actuation element 712 moves the device 700 between open and closed positions and such that the actuation element can be disengaged and removed from the device 700 after implantation. The actuation element 712 and cap 714 can take any suitable form, such as, for example, any of the forms described herein.

[0126] 63 , one or both of the paddles 720, 722 include an indicating feature 701 that allows a user to determine whether the tension force applied to the implantable device or implant 700 has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. For example, at least a portion of the paddles 720, 722 may be made from a flexible or elastic material that allows at least a portion of the paddles 720, 722 to stretch or extend in the Z direction when a tension force T is applied to the device 700 through its connection with the valve leaflets 20, 22. In some embodiments, when one or more of the paddles 720, 722 extends to or beyond a predetermined length in the Z direction, the indicating feature 701 indicates that the tension force applied to the device 700 has reached or exceeded the predetermined tension or optimal tension range, in an over-tension position. If the paddles 720, 722 do not extend to or beyond the predetermined length, the indicating feature 701 is in an acceptable tension position, where the tension force applied to the device 700 is below the predetermined tension or within the optimal tension range. The user may determine the amount of extension of the paddles 720, 722, for example, by comparing the outer edges of the paddles 720, 722 to other components of the device 700 (e.g., the clasp 730, the coaptation element 710, etc.), or the imaging software may be configured to measure the length of the paddles 720, 722 to determine whether the clasp has extended to or beyond the predetermined length. In some embodiments, the indicating feature 701 may include visible markings 739 (e.g., a dot, an X, a radiopaque marker, etc.) that allow the user to more easily determine the extension of the paddles 720, 722 relative to other components of the device 700.

[0127] 64 shows an example of an implantable device or implant 800 that includes an indicator feature 801 that allows a user to determine whether the tension force applied to the implantable device or implant has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. In some embodiments, pulling the clasp hinge portion 838 away from the inner paddle 822 beyond a predetermined distance P indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. For example, bending of the fixation arm 832 of the clasp 830 sufficient to form a visible gap between the clasp hinge portion 838 and the inner paddle 822 can be an indicator that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. The indicator feature 801 provides a visual indication to the user when they are viewing the connection between the device 800 and the valve leaflets 20, 22, either directly, through echocardiogram, or fluoroscopic imaging. When the indicator feature 801 indicates to the user that the tension force applied to the device 800 has reached or exceeded a predetermined tension or optimal tension range, the user can release the device 800, remove it from the valve leaflets 20, 22, and reconnect the device in a position where the indicator feature 801 has not reached or exceeded the predetermined tension or optimal tension range.

[0128] Device 800 may include features of any suitable implantable device or implant, such as, for example, features of device 400 shown in FIGS. 58 and 59 or any other device described herein. For example, device 800 may include a coaptation portion 804, a proximal or attachment portion (e.g., attachment portion 205 shown in FIGS. 22-37), an anchor portion 806, and a distal portion 807. In some embodiments, device coaptation portion 804 optionally includes a coaptation element 810 (e.g., a spacer, coaptation element, plug, etc.) for implantation between the leaflets of a native valve. In some embodiments, anchor portion 806 includes multiple anchors 808. Anchors 808 may be configured in various manners, such as, for example, any of the manners described herein. In some embodiments, each anchor 808 includes an outer paddle 820, an inner paddle 822, a paddle extension or paddle frame (e.g., paddle frame 224 shown in FIGS. 22-37), and a clasp 830. Clasp 830 may have a base or fixed arm 832 and a movable arm 834 connected at joint 838. Fixed arm 832 may be attached to inner paddle 822 by connecting element 823 (e.g., connecting band, fastener, adhesive, etc.). In the illustrated embodiment, fixed arm 832 is connected to inner paddle 822 such that there is a distance D between connecting element 823 and joint 838. Distance D may be between 1 / 8 and 3 / 4 of the length of fixed arm 832, such as 3 / 8 and 1 / 2 of the length of fixed arm 832, such as 1 / 4 and 5 / 8 of the length of fixed arm.

[0129] In some embodiments, clasp 830 includes friction-enhancing elements or means for securing, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc. In some embodiments, clasp 830 is opened by applying tension to actuation line 816 attached to movable arm 834, thereby allowing movable arm 834 to articulate, bend, or pivot on joint portion 838. Actuation line 816 can take a wide variety of forms, such as, for example, any of the forms described herein. Paddles 820, 822 and clasp 830 can take any suitable form, such as, for example, any of the forms described herein.

[0130] In some embodiments, an actuation element 812 (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from an implant catheter (e.g., implant catheter 202 shown in FIG. 43 ) to engage and enable actuation of the implantable device or implant 800. For example, the actuation element 812 can extend through and move relative to the capture mechanism, proximal collar, and coaptation element 810 to engage a cap 814 on the distal portion 807. The actuation element 812 can be configured to releasably engage the cap 814 with a threaded connection, etc., such that the actuation element 812 moves the device 800 between open and closed positions and such that the actuation element can be disengaged and removed from the device 800 after implantation. The actuation element 812 and cap 814 can take any suitable form, such as, for example, any of the forms described herein.

[0131] In the illustrated embodiment, clasp 830 includes an indicating feature 801 that allows a user to determine whether a tension force applied to implantable device or implant 800 has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. For example, at least a portion of clasp 830 may be made from a flexible or elastic material that allows clasp 830 to bend or flex upward in direction P when a tension force T is applied to device 800 through its connection with valve leaflets 20, 22. That is, distance D between connecting element 823 and pivot point 838 allows pivot joint 838 to move freely relative to paddles 820, 822, and tension force T applied to device 800 may cause the movable arm to move in direction X, bending joint 838 in upward direction P. In some embodiments, if one or more of the clasps 830 bend in the direction P by or above a predetermined amount, such as any amount visible via imaging, the indicating feature 801 is in an over-tension position, where the tension force applied to the device 800 has reached or exceeded a predetermined tension or an optimal tension range. If the clasps 830 do not bend by or above the predetermined amount, the indicating feature 801 is in an acceptable tension position, where the tension force applied to the device 800 is below a predetermined tension or within an optimal tension range. A user may determine the amount of bending of the clasps 838, for example, by comparing the joints 838 of the clasps 830 to other components of the device 800 (e.g., paddles 820, 822, joint element 810, etc.), or the imaging software may be configured to measure the amount of bending of the clasps 830 to determine whether the indicating feature 801 is in an over-tension position. In some embodiments, the indicator feature 801 may include a visible marking (e.g., a dot, an X, etc.) that allows a user to more easily determine the bending or pivoting of the clasp 830 relative to other components of the device 800.

[0132] FIG. 65 shows an example of an implantable device or implant 900 that includes an indicator feature 901 that allows a user to determine whether the tension force applied to the implantable device or implant has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. In some embodiments, pushing or pulling the device's actuating element 912 beyond a predetermined distance indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. For example, one or more markers 939 may be applied to the actuating element, and the absence, presence, and / or number of visible markers indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. That is, the indicator feature 901 provides a visual indication to the user when the user is viewing the connection between the device 900 and the valve leaflets 20, 22 directly, through echocardiogram, or fluoroscopic imaging. When the indication feature 901 indicates to the user that the tension force applied to the device 900 has reached or exceeded the predetermined tension or optimal tension range, the user can release the device 900, remove it from the valve leaflets 20, 22, and reconnect the device in a position where the indication feature 901 has not reached or exceeded the predetermined tension or optimal tension range.

[0133] Device 900 may include features of any suitable implantable device or implant, such as, for example, features of device 400 shown in FIGS. 58 and 59 , or any other device described herein. For example, device 900 may include a coaptation portion 904, a proximal or attachment portion (e.g., attachment portion 205 shown in FIGS. 22-37 ), an anchor portion 906, and a distal portion 907. In some embodiments, device coaptation portion 904 optionally includes a coaptation element 910 (e.g., a spacer, coaptation element, plug, etc.) for implantation between the leaflets of a native valve. In some embodiments, anchor portion 906 includes multiple anchors 908. Anchors 908 may be configured in a variety of ways, such as, for example, any of the ways described herein.

[0134] In some embodiments, an actuation element 912 (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from an implant catheter (e.g., implant catheter 202 shown in FIG. 43 ) to engage and enable actuation of the implantable device or implant 900. For example, the actuation element 912 can extend through and move relative to the capture mechanism, proximal collar, and coaptation element 910 to engage a cap 914 on the distal portion 907. The actuation element 912 can be configured to releasably engage the cap 914 with a threaded connection, etc., such that the actuation element 912 moves the device 900 between open and closed positions and such that the actuation element can be disengaged and removed from the device 900 after implantation. The actuation element 912 and cap 914 can take any suitable form, such as, for example, any of the forms described herein.

[0135] In the illustrated embodiment, the actuating element 912 includes an indicating feature 901 that allows a user to determine whether the tensioning force applied to the implantable device or implant 900 has reached or exceeded a predetermined tensioning force (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tensioning range. For example, when the device 900 is in the closed position and connected to the valve leaflets 20, 22 (as shown in FIG. 65 ), the length Y of the actuating element 912 is visible by a user between the coaptation element 910 and the cap 914. When a tensioning force T is applied to the device 900 by its connection with the valve leaflets 20, 22, the anchor portion 908 can move in an outward direction M to an open position, which moves the cap 914 and actuating element 912 in a downward direction N relative to the coaptation element 910. This movement of the actuating element 912 relative to the coaptation element 910 increases the visible length Y of the actuating element 912. In some embodiments, if the visible length Y of the actuating element 912 increases by a predetermined amount, the indicating feature 901 is in an over-tension position, where the tension force applied to the device 900 reaches or exceeds a predetermined tension or optimal tension range. If the visible length Y of the actuating element 912 does not increase by a predetermined amount, the indicating feature 901 is in an acceptable tension position, where the tension force applied to the device 900 is below a predetermined tension or within an optimal tension range. A user may determine the amount by which the visible length Y of the actuating element increases, for example, by comparing the position of the coaptation element 910 relative to other components of the device 900 (e.g., cap 914, anchor portion 908, etc.), or imaging software may be configured to measure the visible length Y of the actuating element 912 to determine whether the indicating feature 901 is in an over-tension position. In some embodiments, the indicating feature 901 may include one or more visible markings (e.g., a dot, an X, a radiopaque marker, etc.) that allow a user to more easily determine whether the visible length Y of the actuation element 912 has increased to or beyond a predetermined length. For example, if the visible marking is visible to the user, the visible length Y has increased to or beyond a predetermined length.

[0136] FIG. 66 shows an example of an implantable device or implant 100 including an indicating feature 1001 that allows a user to determine whether the tension force applied to the implantable device or implant has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. In some embodiments, pushing or pulling the device's actuating element 1012 beyond a predetermined distance indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. For example, one or more markers 1013 may be applied to the actuating element, and the absence, presence, and / or number of visible markers indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. That is, the indicating feature 1001 provides a visual indication to the user when the user is viewing the connection between the device 1000 and the valve leaflets 20, 22 directly, through echocardiogram, or fluoroscopic imaging. When the indication feature 1001 indicates to the user that the tension force applied to the device 1000 has reached or exceeded the predetermined tension or optimal tension range, the user can release the device 1000, remove it from the valve leaflets 20, 22, and reconnect the device in a position where the indication feature 1001 has not reached or exceeded the predetermined tension or optimal tension range.

[0137] Device 1000 may include features of any suitable implantable device or implant, such as, for example, features of device 400 shown in FIGS. 58 and 59 , or any other device described herein. For example, device 1000 may include a coaptation portion 1004, a proximal or attachment portion (e.g., attachment portion 205 shown in FIGS. 22-37 ), an anchor portion 1006, and a distal portion 1007. In some embodiments, device coaptation portion 1004 optionally includes a coaptation element 1010 (e.g., a spacer, coaptation element, plug, etc.) for implantation between the leaflets of a native valve. In some embodiments, anchor portion 1006 includes multiple anchors 1008. Anchors 1008 may be configured in a variety of ways, such as, for example, any of the ways described herein.

[0138] In some embodiments, an actuating element 1012 (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from an implant catheter (e.g., implant catheter 202 shown in FIG. 43 ) to engage and enable actuation of the implantable device or implant 1000. A proximal portion 1011 of the actuating element 1012 is controlled by a user such that the user can engage and actuate the actuating element 1012 with the device 1000. For example, the actuating element 1012 can extend through and move relative to the capture mechanism, proximal collar, and coaptation element 1010 to engage a cap 1014 on the distal portion 1007. The actuating element 1012 can be configured to releasably engage the cap 1014 with a threaded connection or the like such that the actuating element 1012 moves the device 1000 between open and closed positions and such that the actuating element 1012 can be disengaged and removed from the device 1000 after implantation. The actuation element 1012 and cap 1014 can take any suitable form, such as, for example, any of the forms described in this application.

[0139] In the illustrated embodiment, the proximal portion 1011 of the actuation element 1012 includes an indicating feature 1001 that allows a user to determine whether the tensioning force applied to the implantable device or implant 1000 has reached or exceeded a predetermined tensioning force (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tensioning range. For example, when the device 1000 is in a closed position and connected to the valve leaflets 20, 22 (shown in FIG. 66 ), the visible markings 1013 of the indicating feature 1001 are visible on the proximal portion 1011 of the actuation feature 112. When a tensioning force T is applied to the device 1000 by its connection with the valve leaflets 20, 22, the anchor portion 1008 can move in an outward direction M to an open position, which moves the cap 1014 and actuation element 1012 in a downward direction N relative to a delivery device 1002, such as a catheter or catheter handle. This movement of the actuating element 1012 relative to the delivery device 1002 moves the visible marking 1013 of the actuating element 1012 into the delivery device 1002 such that the visible marking 1013 is no longer visible by the user. In some embodiments, after the device 1000 is connected to the valve leaflets 20, 22 and the clasp is in the closed position (and the device is in the open or closed position), when the visible marking 1013 is no longer visible by the user, the indicating feature 1001 is in an over-tension position, where the tension force applied to the device 1000 reaches or exceeds a predetermined tension or optimal tension range. When the visible markings 1013 are visible to the user after the device 1000 is attached to the valve leaflets 20, 22 and the clasp is in a closed position (and the device is in an open or closed position), the indication feature 1001 is in an acceptable tension position where the tension force applied to the device 1000 is below a predetermined tension or optimal tension range.

[0140] FIG. 67 shows an example of an implantable device or implant 1100 that includes an indicator feature 1101 that allows a user to determine whether the tension force applied to the implantable device or implant has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. In some embodiments, bending or buckling of the device's actuating element 1112 beyond a predetermined amount indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. For example, a visible bend in the wire 1112 indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. That is, the indicator feature 1101 provides a visual indication to the user when the user is viewing the connection between the device 1100 and the valve leaflets 20, 22 directly, through echocardiogram, or fluoroscopic imaging. When the indication feature 1101 indicates to the user that the tension force applied to the device 1100 has reached or exceeded the predetermined tension or optimal tension range, the user can release the device 1100, remove it from the valve leaflets 20, 22, and reconnect the device in a position where the indication feature 1101 has not reached or exceeded the predetermined tension or optimal tension range.

[0141] Device 1100 may include features of any suitable implantable device or implant, such as, for example, features of device 400 shown in FIGS. 58 and 59 , or any other device described herein. For example, device 1100 may include a coaptation portion 1104, a proximal or attachment portion (e.g., attachment portion 205 shown in FIGS. 22-37 ), an anchor portion 1106, and a distal portion 1107. In some embodiments, device coaptation portion 1104 optionally includes a coaptation element 1110 (e.g., a spacer, coaptation element, plug, etc.) for implantation between the leaflets of a native valve. In some embodiments, anchor portion 1106 includes multiple anchors 1108. Anchors 1108 may be configured in a variety of ways, such as, for example, any of the ways described herein.

[0142] In some embodiments, an actuating element 1112 (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from an implant catheter (e.g., implant catheter 202 shown in FIG. 43 ) to engage and enable actuation of the implantable device or implant 1100. For example, the actuating element 1112 can extend through and move relative to the capture mechanism, proximal collar, and coaptation element 1110 to engage a cap 1114 on the distal portion 1107. The actuating element 1112 can be configured to releasably engage the cap 1114 with a threaded connection, etc., such that the actuating element 1112 moves the device 1100 between open and closed positions and such that the actuating element can be disengaged and removed from the device 1100 after implantation. The actuating element 1112 and cap 1114 can take any suitable form, such as, for example, any of the forms described herein.

[0143] In the illustrated embodiment, the actuating element 1112 includes an indicating feature 1101 that allows a user to determine whether a tensioning force applied to the implantable device or implant 1100 has reached or exceeded a predetermined tensioning force (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tensioning range. For example, the actuating element 1112 may be made from a flexible or elastic material that allows at least a portion of the actuating element to bend or flex in a direction R when a tensioning force T is applied to the device 1100 through its connection with the valve leaflets 20, 22. That is, when the device 1100 is in the closed position and connected to the valve leaflets 20, 22 (as shown in FIG. 67 ), the actuating element 1112 is substantially aligned with a central axis 1115 of the device 1100. When a tension force T is applied to the device 1100 by its connection with the valve leaflets 20, 22, the tension force can be transmitted to the cap 1114 or the coaptation element 1110, which bends or flexes the flexible actuating element 1112. In some embodiments, when the actuating element 1112 bends or flexes relative to the central axis 1115 of the device 1100, the indicating feature 1101 is in an over-tension position, where the tension force applied to the device 1100 reaches or exceeds a predetermined tension or optimal tension range. When the actuating element 1112 is substantially aligned with the central axis 1115 when the device 1100 is connected to the valve leaflets 20, 22, the indicating feature 1101 is in an acceptable tension position, where the tension force applied to the device 1100 is below the predetermined tension or optimal tension range. A user may determine whether the actuating element 1112 bends or flexes, for example, by comparing the positioning of the actuating element 1112 relative to other components of the device 1100 (e.g., cap 1114, joint element 1110, anchor portion 1108, etc.), or the imaging software may be configured to determine whether the actuating element 1112 is bent or flexed relative to the central axis 1115. In some embodiments, the indicating feature 1101 may include a visible marking (e.g., a dot, an X, a radiopaque marker, etc.) that allows a user to more easily determine whether the actuating element 1112 is bent or flexed.

[0144] FIG. 68 illustrates an example of an implantable device or implant 1200 that includes an indicator feature 1201 that allows a user to determine whether the tension force applied to the implantable device or implant has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. In some embodiments, pulling or expanding a portion of the spacer 1210 outward beyond a predetermined distance indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. For example, pulling or expanding a portion of the spacer 1210 outward indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. That is, the indicator feature 1201 provides a visual indication to the user when the user is viewing the connection between the device 1200 and the valve leaflets 20, 22 directly, through echocardiogram, or fluoroscopic imaging. When the indication feature 1201 indicates to the user that the tension force applied to the device 1200 has reached or exceeded the predetermined tension or optimal tension range, the user can release the device 1200, remove it from the valve leaflets 20, 22, and reconnect the device in a position where the indication feature 1201 has not reached or exceeded the predetermined tension or optimal tension range.

[0145] Device 1200 may include features of any suitable implantable device or implant, such as, for example, features of device 400 shown in FIGS. 58 and 59 or any other device described herein. For example, device 1200 may include a coaptation portion 1204, an actuation element 1212, a proximal or attachment portion (e.g., attachment portion 205 shown in FIGS. 22-37), an anchor portion 1206, and a distal portion 1207. In some embodiments, device coaptation portion 1204 optionally includes a coaptation element 1210 (e.g., a spacer, coaption element, plug, etc.) for implantation between the leaflets of a native valve. In some embodiments, anchor portion 1206 includes multiple anchors 1208. Anchor 1208 may be configured in various manners, such as, for example, any of the manners described herein. Anchor 1208 may be attached to the distal portion of coaptation element 1210.

[0146] In the illustrated embodiment, coaptation element 1210 includes an indicating feature 1201 that allows a user to determine whether a tensioning force applied to implantable device or implant 1200 has reached or exceeded a predetermined tensioning force (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tensioning range. For example, at least a portion of coaptation element 1210 includes one or more flexible portions 1217 that connect to anchor 1208 (e.g., connect to at least one of the inner or outer paddles of anchor 1208) such that flexible portions 1217 may expand in an outward direction X when a tensioning force T is applied to device 1200 via its connection with leaflets 20, 22. In some embodiments, when one or more of the flexible portions 1217 of the coaptation element 1210 are pulled or distended in direction X by or above a predetermined amount, the indicating feature 1201 is in an over-tension position where the tension force applied to the device 1200 reaches or exceeds the predetermined tension or optimal tension range. When the flexible portions 1217 of the coaptation element 1210 are not pulled or distended by or above a predetermined amount, the indicating feature 1201 is in an acceptable tension position where the tension force applied to the device 1200 is below the predetermined tension or within the optimal tension range. A user may determine the amount of tension or bulging of flexible portions 1217 of coaptation elements 1210, for example, by comparing the flexible portions to other components of device 1200 (e.g., the remainder of coaptation element 1210, cap 1214, etc.), or imaging software may be configured to measure the tension or bulging of flexible portions 1217 of coaptation elements 1210 to determine whether they have extended to or beyond a predetermined length. In some embodiments, the connection between anchor 1208 and flexible portions 1217 of coaptation elements 1210 causes anchor 1208 to extend in outward direction X, and a user may determine the amount of extension of flexible portions 1217 by comparing the positioning of anchor 1208 to other components of device 1200 (e.g., the remainder of coaptation element 1210, cap 1214, etc.).In some embodiments, the indicating feature 1201 may include a visible marking (e.g., a dot, an X, a radiopaque marker, etc.) that allows a user to more easily determine the extension of the flexible portion 1217 of the coaptation element 1210 relative to other components of the device 1200. For example, the visible marking may be located on the flexible portion 1217 of the coaptation element 1210, and the visible marking will expand into a distorted shape when the flexible portion 1217 indicates that the indicating feature 1201 is in an over-tensioned position.

[0147] FIG. 69 shows an example of an implantable device or implant 1300 that includes an indicator feature 1301 that allows a user to determine whether the tension force applied to the implantable device or implant has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. In some embodiments, the top of the cap is configured to move between a flat or depressed configuration and a popped-up or dome-shaped configuration when actuated by the actuation element 1112 and / or paddle when a tension force exceeding a preset or predetermined amount is applied to the clasp. For example, a visible dome shape indicates that the tension force applied to the clasp has reached or exceeded the predetermined acceptable tension or preset tension. That is, the indicator feature 1301 provides a visual indication to the user when the user is viewing the connection between the device 1300 and the valve leaflets 20, 22 directly, through echocardiogram, or fluoroscopic imaging. When the indication feature 1301 indicates to the user that the tension force applied to the device 1300 has reached or exceeded the predetermined tension or optimal tension range, the user can release the device 1300, remove it from the valve leaflets 20, 22, and reconnect the device in a position where the indication feature 1301 has not reached or exceeded the predetermined tension or optimal tension range.

[0148] Device 1300 may include features of any suitable implantable device or implant, such as, for example, features of device 400 shown in FIGS. 58 and 59 , or any other device described herein. For example, device 1300 may include a coaptation portion 1304, a proximal or attachment portion (e.g., attachment portion 205 shown in FIGS. 22-37 ), an anchor portion 1306, and a distal portion 1307. In some embodiments, device coaptation portion 1304 optionally includes a coaptation element 1310 (e.g., a spacer, coaptation element, plug, etc.) for implantation between the leaflets of a native valve. In some embodiments, anchor portion 1306 includes multiple anchors 1308. Anchors 1308 may be configured in a variety of ways, such as, for example, any of the ways described herein.

[0149] In some embodiments, an actuating element 1312 (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from an implant catheter (e.g., implant catheter 202 shown in FIG. 43 ) to engage and enable actuation of the implantable device or implant 1300. For example, the actuating element 1312 can extend through and move relative to the capture mechanism, proximal collar, and coaptation element 1310 to engage a cap 1314 on the distal portion 1307. The actuating element 1312 can be configured to releasably engage the cap 1314 with a threaded connection, etc., such that the actuating element 1312 moves the device 1300 between open and closed positions and such that the actuating element can be disengaged and removed from the device 1300 after implantation. The actuating element 1312 and cap 1314 can take any suitable form, such as, for example, any of the forms described herein.

[0150] In the illustrated embodiment, cap 1314 includes an indicator feature 1301 that allows a user to determine whether a tensioning force applied to implantable device or implant 1300 has reached or exceeded a predetermined tensioning force (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tensioning range. For example, cap 1314 includes a flexible membrane 1321 that is movable from a normal substantially flat position to an expanded position or dome shape. Flexible membrane 1321 may be operably connected to anchor 1308 or actuation element 1312 such that when a tensioning force T is applied to device 1300 via its connection with leaflets 20, 22, the flexible membrane may move to the expanded position. When a tension force T is applied to device 1300 by its connection with leaflets 20, 22, anchor portion 1308 may move in outward direction M to an open position, which causes flexible membrane 1321 to move in direction Y relative to cap 1314 to an extended position. When device 1300 is attached to leaflets 20, 22 and in the closed position and flexible membrane 1321 is in the extended position, indicating feature 1301 is in an excess tension position where the tension force applied to device 1300 has reached or exceeded a predetermined tension or optimal tension range. When device 1300 is attached to leaflets 20, 22 and in the closed position and flexible membrane 1321 is in a normal position, indicating feature 1301 is in an acceptable tension position where the tension force applied to device 1300 has not reached or exceeded a predetermined tension or is within the optimal tension range. The user may determine whether flexible membrane 1321 is in the expanded or normal position by comparing the position of flexible membrane 1321 to other components of device 1300 (e.g., the remainder of cap 1314, coaptation element 1310, anchor portion 1308, etc.), or imaging software may be configured to determine when flexible membrane 1321 is in the expanded position. In some embodiments, indicator feature 901 may include a visible marking (e.g., a dot, an X, a radiopaque marker, etc.) that allows the user to more easily determine whether flexible membrane 1321 is in the expanded position.

[0151] 70 and 71 show an example of an implantable device or implant 1400 including an indicator feature 1401 that allows a user to determine whether the tension force applied to the implantable device has reached or exceeded a predetermined tension force (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. The devices / implants of FIGS. 70 and 71 may be the same or similar to the devices / implants exemplified by FIGS. 22-27 or any of the other devices and implants disclosed herein. In some embodiments, the implantable device or implant is configured such that movement or opening of a paddle away from the center indicates that a tension force greater than a preset or predetermined amount, or greater than an optimal tension force, is being applied to the clasp, anchor, and / or device. For example, movement or opening of a paddle away from the center or away from any coaptation elements or spacers may indicate that a tension force greater than a predetermined amount, or greater than an optimal amount, is being applied to the clasp, anchor, and / or device. That is, the indicating feature 1401 may be or include a component, configuration, and / or design of the device and anchor that allows the anchor or paddle to move away from the center or be pulled (or move apart at a wider angle) to provide a visual indication to the user of excessive tension. This can be seen by viewing the connection between the device 1400 and the valve leaflets 20, 22 directly, through echocardiogram, or fluoroscopic imaging. When the indicating feature 1401 indicates to the user that the tension force applied to the device 1400 has reached or exceeded the predetermined tension or optimal tension range, the user can release the device 1400, detach it from the valve leaflets 20, 22, and reconnect the device in a position where the indicating feature 1401 has not reached or exceeded the predetermined tension or optimal tension range.

[0152] Device 1400 may include features of any suitable implantable device or implant, such as, for example, features of the devices shown in FIGS. 22-27 or any other device described herein. For example, device 1400 may include a coaptation portion 1404, a proximal or attachment portion 1405 (e.g., similar to attachment portion 205 shown in FIGS. 22-37) that may include an attachment collar 1411, an anchor portion 1406, and a distal portion 1407 that may include a cap 1414. In some embodiments, device coaptation portion 1404 optionally includes a coaptation element 1410 (e.g., a spacer, coaption element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. The size and / or shape of coaptation element 1410 may be selected to minimize the number of implants (preferably one) required for a single patient while simultaneously maintaining a low transvalvular gradient. In some embodiments, anchor portion 1406 includes multiple anchors 1408. The anchor 1408 may be configured in a variety of ways, such as, for example, any of the ways described in this application.

[0153] In the illustrated example, anchor 1408 includes an indicating feature 1401 (e.g., a component, configuration, and / or design) that allows a user to determine whether a tensioning force applied to implantable device or implant 1400 has reached or exceeded a predetermined tensioning force (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tensioning range. For example, at least a portion of anchor 1408 (e.g., a paddle, a clasp, etc.) may be made from a flexible or elastic material that allows anchor 1408 to bend, flex, and / or move in an outward direction M when a tensioning force is applied to device 1400 via its connection with the leaflets of a native heart valve. In some embodiments, if one or more of the anchors 1408 bend, flex, and / or move in direction M by or beyond a predetermined amount, the indicating feature 1401 is in an over-tension position where the tension force applied to the device 1400 reaches or exceeds a predetermined tension or optimal tension range (e.g., as shown in FIG. 71 ). If the anchors 1408 do not extend by or beyond a predetermined amount, the indicating feature 1401 is in an acceptable tension position where the tension force applied to the device 1400 is below a predetermined tension or within an optimal tension range (e.g., as shown in FIG. 70 ). A user may determine the amount of bending or flexion of the anchors 1408, for example, by comparing the positioning of the anchors 1408 to other components of the device 1400 (e.g., joint element 1410, etc.) and / or by observing the angle between the anchors or paddles. In some embodiments, the imaging software can be configured to measure the positioning of the anchor 1408 relative to other components of the device 1400 to determine whether the indicator feature is in an over-tension position. In some embodiments, the indicator feature 1401 can include a visible marking (e.g., a dot, an X, a radiopaque marker, etc.) that allows a user to more easily determine whether the indicator feature 1401 is in an over-tension position.

[0154] 70A and 71A show an example of an implantable device or implant 1400a that includes an indicator feature 1401a that allows a user to determine whether a tension force applied to the implantable device or implant has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. This example also includes a connecting element 1451a that can be used to lock the paddles of the implantable device or implant in a closed position once it is determined that the implantable device or implant 1400a has not reached or exceeded the predetermined tension or optimal tension range.

[0155] The prosthetic devices of Figures 70A and 71A may be the same devices exemplified by Figures 22-27 or any of the other devices and implants disclosed herein. In some embodiments, the implantable device or implant is configured so that movement or opening of the paddles away from the center indicates that a tension force greater than a preset or predetermined amount, or greater than an optimal tension force, is being applied to the clasp, anchor, and / or device. For example, movement or opening of the paddles away from the center or away from any coaptation elements or spacers may indicate that a tension force greater than a preset or predetermined amount, or greater than an optimal range, is being applied to the clasp, anchor, and / or device. That is, the indicator feature 1401a may be or include a component, configuration, and / or design of the device and anchor that allows the anchors or paddles to move away from the center or be pulled (or move apart at a wider angle) to provide a visual indication to the user of excessive tension. This can be seen by viewing the connection between the device 1400a and the valve leaflets 20, 22, either directly, through echocardiogram, or through fluoroscopic imaging. When the indicator feature 1401a indicates to the user that the tension force applied to the device 1400a has reached or exceeded the predetermined tension or optimal tension range, the user can release the device 1400a, remove it from the valve leaflets 20, 22, and reconnect the device in a position where the indicator feature 1401a has not reached or exceeded the predetermined tension or optimal tension range.

[0156] Device 1400a may include features of any suitable implantable device or implant, such as, for example, features of the devices shown in FIGS. 22-27 or any other device described herein. For example, device 1400a may include a coaptation portion 1404a, a proximal or attachment portion 1405a (e.g., similar to attachment portion 205 shown in FIGS. 22-37) that may include an attachment collar 1411a, an anchor portion 1406a, and a distal portion 1407a that may include a cap 1414a. In some embodiments, device coaptation portion 1404a optionally includes a coaptation element 1410a (e.g., a spacer, coaption element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. The size and / or shape of coaptation element 1410a may be selected to minimize the number of implants (preferably one) required for a single patient while simultaneously maintaining a low transvalvular gradient. In some embodiments, anchor portion 1406a includes multiple anchors 1408a. Anchors 1408a may be configured in a variety of ways, such as, for example, any of the ways described herein.

[0157] In the illustrated embodiment, anchor 1408a includes an indicating feature 1401a that allows a user to determine whether a tensioning force applied to implantable device or implant 1400a has reached or exceeded a predetermined tensioning force (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tensioning range. For example, at least a portion of anchor 1408a (e.g., a paddle, a clasp, etc.) may be made from a flexible or elastic material that allows anchor 1408a to bend, flex, and / or move in an outward direction M when a tensioning force is applied to device 1400a via its connection with the leaflets of a native heart valve. In some embodiments, if one or more of the anchors 1408a bend, flex, and / or move in direction M by or beyond a predetermined amount, the indicating feature 1401a is in an over-tension position where the tension force applied to the device 1400a reaches or exceeds a predetermined tension or optimal tension range (e.g., as shown in FIG. 71A ). If the anchors 1408a do not extend by or beyond a predetermined amount, the indicating feature 1401a is in an acceptable tension position where the tension force applied to the device 1400a is below a predetermined tension or within an optimal tension range (e.g., as shown in FIG. 70A ). A user may determine the amount of bending or flexion of anchor 1408a, for example, by comparing the positioning of anchor 1408a and / or paddles relative to other components of device 1400a (e.g., coaptation element 1410a, etc.) or the center of the device, and / or by locking the angle between the anchor and / or paddle. In some embodiments, imaging software may be configured to measure the positioning of anchor 1408a relative to other components of device 1400a to determine whether the indicator feature is in an over-tensioned position. In some embodiments, indicator feature 1401a may include visible markings (e.g., a dot, an X, a radiopaque marker, etc.) that allow a user to more easily determine whether indicator feature 1401a is in an over-tensioned position.

[0158] The connecting element 1451a is in an unlocked state (as shown by the dashed line in FIG. 71A ) when the implantable device or implant 1400a is connected to a native heart valve. When connected to a native heart valve and the indicator feature 1401a indicates that the tension force applied to the implantable device or implant has not reached or exceeded a predetermined tension or is within an optimal tension range, the connecting element 1451a can be moved to a locked state (as shown by the solid line in FIG. 70A ) to maintain the anchor 1408a in a closed position and prevent movement of the anchor in direction M relative to the spacer or coaptation element 1410a. In the illustrated embodiment, the connecting element 1451a is attached to the paddle frame 1424a of the anchor 1408a and secures the paddle frame 1424a of the anchor together when in the locked state. However, the connecting element 1451a can be connected to any other suitable portion of the anchor 1408a. The connecting elements 1451 a can be, for example, clasps, sutures, clips, fasteners, locks, clamps, connectors, or any other suitable elements for connecting the anchors 1408 together. The connecting elements 1451 a can be moved from an unlocked state to a locked state by an actuation member (not shown), such as, for example, a wire, suture, rod, threaded coupler, or any other suitable member for moving the connecting elements to a locked state. In some embodiments, rather than the anchors 1408 a being connected together, each anchor 1408 a can include a separate locking element (not shown) that locks the positioning of the anchor 1408 a relative to the joint element 1410 a or any other portion of the device 1400 a and prevents movement of the anchor 1408 a in direction M.

[0159] 72 and 73 show an example of an implantable device or implant 1500 including an indicator feature 1501 that allows a user to determine whether the tension force applied to the implantable device or implant has reached or exceeded a predetermined allowable tension force. The prosthetic devices of FIGS. 72 and 73 can be the same device illustrated by FIG. 55 or any of the other devices and implants disclosed herein. In some embodiments, the implantable device or implant is configured such that movement or opening of a paddle away from the center indicates that a tension force greater than a preset or predetermined amount, or greater than an optimal tension force, is being applied to the clasp, anchor, and / or device. For example, movement or opening of a paddle away from the center or away from any coaptation elements or spacers can indicate that a tension force greater than a predetermined amount, or greater than an optimal range, is being applied to the clasp, anchor, and / or device. That is, the indicating feature 1501 may be or include a component, configuration, and / or design of the device and anchor that allows the anchor or paddle to move away from the center or be pulled (or move apart at a wider angle) to provide a visual indication to the user of excessive tension. This can be seen by viewing the connection between the device 1500 and the valve leaflets 20, 22 directly, through echocardiogram, or fluoroscopic imaging. When the indicating feature 1501 indicates to the user that the tension force applied to the device 1500 has reached or exceeded a predetermined amount of tension or an optimal tension range, the user can release the device 1500, detach it from the valve leaflets 20, 22, and reconnect the device in a position where the indicating feature 1501 has not reached or exceeded the predetermined tension or optimal tension range.

[0160] Device 1500 may include features of any suitable implantable device or implant, such as, for example, features of device 400 shown in FIG. 55 or any other device described herein. For example, device 1500 may include a coaptation portion 1504, a proximal or attachment portion 1505 that may include an attachment collar 1511 (e.g., similar to attachment portion 205 shown in FIGS. 22-37 ), an anchor portion 1506, and a distal portion 1507 that may include a cap 1514. In some embodiments, device coaptation portion 1504 optionally includes a coaptation element 1510 (e.g., a spacer, coaption element, plug, etc.) for implantation between the leaflets of the native valve. The size and / or shape of coaptation element 1510 may be selected to minimize the number of implants (preferably one) required for a single patient while simultaneously maintaining a low transvalvular gradient. In some embodiments, anchor portion 1506 includes multiple anchors 1508. The anchor 1508 may be configured in a variety of ways, such as, for example, any of the ways described in this application.

[0161] In the illustrated embodiment, anchor 1508 includes an indicating feature 1501 (e.g., a component, configuration, design, etc.) that allows a user to determine whether a tension force applied to implantable device or implant 1500 has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. For example, at least a portion of anchor 1508 (e.g., a paddle, clasp, etc.) may be made from a flexible or elastic material that allows anchor 1508 to bend, flex, and / or move in an outward direction M when a tension force is applied to device 1500 via its connection with the leaflets of a native heart valve. In some embodiments, if one or more of the anchors 1508 bend, flex, and / or move in direction M by or beyond a predetermined amount, the indicating feature 1501 is in an over-tension position where the tension force applied to the device 1500 reaches or exceeds a predetermined tension or optimal tension range (e.g., as shown in FIG. 73 ). If the anchors 1508 do not extend by or beyond a predetermined amount, the indicating feature 1501 is in an acceptable tension position where the tension force applied to the device 1500 is below a predetermined tension or within an optimal tension range (e.g., as shown in FIG. 72 ). A user may determine the amount of bending, flexion, and / or movement of the anchors 1508 (or the increased angle of the anchors / paddles), for example, by comparing the positioning of the anchors 1508 relative to other components of the device 1500 (e.g., such as the joint elements 1510). In some embodiments, the imaging software may be configured to measure the positioning of the anchor 1508 relative to other components of the device 1500 (and / or measure the angle between the anchor and / or paddle) to determine whether the indicator feature is in an over-tension position. In some embodiments, the indicator feature 1501 may include a visible marking (e.g., a dot, an X, etc.) that allows a user to more easily determine whether the indicator feature 1501 is in an over-tension position.

[0162] 72A and 73A show an example of an implantable device or implant 1500a that includes an indicator feature 1501a that allows a user to determine whether the tension force applied to the implantable device or implant has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. This example also includes a connecting element 1551a that can be used to lock the paddles of the implantable device or implant in a closed position once it is determined that the implantable device or implant 1500a has not reached or exceeded the predetermined amount of tension or optimal tension range.

[0163] The prosthetic device in Figures 72A and 73A may be the same device exemplified by Figure 55 or any of the other devices and implants disclosed herein. In some embodiments, the implantable device or implant is configured so that movement or opening of the paddle away from the center indicates that a tensioning force greater than a preset or predetermined amount, or greater than optimal tensioning force, is being applied to the clasp, anchor, and / or device. For example, movement or opening of the paddle away from the center or away from any coaptation elements or spacers may indicate that a tensioning force greater than a predetermined amount, or greater than optimal amount, is being applied to the clasp, anchor, and / or device. That is, the indicator feature 1501 may be or include a component, configuration, and / or design of the device and anchor that allows the anchor or paddle to move or be pulled (or move away at a wider angle) away from the center to provide a visual indication to the user of excessive tensioning. This can be seen by viewing the connection between the device 1500a and the valve leaflets 20, 22 directly, through echocardiogram, or fluoroscopic imaging. When the indication feature 1501a indicates to the user that the tension force applied to the device 1500a has reached or exceeded the predetermined tension or optimal tension range, the user can release the device 1500a, remove it from the valve leaflets 20, 22, and reconnect the device in a position where the indication feature 1501a has not reached or exceeded the predetermined tension or optimal tension range.

[0164] Device 1500a may include features of any suitable implantable device or implant, such as, for example, features of device 400 shown in FIG. 55 or any other device described herein. For example, device 1500a may include a coaptation portion 1504a, a proximal or attachment portion 1505a (e.g., similar to attachment portion 205 shown in FIGS. 22-37 ) that may include an attachment collar 1511a, an anchor portion 1506a, and a distal portion 1507a that may include a cap. In some embodiments, device coaptation portion 1504a optionally includes a coaptation element 1510a (e.g., a spacer, coaption element, plug, etc.) for implantation between the leaflets of a native valve. The size and / or shape of coaptation element 1510a may be selected to minimize the number of implants (preferably one) required for a single patient while simultaneously maintaining a low transvalvular gradient. In some embodiments, anchor portion 1506a includes multiple anchors 1508a. The anchor 1508a may be configured in a variety of ways, such as, for example, any of the ways described in this application.

[0165] In the depicted example, anchor 1508a includes an indicating feature 1501a (e.g., a component, configuration, design, etc.) that allows a user to determine whether a tension force applied to implantable device or implant 1500a has reached or exceeded a predetermined tension force (e.g., a predetermined allowable tension, a preset tension, etc.) or an optimal tension range. For example, at least a portion of anchor 1508a (e.g., a paddle, clasp, etc.) may be made from a flexible or elastic material that allows anchor 1508a to bend, flex, and / or move in an outward direction M when a tension force is applied to device 1500a via its connection with the leaflets of a native heart valve. In some embodiments, if one or more of the anchors 1508a bend, flex, and / or move in direction M by or beyond a predetermined amount, the indicating feature 1501a is in an over-tension position where the tension force applied to the device 1500a reaches or exceeds a predetermined tension or optimal tension range (e.g., as shown in FIG. 73A ). If the anchors 1508a do not extend by or beyond a predetermined amount, the indicating feature 1501a is in an acceptable tension position where the tension force applied to the device 1500a is below a predetermined tension or within an optimal tension range (e.g., as shown in FIG. 72A ). A user may determine the amount of bending or flexion of the anchors 1508a, for example, by comparing the positioning of the anchors 1508a relative to the center or other components of the device 1500a (e.g., joint element 1510a, etc.) and / or by observing the angle between the anchors / paddles. In some embodiments, the imaging software may be configured to measure the positioning of anchor 1508a relative to other components of device 1500a to determine whether the indicator feature is in an over-tension position. In some embodiments, indicator feature 1501a may include a visible marking (e.g., a dot, an X, etc.) that allows a user to more easily determine whether indicator feature 1501a is in an over-tension position.

[0166] The connecting element 1551a is in an unlocked state (as shown by the dashed line in FIG. 73A ) when the implantable device or implant 1500a is connected to a native heart valve. When connected to a native heart valve and the indicator feature 1501a indicates that the tension force applied to the implantable device or implant has not reached or exceeded a predetermined tension or optimal tension range, the connecting element 1551a can be moved to a locked state (as shown by the solid line in FIG. 72a ) to maintain the anchor 1508a in a closed position and prevent movement of the anchor in direction M relative to the coaptation element 1510a. In the illustrated embodiment, the connecting element 1551a is attached to the paddle frame 1524a of the anchor 1508a and secures the paddle frame 1524a of the anchor together when in the locked state. However, the connecting element 1551a can be connected to any other suitable portion of the anchor 1508a. The connecting element 1551 a can be, for example, a clasp, suture, clip, fastener, lock, clamp, connector, or any other suitable element for connecting the anchors 1508 together. The connecting element 1551 a can be moved from an unlocked state to a locked state by an actuation member (not shown), such as, for example, a wire, suture, rod, threaded shaft, or any other suitable member for moving the connecting element to a locked state. In some embodiments, rather than the anchors 1508 a being connected together, each anchor 1408 a can include a separate locking element (not shown) that locks the positioning of the anchor 1508 a relative to the joint element 1510 a or any other portion of the device 1400 a and prevents movement of the anchor 1408 a in direction M.

[0167] 74 and 77 show examples in which the clasp 24100 is configured to allow a user to determine whether the tension force applied to the implantable device has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. The clasp 24100 may be used with any of the prosthetic devices disclosed herein. In some embodiments, bending the barbs 24104 and / or barb support portion 24106 relative to the movable arms of the clasp indicates that more than a preset or predetermined amount of tension force is being applied to the clasp. For example, bending the barbs 24104 and / or barb support portion 24106 beyond a preset or predetermined angle, such as 30 degrees, may indicate that more than a preset or predetermined amount of tension force is being applied to the clasp.

[0168] 74 and 75 , an example of a barbed portion of a clasp 24100 is illustrated. Shown are optional holes 24102 and barbs 24104 located in the barb support portion 24106 of the clasp 24100. Visible in the figures are portions of the clasp 24100 that are configured to increase the flexibility of the barb support portion 24106 of the clasp 24100. Increasing the flexibility of the barb support portion 24106 of the clasp 24100 can be achieved in a variety of different ways. In some embodiments, as illustrated, a notch 24108 increases the flexibility of the barb support portion 24106 of the clasp 24100. However, in some embodiments, flexibility can be increased by reducing the thickness of selected areas, making portions of the clasp from different materials, heat treating and / or chemically treating different portions of the clasp, etc. Any manner of increasing the barb support portion can be used.

[0169] In some embodiments, the flexibility of the barb support portion 24106 is configured such that upon application of a preset or predetermined pulling force, the barbs rotate and are pulled away from the valve leaflets. In some embodiments, the preset or predetermined pulling force is selected such that the paddle and paddle frame first flex, open, or partially open, and then the barbs rotate and are pulled away from the valve leaflets. FIG. 74 shows the barb support portion 24106 of the clasp 24100 in a "normal" or unflexed position, while FIG. 75 shows the barb support portion 24106 of the clasp 24100 in a flexed position.

[0170] 76-77 illustrate exemplary behavior of a clasp configured according to FIGS. 74 and 75. FIG. 77 illustrates the barb support portion 24106 when tension is applied between the clasp 24100 and the leaflet 20. Tension can be applied for a variety of different reasons. In some embodiments, tension results from capturing a leaflet with the clasp, manipulating one leaflet while capturing a second leaflet, closing paddles after the leaflets are grasped by the clasp, and / or pressure applied to the device by blood due to the beating of the heart.

[0171] In FIG. 76 , the barbs 24104 of the clasp 24100 are embedded in the leaflet 20 (only a small portion of the leaflet is shown). When used with the prosthetic devices 100, 200, 300 (see FIGS. 14 , 26, 55 ), the clasp is secured to the base of the paddle. As discussed above, various conditions can apply tension such that the barbs of the clasp pull against the leaflet. This tension can be caused by the leaflet 20 moving upward and / or laterally while the clasp 24100 is secured, by the clasp 24100 moving downward and / or laterally while the leaflet 20 is secured, or a combination of both the leaflet 20 and the clasp 24100 moving. In either case, tension between the leaflet 20 and the clasp 24100 results. As the application of tension continues, the barb support portion 24106 rotates away from the valve leaflet 20 in a clockwise motion relative to the clasp's movable arm 134 (as illustrated in FIG. 77 ). The amount of rotation can be used to determine whether the tension force applied to the clasp 24100 has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range.

[0172] For example, the user may determine the amount of rotation of the barb 24104 and / or barb support portion 24106 by comparing the positioning of the barb 24104 and / or barb support portion 24106 relative to other components of the device (e.g., the movable clasp arm, the fixed clasp arm, etc.), or the imaging software may be configured to measure the positioning of the barb 24104 and / or barb support portion 24106 relative to other components to determine whether the indicating feature is in an over-tension position. In some embodiments, the barb 24104 and / or barb support portion 24106 may include visible markings (e.g., a dot, an X, a radiopaque marker, etc.) that allow the user to more easily determine whether the barb 24104 and / or barb support portion 24106 is in an over-tension position.

[0173] 78 and 79 show examples in which the clasp 25100 is configured to allow a user to determine whether the tension force applied to the implantable device has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. The clasp 25100 may be used with any of the prosthetic devices disclosed herein and may include features of any of the clasps disclosed herein. For example, in some embodiments, the clasp may include a fixed arm 25132 attached to a paddle of the device and a movable arm 25134 having one or more barbs 25136 for connecting to the leaflets 20, 22 of the native heart valve.

[0174] The clasp 25100 may have an indicator feature 25101 including a first visible marking 25153 and a second visible marking 25155. The visible markings 25153, 25155 may include, for example, a dot, an X, a radiopaque marker, or any other suitable marking that is visible to a user using imaging techniques such as fluoroscopy, magnetic resonance imaging, echocardiography imaging, etc. The first portion 25161 of the clasp 25100 may include the first visible marking 25153, and the second portion 25163 of the clasp 25100 may include the second visible marking 25155. When a tension force is applied to the implantable device or implant, the second portion 25163 of the clasp 25100 may move relative to the first position 25161 such that the second visible marking 25155 moves relative to the first visible marking 25153.

[0175] In some embodiments, the first portion 25161 of the clasp 25100 is configured to maintain a substantially fixed position when a tension force is applied to the implantable device or implant, and the second portion 25163 is stretchable such that when a tension force is applied to the implantable device or implant, the second portion 25163, and consequently the second visible marking 25155, moves in direction Z relative to the first visible marking 25153 (Figure 79). The second visible marking 25155 may be configured to maintain its position relative to the first visible marking 25153 until the tension force reaches or exceeds a predetermined tension or optimal tension range, or the second visible marking 25155 may be configured to move when a tension force is applied to the implantable device or implant, and the determination as to whether the predetermined tension or optimal tension range has been reached or exceeded is based on the distance the second visible marking 25155 moves from the first visible marking 25153.

[0176] 80 shows an example in which the clasp 26100 is configured to allow a user to determine whether the tension force applied to the implantable device has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. The clasp 26100 may be used with any of the prosthetic devices disclosed herein and may include features of any of the clasps disclosed herein. For example, in some embodiments, the clasp may include a fixed arm (not shown) that attaches to a paddle of the device and a movable arm 26134 having one or more barbs 26136 for connecting to a native heart valve.

[0177] The clasp 26100 may have an indicator feature 26101 including a first visible marking 26153 and a second visible marking 26155. The visible markings 26153, 26155 may include, for example, a dot, an X, a radiopaque marker, or any other suitable marking that is visible to a user using a visualization technique such as fluoroscopy, echocardiography, magnetic resonance imaging, etc. The first portion 26161 of the clasp 26100 may include the first visible marking 26153, and the second portion 26163 of the clasp 26100 may include the second visible marking 26155. In the illustrated embodiment, the first portion 26161 of the clasp 26100 is made of a rigid material and the second portion 26163 is made of a stretchable material. When a tensioning force is applied to the implantable device or implant, the second portion 26163 of the clasp 26100 stretches relative to the first portion 26161 such that the second visible marking 26155 moves relative to the first visible marking 26153. The second portion 26163 may be configured to maintain its position relative to the first portion 26161 until the tensioning force reaches or exceeds a predetermined tension or optimal tension range, or the second portion 26163 may be configured to move when a tensioning force is applied to the implantable device or implant, and the determination as to whether the predetermined tension or optimal tension range has been reached or exceeded is based on the distance the second visible marking 26155 has moved from the first visible marking 26153.

[0178] 81 shows an example in which a clasp 27100 is configured to allow a user to determine whether the tension force applied to an implantable device has reached or exceeded a predetermined tension (e.g., a predetermined acceptable tension, a preset tension, etc.) or an optimal tension range. The clasp 27100 may be used with any of the prosthetic devices disclosed herein and may include features of any of the clasps disclosed herein. For example, in some embodiments, the clasp may include a fixed arm (not shown) that attaches to a paddle of the device and a movable arm 27134 having one or more barbs 27136 for connecting to a native heart valve.

[0179] The clasp 27100 may have an indicator feature 27101 including a first visible marking 27153 and a second visible marking 27155. The visible markings 27153, 27155 may include, for example, a dot, an X, a radiopaque marker, or any other suitable marking that is visible to a user. A first portion 27161 of the clasp 27100 may include the first visible marking 27153, and a second portion 27163 of the clasp 27100 may include the second visible marking 27155. In the illustrated embodiment, the second portion 27163 of the clasp 27100 is made from a stretchable material, and the first portion 27161 is decoupled from the stretchable second portion 27163 such that stretching of the second portion 27163 does not adjust the positioning of the first portion 27161. For example, in the illustrated embodiment, the first and second portions 27161, 27163 are both attached to the fixed portion 27165 of the clasp, but the first portion 27161 is disposed within the notch 27167 of the second portion 27163 such that stretching of the second portion 27163 does not cause the first portion 27161 to move relative to the fixed portion 27165 of the clasp 27100. When a tension force is applied to the implantable device or implant, the second portion 27163 of the clasp 27100 stretches relative to the first portion 27161 such that the second visible marking 27155 moves relative to the first visible marking 27153. The second portion 27163 may be configured to maintain its position relative to the first portion 27161 until the tension force reaches or exceeds a predetermined tension or optimal tension range, or the second portion 27163 may be configured to move when a tension force is applied to the implantable device or implant, and the determination as to whether the predetermined tension or optimal tension range has been reached or exceeded is based on the distance the second visible marking 27155 has moved from the first visible marking 27153.

[0180] 78-81 show indicator features on the clasp of the implantable device or implant, it should be understood that the indicator features disclosed in these examples may be located on other portions of the implantable device or implant. For example, the paddle, rather than the clasp, may include first and second visible markings that indicate its volume to the user.

[0181] While various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in the examples herein, these various aspects, concepts, and features may be used in many alternative embodiments, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of this application. Furthermore, while various alternative embodiments of the various aspects, concepts, and features of the disclosure may be described herein, including alternative materials, structures, configurations, methods, devices, and components, alternatives for forming, fitting, and functioning, such descriptions are not intended to be a complete or comprehensive listing of available alternative embodiments, 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 embodiments and uses, even if such embodiments are not explicitly disclosed herein.

[0182] 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, while example or representative values ​​and ranges may be included to aid in the understanding of the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be significant values ​​or ranges only when expressly so described.

[0183] Moreover, while various aspects, features, and concepts may be expressly identified herein as inventive or forming part of the disclosure, such identification is not intended to be exclusive; rather, there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a particular disclosure, the disclosure being instead set forth in the appended claims. The description of an exemplary method or process is not limited to the inclusion of every step that is essential in all cases, nor is the order in which steps are presented such that they are construed as essential or required unless expressly stated to be so. The terms used in the claims have their full ordinary meaning and are not limited in any way by the description of the examples herein. [Explanation of symbols]

[0184] 100 Implants 102 Delivery System 104...joint part 106 Anchor part 108 Anchor 110...Joining means 112....operating element 120, 122 Paddles 130 ···Clasp

Claims

1. 1. A valve repair device comprising: an anchor portion including one or more anchors; the one or more anchors are configured to attach to one or more leaflets of a native heart valve; the one or more anchors are configured to move between an open position and a closed position; The valve repair device comprises: an indication feature that indicates to a user when, when the one or more anchors are attached to the leaflets of the native heart valve, a force magnitude applied to the anchor portion by the leaflets of the native heart valve exceeds a predetermined force magnitude; The indication feature comprises one or more components of the one or more anchors that enable the one or more anchors to be in a non-extended position when the indication feature is in an acceptable tension position and to be in an extended position when the indication feature is in an excessive tension position.

2. 2. The valve repair device of claim 1, wherein each of the one or more anchors comprises a clasp including a fixation arm and a movable arm pivotally connected to the fixation arm, and the indicator feature comprises a flexible material of the movable arm that enables the movable arm to be in an unextended position when the indicator feature is in a first tensioned position and in an extended position when the indicator feature is in a second tensioned position, the second tensioned position indicating to a user when a force magnitude exceeds a predetermined force magnitude.

3. 2. The valve repair device of claim 1, wherein each of the one or more anchors comprises a clasp having the indication feature, each clasp comprising a first portion including a first visible marking of the indication feature and a second portion including a second visible marking of the indication feature, the second portion of each clasp being movable relative to the first portion, such that movement of the second portion moves the second visible marking relative to the first visible marking, causing the indication feature to indicate to a user that the magnitude of the force applied to the anchor portion by the leaflets of the native heart valve exceeds the predetermined force magnitude.

4. 2. The valve repair device of claim 1, wherein the indicator feature includes a flexible material of the one or more anchors, and when the one or more anchors are connected to the leaflets of the native heart valve and in the closed position, the indicator feature is in a second tensioned position when the flexible material of the one or more anchors bends the one or more anchors away from the center of the valve repair device.

5. 1. A valve repair device comprising: an actuation element; an anchor portion including one or more anchors coupled to the actuation element; the anchor is configured to attach to one or more leaflets of a native heart valve; the anchor is configured to move between an open position and a closed position upon movement of the actuation element; at least one of the actuation element and the anchor portion includes an indicator feature movable between a first tensioned position and a second tensioned position; when the anchor is attached to the leaflets of the native heart valve, the indication feature indicates to a user when a force magnitude applied to the anchor portion by the leaflets of the native heart valve exceeds a predetermined force magnitude; The valve repair device further comprises a connection element movable from an unlocked state to a locked state, the connection element attaching to the anchor and locking the anchor in the closed position when the connection element is in the locked state.

6. The valve repair device of claim 5 , wherein the anchor portion comprises one or more clasps that include the indication feature.

7. 7. The valve repair device of claim 6, wherein at least a portion of the one or more clasps comprises a fixation arm attached to the anchor and a movable arm pivotally connected to the fixation arm, and the indicator feature comprises a flexible material of the movable arm that allows the movable arm to be in a non-extended position when the indicator feature is in the first tension position and in an extended position when the indicator feature is in the second tension position.

8. 7. The valve repair device of claim 6, wherein the clasp comprises a first portion including a first visible marking of the indication feature and a second portion including a second visible marking of the indication feature, and the second portion of the clasp is movable relative to the first portion such that movement of the second portion moves the second visible marking relative to the first visible marking, causing the indication feature to indicate to a user that the magnitude of the force applied to the anchor portion by the leaflets of the native heart valve exceeds the predetermined force magnitude.

9. The valve repair device of claim 5 , wherein the anchor comprises the indicating feature.

10. 6. The valve repair device of claim 5, wherein the indicator feature includes a flexible material of the anchor that allows the anchor to be in a non-extended position when the indicator feature is in an acceptable tension position and in an extended position when the indicator feature is in the excessive tension position.

11. 6. The valve repair device of claim 5, wherein the anchor portion comprises one or more clasps corresponding to each of the anchors, and at least a portion of the clasps comprises a fixation arm attached to the anchor at a connection point and a movable arm pivotally connected to the fixation arm at a pivot connection point, the connection point being spaced from the pivot connection point.

12. 12. The valve repair device of claim 11, wherein the indicator feature comprises an attachment between the fixation arms at the connection point that allows at least a portion of the fixation arms to bend relative to the connection point when the indicator feature is in the second tension position, the second tension position indicating that the predetermined force magnitude has been exceeded.

13. 6. The valve repair device of claim 5, wherein the indicator feature includes a flexible material of the anchor, and the indicator feature is in the second tension position when the flexible material of the anchor bends the anchor away from the center of the valve repair device when the anchor is connected to the leaflets of the native heart valve and in the closed position.

14. The valve repair device of claim 5 , wherein the actuation element comprises the indication feature.

15. The valve repair device of claim 5 , wherein the actuation element extends through a catheter.

16. The valve repair device of claim 15 , wherein the indicator feature comprises a visible portion of the actuation element extending proximally of the proximal end of the catheter.

17. The valve repair device of claim 5 , wherein the indicator feature comprises a flexible portion of the actuating element that allows the actuating element to flex.

18. 1. A valve repair system for repairing a patient's native heart valve during a closed-heart procedure, the valve repair system comprising: a delivery device having at least one lumen; A valve repair device according to any one of claims 5 to 17; Equipped with The valve repair system, wherein the actuation element extends through the delivery device.

Images