Heart valve sealing devices and delivery devices therefor

Abstract

To solve the problem in which central jet regurgitation occurs when edges of leaflets do not meet in the middle, and thus the valve does not close and regurgitation is present.SOLUTION: Valve repair devices and systems are configured to detect proper valve leaflet insertion. The valve repair devices can have an indicator. The indicator moves, is positioned, or otherwise changes in response to engagement with the valve leaflet. When the indicator indicates that the valve leaflet is properly positioned in the valve repair devices, the valve repair devices are closed.SELECTED DRAWING: Figure 13

Description

[Technical Field]

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 805,847, entitled "Heart Valve Sealing Devices and Delivery Devices Therefor," filed February 14, 2019, and U.S. Provisional Patent Application No. 62 / 944,325, entitled "Leaflet Depth Indicators," filed December 5, 2019, which are hereby incorporated by reference in their entireties for all purposes. [Background technology]

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform a critical function in ensuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be damaged and therefore less effective due to congenital malformations, inflammatory processes, infectious conditions, disease, etc. Damage to such valves can result in serious cardiovascular side effects 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 one example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, up the inferior vena cava, and into the right atrium). The septum is then punctured and the catheter is threaded into the left atrium. A similar transvascular technique can be used to implant a prosthetic device into the tricuspid valve, which begins similarly to the transseptal technique but stops short of puncturing the septum and instead directs the delivery catheter into the right atrium toward the tricuspid valve.

[0003] A healthy heart has a generally conical shape tapering toward the lower apex. The heart consists of 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 natural mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure from other natural heart valves. The mitral valve includes an annulus portion and a pair of cusps (or leaflets). The annulus portion is the annular portion of natural valve tissue surrounding the mitral orifice, and the pair of cusps extend downward from the annulus into the left ventricle. The mitral valve annulus can have a "D"-shaped cross-sectional shape, an oval cross-sectional shape, or other non-circular cross-sectional shape with a major and minor axis. The anterior leaflet is larger than the posterior leaflet, allowing a generally "C" shaped boundary to form between the abutting sides of the leaflets when they are closed.

[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 forces the sides of the two valve leaflets together, thereby closing the one-way mitral valve and preventing blood from flowing back into the left atrium. Instead, blood is expelled from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and the mitral valve annulus from folding back toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0005] Valve regurgitation involves a valve improperly allowing some blood to flow through it in the wrong direction. For example, mitral regurgitation occurs when the native mitral valve fails to close properly, causing blood to flow from the left ventricle into the left atrium during the systolic phase of cardiac contraction. Mitral regurgitation is one of the most common forms of heart valve disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral annulus as a result of left ventricular dilation, or two or more of these. Mitral regurgitation in the central portion of the valve leaflets can be referred to as central jet mitral regurgitation, while mitral regurgitation closer to one commissure of the leaflets (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the valve leaflets do not meet in the middle, thus preventing closure and resulting in regurgitation. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Application No. PCT / US2019 / 055320 [Patent Document 2] U.S. Provisional Patent Application No. 62 / 744031 [Patent Document 3] International Application No. PCT / US2018 / 028189 [Patent Document 4] International Application No. PCT / US2019 / 062391 [Patent Document 5] U.S. Patent Application No. 62 / 805,847 Summary of the Invention [Means for solving the problem]

[0007] This Summary is meant to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the Examples of this Summary is not required by a claim unless the claim explicitly recites that feature. Also, features, components, steps, concepts, etc. described in Examples in this Summary and Examples elsewhere in this disclosure may be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the Examples summarized here.

[0008] In one exemplary embodiment, a heart valve therapy device or system is configured to detect aspects related to leaflet insertion (e.g., depth of leaflet insertion, thickness of captured leaflet tissue, etc.). The device / system can have an indicator that moves, positions, and / or changes shape in response to engagement with the leaflet. When the position of the indicator indicates that the leaflet is properly positioned within the device / system, the device / system can be closed.

[0009] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a fastener and a leaflet indicator. The fastener (e.g., all or a portion thereof) is movable to form an opening or leaflet receiving area. The opening or leaflet receiving area may be formed between two portions of the fastener (e.g., a fixed arm and a movable arm, etc.), between the fastener or a portion thereof and another portion of the device, between the fastener and a paddle of the device, between the fastener and an anchor of the device, between the movable arm of the fastener and a paddle of the device, etc. The leaflet indicator is movable, repositionable, and / or changes shape or configuration within the opening or receiving area to indicate whether the leaflet of the native valve has been inserted into the opening or receiving area to at least a minimum desired insertion depth and / or a minimum desired tissue thickness. The leaflet indicator may be configured the same as or similar to any of the indicators shown in any of the figures or described elsewhere in this disclosure. For example, the leaflet indicator may include one or more indicator arms, one or more radiopaque markers, one or more springs, one or more levers, one or more snap-through portions, one or more tabs, one or more pads, one or more coils, one or more deflectable portions, one or more hoops or hoop-shaped portions, one or more flattenable indicators, one or more indicator wings, etc.

[0010] A cardiac valve therapy or repair device / system can include one or more of the features or components shown in any of the figures or described with respect to other devices described elsewhere in this disclosure. For example, in some implementations, the device / system includes one or more of an anchor portion, an anchor, a coaption portion, a coaption element, a paddle, a pair of paddles, a plurality of paddles, a delivery sheath, a delivery catheter, an actuating element, a shaft, an actuating line / suture, a cap, a collar, a cover, a braided material, a strip of material, etc.

[0011] The device / system includes a shaft and a proximal portion (e.g., a collar, co-option portion, co-option element, disk, cover, post, tube, etc.) and a cap, where the shaft extends through the proximal portion and the cap is attached to the shaft such that the cap can be moved away from the proximal portion by the shaft. In some implementations, the device / system also includes a pair of paddles attached to the cap. The device / system can be configured such that movement of the cap toward the proximal portion moves the pair of paddles to a closed position, and movement of the cap away from the proximal portion moves the pair of paddles to an open position. In some implementations, the device / system further includes a co-option element configured to fill the space between the leaflets of the native valve.

[0012] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a fastener and multiple indicator arms. The fastener (e.g., all or a portion thereof) is movable to form an opening or leaflet-receiving area. The opening or leaflet-receiving area can be formed between two portions of the fastener (e.g., a fixed arm and a movable arm, etc.), between the fastener or a portion thereof and another portion of the device, between the fastener and a paddle of the device, between the fastener and an anchor of the device, between the movable arm of the fastener and a paddle of the device, etc. In some implementations, the multiple indicator arms have different lengths and are movable within the opening or receiving area to indicate whether the leaflets of the native valve have been inserted into the opening or receiving area to at least a minimum desired insertion depth and / or a minimum desired tissue thickness.

[0013] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a paddle, a hoop-shaped fastener, and an indicator arm. The paddle and fastener are movable to form an opening between the fastener and the paddle. The indicator arm is disposed between two sides of the hoop-shaped fastener and is movable within the opening to indicate whether the leaflets of the native valve have been inserted into the opening between the paddle and the fastener to at least a minimum desired insertion depth.

[0014] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a fastener and a flattenable indicator. The fastener (e.g., all or a portion thereof) is movable to form an opening or receiving area. The opening or leaflet receiving area can be formed between two portions of the fastener (e.g., a fixed arm and a movable arm, etc.), between the fastener or a portion thereof and another portion of the device, between the fastener and a paddle of the device, between the fastener and an anchor of the device, between the movable arm of the fastener and a paddle of the device, etc. The flattenable indicator is located in the opening or receiving area and indicates whether the leaflet of the native valve has been inserted into the opening or receiving area to at least a minimum desired insertion depth and / or a minimum desired tissue thickness.

[0015] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a hoop-shaped fastener and an indicator (e.g., indicator arm, spring, etc.). The fastener (e.g., all or a portion thereof) is movable to form an opening or a receiving area. The opening or leaflet receiving area can be formed between two portions of the fastener (e.g., a fixed arm and a movable arm, etc.), between the fastener or a portion thereof and another portion of the device, between the fastener and a paddle of the device, between the fastener and an anchor of the device, between the movable arm of the fastener and a paddle of the device, etc.

[0016] In one embodiment, the indicator extends through the hoop-shaped fastener and is deformable through the hoop-shaped fastener to indicate whether the leaflets of the native valve have been inserted into the opening or receiving area to at least a minimum desired insertion depth and / or a minimum desired tissue thickness.

[0017] In one embodiment, the indicator includes an indicator arm disposed between two sides of the hoop-shaped fastener, the indicator arm can have a curved portion that is movable through the hoop-shaped fastener to indicate whether the leaflets of the native valve have been inserted into the opening or receiving area between the paddle and the fastener to at least a minimum desired insertion depth and / or a minimum desired tissue thickness.

[0018] In one embodiment, the indicator includes a spring disposed or positionable within the opening or receiving area that indicates whether the leaflets of the native valve are inserted into the opening or receiving area between the paddle and the fastener to at least a minimum desired insertion depth and / or a minimum desired tissue thickness.

[0019] In one embodiment, the indicator includes at least one indicator wing extending outward at a predetermined angle from the side of the fastener to indicate whether the leaflets of the native valve have been inserted into the opening or receiving area between the paddle and the fastener to at least a minimum desired insertion depth and / or a minimum desired tissue thickness.

[0020] In one embodiment, the indicator includes a first leaflet indicator and a second leaflet indicator that are spaced apart when the leaflets of the native valve are inserted into the opening between the paddle and the fastener to at least a minimum desired insertion depth, and in one embodiment, the first leaflet indicator and the second leaflet indicator are in contact when no leaflets of the native valve are within the opening or receiving area between the paddle and the fastener.

[0021] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a fastener and an indicator arm. The fastener (e.g., all or a portion thereof) is movable to form an opening or leaflet-receiving area. The opening or leaflet-receiving area can be formed between two portions of the fastener (e.g., a fixed arm and a movable arm, etc.), between the fastener or a portion thereof and another portion of the device, between the fastener and a paddle of the device, between the fastener and an anchor of the device, between the movable arm of the fastener and a paddle of the device, etc. A single actuation line extends from the delivery device to the fastener and the indicator arm. In some implementations, the single actuation line is configured to separately actuate the fastener and the indicator arm.

[0022] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a fastener and a flexibility indicator. The fastener (e.g., all or a portion thereof) is movable to form an opening or leaflet-receiving area. The opening or leaflet-receiving area can be formed between two portions of the fastener (e.g., a fixed arm and a movable arm, etc.), between the fastener or a portion thereof and another portion of the device, between the fastener and a paddle of the device, between the fastener and an anchor of the device, between the movable arm of the fastener and a paddle of the device, etc. The flexibility indicator is fixedly connected to one arm and slidably connected to the other arm.

[0023] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a fastener and at least one indicator. The fastener (e.g., all or a portion thereof) is movable to form an opening or leaflet-receiving area. The opening or leaflet-receiving area can be formed between two portions of the fastener (e.g., a fixed arm and a movable arm, etc.), between the fastener or a portion thereof and another portion of the device, between the fastener and a paddle of the device, between the fastener and an anchor of the device, between the movable arm of the fastener and a paddle of the device, etc.

[0024] In one embodiment, the at least one indicator extends from the paddle into the opening or leaflet-receiving area. In some implementations, the at least one indicator is configured such that at least a portion of the at least one indicator extends through the catch when the opening or leaflet-receiving area is closed and the indicator is unobstructed. In some implementations, the at least one indicator is also configured such that at least a portion of the at least one indicator extends through the paddle when the opening or leaflet-receiving area is closed and the at least one indicator engages the leaflet.

[0025] In one embodiment, at least one indicator extends from one of the locking arm and the paddle into the opening or receiving area. The at least one indicator can be configured such that at least a portion of the indicator extends through the movable arm of the fastener when the opening or receiving area is closed and the indicator is unobstructed. The at least one indicator can also be configured such that at least a portion of the indicator extends through the locking arm of the fastener when the opening or receiving area is closed and the indicator engages the valve leaflet.

[0026] In some implementations, a portion of the at least one indicator extends through the paddle of the device / system when the opening or receiving area is closed and the at least one indicator engages the valve leaflet, hi some implementations, a portion of the at least one indicator does not extend through the movable arm of the catch when the opening or receiving area is closed and the indicator engages the valve leaflet.

[0027] In some implementations, the at least one indicator has a fixed end connected to the paddle and a free end. In some implementations, the at least one indicator has a fixed end connected to the fixed arm and a free end. In some implementations, the at least one indicator is integrally formed with the fixed arm of the fastener. The at least one indicator can be curved, straight, angled, spherical, hemispherical, and / or another shape.

[0028] In some implementations, the movable arm of the fastener includes a cutout, and at least one indicator extends through the cutout when the opening or receiving area is closed and the indicator is unobstructed. In some implementations, the fixed arm of the fastener includes a cutout, and at least one indicator extends through the cutout. In some implementations, the paddle of the device / system includes a cutout, and at least one indicator extends through the cutout when the opening between the paddle and the movable arm of the fastener is closed and the indicator engages the valve leaflet.

[0029] In some implementations, when the opening or receiving area (e.g., between the movable arm of the fastener and the paddle) is closed and the indicator is unobstructed, a smaller portion of the at least one indicator extends through the cutout in the paddle, and when the opening or receiving area is closed and the indicator engages the valve leaflet, a larger portion of the at least one indicator extends through the cutout in the paddle.

[0030] In one exemplary method of implanting a valve repair device, an indicator on a fastener is engaged. When the mitral valve leaflets are not contacted by the indicator, the indicator is disengaged. When the indicator is engaged and the leaflets are contacted by the indicator, the fastener is closed.

[0031] In one exemplary method of implanting a valve repair device onto a patient's native valve (e.g., mitral valve, tricuspid valve, etc.), an indicator arm of a clasp is actuated. When a leaflet of the native valve is not engaged by the indicator arm, the indicator arm is returned to a non-actuated position. When a leaflet of the native valve is engaged by the actuated indicator arm, the clasp of the valve repair device is closed. In some embodiments, one or more paddles of the valve repair device are closed, bringing one or more leaflets of the native valve into contact with a co-option element of the valve repair device. In some embodiments, one or more paddles of the valve repair device are closed, bringing the leaflets into contact with each other.

[0032] In one exemplary method of implanting a valve repair device, an indicator gauge on the fastener measures the depth of engagement of the leaflets of the native valve. When the depth of engagement is below a desired depth, the indicator gauge is disengaged. When the depth of engagement is at least equal to the desired depth, the fastener is closed.

[0033] The above methods may be performed on a live animal or on a simulation (eg, a cadaver, a cadaver heart, a simulator (eg, where body parts, hearts, tissues, etc. are simulated), etc.).

[0034] In one exemplary embodiment, the valve repair device includes a plurality of paddles, a plurality of fasteners, and an insertion depth indicator. In some embodiments, the valve repair device can also include a co-option element. The plurality of paddles can be connected to the co-option element and / or another portion of the device. Each paddle has an inner portion and an outer portion. The paddles are movable between an open position and a closed position. A fastener is attached to each of the plurality of paddles. Each fastener includes a fixation arm, a movable arm, and a joint or hinge. The fixation arm is attached to the inner portion of the paddle and / or another portion of the valve repair device. The movable arm and / or fixation arm can optionally have one or more friction-enhancing portions (e.g., a barbed portion, a ridged portion, a textured portion, a protruding portion, etc.). The hinge portion connects the movable arm to the fixation arm. The insertion depth indicator indicates whether the leaflets of the native valve have been inserted into the fastener opening formed between the fixation arm and the movable arm to at least a minimum desired insertion depth.

[0035] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a plurality of paddles and a plurality of fasteners. The plurality of paddles are movable between an open position and a closed position. A fastener is attached to each of the paddles. The fastener includes a fixation arm, a movable arm, a hinge portion, an indicator arm, and an indicator hinge portion. The movable arm and / or the fixation arm can have one or more friction-enhancing portions (e.g., a barbed portion, a ridged portion, a textured portion, a protruding portion, etc.). The hinge portion connects the movable arm to the fixation arm. The indicator arm is connected to the fixation arm by the hinge portion.

[0036] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a plurality of paddles, a plurality of fasteners, and a compressible indicator. The paddles are movable between an open position and a closed position. A fastener is attached to each of the plurality of paddles. Each fastener has a fixation arm, a movable arm, and a hinge portion. The fixation arm of each fastener is attached to another portion of the paddle and / or the valve repair device. The movable arm is connected to the fixation arm by the hinge portion. The compressible indicator is configured to engage the leaflets of the native valve.

[0037] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a plurality of paddles, a plurality of fasteners, a plurality of indicators, and a plurality of markers. The paddles are movable between an open position and a closed position. A fastener is attached to each of the paddles. Each fastener includes a fixation arm, a movable arm, and a hinge portion. The fixation arm of each fastener is attached to another portion of the paddle and / or the valve repair device. The movable arm and / or the fixation arm can have one or more friction-enhancing portions (e.g., a barbed portion, a ridged portion, a textured portion, a protruding portion, etc.). The hinge portion connects the movable arm to the fixation arm. Respective markers are attached to the indicator, the fixation arm, and / or the movable arm.

[0038] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a pair of paddles, a pair of fasteners, and an insertion depth gauge. The pair of paddles are movable between an open position and a closed position. A fastener is attached to each of the paddles. Each fastener includes a fixation arm, a movable arm, and a hinge portion. The fixation arm is attached to another portion of the paddle and / or the valve repair device. The movable arm and / or the fixation arm can have one or more friction-enhancing portions (e.g., a barbed portion, a ridged portion, a textured portion, a protruding portion, etc.). The hinge portion connects the movable arm to the fixation arm. The insertion depth gauge indicates the insertion depth of the leaflets of the native valve.

[0039] In one exemplary embodiment, a heart valve therapy device / system or valve repair device / system for repairing a patient's native valve includes a pair of paddles, a pair of fasteners, an indicator arm, and an actuating suture. The pair of paddles are movable between an open position and a closed position. A fastener is attached to each of the paddles. Each fastener includes a fixation arm, a movable arm, and a hinge portion. The fixation arm is attached to another portion of the paddle and / or the valve repair device. The movable arm and / or the fixation arm can have one or more friction-enhancing portions (e.g., a barbed portion, a ridged portion, a textured portion, a protruding portion, etc.). The movable arm is movable between an open position and a closed position. A hinge portion connects the movable arm to the fixation arm. An indicator hinge portion connects the indicator arm to the fixation arm of the fastener. In some implementations, the actuating suture extends from the delivery device to first and second movable loops attached to the movable fastener arm and the indicator arm, respectively. In some implementations, the movable fastener arm and indicator arm are separately actuatable by a single actuation suture.

[0040] In one exemplary embodiment, a fastener for a heart valve treatment device / system or valve repair device / system includes an indicator, such as an insertion depth indicator, configured to provide an indication of the insertion depth and / or thickness of the native valve leaflets within or adjacent to the fastener when the heart valve treatment device is implanted within the native heart valve. The indicator may be configured the same as or similar to any of the indicators shown in any of the figures or described elsewhere in this disclosure. For example, the indicator may include one or more indicator arms, one or more radiopaque markers, one or more springs, one or more levers, one or more snap-through portions, one or more tabs, one or more pads, one or more coils, one or more deflectable portions, one or more hoops or hoop-shaped portions, one or more flattenable indicators, one or more indicator wings, etc.

[0041] In some implementations, the fastener further includes a fixed arm attachable to a device / system (e.g., a paddle, anchor, post, arm, extension, cover, etc. of the device / system) and a movable arm. The fixed arm and / or the movable arm can include friction-enhancing portions (e.g., friction-enhancing elements, barbs, protrusions, ridges, textured surfaces, sticky surfaces, etc.). A connecting or hinge portion connects (e.g., jointed, hinged, etc.) the movable arm to the fixed arm.

[0042] In some implementations, the indicator or insertion depth indicator is deformable, and the shape of the indicator indicates the insertion depth and / or thickness of the native valve leaflets.

[0043] In some implementations, the indicator is movable and the position of the indicator indicates the insertion depth and / or thickness of the native valve leaflets.

[0044] In some implementations, the relative position of the indicator and at least one of the fixed arm and the movable arm indicates the insertion depth of the leaflets of the native valve.

[0045] In some implementations, the indicator includes multiple flexible arms (e.g., two, three, four, five, six, or more arms) attached to the movable arm between the catch hinge portion and the friction-enhancing portion, and the insertion depth of the leaflet can be indicated by the number of flexible arms that are deformed by engagement with the leaflet.

[0046] In some implementations, the indicator includes multiple flexible arms (e.g., two, three, four, five, six, or more arms) attached to a fixed arm, and the insertion depth of the leaflet can be indicated by the number of flexible arms that are deformed by engagement with the leaflet.

[0047] In some implementations, the indicator includes an indicating pad disposed on at least one of the movable arm and the fixed arm, the indicating pad configured to deform when engaged by the leaflets of the native valve, and the insertion depth and / or thickness of the leaflets can be indicated by the size of the deformed portion of the indicating pad.

[0048] In some implementations, the indicator is actuable between a non-deployed position and an actuated position, hi some implementations, the indicator is actuated or actuable when the fastener is at least partially open to determine the insertion depth of the native valve leaflets.

[0049] In some implementations, the insertion depth indicator intersects with at least one of the fixed arm and the movable arm when the insertion depth indicator is in the activated position.

[0050] In some implementations, the movable arm is hoop-shaped and the friction-enhancing portion includes longitudinally offset barbs.

[0051] In some implementations, the fasteners described above can be included in a cardiac valve treatment or repair device / system. The cardiac valve treatment or repair device / system can include one or more of the features or components shown in any of the figures or described with respect to any of the devices / systems of the present disclosure. For example, in some implementations, the device / system includes one or more of an anchor portion, an anchor, a co-option portion, a co-option element, a paddle, a pair of paddles, multiple paddles, a delivery sheath, a delivery catheter, an actuating element, a shaft, an actuating line / suture, a cap, a collar, a cover, a braided material, a strip of material, etc.

[0052] In some implementations, the device / system includes a shaft and a proximal portion (e.g., a collar, co-option portion, co-option element, disk, cover, post, tube, etc.) and a cap, where the shaft extends through the proximal portion and the cap is attached to the shaft such that the cap can be moved away from the proximal portion by the shaft. In some implementations, the device / system also includes a pair of paddles attached to the cap. The device / system can be configured such that movement of the cap toward the proximal portion moves the pair of paddles to a closed position and movement of the cap away from the proximal portion moves the pair of paddles to an open position. In some implementations, the device / system further includes a co-option element configured to fill the space between the leaflets of the native valve.

[0053] An understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings, in which like parts bear like reference numerals and in which: [Brief explanation of the drawings]

[0054] [Figure 1] 1A-1D illustrate an implantable prosthetic device at various stages of deployment. [Figure 1A] 1A-1D illustrate an implantable prosthetic device at various stages of deployment. [Figure 2] 1A-1D illustrate an implantable prosthetic device at various stages of deployment. [Figure 3] 1A-1D illustrate an implantable prosthetic device at various stages of deployment. [Figure 4] 1A-1D illustrate an implantable prosthetic device at various stages of deployment. [Figure 5] 1A-1D illustrate an implantable prosthetic device at various stages of deployment. [Figure 6] 1A-1D illustrate an implantable prosthetic device at various stages of deployment. [Figure 7] FIG. 7 shows the implantable prosthetic device of FIGS. 1-6 being delivered and implanted into a native mitral valve. [Figure 8] FIG. 7 shows the implantable prosthetic device of FIGS. 1-6 being delivered and implanted into a native mitral valve. [Figure 9] FIG. 7 shows the implantable prosthetic device of FIGS. 1-6 being delivered and implanted into a native mitral valve. [Figure 10] FIG. 7 shows the implantable prosthetic device of FIGS. 1-6 being delivered and implanted into a native mitral valve. [Figure 11] FIG. 7 shows the implantable prosthetic device of FIGS. 1-6 being delivered and implanted into a native mitral valve. [Figure 12] FIG. 7 shows the implantable prosthetic device of FIGS. 1-6 being delivered and implanted into a native mitral valve. [Figure 13] 1 illustrates an implantable prosthetic device. [Figure 13A] 1 illustrates an implantable prosthetic device. [Figure 14] FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 15] FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 16] FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 17] FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 18] FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 19] FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 20] FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 21] FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 22] FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 23] FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 23A] FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 23B]FIG. 1 illustrates an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 24] 1A-1C show schematic diagrams of exemplary embodiments of fasteners for implantable prosthetic devices. [Figure 25] 1A-1C show schematic diagrams of exemplary embodiments of fasteners for implantable prosthetic devices. [Figure 24A] 1A-1C show schematic diagrams of exemplary embodiments of fasteners for implantable prosthetic devices. [Figure 25A] 1A-1C show schematic diagrams of exemplary embodiments of fasteners for implantable prosthetic devices. [Figure 26] 26 shows the exemplary fastener of FIGS. 24-25 deployed to engage the leaflets of a native valve. [Figure 27] 26 shows the exemplary fastener of FIGS. 24-25 deployed to engage the leaflets of a native valve. [Figure 28] 26 shows the exemplary fastener of FIGS. 24-25 deployed to engage the leaflets of a native valve. [Figure 29] 26 shows the exemplary fastener of FIGS. 24-25 deployed to engage the leaflets of a native valve. [Figure 30] 1A-1C are front views of exemplary embodiments of fasteners for implantable prosthetic devices. [Figure 31] 1A-1C are front views of exemplary embodiments of fasteners for implantable prosthetic devices. [Figure 32] 1A-1C are front views of exemplary embodiments of fasteners for implantable prosthetic devices. [Figure 33] 1A-1C are front views of exemplary embodiments of fasteners for implantable prosthetic devices. [Figure 34] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 35]1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 36] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 37] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 38] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 39] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 40] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 41] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 42] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 43] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 44] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 45] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 46]1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 47] 1A-1C show an implantable prosthetic device having a fastener with an indicator arm being delivered and implanted into a native valve. [Figure 48] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 49] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 50] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 51] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 52] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 53] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 54] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 55] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 56] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 57] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 58] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 59] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 60]1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 61] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 62] FIG. 1 illustrates an exemplary fastener (which may be configured to be the same as or similar to other barbed fasteners herein) deployed to engage the leaflets of a native valve. [Figure 63] FIG. 1 illustrates an exemplary fastener (which may be configured to be the same as or similar to other barbed fasteners herein) deployed to engage the leaflets of a native valve. [Figure 64] FIG. 1 illustrates an exemplary fastener (which may be configured to be the same as or similar to other barbed fasteners herein) deployed to engage the leaflets of a native valve. [Figure 65] FIG. 1 illustrates an exemplary fastener (which may be configured to be the same as or similar to other barbed fasteners herein) deployed to engage the leaflets of a native valve. [Figure 66] FIG. 1 illustrates an exemplary fastener (which may be configured to be the same as or similar to other barbed fasteners herein) deployed to engage the leaflets of a native valve. [Figure 67] 1A-1C illustrate exemplary embodiments of laser cut fasteners and indicators. [Figure 68] 1A-1C illustrate exemplary embodiments of laser cut fasteners and indicators. [Figure 67A] 1A-1C illustrate exemplary embodiments of laser cut fasteners and indicators. [Figure 68A] 1A-1C illustrate exemplary embodiments of laser cut fasteners and indicators. [Figure 69] 1A-1C illustrate an exemplary embodiment of a laser cut fastener with multiple indicators. [Figure 70]1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 71] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 70A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 71A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 72] 70-71 or 70A-71A shown deployed to engage the leaflets of a native valve. [Figure 73] 70-71 or 70A-71A shown deployed to engage the leaflets of a native valve. [Figure 74] 70-71 or 70A-71A shown deployed to engage the leaflets of a native valve. [Figure 75] 70-71 or 70A-71A shown deployed to engage the leaflets of a native valve. [Figure 76] 10A-10C illustrate a movable arm and an indicator arm according to an exemplary embodiment of an implantable prosthetic device having a T-bar. [Figure 77] 10A-10C illustrate a movable arm and an indicator arm according to an exemplary embodiment of an implantable prosthetic device having a T-bar. [Figure 78] 1A-1C illustrate an exemplary embodiment of a fastener with indicator arms and a T-bar for an implantable prosthetic device. [Figure 79] 1A-1C illustrate an exemplary embodiment of a fastener with indicator arms and a T-bar for an implantable prosthetic device. [Figure 80] 79A-79C show the exemplary fasteners of FIGS. 78-79 deployed to engage the leaflets of a native valve. [Figure 81] 79A-79C show the exemplary fasteners of FIGS. 78-79 deployed to engage the leaflets of a native valve. [Figure 82] 79A-79C show the exemplary fasteners of FIGS. 78-79 deployed to engage the leaflets of a native valve. [Figure 83] 79A-79C show the exemplary fasteners of FIGS. 78-79 deployed to engage the leaflets of a native valve. [Figure 84] 10A-10C illustrate an exemplary embodiment of a fastener having an indicator arm with a curved indicator for an implantable prosthetic device. [Figure 85] FIG. 85 is a schematic diagram of the exemplary fastener of FIG. 84. [Figure 86] FIG. 85 is a schematic diagram of the exemplary fastener of FIG. 84. [Figure 87] 87A-87C show the exemplary fastener of FIGS. 85-86 deployed to engage the leaflets of a native valve. [Figure 88] 87A-87C show the exemplary fastener of FIGS. 85-86 deployed to engage the leaflets of a native valve. [Figure 89] 87A-87C show the exemplary fastener of FIGS. 85-86 deployed to engage the leaflets of a native valve. [Figure 90] 87A-87C show the exemplary fastener of FIGS. 85-86 deployed to engage the leaflets of a native valve. [Figure 91] 1 is a schematic diagram of an exemplary embodiment of a fastener for an implantable prosthetic device having an indicator arm and a flexible curve in the fixation arm as an indicator. [Figure 92] 1 is a schematic diagram of an exemplary embodiment of a fastener for an implantable prosthetic device having an indicator arm and a flexible curve in the fixation arm as an indicator. [Figure 93] 93 shows the exemplary fastener of FIGS. 91-92 deployed to engage the leaflets of a native valve. [Figure 94]93 shows the exemplary fastener of FIGS. 91-92 deployed to engage the leaflets of a native valve. [Figure 95] 93 shows the exemplary fastener of FIGS. 91-92 deployed to engage the leaflets of a native valve. [Figure 96] 93 shows the exemplary fastener of FIGS. 91-92 deployed to engage the leaflets of a native valve. [Figure 97] 1A-1C show schematic diagrams of exemplary embodiments of fasteners with flexible curved indicators in movable arms for implantable prosthetic devices. [Figure 98] 1A-1C show schematic diagrams of exemplary embodiments of fasteners with flexible curved indicators in movable arms for implantable prosthetic devices. [Figure 99] 99 shows the exemplary fastener of FIGS. 97-98 deployed to engage the leaflets of a native valve. [Figure 100] 99 shows the exemplary fastener of FIGS. 97-98 deployed to engage the leaflets of a native valve. [Figure 100A] 99 shows the exemplary fastener of FIGS. 97-98 deployed to engage the leaflets of a native valve. [Figure 101] 1A-1C show schematic diagrams of exemplary embodiments of fasteners with flexible curve indicators in the fixation arms for implantable prosthetic devices. [Figure 102] 1A-1C show schematic diagrams of exemplary embodiments of fasteners with flexible curve indicators in the fixation arms for implantable prosthetic devices. [Figure 103] 10A-10C illustrate an exemplary embodiment of a movable arm and indicator of a fastener. [Figure 103A] 10A-10C illustrate exemplary embodiments of a movable arm of a fastener having various exemplary embodiments of an indicator. [Figure 103B] 10A-10C illustrate exemplary embodiments of a movable arm of a fastener having various exemplary embodiments of an indicator. [Figure 103C] 10A-10C illustrate exemplary embodiments of a movable arm of a fastener having various exemplary embodiments of an indicator. [Figure 103D] 10A-10C illustrate exemplary embodiments of a movable arm of a fastener having various exemplary embodiments of an indicator. [Figure 104] 10A-10C are schematic diagrams of exemplary embodiments of fasteners having flexible curves in the fixation arms as indicators for implantable prosthetic devices. [Figure 105] 10A-10C are schematic diagrams of exemplary embodiments of fasteners having flexible curves in the fixation arms as indicators for implantable prosthetic devices. [Figure 106] 10A-10C are schematic diagrams of exemplary embodiments of fasteners having flexible curves in the fixation arms as indicators for implantable prosthetic devices. [Figure 107] 107 shows the exemplary fastener of FIGS. 104-106 deployed to engage the leaflets of a native valve. [Figure 108] 107 shows the exemplary fastener of FIGS. 104-106 deployed to engage the leaflets of a native valve. [Figure 109] 107 shows the exemplary fastener of FIGS. 104-106 deployed to engage the leaflets of a native valve. [Figure 104A] 10A-10C are schematic diagrams of exemplary embodiments of fasteners having flexible wing indicators on movable arms for implantable prosthetic devices. [Figure 106A] 10A-10C are schematic diagrams of exemplary embodiments of fasteners having flexible wing indicators on movable arms for implantable prosthetic devices. [Figure 108A] 10A-10C are schematic diagrams of exemplary embodiments of fasteners having flexible wing indicators on movable arms for implantable prosthetic devices. [Figure 109A]10A-10C are schematic diagrams of exemplary embodiments of fasteners having flexible wing indicators on movable arms for implantable prosthetic devices. [Figure 104B] 1A-1C are schematic diagrams of exemplary embodiments of fasteners for implantable prosthetic devices having flexible wing indicators on the movable arms and flexible indicators on the fixed arms. [Figure 106B] 1A-1C are schematic diagrams of exemplary embodiments of fasteners for implantable prosthetic devices having flexible wing indicators on the movable arms and flexible indicators on the fixed arms. [Figure 108B] 1A-1C are schematic diagrams of exemplary embodiments of fasteners for implantable prosthetic devices having flexible wing indicators on the movable arms and flexible indicators on the fixed arms. [Figure 109B] 1A-1C are schematic diagrams of exemplary embodiments of fasteners for implantable prosthetic devices having flexible wing indicators on the movable arms and flexible indicators on the fixed arms. [Figure 104C] 1 is a schematic diagram of an exemplary embodiment of a fastener having flexible bump indicators on fixed and movable arms for an implantable prosthetic device. [Figure 106C] 1 is a schematic diagram of an exemplary embodiment of a fastener having flexible bump indicators on fixed and movable arms for an implantable prosthetic device. [Figure 108C] 1 is a schematic diagram of an exemplary embodiment of a fastener having flexible bump indicators on fixed and movable arms for an implantable prosthetic device. [Figure 109C] 1 is a schematic diagram of an exemplary embodiment of a fastener having flexible bump indicators on fixed and movable arms for an implantable prosthetic device. [Figure 104D]1A-1C are schematic diagrams of exemplary embodiments of fasteners having flexible indicators for implantable prosthetic devices. [Figure 106D] 1A-1C are schematic diagrams of exemplary embodiments of fasteners having flexible indicators for implantable prosthetic devices. [Figure 108D] 1A-1C are schematic diagrams of exemplary embodiments of fasteners having flexible indicators for implantable prosthetic devices. [Figure 109D] 1A-1C are schematic diagrams of exemplary embodiments of fasteners having flexible indicators for implantable prosthetic devices. [Figure 104E] 1A-1C are schematic diagrams of exemplary embodiments of fasteners having flexible indicators for implantable prosthetic devices. [Figure 106E] 1A-1C are schematic diagrams of exemplary embodiments of fasteners having flexible indicators for implantable prosthetic devices. [Figure 108E] 1A-1C are schematic diagrams of exemplary embodiments of fasteners having flexible indicators for implantable prosthetic devices. [Figure 109E] 1A-1C are schematic diagrams of exemplary embodiments of fasteners having flexible indicators for implantable prosthetic devices. [Figure 110] 10A-10C illustrate exemplary embodiments of movable and fixed arms with curved indicators of fastener flexibility for an implantable prosthetic device. [Figure 111] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 112] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 113] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 114]1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 115] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 116] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 117] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 118] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 119] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 120] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 121] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 122] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having a flexible, curved indicator. [Figure 123] 10A-10C are schematic diagrams of exemplary embodiments of fasteners with deflectable indicators on movable arms for implantable prosthetic devices. [Figure 124] 10A-10C are schematic diagrams of exemplary embodiments of fasteners with deflectable indicators on movable arms for implantable prosthetic devices. [Figure 123A] 10A-10C are schematic diagrams of exemplary embodiments of fasteners with deflectable indicators on movable arms for implantable prosthetic devices. [Figure 124A] 10A-10C are schematic diagrams of exemplary embodiments of fasteners with deflectable indicators on movable arms for implantable prosthetic devices. [Figure 125] 125 shows the exemplary fastener of FIGS. 123 and 124 deployed to engage the leaflets of a native valve. [Figure 126] 125 shows the exemplary fastener of FIGS. 123 and 124 deployed to engage the leaflets of a native valve. [Figure 127] 125 shows the exemplary fastener of FIGS. 123 and 124 deployed to engage the leaflets of a native valve. [Figure 125A] 123A and 124A deployed to engage the leaflets of a native valve. [Figure 126A] 123A and 124A deployed to engage the leaflets of a native valve. [Figure 127A] 123A and 124A deployed to engage the leaflets of a native valve. [Figure 128] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 129] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 129B] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 129C] 1A-1C illustrate an exemplary embodiment of a spring indicator for a fastener. [Figure 129D] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 129E]1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 129F] 1A-1C illustrate an exemplary embodiment of a spring indicator for a fastener. [Figure 129G] 1A-1C illustrate an exemplary embodiment of a spring indicator for a fastener. [Figure 129H] 1A-1C illustrate an exemplary embodiment of a spring indicator for a fastener. [Figure 129I] 10A-10C illustrate an exemplary embodiment of an indicator element for a spring indicator of a fastener. [Figure 129J] 10A-10C illustrate an exemplary embodiment of an indicator element for a spring indicator of a fastener. [Figure 130] 129A and 129B show the exemplary fasteners of FIGS. 128 and 129 deployed to engage the leaflets of a native valve. [Figure 131] 129A and 129B show the exemplary fasteners of FIGS. 128 and 129 deployed to engage the leaflets of a native valve. [Figure 132] 129A and 129B show the exemplary fasteners of FIGS. 128 and 129 deployed to engage the leaflets of a native valve. [Figure 128A] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 129A] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 130A] 128A and 129A deployed to engage the leaflets of a native valve. FIG. [Figure 131A] 128A and 129A deployed to engage the leaflets of a native valve. FIG. [Figure 132A]128A and 129A deployed to engage the leaflets of a native valve. FIG. [Figure 133] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 134] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 135] 135 shows the exemplary fastener of FIGS. 133 and 134 deployed to engage the leaflets of a native valve. FIG. [Figure 136] 135 shows the exemplary fastener of FIGS. 133 and 134 deployed to engage the leaflets of a native valve. FIG. [Figure 137] 135 shows the exemplary fastener of FIGS. 133 and 134 deployed to engage the leaflets of a native valve. FIG. [Figure 133A] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 134A] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 135A] 133A and 134A deployed to engage the leaflets of a native valve. FIG. [Figure 136A] 133A and 134A deployed to engage the leaflets of a native valve. FIG. [Figure 137A] 133A and 134A deployed to engage the leaflets of a native valve. FIG. [Figure 133B] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 134B] 1A-1C illustrate an exemplary embodiment of a fastener with a spring indicator for an implantable prosthetic device. [Figure 135B] 133B and 134B deployed to engage the leaflets of a native valve. [Figure 136B] 133B and 134B deployed to engage the leaflets of a native valve. [Figure 137B] 133B and 134B deployed to engage the leaflets of a native valve. [Figure 138] 1A-1C illustrate an exemplary embodiment of a fastener with indicator pads for an implantable prosthetic device. [Figure 139] 1A-1C illustrate an exemplary embodiment of a fastener with indicator pads for an implantable prosthetic device. [Figure 140] 139A and 139B show the exemplary fasteners of FIGS. 138 and 139 deployed to engage the leaflets of a native valve. [Figure 141] 139A and 139B show the exemplary fasteners of FIGS. 138 and 139 deployed to engage the leaflets of a native valve. [Figure 142] 139A and 139B show the exemplary fasteners of FIGS. 138 and 139 deployed to engage the leaflets of a native valve. [Figure 138A] 1A-1C illustrate an exemplary embodiment of a fastener with indicator pads for an implantable prosthetic device. [Figure 139A] 1A-1C illustrate an exemplary embodiment of a fastener with indicator pads for an implantable prosthetic device. [Figure 140A] 138A and 139A shown deployed to engage the leaflets of a native valve. [Figure 141A] 138A and 139A shown deployed to engage the leaflets of a native valve. [Figure 142A]138A and 139A shown deployed to engage the leaflets of a native valve. [Figure 143] 10A-10C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having suture holes. [Figure 144] 10A-10C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having suture holes. [Figure 145] 10A-10C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having suture holes. [Figure 146] 10A-10C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having suture holes. [Figure 147] 10A-10C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having suture holes. [Figure 148] 10A-10C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having suture holes. [Figure 149] 10A-10C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having suture holes. [Figure 150] 10A-10C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having suture holes. [Figure 151] 10A-10C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having suture holes. [Figure 152] 10A-10C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device having suture holes. [Figure 153] 144 shows the exemplary fastener of FIG. 143 deployed to engage the leaflets of a native valve. [Fig. 154] 144 shows the exemplary fastener of FIG. 143 deployed to engage the leaflets of a native valve. [Figure 155]FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 156] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 157] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 155A] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 158] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 159] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 160] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 161] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 162] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 163] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Fig. 164] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 165] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 166] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 164A] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 164B] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 167] 1A-1C are schematic diagrams of an exemplary embodiment of a fastener having a screw drive for capturing tissue. [Figure 168] 1A-1C are schematic diagrams of an exemplary embodiment of a fastener having a screw drive for capturing tissue. [Figure 169] 169 shows the exemplary fastener of FIGS. 167-168 deployed to engage the leaflets of a native valve. [Figure 170] 169 shows the exemplary fastener of FIGS. 167-168 deployed to engage the leaflets of a native valve. [Figure 171] 169 shows the exemplary fastener of FIGS. 167-168 deployed to engage the leaflets of a native valve. [Fig. 172] 1A-1C are schematic diagrams of exemplary embodiments of fasteners having flexible indicators. [Figure 173] 1A-1C are schematic diagrams of exemplary embodiments of fasteners having flexible indicators. [Fig. 174] 172-173 shown deployed to engage the leaflets of a native valve. [Figure 175] 172-173 shown deployed to engage the leaflets of a native valve. [Figure 176] 172-173 shown deployed to engage the leaflets of a native valve. [Figure 177] 1A-1C are schematic diagrams of exemplary embodiments of fasteners having barbed wheels for capturing tissue. [Figure 178] 1A-1C are schematic diagrams of exemplary embodiments of fasteners having barbed wheels for capturing tissue. [Figure 179] 177-178 shown deployed to engage the leaflets of a native valve. [Figure 180] 177-178 shown deployed to engage the leaflets of a native valve. [Figure 181] 177-178 shown deployed to engage the leaflets of a native valve. [Figure 182] 1 is a schematic diagram of an exemplary embodiment of a fastener. [Figure 183] 1 is a schematic diagram of an exemplary embodiment of a fastener. [Figure 184] 182-183 shown deployed to engage the leaflets of a native valve. [Figure 185] 182-183 shown deployed to engage the leaflets of a native valve. [Figure 186A] 182-183 shown deployed to engage the leaflets of a native valve. [Figure 186B] 182-183 shown deployed to engage the leaflets of a native valve. [Figure 187] 1 is a schematic diagram of an exemplary embodiment of a fastener with a belt. [Figure 188] 1 is a schematic diagram of an exemplary embodiment of a fastener with a belt. [Figure 189] 187-188 shown deployed to engage the leaflets of a native valve. [Figure 190] 187-188 shown deployed to engage the leaflets of a native valve. [Figure 191] 187-188 shown deployed to engage the leaflets of a native valve. [Figure 192] 1 is a schematic diagram of an exemplary embodiment of a fastener having an indicator. [Figure 193] 1 is a schematic diagram of an exemplary embodiment of a fastener having an indicator. [Figure 194] 192-193 shown deployed to engage the leaflets of a native valve. [Figure 195] 192-193 shown deployed to engage the leaflets of a native valve. [Figure 196] 192-193 shown deployed to engage the leaflets of a native valve. [Figure 197] 192-193 shown deployed to engage the leaflets of a native valve. [Figure 198] 1 is a schematic diagram of an exemplary embodiment of a fastener having an indicator. [Figure 199] 1 is a schematic diagram of an exemplary embodiment of a fastener having an indicator. [Figure 200] 198-199 shown deployed to engage the leaflets of a native valve. [Figure 201] 198-199 shown deployed to engage the leaflets of a native valve. [Figure 202] 198-199 shown deployed to engage the leaflets of a native valve. [Figure 202A] FIG. 203 illustrates an embodiment similar to FIG. 202, in which the indicator arms conform to the shape of the valve leaflets. [Figure 203] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 204] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 205] FIG. 1 illustrates an exemplary actuation mechanism for use with the implantable devices described herein. [Figure 206] 1A-1C illustrate an exemplary embodiment of a fastener having an indicator with a shaped end. [Figure 207] 1A-1C illustrate an exemplary embodiment of a fastener having an indicator with a shaped end. [Figure 208] 1A-1C illustrate an exemplary embodiment of a fastener having an indicator with a shaped end. [Figure 209] 1A-1C illustrate an exemplary embodiment of a fastener having an indicator with a shaped end. [Figure 210] 1 is a schematic diagram of an exemplary embodiment of a fastener having an indicator arm with a shaped end. [Figure 211] 1 is a schematic diagram of an exemplary embodiment of a fastener having an indicator arm with a shaped end. [Figure 212] 1 is a schematic diagram of an exemplary embodiment of a fastener having an indicator arm with a shaped end. [Figure 213] 1 is a schematic diagram of an exemplary embodiment of a fastener having an indicator arm with a shaped end. [Figure 214] 1 is a schematic diagram of an exemplary embodiment of a fastener having an indicator arm with a shaped end. [Figure 215] 1 is a schematic diagram of an exemplary embodiment of a fastener having an indicator. [Figure 216] 1 is a schematic diagram of an exemplary embodiment of a fastener having an indicator. [Figure 217] 217 shows the exemplary fastener of FIGS. 215-216 deployed to engage the leaflets of a native valve. [Figure 218] 217 shows the exemplary fastener of FIGS. 215-216 deployed to engage the leaflets of a native valve. [Figure 219] 217 shows the exemplary fastener of FIGS. 215-216 deployed to engage the leaflets of a native valve. [Figure 220] 217 shows the exemplary fastener of FIGS. 215-216 deployed to engage the leaflets of a native valve. [Figure 221] 1A-1C are schematic diagrams of an exemplary embodiment of a fastener having an indicator and operable by a single suture line. [Figure 222] 1A-1C are schematic diagrams of an exemplary embodiment of a fastener having an indicator and operable by a single suture line. [Figure 223] 221-222 shown deployed to engage the leaflets of a native valve using a single actuation line. [Figure 224] 221-222 shown deployed to engage the leaflets of a native valve using a single actuation line. [Figure 225] 221-222 shown deployed to engage the leaflets of a native valve using a single actuation line. [Figure 226] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 227] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 228] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 229] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 230] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 231] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 232]10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 233] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 234] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 235] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 236] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 237] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 238] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 239] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 240] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 241] 10A-10C illustrate a fastener having a flexible wire indicator according to an exemplary embodiment for an implantable prosthetic device. [Figure 242] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 243] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 244]10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 245] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 246] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 247] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 248] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 249] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 250] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 251] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 252] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 253] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 254] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 255] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 256] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 257] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 258] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 259] 10A-10C illustrate an exemplary embodiment of a fastener with a leaflet insertion sensor. [Figure 260] 1A-1C illustrate an exemplary embodiment of a valve repair device with a leaflet insertion sensor. [Figure 261] 1A-1C illustrate an exemplary embodiment of a valve repair device with a leaflet insertion sensor. [Figure 262] 1A-1C illustrate an exemplary embodiment of a valve repair device with a leaflet insertion sensor. [Figure 263] 1A-1C illustrate an exemplary embodiment of a valve repair device with a leaflet insertion sensor. [Figure 264] 1A-1C illustrate an exemplary embodiment of a valve repair device with a leaflet insertion sensor. [Figure 265] 1A-1C illustrate an exemplary embodiment of a valve repair device with a leaflet insertion sensor. [Figure 266] 1A-1C illustrate an exemplary embodiment of a catheter for a valve actuation catheter. [Figure 267] 1 is a plot of current versus time for an exemplary method for sensing leaflet capture. [Figure 268] 10 is a plot of resistance versus time for an exemplary method for sensing leaflet capture. [Figure 269] 10 is a plot of resistance versus time for an exemplary method for sensing leaflet capture. [Figure 270] 10 is a plot of capacitance versus time for an exemplary method for sensing leaflet capture. [Fig. 271] 10 is a plot of capacitance versus time for an exemplary method for sensing leaflet capture. [Fig. 272] 1 is a schematic illustration of an exemplary embodiment of a curved indicator having a fixed end connected to the arm of a fastener and a free end. [Fig. 273] 1 is a schematic illustration of an exemplary embodiment of a curved indicator having a fixed end connected to the arm of a fastener and a free end. [Fig. 274] 1 is a schematic illustration of an exemplary embodiment of a curved indicator having a fixed end connected to the arm of a fastener and a free end. [Figure 275]275 shows the exemplary indicator and exemplary fastener of FIGS. 272-274 deployed to engage the leaflets of a native valve. [Figure 276] 275 shows the exemplary indicator and exemplary fastener of FIGS. 272-274 deployed to engage the leaflets of a native valve. [Figure 277] 275 shows the exemplary indicator and exemplary fastener of FIGS. 272-274 deployed to engage the leaflets of a native valve. [Fig. 278] 275 illustrates an embodiment similar to that of FIGS. 272-274 in which the curved indicator includes a leaflet depth marker. [Figure 279] 275 illustrates an embodiment similar to that of FIGS. 272-274 in which the curved indicator includes a leaflet depth marker. [Figure 278A] 278 and 279, as indicated by the circles therein. [Figure 279A] 278 and 279, as indicated by the circles therein. [Figure 280] 1 is an exploded perspective view of an exemplary embodiment of a fastener and indicator. [Figure 281] 281 is a perspective view of the exemplary fastener and exemplary indicator of FIG. 280 assembled with an inner paddle of a valve repair device. [Figure 282] 281 is a side view of the exemplary fastener and exemplary indicator of FIG. 280 assembled with a paddle of a valve repair device. [Figure 283] 283 shows the exemplary indicator and exemplary fastener of FIG. 282 with the native valve leaflet inserted into the fastener to less than the full predetermined depth. [Fig. 284] 283 shows the exemplary indicator and exemplary fastener of FIG. 282 with the native valve leaflet inserted fully into the fastener to a predetermined depth. [Figure 285]1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 286] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 287] 287 shows the fastener of FIGS. 285-286 deployed to engage the leaflets of a native valve. FIG. [Figure 288] 287 shows the fastener of FIGS. 285-286 deployed to engage the leaflets of a native valve. FIG. [Figure 289] 287 shows the fastener of FIGS. 285-286 deployed to engage the leaflets of a native valve. FIG. [Figure 290] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 291] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 292] 290-291 shown deployed to engage the leaflets of a native valve. FIG. [Figure 293] 290-291 shown deployed to engage the leaflets of a native valve. FIG. [Fig. 294] 290-291 shown deployed to engage the leaflets of a native valve. FIG. [Figure 292A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 293A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 294A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 295] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 296] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 297] 297 shows the fastener of FIGS. 295-296 deployed to engage the leaflets of the native valve. FIG. [Figure 298] 297 shows the fastener of FIGS. 295-296 deployed to engage the leaflets of the native valve. FIG. [Figure 299] 297 shows the fastener of FIGS. 295-296 deployed to engage the leaflets of the native valve. FIG. [Figure 300] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 301] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 302] 300-301 shown deployed to engage the leaflets of a native valve. [Figure 303] 300-301 shown deployed to engage the leaflets of a native valve. [Figure 304] 300-301 shown deployed to engage the leaflets of a native valve. [Figure 305] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 306] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 306A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 307] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 308] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 309]307-308 shown deployed to engage the leaflets of a native valve. [Figure 310] 307-308 shown deployed to engage the leaflets of a native valve. [Figure 311] 307-308 shown deployed to engage the leaflets of a native valve. [Figure 309A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 310A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 311A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 312] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 313] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 314] 314 shows the fastener of FIGS. 312-313 deployed to engage the leaflets of a native valve. FIG. [Figure 315] 314 shows the fastener of FIGS. 312-313 deployed to engage the leaflets of a native valve. FIG. [Figure 316] 314 shows the fastener of FIGS. 312-313 deployed to engage the leaflets of a native valve. FIG. [Figure 314A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 315A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 316A]1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 317] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 318] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 319] 319 shows the fastener of FIGS. 317-318 deployed to engage the leaflets of a native valve. [Figure 320] 319 shows the fastener of FIGS. 317-318 deployed to engage the leaflets of a native valve. [Figure 321] 319 shows the fastener of FIGS. 317-318 deployed to engage the leaflets of a native valve. [Figure 319A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 320A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 321A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 322] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 323] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 324] 324 shows the fastener of FIGS. 322-323 deployed to engage the leaflets of a native valve. FIG. [Figure 325] 324 shows the fastener of FIGS. 322-323 deployed to engage the leaflets of a native valve. FIG. [Figure 326]324 shows the fastener of FIGS. 322-323 deployed to engage the leaflets of a native valve. FIG. [Figure 324A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 325A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 326A] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device deployed to engage the leaflets of a native valve. [Figure 327] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 328] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 329] 329 shows the fastener of FIGS. 327-328 deployed to engage the leaflets of a native valve. [Figure 330] 329 shows the fastener of FIGS. 327-328 deployed to engage the leaflets of a native valve. [Figure 331] 329 shows the fastener of FIGS. 327-328 deployed to engage the leaflets of a native valve. [Figure 332] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 333] 1A-1C illustrate an exemplary embodiment of a fastener for an implantable prosthetic device. [Figure 334] 332-333 shown deployed to engage the leaflets of a native valve. FIG. [Figure 335] 332-333 shown deployed to engage the leaflets of a native valve. FIG. [Figure 336] 332-333 shown deployed to engage the leaflets of a native valve. FIG. [Figure 337] FIG. 1 is a schematic illustration of a beam exhibiting snap-through buckling. [Figure 338] 1 is a graph of load versus displacement for a beam exhibiting snap-through buckling. [Figure 339] 1A-1C are profile views of exemplary embodiments of fasteners for implantable prosthetic devices. [Figure 340] FIG. 339 is a bottom view of the fastener of FIG. [Figure 341] FIG. 339 is a side view of the fastener of FIG. [Figure 342] A figure illustrating the first and second stable states of the snap-through indicator of the fastener of Figure 339. [Figure 343] 343 shows the fastener of FIGS. 339-342 deployed to engage the leaflets of a native valve. [Figure 344] 343 shows the fastener of FIGS. 339-342 deployed to engage the leaflets of a native valve. [Figure 345] 343 shows the fastener of FIGS. 339-342 deployed to engage the leaflets of a native valve. [Figure 346] 1A-1C are profile views of exemplary embodiments of fasteners for implantable prosthetic devices. [Figure 347] FIG. 347 is a bottom view of the fastener of FIG. 346. [Figure 348] FIG. 347 is a side view of the fastener of FIG. 346. [Figure 349] A figure illustrating the first and second stable states of the snap-through indicator of the fastener of Figure 346. [Figure 350] 346-349 shown deployed to engage the leaflets of a native valve. [Figure 351] 346-349 shown deployed to engage the leaflets of a native valve. [Figure 352] 346-349 shown deployed to engage the leaflets of a native valve. [Figure 353A]10A-10C illustrate exemplary embodiments of flat parts that can be used to create snap-through indicators. [Figure 353B] 10A-10C illustrate exemplary embodiments of flat parts that can be used to create snap-through indicators. [Figure 353C] 10A-10C illustrate exemplary embodiments of flat parts that can be used to create snap-through indicators. [Figure 353D] 353A-353C illustrate bending of the flat parts to create a snap-through indicator and the two stable states of the snap-through indicator. DETAILED DESCRIPTION OF THE INVENTION

[0055] As described herein, when one or more components are described as being connected, coupled, fastened, coupled, attached, or otherwise interconnected, such interconnection can be direct, such as between the components, or can be indirect, such as through the use of one or more intermediate components. Also, as described herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but can also include assemblies of components, members, or elements. Also, as described herein, the terms "substantially" and "about" are defined as at least near (and inclusive of) a given value or condition (preferably, within 10%, more preferably, within 1%, and most preferably, within 0.1% of a given value or condition).

[0056] The prosthetic device can have a wide variety of different configurations. For example, the prosthetic device can have any of the configurations disclosed in U.S. Patent Application Publication No. 2019 / 0129999, filed October 9, 2019, and U.S. Patent Application Publication No. 2018 / 0129999, filed October 10, 2018, which are incorporated herein by reference in their entireties for all purposes. The prosthetic device can have an optional coaptation means or element and at least one anchoring means or anchor. The coaptation element 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 between the native valve leaflets, thereby reducing or preventing regurgitation. The coaptation element can have a blood-tight or blood-resistant structure that allows the native valve leaflets to close around the coaptation element during ventricular systole, preventing blood from flowing back into the left or right atrium, respectively. The prosthetic device can be configured to seal against two or three native valve leaflets; i.e., the device can be used in native mitral (bicuspid) and tricuspid valves. The co-option element is sometimes referred to herein as a spacer because it can fill the space between the leaflets of an improperly functioning native mitral or tricuspid valve that does not close completely.

[0057] Co-option elements (e.g., spacers, co-option elements, etc.) can have a variety of shapes. In some embodiments, the co-option element can have an elongated cylindrical shape with a round cross-sectional shape. In some embodiments, the co-option element can have an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. The co-option element can have an atrial portion positioned in or adjacent to the left atrium, a ventricular or lower portion positioned in or adjacent to the left ventricle, and side surfaces extending between the native valve leaflets. In embodiments configured for use in a tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the side surfaces extend between the native tricuspid valve leaflets.

[0058] The anchor can be configured to anchor the device to one or both of the native valve leaflets, with the co-option element positioned between the two native leaflets. In embodiments configured for use in a tricuspid valve, the anchor can be configured to anchor the device to one, two, or three of the tricuspid valve leaflets, with the co-option element positioned between the three native leaflets. In some embodiments, the anchor can be attached to the co-option element adjacent to the ventricular portion of the co-option element. In some embodiments, the anchor can be attached to an actuating element (e.g., a shaft or actuating wire), with the co-option element also attached to the actuating element.

[0059] The anchor of the implantable prosthetic device includes a fastener that secures the native leaflet tissue between the anchor and the co-option element. An exemplary fastener (e.g., a barbed fastener) includes a movable member or arm that is actuable between an open position and a closed position relative to the fixation member or arm. The movable arm is moved away from the fixation arm, creating a gap or opening between the movable arm and the fixation arm to receive a portion of the native leaflet tissue. Once the leaflet is captured in the gap, the movable arm is actuated to pinch the leaflet tissue, thereby anchoring the leaflet within the device. Generally, positioning the leaflet further into the opening between the arms of the fastener before actuating the movable arm to pinch the leaflet allows the movable arm to engage more of the leaflet tissue. Then, not only is more tissue engaged by the fastener, but as tissue is further disposed within the gap, any barbs or other anchoring members disposed at the distal end of the movable arm or fixation arm are positioned to engage a thicker portion of the native leaflet tissue. Engaging more and thicker tissue by the fasteners ensures a more secure grip on the native leaflets by the fasteners.

[0060] Determining the depth of engagement of the native valve leaflets within the gap between the movable and fixed arms is a challenge using current imaging techniques. Among other things, leaflet tissue moves with each heartbeat and can be translucent or otherwise visually difficult to distinguish from surrounding tissue. In contrast, fasteners formed from materials such as metal (e.g., barbed fasteners) are easier to see with imaging devices. Thus, the surgeon can see the position of the fastener's movable arms and determine whether the fastener has properly engaged the native valve leaflets. For example, the fastener may be configured so that the movable arms bounce slightly with each heartbeat, indicating that the leaflets are captured within the fastener.

[0061] An exemplary implantable device can include an indicator that is used to determine whether the native valve leaflets are sufficiently engaged by or within the fastener or barbed fastener during implantation of the implantable prosthetic device. The indicator is visible via an imaging device during implantation. The indicator indicates to the surgeon that the leaflets have been inserted into the opening to the desired capture depth and / or have not yet reached the desired capture depth. The indicator can be actuable between a non-deployed or starting position and multiple actuated positions that are visually distinct to indicate to the surgeon whether the indicator has engaged the leaflet tissue and / or whether the leaflet tissue has reached the desired position or engagement depth. The use of the indicator allows the surgeon to determine whether the leaflets are properly engaged by looking at the indicator rather than looking at the bounds of the movable arm. Thus, the clamping force of the fastener can be increased without reducing the surgeon's ability to determine whether the leaflets are sufficiently engaged.

[0062] 1-6, an implantable prosthetic device 100 is shown in various stages of deployment. Device 100 and related systems, methods, etc. are described in more detail in U.S. Patent Nos. 6,275,999 and 6,275,999, the disclosures of which are incorporated herein by reference in their entireties. Device 100 can include any other features of implantable prosthetic devices discussed in this application, and device 100 can be positioned to engage valve tissue (e.g., valve leaflets 20, 22) as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0063] Device 100 is deployed from a delivery sheath or other means for delivery and can include a coaptation portion 104 and / or an anchor portion 106. Device 100 can be deployed from a delivery sheath and / or by a pusher tube or rod 81. In some embodiments, coaptation portion 104 of device 100 includes a coaptation element 110 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 member or element 112 (e.g., an actuation wire, shaft, tube, rod, line, suture, tether, etc.). Anchor portion 106 is actuatable between an open condition and a closed condition and can take a variety of forms, such as, for example, a paddle or a grasping element. Actuation of the actuating element or means for actuation 112 opens and closes the anchor portion 106 of the device 100, gripping the native valve leaflets during implantation. The actuating element or other means for actuation 112 (as well as other actuating elements and means for actuation herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, combinations thereof, etc.). As one example, the actuating element can be threaded such that rotation of the actuating element moves the anchor portion 106 relative to the co-option portion 104. Alternatively, the actuating element can be unthreaded, such that pushing or pulling the actuating element 112 moves the anchor portion 106 relative to the co-option portion 104.

[0064] The anchor portion 106 and / or anchor of the device 100 includes an outer paddle 120 and an inner paddle or gripping element 122, which in some embodiments are connected between the cap 114 and the co-option element or means for joining 110 by portions 124, 126, 128. The connecting portions 124, 126, 128 can be jointed and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, co-option element or means for joining 110, and cap 114 by portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.

[0065] In some implementations, an actuation member, actuation element, or other means for actuation 112 (e.g., actuation wire, actuation shaft, actuation tube, actuation rod, etc.) extends through the delivery sheath, pusher tube / rod, and / or co-option element 110 to a cap 114 (e.g., at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the spacing between the proximal end of the device and the cap 114 and / or between the co-option element 110 and the cap 114. An optional attachment means or collar (not shown) removably attaches the device and / or the co-option element 110 of the device to the pusher tube or rod 81 and / or delivery sheath 102 such that the actuation element 112 slides along the actuation element 112 during actuation to open and close the paddles 120, 122 of the anchor portion 106. If device 100 needs to be removed from the valve tissue after it has been connected to the valve tissue, a retrieval device can be used to connect to collar 115 such that an actuation element extends through collar 115 and any co-option element 110 to engage anchor portion 106, open paddles 120, 122, and remove device 100 from the valve tissue. An example of a retrieval device that can be used is shown in U.S. Patent Application Publication No. 2019 / 012999, filed November 20, 2019, which is incorporated herein by reference in its entirety.

[0066] Referring to FIG. 3 , the anchor portion and / or anchor includes a mounting portion for a gripping member. The illustrated gripping member includes a fastener 130, which includes a base or fixed arm 132, a movable arm 134, an optional barb or other means for fastening 136, and a joint, flex, or hinge 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 by the joint, flex, or hinge portion 138, which is disposed adjacent to the co-option element 110. The fastener or barbed fastener can have a flat surface and does not fit into a recess in the inner paddle, but is disposed against the surface of the inner paddle 122. The joint, flex, or hinge portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the fastener 130. The joint, flexure, or hinge portion 138 can be any suitable flexible portion, joint, or hinge, such as a flexible hinge, flexible joint, spring hinge, pivot hinge, etc. In some embodiments, the joint, flexure, or hinge portion 138 is a flexible piece of material integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary relative to the inner paddle 122 when the movable arm 134 is opened to open the catch 130 and expose the barb, friction-enhancing element, or other means for fastening 136. In some embodiments, applying tension to an actuation line 116 attached to the movable arm or the end of the movable arm 134 opens the catch 130, thereby causing the movable arm 134 to move, bend, and / or pivot on the joint, flexure, or hinge portion 138.

[0067] During implantation, the paddles 120, 122 can be opened and closed to grasp or capture a native valve leaflet (such as a native mitral valve leaflet) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element or means for coaptation 110. The fasteners 130 can be used to grasp and / or further secure the native valve leaflet by engaging the leaflet with barbs, friction-enhancing elements, or means for anchoring 136 and by sandwiching the leaflet between the movable arm 134 and the fixed arm 132. The barbs, friction-enhancing elements, or other means for anchoring 136 of the fasteners or barbed fasteners 130 can increase friction with the leaflet or partially or fully pierce the leaflet. The actuation lines 116 can be independently actuated, allowing each fastener 130 to be independently opened and closed. The independent movement allows one leaflet to be grasped or captured at a time, or allows the fasteners 130 to be repositioned on a poorly grasped or captured leaflet without altering the successful grasp on the other leaflet. Not only do the fasteners 130 open and close independently of each other, they can also be opened and closed independently of the position of the inner paddle 122, thereby allowing the leaflets to be grasped or captured in a variety of positions depending on the particular situation.

[0068] The fasteners 130 can be opened independently / separately by pulling on an attached actuation line / suture or other actuation means 116 that extends through the delivery sheath or means for delivery 102 to the fasteners 130. The actuation line 116 can take a variety of forms, such as a line, suture, wire, rod, or catheter. The fasteners 130 can be spring-loaded or otherwise biased so that in the closed position, the fasteners 130 continue to provide a pinching force on the grasped or captured native valve leaflets. This pinching force remains constant regardless of the position of the inner paddle 122. The barbs, friction-enhancing elements, or other means for anchoring 136 of the fasteners or barbed fasteners 130 can pierce the native valve leaflets, further anchoring the leaflets.

[0069] 1, device 100 is shown in an elongated or fully open condition (also called a fully extended or fully bailed-out condition) for deployment from a delivery sheath. Device 100 is loaded into the delivery sheath in the fully open position because it takes up the least space and allows the smallest catheter to be used (or the largest device 100 for a given catheter size).

[0070] In some embodiments, in the elongated condition, the cap 114 is spaced apart from the co-option element or means for joining 110 so that the paddles 120, 122 of the anchor portion 106 are fully open or extended. In some embodiments, the angle formed between the interior of the outer paddle 120 and the interior of the inner paddle 122 is approximately 180 degrees. The fastener 130 is maintained in a closed condition during deployment through the delivery sheath or means for delivering 102 so that the barbs, friction-enhancing elements, or other means for securing 136 ( FIG. 3 ) do not catch or damage tissue within the sheath or the patient's heart.

[0071] 1A, device 100 is shown in an elongated, intertwined condition similar to that of FIG. 1, but with fasteners 130 in a fully open position, with the angle between the fixed and movable portions of fasteners 130 ranging from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or at about 180 degrees. Fully opening paddles 120, 122 and fasteners 130 has been found to improve the ease of disentanglement or removal of device 100 from a patient's anatomy (e.g., chordae tendineae, etc.) during implantation.

[0072] Referring now to FIG. 2 , the device 100 is shown in a shortened or fully closed condition. The compact size of the device 100 in the shortened condition allows for easier manipulation and placement within the heart. To move the device 100 from the elongated condition to the shortened condition, the actuation member or element or other means for actuation 112 is retracted, pulling the cap 114 toward the proximal end of the device and / or toward the co-option element 110. The connection 126 (e.g., joint, hinge, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is limited or constrained in movement such that a compressive force acting on the outer paddle 120 from the cap 114, which is retracted toward the proximal end of the device and / or toward the co-option element 110, moves the paddles or gripping elements 120, 122 radially outward. During movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with respect to the actuation element 112. The outer paddle 120 can optionally be biased toward a closed position. The inner paddle 122 moves through a significantly larger angle during the same movement because, in the open condition, they are oriented away from the proximal end of the device and / or the co-option element 110, and in the closed condition, they are folded toward the middle of the device (e.g., folded along the side of the co-option element 110). 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, hinges, flexible connections, etc.) connected to the inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility can allow 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 and allow for more movement than, for example, the connecting portion 124 connecting the outer paddle 120 to the cap 114 .In some embodiments, the inner paddle 122 can be the same or substantially the same width as the outer paddle.

[0073] 3-5, the device 100 is shown in a partially open, grasp-ready condition. To transition from the fully closed condition to the partially open condition, the actuation member or element 112 (e.g., actuation wire, actuation shaft, etc.) is extended, pushing the cap 114 away from the proximal end of the device (e.g., away from the co-option element 110), thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, partially expanding the anchor or anchor portion 106. The actuation line 116 is also retracted to open the catch 130 so that the leaflets can be captured or grasped. In some embodiments, the pair of inner and outer paddles 122, 120 are moved in unison by a single actuation element 112, rather than independently. The position of the catch 130 can also depend on the position of the paddles 122, 120. For example, closing the paddles 122, 120 can also close the catch. In some embodiments, the paddles 120, 122 may be independently controllable. For example, the device 100 may have two actuation elements and two independent caps, such that one independent wire and cap is used to control one paddle and another independent wire and cap is used to control the other paddle.

[0074] 4, one of the actuation lines 116 is stretched, allowing one of the fasteners 130 to close. Now referring to Figure 5, the other actuation line 116 is stretched, allowing the other fastener 130 to close. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the fasteners 130.

[0075] 6, device 100 is shown in a fully closed and deployed condition. Delivery sheath or means for delivering 102 and actuation element or means for actuation 112 are retracted, while paddles 120, 122 and catch 130 remain in the fully closed position. Once deployed, 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 (e.g., steel, other metals, plastics, composites, etc.) or a shape memory alloy (e.g., Nitinol, etc.). For example, connecting portions 124, 126, 128, joint portion 138, and / or inner and outer paddles 122, 120, and / or additional biasing components (see reference numeral 224 in FIG. 13) may be formed from a metal (such as, for example, steel) or a shape-memory alloy (such as, for example, Nitinol) (created from wire, sheet, tubing, or laser-sintered powder) and are biased to hold outer paddle 120 closed around the center of the device or around co-option element 110, and to hold catch 130 sandwiched around the native valve leaflets. Similarly, fixed arm 132 and movable arm 134 of catch 130 are biased to sandwich the leaflets. In some embodiments, the attachment or connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, 120, and / or additional biasing components (see reference numeral 224 in FIG. 13) are formed from any other suitably resilient material (e.g., a metal or polymeric material, etc.) capable of maintaining the device in a closed condition after implantation.

[0076] 7-12, the implantable device 100 of FIGS. 1-6 is shown delivered and implanted into a native valve or native mitral valve 40 of the heart 10. Referring now to FIG. 7, a delivery sheath is inserted through the septum into the left atrium 20, and the device 100 is deployed from the delivery sheath in a fully open condition. The actuating element 112 is then retracted, moving the device 100 to a fully closed condition, shown in FIG. 8. As can be seen in FIG. 9, the device 100 is moved into the ventricle 30 and into the mitral valve 40, partially opening the device so that the leaflets 42, 44 may be captured. Referring now to FIG. 10, the actuating line 116 is extended, closing one of the fasteners 130 and capturing the leaflet 42. FIG. 11 shows that the other actuating line 116 is then extended, closing the other fastener 130 and capturing the remaining leaflet 44. Finally, as can be seen in FIG. 12, the delivery sheath 102 and working element 112 are then retracted, leaving the device 100 fully closed and deployed within the native mitral valve 400.

[0077] Referring now to FIG. 13, an implantable prosthetic device 200 is shown. The implantable device 200 is one of many different configurations that the device 100, illustrated generally in FIGS. 1-12, can assume. The device 200 is deployed from a delivery sheath (not shown). The device 200 can include a co-option portion 204 and / or an anchor portion 206. The device 200 is loaded into the delivery sheath in a fully open position because this position takes up the least space, allowing the smallest catheter to be used (or the largest device 200 for a given catheter size).

[0078] In some embodiments, the co-option portion 204 of the device includes a co-option element 210 for implantation between the native leaflets of a native valve, the co-option element 210 being slidably attached to an actuation element 212 (e.g., an actuation wire, rod, shaft, tube, screw, suture, line, combinations thereof, etc.). The anchor of the device can include an outer paddle portion and an inner paddle portion. Actuation of the actuation element 212 opens and closes the anchor portion 206 of the device 200 to grasp or capture the native valve leaflets during implantation.

[0079] The anchor portion 206 of the device 200 includes an outer paddle 220 and an inner paddle 222, which are jointly, flexibly, or hingedly connected to the cap 214 and / or the co-option element 210. The actuating element 212 extends through one, some, or all of the delivery sheath (not shown), collar 211, and co-option element 210, and extends to the cap 214 at the distal end of the anchor portion 206. In some embodiments, extending and retracting the actuating element 212 increases and decreases the spacing between the co-option element 210 and the cap 214, respectively.

[0080] Collar 211 optionally includes collar seal 213, which forms a seal around actuating element 212 during implantation of device 200 and which seals shut when actuating element 212 is removed, closing or substantially closing device 200 to blood flow through the interior of co-option element 210 after implantation. In some embodiments, collar 211 removably engages and attaches co-option element 210 to a delivery sheath such that co-option element 210 slides along actuating element 212 during actuation to open and close paddles 220, 222 of anchor portion 206. In some embodiments, collar 211 is held closed around co-option element 210 by actuating element 212, such that removal of actuating element 212 allows fingers (not shown) of the collar to open and release co-option element 210. In some embodiments, cap 214 optionally includes a seal 216 and / or an insert 218 that fit inside opening 215 of co-option element 210, which has a hollow interior. Seal 216 and / or insert 218 maintains co-option element 210 closed or substantially closed to blood flow when working element 212 is withdrawn and when device 200 is implanted.

[0081] The co-option element 210 and / or paddles 220, 222 may include and / or be formed from a covering, which may be mesh, woven, braided, or formed in any other suitable manner. The covering may be fabric, a shape-memory alloy wire (e.g., Nitinol) to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body. In some embodiments, the paddle frame 224 provides a clamping force between the inner paddle 222 and the co-option element 210 and also helps wrap the leaflets around the sides of the co-option element 210 for a better seal between the co-option element 210 and the valve leaflets. In some embodiments, the covering extends around the paddle frame 224.

[0082] Fastener 230 includes a base or fixed arm 232, a movable arm 234, a friction-enhancing element or barb 236, and a flex or hinge portion 238. Fixed arm 232 is attached to inner paddle 222, with flex or hinge portion 238 disposed proximate the center of the device and / or co-option element 210. Fixed arm 232 is attached to inner paddle 222 by sutures (not shown) through holes or slots 233. Fixed arm 232 may be attached to inner paddle 222 or another portion of the device by any suitable means (e.g., screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc.). Fixed arm 232 remains stationary or substantially stationary relative to inner paddle 222 when movable arm 234 is opened to open fastener 230 and expose friction-enhancing element or barb 236. By applying tension to an actuation line (not shown) attached to a hole 235 disposed at the end of the movable arm 234, the fastener 230 is opened, thereby causing the movable arm 234 to move, bend and / or pivot on the joint, flex or hinge portion 238.

[0083] During implantation, the anchors and / or paddles 220, 222 are opened and closed to capture the native mitral valve leaflets between the anchors and / or paddles 220, 222 and / or between the anchors or paddles and the co-option element 210. In some embodiments, the fasteners 230 (e.g., barbed fasteners) further secure the native valve leaflets by engaging the leaflets with friction-enhancing elements or barbs 236 and by pinching the leaflets between the movable arm 234 and the fixed arm 232. In some embodiments, the friction-enhancing elements or barbs 236 of the fasteners 230 increase friction with the leaflets or can partially or fully pierce the leaflets. The actuation lines can be independently actuated, allowing each fastener 230 to be opened and closed independently. Independent actuation allows one leaflet to be grasped / captured at a time or allows the fastener 230 to be repositioned over a poorly captured leaflet without altering its successful grasp over the other leaflets. Not only do the catches 230 open and close independently of one another, but they can also be opened and closed completely independent of the position of the inner paddle 222, thereby allowing the leaflets to be captured in various positions depending on the particular situation.

[0084] 14-23, 23A, and 22B, there is shown an implantable device 300 delivered and implanted into the native mitral valve 40 of the heart 10. The methods and steps shown and / or discussed may be performed on a live animal or on a simulation (e.g., a cadaver, a cadaver heart, a simulator (e.g., where body parts, hearts, tissues, etc. are simulated), etc.).

[0085] Device 300 can be the same as or similar to implantable device 200 of FIG. 13 , except that device 300 includes coverings over co-option element 310, fastener 330, inner paddle 322, and / or outer paddle 320. Device 300 is deployed from a delivery sheath 302. The device can include a co-option portion 304 and / or an anchor portion 306 including multiple anchors (e.g., two in the illustrated embodiment, but more or fewer are possible). In some embodiments, co-option portion 304 of the device can include a co-option element 310 for implantation between the leaflets of a native valve. Co-option element 310 can be slidably attached to an actuation element 312 (such as an actuation wire or an actuation shaft). Actuation of actuation element 312 opens or closes anchor portion 306 of device 300, capturing the native valve leaflets during implantation.

[0086] The anchor portion 306 of the device 300 includes an outer paddle 320 and an inner paddle 322, which are flexibly connected to the cap 314 and / or the co-option element 310. An actuation element 312 extends through one or more of the collar 303 (see FIG. 20 ), the delivery sheath 302, and the co-option element 310 to the cap 314 at the distal end of the anchor portion 306. Extending and retracting the actuation element 312 increases and decreases the spacing between the proximal end of the device and the cap 314 and / or the spacing between the co-option element 310 and the cap 314. In some embodiments, fingers on the collar 303 removably attach the co-option element 310 to the delivery sheath 302, such that the co-option element 310 slides along the actuation element 312 during actuation to open and close the paddles 320, 322 of the anchor portion 306. In some embodiments, collar 303 is held closed around co-option element 310 by actuation element 312 such that removal of actuation element 312 allows the fingers of collar 303 to open, releasing co-option element 310.

[0087] The co-option element 310 and / or paddles 320, 322 are formed from a flexible material, which may be meshed, woven, braided, or formed in any other suitable manner, such as a fabric, a shape memory alloy wire (e.g., Nitinol) to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0088] The fastener 330 (shown as a barbed fastener) includes a base or fixed arm 332, a movable arm 334, and a connecting, joint, flex, or hinge portion 338. The fastener can be configured as a barbed fastener and can include barbs 336 (see FIG. 20 ), or the fastener can include another type of friction-enhancing element, fastening element, or means for fastening. The fixed arm 332 is attached to the inner paddle 322 by the connecting, joint, flex, or hinge portion 338. In some embodiments, the connecting, joint, flex, or hinge portion 338 is disposed proximate to the co-option element 310. In some embodiments, a suture (not shown) attaches the fixed arm 332 to the inner paddle 322. However, fixed arm 332 may be attached to inner paddle 322 by any suitable means (e.g., screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc.) Fixed arm 332 remains stationary or substantially stationary when movable arm 334 is opened to open barbed catch 330 and expose barb 336. Applying tension to actuation line 316 attached to the end of movable arm 334 opens barbed catch 330, thereby causing movable arm 334 to move, bend, and / or pivot on connection, joint, flex, or hinge portion 338.

[0089] During implantation, the paddles 320, 322 are opened and closed to capture the native valve leaflets between them and / or between the paddles 320, 322 and the co-option element 310. In some embodiments, the outer paddle 320 has a wide, curved shape that fits around the curved shape of the co-option element 310 to more securely grip the leaflets. The curved shape and rounded edges of the outer paddle 320 also inhibit tearing of the leaflet tissue. The fasteners 330 can be barbed fasteners that further secure the native valve leaflets by engaging the leaflets with barbs 336 and sandwiching the leaflets between the movable arm 334 and the fixed arm 332. The barbs 336 (and / or other friction-enhancing elements) of the fasteners 330 can increase friction with the leaflets or partially or completely pierce the leaflets. The actuation lines can be independently actuated, allowing each fastener 330 to be opened and closed independently. Independent actuation allows one leaflet to be captured at a time, or allows the fastener 330 to be repositioned on a poorly captured leaflet without altering its successful grasp on the other leaflets. Not only do the fasteners 330 open and close independently of each other, they can also be fully opened and closed independently of the position of the inner paddle 322, thereby allowing the leaflets to be grasped and / or captured in various positions depending on the particular situation.

[0090] The device 300 is loaded into the delivery sheath in the fully open position because it takes up the least space, allowing the smallest catheter to be used (or the largest device 300 for a given catheter size). Referring now to FIG. 14 , the delivery sheath is inserted through the septum into the left atrium 20, and the device 300 is deployed from the delivery sheath 302 in the fully open condition. The actuating element 312 is then retracted, moving the device 300 to the fully closed condition shown in FIGS. 15-16 and then maneuvered toward the native valve (e.g., the mitral valve 40), as shown in FIG. 17 . Referring now to FIG. 18 , when the device 300 is aligned with the native valve 40, the actuating element 312 is extended, opening the paddles 320, 322 to a partially open position, and the actuating line 316 is retracted, opening the clasp or barbed clasp 330 and preparing it for leaflet capture. Next, as shown in Figures 19-20, the partially open device 300 is inserted through the native or mitral valve 40 until the leaflets are properly positioned between the inner paddle 322 and the co-option element 310 and within the open catches 330. Figure 21 shows the device 300 with both catches 330 closed, but the barb 336 of one catch 330 has missed or is improperly positioned over one of the leaflets 44. As can be seen in Figures 22-23, the out-of-place catch 330 is again opened and closed to properly capture the missed leaflet 44. When both leaflets 42, 44 are properly captured, the actuating element 312 is retracted, moving the device 300 to the fully closed position shown in Figure 23A. Referring to FIG. 23B, with the device 300 fully implanted within the native valve 40, the actuating element 312 is withdrawn, releasing the collar 303 from the upper end or plate 311 of the device 300 or of the co-option element 310, leaving the device 300 implanted on the native valve.Once deployed, the device 300 may be maintained in a fully closed position by mechanical means (e.g., a latch, etc.) or may be biased to remain closed through the use of a spring material (e.g., steel, etc.) and / or a shape memory alloy (e.g., Nitinol, etc.). For example, the paddles 320, 322 may be formed from steel or Nitinol shape memory alloy (created from wire, sheet, tubing, or laser-sintered powder) and are biased, for example, to hold the outer paddle 320 closed around the co-option element 310 and the barbed clasp 330 in a position that pinches or anchors the natural valve leaflets.

[0091] 24-25 , an exemplary fastener 3500 is shown configured as a barbed fastener for use in an implantable prosthetic device (e.g., devices 100, 200, 300, etc., described above). While shown and described as a barbed fastener, the barbed portion 3540 may be replaced with another type of friction-enhancing portion. The fastener 3500 is configured to capture natural tissue when the implantable prosthetic device (e.g., any device described herein) is attached to the natural tissue. Similar to the fasteners described above, the barbed fastener 3500 includes a fixed arm 3510, a joint, flex, or hinge portion 3520, and a movable arm 3530 having a barbed portion 3540. The fastener 3500 may be used in any of the implantable prosthetic devices of the present application and may include any or a combination of the features of the fasteners described herein.

[0092] The fastener 3500 also includes an indicator arm 3550 adjacent the movable arm 3530 and extending from an indicator flex or hinge portion 3560. In an exemplary embodiment, the indicator arm 3550 and / or indicator flex or hinge portion 3560 are more resilient and / or flexible than the movable arm 3530 and / or movable arm joint portion, flex or hinge portion 3520. This increased resilience and / or flexibility allows the indicator arm to bounce, pulsate, or jump, while the movable arm 3530 provides a firm grip on the leaflet tissue and does not bounce, pulsate, or jump. The bouncing, pulsating, or jumping of the indicator arm 3550 can be seen using standard imaging equipment to determine when the fastener is properly engaged with the leaflet tissue. As such, the indicator function of the indicator arm 3550 can be decoupled from the leaflet grasping and fixation function of the movable arm 3530. This decoupling can be applied to any of the embodiments described herein.

[0093] 24 and 25, in an exemplary embodiment, the indicator flex or hinge portion 3560 allows the indicator arm 3550 to be actuated separately from the movable arm 3530. The indicator flex or hinge portion 3560 may be formed from a portion of the indicator arm 3550 or may be formed from a series of cutouts.

[0094] The indicator arm 3550 can be actuated separately from the movable arm 3530 to facilitate detection of the depth of engagement of the native leaflet between the movable arm 3530 and the fixation arm 3510 of the fastener 3500. In the illustrated embodiment, the indicator arm 3550 is narrower than the movable arm 3530 and has a length that is less than the distance from the joint, flexure, or hinge portion 3520 to the barbed portion 3540. The indicator arm can have optional barbs 3555 thereon.

[0095] The length of the indicator arm 3550 is used to determine the desired minimum engagement depth as measured from the end of the movable arm 3530 of the fastener 3500. Configuring the length of the indicator arm 3550 to be less than the distance from the joint, flexion, or hinge portion 3520 to the barbed portion 3540 ensures that the barbed portion 3540 will engage a valve leaflet that is positioned at the minimum engagement depth as indicated by the indicator arm 3550. That is, if a natural valve leaflet positioned within the fastener 3500 is engaged by the indicator arm 3550 when the indicator arm 3550 is actuated, the valve leaflet will be engaged by the barbed portion 3540 of the movable arm 3530. The opposite is also true. That is, if a natural valve leaflet positioned within the fastener 3500 is not engaged by the indicator arm 3550 when the indicator arm 3550 is actuated, the valve leaflet will not be engaged by the barbed portion 3540 of the movable arm 3530.

[0096] 24A and 25A, an exemplary embodiment of a fastener such as that shown in FIGS. 24 and 25 is shown, with the addition of a radiopaque marker 2410 on the indicator arm 3550. The radiopaque indicator can be printed directly on the bump, printed on a coil wrapped around the bump, printed on fabric covering the bump, or otherwise secured to the bump. The radiopaque indicator can be a platinum coil wrapped around the bump, or it can be radiopaque ink printed thereon. Although no barb is shown on the indicator arm in FIGS. 24A and 25A, optionally, a barb can be present on the indicator arm as shown in FIGS. 24 and 25.

[0097] 26-29, an exemplary fastener or barbed fastener 3500 is shown placed within a native valve 40 to secure an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 26, the barbed fastener 3500 is shown in an open condition, with the native valve leaflet 42, 44 partially inserted into an opening in the barbed fastener 3500 formed between the fixed arm 3510 and the movable arm 3530. To determine whether the leaflet 42, 44 has reached a desired engagement depth, an indicator arm 3550 can be actuated via an actuation line (not shown). Referring now to FIG. 27, the fastener is shown in a closed configuration, closed onto the leaflets 42, 44. The indicator arm 3550 has not yet been actuated.

[0098] 28 , the indicator arm 3550 is shown in an activated condition. The barb 3540 on the movable arm 3530 pierces the native valve leaflets. The leaflets 42, 44 are inserted into the opening of the fastener 3540 approximately halfway between the barbed portion 3540 and the articulated, flexible, or hinged portion 3520, and the indicator arm 3550 is not inserted far enough into the fastener to overlap the length of the indicator arm 3550, so the indicator arm 3550 is not engaged with the leaflets 42, 44. Instead, the indicator arm swings toward the fixation arm 3510. The position of the indicator arm is visible via an imaging device used to monitor the implantation and placement of the prosthetic device.

[0099] Referring now to FIG. 29 , the fastener is closed over the leaflets 42, 44, and the leaflets are positioned deep enough into the fastener 3500 so that they overlap the indicator arm 3550. A barb 3540 on the movable arm 3530 pierces the native leaflet. The indicator arm rests on the leaflet tissue, and the leaflet prevents the indicator arm from moving completely toward the fixed arm 3510 of the fastener. The indicator arm as shown in FIG. 29 has a barb 3540 to further anchor the leaflet in place. In embodiments without a barb on the indicator arm, the indicator arm may bounce due to the pulsation of the heartbeat that pulsates the leaflets. This pulsation can be seen with the imaging techniques described above and can be used to indicate to the operator that the leaflet is positioned deep enough into the fastener.

[0100] 30-37, various exemplary arrangements of movable and indicator arms for fasteners are shown. Referring now to FIG. 30, an exemplary fastener 3600 (illustrated as a barbed fastener) for use in an implantable prosthetic device (e.g., devices 100, 200, 300, etc., described above) is shown. Similar to the barbed fastener 3500 described above, the barbed fastener 3600 includes a fixed arm 3610, a joint, flex, or hinge portion 3620, a movable arm 3630 having a barbed portion 3640 (although other friction-enhancing portions may also be used), and an indicator arm 3650 connected to the joint, flex, or hinge portion 3620 via an indicator flex or hinge portion 3660. The fastener 3600 may be used in any of the implantable prosthetic devices of the present application and may include any or a combination of features of the other fasteners described herein.

[0101] The indicator arm 3650 has a width approximately the same as the width of the movable arm 3630, which is wider than the indicator arm 3550 of the fastener 3500 described above. Increasing the width of the indicator arm 3650 increases the area of ​​the arm that can engage the native valve leaflets. A wider indicator arm 3650 can also help pinch the native valve leaflets against the fixation arms when the fastener 3600 is closed. The indicator flex or hinge portion 3660 is similar to the patterned hinge portion 2120 described above, which allows the indicator arm 3650 to bend further in the closing direction than the movable arm 3630 and to assume a set shape in the preloading or shape-set position (not shown), providing increased pinching force when in contact with the native leaflet tissue in the closed or engaged position (not shown).

[0102] 31 , an exemplary fastener 3700 for use in an implantable prosthetic device (such as, for example, devices 100, 200, 300 described above) is shown. Similar to fastener 3500 described above, fastener 3700 includes a fixed arm 3710, a joint, flex, or hinge portion 3720, a movable arm 3730 having a barbed portion 3740 (although other friction-enhancing portions may be used), and an indicator arm 3750 connected to joint, flex, or hinge portion 3720 via an indicator flex or hinge portion 3760. Fastener 3700 may be used in any of the implantable prosthetic devices of the present application and may include any or combination of features of the other fasteners described herein.

[0103] The movable arm 3730 is formed in a hoop or loop shape having two side arms 3732 surrounding a central opening 3734 that extends from the joint, flexure, or hinge portion 3720 to a barbed portion 3740 of the movable arm 3730. The indicator arm 3750 is disposed within the central opening 3734 between the two side arms 3732. Because the movable arm 3730 spans the entire width of the fastener 3700, the barbed portion 3740 of the movable arm 3730 is as wide as the fastener 3700, allowing a larger area of ​​the barbed portion 3740 to engage the natural leaflet tissue.

[0104] 32 , an exemplary fastener 3800 for use in an implantable prosthetic device (e.g., devices 100, 200, 300, etc., described above) is shown. Similar to fastener 3500 described above, fastener 3800 includes a fixed arm 3810, a joint, flex, or hinge portion 3820, a movable arm 3830 having a barbed portion 3840 (although other friction-enhancing portions may be used), and an indicator arm 3850 connected to joint, flex, or hinge portion 3820 via an indicator flex or hinge portion 3860. Fastener 3800 may be used in any of the implantable prosthetic devices of the present application and may include any or a combination of features of the other fasteners described herein.

[0105] The movable arm 3830 is formed from two side arms 3832 flanked by a central opening 3834 that extends from the joint, flexure, or hinge portion 3820 to the end of the movable arm 3830. That is, the central opening 3834 separates the movable arm 3830 into two independently actuatable side arms 3832, each including a barbed portion 3840. An indicator arm 3850 is disposed within the central opening 3834 between the two side arms 3832. The barbed portions 3840 of the side arms 3832 span the entire width of the fastener 3800, providing a wide gripping area for the movable arm 3830 to engage the native leaflet tissue. The side arms 3832 can be independently actuated to allow for lateral variation in the thickness of the native leaflet tissue.

[0106] 33 , an exemplary fastener 3900 for use in an implantable prosthetic device (e.g., devices 100, 200, 300, etc., described above) is shown. Similar to fastener 3500 described above, fastener 3900 includes a fixed arm 3910, a joint, flex, or hinge portion 3920, a movable arm 3930 having a barbed portion 3940 (although other friction-enhancing portions may be used), and an indicator arm 3950 having a barbed portion 3970. Indicator arm 3950 is connected to joint, flex, or hinge portion 3920 via indicator flex or hinge portion 3960. Fastener 3900 is similar to fastener 3500 described above, except for the addition of barbed portion 3970 located at the end of indicator arm 3950. The barbed portion 3970 allows the indicator arm 3950 to assist the movable arm 3930 in pinching the native valve leaflet against the fixation arm (not shown). The fastener 3900 may be used in any of the implantable prosthetic devices of the present application and can include any or a combination of features of the other fasteners described herein.

[0107] 34-37, exemplary fasteners are shown with indicator arms having lengths based on a percentage of the fastener's minimum engagement depth. The fastener's minimum engagement depth is the minimum length of natural tissue that must be inserted into the fastener beyond the barbed portion to ensure a reliable grip on the tissue. That is, the minimum engagement depth is the distance between the barbed portion of the fastener and the joint, flexion, or hinge portion. The minimum engagement depth for mitral valve tissue can vary depending on a variety of different factors (e.g., patient age, tissue thickness, tissue health, etc.). As such, the minimum engagement depth can vary from patient to patient.

[0108] 34 , an exemplary fastener 4000 (illustrated as a barbed fastener) for use in an implantable prosthetic device (such as, for example, devices 100, 200, 300 described above) is shown. Similar to fastener 3500 described above, fastener 4000 includes a fixed arm 4010, a joint, flex, or hinge portion 4020, a movable arm 4030 having a barbed portion 4040 (although other friction-enhancing portions may be used), and an indicator arm 4050 connected to joint, flex, or hinge portion 4020 via an indicator flex or hinge portion 4060. Indicator arm 4050 has a length of approximately 25 percent of the maximum engagement depth measured between joint, flex, or hinge portion 4020 and barbed portion 4040. Thus, indicator arm 4050 will not indicate that the native valve leaflet has reached the desired engagement depth until the leaflet is inserted at least about 75 percent of the maximum engagement depth. Fastener 4000 may be used in any of the implantable prosthetic devices of the present application and may include any or a combination of features of the other fasteners described herein.

[0109] 35 , an exemplary fastener 4100 for use in an implantable prosthetic device (such as, for example, devices 100, 200, 300 described above) is shown. Similar to fastener 3500 described above, fastener 4100 includes a fixed arm 4110, a joint, flex, or hinge portion 4120, a movable arm 4130 having a barbed portion 4140 (although other friction-enhancing portions may be used), and an indicator arm 4150 connected to the joint, flex, or hinge portion 4120 via an indicator flex or hinge portion 4160. Indicator arm 4150 has a length of approximately 50 percent of the maximum engagement depth measured between the joint, flex, or hinge portion 4120 and the barbed portion 4140. Thus, indicator arm 4150 will not indicate that the native valve leaflet has reached the desired engagement depth until the leaflet has been inserted at least approximately 50 percent of the maximum engagement depth. Fastener 4100 may be used in any of the implantable prosthetic devices of the present application and may include any or a combination of features of the other fasteners described herein.

[0110] 36 , an exemplary fastener 4200 for use in an implantable prosthetic device (such as devices 100, 200, 300 described above) is shown. Similar to fastener 3500 described above, fastener 4200 includes a fixed arm 4210, a joint, flex, or hinge portion 4220, a movable arm 4230 having a barbed portion 4240 (although other friction-enhancing portions may be used), and an indicator arm 4250 connected to the joint, flex, or hinge portion 4220 via an indicator flex or hinge portion 4260. Indicator arm 4250 has a length of approximately 75 percent of the maximum engagement depth measured between the joint, flex, or hinge portion 4220 and the barbed portion 4240. Thus, indicator arm 4250 will not indicate that the native valve leaflet has reached the desired engagement depth until the leaflet has inserted at least approximately 25 percent of the maximum engagement depth. Fastener 4200 may be used in any of the implantable prosthetic devices of the present application and may include any or a combination of features of the other fasteners described herein.

[0111] 37 , an exemplary fastener 4300 for use in an implantable prosthetic device (e.g., devices 100, 200, 300, etc., described above) is shown. Similar to fastener 3500 described above, fastener 4300 includes a fixed arm 4310, a joint, flex, or hinge portion 4320, a movable arm 4330 having a barbed portion 4340, and an indicator arm 4350 connected to the joint, flex, or hinge portion 4320 via an indicator flex or hinge portion 4360. Indicator arm 4350 has a length of approximately 90 percent of the maximum engagement depth measured between the joint, flex, or hinge portion 4320 and the barbed portion 4340 (although other friction-enhancing portions may be used). Thus, indicator arm 4350 will not indicate that the native valve leaflet has reached the desired engagement depth until the leaflet has inserted at least approximately 10 percent of the maximum engagement depth. Fastener 4300 may be used in any of the implantable prosthetic devices of the present application and may include any or a combination of features of the other fasteners described herein.

[0112] 38-47, an exemplary fastener 3500 is shown attached to a paddle of an implantable prosthetic device (e.g., devices 100, 200, 300, etc.) and placed within the native valve 40 to secure the device to the native valve leaflets 42, 44. While fastener 3500 is shown in FIGS. 93-102, fasteners 3600, 3700, 3800, 3900, 4000, 4100, 4200, and 4300 with indicator arms as described above would be attached to the native valve leaflets in a manner similar to fastener 3500. Fastener 3500 is attached to paddle 122 of device 100, which is moved between open and closed positions to capture and secure the native valve leaflets 42, 44 within device 100, as described above.

[0113] 39 , the device 100 is shown deployed through the native mitral valve 40, with the paddles 122 open. The fastener 3500 is then opened by applying tension to the actuation lines 3502, 3504 attached to the ends of the movable arm 3530 and the indicator arm 3550, respectively. Opening the fastener 3500 and paddles 122 as shown in FIG. 39 allows the device 100 to be manipulated such that the leaflets 42, 44 are at least partially disposed within the openings 3506 formed between the fixed and movable arms 3510, 3530 of the fastener, facilitating capture of the leaflets 42, 44 by the fastener 3500.

[0114] 39 , the paddle 122 and catch 3500 are partially closed to position the leaflets for detection by the indicating arm 3550 and eventual capture by the catch 3500. The partially closed position of the paddle 122 and catch 3500 allows the barbed portion 3540 of the movable arm 3530 to pinch the leaflets 42, 44 against the fixed arm 3510 without stretching or displacing the leaflets 42, 44 so much that they would be pushed away by the movable arm 3530 or slip off the barbed portion 3540 during attempted leaflet capture.

[0115] 40 , both indicator arms 3550 are actuated by releasing tension on the actuation line 3504. Both indicator arms 3550 have cleared or slid off the leaflets 42, 44 and moved to a fully actuated position, which is beyond the fixation arms 3510 of the fastener 3500. The indicator arms 3550 crossing the fixation arms 3510 form an X-shape that is visible via imaging devices used to monitor the implantation and placement of the device.

[0116] 41 , the indicator arm 3550 has been retracted by applying tension to the actuation line 3504, and the device 100 has been repositioned so that the leaflets 42, 44 are inserted deeper into the openings 3506 of the fastener 3500. One of the indicator arms 3550 is then allowed to close by releasing the tension on one of the actuation lines 3504, as can be seen in FIG. 42 . The indicator arm 3550 has engaged the leaflet 42, pinching it against the fixation arm 3510 and paddle 122. FIG. 43 shows the same, with the other indicator arm 3550 having been actuated to engage the other leaflet 44 and pinch it against the other fixation arm 3510 and paddle 122. Engagement with the leaflets 42, 44 prevents the indicator arms 3550 from passing through the locking arms 3510 of the fastener 3500 and forming the X-shape shown in FIGURE 40. Thus, the indicator arms 3550 indicate to an observer viewing the installation via an imaging device that the leaflets 42, 44 have been inserted into the openings 3506 beyond the minimum desired engagement depth, which is determined by the length of the indicator arms 3550.

[0117] 44-47, once the indicator arm 3550 indicates that the leaflets 42, 44 are fully inserted into the opening 3506, the movable arm 3530 is actuated by releasing tension on the actuation line 3502, causing the leaflets 42, 44 to be sandwiched between the barbed portion 3540 of the respective fastener 3500 and the fixation arm 3510. The paddle 122 is then moved to the fully closed position (shown in FIG. 46), firmly anchoring the leaflets within the device 100. The indicator 3550 can be monitored in any of the positions illustrated by FIGS. 42-46. For example, the indicator 3550 will pulse or jump as the heart beats. This pulsation or jumping can be visualized to confirm that the mitral valve repair device is correctly positioned. The indicator 3550 is flexible enough to bend or jump when the heart beats, so that the movable arm 3530 can be closed and / or made to close with a force high enough so that the closed movable arm 3530 does not pulsate or jump when the heart beats.

[0118] Referring now to FIG. 47 , one of the valve leaflets 44 is shown partially withdrawn from the device 100, which may occur due to movement of the leaflets 42, 44 during heartbeats. As can be seen in FIG. 47 , the leaflet 44 remains partially anchored by the barbed portion 3540. However, the leaflet 44 is no longer anchored at or beyond the minimum engagement depth as determined by the length of the indicator arm 3550. The withdrawal of the leaflet 44 allows the indicator arm 3550 to move beyond the fixation arm 3510, thereby forming an X-shape that is visible to an observer using an imaging device. Additionally, or alternatively, the indicator arm 3550, not in contact with the leaflet, does not pulsate or jump as the heart beats. Thus, insufficient retention or slippage of the leaflets 42, 44 from the device 100 can be detected before the device 100 is removed from the delivery device (not shown). Once a slipped leaflet is detected, the catch 3500 and paddle 122 can be opened and repositioned to better secure the slipped leaflet. In other exemplary embodiments (see FIGS. 221-225), a single actuation line can be used to raise and lower the movable and indicator arms of the catch.

[0119] In some exemplary embodiments, the first movable arm on the catch can have barbs and can be strong enough to hold the leaflet in place when the first movable arm is lowered onto the leaflet. If the leaflet is not positioned far enough into the leaflet, the first movable arm can be raised again. The barbs on the first movable arm are temporary, allowing the first movable arm to be repeatedly raised and lowered until the leaflet is properly positioned. Once the leaflet is positioned sufficiently within the catch, one or more secondary movable arms (having barbs or barb regions) can be lowered to hold or capture the leaflet in place within the catch.

[0120] 48-66, an exemplary fastener 4400 for use in an implantable prosthetic device (e.g., devices 100, 200, 300, etc., described above) is shown. The fastener 4400 has a fixed arm 4410, a patterned flex or patterned hinge portion 4420, a movable arm 4430 formed in the shape of a hoop or loop, and a barbed portion 4440 of the movable arm 4430. The fastener 4400 also includes an indicator arm 4450 extending from an indicator flex or hinge portion 4460 that couples the indicator arm to the patterned flex or hinge portion 4420. The fastener 4400 may be used in any of the implantable prosthetic devices of the present application and may include any or a combination of features of the other fasteners described herein. For example, the fastener 4400 may be laser cut from a flat sheet or tube of a shape memory alloy (eg, Nitinol, etc.) and then shape-set into the desired shape.

[0121] The illustrated fixation arm 4410 has two tongue portions 4411, each including an aperture 4412 for attaching the fixation arm 4410 to an implantable device. A central opening 4454 disposed between the tongue portions 4411 is wider than the indicator arm 4450, allowing the indicator arm 4450 to pass through the fixation arm 4410 between the tongue portions 4411, forming an X-shape when viewed from the side ( FIG. 51 ) when the indicator arm 4450 is not engaged with leaflet tissue.

[0122] The patterned flexure or patterned hinge portion 4420 is formed from a plurality of spring segments 4422 and cutouts 4424. The two tongue portions 4411 of the fixed arm 4410 extend from one end of the patterned flexure or patterned hinge portion 4420, and the movable arm 4430 extends from the other end of the flexure or hinge portion 4420.

[0123] The movable arm 4430 of the fastener 4400 has a hoop-like shape. The hoop-shaped movable arm 4430 includes side beams 4432 that are thinner and more flexible, particularly laterally. The side beams 4432 include a first bend or hinge portion 4434 located toward the proximal end of the movable arm 4430 and a second bend or hinge portion 4436 located at the distal end of the movable arm 4430. The first bend or hinge portion 4434 is formed by one or more bends in the side beam 4432. The second bend or hinge portion 4436 includes a thinner (and therefore more flexible) portion, reducing the force required to collapse the fastener 4400. The hoop shape of the movable arm 4430 and flexible side arm 4432 allows the movable arm 4430 to be collapsed by simply retracting the fastener 4400 into a delivery sheath (not shown). In certain embodiments, the expansion and contraction of the fastener 4400 is controlled by an actuation line (not shown).

[0124] The hoop-like shape of the movable arm 4430 provides a wider barbed portion 4440, which can include more barbs 4442 with the same or greater lateral spacing than other fasteners. The wider spacing of the barbs 4442 improves capture of the native valve leaflets. The barbs 4442 are also longitudinally offset as a result of their location on the hoop-like shape of the movable arm 4430. That is, the two middle barbs 4444 are positioned further away from the joint, flexion, or hinge portion 4420, and the two outer barbs 4446 are positioned closer to the joint, flexion, or hinge portion 4420. The barbed portion 4440 of the movable arm 4430 also includes holes 4448 for receiving an actuating suture (not shown). In certain embodiments, the hoop shape of the movable arm 4430 is similar to the shape of the wide outer paddle of the implantable device so that the pinching force of the paddle is evenly distributed over the barbs, further improving retention of the native valve leaflets. The ends of the barbs 4442 may be further sharpened using any suitable sharpening means.

[0125] The indicator arm 4450 includes a beam 4451 that extends from a joint, flexure, or hinge portion 4420 within the hoop-shaped movable arm 4430 between two side arms 4432 to a barbed portion 4456. The indicator arm 4450 includes a hole 4452 at its end for receiving an actuation line (not shown) for actuating the indicator arm 4450. The barbed portion 4456 is disposed at the end of the beam 4451 of the indicator arm 4450 and includes at least one barb 4456. The barbed portion 4456 helps the indicator arm 4450 anchor the valve leaflets until the movable arm 4430 is closed. The barb 4456 may be laser cut from the indicator arm 4450 and bent outward so that it projects away from the indicator arm 4450 at approximately the same angle that the barb 4442 projects from the movable arm 4430. In some embodiments, the indicator arm 4450 includes a barb that is cut from a flat sheet of material, similar to the barb 2244 of the fastener 2200, and then rotated 90 degrees to protrude outward at a predetermined angle.

[0126] The barbed portion 4456 of the indicator arm 4450 is positioned a predetermined distance from the joint, flexure, or hinge portion 4420 such that the barbs 4456 of the indicator arm 4450 are longitudinally positioned between the central barbs 4444 and the outer barbs 4446 of the barbed portion 4440. This positioning ensures that the barbed portion 4440 will engage the leaflet being engaged by the indicator arm 4450. That is, if a native valve leaflet positioned in the fastener 4400 is engaged by the barbed portion 4456 of the indicator arm 4450 when the indicator arm 4450 is actuated, the leaflet will also be engaged by the barbed portion 4440 of the movable arm 4430. The opposite is also true. That is, if the natural valve leaflet positioned in the fastener 4400 is not engaged by the indicator arm 4450 when the indicator arm 4450 is actuated, the leaflet will not be fully engaged by the barbed portion 4440 of the movable arm 4430.

[0127] The indicator flex or hinge portion 4460 allows the indicator arm 4450 to be actuated separately from the movable arm 4430, facilitating detection of the depth of engagement of a native valve leaflet disposed between the movable arm 4430 and the fixation arm 4410 of the fastener 4400. The indicator flex or hinge portion 4460 is similar to the patterned flex / hinge portion 4420 and is formed from a series of spring segments 4462 and cutouts 4464. In some embodiments, the spring force of the indicator flex / hinge portion 4460 is less than the pinching force imparted to the movable arm 4430 by the joint portion, flex or hinge portion 4420, allowing the indicator arm 4450 to be actuated multiple times to detect the position of the valve leaflet, while the movable arm 4430, which has a stronger pinching force, is actuated once the leaflet is held in the desired position by the indicator arm 4450 via the barbs. The lower pinching force of the indicator arm 4450 reduces the force exerted on the leaflet tissue, allowing the indicator arm 4450 to be repeatedly repositioned and making it less likely to puncture or otherwise damage the leaflet tissue. The lower pinching force also allows the indicator arm 4450 to pulse or jump as the heart beats.

[0128] 48-50, the catch or catch 4400 is shown in the open position. The movable arm 4430 and the indicator arm 4450 are biased or spring loaded in a closing direction and are moved to and held in the open position by tension applied to actuation lines (not shown) attached to holes 4448, 4452 in the movable arm 4430 and the indicator arm 4450, respectively.

[0129] 51-52, the clasp or barbed clasp 4400 is shown with the indicator arm 4450 in a fully deployed or actuated position (i.e., the furthest reach the indicator arm 4450 can reach when it is not engaging the valve leaflet tissue during actuation). The indicator arm 4450 is permitted to actuate in a closing direction when tension is reduced on an actuation line (not shown) attached to a hole 4452 in the end of the indicator arm 4450. In the fully actuated position, the indicator arm 4450 forms an X-shape with the fixation arm 4410, which is visible via an imaging device, allowing the operator to know that the indicator arm 4450 is not engaging the valve leaflet tissue.

[0130] 53-55, the catch or barbed catch 4400 is shown with the indicator arm 4450 in the engaged or closed position, i.e., the position the indicator arm 4450 will be in when leaflet tissue is engaged during actuation. The indicator arm 4450 is permitted to actuate in the closing direction when tension is reduced on an actuation line (not shown) attached to a hole 4452 in the end of the indicator arm 4450. In the closed position, the indicator arm 4450 does not cross the fixation arm 4410 and does not form an X-shape with the fixation arm 4410. Thus, when the indicator arm 4450 is actuated and no X-shape is visible when the catch 4400 is viewed with an imaging device, the operator knows that the indicator arm 4450 has engaged the leaflet tissue. Additionally or alternatively, the indicator arm 4450 can be optically monitored to detect pulsations or jumps of the indicator arm as the heart beats. This jump or bound of the indicator arm indicates to the operator that the indicator arm has engaged the leaflet tissue.

[0131] 56-58, the catch or barbed catch 4400 is shown with the movable arm 4430 and the indicator arm 4450 both in a closed position. When the catch 4400 is closed, the movable arm 4430 and the indicator arm 4450 exert a pinching force that keeps the native leaflet tissue secured within the catch 4400. Additionally, a tortuous path for retaining the captured leaflet tissue is formed by the fixation arm 4410, the movable arm 4430, and the barbed portion 4440. The catch 4400 is biased in a closed direction by the configuration of the movable arm 4430 and the indicator arm 4450 in the preloading position (FIGS. 59-61).

[0132] 59-61, the fastener 4400 is shown with the fixed arm 4410 and the indicator arm 4450 in a shape-set or preloading position. As discussed with respect to other embodiments, the shape-set of the fixed arm 4410 and the indicator arm 4450 relative to the movable arm 4430 creates a pinching force between the components of the fastener 4400 when the fastener 4400 is in the closed position.

[0133] 59 , the fixed arm 4410 is shape-set at an angle 4410A from the movable arm 4430. In certain embodiments, the angle 4410A between the neutral position and the shape-set position of the tongue 4411 of the fixed arm 4410 is between about 180 degrees and about 270 degrees, or is about 270 degrees. To move the fixed arm 4410 to the shape-set position, the fixed arm 4410 is bent upward and the tongue 4411 of the fixed arm 4410 is passed through an opening in the movable arm 4430 formed between the side beam 4432 and the indicator arm 4450.

[0134] 59 , the indicator arm 4450 is shaped at an angle 4450A from the movable arm 4430. In certain embodiments, the angle 4450A between the neutral position and the shaped position of the beam 4451 of the indicator arm 4450 is between about 90 degrees and about 180 degrees, between about 100 degrees and about 150 degrees, or about 135 degrees. The shaped position of the indicator arm 4450 is selected such that the indicator arm 4450 passes between the tongues 4411 of the fixed arm 4410, forming the X-shape described above.

[0135] 62-66, an exemplary fastener or barbed fastener 4400 is shown for placement within the native valve 40 to secure an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 62, the fastener 4400 is shown in an open condition, with the native valve leaflet 42, 44 partially inserted into an opening 4406 in the fastener 4400 formed between the fixed arm 4410 and the movable arm 4430. To determine whether the leaflet 42, 44 has reached the desired engagement depth, the indicator arm 4450 is actuated via an actuation line (see FIG. 41), as shown in FIGS. 63 and 65.

[0136] 63, the indicator arm 4450 has been actuated by releasing tension on the actuation line (see FIG. 41) connected to the hole 4452 at the end of the indicator arm 4450. Because the leaflets 42, 44 are not at or beyond the minimum engagement depth, the indicator arm 4450 has cleared or slipped off the leaflets 42, 44 and moved to a fully actuated position beyond the fixation arm 4410 of the fastener 4400. The indicator arm 4450 crosses the fixation arm 4410, forming an X-shape that is visible via imaging devices used to monitor the implantation and placement of the prosthetic device.

[0137] 64 , the indicator arm 4450 is retracted by applying tension to the actuation line, and the fastener 4400 is repositioned so that the leaflets 42, 44 are inserted deeper into the opening 4406 of the fastener 4400. The indicator arm 4450 is then actuated by releasing tension on the actuation line, as can be seen in FIG. 65 . As the leaflets 42, 44 are inserted into the fastener 4400 at or beyond the minimum desired engagement depth, the indicator arm 4450 engages and pinches the leaflets 42, 44 against the fixation arm 4410. Engagement with the leaflets 42, 44 prevents the indicator arm 4450 from passing through the fixation arm 4410 of the fastener 4400 and forming the X-shape shown in FIG. 63 . Additionally or alternatively, the indicator arm 4450 may be optically monitored to detect pulsations or jumps of the indicator arm as the heart beats. This jump or bounce of the indicator arm indicates to the operator that the indicator arm has engaged the leaflet tissue. Thus, the indicator arm 4450 indicates to an observer viewing the installation via an imaging device that the leaflets 42, 44 have been inserted into the opening 4406 beyond the minimum desired engagement depth, which is determined by the length of the indicator arm 4450.

[0138] Referring now to FIG. 66 , when the indicator arm 4450 indicates that the leaflets 42, 44 are fully inserted into the opening 4406, the movable arm 4430 is actuated by releasing tension on the actuation line, causing the leaflets 42, 44 to be sandwiched between the barbed portion 4440 and the fixed arm 4410, firmly securing the leaflets 42, 44 within the fastener 4400.

[0139] 84-102, exemplary fasteners (often illustrated as barbed fasteners, although other friction-enhancing elements besides barbs may also be used) are shown with indicating features that are altered upon engagement with the native leaflet tissue. For example, the fasteners can include bumps or protrusions that flatten when the native leaflet tissue is pressed against the bumps. The bumps are of sufficient size to be visible via an imaging device, such that the absence of the bumps indicates that the bumps have been pressed against the native leaflet tissue. Thus, the depth of engagement of the native leaflet can be determined by the location of the bumps and whether or not they are visible.

[0140] Referring now to FIG. 84, an exemplary embodiment of a portion of a laser-cut fastener is illustrated. The fastener can have a movable arm 4530, a barbed region 4540, and an indicator arm 4550. The movable arm and indicator arm each have a flexible or hinged portion 4520, 4560, respectively. The flexible region 4520 of the movable arm allows the fastener to be configured into the proper shape for implantation and / or allow the movable arm to move over the fixed arm (see FIGS. 85-89). The flexible region 4560 of the indicator arm allows the indicator arm to drop and / or bounce over the leaflet. The indicator arm 4550 can have a flexible bump 4552 thereon, which can be flattened to indicate that the leaflet is positioned sufficiently deep within the fastener. The bump 4552 may be positioned at a location on the indicator arm between the free end of the indicator arm and the flexible region 4560. The catch (a portion of which is shown in FIG. 84) operates in the manner described with respect to FIGS. 85-89.

[0141] 85-86 , an exemplary fastener 4500 for use in an implantable prosthetic device (such as devices 100, 200, 300 described above) is shown. Similar to fastener 3500 described above, fastener 4500 includes a fixed arm 4510, a joint, flex, or hinge portion 4520, a movable arm 4530 having a barbed portion 4540 (although other friction-enhancing portions may be used), and an indicator arm 4550 connected to the joint, flex, or hinge portion 4520 via an indicator flex or hinge portion 4560. Indicator arm 4550 includes an indicating feature or bump 4552 that deforms when pressed against the native leaflet tissue to indicate that the leaflet tissue has reached a desired engagement depth. Thus, the indicating feature 4552 will not indicate that the native valve leaflet has reached the minimum desired engagement depth until the leaflet is inserted at or beyond the indicating feature 4552. Once the leaflet 42, 44 reaches the desired engagement depth, actuation of the indicator arm 4550 presses the indicating feature 4552 against the leaflet tissue 42, 44, causing the indicating feature 4552 to flatten, thereby indicating that the leaflet 42, 44 has been inserted into the fastener 4500 at or beyond the desired engagement depth. The fastener 4500 may be used in any of the implantable prosthetic devices of the present application and may include any or combination of features of the other fasteners described herein.

[0142] 87-90, an exemplary fastener 4500 is shown placed within the native valve 40 to secure an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 87, the fastener 4500 is shown in an open condition, with the native valve leaflet 42, 44 partially inserted into the opening 4506 of the fastener 4500 formed between the fixed arm 4510 and the movable arm 4530. To determine whether the leaflet 42, 44 has reached the desired engagement depth, the indicator arm 4550 is actuated via an actuation line (see FIG. 133), as shown in FIGS. 88-89.

[0143] 88, when the indicator arm 4550 is actuated to press the leaflets 42, 44 against the fixation arm 4510, a portion of the indicator arm 4550 may contact the leaflets 42, 44 without contacting the indicating feature 4552 when the engagement depth of the leaflets 42, 44 is less than the minimum engagement depth. As can be seen in FIG. 89, the indicating feature 4552 is deformed or flattened from contact with the leaflets 42, 44 when the leaflets are inserted into the fastener 4500 at or beyond the minimum engagement depth. Referring now to FIG. 90, the indicating feature 4552 is deformed by the leaflets 42, 44, indicating that the leaflets 42, 44 have been inserted at or beyond the minimum engagement depth. When the leaflets 42, 44 have been moved to a desired position, the movable arm 4530 can be actuated to secure the leaflets 42, 44 within the barbed fastener 4500 by the barbed portion 4540.

[0144] 91-92 , an exemplary fastener 4600 for use in an implantable prosthetic device (such as devices 100, 200, 300 described above) is shown. Similar to fastener 3500 described above, fastener 4600 includes a fixation arm 4610, a joint, flex, or hinge portion 4620, a movable arm 4630 having a barbed portion 4640 (although other friction-enhancing portions may be used), and an indicator arm 4650 connected to joint, flex, or hinge portion 4620 via an indicator flex or hinge portion 4660. Fixation arm 4610 includes an indicating feature or bump 4612 that deforms when the native leaflet tissue is pressed against it by indicating arm 4650, indicating that the leaflet tissue has reached a minimum desired engagement depth. Thus, the indicating feature 4612 will not indicate that the native valve leaflet has reached the minimum desired engagement depth until the leaflet is inserted at or beyond the indicating feature 4612. Once the leaflet 42, 44 reaches the desired engagement depth, actuation of the indicator arm 4650 presses the leaflet tissue 42, 44 against the indicating feature 4612, causing the indicating feature 4612 to flatten, thereby indicating that the leaflet 42, 44 has been inserted into the fastener 4600 at or beyond the desired engagement depth. The fastener 4600 may be used in any of the implantable prosthetic devices of the present application and may include any or combination of features of the other fasteners described herein.

[0145] 93-94 , an exemplary fastener 4600 is shown placed within the native valve 40 to secure an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 93 , the fastener 4600 is shown in an open condition, with the native valve leaflet 42, 44 partially inserted into an opening 4606 in the fastener 4600 formed between the fixed arm 4610 and the movable arm 4630. To determine whether the leaflet 42, 44 has reached the desired engagement depth, the indicator arm 4650 is actuated via an actuation line (not shown), as shown in FIGS. 94-95 .

[0146] 94 , when the indicator arm 4650 is actuated to push the leaflets 42, 44 against the fixation arm 4610, the leaflets 42, 44 may contact a portion of the fixation arm 4610 without contacting the indicating feature 4612 when the engagement depth of the leaflets 42, 44 is less than the minimum engagement depth. As can be seen in FIG. 95 , when the leaflets are inserted into the fastener 4600 at or beyond the minimum engagement depth, and when the leaflets are pressed against the indicating feature 4612 by the indicating arm 4650, the indicating feature 4612 is deformed or flattened from contact with the leaflets 42, 44. Referring now to FIG. 96 , the indicating feature 4612 is deformed by the leaflets 42, 44, indicating that the leaflets 42, 44 have been inserted at or beyond the minimum engagement depth. When the leaflets 42, 44 have been moved to a desired position, the movable arm 4630 can be actuated to secure the leaflets 42, 44 within the barbed fastener 4600 by the barbed portion 4640.

[0147] 97-98 , an exemplary fastener 4700 for use in an implantable prosthetic device (such as devices 100, 200, 300 described above) is shown. Similar to fastener 3500 described above, fastener 4700 includes a fixation arm 4710, a joint, flex, or hinge portion 4720, and a movable arm 4730 having a barbed portion 4740 (although other friction-enhancing portions may also be used). The movable arm 4730 also includes an indicating feature or bump 4732 disposed between the barbed portion 4740 and the joint, flex, or hinge portion 4720. The indicating feature 4732 deforms as the native leaflet tissue is pressed against it by the fixation arm 4710, indicating that the leaflet tissue has reached a minimum desired engagement depth. Thus, the indicating feature 4732 will not indicate that the native valve leaflet has reached the minimum desired engagement depth until the leaflet is inserted at or beyond the location of the indicating feature 4732. Once the leaflet 42, 44 reaches the desired engagement depth, actuation of the movable arm 4730 compresses the leaflet tissue 42, 44 between the fixation arm 4710 and the indicating feature 4732, causing the indicating feature 4732 to flatten, thereby indicating that the leaflet 42, 44 has been inserted into the fastener 4700 at or beyond the desired engagement depth. The fastener 4700 may be used in any of the implantable prosthetic devices of the present application and can include any or combination of features of the other fasteners described herein.

[0148] 99-100 , an exemplary barbed fastener 4700 is shown placed within a native valve 40 for anchoring an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 99 , the barbed fastener 4700 is shown in an open condition, with the native valve leaflet 42, 44 partially inserted into an opening 4706 in the barbed fastener 4700 formed between a fixed arm 4710 and a movable arm 4730. To determine whether the leaflet 42, 44 has reached a desired engagement depth, the movable arm 4730 is actuated via an actuation line (not shown), as shown in FIG.

[0149] Referring to FIG. 100, when the movable arm 4730 is actuated to push the leaflets 42, 44 against the fixed arm 4710, the leaflets 42, 44 may contact a portion of the movable arm 4730 without contacting the indicating feature 4732 when the engagement depth of the leaflets 42, 44 is less than the minimum engagement depth.

[0150] 100A , the indicating feature 4732 is deformed or flattened from contact with the leaflets 42, 44 when the leaflets are inserted into the fastener 4700 at or beyond the minimum engagement depth and when the leaflets are pressed against the indicating feature 4732. That is, the indicating feature 4732 is deformed by the leaflets 42, 44, indicating that the leaflets 42, 44 have been inserted at or beyond the minimum engagement depth. Also, in some embodiments, actuation of the movable arm 4730 engages and secures the barbed portion 4740 to the leaflets 42, 44 within the barbed fastener 4700. If the indicating feature 4732 indicates that the leaflets 42, 44 have not been inserted to the desired depth, the fastener 4700 can be opened to allow repositioning of the leaflets 42, 44.

[0151] 101-102 , an exemplary fastener 4800 for use in an implantable prosthetic device (such as devices 100, 200, 300 described above) is shown. Similar to fastener 3500 described above, fastener 4800 includes a fixed arm 4810, a joint, flex, or hinge portion 4820, and a movable arm 4830 having a barbed portion 4840 (although other friction-enhancing portions may also be used). Additionally, fixed arm 4810 includes an indicating feature or bump 4812 that is disposed a distance from the joint, flex, or hinge portion that is less than the distance between barbed portion 4840 and joint, flex, or hinge portion 4820. The indicating feature 4812 deforms as the native leaflet tissue is pressed against it by the movable arm 4830, indicating that the leaflet tissue has reached a minimum desired engagement depth. Thus, the indicating feature 4812 will not indicate that the native leaflet 42, 44 has reached the desired engagement depth until the leaflet 42, 44 is inserted at or beyond the location of the indicating feature 4812. Once the leaflet 42, 44 reaches the desired engagement depth, actuation of the movable arm 4830 compresses the leaflet tissue 42, 44 against the indicating feature 4812 of the fixation arm 4810, causing the indicating feature 4812 to flatten, thereby indicating that the leaflet 42, 44 has been inserted into the fastener 4800 at or beyond the desired engagement depth. Fastener 4800 may be used in any of the implantable prosthetic devices of the present application and may include any or a combination of features of the other fasteners described herein.

[0152] 101 , a catch 4800 is shown with the native leaflets 42, 44 partially inserted into openings 4806 of the catch 4800 formed between a fixed arm 4810 and a movable arm 4830. The movable arm 4830 is actuated via an actuation line to determine if the leaflets 42, 44 have reached the desired engagement depth.

[0153] Referring now to FIG. 101, when the movable arm 4830 is actuated to push the leaflets 42, 44 against the fixed arm 4810, the leaflets 42, 44 may contact a portion of the fixed arm 4810 without contacting the indicating feature 4812 when the engagement depth of the leaflets 42, 44 is less than the desired minimum engagement depth.

[0154] 102 , when the leaflets 42, 44 are inserted into the fastener 4800 at or beyond the minimum engagement depth, and when the leaflets 42, 44 are pressed against the indicating feature 4812 by the movable arm 4830, the indicating feature 4812 is deformed or flattened from contact with the leaflets 42, 44. That is, the indicating feature 4812 is deformed by the leaflets 42, 44, indicating that the leaflets 42, 44 have been inserted at or beyond the minimum engagement depth. Also, in some embodiments, actuation of the movable arm 4830 causes the barbed portion 4840 to engage and secure the leaflets 42, 44 within the barbed fastener 4800. If the indicating feature 4812 indicates that the leaflets 42, 44 have not been inserted to the desired depth, the barbed fastener 4800 can be opened to allow repositioning of the leaflets 42, 44.

[0155] Referring now to FIG. 103, an exemplary embodiment of a portion of a laser-cut fastener is illustrated. In FIG. 103, a fastener having a movable arm 5230, a fixed arm 5210, and a flexibility indicator 1031 is cut from a single sheet. The movable arm 5230 has a cutout opening 6730 and at least one barb 5240, as well as a flexible section 5220 that allows the movable arm to bend, shape, or otherwise position itself in the proper configuration to form the fastener. The fixed arm 5210 has two cutouts 6740 and a flexibility indicator therein, each extending along the length of the fixed arm, and the flexibility indicator extends across the length of the fixed arm between the cutouts 6740. The fixation arm 5210 can also have an optional flexible section 4470 that can be attached to the paddle portion or the co-option portion or the spacer portion, allowing the paddle and fastener to be optionally made from a single piece, or the fastener and the co-option or spacer portion to be optionally made from a single piece. The flexible indicator 1031 can have an optional indicator element 1030 thereon. The optional indicator element 1030 can be a radiopaque marker. The radiopaque marker can be an additional piece attached to the flexible indicator, or it can be printed on the flexible indicator or applied to the flexible indicator in the manner of any of the embodiments described herein.

[0156] 104-106, there are shown schematic diagrams of an exemplary embodiment of a fastener (illustrated as a barbed fastener) for use in an implantable prosthetic device (such as, for example, devices 100, 200, and 300 described above). Similar to fastener 3500 described above, fastener 5200 includes a fixed arm 5210, a joint, flexure, or hinge portion 5220, and a movable arm 5230 having a barbed portion 5240 (although other friction-enhancing portions may also be used). The fixed arm 5210 also includes at least one flexibility indicator 1031 positioned between cutouts 6740, as shown in FIGS. 103 and 110. FIG. 104 illustrates a schematic diagram of a fastener having one flexibility indicator 1031 on the fixed arm that fits through an opening 6730 in the movable arm 5230. FIG. 105 illustrates a schematic diagram of a fastener having two flexible indicators 1031 on a fixed arm that fit between two cutout openings 6730 on a movable arm. When multiple flexible indicators are present, the flexible indicators can be aligned or offset along the length of the fixed arm. The flexible indicators can be part of the laser-cut fastener or can be attached to the laser-cut fastener frame by welding, rivets, or other known means. FIG. 106 illustrates a schematic side view of the embodiment illustrated in FIGS. 104 and 105. From the side view, the fastener looks the same whether there is one flexible indicator 1031 or two because the two indicators are aligned in the illustrated example. In FIG. 106, the fastener is in the open position and the flexible indicators are bent into a “bump” configuration. 106-109 also illustrate an optional radiopaque indicator 1030 on the flexible bump 1031. The radiopaque indicator may be printed on the flexible bump 1031 or may be attached to the flexible bump 1031 as a separate piece of material.For example, the radiopaque material can be a coil made from platinum or another radiopaque material. The radiopaque indicator can be visible under fluoroscopy and / or other imaging techniques and can assist the user in determining whether the leaflets are properly positioned within the fasteners.

[0157] The bumps 1031 deform and flatten as the native leaflet tissue is pressed against them by the movable arms 5230, indicating that the leaflet tissue has reached a minimum desired engagement depth. Thus, the bumps 1031 will not indicate that the native leaflets 42, 44 have reached the desired engagement depth until the leaflets 42, 44 have been inserted at or beyond the bumps 1031. Once the leaflets 42, 44 have reached the desired engagement depth, actuation of the movable arms 5230 compresses the leaflet tissue 42, 44 against the bumps 1031 of the fixation arms 5210, causing the bumps 1031 to flatten, thereby indicating that the leaflets 42, 44 have been inserted into the fastener 5200 at or beyond the desired engagement depth. The fastener 5200 may be used in any of the implantable prosthetic devices of the present application and may include any or a combination of features of the other fasteners described herein.

[0158] 107-109, the exemplary fastener 5200 depicted in FIGS. 104-106 is shown deployed within the native valve 40 for securing an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 107, the fastener 5200 is shown in an open condition, with the native valve leaflet 42, 44 partially inserted into the opening of the fastener 5200 formed between the fixed arm 5210 and the movable arm 5230. In FIGS. 107-109, the bump 1031 can have an optional radiopaque indicator thereon. The radiopaque indicator can be printed directly on the bump, printed on a coil wrapped around the bump, printed on a fabric covering the bump, or otherwise secured to the bump. The radiopaque indicator can be a platinum coil wrapped around the bump, or it can be radiopaque ink printed thereon.

[0159] 108, when the movable arm 5230 is actuated to push the leaflets 42, 44 against the fixation arm 5210, the leaflets 42, 44 may contact a portion of the fixation arm 5210 without contacting the bump 1031 when the engagement depth of the leaflets 42, 44 is less than the minimum engagement depth. As can be seen in FIG. 109, when the leaflets are inserted into the fastener 4600 at or beyond the minimum engagement depth, and when the leaflets are pressed against the bump 1031 by the movable arm 5230, the bump 1031 is deformed or flattened from contact with the leaflets 42, 44.

[0160] 103A-103D, an exemplary embodiment of an indicator 1031 having an optional marker 1030 on a fastener (such as the fastener illustrated in FIG. 103) is illustrated. Referring to FIG. 103A, the flexible indicator arms can be flexible "wing" indicators 1032, with one attached to each side of the movable arm 5230. In another exemplary embodiment, a single wing is disposed on only one side of the fastener. The flexible wing indicator can be cut from the same sheet of material as the laser-cut fastener or can be a separately cut piece attached to the fastener. As with the other exemplary embodiments described herein, the indicator arm can have a different thickness than the fastener to provide different amounts of flexibility. The flexible wing indicator can extend outward and inward at a predetermined angle from the movable arm, similar to butterfly wings. The flexible wing indicator can be attached to the movable arm or a fixed arm. The flexible wing indicators 1032 can each have an optional radiopaque indicator element 1030 thereon. As with other exemplary embodiments described herein, the indicator element can be radiopaque and can be printed or otherwise attached directly to the flexible wing indicator or to a fabric covering the flexible wing indicator. The flexible wing indicator extends at an angle from the fastener's movable arm 5230 outward, away from the fastener's longitudinal axis, and toward the center of the fastener toward the fixed arm. When a leaflet is captured by the fastener and applies a force to the flexible wing indicator 1032, the flexible wing indicator bends back toward the movable arm (see FIGS. 108A and 109A for a schematic illustration).

[0161] 103B, a flexible wire indicator 1031 may be positioned within the opening 6740 of the fastener's fixed arm 5210. This may be in addition to the flexible wing indicator 1032, or may be present without a flexible wing indicator. The flexible wire indicator may be a wire that extends along the longitudinal axis of the fastener's opening 6740, attached at one end closer to the bend or hinge portion 4470 and at the other end closer to the bend or hinge portion 5220. There may be optional radiopaque markers 1030 positioned along the length of the flexible wire indicator 1031. The wire may be held in place by being secured at attachment points 1034, which may have the wire indicator attached by welding, suturing, or other known methods of attachment. Figures 108B and 109B illustrate schematic views of the exemplary embodiment of the fastener in Figure 103B when the leaflet is positioned within the fastener deep enough to bend the indicators 1031, 1032. Figure 103D illustrates an exemplary embodiment having only a flexible wire indicator 1031 without a flexible wing indicator. Figures 108D and 109D illustrate schematic views of the exemplary embodiment of the fastener in Figure 103D when the leaflet is positioned within the fastener deep enough to bend the indicator 1031.

[0162] 103C, an exemplary embodiment of a fastener having a flexible wire indicator 1031 is illustrated. The flexible wire indicator 1031 can be present and extends longitudinally across the opening 6740, has an optional radiopaque indicator 1030 positioned along the wire indicator 1031, and is secured to the fastener at an attachment point 1034. The flexible wire indicator 1031 can also be positioned longitudinally across the opening 6730 in the movable arm 5230 in addition to or instead of the flexible wire indicator in the opening 6740 of the fixed arm. The flexible wire indicator 1031 in the movable arm opening 6730 can extend partway across the opening and can be attached at one end near the bend or hinge portion 5220 and at the other end at a crosspiece 1033 that extends horizontally across the opening 6740. The crosspiece can have an optional radiopaque indicator printed or attached thereto. The flexible wire indicator can have optional radiopaque markers 1030 positioned along its length. Figures 108C and 109C illustrate a schematic view of an exemplary embodiment of the fastener in Figure 103C when the leaflets are positioned deep enough in the fastener to bend the indicator 1031.

[0163] 104A and 106A, schematic diagrams of exemplary embodiments of fasteners for use in implantable prosthetic devices (such as the exemplary embodiment shown in FIG. 103A) having flexible "wing" indicators 1032 (one attached to each side of the movable arm 5230). The flexible wing indicators can extend laterally outward from the movable arm and at an angle toward the end of the fixed arm. While shown attached to the movable arm here, the flexible wing indicators can optionally be attached to the fixed arm instead. The flexible wing indicators 1032 can each have an optional indicator element 1030 thereon. FIG. 106A illustrates a side view of the embodiment shown in FIG. 104A. In Figures 104A and 106A, the catch is in the open position, with flexible wing indicators 1032 extending outward from the movable arms as shown in Figure 104A and inward toward the portion of the catch where the leaflet will be positioned as shown in Figure 106A. An optional radiopaque indicator 1030 is shown above the flexible wing indicators.

[0164] The flexible wing indicators 1032 deform and flatten as the native leaflet tissue presses against them when the fastener is closed, indicating that the leaflet tissue has reached a minimum desired engagement depth within the fastener. In one exemplary embodiment, if the leaflet is inserted off-center into the fastener, only one flexible wing indicator may bend and deform, while the other remains undeformed. The fastener 5200 may be used in any of the implantable prosthetic devices of the present application and may include any or a combination of features of the other fasteners described herein.

[0165] 108A and 109A, use of the exemplary embodiment fastener of Fig. 103 A is illustrated. Referring now to Fig. 108A, when the movable arm 5230 is actuated to press the leaflets 42, 44 against the fixed arm 5210, the leaflets 42, 44 may contact a portion of the fixed arm 5210 and a portion of the movable arm 5230 without contacting the flexible wing indicator 1032 when the engagement depth of the leaflets 42, 44 is less than the minimum engagement depth. 109A, when the leaflet is inserted into the fastener 4600 at or beyond the minimum engagement depth, and when the leaflet is pressed against the flexible wing indicators 1032 by the fixation arms 5210, the flexible wing indicators 1032 (only one flexible wing indicator is visible in FIG. 109A because the other is directly behind it) are deformed or flattened from contact with the leaflets 42, 44. The location of the optional radiopaque indicating element 1030 can indicate to the user how far the flexible wing indicators have been moved, and thus the position of the leaflet can be determined.

[0166] 104B and 106B, there are shown schematic diagrams of an exemplary embodiment of a fastener (shown as a barbed fastener) for use in an implantable prosthetic device (such as the exemplary embodiment shown in FIG. 103B) having flexible “wing” indicators 1032 (one attached to each side of the movable arm 5230). The flexible wing indicators can extend at an angle away from the movable arm and toward the open end of the fastener. While shown here attached to the movable arm, the flexible wing indicators can optionally be attached to the fixed arm. The flexible wing indicators 1032 can each have an indicator element 1030 thereon. FIG. 106B shows a schematic side view of the embodiment shown in FIG. 104B. In Figures 104B and 106B, the catch is in the open position, with the flexible wing indicator 1032 extending outward from the movable arm as shown in Figure 104B and inward toward the portion of the catch where the leaflet will be positioned as shown in Figure 106B. The longitudinally extending wire indicator 1031 has a bump configuration when in its resting, uncompressed state (e.g., when the catch is open). Optional radiopaque indicators 1030 are shown on the flexible wing indicator and on the wire indicator 1031.

[0167] The flexible wing indicators 1032 deform and flatten as the native leaflet tissue presses against them when the fasteners are closed, indicating that the leaflet tissue has reached the minimum desired engagement depth and horizontal position along the fasteners. In one exemplary embodiment, if the leaflet is inserted off-center into the fasteners, only one flexible wing indicator may bend and deform, while the other remains undeformed. Also, the wire indicator 1031 flattens and deforms due to the pressure exerted thereon by the leaflet when it is positioned thereon when the fasteners are closed.

[0168] Referring now to FIG. 108B, when the movable arm 5230 is actuated to press the leaflets 42, 44 against the fixed arm 5210, the leaflets 42, 44 may contact a portion of the fixed arm 5210 and a portion of the movable arm 5230 without contacting either the flexible wing indicator 1032 or the wire indicator 1031 when the engagement depth of the leaflets 42, 44 is less than the minimum engagement depth. As can be seen in FIG. 109B , when a leaflet is inserted into the fastener 4600 at or beyond its minimum engagement depth, and when the leaflet is pressed by the fixed arm 5210 against the flexible wing indicator 1032 and by the movable arm against the wire indicator 1031, the flexible wing indicator 1032 (only one flexible wing indicator is visible in FIG. 109B because the other is directly behind it) and wire indicator 1031 are deformed or flattened from contact with the leaflets 42, 44. The wire indicator can be a wire or a laser-cut sheet attached to the fixed arm, as described in other exemplary embodiments having flexible bump indicators described herein. The location of the optional radiopaque indicating element 1030 can indicate to the user how far the flexible wing indicator has been moved, and thus the position of the leaflet can be determined.

[0169] 104C and 106C, schematic diagrams of exemplary embodiments of fasteners (illustrated as barbed fasteners) for use in implantable prosthetic devices (such as, but not limited to, the exemplary embodiment shown in FIG. 103C having flexible two-wire indicators 1031) are shown. Each of the indicators has a bump configuration. One indicator is attached to the movable arm and one indicator is attached to the fixed arm. Also, in some exemplary embodiments, the indicators extending along the movable and fixed arms may be laser cut and attached to the arms. The wire indicators 1031 can have optional radiopaque indicator elements attached to them, printed on them, and / or wrapped around them. For example, the radiopaque indicator can be a coil made of a radiopaque material wrapped around at least a portion of a wire. FIG. 106C illustrates a schematic side view of the embodiment shown in FIG. 104C. In Figures 104C and 106C, the fastener is in the open position and the wire indicator 1031 has a bump configuration in which the bump extends inward into the fastener toward where the valve leaflet will be inserted.

[0170] 108C , when the movable arm 5230 is actuated to press the leaflets 42, 44 against the fixed arm 5210, the leaflets 42, 44 may contact a portion of the fixed arm 5210 and a portion of the movable arm 5230 without contacting either of the wire indicators 1031 when the engagement depth of the leaflets 42, 44 is less than the minimum engagement depth. When the catch is closed and the leaflets are not at the minimum engagement depth or are not present in the catch at all, the wire indicators 1031 flatten and deform as they press against each other due to the pressure applied by each wire indicator against the other. As shown, two optional radiopaque indicating elements 1030 become adjacent to each other, providing an indication that the leaflets have not been engaged.

[0171] 109C, the wire indicator 1031 deforms and flattens against the leaflets as the native leaflet tissue presses against them when the fastener is closed, indicating that the leaflet tissue has reached the minimum desired engagement depth and horizontal position along the fastener. If the leaflet is not centered over the wire indicator when the fastener is closed, the wire indicator 1031 retains its bump shape and passes through an opening 6730 on the movable arm of the fastener. As shown, two optional radiopaque indicating elements 1030 are spaced apart to indicate that the leaflets are engaged.

[0172] 104D and 106D, schematic diagrams of exemplary embodiments of a fastener (shown as a barbed fastener) for use in an implantable prosthetic device (such as, but not limited to, the exemplary embodiment shown in FIG. 103D having a flexible indicator 1031 with a bump configuration) are shown. The flexible indicator can be a wire indicator. Also, in some exemplary embodiments, the indicator 1031 can be laser cut and attached to one of the arms or integrally formed with one of the arms. The indicator 1031 can have an optional radiopaque indicator element 1030 attached to or wrapped around it. For example, the radiopaque indicator can be a coil made of a radiopaque material wrapped around at least a portion of a wire. The movable arm 5230 can also have an optional radiopaque indicator element 1030 thereon. FIG. 106D illustrates a schematic side view of the embodiment shown in FIG. 104D. In Figures 104D and 106D, the fastener is in the open position and the indicator 1031 has a bump configuration in which the bump extends into the fastener toward where the leaflet will be inserted.

[0173] 108D , when the movable arm 5230 is actuated to press the leaflets 42, 44 against the fixed arm 5210, the leaflets 42, 44 may contact a portion of the fixed arm 5210 and a portion of the movable arm 5230 without contacting the wire indicator 1031 when the engagement depth of the leaflets 42, 44 is less than the minimum engagement depth. When the catch is closed and the leaflets are not at the minimum engagement depth or are not present in the catch at all, the wire indicator 1031 may at least partially flatten and deform due to the pressure applied thereto by the movable arm. In some exemplary embodiments, the wire indicator 1031 may be attached to the movable arm and be partially flattened by the pressure applied thereto by the fixed arm. As shown, two optional radiopaque indicating elements 1030 become adjacent to each other, providing an indication that the leaflets have not been engaged.

[0174] 109D, the wire indicator 1031 deforms and flattens against the leaflets as the native leaflet tissue presses against them when the fasteners are closed, indicating that the leaflet tissue has reached the minimum desired engagement depth and horizontal position along the fasteners. As shown, two optional radiopaque indicating elements 1030 are spaced apart to indicate that the leaflets are engaged.

[0175] 104E and 106E, schematic diagrams of exemplary embodiments of a fastener (shown as a barbed fastener) for use in an implantable prosthetic device are shown having a flexible indicator 1031 with a bump configuration connected to the fixed arm 5210 and an opening 6730 in the movable arm 5230. The flexible indicator can be a wire indicator. In some exemplary embodiments, the flexible indicator can be laser cut and attached to the arm. The indicator 1031 can have an optional radiopaque indicator element 1030 attached to or wrapped around it. For example, the radiopaque indicator can be a coil made of a radiopaque material wrapped around at least a portion of a wire. The movable arm 5230 has an opening 6730 therein and can also have an optional radiopaque indicator element 1030 on a side arm of its frame. FIG. 106E illustrates a schematic side view of the embodiment shown in FIG. 104E. In Figures 104E and 106E, the fastener is in the open position and the indicator 1031 has a bump configuration in which the bump extends inward into the fastener toward where the valve leaflet will be inserted.

[0176] 108E , when the movable arm 5230 is actuated to press the leaflets 42, 44 against the fixed arm 5210, the leaflets 42, 44 may contact a portion of the fixed arm 5210 and a portion of the movable arm 5230 without contacting the indicator 1031 when the engagement depth of the leaflets 42, 44 is less than the minimum engagement depth. When the fastener is closed and the leaflets are not at the minimum engagement depth or are not present in the fastener at all, the indicator 1031 remains unflattened or is only partially flattened, and the indicator 1031 can move into or pass through the opening 6730 in the movable arm when the leaflet is not properly inserted into the fastener. As shown, the optional radiopaque indicating element 1030 becomes aligned as the indicator 1031 moves into the opening in the movable arm, providing an indication that the leaflet has not been engaged.

[0177] 109E, the wire indicators 1031 deform and flatten against the leaflets as the native leaflet tissue presses against them when the fasteners are closed, indicating that the leaflet tissue has reached a minimum desired engagement depth within the fasteners. As shown, two optional radiopaque indicating elements 1030 are spaced apart to indicate that the leaflets have been engaged.

[0178] 226-229 illustrate a variation of the fastener 4400 illustrated by FIGS. 48-66. In the example illustrated by FIGS. 226-229, the fastener includes a flexible wire indicator 1031 extending longitudinally across a hoop-shaped movable arm 4430. One end of the flexible wire indicator 1031 is attached at or near the bend or hinge portion 4420 (see FIG. 227), and the other end of the wire is attached at the opposite end of the movable arm 4430, between the barbs 4444. The fastener 4400 may be used in an implantable prosthetic device (such as, for example, devices 100, 200, 300 described above or any other implantable prosthetic device).

[0179] The fastener 4400 illustrated by FIGS. 226-229 includes a fixed arm 4410, a patterned bend or hinge portion 4420, a movable arm 4430 formed in the shape of a hoop or loop, and a barbed portion 4440 of the movable arm 4430 (although other friction-enhancing portions may be used). In this embodiment, the leaflet depth indicator may be a flexible feature, which may be a wire indicator 1031, which remains flat in a straight configuration when the fastener is open and when there are no leaflets positioned over it in the closed fastener. When a leaflet is present, the wire indicator 1031 is pressed through the hoop-shaped movable arm 4430. An optional radiopaque coil 1030 may be wrapped around the indicating wire 1031 and may be viewed using imaging techniques such as fluoroscopy. When the indicating wires and coils are visible outside the movable arms 4430 of the fastener, the amount of visible indicating arms 1031 and / or coils 1030 indicates to the operator the depth of the leaflet.

[0180] Fastener 4400 can include any or a combination of features of the other fasteners described herein. Fastener 4400 can be laser cut from a flat sheet or tube of a shape memory alloy (e.g., Nitinol, etc.) and then shape-set into the desired shape.

[0181] The fixation arm 4410 shown has two tongue portions 4411, each including an optional hole 4412 for attaching the fixation arm 4410 to an implantable device.

[0182] The flex or hinge portion 4420 can take a wide variety of different forms. In the illustrated example, the flex or hinge portion 4420 is formed from a plurality of spring segments 4422 and cutouts 4424. A tongue portion 4411 of the fixed arm 4410 extends from one end of the patterned flex or hinge portion 4420, and a movable arm 4430 extends from the other end of the flex or hinge portion 4420.

[0183] The movable arm 4430 of the fastener 4400 has a hoop-like shape. The hoop-shaped movable arm 4430 includes side beams 4432 that are thinner and more flexible, particularly laterally. The side beams 4432 include a first bend or hinge portion 4434 located toward the proximal end of the movable arm 4430 and a second bend or hinge portion 4436 located at the distal end of the movable arm 4430. The first bend or hinge portion 4434 is formed by one or more bends in the side beam 4432. The hoop shape of the movable arm 4430 and the flexible side arms 4432 allows the movable arm 4430 to be collapsed by simply retracting the fastener 4400 into a delivery sheath (not shown).

[0184] The hoop-like shape of the movable arm 4430 provides a wider barbed portion 4440, which can include more barbs 4442 with the same or greater lateral spacing than other fasteners. Wider spacing of the barbs 4442 improves capture of the native valve leaflets. Additionally, the barbs 4442 are optionally longitudinally offset as a result of their location on the hoop-like shape of the movable arm 4430. That is, the two middle barbs 4444 are positioned further away from the flexion or hinge portion 4420, and the two outer barbs 4446 are positioned closer to the flexion or hinge portion 4420. The barbed portion 4440 of the movable arm 4430 also includes optional holes 4448 for receiving an actuating suture (not shown). In certain embodiments, the hoop shape of the movable arm 4430 is similar to the shape of the wide outer paddle of the implantable device so that the pinching force of the paddle is evenly distributed over the barbs, further improving retention of the native valve leaflets. The ends of the barbs 4442 may be further sharpened using any suitable sharpening means.

[0185] 226 and 227, the catch 4400 is shown in the open position. The movable arm 4430 is biased or spring loaded in a closing direction and is moved to and held in the open position by tension applied to an actuation line (not shown). The indicating wire 1031 is in a straight, unflexed configuration because there are no leaflets engaged in the open catch in FIGS. 226-227.

[0186] 228, the fastener 4400 is shown in a fully deployed or actuated position with no leaflets in place. The indicating wire 1031 with optional radiopaque coil 1030 remains unflexed and is positioned on the interior side of the movable arm 4430 and / or does not extend beyond the outer profile of the movable arm 4430. The indicating wire 1031 and coil 1030 are not visible outside the profile of the movable arm 4430. The absence of the indicator arm outside the profile of the fastener 4400 by the imaging equipment indicates to the operator that no leaflets have been captured.

[0187] 229 , the fastener 4400 is shown with the movable arm 4430 in a closed position. When the fastener 4400 is closed, the movable arm 4430 and the indicator arm 4450 exert a pinching force that holds the native leaflet tissue secured within the fastener 4400. The fastener 4400 is biased toward closure by the configuration of the movable arm 4430 in the preloading position. The closed fastener has captured a sufficient amount of leaflet tissue, i.e., the depth of the leaflets within the fastener is sufficient for the fastener to be considered properly positioned, as indicated by the indicating wire 1031 and coil 1030 being deflected through the opening in the hoop-shaped movable arm, allowing a portion of the indicating wire 1031 and / or coil 1030 to move through the outer profile of the movable arm 4430 of the fastener 4400. The indicating wire 1031 and / or coil 1030 beyond the profile of the fastener can be seen on an imaging device (e.g., an X-ray fluoroscopy device), as shown in FIG. 229, to indicate that the valve leaflet has been properly captured by the fastener 4400.

[0188] 230-233 illustrate a variation of the fastener 4400 illustrated by FIGS. 48-66. In the example illustrated by FIGS. 230-233, the fastener includes a flexible wire indicator 1031 extending horizontally across a hoop-shaped movable arm 4430. Each end of the wire is attached to a side arm 4432 of the movable arm 4430. The wire indicator 1031 may be positioned anywhere to indicate proper insertion of the native valve leaflet. In one exemplary embodiment, the wire indicator is positioned closer to the bend or hinge region of the fastener than the barbed region. The fastener 4400 may be used in an implantable prosthetic device (such as, for example, devices 100, 200, 300 described above or any other implantable prosthetic device).

[0189] The fastener 4400 illustrated by FIGS. 230-233 includes a fixed arm 4410, a patterned bend or hinge portion 4420, a movable arm 4430 formed in the shape of a hoop or loop, and a barbed portion 4440 of the movable arm 4430. In this embodiment, the leaflet depth indicator can be a flexible feature, which can be a wire indicator 1031, which remains flat in a straight configuration when the fastener is open and when there are no leaflets positioned over it in the closed fastener. When a leaflet is present, the wire indicator 1031 is pressed through the hoop-shaped movable arm 4430. An optional radiopaque coil 1030 can be wrapped around the indicating wire 1031 and can be viewed using imaging techniques such as fluoroscopy. When the indicating wires and coils are visible outside the movable arms 4430 of the fastener, the amount of visible indicating arms 1031 and / or coils 1030 indicates to the operator the depth of the leaflet.

[0190] 230 and 231, the catch 4400 is shown in the open position. The movable arm 4430 is biased or spring loaded in a closing direction and is moved to and held in the open position by tension applied to an actuation line (not shown). The indicating wire 1031 is in a straight, unflexed configuration because there are no leaflets engaged in the open catch in FIGS. 230 and 231.

[0191] 232, the fastener 4400 is shown in a fully deployed or actuated position with no leaflets in place. The indicating wire 1031 with optional radiopaque coil 1030 remains unflexed and is positioned on the interior side of the movable arm and / or does not extend beyond the outer profile of the movable arm 4430. The indicating wire 1031 and coil 1030 are not visible outside the profile of the movable arm 4430 in FIG. 232. The absence of the indicator arm outside the profile of the fastener 4400 by the imaging equipment indicates to the operator that no leaflets have been captured.

[0192] 233 , the fastener 4400 is shown with the movable arm 4430 in a closed position. When the fastener 4400 is closed, the movable arm 4430 and the indicator arm 4450 exert a pinching force that holds the native leaflet tissue secured within the fastener 4400. The fastener 4400 is biased toward closure by the configuration of the movable arm 4430 in the preloading position. The closed fastener has captured a sufficient amount of leaflet tissue, i.e., the depth of the leaflets within the fastener is sufficient for the fastener to be considered properly positioned, as indicated by the indicating wire 1031 and coil 1030 being deflected through the opening in the hoop-shaped movable arm, allowing a portion of the indicating wire 1031 and / or coil 1030 to move through the outer profile of the movable arm 4430 of the fastener 4400. The indicating wire 1031 and / or coil 1030 beyond the profile of the fastener can be seen on an imaging device (e.g., an X-ray fluoroscopy device), as shown in FIG. 233, to indicate that the valve leaflet has been properly captured by the fastener 4400.

[0193] FIGS. 234-237 illustrate variations of the fastener 4400 illustrated by FIGS. 48-66. In the example illustrated by FIGS. 234-237, the fastener includes a flexible wire indicator 1031 extending longitudinally across a hoop-shaped movable arm 4430. One end of the flexible wire indicator 1031 is attached near the bend or hinge portion 4420. The other end of the wire is attached to a cross wire 1033 extending horizontally across the opening of the movable arm 4430. The cross wire 1033 may be positioned across the middle of the movable arm, closer to the barbed end than the bend or hinge portion, or closer to the bend or hinged portion than the barbed portion, depending on the minimum leaflet insertion depth. The cross wire 1033 may be replaced with a laser-cut sheet component, which may be integrally formed with the fastener or may be a separate piece attached to the fastener. The fastener 4400 may be used in an implantable prosthetic device (such as, for example, devices 100, 200, 300 described above or any other implantable prosthetic device).

[0194] The fastener 4400 has a fixed arm 4410, a patterned bend or hinge portion 4420, a movable arm 4430 formed in the shape of a hoop or loop, and a barbed portion 4440 of the movable arm 4430. In this embodiment, the leaflet depth indicator can be a flexible wire 1031 that remains flat in a straight configuration when the fastener is open and when there are no leaflets positioned against it in the closed fastener. When a leaflet is present, the wire indicator 1031 is pressed through the hoop-shaped movable arm 4430. An optional radiopaque coil 1030 can be wrapped around the indicating wire 1031 and can be viewed using imaging equipment such as fluoroscopy. When the fastener is closed over a leaflet that has been inserted sufficiently deep into the fastener, the indicating wire 1031 and coil 1030 extend past the outer periphery or edge of the movable arm 4430 of the fastener 4400. The amount of the indicating arm 1031 and coil 1030 that is exposed past the periphery or outer edge of the movable arm 4430 indicates to the operator the depth of the leaflet.

[0195] 234 and 235, the catch 4400 is shown in the open position. The movable arm 4430 is biased or spring loaded in a closing direction and is moved to and held in the open position by tension applied to an actuation line (not shown). The indicating wire 1031 is in a straight, unflexed configuration because there are no leaflets engaged in the open catch in FIGS. 234 and 235.

[0196] 236, the fastener 4400 is shown in a fully deployed or actuated position with no leaflets in place. The indicating wire 1031 with optional radiopaque coil 1030 remains unflexed and is positioned on the interior side of the movable arm 4430. The indicating wire 1031 and coil 1030 are not visible outside the profile of the movable arm 4430. The absence of the indicator arm outside the profile of the fastener by the imaging equipment indicates to the operator that no leaflets have been captured.

[0197] 237 , the fastener 4400 is shown with the movable arm 4430 in a closed position. When the fastener 4400 is closed, the movable arm 4430 and the indicator arm 4450 exert a pinching force that holds the native leaflet tissue secured within the fastener 4400. The fastener 4400 is biased toward closure by the configuration of the movable arm 4430 in the preloading position. The closed fastener has captured a sufficient amount of leaflet tissue; that is, the depth of the leaflet within the fastener is sufficient for the fastener to be considered properly positioned, as indicated by the indicating wire 1031 and coil 1030 being deflected through the hoop-shaped movable arm 4430, allowing a portion of the indicating wire 1031 and / or coil 1030 to move through the outer profile of the movable arm 4430 of the fastener 4400. The indicating wire 1031 and / or coil 1030 beyond the profile of the fastener can be seen on an imaging device (e.g., an X-ray fluoroscopy device), as shown in FIG. 237, to indicate that the valve leaflet has been properly captured by the fastener 4400.

[0198] FIGS. 238-241 illustrate a variation of the fastener 4400 illustrated by FIGS. 48-66. In the example illustrated by FIGS. 238-241, the fastener has a flexible wire indicator 1031 that loops multiple times through an opening 2380 in the side beams 4432 of the movable arm 4430. The flexible wire indicator 1031 is "braided" or strung through the opening 2380. In the illustrated embodiment, the wire indicator 1031 passes across the hoop shape of the movable arm and includes an inner portion 1031a of the fastener and an outer portion 1031b of the movable arm 4430. The wire indicator portion 1031a is curved and extends inward toward the interior of the fastener. In the illustrated example, the outer portion 1031b of the movable arm extends straight or substantially straight across between the side beams 4432 when the fastener is open. However, in some exemplary embodiments, portion 1031b can have the same or substantially the same shape as portion 1031a. Fastener 4400 can be used in an implantable prosthetic device (such as, for example, devices 100, 200, 300 described above or any other implantable prosthetic device).

[0199] The fastener 4400 illustrated in FIGS. 238-241 includes a fixed arm 4410, a patterned bend or hinge portion 4420, and a movable arm 4430 formed in the shape of a hoop or loop. In the illustrated embodiment, the inner curved portion 1031a is curved in a bump configuration, and the outer portion 1031b is flattened or substantially flat and positioned immediately outside the movable arm 4430 when the fastener 4400 is open and when no leaflets are positioned to overlap the indicator when the fastener is closed. In the illustrated example, there are four inner portions 1031a and three outer portions 1031b. However, any number of inner and outer portions can be present. For example, there can be only one or two of each, or as many as eight to ten of each.

[0200] 241, when a leaflet is present, the inner curved portion 1031a of the wire indicator 1031 is depressed, pushing portions 1031b outward against the movable arm 4430. The number of portions 1031b that are pushed out from the movable arm 4430 indicates to the operator the depth of the leaflet.

[0201] 238 and 239, the catch 4400 is shown in the open position. The movable arm 4430 is biased or spring loaded in a closing direction and is moved to and held in the open position by tension applied to an actuation line (not shown). The indicating wire 1031 is in an unflexed configuration because there are no leaflets engaged in the open catch in FIGS. 238 and 239.

[0202] 240, the fastener 4400 is shown in a fully deployed or actuated position with no leaflets in place. The indicating wire 1031 remains undeflected, the inner portion 1031a remains positioned on the inner side of the fixed arm, and the outer portion 1031b is flush or substantially flush with the movable arm 4430. On imaging equipment, the absence of the outer portion 1031b extending outward from the movable arm 4430 indicates that no leaflets have been captured.

[0203] Referring now to FIG. 241 , the fastener 4400 is shown with the movable arm 4430 in a closed position. When the fastener 4400 is closed, the movable arm 4430 exerts a pinching force that holds the native leaflet tissue within the fastener 4400. The fastener 4400 is biased toward closure by the configuration of the movable arm 4430 in the preloading position. The closed fastener captures a sufficient amount of leaflet tissue; that is, the depth of the leaflets within the fastener is sufficient for the fastener to be considered properly positioned. The indicating wire 1031 is deflected such that the portion 1031b extends outward from the movable arm 4430. The outwardly extending portion 1031b can be viewed using imaging equipment such as fluoroscopy. That is, the inner portion 1031a is forced towards the movable arm 4430 by the pressure applied by the leaflets, thereby causing the outer portion 1031b to extend further outward from the movable arm 4430 of the catch.

[0204] In embodiments described herein, including but not limited to those described in Figures 226-241, the indicator can be a coil over a wire; a flexible superelastic member with an optional embedded radiopaque marker; a protruding member from the fastener body arising from the bend or hinge region cut from the same continuous sheet as the fastener; and / or a V-shaped radiopaque marker positioned near the bend or hinge region of the fastener. The indicator can be made from a superelastic or flexible material; i.e., the material does not undergo plastic deformation upon leaflet capture.

[0205] Referring now to FIG. 110, a portion of an exemplary embodiment of a laser-cut fastener is illustrated. Similar to the embodiment illustrated in FIG. 103, the fastener has a movable arm 5230, a fixed arm 5210, and one or more flexible segments to allow molding and bending of the laser-cut sheet into the fastener shape. The movable arm can have a barb 5240 at its end. The fixed arm can have three elongated cutouts and two flexible bumps 1031 that serve as indicators. FIG. 105, described above, is a schematic diagram corresponding to an embodiment having two flexible bumps 1031, such as that of FIG. 110. Accordingly, FIGS. 106-109 also depict the operation of the embodiment illustrated in FIG. 110 when positioned and deployed over a native valve leaflet.

[0206] 111-122, which illustrate a variation of the fastener 4400 illustrated by FIGS. 48-66 that has flexibility features, such as the illustrated bump 1031, that flatten when pressed against leaflet tissue. The fastener 4400 may be used in an implantable prosthetic device (e.g., devices 100, 200, 300, etc., as described above). The fastener 4400 has a fixed arm 4410, a patterned flex portion or patterned hinge portion 4420, a movable arm 4430 formed in the shape of a hoop or loop, and a barbed portion 4440 of the movable arm 4430. The fastener 4400 also includes an indicator arm 4450 extending from an indicator flex portion or hinge portion 4460, which couples the indicator arm to the flex portion or hinge portion 4420. In this embodiment, the indicator arm 4450 can have a flexible feature, which can be a bump 1031 that flattens when pressed against the leaflet tissue. The fastener 4400 can be used in any of the implantable prosthetic devices of the present application and can include any or a combination of features of the other fasteners described herein. The fastener 4400 can be laser cut from a flat sheet or tube of a shape memory alloy (such as, for example, Nitinol) and then shape-set into the desired shape.

[0207] The illustrated fixation arm 4410 has two tongue portions 4411, each including an optional hole 4412 for attaching the fixation arm 4410 to an implantable device. A central opening 4454 disposed between the tongue portions 4411 is wider than the indicator arm 4450, allowing the indicator arm 4450 to pass through the fixation arm 4410 between the tongue portions 4411 and form an X-shape when viewed from the side ( FIG. 106 ) when the indicator arm 4450 is not engaged with leaflet tissue.

[0208] The patterned flexure or patterned hinge portion 4420 is formed from a plurality of spring segments 4422 and cutouts 4424. The two tongue portions 4411 of the fixed arm 4410 extend from one end of the patterned flexure / hinge portion 4420, and the movable arm 4430 extends from the other end of the flexure / hinge portion 4420.

[0209] The movable arm 4430 of the fastener 4400 has a hoop-like shape. The hoop-shaped movable arm 4430 includes side beams 4432 that are thinner and more flexible, particularly laterally. The side beams 4432 include a first bend or hinge portion 4434 located toward the proximal end of the movable arm 4430 and a second bend or hinge portion 4436 located at the distal end of the movable arm 4430. The first bend or hinge portion 4434 is formed by one or more bends in the side beam 4432. The second bend or hinge portion 4436 includes a thinner (and therefore more flexible) portion, reducing the force required to collapse the fastener 4400. The hoop shape of the movable arm 4430 and flexible side arm 4432 allows the movable arm 4430 to be collapsed by simply retracting the fastener 4400 into a delivery sheath (not shown). In certain embodiments, the expansion and contraction of the fastener 4400 is controlled by an actuation line (not shown).

[0210] The hoop-like shape of the movable arm 4430 provides a wider barbed portion 4440, which can include more barbs 4442 with the same or greater lateral spacing than other fasteners. The wider spacing of the barbs 4442 improves capture of the native valve leaflets. The barbs 4442 are also longitudinally offset as a result of their location on the hoop-like shape of the movable arm 4430. That is, the two middle barbs 4444 are positioned further away from the flexion or hinge portion 4420, and the two outer barbs 4446 are positioned closer to the flexion or hinge portion 4420. The barbed portion 4440 of the movable arm 4430 also includes holes 4448 for receiving an actuating suture (not shown). In certain embodiments, the hoop shape of the movable arm 4430 is similar to the shape of the wide outer paddle of the implantable device so that the pinching force of the paddle is evenly distributed over the barbs, further improving retention of the native valve leaflets. The ends of the barbs 4442 may be further sharpened using any suitable sharpening means.

[0211] The indicator arm 4450 includes a beam 4451 that extends from an internal bend or hinge portion 4420 of the hoop-shaped movable arm 4430 between the two side arms 4432 to a barbed portion 4456. The indicator arm 4450 includes a hole 4452 at its end for receiving an actuation line (not shown) for actuating the indicator arm 4450. The optional barbed portion 4456 is disposed at the end of the beam 4451 of the indicator arm 4450 and includes at least one barb 4456 (when the optional barbed portion is included). The optional barbed portion 4456 helps the indicator arm 4450 anchor the valve leaflets until the movable arm 4430 is closed. The optional barb 4456 may be laser cut from the indicator arm 4450 and bent outward so that it projects away from the indicator arm 4450 at approximately the same angle that the barb 4442 projects from the movable arm 4430. In some embodiments, the indicator arm 4450 includes a barb that is cut from a flat sheet of material, similar to the barb 2244 of the fastener 2200, and then rotated approximately 90 degrees to project outward at the angle.

[0212] The optional barbed portion 4456 of the indicator arm 4450 is positioned a predetermined distance from the bend or hinge portion 4420 such that the barbs 4456 of the indicator arm 4450 are longitudinally positioned between the central barbs 4444 and the outer barbs 4446 of the barbed portion 4440. This positioning ensures that the barbed portion 4440 will engage the leaflet being engaged by the indicator arm 4450. That is, when the indicator arm 4450 is actuated, if a native valve leaflet positioned in the fastener 4400 is engaged by the barbed portion 4456 of the indicator arm 4450, the leaflet will also be engaged by the barbed portion 4440 of the movable arm 4430.

[0213] In the exemplary embodiment illustrated by FIGS. 111-122, when the native leaflet is properly positioned and engaged within the fastener, the bump 1031 will flatten, indicating proper depth placement of the leaflet. The opposite is also true: if the native leaflet is not properly positioned within the fastener 4400 (i.e., not positioned far enough), the bump 1031 will not flatten when the indicator arm 4450 is actuated. The bump 1031 can be positioned along the indicator arm at a location within the fastener that indicates the distance within the fastener that the native leaflet must extend to be properly positioned. Thus, the exemplary embodiment illustrated by FIGS. 111-122 provides two indications. First, any engagement of the leaflet with the barbs on the indicator arm indicates that the barbs 4444, 4446 also engage the leaflet (but does not indicate proper insertion depth). Second, compression or flattening of the bump 1031 indicates proper leaflet insertion.

[0214] The indicator flex or hinge portion 4460 allows the indicator arm 4450 to be actuated separately from the movable arm 4430, facilitating detection of the depth of engagement of a native valve leaflet disposed between the movable arm 4430 and the fixation arm 4410 of the fastener 4400. The indicator flex or hinge portion 4460 can be similar to the patterned flex or hinge portion 4420 and can be formed from a series of spring segments 4462 and cutouts 4464. In some embodiments, the spring force of the indicator flex or hinge portion 4460 is less than the pinching force imparted to the movable arm 4430 by the flex or hinge portion 4420, allowing the indicator arm 4450 to be actuated multiple times to detect the position of the valve leaflet, while the movable arm 4430, which has a stronger pinching force, is actuated once the leaflet is held in the desired position by the indicator arm 4450. The lower pinching force of the indicator arm 4450 reduces the force exerted on the leaflet tissue, allowing the indicator arm 4450 to be repeatedly repositioned and less likely to puncture or otherwise damage the leaflet tissue. The lower pinching force can also allow the indicator arm 4450 to pulse or jump as the heart beats.

[0215] 111-113, the catch 4400 is shown in the open position. The movable arm 4430 and the indicator arm 4450 are biased or spring loaded in a closing direction and are moved to and held in the open position by tension applied to actuation lines (not shown) which may be attached to holes 4448, 4452 in each of the movable arm 4430 and the indicator arm 4450. The bump 1031 is in its curved bump configuration because there are no leaflets engaged in the open catch of FIGS. 111-113.

[0216] 114-116, the fastener 4400 is shown with the indicator arm 4450 in a fully deployed or actuated position (i.e., the furthest reach the indicator arm 4450 can reach when it is not engaging the valve leaflet tissue during actuation). When tension on the actuation line (not shown) is reduced, the indicator arm 4450 is permitted to actuate in the closing direction. In the fully actuated position, the indicator arm 4450 forms an X-shape with the locking arm 4410, which is visible via an imaging device, allowing the operator to know that the indicator arm 4450 is not engaged with any valve leaflets. Because the leaflets are not engaged in the fastener of FIG. 114, the bump 1031 is also in its curved configuration.

[0217] 117-119, the fastener 4400 is shown with the indicator arm 4450 in the engaged or closed position, i.e., the position the indicator arm 4450 will be in when leaflet tissue is engaged during actuation. When tension on the actuation line (not shown) is reduced, the indicator arm 4450 is permitted to actuate in the closing direction. In the closed position, the indicator arm 4450 does not cross the fixation arm 4410 and does not form an X-shape with the fixation arm 4410. In the closed position, the leaflet is only partially inserted into the fastener, and therefore the bump 1031 on the indicator arm 4450 retains its curved configuration rather than being flattened. Thus, the operator knows that the leaflet tissue is engaged but not yet positioned far enough into the fastener to be considered properly positioned.

[0218] 120-122, the fastener 4400 is shown with both the movable arm 4430 and the indicator arm 4450 in the closed position. When the fastener 4400 is closed, the movable arm 4430 and the indicator arm 4450 exert a pinching force that holds the native leaflet tissue secured within the fastener 4400. The fastener 4400 is biased in the closed direction by the configuration of the movable arm 4430 and the indicator arm 4450 in the preloading position. The closed fastener has captured a sufficient amount of leaflet tissue, i.e., the depth of the leaflet within the fastener is sufficient for the fastener to be considered properly positioned, as indicated by the flattening of the bump 1031 on the indicator arm. In FIGS. 120-122, the portion of the indicator arm bearing the bump 1031 is not visible. This is because the leaflets block the view of that portion of the indicator arm and also because the bumps are flattened by engagement with the leaflets.

[0219] 67A-68A, an exemplary embodiment of a laser-cut fastener 4400 is illustrated. FIG. 67 illustrates a flattened view of a portion of the laser-cut fastener 4400 having a movable arm 4430, a fixed arm 4410, and an indicator arm 4450. In the example illustrated by FIGS. 67 and 68, a portion of the paddle 6720 is optionally also formed from the same piece of material as the fastener 4400. However, in some embodiments, only the fastener is cut from the piece of material, and the paddle portion 6720 is omitted. The movable arm can have a cutout section 6730 and a barb 4440 at its free end for anchoring to the tissue of the native valve leaflet. The fastener can have flexible sections where bending of the fastener into a usable shape occurs. The flexible sections can each be hinged, jointed, and / or otherwise flexible. There is a flexible or hinged portion 4460 that allows the indicator arm to flex. There is also a flex or hinge portion 4420 that allows dynamic bending of the movable arm 4430 relative to the fixed arm 4410. An optional flex or hinge portion 4470 allows bending between the fixed arm 4410 and the optional paddle portion 6720. The catch can also have an optional foot 6710 that extends outward from the side of the catch near the flexible portion 4420 between the movable and fixed arms. The foot 6710 can lock into a bushing-type collar (not shown) or another connector. The connector can be attached to a spacer that interfaces with the native mitral valve leaflets. The catch can be configured such that its resting configuration has the indicator arm 4450 extending through or toward the opening 6730 in the movable arm 4430.

[0220] FIG. 68 illustrates the fastener 4400 in a partially open configuration. The fastener can be oriented to capture a leaflet. When the leaflet is inserted to a predetermined allowable depth, the leaflet depresses the indicator arm 4450. The depression or flattening of the indicator arm 4450 indicates that a sufficient amount of the leaflet is disposed within the fastener. Once a sufficient amount of the leaflet is within the fastener, the fastener can be closed to capture the leaflet. In the example illustrated by FIG. 68, the indicator arm 4450 extends in a direction opposite or substantially opposite the movable fastener arm 4430. FIG. 68 also illustrates an optional suture loop 6810 through which and / or through which a suture or other actuation line can pass and / or connect to actuate the fastener.

[0221] The indicator arm has a flexible or hinged section 4460 to allow for flexing of the fastener. The indicator can pass through an opening 6730 in the movable arm when no captured leaflet is present (see FIG. 67). When a captured leaflet is present in the fastener, the indicator arm 4450 can rest on the leaflet. The length and / or position of the indicator can be selected to represent the minimum capture depth required for the device. The optional integral paddle 6720 can be used to approximate the leaflet and / or can be configured to allow for extension of the laser-cut paddle. The flex or hinge regions 4420, 4470, and 4460 allow for shaping in a desired shape and / or facilitate relative flexing of the movable fastener portion, fixed fastener portion, indicator arm, and / or paddle portion 6720.

[0222] 67A and 68A, an exemplary embodiment of a fastener similar to that of FIGS. 67 and 68 is illustrated. FIG. 67A illustrates that an indicator arm 4450 is connected to a movable arm 4430 at a flex or hinge region 4460. As shown in FIG. 68A, when no leaflets are present and the fastener is not yet closed, the indicator arm flexes toward the interior region of the fastener. When the fastener is closed, the indicator arm 4450 can pass through an opening 6740 in the fixed arm when no leaflets are positioned deep enough into the fastener to engage the indicator arm 4450. When a leaflet is positioned deep enough into the fastener to engage the indicator arm, the indicator arm can flex at the flexible or hinged region 4460 toward and through the opening 6730 in the movable arm 4430.

[0223] 69, a portion of an exemplary laser-cut fastener 4900 is illustrated. The laser-cut fastener has a movable arm 4930, a barbed portion 4940, and three indicator arms 4954, 4956, and 4958. The fixed arm of fastener 4900 is not shown in FIG. 69. The fixed arm may be included, as in other embodiments described herein, or the fixed arm may be omitted in any of the embodiments, and the movable arm may extend from and / or be connected to the spacer or paddle.

[0224] Similar to the exemplary embodiment described above in Figures 67-68, there are flexible sections of the laser-cut sheet that allow the movable arms to be shaped and / or form flexible or hinged portions 4920, 4960 that allow the movable arms and / or indicator arms to bend. The multiple indicators and movable arms in the embodiment illustrated in Figure 69 are all cut from a single sheet. The indicators can be cut from a single sheet, which does not require the indicators to be individually attached to the movable arms.

[0225] 70-71 and 70A-71A schematically illustrate examples of how the movable arm with indicator of FIG. 69 can be used in fastener 4900. FIGS. 70-71 and 70A-71A illustrate that indicators having very different physical constructions can operate in the same or substantially the same manner. In the example of FIGS. 70A and 71A, movable fastener arm 4930 and each of indicators 4952, 4954, 4956, 4958 are elongated and positioned adjacent to one another. In the example of FIGS. 70 and 71, movable fastener arm 4930 is disposed around indicators 4954, 4956, 4958, indicator 4954 is disposed around indicators 4956, 4958, and indicator 4956 is disposed around indicator 4958. The fasteners illustrated by the schematic illustrations of Figures 70-75 can be (but are not required to be) laser cut from a flat sheet.

[0226] 70-71 , an exemplary fastener 4900 (illustrated as a barbed fastener) for use in an implantable prosthetic device (such as devices 100, 200, 300 described above) is shown. Similar to fastener 3500 described above, fastener 4900 includes a fixed arm 4910, a bent or hinged portion 4920, and a movable arm 4930 having a barbed portion 4940 (although other friction-enhancing portions may also be used). Fastener 4900 may be used in any of the implantable prosthetic devices of the present application and may include any or combination of features of the other fasteners described herein.

[0227] The fastener 4900 also includes an indicator portion 4950 formed from first, second, and third indicator arms 4954, 4956, 4958 adjacent the movable arm 4930 and each extending from an indicator flex or hinge portion 4960. The indicator flex or hinge portion 4960 allows the indicator arms 4954, 4956, 4958 to be actuated individually and separately from the movable arm 4930. The indicator flex or hinge portion 4960 may be formed from a portion of the indicator arms 4954, 4956, 4958, may be formed from a series of cutouts, and / or the indicator flex or hinge portion 4960 can be part of the flex or hinge portion 4920.

[0228] The indicator arms 4954, 4956, 4958 can be actuated separately from the movable arm 4930 and optionally each other to facilitate detection of the depth of engagement of the native valve leaflets between the movable arm 4930 and the fixation arm 4910 of the fastener 4900. In some exemplary embodiments, the indicator arms 4954, 4956, 4958 release from the valve tissue in unison (i.e., release or retraction of one indicator arm releases or retracts all of the indicator arms). In the illustrated embodiment, the indicator arms 4954, 4956, 4958 are narrower than the movable arm 4930 and each have a length that is less than the distance from the flexion or hinge portion 4920 to the barbed portion 4940. The first indicator arm 4954 can have a length that is about 75 to about 100 percent of the distance between the flexion or hinge portion 4920 and the barbed portion 4940. The second indicator arm 4956 can have a length that is about 65 to about 95 percent of the distance between the bend or hinge portion 4920 and the barbed portion 4940. The third indicator arm 4958 can have a length that is about 50 to about 80 percent of the distance between the bend or hinge portion 4920 and the barbed portion 4940. In some embodiments, the first indicator arm 4954 has a length that is about 60 to about 100 percent of the distance between the bend or hinge portion 4920 and the barbed portion 4940. The second indicator arm 4956 has a length that is about 50 to about 75 percent of the distance between the bend or hinge portion 4920 and the barbed portion 4940. The third indicator arm 4958 has a length that is about 30 to about 60 percent of the distance between the bend or hinge portion 4920 and the barbed portion 4940. Any combination of indicator arm lengths can be used to provide an indication of the depth to which the leaflet is positioned within the fastener, so long as the length continues to decrease with each successive indicator arm. There can also be a fourth indicator arm (not shown).Any number of different indicator arms may be included.

[0229] The different lengths of the indicator arms 4954, 4956, 4958 are used to determine a desired minimum engagement depth as measured from the end of the movable arm 4930 of the fastener 4900. Configuring the length of the first indicator arm 4954 to be less than the distance from the bend or hinge portion 4920 to the barbed portion 4940 ensures that the barbed portion 4940 will engage a leaflet that is positioned at the minimum engagement depth as indicated by the first indicator arm 4954. That is, if a native valve leaflet positioned in the fastener 4900 is engaged by the first indicator arm 4954 when the first indicator arm 4954 is actuated, the leaflet will be engaged by the barbed portion 4940 of the movable arm 4930. The opposite is also true. That is, if the natural valve leaflet positioned in the fastener 4900 is not engaged by the first indicator arm 4954 when the first indicator arm is actuated, the leaflet is not sufficiently engaged by the barbed portion 4940 of the movable arm 4930.

[0230] The second and third indicator arms 4956, 4958 are configured with decreasing lengths to allow the surgeon to determine how far the native valve leaflet has inserted into the fastener 4900 beyond the minimum engagement depth. That is, whether the native valve leaflet is engaged by the second and third indicator arms 4956, 4958 indicates whether the native valve leaflet has reached the engagement depth measured by each of the second and third indicator arms 4956, 4958. For example, if a native valve leaflet positioned within the fastener 4900 is engaged by the third indicator arm 4958 when the third indicator arm 4958 is actuated, the leaflet has been inserted, for example, from about 50 percent to about 80 percent of the distance from the barbed portion 4940 to the flexion or hinge portion 4920. The opposite is also true. That is, if the native valve leaflet positioned in the fastener 4900 is not engaged by the third indicator arm 4958 when the third indicator arm 4958 is actuated, the leaflet has not reached approximately 50 percent of the distance between the barbed portion 4940 and the flexion or hinge portion 4920.

[0231] 70A-71A, an exemplary fastener 4900 for use in an implantable prosthetic device (e.g., devices 100, 200, 300, etc., described above) is shown. The barbed fastener 4900 includes a fixed arm 4910, a hinged portion 4920, and a movable arm 4930. The movable arm 4930 can include a barbed portion 4940 and / or some other friction-enhancing portion. The fastener 4900 can be used in any of the implantable prosthetic devices of the present application and can include any or a combination of features of the fasteners or barbed fasteners described herein.

[0232] The fastener 4900 also includes an indicator portion 4950 formed from first, second, third, and fourth indicator arms 4952, 4954, 4956, 4958 adjacent the movable arm 4930 and extending from an indicator hinge portion 4960. The indicator hinge portion 4960 allows the indicator arms 4952, 4954, 4956, 4958 to be actuated individually and separately from the movable arm 4930. The indicator hinge portion 4960 may be formed from a portion of the indicator arms 4952, 4954, 4956, 4958, or may be formed from a series of cutouts, similar to the patterned hinge of fastener 2100 described above.

[0233] The indicator arms 4952, 4954, 4956, 4958 can be actuated separately from the movable arm 4930 to facilitate detection of the depth of engagement of the native valve leaflets between the movable arm 4930 and the fixation arm 4910 of the fastener 4900. In the illustrated embodiment, the indicator arms 4952, 4954, 4956, 4958 are narrower than the movable arm 4930 and each have a length less than the distance from the hinge portion 4920 to the barbed portion 4940. In some embodiments, the first indicator arm 4952 has a length that is between about 75 percent and about 100 percent of the length of the distance between the hinge portion 4920 and the barbed portion 4940. In some embodiments, the second indicator arm 4954 has a length that is between about 65 percent and about 95 percent of the length of the distance between the hinge portion 4920 and the barbed portion 4940. In some embodiments, the third indicator arm 4956 has a length that is about 50 to about 80 percent of the length of the distance between the hinge portion 4920 and the barbed portion 4940. In some embodiments, the fourth indicator arm 4958 has a length that is about 35 to about 65 percent of the length of the distance between the hinge portion 4920 and the barbed portion 4940.

[0234] The different lengths of the indicator arms 4952, 4954, 4956, 4958 are used to determine a desired minimum engagement depth as measured from the end of the movable arm 4930 of the fastener 4900. In some embodiments, configuring the length of the first indicator arm 4952 to be less than the distance from the hinge portion 4920 to the barbed portion 4940 ensures that the barbed portion 4940 will engage a leaflet that is positioned at the minimum engagement depth as indicated by the first indicator arm 4952. That is, if a native valve leaflet positioned in the fastener 4900 is engaged by the first indicator arm 4952 when the first indicator arm 4952 is actuated, the leaflet will be engaged by the barbed portion 4940 of the movable arm 4930. The opposite is also true. That is, if the natural valve leaflet positioned in the fastener 4900 is not engaged by the first indicator arm 4952 when the first indicator arm 4952 is actuated, the leaflet is not sufficiently engaged by the barbed portion 4940 of the movable arm 4930.

[0235] The second, third, and fourth indicator arms 4954, 4956, 4958 are configured with decreasing lengths to allow the surgeon to determine how far the native valve leaflet has inserted into the fastener 4900 beyond the minimum engagement depth. That is, whether the native valve leaflet is engaged by the second, third, and fourth indicator arms 4954, 4956, 4958 indicates whether the native valve leaflet has reached the engagement depth measured by each of the second, third, and fourth indicator arms 4954, 4956, 4958. For example, in some embodiments, if a native valve leaflet positioned within the fastener 4900 is engaged by the third indicator arm 4956 when the third indicator arm 4956 is actuated, the leaflet has been inserted, for example, from about 50 percent to about 80 percent of the distance from the barbed portion 4940 to the hinge portion 4920. The opposite is also true. That is, when the third indicator arm 4956 is actuated, if the native valve leaflet positioned in the fastener 4900 is not engaged by the third indicator arm 4956, the leaflet has not reached approximately 50 percent of the distance between the barbed portion 4940 and the hinge portion 4920.

[0236] 72-74 schematically illustrate the fastener 4900 of FIGS. 70-71 (or FIGS. 70A-71A) deployed to anchor the native leaflets of a native valve (such as a native mitral valve). The exemplary fastener 4900 is shown deployed within the native valve 40 to anchor an implantable device (not shown) (such as devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 72, the fastener 4900 is shown in an open condition, with the native valve leaflets 42, 44 partially inserted into the opening 4906 of the fastener 4900 formed between the fixed arm 4910 and the movable arm 4930. To determine whether the leaflets 42, 44 have reached the desired engagement depth, the indicator arms 4954, 4956, 4958 are actuated either individually or all at once by one or more actuation lines (not shown in Figures 72-75), as shown in Figures 73 and 75.

[0237] 73 , the indicator arms 4954, 4956, 4958 are shown in an actuated or released condition. The leaflets 42, 44 are inserted into the opening 4906 of the fastener 4900 approximately halfway between the barbed portion 4940 and the flexed or hinged portion 4920 so that the first indicator arm 4954 engages the leaflets, while the second and third indicator arms 4956, 4958 have cleared or slipped off the leaflets 42, 44 and moved to a fully actuated position at or beyond the fixation arm 4910. In the illustrated example, the second and third indicator arms 4956, 4958 form an X-shape or cross shape with the fixation arm, which is visible via an imaging device used to monitor the implantation and placement of the prosthetic device. In an exemplary embodiment, the second and third indicator arms will engage the fixation arms or coverings on the fixation arms, so that there will not be a cross or X-shape, but the lack of space between the indicator arms and the fixation arms will still indicate the absence of leaflet tissue. Additionally, or alternatively, indicator arms 4954, 4956 engaging the leaflets will bounce or pulsate as the heart beats, while arm 4958 will not. This bouncing or pulsating can be seen on imaging. Thus, the depth of engagement can be determined from the relative positions of indicator arms 4954, 4956, 4958 to fixation arm 4910 and / or the number of indicator arms that bounce or pulsate versus those that do not.

[0238] 74 , the indicator arms 4954, 4956, 4958 are retracted by applying tension to the actuation lines, and the fastener 4900 is repositioned so that the leaflets 42, 44 are inserted deeper into the openings 4906 of the fastener 4900. However, in some cases, engagement by only some of the indicator arms may indicate correct leaflet positioning. The indicator arms 4954, 4956, 4958 are then actuated by releasing tension on the actuation lines, as can be seen in FIG. 75 . Because the leaflets 42, 44 are inserted into the fastener 4900 at or beyond the minimum desired engagement depth of the third indicator arm 4958, all three of the indicator arms 4954, 4956, 4958 engage and pinch the leaflets 42, 44 against the locking arms 4910. Engagement with the leaflets 42, 44 prevents the indicator arms 4954, 4956, 4958 from moving up to or past the fixation arms 4910 of the fastener 4900 and forming the X-shape shown in FIG. 73 (or another shape indicating the absence of leaflet tissue). Thus, the indicator arms 4954, 4956, 4958 indicate to an observer viewing the installation via an imaging device that the leaflets 42, 44 have been inserted into the opening 4906 beyond the depth established by at least the third indicator arm 4958.

[0239] Referring now to FIG. 75 , once the indicator arms 4954, 4956, 4958 indicate that the leaflets 42, 44 are fully inserted into the opening 4906, the movable arm 4930 is actuated by releasing tension on the actuation line (not shown), causing the leaflets 42, 44 to be sandwiched between the barbed portion 4940 and the fixation arm 4910, firmly securing the leaflets 42, 44 within the fastener 4900.

[0240] 76-77, a movable arm 4930 and indicator arms 4954, 4956, and 4958 of a laser-cut embodiment of fastener 4900 are illustrated. The embodiment illustrated in FIGS. 76-77 is similar to that described above with respect to FIG. 69, and includes a movable arm 4930 with a cutout opening 6730 and multiple indicator arms 4954, 4956, 4958 all cut from the same sheet, each of which has a flexible section 4960 to allow bending and / or flexion relative to the fixed arm and / or to allow configuration of the fastener's non-flexed position. In these embodiments, the multiple indicators assist in identifying the depth of the leaflets.

[0241] The embodiment of FIGS. 76-77 further includes a bar 7610 above the shortest indicator arm 4958, which forms a "T" shape with the shortest indicator arm 4958 (referred to herein as a T-bar). The T-bar can allow the indicators and optionally the movable fastener arm 4930 to lift together (i.e., open relative to the fixed arm). The T-bar can be attached to the indicator arm 4958 by welding, riveting, or other known means for attachment. In FIG. 76, the T-bar extends all the way to the outermost layer of the movable arm 4930, which can be a movable arm with optional barbs (barbs not shown) that close after the leaflet is properly positioned in the fastener.

[0242] 77 illustrates an exemplary embodiment in which the T-bar 7610 extends outward to the outermost indicator arm 4954, but is positioned inward of the movable arm, where the indicator arms increase in length as they move outward from the centrally located indicator arm 4958 (centered along the width of the movable arm frame). Indicator arms 4956, 4958, which have a longer length than the centrally located indicator arm, can be "U" shaped or other shaped, where the indicator arm has sides 7620 and a distal end 7630.

[0243] The indicator arms may be pulled up or opened by the T-bar by a suture line attached to the T-bar or by another actuator means. The movable arm may be pulled up or opened by another suture line or other actuator means. As with other embodiments having suture lines described herein, the suture line connected to the T-bar or shortest indicator arm is given slack before the suture line connected to the movable arm. This slack allows the shortest indicator arm to drop toward the fixation arm (or toward the leaflet, if the leaflet is positioned in the fastener). The drop of the shortest indicator arm (and thus the T-bar) allows the remaining indicator arms and optionally the movable arm 4930 to drop toward the fixation arm as well. If the leaflet is partially captured, some of the indicator arms (but not those overlapping the leaflet) will still drop past the leaflet. Figures 80-83 illustrate the drop of the indicator arms based on the position of the leaflet and are described below.

[0244] 78-79 , an exemplary fastener 4900 for use in an implantable prosthetic device (e.g., devices 100, 200, 300, etc., described above) is shown. Similar to fastener 3500 described above, fastener 4900 includes a fixed arm 4910, a bent or hinged portion 4920, and a movable arm 4930. Similar to FIGS. 76 and 77 , the shortest indicator arm 4958 has a T-bar connected to it, which lifts all of the indicator arms together simultaneously when positioning the fastener. Fastener 4900 may be used in any of the implantable prosthetic devices of the present application and can include any or a combination of the features of the fasteners described herein. Although the example illustrated by Figures 78 and 79 does not show a barb on the movable arm 4930, the movable arm can have one or more barbs in this embodiment or any other embodiment disclosed herein (see, for example, barb 3540 in Figures 24-29).

[0245] The fastener 4900 also includes an indicator portion 4950 formed from first, second, and third indicator arms 4954, 4956, 4958 adjacent the movable arm 4930 and each extending from an indicator flex or hinge portion 4960. The indicator flex or hinge portion 4960 allows the indicator arms 4954, 4956, 4958 to be actuated individually and separately from the movable arm 4930. The indicator flex or hinge portion 4960 may be formed from a portion of the indicator arms 4954, 4956, 4958, may be formed from a series of cutouts, and / or may be part of the flex or hinge portion 4920. The T-bar may be connected by welding, using rivets, or by other known means. The T-bar can be made from the same material as the indicator arms. The T-bar is used to lift the indicator arms together. As described below, during placement of the fastener over the native valve leaflet, an indicator arm that falls down to or beyond the fastener's locking arm indicates that the leaflet is not positioned in the fastener to the depth indicated by that particular indicator arm. The T-bar does not affect the function of the indicator arms, which operate similarly to the exemplary embodiment illustrated in FIGS. 70-75, as described below.

[0246] The indicator arms 4954, 4956, 4958 can be actuated separately from the movable arm 4930 to facilitate detection of the depth of engagement of the native valve leaflets between the movable arm 4930 and the fixation arm 4910 of the fastener 4900. In the illustrated embodiment, the indicator arms 4954, 4956, 4958 are narrower than the movable arm 4930 and each have a length less than the distance from the flex or hinge portion 4920 to the barbed portion 4940. The first indicator arm 4954 has a length that is about 75 to about 100 percent of the distance between the flex or hinge portion 4920 and the barbed portion 4940. The second indicator arm 4956 has a length that is about 65 to about 85 percent of the length between the flex or hinge portion 4920 and the barbed portion 4940. The third indicator arm 4958 has a length that is about 50 to about 70 percent of the distance between the bend or hinge portion 4920 and the barbed portion 4940. Any combination of indicator arm lengths can be used to provide an indication of the depth to which the leaflet is positioned within the fastener, so long as the length continues to decrease with each successive indicator arm. There can also be a fourth indicator arm (not shown) or any number of indicator arms.

[0247] The different lengths of the indicator arms 4954, 4956, 4958 are used to determine a desired minimum engagement depth as measured from the end of the movable arm 4930 of the fastener 4900. Configuring the length of the first indicator arm 4954 to be less than the distance from the bend or hinge portion 4920 to the barbed portion 4940 ensures that the barbed portion 4940 will engage a leaflet that is positioned at the minimum engagement depth as indicated by the first indicator arm 4954. That is, if a native valve leaflet positioned in the fastener 4900 is engaged by the first indicator arm 4954 when the first indicator arm 4954 is actuated, the leaflet will be engaged by the barbed portion 4940 of the movable arm 4930. The opposite is also true. That is, if the natural valve leaflet positioned in the fastener 4900 is not engaged by the first indicator arm 4954 when the first indicator arm is actuated, the leaflet is not sufficiently engaged by the barbed portion 4940 of the movable arm 4930.

[0248] The first, second, and third indicator arms 4954, 4956, 4958 are configured with decreasing lengths to allow the surgeon to determine how far the native valve leaflet has inserted into the fastener 4900 beyond the minimum engagement depth. That is, whether the native valve leaflet is engaged by the second and third indicator arms 4956, 4958 indicates whether the native valve leaflet has reached the engagement depth measured by each of the first, second, and third indicator arms 4954, 4956, 4958. For example, if a native valve leaflet positioned within the fastener 4900 is engaged by the third indicator arm 4958 when the third indicator arm 4958 is actuated, the leaflet has been inserted about 50 to about 80 percent of the distance from the barbed portion 4940 to the flexion or hinge portion 4920. The opposite is also true. That is, if the native valve leaflet positioned in the fastener 4900 is not engaged by the third indicator arm 4958 when the third indicator arm 4958 is actuated, the leaflet has not reached approximately 50 percent of the distance between the barbed portion 4940 and the flexion or hinge portion 4920.

[0249] 80-83 , an exemplary fastener 4900 is shown placed within a native valve 40 for securing an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 80 , the fastener 4900 is shown in an open condition, with the native valve leaflet 42, 44 partially inserted into an opening 4906 in the fastener 4900 formed between a fixed arm 4910 and a movable arm 4930. To determine whether the leaflets 42, 44 have reached a desired engagement depth, the indicator arms 4954, 4956, 4958 are individually actuated via multiple actuation lines (not shown), as shown in FIGS. 81 and 83 . Alternatively, a single actuation line may be connected to indicator arm 4958 with T-bar 7610, such that pulling the single line causes all of indicator arms 4954, 4956, 4958 to open via T-bar 7610, and releasing the single line allows all of indicator arms 4954, 4956, 4958 to drop or close.

[0250] 81 , the indicator arms 4954, 4956, 4958 are shown in a released condition. The leaflets 42, 44 are inserted into the opening 4906 of the fastener 4900 approximately halfway between the barbed portion 4940 and the flexible or hinged portion 4920 so that the first indicator arm 4954 engages the leaflets, while the second and third indicator arms 4956, 4958 have cleared or slid off the leaflets 42, 44 and moved to a fully actuated position at or beyond the fixation arm 4910. The second and third indicator arms 4956, 4958 form a predetermined shape with the fixation arm that is visible via an imaging device used to monitor the implantation and placement of the prosthetic device. Additionally or alternatively, indicator arms 4954 that engage the valve leaflets bounce or pulsate as the heart beats, while arms 4956, 4958 do not. This bouncing or pulsating can be seen on imaging. Thus, the depth of engagement can be determined from the number of visible shapes formed by indicator arms 4954, 4956, 4958 and fixation arms 4910 and / or the number of indicator arms that bounce or pulsate versus the number that do not.

[0251] 82 , the indicator arms 4954, 4956, 4958 are retracted by applying tension to the actuation line connected to the indicator arm 4958 with the T-bar 7610, and the fastener 4900 is repositioned so that the leaflets 42, 44 are inserted deeper into the opening 4906 of the fastener 4900. (In the illustration, a space is shown between the indicator arms 4958, 4956, 4954 so that they can be seen in the drawing. However, in reality, the indicator arms 4956, 4954 are positioned above the T-bar 7610, and no space is present.) However, in some cases, engagement by only some of the indicator arms can indicate correct leaflet positioning. The indicator arms 4954, 4956, 4958 are then actuated by releasing tension on the actuation line (not shown) attached to the indicator arm 4958 or the T-bar 7610, as can be seen in FIG. 83 . As the leaflets 42, 44 are inserted into the fastener 4900 at or beyond the minimum desired engagement depth of the third indicator arm 4958, all three of the indicator arms 4954, 4956, 4958 engage and pinch the leaflets 42, 44 against the fixation arm 4910. Engagement with the leaflets 42, 44 prevents the indicator arms 4954, 4956, 4958 from passing through the fixation arm 4910 of the fastener 4900 and forming the shape shown in FIG. 81 . Thus, the indicator arms 4954, 4956, 4958 indicate to an observer observing the installation via an imaging device that the leaflets 42, 44 have been inserted into the opening 4906 at least beyond the depth established by the third indicator arm 4958.

[0252] Referring now to FIG. 83 , when the indicator arms 4954, 4956, 4958 indicate that the leaflets 42, 44 are fully inserted into the opening 4906, the movable arm 4930 is actuated by releasing tension on the actuation line (not shown), causing the leaflets 42, 44 to be sandwiched between the movable arm 4930 and the fixed arm 4910, firmly securing the leaflets 42, 44 within the fastener 4900.

[0253] 123 and 124 , an exemplary fastener 5000 (shown as a barbed fastener) for use in an implantable prosthetic device (such as devices 100, 200, 300 described above) is shown. Similar to fastener 3500 described above, fastener 5000 includes a fixed arm 5010, a bent portion or hinge portion 5020, and a movable arm 5030 having a barbed portion 5040 (although other friction-enhancing portions may be used). Movable arm 5030 also includes an optional first indicating lever 1241 disposed a distance from the bent portion or hinge that is greater than the distance of barb 5040. The movable arm 5030 also includes a second indicating lever 1242 that is disposed a distance from the flex or hinge portion 5020 that is less than the distance between the barbed portion 5040 and the flex or hinge portion 5020. The indicating levers 1241, 1242 deform when the native leaflet tissue is pressed against the fixation arm 5010 by the movable arm 5030, indicating the engagement depth reached by the leaflet tissue. The first indicating lever 1241 deforms when the native leaflet is partially inserted into the catch. The second indicating lever 1242 deforms when the native leaflet reaches the minimum desired engagement depth. The fastener is not limited to two indicating levers, but can have additional indicating levers located between the first and second indicating levers (as described in U.S. Patent Application Publication No. 2019 / 0123999, filed February 14, 2019, which is incorporated by reference in its entirety, and as described below with reference to FIGS. 123A-127A). Thus, the second indicating lever 1242 will not indicate that the native leaflets 42, 44 have reached the desired engagement depth until the leaflets 42, 44 are inserted at or beyond the second indicating lever 1242.Once the leaflets 42, 44 reach the desired engagement depth, actuation of the movable arm 5030 compresses the leaflet tissue 42, 44 against the indicating lever 1242, causing the indicating lever 1242 to flatten or bend against the leaflets, thereby indicating that the leaflets 42, 44 have been inserted into the fastener 5000 at or beyond the desired engagement depth. The fastener 5000 may be used in any of the implantable prosthetic devices of the present application and may include any or combination of features of the other fasteners described herein.

[0254] 125, 126, and 127, an exemplary fastener 5000 is shown placed within a native valve 40 to secure an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 125, the fastener 5000 is shown in an open condition, with the native valve leaflet 42, 44 partially inserted into an opening in the fastener 5000 formed between the fixed arm 5010 and the movable arm 5030. With the fastener in the open condition, none of the indicating levers 1241, 1242 are bent or flattened. To determine whether the leaflets 42, 44 have reached a desired engagement depth, the movable arm 5030 is actuated via an actuation line (not shown), as shown in FIGS. 126-127.

[0255] 126 , when the movable arm 5030 is actuated to press the leaflets 42, 44 against the fixed arm 5010, the leaflets 42, 44 may contact a portion of the movable arm 5030, and when the engagement depth of the leaflets 42, 44 is less than the minimum desired engagement depth, they will only contact the first indicating lever 1241 but not the second indicating lever 1242. As can be seen in FIG. 126 , when the leaflets 42, 44 are partially inserted into the fastener 5000, and when the leaflets 42, 44 are pressed against the first indicating lever 1241 by the fixed arm 5010, the first indicating lever 1241 is bent out of the way of the movable arm due to contact with the leaflets 42, 44. That is, the first indicating lever 1241 is deformed by the leaflets 42, 44, indicating that the leaflets 42, 44 have been partially inserted into the fastener. In some embodiments, actuation of the movable arm 5030 also causes the barbed portion 5040 to engage and secure the leaflets 42, 44 within the barbed fastener 5000. Because the second indicating lever 1242 is not bent and / or flattened, this indicates to the operator that the leaflets have not been inserted into the fastener at or beyond the minimum engagement depth. If the indicating lever 1242 indicates that the leaflets 42, 44 have not been inserted to the desired depth, the fastener 5000 can be opened to allow repositioning of the leaflets 42, 44.

[0256] 127 , when the movable arm 5030 is actuated to press the leaflets 42, 44 against the fixed arm 5010, the leaflets 42, 44 may contact a portion of the movable arm 5030 and, when the engagement depth of the leaflets 42, 44 is greater than or equal to the minimum desired engagement depth, contact the first and second indicating levers 1241, 1242. As can be seen in FIG. 127 , when the leaflets 42, 44 are inserted into the fastener 5000 at or beyond the minimum engagement depth, and when the leaflets 42, 44 are pressed against both the first and second indicating levers 1241, 1242 by the fixed arm 5010, both the first and second indicating levers 1241, 1242 are bent out of the way of the movable arm due to contact with the leaflets 42, 44. That is, the first and second indicating levers 1241 and 1242 are deformed by the leaflets 42, 44, respectively, indicating that the leaflets 42, 44 have been inserted into the fastener at or beyond the minimum engagement depth. In some embodiments, actuation of the movable arm 5030 also causes the barbed portion 5040 to engage and secure the leaflets 42, 44 within the barbed fastener 5200. The indicating lever 1241 is optional, and in some exemplary embodiments, there is no indicating lever 1241 positioned above the barbs 5040.

[0257] 123A-127A, an exemplary fastener 5000 (illustrated as a barbed fastener), such as that shown in FIGS. 123-127, is illustrated with a plurality of flexible indicating levers 1242. Referring to FIGS. 123A and 124A, an exemplary fastener 5000 for use in an implantable prosthetic device (such as, for example, devices 100, 200, 300 described above, or any other implantable prosthetic device) is shown. Similar to fastener 3500 described above, fastener 5000 includes a fixed arm 5010, a bending or hinged portion 5020, and a movable arm 5030 having a barbed portion 5040 (although other friction-enhancing portions may also be used). The movable arm 5030 also includes an optional first indicating lever 1241, which is disposed a distance from the flexible portion or hinge that is greater than the distance of the barb 5040. The movable arm 5030 also includes a plurality of additional indicating levers 1242, which are disposed a distance from the flex or hinge portion 5020 that is less than the distance between the barb portion 5040 and the flex or hinge portion 5020. The indicating levers 1241, 1242 deform when the native leaflet tissue is pressed against the fixation arm 5010 by the movable arm 5030, indicating the depth of engagement that the leaflet tissue has reached. The first indicating lever 1241 deforms when the native leaflet is partially inserted into the fastener. Each of the plurality of indicating levers 1242 deforms when the native valve leaflet reaches the engagement depth at which the respective indicating lever 1242 is positioned.

[0258] Once the leaflets 42, 44 reach the desired engagement depth, actuation of the movable arm 5030 compresses the leaflet tissue 42, 44 against at least one indicating lever 1242, causing the indicating lever 1242 to flatten or bend against the leaflet, thereby indicating that the leaflets 42, 44 have been inserted into the fastener 5000 at or beyond the desired engagement depth. The indicating lever 1242 can also be used to indicate whether the leaflets 42, 44 have been inserted too far into the fastener. For example, if the leaflet deforms the indicating lever 1242 closest to the bend or hinge portion 5020, this can indicate to the operator that the leaflet has been inserted too far into the fastener.

[0259] 125A, 126A, and 127A, an exemplary fastener 5000 is shown placed within a native valve 40 to secure an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 125A, the fastener 5000 is shown in an open condition, with the native valve leaflet 42, 44 partially inserted into an opening in the fastener 5000 formed between the fixed arm 5010 and the movable arm 5030. With the fastener in the open condition, none of the indicating levers 1241, 1242 are bent or flattened. To determine whether the leaflet 42, 44 has reached the desired engagement depth, the movable arm 5030 is actuated as shown in FIGS. 126A and 127A.

[0260] 126A , when the movable arm 5030 is actuated to press the leaflets 42, 44 against the fixed arm 5010, the leaflets 42, 44 may contact a portion of the movable arm 5030, and when the engagement depth of the leaflets 42, 44 is less than the minimum desired engagement depth, they will contact only the first indicating lever 1241 but none of the plurality of indicating levers 1242. As can be seen in FIG. 126A , when the leaflets 42, 44 are partially inserted into the fastener 5000, and when the leaflets 42, 44 are pressed against the first indicating lever 1241 by the fixed arm 5010, the first indicating lever 1241 is bent out of the way of the movable arm due to contact with the leaflets 42, 44. That is, the first indicating lever 1241 is deformed by the leaflets 42, 44, indicating that the leaflets 42, 44 have been partially inserted into the fastener. In some embodiments, actuation of the movable arm 5030 also causes the barbed portion 5040 to engage and secure the leaflets 42, 44 within the barbed fastener 5000. The lack of bending and / or flattening of all of the indicating levers 1242 indicates to the operator that the leaflets have not been inserted into the fastener at or beyond the minimum engagement depth. If the indicating levers 1242 indicate that the leaflets 42, 44 have not been inserted to the desired depth, the fastener 5000 can be reopened to allow repositioning of the leaflets 42, 44.

[0261] Referring now to FIG. 127A , the movable arm 5030 is actuated to press the leaflets 42, 44 against the fixation arm 5010. In FIG. 127A , the leaflets 42, 44 contact the first and second indicating levers 1241 and 1242, indicating that the depth of the leaflets 42, 44 is greater than or equal to the minimum desired engagement depth. In FIG. 127A , the two indicating levers 1242 closest to the flexion or hinge region 5020 are not deformed, which can indicate to the operator that the leaflets have not been inserted too far into the fastener. If the leaflets are inserted too far into the fastener, the fastener can be reopened and the leaflets can be repositioned. In some embodiments, actuation of the movable arm 5030 also causes the barbed portion 5040 to engage and secure the leaflets 42, 44 within the barbed fastener 5200. The indicating lever 1241 is optional, and in some exemplary embodiments, there is no indicating lever 1241 positioned above the barb 5040.

[0262] 128-129 , an exemplary fastener 5200 (shown as a barbed fastener) for use in an implantable prosthetic device (such as devices 100, 200, 300 described above) is shown. Similar to fastener 3500 described above, fastener 5200 includes a fixed arm 5210, a flex or hinge portion 5220, and a movable arm 5230 having a barbed portion 5240 (although other friction-enhancing portions may be used). Fixed arm 5210 also includes an indicating spring 5212 that is disposed a distance from the flex or hinge portion that is less than the distance between barbed portion 5240 and flex or hinge portion 5220. In the exemplary embodiment, the movable arm 5230 also includes an indicating spring 5212 that is disposed a distance from the bend or hinge portion that is less than the distance between the barbed portion 5240 and the bend or hinge portion 5220. The indicating spring is illustrated schematically and can take a wide variety of different forms. For example, the indicating spring can be any elastically deformable component. The indicating spring 5212 can include closed ends and / or can be covered with fabric or other material to inhibit damage to the leaflet tissue. The indicating spring 5212 deforms when the native leaflet tissue is pressed against the indicating spring 5212 by the movable arm 5230, indicating that the leaflet tissue has reached a minimum desired engagement depth. Thus, the indicating spring 5212 will not indicate that the native leaflets 42, 44 have reached the desired engagement depth until the leaflets 42, 44 are inserted at or beyond the location of the indicating spring 5212.Once the leaflets 42, 44 reach the desired engagement depth, actuation of the movable arm 5230 compresses the leaflet tissue 42, 44 against the indicating spring 5212 of the fixation arm 5210, causing the indicating spring 5212 to flatten, thereby indicating that the leaflets 42, 44 have been inserted into the fastener 5200 at or beyond the desired engagement depth. The fastener 5200 may be used in any of the implantable prosthetic devices of the present application and may include any or combination of features of the other fasteners described herein.

[0263] 130-132, an exemplary fastener 5200 is shown placed within a native valve 40 to secure an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 130, the fastener 5200 is shown in an open condition, with the native valve leaflet 42, 44 partially inserted into an opening 5206 in the fastener 5200 formed between the fixed arm 5210 and the movable arm 5230. To determine whether the leaflet 42, 44 has reached a desired engagement depth, the movable arm 5230 is actuated via an actuation line (not shown), as shown in FIGS. 131-132.

[0264] 131 , when the movable arm 5230 is actuated to press the leaflets 42, 44 against the fixed arm 5210, the leaflets 42, 44 may contact a portion of the fixed arm 5210 without contacting the indicating spring 5212 when the engagement depth of the leaflets 42, 44 is less than the minimum desired engagement depth. As can be seen in FIG. 132 , when the leaflets 42, 44 are inserted into the fastener 5200 at or beyond the minimum engagement depth, and when the leaflets 42, 44 are pressed against the indicating spring 5212 by the movable arm 5230, the indicating spring 5212 is deformed or flattened from contact with the leaflets 42, 44. That is, the indicating spring 5212 is deformed by the leaflets 42, 44, indicating that the leaflets 42, 44 have been inserted at or beyond the minimum engagement depth. In some embodiments, actuation of the movable arm 5230 also causes the barbed portion 5240 to engage and secure the leaflets 42, 44 within the barbed catch 5200. If the indicating spring 5212 indicates that the leaflets 42, 44 have not been inserted to the desired depth, the catch 5200 can be opened to allow repositioning of the leaflets 42, 44.

[0265] 129B-129C, additional views and configurations of the fastener 5200 and indicator spring 5212 are illustrated. FIG. 129B illustrates that the indicator spring 5212 is attached to the fixation arm 5210. The spring 5212 can be depressed by a force as shown by arrows 5214. Arrows 5214 represent the force of the valve leaflets 42, 44 pressing against the spring. The rings of the indicator spring 2512 are stacked on top of each other in the exemplary embodiment of FIG. 129B because they are all the same or approximately the same size. FIG. 129C illustrates a top view of the indicator spring 5212.

[0266] 129D-129F, an exemplary fastener 5200 having a cone-shaped indicator spring 5213 is illustrated. FIG. 129D illustrates the fastener 5200 in an open configuration with the cone-shaped indicator spring 5213 attached to a fixed arm 5210. In some exemplary embodiments, the cone-shaped indicator spring 5213 can be attached to a movable arm 5230. FIG. 129E illustrates the cone-shaped indicator spring 5213 in a compressed configuration. Arrows 5214 represent the force of the valve leaflets pressing against the spring. The outermost, widest diameter ring of the cone-shaped indicator spring 5213 can be seen. The remainder of the rings (where the diameter decreases with each successive ring, forming the conical shape) nest within each other to form the concentric circles seen in the top view of the spring 5213 in FIG. 129F. As a result, the spring 5212 is flattened or substantially flattened. In Figures 129D-129F, the cone-shaped indicator spring 5213 is positioned on the fixed arm 5230, but in some exemplary embodiments, it may be fixed on a movable arm.

[0267] 129G-129H, an exemplary embodiment of a fastener is illustrated having a supplemental indicator element 5315 on a cone-shaped indicator spring 5213. Referring to FIGS. 129G and 129H, the indicator element 5315 can be attached to the cone-shaped indicator spring 5213 at the free end of the spring 5213. When in the rest configuration as shown in FIG. 129G, the indicator element 5315 extends downward from the free end of the spring 5213 toward the fixed arm 5210. When in the compressed configuration as shown in FIG. 129H, due to the force indicated by arrow 5214, the spring 5213 flattens and the indicator element 5315 extends through an opening 1291 in the fixed arm such that the indicator element 5315 is visible on the exterior side of the fixed arm 5210.

[0268] 129I and 129J, an exemplary embodiment of indicator element 5315 is illustrated. In FIG. 129I, indicator element 5315a is a conical spring or conical spring portion having its largest diameter coil attached to the free end of conical indicator spring 5213 and its smallest diameter coil positioned proximate fixed arm 5210. In one exemplary embodiment, spring 5213 and conical spring indicator element 5315a are formed from a single piece of material (e.g., a single piece of wire, etc.). In the example illustrated by FIG. 129J, indicator element 5315b is a piece of material affixed to the free end of the conical indicator spring. Indicator element 5315b can take a wide variety of different forms. Indicator element 5315b can be a U-shaped, cup-shaped, or rod-shaped piece of radiopaque material affixed to the free end of the conical indicator spring. In the illustrated example, the bottom curve of the "U" extends downward toward the fixed arm, and the free end of the "U" is attached to a cone-shaped indicator spring 5213. In some exemplary embodiments, the indicator element 5315 may be attached to a spring indicator having a coil of the same diameter, and / or the spring indicator 5213 may be attached to the movable arm. The indicator element 5315 may be encased in a radiopaque material, made from a radiopaque material, covered in a radiopaque fabric sheath, and / or printed with radiopaque ink.

[0269] 128A, 129A, 130A, 131A, and 132A, an exemplary fastener is shown having similar features to the fastener illustrated in Figures 128-132. In Figures 128-132A, fastener 5200 and indicating spring 5212 operate in the same manner as the embodiment illustrated in Figures 128-132, with one difference. In Figures 128A, 129A, 130A, 131A, and 132A, indicating spring 5213 is positioned above movable arm 5230.

[0270] 133-134, an exemplary fastener 5200 having an indicator on a fixation arm is shown. The fastener may be used in an implantable prosthetic device (e.g., devices 100, 200, 300, etc., as described above). The fastener 5200 includes a fixation arm 5210, a bent or hinged portion 5220, and a movable arm 5230 having a barbed portion 5240 (although other friction-enhancing portions may also be used). The fixation arm 5210 also includes an indicating spring 5212 disposed at a distance between the bent or hinged portion 5220 and the barbed portion 5240. The indicating spring 5212 depicted in FIGS. 133-134 has coils aligned such that the spring extends longitudinally along the fixation arm. The indicating spring is shown schematically and can take a variety of different forms. For example, the indicating spring can be any elastically deformable component. The indicating spring 5212 can include a closed end and / or can be covered with fabric or other material to inhibit damage to the leaflet tissue. The indicating spring 5212 deforms as the native leaflet tissue is pressed against it by the movable arm 5230, indicating that the leaflet tissue has reached a minimum desired engagement depth. Thus, the indicating spring 5212 will not indicate that the native leaflet 42, 44 has reached the desired engagement depth until the leaflet 42, 44 is inserted at or beyond the indicating spring 5212.Once the leaflets 42, 44 reach the desired engagement depth, actuation of the movable arm 5230 compresses the leaflet tissue 42, 44 against the indicating spring 5212 or a portion of the indicating spring of the fixation arm 5210, causing the indicating spring 5212 or a portion of the indicating spring to flatten, thereby indicating that the leaflets 42, 44 have been inserted into the fastener 5200 at or beyond the desired engagement depth. The indicating spring 5212 can also provide a precise visual indication of leaflet insertion because the amount the indicating spring is depressed is directly related to the amount of leaflet insertion. The fastener 5200 can be used in any of the implantable prosthetic devices of the present application and can include any or a combination of the features of the fasteners described herein.

[0271] 135-137 , an exemplary fastener 5200 is shown placed within the native valve 40 to secure an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. Referring now to FIG. 135 , the fastener 5200 is shown in an open condition, with the native valve leaflet 42, 44 partially inserted into the opening 5206 of the fastener 5200 formed between the fixed arm 5210 and the movable arm 5230. To determine whether the leaflet 42, 44 has reached a desired engagement depth, the movable arm 5230 is actuated via an actuation line (not shown), as shown in FIGS. 136-137 .

[0272] 136 , when the movable arm 5230 is actuated to press the leaflets 42, 44 against the locking arm 5210, the leaflets 42, 44 may contact a portion of the locking arm 5210 without contacting the indicating spring 5212 when the engagement depth of the leaflets 42, 44 is less than the minimum desired engagement depth. As can be seen in FIG. 137 , when the leaflets 42, 44 are inserted into the fastener 5200 at or beyond the minimum engagement depth, and when the leaflets 42, 44 are pressed against the indicating spring 5212 by the movable arm 5230, the indicating spring 5212 is deformed or flattened from contact with the leaflets 42, 44. That is, the indicating spring 5212 is deformed by the leaflets 42, 44, indicating that the leaflets 42, 44 have been inserted at or beyond the minimum engagement depth. In some embodiments, actuation of the movable arm 5230 also causes the barbed portion 5240 to engage and secure the leaflets 42, 44 within the barbed catch 5200. If the indicating spring 5212 indicates that the leaflets 42, 44 have not been inserted to the desired depth, the catch 5200 can be opened to allow repositioning of the leaflets 42, 44.

[0273] 133A , 134A , 135A , 136A , and 137A , in an exemplary embodiment of the fastener, the indicating spring 5212 as illustrated in FIGS. 133-137 may be secured to the movable arm 5230 rather than the fixed arm 5210. The indicating spring 5212 may be made from one or more materials visible under fluoroscopy. The indicating spring 2512 may be made from nitinol or other materials visible under fluoroscopy. The indicating spring may be secured between the barb 5240 and the flexion or hinge region 5220. The indicator spring 5212 secured to the movable arm 5230 operates in the same manner as the indicator spring 5212 with respect to FIGS. 133-134 and indicates when the leaflets 42, 44 are fully inserted into the fastener.

[0274] 133A and 134A, the clamp 5200 is in an open configuration with the leaflets not positioned between the clamp arms. The indicating spring 5212 is secured to the interior side of the movable arm 5230 at a location between the barbed portion 5240 and the bent or hinged portion 5220.

[0275] Referring to FIG. 135A, the leaflets 42, 44 are partially positioned within the fastener 5200, and the fastener is in an open configuration. Referring to FIG. 136A, the fastener 5220 is closed over the leaflets 42, 44, and the indicating spring 5212 is not compressed because the leaflets 42, 44 have not been inserted into the fastener at or beyond the minimum depth. Referring to FIG. 137A, the indicating spring 5212 is partially compressed, indicating the depth of the leaflets within the fastener. Compression of the indicating spring 5212 can indicate that the leaflets are fully engaged by the fastener. The barbed region 5240 can pierce the leaflet and hold it in place within the fastener. The fastener can be reopened so that the leaflets can be repositioned until they are positioned at or beyond the minimum depth as desired by the operator.

[0276] In exemplary embodiments having a coil indicator, the coil can be nitinol, nitinol wire with a platinum core, or nitinol wrapped with platinum wire. The coil can be any other combination of materials that can be visualized by fluoroscopic imaging techniques.

[0277] 133B, 134B, 135B, 136B, and 137B, in an exemplary embodiment of the fastener, an indicating spring 5212 as illustrated in FIGS. 133-137 may be secured at or near the flex or hinge region 5220. The indicating spring is secured to the fastener at one end thereof and extends, when in its resting state, away from the flex or hinge region toward a central region within the fastener (where the leaflets will be positioned), with the other end of the indicating spring being free and unattached. The indicating spring 5212 may be made of one or more materials visible under fluoroscopy. The indicating spring 2512 may be made of nitinol or other materials visible under fluoroscopy.

[0278] 133B and 134B, the fastener 5200 is in an open configuration, with no leaflets positioned between the arms of the fastener.

[0279] Referring to FIG. 135B, the leaflets 42, 44 are partially positioned within the fastener 5200, and the fastener is in an open configuration. Referring to FIG. 136B, the fastener 5220 is closed over the leaflets 42, 44, and the indicating spring 5212 is not compressed because the leaflets 42, 44 have not been inserted into the fastener at or beyond the minimum depth. Referring to FIG. 137B, the indicating spring 5212 is partially compressed, indicating the depth of the leaflets within the fastener. Compression of the indicating spring 5212 can indicate that the leaflets are fully engaged by the fastener. The barbed region 5240 can pierce the leaflet and hold it in place within the fastener. The fastener can be reopened so that the leaflets can be repositioned until they are positioned at or beyond the minimum depth as desired by the operator.

[0280] 138-142, an exemplary fastener 6400 for use in an implantable prosthetic device (e.g., devices 100, 200, 300, etc., described above) is shown. Similar to fastener 3500 described above, fastener 6400 includes a fixed arm 6410, a bent or hinged portion 6420, and a movable arm 6430 having a barbed portion 6440 (although other friction-enhancing portions may also be used). Fixed arm 6410 also includes an indicating pad 6450, which is disposed a distance from the bent or hinged portion that is less than the distance between barbed portion 6440 and bent or hinged portion 6420. Indicating pad 6450 can take a variety of different forms. For example, the indicating pad can include upstanding strands (e.g., carpet strands, toothbrush bristles, etc.), braided wire mesh, compressible foam, nonwoven fabrics (e.g., spunbond, air laid, and / or lofted plastics, such as polyethylene terephthalate ("PET")), woven fabrics, etc. The indicating pad 6450 can be made from a radiopaque material, can be covered by a radiopaque material, and / or can be made partially from a radiopaque material (e.g., PET, etc.) and partially from a non-radiopaque material. In some embodiments, the indicating pad 6450 can be formed by a hoop of wire extending from the fixed arm 6410. In some embodiments, the indicating pad 6450 is disposed on the movable arm 6430 instead of the fixed arm 6410. The fastener 6400 can also include a separate indicating arm (not shown) to press the leaflets 42, 44 against the indicating pad 6450 without actuating the movable arm 6430. The indicating pad can be included on any of the fixed arms, movable arms, and / or indicating arms disclosed herein.

[0281] 138A and 139A illustrate an exemplary fastener 6400 similar to that described above with reference to FIGS. 138 and 139. Similar to fastener 3500 described above, fastener 6400 includes a fixed arm 6410, a bent or hinged portion 6420, and a movable arm 6430 having a barbed portion 6440 (although other friction-enhancing portions may be used). Fixed arm 6410 also includes an indicating pad 6450 disposed a distance from the bent or hinged portion that is less than the distance between barbed portion 6440 and bent or hinged portion 6420. Movable arm 6430 also includes an opening 6480 through which indicating pad 6450 can pass when the fastener is closed and the leaflets 42, 44 are not fully engaged.

[0282] The indicating pad 6450 is configured to deform (e.g., elastically deform) when engaged by native leaflet tissue, which is pressed against the indicating pad 6450 by the fixed arm 6410 and the movable arm 6430. When the tissue disengages from the indicating pad 6450, the indicating pad 6450 optionally returns to a neutral position. More specifically, the indicating pad 6450 deforms only in areas engaged by the leaflets, while areas not engaged by the leaflets, in one exemplary embodiment, remain in a substantially initial or resting condition. Thus, the indicating pad 6450 can indicate that the native leaflets 42, 44 have reached a desired engagement depth when a predetermined portion or the entire indicating pad 6450 is deformed by the leaflets 42, 44. Once the leaflets 42, 44 reach the desired engagement depth, actuation of the movable arm 6430 compresses the leaflet tissue 42, 44 against the indicating pad 6450 of the fixation arm 6410, deforming the indicating pad 6450, thereby indicating that the leaflets 42, 44 have been inserted into the fastener 6400 at or beyond the desired engagement depth. The fastener 6400 may be used in any of the implantable prosthetic devices of the present application and may include any or combination of features of the other fasteners described herein.

[0283] 140-142, an exemplary fastener 6400 having an indicating pad 6450 as a leaflet depth indicator is shown placed within a native valve 40 to secure an implantable device (not shown) (such as, for example, devices 100, 200, 300 described above) to one of the native valve leaflets 42, 44. FIGS. 141 and 142 illustrate the indicating pad 6450, which may deform or flatten upon contact with the leaflet. Referring now to FIG. 140, the fastener 6400 is shown in an open condition, with the native leaflet 42, 44 partially inserted into the opening 6406 of the fastener 6400 formed between the fixed arm 6410 and the movable arm 6430. To determine whether the leaflet 42, 44 has reached the desired engagement depth, the movable arm 6430 is actuated via an actuation line (not shown), as shown in FIGS. 141-142.

[0284] Referring now to FIG. 141, when the movable arm 6430 is actuated to push the leaflets 42, 44 against the fixed arm 6410, the leaflets 42, 44 may contact a portion of the fixed arm 6410 without contacting the indicating pad 6450 when the engagement depth of the leaflets 42, 44 is less than the minimum desired engagement depth.

[0285] 142 , when the leaflets 42, 44 are inserted into the fastener 6400 at or beyond the minimum engagement depth, and when the leaflets 42, 44 are pressed against the indicating pad 6450 by the movable arm 6430, the indicating pad 6450 is deformed or flattened from contact with the leaflets 42, 44. That is, the portion of the indicating pad 6450 that is deformed by the leaflets 42, 44 indicates that the leaflets 42, 44 have been inserted at or beyond the minimum engagement depth. In some embodiments, actuation of the movable arm 6430 also causes the barbed portion 6440 to engage and secure the leaflets 42, 44 within the barbed fastener 6400. If the indicating pad 6450 indicates that the leaflets 42, 44 have not been inserted to the desired depth, the fastener 6400 can be opened to allow repositioning of the leaflets 42, 44.

[0286] 140A, 141A, and 142A, the indicating pad can pass through the opening 6480 in the movable arm 6430 when the catch is closed and the leaflets are not fully engaged. Referring to FIG. 140A, similar to FIG. 140, the catch 6400 is open and the leaflets 42, 44 are partially inserted into the catch. Referring to FIG. 141A, the catch 6400 is closed and the leaflets 42, 44 are not inserted into the catch at or beyond a minimum depth. The indicating pad 6450 is not deformed and instead passes through the opening 6480 in the movable arm 6430. The indicating pad positioned through the opening 6480 is visible to the operator and indicates that the leaflets are not inserted deep enough into the catch. 142A , when the leaflets 42, 44 are inserted into the fastener 6400 at or beyond the minimum engagement depth, and when the leaflets 42, 44 are pressed against the indicating pad 6450 by the movable arm 6430, the indicating pad 6450 is deformed or flattened from contact with the leaflets 42, 44. That is, the portion of the indicating pad 6450 that is deformed by the leaflets 42, 44 indicates that the leaflets 42, 44 have been inserted at or beyond the minimum engagement depth. In some embodiments, actuation of the movable arm 6430 also causes the barbed portion 6440 to engage and secure the leaflets 42, 44 within the barbed fastener 6400. The portion of the indicating pad 6450 that is not deformed or flattened by the leaflets 42, 44 extends through the opening 6480 of the movable arm 6430 when the fastener is closed. If the indicating pads 6450 indicate that the leaflets 42, 44 have not been inserted to the desired depth, the catches 6400 can be opened to allow repositioning of the leaflets 42, 44.

[0287] 143-154, an exemplary fastener 4400 is the same or substantially the same as the embodiment illustrated by FIGS. 48-66 or 111-122, except that the fastener is actively collapsible by a line (e.g., a suture line, etc.). Referring to FIGS. 144 and 145, a movable arm 4430 includes side beams that are particularly flexible laterally. The movable arm 4430 includes a hole 1431 for receiving one or more actuating sutures 2152 used to collapse the movable arm 4430. For example, as the fastener is threaded through a native valve (e.g., a native mitral valve and associated chordae tendineae), tension on the sutures 2152 can pull the side beams of the movable arm 4430 inward. In the illustrated example, the line 2152 is threaded through the hole 1431 and also through a hole 1433 in the indicator arm 4450. The hole 1433 in the indicator arm is centered between the holes 1431 in the movable a...

Claims

1. 1. A valve repair device for repairing a native valve in a patient, comprising: Paddle and; a movable fastener arm having a first side and a second side spaced apart, the paddle and the movable fastener arm being movable to form an opening between the movable fastener arm and the paddle; an indicator arm disposed between the first and second spaced apart sides of the movable catch arm, the indicator arm being movable within the opening to indicate whether the leaflets of the native valve have been inserted into the opening between the paddle and the movable catch arm to at least a minimum desired insertion depth; A device comprising:

2. The device of claim 1 , wherein the indicator arm is movable relative to the paddle independently of the movable catch arm.

3. The device of claim 1 or 2, wherein the indicator arm includes a barb.

4. 4. The device of claim 1, wherein the movable clamp arm is attached to a fixed clamp arm, the fixed clamp arm being attached to the paddle.

5. The device of claim 1 , wherein the movable clasp arm comprises a loop.

6. 6. The device of claim 5, wherein the indicator arm is at least partially disposed within the loop when the leaflets of the native valve are inserted to a depth less than the minimum desired insertion depth, and an end of the indicator arm extends outside the loop when the leaflets of the native valve are inserted to at least the minimum desired insertion depth.

7. The device of claim 1 , further comprising a hinge portion connecting the indicator arm to the movable clasp arm.

8. The device of claim 1 , wherein the movable clasp arm and the indicator arm are formed from a single piece of material.

9. 9. The device of claim 1, wherein the movable clasp arm has a higher clamping force than the indicator arm.

10. The device of claim 1 , wherein the indicator arm is configured to pulsate when the heart beats.

11. The device of claim 1 , wherein the device includes a second paddle and a second movable clasp arm.

12. The device of claim 11 , wherein the movable clasp arm and the second movable clasp arm are disposed between the paddle and the second paddle.

13. 13. A device according to any preceding claim, wherein each indicator arm is actuatable between a rest position and an open position, the open position being spaced apart from the respective movable catch arm.

14. 14. The device of claim 13, wherein the indicator arm is configured to return to the rest position when no native valve leaflets extend beyond the free end of the indicator arm into the opening.

15. 1. A valve repair system comprising: a delivery catheter; a valve repair device coupled to the delivery catheter, Paddle and; a movable fastener arm having a first side and a second side spaced apart, the paddle and the movable fastener arm being movable to form an opening between the movable fastener arm and the paddle; an indicator arm disposed between the first and second spaced apart sides of the movable catch arm, the indicator arm being movable within the opening to indicate whether a leaflet of a native heart valve has been inserted into the opening between the paddle and the movable catch arm to at least a minimum desired insertion depth; Equipped with a valve repair device; A system comprising:

16. The system of claim 15 , wherein the indicator arm is movable relative to the paddle independently of the movable catch arm.

17. 17. The system of claim 15 or 16, wherein the movable clamp arm is attached to a fixed clamp arm, and the fixed clamp arm is attached to the paddle.

18. 18. The system of any one of claims 15 to 17, wherein the movable clasp arm comprises a loop.

19. 20. The system of claim 18, wherein the indicator arm is at least partially disposed within the loop when the leaflets of the native heart valve are inserted to a depth less than the minimum desired insertion depth, and an end of the indicator arm extends outside the loop when the leaflets of the native heart valve are inserted to at least the minimum desired insertion depth.

20. 19. The system of any one of claims 15 to 18, further comprising a hinge portion connecting the indicator arm to the movable clasp arm.

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