Heart valve sealing device and delivery device 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 on February 14, 2019, and U.S. Provisional Patent Application No. 62 / 944,325, entitled "Leaflet Depth Indicators," filed on December 5, 2019, which are hereby incorporated by reference in their entireties for all purposes.

Background Art

[0002] Natural heart valves (i.e., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play an important role in ensuring the forward flow of sufficient blood supply through the cardiovascular system. These heart valves can be damaged by congenital malformations, inflammatory processes, infectious conditions, diseases, etc., and thus their effectiveness may be reduced. 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 complications may occur. 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 natural mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, ascending the inferior vena cava, and inserting it into the right atrium). Then, the septum is punctured and the catheter is passed into the left atrium. A similar transvascular technique can be used to implant a prosthetic device into the tricuspid valve, which starts in the same way as the transseptal technique but stops before puncturing the septum and instead directs the delivery catheter towards the tricuspid valve in the right atrium.

[0003] A healthy heart has a generally conical shape that tapers towards the inferior 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 generally separated by a wall called the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure from other natural heart valves. The mitral valve includes an annulus portion and a pair of leaflets (or cusps), where the annulus portion is a circular portion of natural valve tissue surrounding the mitral valve orifice, and the pair of leaflets extend downward from the annulus into the left ventricle. The mitral valve annulus can form a "D"-shaped cross-sectional shape, an oval cross-sectional shape, or other non-circular cross-sectional shapes with a major axis and a minor axis. The anterior leaflet is larger than the posterior leaflet, and when they are closed, it is possible to form a generally "C"-shaped boundary between the sides where the leaflets abut.

[0004] When operating 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 muscles of the left atrium contract and the left ventricle dilates (also referred to as "ventricular diastole" or "cardiac diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as "ventricular systole" or "cardiac systole"), the elevated blood pressure in the left ventricle biases the sides of the two leaflets together, thereby closing the one-way mitral valve and preventing blood from flowing back into the left atrium. Instead, the blood is discharged from the left ventricle through the aortic valve. To prevent the two leaflets from deviating under pressure and the mitral valve annulus from folding back towards the left atrium, a plurality of fibrous cords called chordae tendineae anchor the leaflets to the papillary muscles in the left ventricle.

[0005] Valvular regurgitation involves the valve inappropriately allowing some blood to flow through the valve in the wrong direction. For example, mitral regurgitation occurs when the natural mitral valve cannot close properly, and blood flows from the left ventricle into the left atrium during systole of ventricular contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as, for example, leaflet prolapse, dysfunctional papillary muscles, elongation of the mitral valve annulus as a result of left ventricular dilation, two or more of these, etc. Mitral regurgitation at the central portion of the leaflet can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the commissures of the leaflet (i.e., the place where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, and thus when the valve does not close and there is regurgitation present.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Summary of the Invention

Means for Solving the Problems

[0007] This summary is meant to provide some examples and is in no way intended to limit the scope of the invention. For example, any feature included in the examples of this summary is not required by the claims unless the claims explicitly recite that feature. Also, the features, components, steps, concepts, etc. described in the examples of this summary and in other places in this disclosure can be combined in various ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

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

[0009] In one exemplary embodiment, a heart valve treatment device / system or valve repair device / system for repairing a patient's native valve includes a fastener and a cusp indicator. The fastener (e.g., all or a portion thereof) is movable to form an opening or cusp receiving area. The opening or cusp receiving area can be formed between two portions of the fastener (such as a fixed arm and a movable arm), between the fastener or a portion thereof and another portion of the device, between the fastener and the paddle of the device, between the fastener and the anchor of the device, between the movable arm of the fastener and the paddle of the device, etc. The cusp indicator is movable within the opening or receiving area, repositionable, and / or changes shape or configuration to indicate whether the cusp 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 cusp indicator can be configured the same or similar to any of the indicators shown in any of the figures or described anywhere in the present disclosure. For example, the cusp indicator can 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 flexible portions, one or more hoops or hoop-shaped portions, one or more flattenable indicators, one or more indicator wings, etc.

[0010] A heart valve treatment device / system or a valve repair device / system can include one or more of the features or components shown in any of the figures or described elsewhere in this disclosure. For example, in some implementations, the device / system can include 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 actuation element, a shaft, an actuation 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 (such as a collar, a coaption portion, a coaption element, a disk, a cover, a post, a tube, etc.) and a cap, the shaft extends through the proximal portion, the cap is attached to the shaft, and 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 coaption element configured to fill the space between the leaflets of a natural valve.

[0012] In one exemplary embodiment, a heart valve treatment device / system or valve repair device / system for repairing a patient's native valve includes a fastener and a plurality of indicator arms. The fastener (e.g., all or a portion thereof) is movable to form an opening or cusp receiving area. The opening or cusp receiving area can be formed between two portions of the fastener (such as a fixed arm and a movable arm), 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 plurality of indicator arms have different lengths and are movable within the opening or receiving area to indicate whether the cusp 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.

[0013] In one exemplary embodiment, a heart valve treatment device / system or valve repair device / system for repairing a patient's native valve includes a paddle, a hoop-shaped fastener, and indicator arms. The paddle and the fastener are movable to form an opening between the fastener and the paddle. The indicator arms are disposed between two sides of the hoop-shaped fastener and are movable within the opening to indicate whether the cusp of the native valve has 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 treatment 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 cusp 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 a movable arm of the fastener and a paddle of the device, etc. The flattenable indicator is within the opening or receiving area and indicates whether the cusp 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 treatment device / system or valve repair device / system for repairing a patient's native valve includes a hoop-shaped fastener and an indicator (e.g., an indicator arm, a spring, etc.). The fastener (e.g., all or a portion thereof) is movable to form an opening or receiving area. The opening or cusp 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 a movable arm of the fastener and a paddle of the device, etc.

[0016] In one embodiment, the indicator extends over the hoop-shaped fastener and is deformable through the hoop-shaped fastener and indicates whether the cusp 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.

[0017] In one embodiment, the indicator includes an indicator arm disposed between two sides of a hoop-shaped fastener. The indicator arm can have a curved portion that is movable through the hoop-shaped fastener and indicates whether the tip of the native valve has 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 that is disposed or positionable within the opening or receiving area and indicates whether the tip of the native valve has 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.

[0019] In one embodiment, the indicator includes at least one indicator wing that extends outwardly from a side of the fastener at a predetermined angle and indicates whether the tip of the native valve has 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 valve tip indicator and a second valve tip indicator that are spaced apart when the tip of the native valve has been inserted into the opening between the paddle and the fastener to at least a minimum desired insertion depth. In one embodiment, the first valve tip indicator and the second valve tip indicator are in contact when there is no tip of the native valve in the opening or receiving area between the paddle and the fastener.

[0021] In one exemplary embodiment, a heart valve treatment 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 cusp receiving area. The opening or cusp receiving area can be formed between two portions of the fastener (such as a fixed arm and a movable arm), 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 actuate the fastener and the indicator arm separately.

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

[0023] In one exemplary embodiment, a heart valve treatment 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 cusp receiving area. The opening or cusp receiving area can be formed between two portions of the fastener (such as a fixed arm and a movable arm), 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 the paddle of the device, etc.

[0024] In one embodiment, at least one indicator extends from a paddle into the opening or cusp receiving area. In some implementations, at least one indicator is configured such that at least a portion of the at least one indicator extends through the fastener when the opening or cusp receiving area is closed and the indicator is not obstructed. In some implementations, also, at least one indicator is configured such that a portion of the at least one indicator extends through the paddle when the opening or cusp receiving area is closed and the at least one indicator is engaged with the cusp.

[0025] In one embodiment, at least one indicator extends from one of a fixed arm and a paddle into the opening or receiving area. 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 not obstructed. Also, at least one indicator can be configured such that a portion of the indicator extends through the fixed arm of the fastener when the opening or receiving area is closed and the indicator is engaged with the cusp.

[0026] In some embodiments, when the opening or receiving area is closed and at least one indicator is engaged with the valve tip, a portion of at least one indicator extends through the paddle of the device / system. In some embodiments, when the opening or receiving area is closed and the indicator is engaged with the valve tip, a portion of at least one indicator does not extend through the movable arm of the fastener.

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

[0028] In some embodiments, the movable arm of the fastener includes a cutout, and when the opening or receiving area is closed and the indicator is not obstructed, at least one indicator extends through the cutout. In some embodiments, the fixed arm of the fastener includes a cutout, and at least one indicator extends through the cutout. In some embodiments, the paddle of the device / system includes a cutout, and when the opening between the paddle and the movable arm of the fastener is closed and the indicator is engaged with the valve tip, at least one indicator extends through the cutout.

[0029] In some embodiments, when the opening or receiving area (e.g., between the movable arm of the fastener and the paddle) is closed and the indicator is not obstructed, a smaller portion of at least one indicator extends through the cutout of the paddle, and when the opening or receiving area is closed and the indicator is engaged with the valve tip, a larger portion of at least one indicator extends through the cutout of the paddle.

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

[0031] In one exemplary method of implanting a valve repair device over a patient's native valve (e.g., mitral valve, tricuspid valve, etc.), the indicator arm of the fastener is actuated. When the valve tip of the native valve is not engaged by the indicator arm, the indicator arm is returned to its unactuated position. When the valve tip of the native valve is engaged by the actuated indicator arm, the fastener of the valve repair device is closed. In some embodiments, one or more paddles of the valve repair device are closed to contact one or more valve tips of the native valve with the core capture element of the valve repair device. In some embodiments, one or more paddles of the valve repair device are closed to contact the valve tips with each other.

[0032] In one exemplary method of implanting a valve repair device, the indicator gauge of the fastener measures the depth of engagement of the valve tip of the native valve. When the depth of engagement is below the 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 method can be carried out on a living animal or on a simulation (for example, a cadaver, a cadaver heart, a simulator (for example, a body part, a heart, a tissue, 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 core capture element. The plurality of paddles can be connected to the core capture element and / or another part 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. The fasteners are attached to each of the plurality of paddles. Each fastener includes a fixed arm, a movable arm, and a joint or hinge. The fixed arm is attached to the inner portion of the paddle and / or another part of the valve repair device. The movable arm and / or the fixed arm can optionally have one or more friction-enhancing portions (for example, a return portion, a ridged portion, a textured portion, a protrusion portion, etc.). The hinge portion connects the movable arm to the fixed arm. The insertion depth indicator indicates whether the valve tip of the native valve has been inserted into the opening of the fastener formed between the fixed arm and the movable arm to at least a minimum desired insertion depth.

[0035] In one exemplary embodiment, a heart valve treatment 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. The fasteners are attached to each of the paddles. The fasteners include a fixed arm, a movable arm, a hinge portion, an indicator arm, and an indicator hinge portion. The movable arm and / or the fixed arm can have one or more friction enhancing portions (e.g., a return portion, a ridged portion, a textured portion, a protrusion portion, etc.). The hinge portion connects the movable arm to the fixed arm. The indicator arm is connected to the fixed arm by the hinge portion.

[0036] In one exemplary embodiment, a heart valve treatment 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. The fasteners are attached to each of the plurality of paddles. Each fastener has a fixed arm, a movable arm, and a hinge portion. The fixed arm of each fastener is attached to the paddle and / or another portion of the valve repair device. The movable arm is connected to the fixed arm by the hinge portion. The compressible indicator is configured to engage the valve leaflets of the native valve.

[0037] In one exemplary embodiment, a heart valve treatment 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. The fasteners are attached to respective ones of the paddles. Each fastener includes a fixed arm, a movable arm, and a hinge portion. The fixed arm of each fastener is attached to the paddle and / or another portion of the valve repair device. The movable arm and / or the fixed arm can have one or more friction enhancing portions (e.g., a return portion, a ridged portion, a textured portion, a protrusion portion, etc.). The hinge portion connects the movable arm to the fixed arm. Each marker is attached to the indicator, the fixed arm, and / or the movable arm.

[0038] In one exemplary embodiment, a heart valve treatment 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. The fasteners are attached to respective ones of the paddles. Each fastener includes a fixed arm, a movable arm, and a hinge portion. The fixed arm is attached to the paddle and / or another portion of the valve repair device. The movable arm and / or the fixed arm can have one or more friction enhancing portions (e.g., a return portion, a ridged portion, a textured portion, a protrusion portion, etc.). The hinge portion connects the movable arm to the fixed arm. The insertion depth gauge indicates the insertion depth of the tip of the native valve.

[0039] In one exemplary embodiment, a heart valve treatment 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 is movable between an open position and a closed position. The fasteners are attached to respective ones of the paddles. Each fastener includes a fixed arm, a movable arm, and a hinge portion. The fixed arm is attached to the paddle and / or another portion of the valve repair device. The movable arm and / or the fixed arm can have one or more friction enhancing portions (e.g., a return portion, a ridged portion, a textured portion, a protrusion portion, etc.). The movable arm is movable between an open position and a closed position. The hinge portion connects the movable arm to the fixed arm. The indicator hinge portion connects the indicator arm to the fixed arm of the fastener. In some implementations, the actuating suture extends from a delivery device to first and second movable loops respectively attached to the movable fastener arm and the indicator arm. In some implementations, the movable fastener arm and the indicator arm are separately actuatable by a single actuating suture.

[0040] In one exemplary embodiment, a fastener for a heart valve treatment device / system or a 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 leaflet of the native valve within or adjacent to the fastener when the heart valve treatment device is implanted within the native heart valve. The indicator can be configured the same or similar to any of the indicators shown in any of the figures or described anywhere in the present disclosure. For example, the indicator can 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 flexible portions, one or more hoops or hoop-shaped portions, one or more flattenable indicators, one or more indicator wings, and the like.

[0041] In some implementations, the fastener further includes a fixed arm attachable to a device / system (e.g., 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, returns, protrusions, ridges, textured surfaces, adhesive surfaces, etc.). A connecting portion or hinge portion connects the movable arm to the fixed arm (e.g., in a jointed, hinged manner, etc.).

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

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

[0044] In some embodiments, the relative position of at least one of the indicator and the fixed arm and the movable arm indicates the insertion depth of the tip of the natural valve.

[0045] In some embodiments, the indicator includes a plurality of flexible arms (e.g., two, three, four, five, six, or more arms) attached to the movable arm between the fastener hinge portion and the friction enhancement portion. The insertion depth of the valve tip can be indicated by the number of flexible arms deformed by engagement with the valve tip.

[0046] In some embodiments, the indicator includes a plurality of flexible arms (e.g., two, three, four, five, six, or more arms) attached to the fixed arm. The insertion depth of the valve tip can be indicated by the number of flexible arms deformed by engagement with the valve tip.

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

[0048] In some embodiments, the indicator is operable between a non-retained position and an actuated position. In some embodiments, the indicator is actuated or operable when the fastener is at least partially open and determines the insertion depth of the tip of the natural valve.

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

[0050] In some embodiments, the movable arm is in the shape of a loop, and the friction enhancing portion includes a return that is longitudinally offset.

[0051] In some embodiments, the fastener described above may be included within a heart valve treatment device / system or a valve repair device / system. The heart valve treatment device / system or valve 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 embodiments, the device / system includes one or more of an anchor portion, an anchor, a core capture portion, a core capture element, a paddle, a pair of paddles, a plurality of paddles, a delivery sheath, a delivery catheter, an actuation element, a shaft, an actuation line / suture, a cap, a collar, a cover, a braided material, a strip of material, etc.

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

[0053] The nature and advantages of the present invention will be apparent from, among other things, the following description and the claims, when considered in conjunction with the accompanying drawings, in which like parts are designated by like reference numerals.

Brief Description of the Drawings

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Embodiments for Carrying Out the Invention

[0055] As described herein, when one or more components are described as being connected, coupled, fixed, linked, attached, or interconnected in some other way, such interconnection can be direct between the components, or can be indirect, for example, through the use of one or more intermediate components. Also, as described herein, reference to a “member,” “component,” or “portion” is not limited to a single structural member, component, or element, but can also include an assembly of components, members, or elements. Also, as described herein, the terms “substantially” and “about” are defined as being at least nearly (and including) a given value or state (preferably within 10% of a given value or state, more preferably within 1% of a given value or state, and most preferably within 0.1% of a given value or state).

[0056] The prosthetic device can have a wide variety of different forms. For example, the prosthetic device can have any of the configurations disclosed by Patent Document 1 filed on October 9, 2019, and Patent Document 2 filed on October 10, 2018, which are hereby incorporated by reference in their entirety for all purposes. The prosthetic device can have optional coaptation means or coaptation elements, and at least one anchor means or anchor. The coaptation element is configured to be positioned within the natural heart valve orifice, help fill the space between the valve leaflets, and form a more effective seal between the natural valve leaflets, thereby reducing or preventing backflow. The coaptation element can have a structure that does not allow blood to pass through or is resistant to blood, which allows the natural valve leaflets to close around the coaptation element during ventricular systole and prevents blood from flowing back from the left or right ventricle into the left or right atrium, respectively. The prosthetic device can be configured to seal against two or three natural valve leaflets; that is, the device can be used in the natural mitral and tricuspid valves. The coaptation element may be referred to herein as a spacer. This is because the coaptation element can fill the space between the valve leaflets of a natural mitral or tricuspid valve that is functioning improperly and not closing completely.

[0057] The core capture element (e.g., a spacer, a core capture element, etc.) can have various shapes. In some embodiments, the core capture element can have an elongated cylindrical shape with a round cross-sectional shape. In some embodiments, the core capture 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 core capture element can have an atrial portion positioned within or adjacent to the left atrium, a ventricular portion or a lower portion positioned within or adjacent to the left ventricle, and a side surface extending between the natural valve leaflets. In embodiments configured for use in the tricuspid valve, the atrial portion or the upper portion is positioned within or adjacent to the right atrium, the ventricular portion or the lower portion is positioned within or adjacent to the right ventricle, and the side surface extends between the natural tricuspid valve leaflets.

[0058] The anchor can be configured to secure the device to one or both of the natural valve leaflets such that the core capture element is positioned between the two natural valve leaflets. In embodiments configured for use in the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid valve leaflets such that the core capture element is positioned between the three natural valve leaflets. In some embodiments, the anchor can be attached to the core capture element at a location adjacent to the ventricular portion of the core capture element. In some embodiments, the anchor can be attached to an actuation element (e.g., a shaft or an actuation wire, etc.) and the core capture element is also attached to the actuation element.

[0059] The anchor of an implantable prosthesis device includes a fastener that secures native leaflet tissue between the anchor and a core capture element. Exemplary fasteners (e.g., a reversible fastener, etc.) include a movable member or arm that is operable between an open position and a closed position relative to a fixed member or arm. The movable arm is moved away from the fixed arm to form a gap or opening between the movable arm and the fixed arm to receive a portion of the native leaflet tissue. When the leaflet is captured within the gap, the movable arm is actuated to clamp the leaflet tissue, thereby securing the leaflet within the fastener. Generally, positioning the leaflet within the opening between the arms of the fastener prior to actuating the movable arm to clamp the leaflet allows the movable arm to engage more of the leaflet tissue. Then, not only is more of the tissue engaged by the fastener, but the tissue is further disposed within the gap so that any return or other securing member located at the distal end of the movable arm or fixed arm is positioned to engage a thicker portion of the native leaflet tissue. Engaging more and thicker tissue by the fastener ensures more secure gripping of the native leaflet by the fastener.

[0060] Determining the depth of native leaflet engagement within the gap between the movable arm and the fixed arm is a challenge when using current imaging techniques. In particular, the leaflet tissue moves with each heartbeat of the heart and may be translucent or visually difficult to distinguish from the surrounding tissue. In contrast, fasteners (e.g., reversible fasteners, etc.) formed from materials such as metal are more easily seen by an imaging device. Thus, a surgeon is able to view the position of the movable arm of the fastener and determine whether the fastener is properly engaged with the native leaflet. For example, the fastener may be configured such that the movable arm bounces slightly with each heartbeat of the heart, indicating that the leaflet is captured within the fastener.

[0061] Exemplary implantable devices can include an indicator, which is used to determine whether a natural valve cusp is sufficiently engaged by or within a fastener or a return fastener during implantation of the implantable prosthesis device. The indicator can be viewed via an imaging device during implantation. The indicator indicates to the surgeon that the valve cusp has been inserted into the opening to the desired capture depth and / or that the valve cusp has not reached the desired capture depth. The indicator can be operable between a non-retained or starting position and a plurality of actuated positions, the plurality of actuated positions being visually distinct to indicate to the surgeon whether the indicator has engaged the valve cusp tissue and / or whether the valve cusp tissue has reached a desired position or engagement depth. Using the indicator enables the surgeon to determine that the valve cusp is 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 valve cusp is sufficiently engaged.

[0062] Referring now to FIGS. 1-6, implantable prosthesis device 100 is shown at various stages of implantation. Device 100 and related systems, methods, etc. are described in more detail in Patent Document 3 and Patent Document 1, the disclosures of which are hereby incorporated by reference in their entirety. Device 100 can include any other features related to the implantable prosthesis device discussed in this application, and device 100 can be positioned to engage valve tissue (e.g., valve cusps 20, 22) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0063] Device 100 can be implanted from a delivery sheath or other means for delivery and can include a core capture portion or core captor portion 104 and / or an anchor portion 106. Device 100 can be implanted from a delivery sheath and / or can be implanted by a pusher tube or rod 81. In some embodiments, the core capture portion or core captor portion 104 of device 100 includes a core captor element 110, which is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and is slidably attached to an actuating member or actuating element 112 (e.g., an actuating wire, shaft, tube, rod, line, suture, tether, etc.). The anchor portion 106 is operable between an open condition and a closed condition and can take a wide variety of forms, such as, for example, a paddle or gripping element. Actuation of the actuating element or means 112 for actuation opens and closes the anchor portion 106 of device 100 and grasps the native valve leaflets during implantation. The actuating element or other means 112 for actuation (as well as other actuating elements and means for actuation herein) can take a wide variety of different forms (such as, for example, wire, rod, shaft, tube, screw, suture, line, 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 core captor portion 104. Or, the actuating element can be unthreaded and pushing or pulling on the actuating element 112 is adapted to move the anchor portion 106 relative to the core captor portion 104.

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

[0065] In some embodiments, an actuating member, actuating element, or other means 112 for actuation (e.g., an actuating wire, actuating shaft, actuating tube, actuating rod, etc.) extends through a delivery sheath, pusher tube / rod, and / or core option element 110 to a cap 114 (e.g., at the distal connection of the anchor portion 106). Extending and retracting the actuating element 112 increases and decreases the spacing between the proximal end of the device and the cap 114 and / or between the core option element 110 and the cap 114. Optional attachment means or a collar (not shown) removably attaches the device and / or the core option element 110 of the device to the pusher tube or rod 81 and / or the delivery sheath 102 such that the actuating element 112 slides along the actuating element 112 during actuation to open and close the paddles 120, 122 of the anchor portion 106. If, after the device 100 is connected to the valve tissue, it is necessary for the device 100 to be removed from the valve tissue, a retrieval device can be used to connect to the collar 115, and the actuating element extends through the collar 115 and any core option element 110 to engage the anchor portion 106, open the paddles 120, 122, and enable the device 100 to be removed from the valve tissue. An example of a retrieval device that can be used is shown in Patent Document 4 filed on November 20, 2019, which is hereby incorporated by reference in its entirety.

[0066] Referring to FIG. 3, the anchor portion and / or the anchor includes an attachment portion for the gripping member. The gripping member shown includes a fastener 130, and the fastener 130 includes a base or fixed arm 132, a movable arm 134, means 136 for optional return or other securing, and a joint portion, flexure portion, 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 a joint portion, flexure portion, hinge portion 138 disposed proximate the core option element 110. The fastener or a return fastener can have a flat surface and is disposed against the surface of the inner paddle 122 without fitting into a recess of the inner paddle. The joint portion, flexure portion, or hinge portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the fastener 130. The joint portion, flexure portion, 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 portion, flexure portion, 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 with respect to the inner paddle 122 when the movable arm 134 is opened to open the fastener 130 and when exposing the return, friction enhancing element, or means 136 for other securing. In some embodiments, the fastener 130 is opened by applying tension to an actuation line 116 attached to the end of the movable arm or the movable arm 134, thereby moving, flexing, and / or pivoting the movable arm 134 over the joint portion, flexure portion, or hinge portion 138.

[0067] During implantation, paddles 120, 122 are opened and closed, and it is possible to grasp or capture a natural valve tip (e.g., a natural mitral valve tip, etc.) between, for example, paddles 120, 122 and / or between paddles 120, 122 and the core capture element or means 110 for joining. Returning, the fastener 130 can be used to grasp and / or further secure the natural valve tip by engaging the valve tip by a friction enhancing element, or means 136 for fixation, and by sandwiching the valve tip between the movable arm 134 and the fixed arm 132. The return of the fastener or the returnable fastener 130, the friction enhancing element, or other means 136 for fixation can increase the friction with the valve tip or can puncture the valve tip partially or completely. The actuation lines 116 can be actuated independently so that each fastener 130 can be opened and closed independently. The independent movement allows one valve tip to be grasped or captured at a time, or allows the fastener 130 to be repositioned on a poorly grasped or captured valve tip without altering a successful grasp on the other valve tip. The fasteners 130 not only open and close independently of each other, but they can also be opened and closed independently of the position of the inner paddle 122, thereby allowing the valve tip to be grasped or captured at various positions depending on the particular situation.

[0068] Fastener 130 can be opened independently / separately by pulling an attached actuation line / suture or other actuation means 116 that extends through the delivery sheath or means 102 for delivery to the fastener 130. The actuation line 116 can take a variety of forms, such as, for example, a line, suture, wire, rod, or catheter. The fastener 130 can be spring-loaded or otherwise biased and, in the closed position, is adapted to continue to provide a force that clamps the grasped or captured natural valve tip. This clamping force remains constant regardless of the position of the inner paddle 122. The return of the fastener or reversible fastener 130, friction-enhancing elements, or other means 136 for fixation can pierce the natural valve tip and further secure the valve tip.

[0069] Referring now to FIG. 1, device 100 is shown in an elongated condition or fully open condition (also referred to as a fully extended condition or a full bailout condition) for placement from the delivery sheath. The device 100 is loaded into the delivery sheath in a fully open position. The reason is that the fully open position occupies the least amount of space and allows the least amount of catheter to be used (or the largest device 100 to be used for a given catheter size).

[0070] In some embodiments, in the elongated condition, the cap 114 is spaced apart from the core capture element or means 110 for engagement, and the paddles 120, 122 of the anchor portion 106 are adapted to be 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 placement through the delivery sheath or means 102 for delivery, and the return, friction-enhancing elements, or other means 136 for fixation (FIG. 3) are adapted not to catch or damage the sheath or tissue within the patient's heart.

[0071] Referring now to FIG. 1A, device 100 is shown in an elongated intertwined condition as in FIG. 1, but with fastener 130 in a fully open position, and between the fixed and movable portions of fastener 130, in a range from about 140 degrees to about 200 degrees, in a range from about 170 degrees to about 190 degrees, or at about 180 degrees. It has been found that fully opening paddles 120, 122 and fastener 130 improves the ease of untying or removing entanglement from the patient's anatomical structures (such as chordae tendineae, etc.) during implantation of device 100.

[0072] Referring now to FIG. 2, device 100 is shown in a shortened condition or a fully closed condition. The compact size of device 100 in the shortened condition allows for easier manipulation and placement within the heart. To move device 100 from the elongated condition to the shortened condition, an actuating member or actuating element or means 112 for other actuation is retracted, pulling cap 114 toward the proximal end of the device and / or toward core capture element 110. A connection portion 126 (e.g., a joint, hinge, flexible connection, etc.) between outer paddle 120 and inner paddle 122 is restricted or constrained in movement, and a compressive force acting on outer paddle 120 from cap 114 retracted toward the proximal end of the device and / or toward core capture element 110 causes the paddles or gripping elements 120, 122 to move radially outward. During movement from the open position to the closed position, outer paddle 120 maintains an acute angle with respect to actuating element 112. Outer paddle 120 may optionally be biased toward the closed position. Inner paddle 122 moves over a relatively large angle during the same movement. The reason is that they are oriented away from the proximal end of the device and / or core capture element 110 in the open condition and are folded toward the middle of the device (e.g., along the side of core capture element 11) in the closed condition. In some embodiments, inner paddle 122 is thinner and / or narrower than outer paddle 120, and connection portions 126, 128 (e.g., joints, hinges, flexible connections, etc.) connected to inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility can allow for more movement than connection portion 124 connecting outer paddle 120 to cap 114. In some embodiments, outer paddle 120 is narrower than inner paddle 122. Connection portions 126, 128 connected to inner paddle 122 are more flexible and can allow for more movement, for example, than connection portion 124 connecting outer paddle 120 to cap 114.In some embodiments, the inner paddle 122 can be the same or substantially the same width as the outer paddle.

[0073] Referring now to FIGS. 3 - 5, device 100 is shown in a partially open, ready - to - grasp condition. To transition from a fully closed condition to a partially open condition, an actuating member or element 112 (e.g., an actuating wire, an actuating shaft, etc.) is extended to push cap 114 away from the proximal end of the device (e.g., away from core capture element 110), thereby pulling outer paddle 120, and it pulls inner paddle 122, partially spreading anchor or anchor portion 106. Also, actuating line 116 is retracted to open fastener 130 so that the valve tip can be captured or grasped. In some embodiments, the pair of inner and outer paddles 122, 120 are not independent and are moved together by a single actuating element 112. Also, the position of fastener 130 can be dependent on the position of paddles 122, 120. For example, closing paddles 122, 120 can also close the fastener. In some embodiments, paddles 120, 122 can be controllable independently. For example, device 100 can have two actuating elements and two independent caps, where one independent wire and cap are used to control one paddle and the other independent wire and cap are used to control the other paddle.

[0074] Referring now to FIG. 4, one of the actuating lines 116 is extended to enable one of the fasteners 130 to close. Referring now to FIG. 5, the other actuating line 116 is extended to enable the other fastener 130 to close. Either or both of the actuating lines 116 can be repeatedly actuated to repeatedly open and close fastener 130.

[0075] Referring now to FIG. 6, device 100 is shown in a fully closed and retained condition. Delivery sheath or means 102 for delivery and actuation element or means 112 for actuation are retracted, and paddles 120, 122 and fastener 130 remain in a fully closed position. When retained, device 100 can be maintained in a fully closed position by a mechanical latch or can 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, connection 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) can be formed from metal (e.g., steel, etc.) or a shape memory alloy (e.g., nitinol, etc.) (created with wire, sheet, tubing, or laser sintered powder) such that outer paddle 120 holds a closed state around the center of the device or around core aspiration element 110 and fastener 130 holds a clamped state around the natural valve tip. Similarly, the fixed arm 132 and movable arm 134 of fastener 130 are biased to clamp the valve tip. In some embodiments, attachment or connection 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) are formed from any other suitably elastic material (e.g., metal or polymer material, etc.) and are capable of maintaining the device in a closed condition after implantation.

[0076] Referring now to FIGS. 7 - 12, an implantable device 100 of FIGS. 1 - 6 is shown being delivered and implanted within a native valve of the heart 10 or a native mitral valve 40. Referring now to FIG. 7, the 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 to move the device 100 to the fully closed condition shown in FIG. 8. As can be seen in FIG. 9, the device 100 is moved into the ventricle 30 and to an appropriate position within the mitral valve 40 and is partially opened such that the valve leaflets 42, 44 can be captured. Referring now to FIG. 10, the actuating line 116 is extended to close one of the fasteners 130 and capture the valve leaflet 42. FIG. 11 shows that the other actuating line 116 is then extended to close the other fastener 130 and capture the remaining valve leaflet 44. Finally, as can be seen in FIG. 12, the delivery sheath 102 and the actuating element 112 are then retracted and the device 100 is fully closed and left within the native mitral valve 400.

[0077] Referring now to FIG. 13, an implantable prosthesis device 200 is shown. The implantable device 200 is one of many different configurations that the device 100 schematically illustrated in FIGS. 1 - 12 can take. The device 200 is deployed from a delivery sheath (not shown). The device 200 can include a core capture portion 204 and / or an anchor portion 206. The device 200 is loaded into the delivery sheath in a fully open position. The reason is that the fully open position occupies the least amount of space and enables the use of the smallest catheter (or the use of the largest device 200 for a given catheter size).

[0078] In some embodiments, the core capture portion 204 of the device includes a core capture element 210 for implantation between the natural leaflets of a native valve, and the core capture element 210 is 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 and grasps or captures the native leaflets during implantation.

[0079] The anchor portion 206 of the device 200 includes an outer paddle 220 and an inner paddle 222, which are connected to the cap 214 and / or the core capture element 210 in a jointed, flexible, or hinged manner. The actuation element 212 extends through one, some, or all of a delivery sheath (not shown), a collar 211, and the core capture element 210 and extends to the cap 214 at the distal end of the anchor portion 206. In some embodiments, extending and retracting the actuation element 212 increases and decreases the spacing between the core capture element 210 and the cap 214, respectively.

[0080] Color 211 optionally includes a color seal 213 that forms a seal around the actuating element 212 during implantation of the device 200 and also seals to close or substantially close the device 200 against blood flow through the interior of the core capture element 210 after implantation when the actuating element 212 is removed. In some embodiments, the color 211 removably engages and attaches the core capture element 210 to the delivery sheath such that the core capture element 210 slides along the actuating element 212 during operation to open and close the paddles 220, 222 of the anchor portion 206. In some embodiments, the color 211 is closed and held around the core capture element 210 by the actuating element 212 such that removal of the actuating element 212 allows the fingers of the color (not shown) to open and release the core capture element 210. In some embodiments, the cap 214 optionally includes a seal 216 and / or an insert 218 that fit inside the opening 215 of the core capture element 210, which has a hollow interior. The seal 216 and / or insert 218 maintain the core capture element 210 in a closed or substantially closed state against blood flow when the actuating element 212 is withdrawn and when the device 200 is implanted.

[0081] The core capture element 210 and / or paddles 220, 222 may include and / or be formed from a covering, which may be a mesh, woven, braided, or formed in any other suitable manner. The covering can be a cloth, a shape memory alloy wire (such as nitinol) for providing shape setting ability, or any other flexible material suitable for implantation in the human body. In some embodiments, the paddle frame 224 provides a force to sandwich between the inner paddle 222 and the core capture element 210, and also assists in wrapping the tip around the sides of the core capture element 210 for a better seal between the core capture element 210 and the tip. In some embodiments, the covering extends around the paddle frame 224.

[0082] The fastener 230 includes a base or fixed arm 232, a movable arm 234, a friction enhancing element or return 236, and a flexure or hinge portion 238. The fixed arm 232 is attached to the inner paddle 222, and the flexure or hinge portion 238 is disposed proximate to the center of the device and / or the core capture element 210. The fixed arm 232 is attached to the inner paddle 222 by a suture (not shown) through a hole or slot 233. The fixed arm 232 can be attached to the inner paddle 222 or another part of the device by any suitable means (such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, or adhesives). The fixed arm 232 remains stationary or substantially stationary with respect to the inner paddle 222 when the movable arm 234 is opened to open the fastener 230 and to expose the friction enhancing element or return 236. The fastener 230 is opened by applying tension to an actuation line (not shown) attached to a hole 235 disposed at the end of the movable arm 234, thereby moving, flexing, and / or pivoting the movable arm 234 over the joint, flexure, or hinge portion 238.

[0083] During implantation, the anchors and / or paddles 220, 222 are opened and closed, and a natural mitral valve leaflet is captured between the anchors and / or paddles 220, 222 and / or between the anchor or paddle and the core capture element 210. In some embodiments, the fastener 230 (e.g., a return fastener, etc.) further secures the natural leaflet by engaging the leaflet by means of a friction enhancing element or return 236 and by sandwiching the leaflet between the movable arm 234 and the fixed arm 232. In some embodiments, the friction enhancing element or return 236 of the fastener 230 can increase the friction with the leaflet or can partially or fully penetrate the leaflet. The actuation lines can be actuated independently such that each fastener 230 can be opened and closed independently. The independent movement allows one leaflet to be grasped / captured at a time or allows the fastener 230 to be repositioned on a poorly captured leaflet without altering a successful grasp on the other leaflet. The fasteners 230 not only open and close independently of each other, but they can also be fully opened and closed independently of the position of the inner paddle 222, thereby allowing the leaflets to be captured at various positions depending on the particular situation.

[0084] Referring now to FIGS. 14 - 23, 23A, and 22B, an implantable device 300 is shown that is delivered and implanted into the natural mitral valve 40 of the heart 10. The methods and steps shown and / or discussed can be performed on a living animal or on a simulation (e.g., a cadaver, a cadaveric heart, a simulator (e.g., where body parts, the heart, tissue, etc. are simulated), etc.).

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

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

[0087] The core capture element 310 and / or the paddles 320, 322 are formed from a flexible material, which can be a mesh, woven, braided, or formed in any other suitable manner. The flexible material can be cloth, a shape memory alloy wire (such as nitinol) to provide shape setting ability, or any other flexible material suitable for implantation in the human body.

[0088] The fastener 330 (shown as a reversible fastener) includes a base or fixed arm 332, a movable arm 334, and a connecting portion, or joint portion, flexure portion, or hinge portion 338. The fastener can be configured as a reversible fastener and can include a return 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 a connecting portion, or joint portion, flexure portion, or hinge portion 338. In some embodiments, the connecting portion, or joint portion, flexure portion, or hinge portion 338 is disposed proximate to the core capture element 310. In some embodiments, a suture (not shown) attaches the fixed arm 332 to the inner paddle 322. However, the fixed arm 332 can be attached to the inner paddle 322 by any suitable means (such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, or adhesives). The fixed arm 332 remains stationary or substantially stationary when the movable arm 334 is opened to open the reversible fastener 330 and to expose the return 336. By applying tension to the actuating line 316 attached to the end of the movable arm 334, the reversible fastener 330 is opened, thereby moving, flexing and / or pivoting the movable arm 334 over the connecting portion, or joint portion, flexure portion, or hinge portion 338.

[0089] During implantation, paddles 320, 322 are opened and closed, and natural valve leaflets are captured between paddles 320, 322 and / or between paddles 320, 322 and core capture element 310. In some embodiments, outer paddle 320 has a wide, curved shape that fits around the curved shape of core capture element 310 to more securely grip the valve leaflet. Also, the curved shape and rounded edges of outer paddle 320 prevent tearing of the valve leaflet tissue. Fastener 330 can be a reversible fastener, and the reversible fastener further secures the natural valve leaflet by engaging the valve leaflet by return 336 and sandwiching the valve leaflet between movable arm 334 and fixed arm 332. Return 336 (and / or other friction enhancing elements) of fastener 330 can increase friction with the valve leaflet or can partially or fully penetrate the valve leaflet. The actuation lines can be actuated independently such that each fastener 330 can be opened and closed independently. The independent movement allows one valve leaflet to be captured at a time or allows repositioning of fastener 330 on an inadequately captured valve leaflet without altering a successful grasp on the other valve leaflet. Fasteners 330 not only open and close independently of each other, but they can also be fully opened and closed independently of the position of inner paddle 322, thereby allowing valve leaflets to be grasped and / or captured at various positions depending on the particular situation.

[0090] Device 300 is loaded into the delivery sheath in a fully open position. The reason is that the fully open position occupies the least space, enabling the use of the smallest catheter (or enabling the use of the largest device 300 for a given catheter size). Referring to FIG. 14 here, the delivery sheath is inserted into the left atrium 20 through the septum, and device 300 is deployed from the delivery sheath 302 in a fully open condition. Then, the actuating element 312 is retracted to move device 300 to the fully closed condition shown in FIGS. 15 - 16, and then it is maneuvered towards the native valve (e.g., mitral valve 40) as shown in FIG. 17. Referring to FIG. 18 here, when device 300 is aligned with the native valve 40, the actuating element 312 is extended to open paddles 320, 322 to a partially open position, the actuating line 316 is retracted to open the fastener or releasable fastener 330, and preparations are made for cusp capture. Next, as shown in FIGS. 19 - 20, device 300, which is partially open, is inserted through the native valve or mitral valve 40 until the valve cusps are properly positioned between the inner paddle 322 and the core capture element 310 and inside the open fastener 330. FIG. 21 shows device 300 with both fasteners 330 closed, but the return 336 of one of the fasteners 330 has let one of the valve cusps 44 escape or is mispositioned over the valve cusp. As can be seen in FIGS. 22 - 23, the misaligned fastener 330 is opened and closed again to properly capture the escaped valve cusp 44. When both valve cusps 42, 44 are properly captured, the actuating element 312 is retracted to move device 300 to the fully closed position shown in FIG. 23A. Referring to FIG. 23B, with device 300 fully implanted in the native valve 40, the actuating element 312 is withdrawn, releasing the collar 303 from the upper end or plate 311 of device 300 or the core capture element 310, leaving device 300 implanted over the native valve.When implanted, the device 300 can be maintained in a fully closed position by mechanical means (e.g., a latch, etc.), or can 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 can be formed from steel or a nitinol shape memory alloy (created from wire, sheet, tubing, or laser sintered powder), and are biased, for example, to hold the outer paddle 320 in a closed state around the core capture element 310 and to hold the return fastener 330 in a state of sandwiching or adhering to the natural valve tip.

[0091] Referring now to FIGS. 24 - 25, an exemplary fastener 3500 configured as a return fastener for use in an implantable prosthesis device (e.g., the devices 100, 200, 300, etc. described above) is shown. Although shown and described as a return fastener, the return portion 3540 can be replaced with another type of friction enhancing portion. When an implantable prosthesis device (e.g., any device described in this application) is attached to natural tissue, the fastener 3500 is configured to capture the natural tissue. Similar to the fasteners described above, the return fastener 3500 includes a fixed arm 3510, a joint portion, flexure portion, or hinge portion 3520, and a movable arm 3530 having a return portion 3540. The fastener 3500 can be used in any of the implantable prosthesis devices of this application and can include any one or combination of the features of the fasteners described herein.

[0092] Also, the fastener 3500 includes an indicator arm 3550, which is adjacent to the movable arm 3530 and extends from an indicator bend or hinge portion 3560. In an exemplary embodiment, the indicator arm 3550 and / or the indicator bend or hinge portion 3560 is more elastic and / or flexible than the movable arm 3530 and / or the movable arm joint portion, bend portion, or hinge portion 3520. This increased elasticity and / or flexibility allows the indicator arm to bounce, pulsate, or jump, while the movable arm 3530 provides a firm grip on the valve tip 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 and can be used to determine that the fastener is properly engaged with the valve tip tissue. Thus, the indicator function of the indicator arm 3550 can be decoupled from the valve tip gripping and anchoring function of the movable arm 3530. This decoupling can be applied to any of the embodiments described herein.

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

[0094] The indicator arm 3550 is actuated separately from the movable arm 3530 and can facilitate the detection of the depth of engagement of the natural valve tip between the movable arm 3530 and the fixed 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 portion, bend portion, or hinge portion 3520 to the return portion 3540. The indicator arm can optionally have a return 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 portion, bend portion, or hinge portion 3520 to the return portion 3540 ensures that the valve tip positioned at the minimum engagement depth as indicated by the indicator arm 3550 engages the return portion 3540. That is, if the natural valve tip positioned within the fastener 3500 is engaged by the indicator arm 3550 when the indicator arm 3550 is actuated, the valve tip will be engaged by the return portion 3540 of the movable arm 3530. The opposite is also true. That is, if the natural valve tip positioned within the fastener 3500 is not engaged by the indicator arm 3550 when the indicator arm 3550 is actuated, the valve tip will not be engaged by the return portion 3540 of the movable arm 3530.

[0096] Referring now to FIGS. 24A and 25A, exemplary embodiments of fasteners such as those illustrated in FIGS. 24 and 25 are shown, with an X-ray opaque marker 2410 added on the indicator arm 3550. The X-ray opaque indicator can be printed directly on the bump, printed on a coil wound around the bump, printed on a fabric covering the bump, or otherwise fixed to the bump. The X-ray opaque indicator can be a platinum coil wound around the bump, or it can be X-ray opaque ink printed thereon. In FIGS. 24A and 25A, no return is shown on the indicator arm, but optionally, a return can be present on the indicator arm as shown in FIGS. 24 and 25.

[0097] Referring now to FIGS. 26-29, an exemplary fastener or a fastener with a return 3500 is shown that is disposed within a natural valve 40 for securing an implantable device (not shown) (e.g., devices 100, 200, 300, etc. described above) to one of the natural valve cusps 42, 44. Referring now to FIG. 26, the fastener with a return 3500 is shown in an open condition, with the natural valve cusps 42, 44 partially inserted into the opening of the fastener with a return 3500 formed between the fixed arm 3510 and the movable arm 3530. The indicator arm 3550 can be actuated via an actuation line (not shown) to determine whether the valve cusps 42, 44 have reached the desired engagement depth. Referring now to FIG. 27, the fastener is shown in a closed configuration, closed over the valve cusps 42, 44. The indicator arm 3550 has not yet been actuated.

[0098] Referring now to FIG. 28, the indicator arm 3550 is shown in the operative condition. The return 3540 on the movable arm 3530 pierces the native valve leaflets. The valve leaflets 42, 44 are inserted into the opening of the fastener 3540 at approximately half way between the return portion 3540 and the jointed, flexible or hinged portion 3520 and are 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 valve leaflets 42, 44. Instead, the indicator arm is swinging towards the fixed arm 3510. The position of the indicator arm can be viewed via an imaging device used to monitor the implantation and placement of the prosthesis device.

[0099] Referring now to FIG. 29, the fastener is closed over the valve leaflets 42, 44 and the valve leaflets are positioned deep enough into the fastener 3500 such that it overlaps the indicator arm 3550. The return 3540 on the movable arm 3530 pierces the native valve leaflets. The indicator arm is placed over the valve leaflet tissue and the valve leaflets prevent the indicator arm from moving completely towards the fixed arm 3510 of the fastener. The indicator arm as shown in FIG. 29 has a return 3540 to further secure the valve leaflets in place. In embodiments without a return on the indicator arm, the indicator arm may bounce with the pulsations of the heartbeat that pulsate the valve leaflets. This pulsation can be viewed by the imaging technique described above and can be used to indicate to the operator that the valve leaflets are positioned deep enough into the fastener.

[0100] Referring now to FIGS. 30 - 37, various exemplary arrangements of the movable arm and the indicator arm for the fastener are shown. Referring now to FIG. 30, an exemplary fastener 3600 (shown as a snap - back fastener) for use within an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) is shown. Similar to the snap - back fastener 3500 described above, the snap - back fastener 3600 includes a fixed arm 3610, a joint portion, bend portion, or hinge portion 3620, a movable arm 3630 having a snap - back portion 3640 (although other friction - enhancing portions may also be used), and an indicator arm 3650 connected to the joint portion, bend portion, or hinge portion 3620 via an indicator bend or hinge portion 3660. The fastener 3600 can be used within any of the implantable prosthesis devices of the present application and can include any one or 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 natural valve cusp. Also, the wider indicator arm 3650 can help sandwich the natural valve cusp against the fixed arm when the fastener 3600 is closed. The indicator bend 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 shape set at a pre - loading position or shape - setting position (not shown), providing an increased clamping force when in contact with the natural valve cusp tissue in the closed or engaged position (not shown).

[0102] Referring now to FIG. 31, an exemplary fastener 3700 for use in an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) is shown. Similar to the fastener 3500 described above, the fastener 3700 includes a fixed arm 3710, a joint portion, bending portion, or hinge portion 3720, a movable arm 3730 having a return portion 3740 (although other friction enhancing portions may be used), and an indicator arm 3750 connected to the joint portion, bending portion, or hinge portion 3720 via an indicator bending portion or hinge portion 3760. The fastener 3700 can be used in any of the implantable prosthesis devices of the present application and can include any one 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, and the central opening 3734 extends from the joint portion, bending portion, or hinge portion 3720 to the return portion 3740 of the movable arm 3730. The indicator arm 3750 is disposed within the central opening 3734 between the two side arms 3732. Since the movable arm 3730 extends across the full width of the fastener 3700, the return portion 3740 of the movable arm 3730 is as wide as the fastener 3700, and a larger area of the return portion 3740 is adapted to engage the natural valve cusp tissue.

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

[0105] The movable arm 3830 is formed from two side arms 3832 adjacent to a central opening 3834, which extends from the joint portion, flexure portion, 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 operable side arms 3832 each including a return portion 3840. The indicator arm 3850 is disposed within the central opening 3834 between the two side arms 3832. The return portions 3840 of the side arms 3832 extend across the full width of the fastener 3800, providing a wide gripping area for the movable arm 3830 to engage the native valve leaflet tissue. The side arms 3832 can be independently actuated to allow for lateral variations in the thickness of the native valve leaflet tissue.

[0106] Referring now to FIG. 33, an exemplary fastener 3900 for use within an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) is shown. Similar to the fastener 3500 described above, the fastener 3900 includes a fixed arm 3910, a joint portion, flexure portion, or hinge portion 3920, a movable arm 3930 having a return portion 3940 (although other friction enhancing portions may be used), and an indicator arm 3950 having a return portion 3970. The indicator arm 3950 is connected to the joint portion, flexure portion, or hinge portion 3920 via an indicator flexure or hinge portion 3960. The fastener 3900 is similar to the fastener 3500 described above, except for the addition of a return portion 3970 disposed at the end of the indicator arm 3950. The return portion 3970 enables the indicator arm 3950 to assist the movable arm 3930 when clamping a native valve cusp against a fixed arm (not shown). The fastener 3900 may be used within any of the implantable prosthesis devices of the present application and may include any one or combination of features of the other fasteners described herein.

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

[0108] Referring now to FIG. 34, an exemplary fastener 4000 (shown as a snap-back fastener) for use within an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) is shown. Similar to the fastener 3500 described above, the fastener 4000 includes a fixed arm 4010, a joint portion, bend portion, or hinge portion 4020, a movable arm 4030 having a snap-back portion 4040 (although other friction enhancing portions may be used), and an indicator arm 4050 connected to the joint portion, bend portion, or hinge portion 4020 via an indicator bend or hinge portion 4060. The indicator arm 4050 has a length that is approximately 25 percent of the maximum engagement depth measured between the joint portion, bend portion, or hinge portion 4020 and the snap-back portion 4040. Thus, the indicator arm 4050 will not indicate that the natural valve tip has reached the desired engagement depth until the valve tip is inserted at least approximately 75 percent of the maximum engagement depth. The fastener 4000 may be used within any of the implantable prosthesis devices of the present application and may include any one or combination of features of the other fasteners described herein.

[0109] Referring now to FIG. 35, an exemplary fastener 4100 for use in an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) is shown. Similar to the fastener 3500 described above, the fastener 4100 includes a fixed arm 4110, a joint portion, bend portion, or hinge portion 4120, a movable arm 4130 having a return portion 4140 (although other friction enhancing portions may be used), and an indicator arm 4150 connected to the joint portion, bend portion, or hinge portion 4120 via an indicator bend or hinge portion 4160. The indicator arm 4150 has a length that is about 50 percent of the maximum engagement depth measured between the joint portion, bend portion, or hinge portion 4120 and the return portion 4140. Thus, the indicator arm 4150 will not indicate that the natural valve tip has reached the desired engagement depth until the valve tip has been inserted at least about 50 percent of the maximum engagement depth. The fastener 4100 may be used in any of the implantable prosthesis devices of the present application and may include any or a combination of the features of the other fasteners described herein.

[0110] Referring now to FIG. 36, an exemplary fastener 4200 for use within an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) is shown. Similar to the fastener 3500 described above, the fastener 4200 includes a fixed arm 4210, a joint portion, bend portion, or hinge portion 4220, a movable arm 4230 having a snap-back portion 4240 (although other friction enhancing portions may be used), and an indicator arm 4250 connected to the joint portion, bend portion, or hinge portion 4220 via an indicator bend or hinge portion 4260. The indicator arm 4250 has a length that is about 75 percent of the maximum engagement depth measured between the joint portion, bend portion, or hinge portion 4220 and the snap-back portion 4240. Thus, the indicator arm 4250 will not indicate that the natural valve tip has reached the desired engagement depth until the valve tip has been inserted at least about 25 percent of the maximum engagement depth. The fastener 4200 can be used within any of the implantable prosthesis devices of the present application and can include any one or combination of features of the other fasteners described herein.

[0111] Referring now to FIG. 37, an exemplary fastener 4300 for use within an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) is shown. Similar to the fastener 3500 described above, the fastener 4300 includes a fixed arm 4310, a joint portion, bend portion, or hinge portion 4320, a movable arm 4330 having a return portion 4340, and an indicator arm 4350 connected to the joint portion, bend portion, or hinge portion 4320 via an indicator bend or hinge portion 4360. The indicator arm 4350 has a length that is about 90 percent of the maximum engagement depth measured between the joint portion, bend portion, or hinge portion 4320 and the return portion 4340 (although other friction enhancing portions may be used). Thus, the indicator arm 4350 will not indicate that the natural valve tip has reached the desired engagement depth until the valve tip is inserted at least about 10 percent of the maximum engagement depth. The fastener 4300 can be used within any of the implantable prosthesis devices of the present application and can include any one or combination of features of the other fasteners described herein.

[0112] Referring now to FIGS. 38 - 47, an exemplary fastener 3500 is shown, which is attached to the paddle of an implantable prosthesis device (e.g., devices 100, 200, 300, etc.) and is positioned within the natural valve 40 to secure the device to the natural valve tips 42, 44. Although the fastener 3500 is shown in FIGS. 93 - 102, the fasteners 3600, 3700, 3800, 3900, 4000, 4100, 4200, and 4300, which include the indicator arms described above, will be attached to the natural valve tips in a similar manner as the fastener 3500. The fastener 3500 is attached to the paddle 122 of the device 100, and the paddle 122 is moved between an open position and a closed position to capture and secure the natural valve tips 42, 44 within the device 100 as described above.

[0113] Referring now to FIG. 39, there is shown a device 100 that is positioned through a native mitral valve 40, with paddle 122 being open. Next, fastener 3500 is opened by applying tension to actuation lines 3502, 3504 that are respectively attached to the ends of movable arm 3530 and indicator arm 3550. Opening fastener 3500 and paddle 122 as shown in FIG. 39 allows device 100 to be maneuvered such that valve leaflets 42, 44 are at least partially disposed within an opening 3506 formed between fixed arm 3510 and movable arm 3530 of the fastener, facilitating capture of valve leaflets 42, 44 by fastener 3500.

[0114] Referring now to FIG. 39, paddle 122 and fastener 3500 are partially closed to position the valve leaflets for detection by indicator arm 3550 and for ultimate capture by fastener 3500. The partially closed position of paddle 122 and fastener 3500 allows return portion 3540 of movable arm 3530 to sandwich valve leaflets 42, 44 against fixed arm 3510 without stretching or moving valve leaflets 42, 44 so far that they are pushed aside by movable arm 3530 or slip off return portion 3540 during an attempted valve leaflet capture.

[0115] Referring now to FIG. 40, both indicator arms 3550 are actuated by releasing the tension on actuation line 3504. Both indicator arms 3550 have escaped or slipped off valve leaflets 42, 44 and have moved to a fully actuated position that extends beyond fixed arm 3510 of fastener 3500. Indicator arms 3550 that cross fixed arm 3510 form an X-shape that can be viewed via an imaging device used to monitor implantation and positioning of the device.

[0116] Referring now to FIG. 41, the indicator arm 3550 has been retracted by applying tension to the actuation line 3504, and the device 100 has been repositioned such that the valve tips 42, 44 are inserted deeper into the opening 3506 of the fastener 3500. Next, one of the indicator arms 3550 is allowed to close by releasing the tension applied to one of the actuation lines 3504, as can be seen in FIG. 42. The indicator arm 3550 engages the valve tip 42 and sandwiches the valve tip 42 against the fixed arm 3510 and the paddle 122. FIG. 43 shows the same, with the other indicator arm 3550 actuated to engage the other valve tip 44 and sandwich the valve tip 44 against the other fixed arm 3510 and the paddle 122. Engagement with the valve tips 42, 44 prevents the indicator arm 3550 from passing through the fixed arm 3510 of the fastener 3500 and forming the X-shaped configuration shown in FIG. 40. Thus, the indicator arm 3550 indicates to an observer observing the installation via the imaging device that the valve tips 42, 44 are inserted into the opening 3506 beyond a minimum desired engagement depth determined by the length of the indicator arm 3550.

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

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

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

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

[0121] The illustrated fixed arm 4410 has two tongue portions 4411, each tongue portion 4411 including a hole 4412 for attaching the fixed arm 4410 to an implantable device. A central opening 4454 disposed between the tongue portions 4411 is wider than the indicator arm 4450 such that the indicator arm 4450 passes through the fixed arm 4410 between the tongue portions 4411 and forms an X - shape when viewed from the side (FIG. 51) when the indicator arm 4450 is not engaged with the valve tip tissue.

[0122] The patterned flexure or patterned hinge portion 4420 is formed from a plurality of spring segments 4422 and cutouts 4424. 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 in the lateral direction. The side beams 4432 include a first flexure or hinge portion 4434 disposed toward the proximal end of the movable arm 4430 and a second flexure or hinge portion 4436 disposed at the distal end of the movable arm 4430. The first flexure or hinge portion 4434 is formed by one or more bends in the side beam 4432. The second flexure or hinge portion 4436 includes a thinner (and thus more flexible) portion that reduces the force required to fold the fastener 4400. The hoop shape of the movable arm 4430 and the flexible side arms 4432 allows the movable arm 4430 to be folded 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 looped shape of the movable arm 4430 provides a wider return portion 4440, which can include more returns 4442 with a lateral spacing that is the same as or greater than that of other fasteners. The wider spacing of the returns 4442 improves the capture of the natural valve tip. Also, the returns 4442 are longitudinally offset as a result of their position on the looped shape of the movable arm 4430. That is, the two central returns 4444 are positioned further away from the joint portion, bend portion, or hinge portion 4420, and the two outer returns 4446 are positioned closer to the joint portion, bend portion, or hinge portion 4420. Also, the return portion 4440 of the movable arm 4430 includes apertures 4448 for receiving an actuating suture (not shown). In certain embodiments, the loop shape of the movable arm 4430 is similar to the shape of the wide outer paddles of the implantable device, and the pinching force of the paddles is uniformly distributed over the returns to further improve the retention of the natural valve tip. The ends of the returns 4442 can be further sharpened using any suitable sharpening means.

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

[0126] The return portion 4456 of the indicator arm 4450 is disposed at a predetermined distance from the joint portion, the bending portion, or the hinge portion 4420, and the return 4456 of the indicator arm 4450 is arranged to be disposed longitudinally between the central return 4444 and the outer return 4446 of the return portion 4440. This arrangement ensures that the return portion 4440 engages the valve tip engaged by the indicator arm 4450. That is, when the indicator arm 4450 is actuated, if the natural valve tip positioned in the fastener 4400 is engaged by the return portion 4456 of the indicator arm 4450, the valve tip will also be engaged by the return portion 4440 of the movable arm 4430. The opposite is also true. That is, when the indicator arm 4450 is actuated, if the natural valve tip positioned in the fastener 4400 is not engaged by the indicator arm 4450, the valve tip will not be sufficiently engaged by the return portion 4440 of the movable arm 4430.

[0127] The indicator bending portion or hinge portion 4460 enables the indicator arm 4450 to be actuated separately from the movable arm 4430 and is disposed between the movable arm 4430 and the fixed arm 4410 of the fastener 4400 to facilitate detection of the depth of engagement of the natural valve tip. The indicator bending portion or hinge portion 4460 is similar to the patterned bending portion / 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 bending portion / hinge portion 4460 is less than the clamping force applied to the movable arm 4430 by the joint portion, bending portion, or hinge portion 4420, such that the indicator arm 4450 can be actuated multiple times to detect the position of the valve tip, while on the other hand, when the valve tip is held in the desired position by the indicator arm 4450 by return, the movable arm 4430 having a stronger clamping force is actuated. The lower clamping force of the indicator arm 4450 reduces the force applied onto the valve tip tissue and enables the indicator arm 4450 to be repositioned repeatedly, such that the likelihood of the indicator arm 4450 piercing or otherwise damaging the valve tip tissue is lower. Also, the lower clamping force enables the indicator arm 4450 to pulsate or jump when the heart beats.

[0128] Referring now to FIGS. 48 - 50, the fastener or fastener 4400 is shown in the open position. The movable arm 4430 and the indicator arm 4450 are biased in the closing direction or are spring-loaded and are moved to and held in the open position by the tension applied to an actuating line (not shown) attached respectively to holes 4448, 4452 in each of the movable arm 4430 and the indicator arm 4450.

[0129] Referring now to FIGS. 51-52, the fastener or reversible fastener 4400 is shown in a state where the indicator arm 4450 is in a fully deployed or actuated position (i.e., the farthest range that the indicator arm 4450 can reach when the indicator arm 4450 is not engaged with the valve tip tissue during actuation). When the tension applied to an actuating line (not shown) attached to the aperture 4452 in the end of the indicator arm 4450 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 fixed arm 4410, which can be seen via an imaging device, such that the operator knows that the indicator arm 4450 is not engaged with the valve tip.

[0130] Referring now to FIGS. 53-55, the fastener or reversible fastener 4400 is shown in a state where the indicator arm 4450 is in an engaged or closed position. That is, it is the position where the indicator arm 4450 would be when the valve tip tissue is engaged during actuation. When the tension applied to an actuating line (not shown) attached to the aperture 4452 in the end of the indicator arm 4450 is reduced, the indicator arm 4450 is permitted to actuate in the closing direction. In the closed position, the indicator arm 4450 does not intersect the fixed arm 4410 and does not form an X-shape with the fixed arm 4410. Thus, when the indicator arm 4450 is actuated and the X-shape cannot be seen when the fastener 4400 is viewed by the imaging device, the operator knows that the indicator arm 4450 is engaged with the valve tip tissue. Additionally, or alternatively, the indicator arm 4450 can be optically monitored to detect pulsation or jumping of the indicator arm when the heart beats. This jump or bound of the indicator arm indicates to the operator that the indicator arm is engaged with the valve tip tissue.

[0131] Referring now to FIGS. 56 - 58, the fastener or reversible 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 clamping force that holds the natural valve leaflet tissue in place within the fastener 4400. Additionally, a tortuous path for retaining the captured valve leaflet tissue is formed by the fixed arm 4410, the movable arm 4430, and the reversible portion 4440. The fastener 4400 is biased in the closed direction by the shaping of the movable arm 4430 and the indicator arm 4450 in the preloading position (FIGS. 59 - 61).

[0132] Referring now to FIGS. 59 - 61, the fastener 4400 is shown with the fixed arm 4410 and the indicator arm 4450 in the shaped or preloading position. As has been discussed with respect to other embodiments, the shaping of the fixed arm 4410 and the indicator arm 4450 relative to the movable arm 4430 forms a clamping force between the components of the fastener 4400 when the fastener 4400 is in the closed position.

[0133] Referring now to FIG. 59, the fixed arm 4410 is shaped at an angle 4410A from the movable arm 4430. In a particular embodiment, the angle 4410A between the neutral position and the shaped position of the tongue 4411 of the fixed arm 4410 is between about 180 degrees and about 270 degrees, or about 270 degrees. To move the fixed arm 4410 to the shaped position, the fixed arm 4410 is bent upwardly such that the tongue 4411 of the fixed arm 4410 passes through an opening in the movable arm 4430 formed between the side beam 4432 and the indicator arm 4450.

[0134] Referring back to FIG. 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 tangs 4411 of the fixed arm 4410 and forms the X-shape described above.

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

[0136] Referring now to FIG. 63, the indicator arm 4450 is actuated by releasing the tension on an actuation line (see FIG. 41) connected to the aperture 4452 at the end of the indicator arm 4450. Since the valve leaflets 42, 44 are not at or beyond the minimum engagement depth, the indicator arm 4450 escapes or slides off the valve leaflets 42, 44 and moves to a fully actuated position beyond the fixed arm 4410 of the fastener 4400. The indicator arm 4450 intersects the fixed arm 4410 and forms an X-shape that can be viewed via an imaging device used to monitor the implantation and placement of the prosthesis device.

[0137] Referring now to FIG. 64, the indicator arm 4450 is retracted by applying tension to the actuation line, and the fastener 4400 is repositioned so that the valve tips 42, 44 are inserted deeper into the opening 4406 of the fastener 4400. The indicator arm 4450 is then actuated by releasing the tension on the actuation line, as can be seen in FIG. 65. Since the valve tips 42, 44 are inserted into the fastener 4400 at or beyond the minimum desired engagement depth, the indicator arm 4450 engages and clamps the valve tips 42, 44 against the fixed arm 4410. The engagement with the valve tips 42, 44 prevents the indicator arm 4450 from passing through the fixed arm 4410 of the fastener 4400 and forming the cross shape shown in FIG. 63. 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 valve tip tissue. Thus, the indicator arm 4450 indicates to an observer observing the implantation via the imaging device that the valve tips 42, 44 are inserted into the opening 4406 beyond the minimum desired engagement depth determined by the length of the indicator arm 4450.

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

[0139] Referring now to FIGS. 84 - 102, an exemplary fastener (often illustrated as a return fastener, although other friction enhancing elements besides a return may be used) is shown with indicating features that are altered by engagement with native valve cusp tissue. For example, the fastener can include a bump or protrusion that flattens when native valve cusp tissue is pressed against it. The bump is sized large enough to be visible via an imaging device, and the absence of the bump is indicative that the bump has been pressed against native valve cusp tissue. Thus, the depth of engagement of the native valve cusp can be determined by the position of the bump and whether the bump is visible.

[0140] Referring now to FIG. 84, an exemplary embodiment of a portion of a laser cut fastener is shown. The fastener can have a movable arm 4530, a return region 4540, and an indicator arm 4550. The movable arm and the indicator arm each have a flexible portion or hinge portion 4520, 4560, respectively. The flexible region 4520 of the movable arm allows the fastener to be configured in an appropriate shape for implantation and / or allows the movable arm to approach the fixed arm (see FIGS. 85 - 89). The flexible region 4560 of the indicator arm allows the indicator arm to fall onto and / or bounce on the valve cusp. The indicator arm 4550 can have a flexible bump 4552 thereon that can be flattened to indicate that the valve cusp is positioned at a sufficient depth within the fastener. The bump 4552 can be positioned at a location on the indicator arm between the free end of the indicator arm and the flexible region 4560. The fastener (a portion of which is shown in FIG. 84) operates in the manner described with respect to FIGS. 85 - 89.

[0141] Referring now to FIGS. 85 - 86, an exemplary fastener 4500 for use within an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) is shown. Similar to the fastener 3500 described above, the fastener 4500 includes a fixed arm 4510, a joint, bend, or hinge portion 4520, a movable arm 4530 having a return portion 4540 (although other friction enhancing portions may be used), and an indicator arm 4550 connected to the joint, bend, or hinge portion 4520 via an indicator bend or hinge portion 4560. The indicator arm 4550 includes an indicating feature or bump 4552, which deforms when pressed against the native valve cusp tissue, indicating that the valve cusp tissue has reached the desired engagement depth. Thus, the indicating feature 4552 will not indicate that the native valve cusp has reached the minimum desired engagement depth until the valve cusp is inserted at or beyond the location of the indicating feature 4552. When the valve cusps 42, 44 reach the desired engagement depth, actuation of the indicator arm 4550 presses the indicating feature 4552 against the valve cusp tissue, flattening the indicating feature 4552, thereby indicating that the valve cusps 42, 44 have been inserted into the fastener 4500 at or beyond the desired engagement depth. The fastener 4500 may be used within any of the implantable prosthesis devices of the present application and may include any of the features or combinations of features of the other fasteners described herein.

[0142] Referring now to FIGS. 87-90, an exemplary fastener 4500 is shown disposed within a natural valve 40 for securing an implantable device (not shown) (e.g., devices 100, 200, 300, etc. described above) to one of the natural valve leaflets 42, 44. Referring now to FIG. 87, the fastener 4500 is shown in the open condition, with the natural valve leaflets 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 when the leaflets 42, 44 have reached the desired engagement depth, the indicator arm 4550 is actuated via an actuation line as shown in FIGS. 88-89 (see FIG. 133).

[0143] Referring now to FIG. 88, when the indicator arm 4550 is actuated to press the leaflets 42, 44 against the fixed 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 the desired position, the movable arm 4530 is actuated so that the leaflets 42, 44 can be secured within the snap fastener 4500 by the snap portion 4540.

[0144] Referring now to FIGS. 91-92, an exemplary fastener 4600 for use within an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) is shown. Similar to the fastener 3500 described above, the fastener 4600 includes a fixed arm 4610, a joint, bend, or hinge portion 4620, a movable arm 4630 having a return portion 4640 (although other friction enhancing portions may be used), and an indicator arm 4650 connected to the joint, bend, or hinge portion 4620 via an indicator bend or hinge portion 4660. The fixed arm 4610 includes an indicating feature or bump 4612, which deforms when natural valve tip tissue is pressed against the indicating feature 4612 by the indicator arm 4650, indicating that the valve tip tissue has reached a minimum desired engagement depth. Thus, the indicating feature 4612 will not indicate that the natural valve tip has reached the minimum desired engagement depth until the valve tip is inserted at or beyond the location of the indicating feature 4612. When the valve tips 42, 44 reach the desired engagement depth, actuation of the indicator arm 4650 presses the valve tip tissue 42, 44 against the indicating feature 4612, flattening the indicating feature 4612, thereby indicating that the valve tips 42, 44 have been inserted into the fastener 4600 at or beyond the desired engagement depth. The fastener 4600 may be used within any of the implantable prosthesis devices of the present application and may include any one or combination of features of the other fasteners described herein.

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

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

[0147] Referring now to FIGS. 97 - 98, an exemplary fastener 4700 for use within an implantable prosthesis device (e.g., devices 100, 200, 300 etc. described above) is shown. Similar to the fastener 3500 described above, the fastener 4700 includes a fixed arm 4710, a joint, bend, or hinge portion 4720, and a movable arm 4730 having a catch portion 4740 (although other friction enhancing portions may be used). Further, the movable arm 4730 includes an indicating feature or bump 4732 disposed between the catch portion 4740 and the joint, bend, or hinge portion 4720. The indicating feature 4732 deforms when natural valve leaflet tissue is pressed against the indicating feature 4732 by the fixed arm 4710, indicating that the valve leaflet tissue has reached a minimum desired engagement depth. Thus, the indicating feature 4732 will not indicate that the natural valve leaflet has reached the minimum desired engagement depth until the valve leaflet is inserted at or beyond the location of the indicating feature 4732. When the valve leaflets 42, 44 reach the desired engagement depth, actuation of the movable arm 4730 compresses the valve leaflet tissue 42, 44 between the fixed arm 4710 and the indicating feature 4732, flattening the indicating feature 4732, thereby indicating that the valve leaflets 42, 44 have been inserted into the fastener 4700 at or beyond the desired engagement depth. The fastener 4700 may be used within any of the implantable prosthesis devices of the present application and may include any one or combination of features of the other fasteners described herein.

[0148] Referring now to FIGS. 99-100, there is shown an exemplary releasable fastener 4700 disposed within natural valve 40 for securing an implantable device (not shown) (e.g., devices 100, 200, 300, etc. described above) to one of natural valve leaflets 42, 44. Referring now to FIG. 99, the releasable fastener 4700 is shown in an open condition, with natural valve leaflets 42, 44 partially inserted into opening 4706 of the releasable fastener 4700 formed between fixed arm 4710 and movable arm 4730. To determine whether the valve leaflets 42, 44 have reached a desired engagement depth, movable arm 4730 is actuated via an actuation line (not shown) as shown in FIG. 100.

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

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

[0151] Referring now to FIGS. 101 - 102, an exemplary fastener 4800 for use within an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) is shown. Similar to the fastener 3500 described above, the fastener 4800 includes a fixed arm 4810, a joint portion, bend portion, or hinge portion 4820, and a movable arm 4830 having a snap-back portion 4840 (although other friction enhancing portions may be used). The fixed arm 4810 also includes an indicating feature or bump 4812, which is disposed at a distance from the joint portion, bend portion, or hinge portion that is less than the distance between the snap-back portion 4840 and the joint portion, bend portion, or hinge portion 4820. The indicating feature 4812 deforms when natural valve leaflet tissue is pressed against the indicating feature 4812 by the movable arm 4830, indicating that the valve leaflet tissue has reached a minimum desired engagement depth. Thus, the indicating feature 4812 will not indicate that the natural valve leaflets 42, 44 have reached the desired engagement depth until the valve leaflets 42, 44 are inserted at or beyond the location of the indicating feature 4812. When the valve leaflets 42, 44 reach the desired engagement depth, actuation of the movable arm 4830 compresses the valve leaflet tissue 42, 44 against the indicating feature 4812 of the fixed arm 4810, flattening the indicating feature 4812, thereby indicating that the valve leaflets 42, 44 have been inserted into the fastener 4800 at or beyond the desired engagement depth. The fastener 4800 can be used within any of the implantable prosthesis devices of the present application and can include any one or combination of features of the other fasteners described herein.

[0152] Referring now to FIG. 101, a fastener 4800 is shown, and the natural valve tips 42, 44 are partially inserted into the opening 4806 of the fastener 4800 formed between the fixed arm 4810 and the movable arm 4830. To determine whether the valve tips 42, 44 have reached the desired engagement depth, the movable arm 4830 is actuated via an actuation line.

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

[0154] As can be seen in FIG. 102, when the valve tips 42, 44 are inserted into the fastener 4800 at or beyond the minimum engagement depth, and when the valve tips 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 valve tips 42, 44. That is, the indicating feature 4812 is deformed by the valve tips 42, 44, indicating that the valve tips 42, 44 have been inserted at or beyond the minimum engagement depth. Also, in some embodiments, the actuation of the movable arm 4830 engages and secures the return portion 4840 with the valve tips 42, 44 within the return fastener 4800. If the indicating feature 4812 indicates that the valve tips 42, 44 have not been inserted to the desired depth, the return fastener 4800 can be opened to allow repositioning of the valve tips 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 flexible indicator 1031 is cut from a single sheet. The movable arm 5230 has a cutout opening 6730 and at least one tab 5240, as well as a flexible section 5220, and the flexible section 5220 allows the movable arm to bend, be shaped, or otherwise be positioned in a proper configuration to form the fastener. The fixed arm 5210 has two cutouts 6740 and the flexible indicator therein, the two cutouts 6740 each extending along the length of the fixed arm, and the flexible indicator extending across the length of the fixed arm between the cutouts 6740. Also, the fixed arm 5210 can have an optional flexible section 4470, and the optional flexible section 4470 can be attached to a paddle portion or a core portion or a spacer portion, enabling the paddle and the fastener to optionally be made from a single piece, or enabling the fastener and the core or spacer portion to optionally be made from a single piece. The flexible indicator 1031 can optionally have an 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 it can be applied to the flexible indicator in any of the manners of the embodiments described herein.

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

[0157] Bump 1031 deforms and flattens when natural valve leaflet tissue is pressed against bump 1031 by movable arm 5230, indicating that the valve leaflet tissue has reached the minimum desired engagement depth. Thus, bump 1031 will not indicate that natural valve leaflets 42, 44 have reached the desired engagement depth until valve leaflets 42, 44 are inserted at or beyond the location of bump 1031. When valve leaflets 42, 44 reach the desired engagement depth, actuation of movable arm 5230 compresses valve leaflet tissue 42, 44 against bump 1031 of fixed arm 5210, flattening bump 1031, thereby indicating that valve leaflets 42, 44 have been inserted into fastener 5200 at or beyond the desired engagement depth. Fastener 5200 can be used in any of the implantable prosthesis devices of the present application and can include any or combination of features of the other fasteners described herein.

[0158] Referring now to FIGS. 107-109, an exemplary fastener 5200 shown in FIGS. 104-106 is disposed within a natural valve 40 for securing an implantable device (not shown) (e.g., devices 100, 200, 300, etc. described above) to one of the natural valve leaflets 42, 44. Referring now to FIG. 107, the fastener 5200 is shown in an open condition, with the natural valve leaflets 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 optionally have an X-ray opaque indicator thereon. The X-ray opaque 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 fixed to the bump. The X-ray opaque indicator can be a platinum coil wrapped around the bump, or it can be an X-ray opaque ink printed thereon.

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

[0160] Referring now to FIGS. 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 shown. Referring to FIG. 103A, the flexible indicator arm can be a flexible “wing” indicator 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 a sheet of the same material as the laser cut fastener or can be a separately cut piece attached to the fastener. Similar to other exemplary embodiments described herein, the indicator arm can have a different thickness than the fastener and can provide a different amount of flexibility. The flexible wing indicator can extend outwardly and inwardly at a predetermined angle from the movable arm, similar to the wings of a butterfly. The flexible wing indicator can be attached to the movable or fixed arm. The flexible wing indicators 1032 can each have an optional radiopaque indicator element 1030 thereon. Similar to 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 a predetermined angle from the movable arm 5230 of the fastener outwardly away from the longitudinal axis of the fastener and toward the center of the fastener toward the fixed arm. When the valve tip is captured by the fastener and a force is applied to the flexible wing indicator 1032, the flexible wing indicator flexes back toward the movable arm (see FIGS. 108A and 109A with respect to the schematic illustrations).

[0161] Referring now to FIG. 103B, a flexible wire indicator 1031 can be positioned within the opening 6740 of the fixing arm 5210 of the fastener. This can be in addition to the flexible wing indicator 1032, or can exist without the flexible wing indicator. The flexible wire indicator can be a wire extending along the longitudinal axis of the opening 6740 of the fastener, attached near the bend or hinge portion 4470 at one end and near the bend or hinge portion 5220 at the other end. Optionally, there can be X-ray opaque markers 1030 positioned along the length of the flexible wire indicator 1031. The wire can be held in place by being fixed at the attachment point 1034. The attachment point can have a wire indicator attached by welding, suturing, or other known attachment methods. FIGS. 108B and 109B illustrate schematic views of an exemplary embodiment of the fastener in FIG. 103B when the valve tip is positioned within the fastener at a depth sufficient to bend the indicators 1031, 1032. FIG. 103D illustrates an exemplary embodiment having only the flexible wire indicator 1031 without the flexible wing indicator. FIGS. 108D and 109D illustrate schematic views of an exemplary embodiment of the fastener in FIG. 103D when the valve tip is positioned within the fastener at a depth sufficient to bend the indicator 1031.

[0162] Referring now to FIG. 103C, an exemplary embodiment of a fastener having a flexible wire indicator 1031 is illustrated. A flexible wire indicator 1031 can be present, which extends longitudinally across the opening 6740 and has an optional radiopaque indicator 1030 positioned along the wire indicator 1031 and is secured to the fastener at an attachment point 1034. Also, the flexible wire indicator 1031 can 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 part way across the opening and can be attached near the bend or hinge portion 5220 at one end and at the other end can be attached at a cross-piece 1033 that extends horizontally across the opening 6740. The cross-piece can optionally have a radiopaque indicator printed or attached thereto. The flexible wire indicator can optionally have a radiopaque marker 1030 positioned along its length. FIGS. 108C and 109C illustrate schematic views of the exemplary embodiment of the fastener in FIG. 103C when the valve tip is positioned in the fastener at a depth sufficient to bend the indicator 1031.

[0163] Referring now to FIGS. 104A and 106A, a schematic view of an exemplary embodiment of a fastener for use in an implantable prosthesis device (such as, for example, the exemplary embodiment shown in FIG. 103A) having a flexible "wing" indicator 1032 (one attached to each side of the movable arm 5230) is illustrated. The flexible wing indicator is capable of extending laterally outwardly from the movable arm and at a predetermined angle toward the end of the fixed arm. Although shown attached to the movable arm here, the flexible wing indicator may alternatively be attached to the fixed arm, optionally. The flexible wing indicator 1032 can each have an optional indicator element 1030 thereon. FIG. 106A illustrates a side view of the embodiment illustrated in FIG. 104A. In FIGS. 104A and 106A, the fastener is in the open position and the flexible wing indicator 1032 extends outwardly from the movable arm as shown in FIG. 104A and inwardly toward the portion of the fastener where the valve tip will be positioned as shown in FIG. 106A. An optional radiopaque indicator 1030 on the flexible wing indicator is shown.

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

[0165] Referring now to FIGS. 108A and 109A, the use of the fastener of the exemplary embodiment of FIG. 103A is illustrated. Referring now to FIG. 108A, when the movable arm 5230 is actuated to push the valve tips 42, 44 against the fixed arm 5210, the valve tips 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 valve tips 42, 44 is less than the minimum engagement depth. As can be seen in FIG. 109A, when the valve tips are inserted into the fastener 4600 at or beyond the minimum engagement depth and when the valve tips are pressed against the flexible wing indicator 1032 by the fixed arm 5210, the flexible wing indicator 1032 (only one flexible wing indicator can be seen in FIG. 109A because the other is directly behind it) is deformed or flattened from contact with the valve tips 42, 44. The location of the optional radiopaque indicating element 1030 can indicate to the user how far the flexible wing indicator has moved and thus can determine the position of the valve tips.

[0166] Referring now to FIGS. 104B and 106B, a schematic view of an exemplary embodiment of a fastener (shown as a snap fastener) for use in an implantable prosthesis 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) is illustrated. The flexible wing indicators are capable of extending at a predetermined angle away from the movable arm and toward the open end of the fastener. Although shown attached to the movable arm here, the flexible wing indicators may optionally be attached to the fixed arm. The flexible wing indicators 1032 can each have indicator elements 1030 thereon. FIG. 106B illustrates a schematic side view of the embodiment shown in FIG. 104B. In FIGS. 104B and 106B, the fastener is in the open position and the flexible wing indicators 1032 extend outwardly from the movable arm as shown in FIG. 104B and inwardly toward the portion of the fastener where the valve tip will be positioned as shown in FIG. 106B. The longitudinally extending wire indicator 1031 has a bump configuration when in its non-compressed state at rest (such as when the fastener is open). Optional radiopaque indicators 1030 are shown on the flexible wing indicators and on the wire indicator 1031.

[0167] The flexible wing indicator 1032 deforms to be flat when the fastener is closed and the natural valve leaflet tissue is pressed against them, indicating that the valve leaflet tissue has reached the minimum desired engagement depth and a horizontal position along the fastener. In one exemplary embodiment, if the valve leaflet is inserted off-center into the fastener, only one of the flexible wing indicators 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 valve leaflet when the valve leaflet is positioned thereon when the fastener is closed.

[0168] Referring now to FIG. 108B, when the movable arm 5230 is actuated to push the valve tips 42, 44 against the fixed arm 5210, the valve tips 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 valve tips 42, 44 is less than the minimum engagement depth. As can be seen in FIG. 109B, when the valve tips are inserted into the fastener 4600 at or beyond the minimum engagement depth, and when the valve tips are pressed against the flexible wing indicator 1032 by the fixed arm 5210 and against the wire indicator 1031 by the movable arm, the flexible wing indicator 1032 (only one flexible wing indicator can be seen in FIG. 109B because the other is directly behind it) and the wire indicator 1031 are deformed or flattened from contact with the valve tips 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 the 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 moved and thus can determine the position of the valve tips.

[0169] Referring now to FIGS. 104C and 106C, a schematic view of an exemplary embodiment of a fastener (shown as a snap fastener) for use within an implantable prosthesis device (e.g., but not limited to, the exemplary embodiment shown in FIG. 103C having two flexible wire indicators 1031) is illustrated. Each of the indicators has a bump configuration. One indicator is attached to a movable arm and one indicator is attached to a fixed arm. Also, in some exemplary embodiments, the indicators extending along the movable and fixed arms can be laser cut and attached to the arms. The wire indicators 1031 can optionally have radiopaque indicator elements, and the optional radiopaque indicator elements can be attached to, printed on, and / or wound around them. For example, the radiopaque indicator can be a coil made of a radiopaque material wound around at least a portion of the wire. FIG. 106C illustrates a schematic side view of the embodiment shown in FIG. 104C. In FIGS. 104C and 106C, the fastener is in an open position, the wire indicators 1031 have a bump configuration in which the bumps extend inwardly into the fastener toward the location where the valve tip will be inserted.

[0170] Referring now to FIG. 108C, when the movable arm 5230 is actuated to push the valve tips 42, 44 against the fixed arm 5210, the valve tips 42, 44 may contact a portion of the fixed arm 5210 and a portion of the movable arm 5230 without contacting any of the wire indicators 1031 when the engagement depth of the valve tips 42, 44 is less than the minimum engagement depth. When the fastener is closed and the valve tips are not at the minimum engagement depth or there are no valve tips in the fastener at all, the wire indicators 1031 flatten and deform due to the pressure applied by each wire indicator against the other wire indicators when they are pressed against each other. As shown, two optional radiopaque indicating elements 1030 become adjacent to each other and provide an indication that the valve tips were not engaged.

[0171] Referring now to FIG. 109C, the wire indicators 1031 deform and flatten against the valve tips when natural valve tip tissue is pressed against them when the fastener is closed, indicating that the valve tip tissue has reached the minimum desired engagement depth and a horizontal position along the fastener. When the valve tips are off-center over the wire indicators when the fastener is closed, the wire indicators 1031 maintain their bump shape and pass through the opening 6730 in the movable arm of the fastener. As shown, two optional radiopaque indicating elements 1030 are spaced apart and indicate that the valve tips are engaged.

[0172] Referring now to FIGS. 104D and 106D, there is shown a schematic view of an exemplary embodiment of a fastener (shown as a snap fastener) for use in an implantable prosthesis device (such as, but not limited to, the exemplary embodiment shown in FIG. 103D having a flexible indicator 1031 with a bump configuration). 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 formed integrally with one of the arms. The indicator 1031 can have an optional radiopaque indicator element 1030 attached to or wound around it. For example, the radiopaque indicator can be a coil made of a radiopaque material wound around at least a portion of the wire. Also, the movable arm 5230 can have an optional radiopaque indicator element 1030 thereon. FIG. 106D shows a schematic side view of the embodiment shown in FIG. 104D. In FIGS. 104D and 106D, the fastener is in an open position, and the indicator 1031 has a bump configuration in which the bumps extend into the fastener toward the location where the valve tip is to be inserted.

[0173] Referring now to FIG. 108D, when the movable arm 5230 is actuated to push the valve tips 42, 44 against the fixed arm 5210, the valve tips 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 valve tips 42, 44 is less than the minimum engagement depth. When the fastener is closed and the valve tips are not at the minimum engagement depth or there are no valve tips in the fastener at all, the wire indicator 1031 can be deformed to be at least partially flat 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 is partially flattened by the pressure applied thereto by the fixed arm. As shown, two optional radiopaque indicating elements 1030 are adjacent to each other and provide an indication that the valve tips were not engaged.

[0174] Referring now to FIG. 109D, the wire indicator 1031 deforms to be flat against the valve tips when natural valve tip tissue is pressed against them when the fastener is closed, indicating that the valve tip tissue has reached the minimum desired engagement depth and a horizontal position along the fastener. As shown, two optional radiopaque indicating elements 1030 are spaced apart and indicate that the valve tips are engaged.

[0175] Referring now to FIGS. 104E and 106E, there is shown a schematic view of an exemplary embodiment of a fastener (shown as a snap fastener) for use in an implantable prosthesis device having a flexible indicator 1031 with a bump configuration connected to a fixed arm 5210 and an opening 6730 in a 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. Indicator 1031 can have an optional radiopaque indicator element 1030 attached or wound thereon. For example, the radiopaque indicator can be a coil made of a radiopaque material wound around at least a portion of a wire. Movable arm 5230 has an opening 6730 therein and can also have an optional radiopaque indicator element 1030 on the side arms of its frame. FIG. 106E shows a schematic side view of the embodiment illustrated in FIG. 104E. In FIGS. 104E and 106E, the fastener is in an open position and indicator 1031 has a bump configuration in which the bumps extend inwardly into the fastener toward the location where the valve tip will be inserted.

[0176] Referring now to FIG. 108E, when the movable arm 5230 is actuated to push the valve tips 42, 44 against the fixed arm 5210, the valve tips 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 valve tips 42, 44 is less than the minimum engagement depth. When the fastener is closed and the valve tips are not at the minimum engagement depth or there are no valve tips in the fastener at all, the indicator 1031 remains unflattened or is only partially flattened, and the indicator 1031 can enter or pass through the opening 6730 of the movable arm when the valve tips are not properly inserted into the fastener. As shown, an optional radiopaque indicating element 1030 is aligned when the indicator 1031 moves into the opening in the movable arm, providing an indication that the valve tips were not engaged.

[0177] Referring now to FIG. 109E, the wire indicator 1031 deforms and flattens against the valve tips when the natural valve tip tissue is pressed against them when the fastener is closed, indicating that the valve tip tissue has reached the minimum desired engagement depth within the fastener. As shown, two optional radiopaque indicating elements 1030 are spaced apart, indicating that the valve tips are engaged.

[0178] Figures 226-229 illustrate variations of the fastener 4400 shown by Figures 48-66. In the examples illustrated by Figures 226-229, the fastener includes a flexible wire indicator 1031 that extends longitudinally across the 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 Figure 227), and the other end of the wire is attached at the opposite end of the movable arm 4430 between the returns 4444. The fastener 4400 can be used within an implantable prosthesis device (e.g., the devices 100, 200, 300 described above or any other implantable prosthesis device).

[0179] The fastener 4400 illustrated by Figures 226-229 has a fixed arm 4410, a patterned bend or patterned hinge portion 4420, a movable arm 4430 formed in the shape of a hoop or loop, and a return portion 4440 of the movable arm 4430 (although other friction-enhancing portions can also be used). In this embodiment, the valve tip depth indicator can be a flexible feature, the flexible feature can be the wire indicator 1031, and the wire indicator 1031 remains flat in a straight configuration when the fastener is open and when there is no valve tip positioned to overlap it within the closed fastener. When a valve tip is present, the wire indicator 1031 is pressed through the hoop-shaped movable arm 4430. An optional radiopaque coil 1030 can be wound around the indicating wire 1031 and can be seen using imaging techniques such as fluoroscopy. When the indicating wire and coil are visible outside the movable arm 4430 of the fastener, the amount of the indicating arm 1031 and / or coil 1030 that can be seen indicates the valve tip depth to the operator.

[0180] Fastener 4400 can include any one or combination of features of the other fasteners described herein. Fastener 4400 can be laser cut from a flat sheet or tube of shape memory alloy (such as Nitinol, for example), and then shaped to a desired shape.

[0181] The illustrated fixed arm 4410 has two tong portions 4411, each of which includes an optional aperture 4412 for attaching the fixed arm 4410 to a device into which it can be implanted.

[0182] The flexure or hinge portion 4420 can take a wide variety of different forms. In the illustrated example, the flexure or hinge portion 4420 is formed from a plurality of spring segments 4422 and cutouts 4424. The tong 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.

[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 in the lateral direction. The side beams 4432 include a first flexure or hinge portion 4434 disposed toward the proximal end of the movable arm 4430 and a second flexure or hinge portion 4436 disposed at the distal end of the movable arm 4430. The first flexure 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 allow the movable arm 4430 to be folded by simply retracting the fastener 4400 into a delivery sheath (not shown).

[0184] The looped shape of the movable arm 4430 provides a wider return portion 4440, which can include more returns 4442 with a lateral spacing that is the same as or greater than that of other fasteners. The wider spacing of the returns 4442 improves the capture of the natural valve tip. Also, the returns 4442 are optionally longitudinally offset as a result of their position on the looped shape of the movable arm 4430. That is, the two central returns 4444 are positioned further away from the flexure or hinge portion 4420, and the two outer returns 4446 are positioned closer to the flexure or hinge portion 4420. Also, the return portion 4440 of the movable arm 4430 includes optional apertures 4448 for receiving an actuating suture (not shown). In certain embodiments, the loop shape of the movable arm 4430 is similar to the shape of the wide outer paddles of the implantable device, and the clamping force of the paddles is uniformly distributed over the returns to further improve the retention of the natural valve tip. The ends of the returns 4442 can be further sharpened using any suitable sharpening means.

[0185] Referring now to FIGS. 226 and 227, the fastener 4400 is shown in the open position. The movable arm 4430 is biased or spring-loaded in the closing direction and is moved to and held in the open position by the tension applied to an actuating line (not shown). The indicating wire 1031 is in a straight, unbent configuration because there is no valve tip engaged within the open fastener in FIGS. 226-227.

[0186] Referring now to FIG. 228, the fastener 4400 is shown in a fully implanted or actuated position with the valve tip not in the proper location. The indicating wire 1031 with an optional radiopaque coil 1030 remains unbent and is positioned inside 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 an indicator arm outside the profile of the fastener 4400, as seen by the imaging device, indicates to the operator that the valve tip has not been captured.

[0187] Referring now to FIG. 229, the fastener 4400 is shown with the movable arm 4430 in the closed position. When the fastener 4400 is closed, the movable arm 4430 and the indicator arm 4450 exert a clamping force that holds the native valve tip tissue in place so as to be fixed within the fastener 4400. The fastener 4400 is biased in the closing direction by the shaping of the movable arm 4430 in the preloading position. The closed fastener has captured a sufficient amount of valve tip tissue, i.e., the depth of the valve tip within the fastener is sufficient such that, as indicated by the indicating wire 1031 and coil 1030 that are bent through the opening of the hoop-shaped movable arm, the fastener is considered to be properly positioned, and a portion of the indicating wire 1031 and / or coil 1030 is adapted to move through the outer profile of the movable arm 4430 of the fastener 4400. The indicating wire 1031 and / or coil 1030 extending beyond the profile of the fastener can be seen on an imaging device (e.g., a fluoroscopy device, etc.) as represented by FIG. 229 and can indicate that the valve tip has been properly captured by the fastener 4400.

[0188] Figures 230-233 illustrate variations of the fastener 4400 shown by Figures 48-66. In the example illustrated by Figures 230-233, the fastener includes a flexible wire indicator 1031 that extends horizontally across the hoop-shaped movable arm 4430. Each end of the wire is attached to the side arm 4432 of the movable arm 4430. The wire indicator 1031 can be positioned anywhere that indicates proper insertion of the natural valve tip. In one exemplary embodiment, the wire indicator is positioned closer to the bending region or hinge region than the return region of the fastener. The fastener 4400 can be used within an implantable prosthesis device (e.g., device 100, 200, 300 described above or any other implantable prosthesis device).

[0189] The fastener 4400 illustrated by Figures 230-233 has a fixed arm 4410, a patterned bending portion or patterned hinge portion 4420, a movable arm 4430 formed in the shape of a hoop or loop, and a return portion 4440 of the movable arm 4430. In this embodiment, the valve tip depth indicator can be a flexible feature, the flexible feature can be the wire indicator 1031, and the wire indicator 1031 remains flat in a straight configuration when the fastener is open and when there is no valve tip positioned to overlap it within the closed fastener. When a valve tip is present, the wire indicator 1031 is pressed through the hoop-shaped movable arm 4430. An optional radiopaque coil 1030 can be wound around the indicating wire 1031 and can be seen using imaging techniques such as fluoroscopy. When the indicating wire and coil are visible outside the movable arm 4430 of the fastener, the amount of the indicating arm 1031 and / or coil 1030 that is visible indicates the depth of the valve tip to the operator.

[0190] Referring now to FIGS. 230 and 231, the fastener 4400 is shown in the open position. The movable arm 4430 is biased in the closing direction or is spring-loaded and is moved to and held in the open position by the tension applied to an actuation line (not shown). The indicating wire 1031 is configured to be straight and unbent. This is because there is no valve tip engaged within the open fastener in FIGS. 230 and 231.

[0191] Referring now to FIG. 232, the fastener 4400 is shown in the fully seated or actuated position with the valve tip not in place. The indicating wire 1031 with an optional radiopaque coil 1030 remains unbent, is positioned on the inner side of the movable arm, and / or does not extend beyond the outer profile of the movable arm 4430. The indicating wire 1031 and the coil 1030 are not visible outside the profile of the movable arm 4430 in FIG. 232. The absence of an indicator arm outside the profile of the fastener 4400 as seen by the imaging device indicates to the operator that the valve tip has not been captured.

[0192] Referring now to FIG. 233, the fastener 4400 is shown with the movable arm 4430 in the closed position. When the fastener 4400 is closed, the movable arm 4430 and the indicator arm 4450 exert a clamping force that holds the natural valve tip tissue so as to be fixed within the fastener 4400. The fastener 4400 is biased in the closing direction by the shaping of the movable arm 4430 in the preloading position. The closed fastener has captured a sufficient amount of valve tip tissue, i.e., the depth of the valve tip within the fastener is sufficient such that, as indicated by the indicating wire 1031 and coil 1030 that are deflected through the opening of the hoop-shaped movable arm, it is considered that the fastener is properly positioned, and a portion of the indicating wire 1031 and / or coil 1030 is adapted to move through the outer profile of the movable arm 4430 of the fastener 4400. The indicating wire 1031 and / or coil 1030 that extends beyond the profile of the fastener can be seen on an imaging device (e.g., a fluoroscopy device, etc.) as represented by FIG. 233 and can indicate that the valve tip has been properly captured by the fastener 4400.

[0193] Figures 234 - 237 illustrate variations of the fastener 4400 shown by Figures 48 - 66. In the example shown by Figures 234 - 237, the fastener includes a flexible wire indicator 1031 that extends longitudinally across the 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 that extends horizontally across an opening in the movable arm 4430. The cross wire 1033 can be positioned across the middle of the movable arm, near the return end rather than the hinge portion, or near the hinge or hinge-like portion rather than the return portion, depending on the minimum valve tip insertion depth. The cross wire 1033 can be replaced with a laser cut sheet component, which can be integrally formed with the fastener or can be a separate piece attached to the fastener. The fastener 4400 can be used within an implantable prosthesis device (e.g., device 100, 200, 300 described above or any other implantable prosthesis device).

[0194] The fastener 4400 has a fixed arm 4410, a patterned flexure or patterned hinge portion 4420, a movable arm 4430 formed in the shape of a hoop or loop, and a return portion 4440 of the movable arm 4430. In this embodiment, the valve tip depth indicator can be a flexible wire 1031, and the flexible wire 1031 remains flat in a straight configuration when the fastener is open and when there is no valve tip positioned against the indicator within the closed fastener. When the valve tip is present, the wire indicator 1031 is pressed through the hoop-shaped movable arm 4430. An optional radiopaque coil 1030 can be wound around the indicating wire 1031 and can be seen using imaging equipment such as fluoroscopy. When the fastener is closed over a valve tip inserted to a sufficient depth within the fastener, the indicating wire 1031 and coil 1030 extend through and beyond the peripheral or edge outside the movable arm 4430 of the fastener 4400. The amount of the indicating arm 1031 and coil 1030 that is exposed passing through the periphery or outer edge of the movable arm 4430 indicates to the operator the depth of the valve tip.

[0195] Referring now to FIGS. 234 and 235, the fastener 4400 is shown in the open position. The movable arm 4430 is biased or spring-loaded in the 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, unbent configuration. This is because there is no valve tip engaged within the open fastener in FIGS. 234 and 235.

[0196] Referring now to FIG. 236, the fastener 4400 is shown in a fully implanted or actuated position with the valve tip not in the proper location. The indicating wire 1031 with an optional radiopaque coil 1030 remains unbent and is positioned inside the inner side of the movable arm 4430. The indicating wire 1031 and the coil 1030 are not visible outside the profile of the movable arm 4430. The absence of an indicator arm outside the profile of the fastener, as seen by the imaging device, indicates to the operator that the valve tip has not been captured.

[0197] Referring now to FIG. 237, the fastener 4400 is shown with the movable arm 4430 in the closed position. When the fastener 4400 is closed, the movable arm 4430 and the indicator arm 4450 exert a clamping force that holds the native valve tip tissue so as to be fixed within the fastener 4400. The fastener 4400 is biased in the closing direction by the shaping of the movable arm 4430 in the preloading position. The closed fastener has captured a sufficient amount of valve tip tissue. That is, the depth of the valve tip within the fastener is sufficient such that, as indicated by the indicating wire 1031 and the coil 1030 that are deflected through the hoop-shaped movable arm 4430, it is considered that the fastener is properly positioned, and a portion of the indicating wire 1031 and / or the coil 1030 is adapted to move through the outer profile of the movable arm 4430 of the fastener 4400. The indicating wire 1031 and / or the coil 1030 that extends beyond the profile of the fastener can be seen on an imaging device (e.g., a fluoroscopy device, etc.) as represented by FIG. 237, and can indicate that the valve tip has been properly captured by the fastener 4400.

[0198] Figures 238-241 illustrate variations of the fastener 4400 illustrated by Figures 48-66. In the example illustrated by Figures 238-241, the fastener has a flexible wire indicator 1031 that loops multiple times through an opening 2380 in a side beam 4432 of a movable arm 4430. The flexible wire indicator 1031 is “woven” or stretched 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 portion 1031a of the wire indicator is curved and extends inwardly toward the interior of the fastener. In the illustrated example, the outer portion 1031b of the movable arm extends straight or substantially straight across the side beams 4432 when the fastener is open. However, in some exemplary embodiments, the portion 1031b can have the same or substantially the same shape as the portion 1031a. The fastener 4400 can be used in an implantable prosthesis device (e.g., the devices 100, 200, 300 described above or any other implantable prosthesis device).

[0199] The fastener 4400 illustrated by FIGS. 238 to 241 has a fixed arm 4410, a patterned bent portion or a patterned hinge portion 4420, and a movable arm 4430 formed in the shape of a hoop or a loop. In the illustrated embodiment, the inner curved portion 1031a is curved in a bump configuration, the outer portion 1031b is flat or substantially flat, and is positioned immediately outside the movable arm 4430 when the fastener 4400 is open and when there is no valve tip positioned to overlap the indicator when the fastener is closed. In the example shown, there are four inner portions 1031a and three outer portions 1031b. However, any number of inner and outer portions can be present. For example, only one or two of each can be present, or each can be present in a quantity of about 8 to 10.

[0200] Referring to FIG. 241, when there is a valve tip, the inner curved portion 1031a of the wire indicator 1031 is pushed down, pushing the portion 1031b outwardly against the movable arm 4430. The number of portions 1031b pushed out from the movable arm 4430 indicates the depth of the valve tip to the operator.

[0201] Referring now to FIGS. 238 and 239, the fastener 4400 is shown in the open position. The movable arm 4430 is biased in the closing direction or is spring-loaded and is moved to and held in the open position by the tension applied to an actuation line (not shown). The indicating wire 1031 is in a non-flexed configuration. This is because there is no valve tip engaged within the open fasteners in FIGS. 238 and 239.

[0202] Referring now to FIG. 240, the fastener 4400 is shown in a fully implanted or actuated position with the valve tip not in the proper location. The indicating wire 1031 remains unbent, with the inner portion 1031a remaining positioned on the inner side of the fixed arm and the outer portion 1031b being in or substantially in the same plane as the movable arm 4430. The absence of the outer portion 1031b extending outwardly from the movable arm 4430 above the imaging device indicates that the valve tip has not been captured.

[0203] Referring now to FIG. 241, the fastener 4400 is shown with the movable arm 4430 in the closed position. When the fastener 4400 is closed, the movable arm 4430 exerts a clamping force that holds the native valve tip tissue within the fastener 4400. The fastener 4400 is biased in the closing direction by the shaping of the movable arm 4430 in the preloading position. The closed fastener has captured a sufficient amount of valve tip tissue. That is, the depth of the valve tip within the fastener is sufficient to be considered properly positioned. The indicating wire 1031 is bent such that the portion 1031b extends outwardly from the movable arm 4430. The outwardly extending portion 1031b can be seen using an imaging device such as fluoroscopy. That is, the inner portion 1031a is pressed toward the movable arm 4430 by the pressure applied from the valve tip, thereby extending the outer portion 1031b further outwardly from the movable arm 4430 of the fastener.

[0204] In the embodiments described herein (but not limited thereto, including the embodiments described in FIGS. 226-241), the indicator can be a coil on a wire; a flexible superelastic member with an optional embedded radiopaque marker; a projecting member from the fastener body resulting from a bent or hinged region cut from the same continuous sheet as the fastener; and / or a V-shaped radiopaque marker positioned near the bent or hinged region of the fastener. The indicator can be made of a superelastic or flexible material; that is, the material does not undergo plastic deformation upon cusp capture.

[0205] Referring now to FIG. 110, a portion of an exemplary embodiment of a laser cut fastener is shown. Similar to the embodiment shown in FIG. 103, the fastener has a movable arm 5230, a fixed arm 5210, and one or more flexible segments to enable shaping and bending the laser cut sheet into the fastener shape. The movable arm can have a loop 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. Thus, FIGS. 106-109 also depict the operation of the embodiment shown in FIG. 110 positioned and retained on a native valve cusp.

[0206] Referring now to FIGS. 111 - 122, it illustrates a variation of the fastener 4400 illustrated by FIGS. 48 - 66 having flexible features such as the illustrated bump 1031 that flattens when pressed against the leaflet tissue. The fastener 4400 can be used within an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above). The fastener 4400 has a fixed arm 4410, a patterned flexure or patterned hinge portion 4420, a movable arm 4430 formed in the shape of a hoop or loop, and a return portion 4440 of the movable arm 4430. The fastener 4400 also includes an indicator arm 4450 extending from an indicator flexure or hinge portion 4460, and the indicator flexure or hinge portion 4460 couples the indicator arm to the flexure or hinge portion 4420. In this embodiment, the indicator arm 4450 can have flexible features, and the flexible features can be bumps 1031 that flatten when pressed against the leaflet tissue. The fastener 4400 can be used within any of the implantable prosthesis devices of the present application and can include any of the features or combinations of features of the other fasteners described herein. The fastener 4400 can be laser cut from a flat sheet or tube of shape memory alloy (e.g., nitinol, etc.) and then shape set to the desired shape.

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

[0208] The patterned flexure portion or patterned hinge portion 4420 is formed from a plurality of spring segments 4422 and cutouts 4424. 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 in the lateral direction. The side beams 4432 include a first flexure portion or hinge portion 4434 disposed toward the proximal end of the movable arm 4430 and a second flexure portion or hinge portion 4436 disposed at the distal end of the movable arm 4430. The first flexure portion or hinge portion 4434 is formed by one or more bends in the side beam 4432. The second flexure portion or hinge portion 4436 includes a thinner (and thus more flexible) portion that reduces the force required to fold the fastener 4400. The hoop shape of the movable arm 4430 and the flexible side arms 4432 allow the movable arm 4430 to be folded by simply retracting the fastener 4400 into a delivery sheath (not shown). In certain embodiments, the expansion and contraction of the fastener 4400 are controlled by an actuation line (not shown).

[0210] The loop-like shape of the movable arm 4430 provides a wider return portion 4440, which can include more returns 4442 with a lateral spacing that is the same as or greater than that of other fasteners. The wider spacing of the returns 4442 improves the capture of the natural valve tip. Also, the returns 4442 are longitudinally offset as a result of their position on the loop-like shape of the movable arm 4430. That is, the two central returns 4444 are located further away from the bending or hinge portion 4420, and the two outer returns 4446 are located closer to the bending or hinge portion 4420. Further, the return portion 4440 of the movable arm 4430 includes a hole 4448 for receiving an actuating suture (not shown). In certain embodiments, the loop shape of the movable arm 4430 is similar to the shape of the wide outer paddle of the implantable device, and the pinching force of the paddle is evenly distributed over the returns to further improve the retention of the natural valve tip. The ends of the returns 4442 can be further sharpened using any suitable sharpening means.

[0211] The indicator arm 4450 includes a beam 4451 that extends from a bent or hinge portion 4420 inside the hoop-shaped movable arm 4430 between two side arms 4432 to a return portion 4456. The indicator arm 4450 includes a hole 4452 at an end for receiving an activation line (not shown) for activating the indicator arm 4450. An optional return portion 4456 is disposed at an end of the beam 4451 of the indicator arm 4450 and includes at least one return 4456 (when an optional return portion is included). The optional return portion 4456 helps the indicator arm 4450 to secure the valve tip until the movable arm 4430 is closed. The optional return 4456 can be laser cut from the indicator arm 4450 and bent outwardly so that it projects away from the indicator arm 4450 at approximately the same angle that the return 4442 projects from the movable arm 4430. In some embodiments, the indicator arm 4450 includes a return that is cut from a flat sheet of material and then rotated approximately 90 degrees and projects outwardly at a predetermined angle, similar to the return 2244 of the fastener 2200.

[0212] The optional return portion 4456 of the indicator arm 4450 is disposed at a predetermined distance from the bent or hinge portion 4420 such that the return 4456 of the indicator arm 4450 is disposed longitudinally between the central return 4444 and the outer return 4446 of the return portion 4440. This arrangement ensures that the return portion 4440 engages the valve tip engaged by the indicator arm 4450. That is, when the natural valve tip positioned within the fastener 4400 is engaged by the return portion 4456 of the indicator arm 4450 when the indicator arm 4450 is actuated, the valve tip will also be engaged by the return portion 4440 of the movable arm 4430.

[0213] In the exemplary embodiments illustrated by FIGS. 111 - 122, when the natural valve tip is properly positioned and engaged within the fastener, the bump 1031 will be flattened, indicating proper depth placement of the valve tip. The opposite is also true. That is, if the natural valve tip is not properly positioned within the fastener 4400 (i.e., not positioned far enough), the bump 1031 will not be flattened 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 natural valve tip must extend to be properly positioned. Thus, the exemplary embodiments illustrated by FIGS. 111 - 122 provide two indications. First, any engagement of the valve tip with the catch on the indicator arm indicates that the catches 4444, 4446 also engage the valve tip (but does not indicate proper insertion depth). Second, compression or flattening of the bump 1031 indicates proper valve tip insertion.

[0214] The indicator bending portion or hinge portion 4460 enables the indicator arm 4450 to be actuated separately from the movable arm 4430 and is disposed between the movable arm 4430 and the fixed arm 4410 of the fastener 4400 to facilitate detection of the depth of engagement of the natural valve tip. The indicator bending portion or hinge portion 4460 can be similar to the patterned bending portion 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 bending portion or hinge portion 4460 is less than the clamping force applied to the movable arm 4430 by the bending portion or hinge portion 4420, such that the indicator arm 4450 can be actuated multiple times to detect the position of the valve tip, while on the other hand, when the valve tip is held in the desired position by the indicator arm 4450, the movable arm 4430 having a stronger clamping force is actuated. The lower clamping force of the indicator arm 4450 reduces the force applied on the valve tip tissue and enables the indicator arm 4450 to be repositioned repeatedly, making it less likely for the indicator arm 4450 to puncture or otherwise damage the valve tip tissue. Also, the lower clamping force can enable the indicator arm 4450 to pulsate or jump when the heart beats.

[0215] Referring now to FIGS. 111 - 113, the fastener 4400 is shown in the open position. The movable arm 4430 and the indicator arm 4450 are biased or spring - loaded in the closing direction and are moved to and held in the open position by the tension applied to an actuation line (not shown) that can be respectively attached to the holes 4448, 4452 in each of the movable arm 4430 and the indicator arm 4450. The bump 1031 has its curved bump configuration. The reason is that there is no valve tip engaged within the open fastener of FIGS. 111 - 113.

[0216] Referring now to FIGS. 114 - 116, the fastener 4400 is shown in a state where the indicator arm 4450 is in a fully seated or actuated position (i.e., the farthest range that the indicator arm 4450 can reach when it is not engaged with the valve tip tissue during actuation). When the tension applied to the actuation line (not shown) is reduced, the indicator arm 4450 is allowed to actuate in the closing direction. In the fully actuated position, the indicator arm 4450 forms an X - shape with the fixed arm 4410, which can be seen via the imaging device, enabling the operator to know that the indicator arm 4450 is not engaged with the valve tip at all. Since the valve tip is not engaged within the fastener of FIG. 114, the bump 1031 is also in its curved configuration.

[0217] Referring now to FIGS. 117 - 119, the fastener 4400 is shown in a state where the indicator arm 4450 is in an engaged or closed position. That is, it is the position where the indicator arm 4450 would be when the valve tip tissue is engaged during actuation. When the tension applied to the actuation line (not shown) is reduced, the indicator arm 4450 is allowed to actuate in the closing direction. In the closed position, the indicator arm 4450 does not cross the fixed arm 4410 and does not form an X - shape with the fixed arm 4410. In the closed position, the valve tip is only partially inserted into the fastener, and thus the bump 1031 on the indicator arm 4450 does not flatten but maintains its curved configuration. Thus, the operator knows that the valve tip tissue is engaged but not yet positioned within the fastener at a sufficient distance to be considered properly positioned.

[0218] Referring now to FIGS. 120-122, 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 clamping force that holds the natural valve tip tissue secured within the fastener 4400. The fastener 4400 is biased in the closed direction by the shaping of the movable arm 4430 and the indicator arm 4450 in the preloading position. The closed fastener has captured a sufficient amount of valve tip tissue, i.e., the depth of the valve tip within the fastener is sufficient such that it is 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 having the bump 1031 cannot be seen. This is because the valve tip obscures the view of that portion of the indicator arm and also because the bump is flattened by engagement with the valve tip.

[0219] Referring now to FIGS. 67A - 68A, an exemplary embodiment of a laser cut fastener 4400 is illustrated. FIG. 67 shows a plan view of a portion of a 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 formed from a piece of the same 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 return 4440 at the free end of the movable arm to adhere to the tissue of the natural valve tip. The fastener can have a flexible section at the location where the fastener bends into a usable shape. The flexible sections can each be a hinge - type portion, a joint - type portion, and / or otherwise a flexible portion. There is a flexible portion or hinge - type portion 4460 that allows the indicator arm to bend. There is also a bending portion or hinge portion 4420 that allows dynamic bending of the movable arm 4430 relative to the fixed arm 4410. An optional bending portion or hinge portion 4470 allows bending between the fixed arm 4410 and an optional paddle portion 6720. Also, the fastener can have an optional foot 6710 that extends outwardly from the side of the fastener near the flexible portion 4420 between the movable arm and the fixed arm. The foot 6710 can lock into a bushing - type collar (not shown) or another connector. The connector can be attached to a spacer that joins to the natural mitral valve leaflet tip. The fastener can be shaped such that in its rest configuration it has an indicator arm 4450 that extends through or towards the opening 6730 of the movable arm 4430.

[0220] Figure 68 illustrates a fastener 4400 in a partially open configuration. The fastener can be oriented to capture a valve tip. When the valve tip is inserted to a predetermined acceptable depth, the valve tip depresses an indicator arm 4450. The depression or flattening of the indicator arm 4450 indicates that a sufficient amount of the valve tip is disposed within the fastener. When a sufficient amount of the valve tip is within the fastener, the fastener can be closed to capture the valve tip. In the example illustrated by FIG. 68, the indicator arm 4450 extends in a direction opposite or substantially opposite to the movable fastener arm 4430. Also, FIG. 68 illustrates an optional suture loop 6810 through which a suture or other actuation line passes and / or connects 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 the opening 6730 of the movable arm when no captured valve tip is present (see FIG. 67). When a captured valve tip is present within the fastener, the indicator arm 4450 can sit on top of the valve tip. The length and / or position of the indicator can be chosen to represent the minimum capture depth required for the device. An optional integral paddle 6720 can be used to approximate the valve tip and / or can be configured to allow for elongation of a laser cut paddle. The flexure regions or hinge regions 4420, 4470, and 4460 allow for shaping in a desired shape and / or facilitate relative flexing of the movable fastener portion, the fixed fastener portion, the indicator arm, and / or the paddle portion 6720.

[0222] Referring now to FIGS. 67A and 68A, illustrative embodiments of fasteners similar to those of FIGS. 67 and 68 are shown. FIG. 67A illustrates that the indicator arm 4450 is connected to the movable arm 4430 in the bending region or hinge region 4460. As shown in FIG. 68A, when there is no valve tip and the fastener is not yet closed, the indicator arm bends toward the interior region of the fastener. When the fastener is closed, the indicator arm 4450 can pass through the opening 6740 of the fixed arm when there is no valve tip positioned deep enough in the fastener to engage the indicator arm 4450. When the valve tip is positioned deep enough in the fastener to engage the indicator arm, the indicator arm can bend in and through the opening 6730 of the movable arm 4430 in the flexible or hinge-like region 4460.

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

[0224] In FIGS. 67-68, similar to the exemplary embodiments described above, there are flexible sections of the laser cut sheet that enable shaping of the movable arm and / or form flexible portions or hinge portions 4920, 4960 to enable bending of the movable arm and / or the indicator arm. In the embodiment illustrated in FIG. 69, the plurality of indicators and movable arms are all cut from a single sheet. The indicator can be cut from a single sheet, which does not require the indicator to be individually attached to the movable arm.

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

[0226] Referring now to FIGS. 70-71, an exemplary fastener 4900 for use within an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) (shown as a reversible fastener) is shown. Similar to the fastener 3500 described above, the fastener 4900 includes a fixed arm 4910, a flexure or hinge portion 4920, and a movable arm 4930 having a reversible portion 4940 (although other friction enhancing portions may be used). The fastener 4900 may be used within any of the implantable prosthesis devices of the present application and may include any one or combination of features of the other fasteners described herein.

[0227] Further, the fastener 4900 includes an indicator portion 4950, which is formed from first, second, and third indicator arms 4954, 4956, 4958. The first, second, and third indicator arms 4954, 4956, 4958 are adjacent to the movable arm 4930 and extend from an indicator flexure or hinge portion 4960, respectively. The indicator flexure or hinge portion 4960 allows the indicator arms 4954, 4956, 4958 to be actuated individually and separately from the movable arm 4930. The indicator flexure 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 flexure or hinge portion 4960 may be part of the flexure or hinge portion 4920.

[0228] The indicator arms 4954, 4956, 4958 are operated separately from the movable arm 4930 and optionally separately from each other, and can facilitate the detection of the depth of engagement of the natural valve tip between the movable arm 4930 and the fixed arm 4910 of the fastener 4900. In some exemplary embodiments, the indicator arms 4954, 4956, 4958 are released simultaneously from the valve tissue (i.e., the release or retraction of one indicator arm causes the release or retraction of all of the indicator arms). In the illustrated embodiment, the indicator arms 4954, 4956, 4958 are narrower than the movable arm 4930 and have lengths that are each smaller than the distance from the bent or hinged portion 4920 to the return portion 4940. The first indicator arm 4954 can have a length from about 75 percent to about 100 percent of the distance between the bent or hinged portion 4920 and the return portion 4940. The second indicator arm 4956 can have a length from about 65 percent to about 95 percent of the distance between the bent or hinged portion 4920 and the return portion 4940. The third indicator arm 4958 can have a length from about 50 percent to about 80 percent of the distance between the bent or hinged portion 4920 and the return portion 4940. In some embodiments, the first indicator arm 4954 has a length from about 60 percent to about 100 percent of the distance between the bent or hinged portion 4920 and the return portion 4940. The second indicator arm 4956 has a length from about 50 percent to about 75 percent of the distance between the bent or hinged portion 4920 and the return portion 4940. The third indicator arm 4958 has a length from about 30 percent to about 60 percent of the distance between the bent or hinged portion 4920 and the return portion 4940. As long as the length continues to decrease for each successive indicator arm, any combination of indicator arm lengths can be used to provide an indication of the depth at which the valve tip is positioned within the fastener. It is also possible for there to 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. Constructing the length of the first indicator arm 4954 to be less than the distance from the flexure or hinge portion 4920 to the return portion 4940 ensures that the return portion 4940 engages the valve tip positioned at the minimum engagement depth as indicated by the first indicator arm 4954. That is, when the first indicator arm 4954 is actuated, if the natural valve tip positioned within the fastener 4900 is engaged by the first indicator arm 4954, the valve tip will be engaged by the return portion 4940 of the movable arm 4930. The opposite is also true. That is, when the first indicator arm is actuated, if the natural valve tip positioned within the fastener 4900 is not engaged by the first indicator arm 4954, the valve tip will not be sufficiently engaged by the return portion 4940 of the movable arm 4930.

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

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

[0232] Also, the fastener 4900 includes an indicator portion 4950, and the indicator portion 4950 is formed from first, second, third, and fourth indicator arms 4952, 4954, 4956, 4958. The first, second, third, and fourth indicator arms 4952, 4954, 4956, 4958 are adjacent to the movable arm 4930 and each extend from an indicator hinge portion 4960. The indicator hinge portion 4960 enables 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 the fastener 2100 described above.

[0233] The indicator arms 4952, 4954, 4956, 4958 are actuated separately from the movable arm 4930 and can facilitate the detection of the depth of engagement of the natural valve tip between the movable arm 4930 and the fixed 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 have lengths that are each smaller than the distance from the hinge portion 4920 to the return portion 4940. In some embodiments, the first indicator arm 4952 has a length that is about 75 percent to about 100 percent of the length of the distance between the hinge portion 4920 and the return portion 4940. In some embodiments, the second indicator arm 4954 has a length that is about 65 percent to about 95 percent of the length of the distance between the hinge portion 4920 and the return portion 4940. In some embodiments, the third indicator arm 4956 has a length that is about 50 percent to about 80 percent of the length of the distance between the hinge portion 4920 and the return portion 4940. In some embodiments, the fourth indicator arm 4958 has a length that is about 35 percent to about 65 percent of the length of the distance between the hinge portion 4920 and the return 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 return portion 4940 ensures that the return portion 4940 engages the valve tip positioned at the minimum engagement depth as indicated by the first indicator arm 4952. That is, when the first indicator arm 4952 is actuated, if the natural valve tip positioned within the fastener 4900 is engaged by the first indicator arm 4952, the valve tip will be engaged by the return portion 4940 of the movable arm 4930. The opposite is also true. That is, when the first indicator arm 4952 is actuated, if the natural valve tip positioned within the fastener 4900 is not engaged by the first indicator arm 4952, the valve tip will not be fully engaged by the return portion 4940 of the movable arm 4930.

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

[0236] Figures 72-74 schematically illustrate the fastener 4900 of FIGS. 70-71 (or FIGS. 70A-71A) that is implanted to secure the natural leaflets of a natural valve (e.g., a natural mitral valve, etc.). The exemplary fastener 4900 is shown to be implanted within the natural valve 40 to secure an implantable device (not shown) (e.g., devices 100, 200, 300, etc. described above) to one of the natural leaflets 42, 44. Referring now to FIG. 72, the fastener 4900 is shown in the open condition with the natural 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 when 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 FIGS. 72-75).

[0237] Referring now to FIG. 73, indicator arms 4954, 4956, 4958 are shown in an actuated condition or a released condition. Since valve tips 42, 44 are inserted into opening 4906 of fastener 4900 approximately midway between return portion 4940 and flexure or hinge portion 4920, first indicator arm 4954 engages the valve tips, while second and third indicator arms 4956, 4958 are clear of or have slipped off valve tips 42, 44 and are moving to a fully actuated position at or beyond fixed arm 4910. In the example shown, second and third indicator arms 4956, 4958 form an X-shaped or cross-shaped configuration with the fixed arm and they can be viewed via an imaging device used to monitor implantation and placement of the prosthesis device. In an exemplary embodiment, the second and third indicator arms will engage a fixed arm or a covering over the fixed arm and there will be no cross-shaped or X-shaped configuration, but the lack of space between the indicator arm and the fixed arm is still to indicate the absence of valve tip tissue. Additionally, or alternatively, indicator arms 4954, 4956 that engage the valve tips will bound or pulse as the heart beats, while arm 4958 will not. This bounding or pulsing can be seen on imaging. Thus, the depth of engagement can be determined from the relative positions of indicator arms 4954, 4956, 4958 with respect to fixed arm 4910, and / or the ratio of the number of indicator arms that bound or pulse to the number that do not.

[0238] Referring now to FIG. 74, the indicator arms 4954, 4956, 4958 are retracted by applying tension to the activation line, and the fastener 4900 is repositioned such that the valve tips 42, 44 are inserted deeper into the opening 4906 of the fastener 4900. However, in some cases, engagement by only some of the indicator arms may indicate correct valve tip positioning. The indicator arms 4954, 4956, 4958 are then actuated by releasing the tension applied to the activation line, as can be seen in FIG. 75. Since the valve tips 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 clamp the valve tips 42, 44 against the fixed arm 4910. Engagement with the valve tips 42, 44 prevents the indicator arms 4954, 4956, 4958 from moving to or past the fixed arm 4910 of the fastener 4900 and forming the cross-shaped pattern (or another pattern indicating the absence of the valve tip tissue) shown in FIG. 73. Thus, the indicator arms 4954, 4956, 4958 indicate to an observer observing the installation via the imaging device that the valve tips 42, 44 are inserted into the opening 4906 beyond at least the depth established by the third indicator arm 4958.

[0239] Referring now to FIG. 75, when the indicator arms 4954, 4956, 4958 indicate that the valve tips 42, 44 are sufficiently inserted into the opening 4906, the movable arm 4930 is actuated by releasing the tension applied to the activation line (not shown), and the valve tips 42, 44 are clamped between the return portion 4940 and the fixed arm 4910 to firmly secure the valve tips 42, 44 within the fastener 4900.

[0240] Referring now to FIGS. 76-77, the movable arm 4930 and the indicator arms 4954, 4956, and 4958 of the laser cut embodiment of the fastener 4900 are shown. The embodiments shown in FIGS. 76-77 are similar to those described above with respect to FIG. 69 and have a movable arm 4930 with a cutout opening 6730 and a plurality of indicator arms 4954, 4956, 4958 all cut from the same sheet, each of the movable arm and the indicator arms having a flexible section 4960 that allows it to bend and / or flex relative to the fixed arm and / or allows shaping of the fastener in its non-flexed position. In these embodiments, the plurality of indicators assist in identifying the depth of the valve tip.

[0241] The embodiment of FIGS. 76-77 further includes a bar 7610 on 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 plurality of indicators and optionally the movable fastener arm 4930 to be lifted together (i.e., opened 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 completely to the outermost layer of the movable arm 4930, and the movable arm 4930 can be a movable arm with an optional return (not shown) that closes after the valve tip is properly positioned within the fastener.

[0242] In FIG. 77, an exemplary embodiment is illustrated, where the T-bar 7610 extends outwardly to the outermost indicator arm 4954 but is positioned inside the movable arm. Here, the indicator arms increase in length as they move outward from the indicator arms 4958 (positioned centrally along the width of the movable arm frame) which are positioned centrally. Indicator arms 4956, 4958 having a length longer than the centrally positioned indicator arms can be in a "U" shape or other shape, where the indicator arms have sides 7620 and distal ends 7630.

[0243] The indicator arms can 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 can be pulled up or opened by another suture line or other actuator means. Similar to other embodiments having suture lines described herein, the suture line connected to the T-bar or the shortest indicator arm is given slack before the suture line connected to the movable arm. This slack allows the shortest indicator arm to fall towards the fixed arm (or towards the valve tip if the valve tip is positioned within the fastener). The fall of the shortest indicator arm (and thus the T-bar) allows the remaining indicator arms and optionally the movable arm 4930 to fall towards the fixed arm as well. If the valve tip is partially captured, some of the indicator arms (but not those overlapping the valve tip) will still fall past the valve tip. FIGS. 80 - 83 illustrate the fall of the indicator arms based on the position of the valve tip and are described below.

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

[0245] Also, the fastener 4900 includes an indicator portion 4950 formed from first, second, and third indicator arms 4954, 4956, 4958. The first, second, and third indicator arms 4954, 4956, 4958 are adjacent to the movable arm 4930 and extend from an indicator bending portion or hinge portion 4960, respectively. The indicator bending portion or hinge portion 4960 enables the indicator arms 4954, 4956, 4958 to be actuated individually and separately from the movable arm 4930. The indicator bending portion or hinge portion 4960 can be formed from a portion of the indicator arms 4954, 4956, 4958, can be formed from a series of cutouts, and / or can be a portion of the bending portion or hinge portion 4920. The T-bar can be connected by welding, or by using rivets, or by other known means. The T-bar can be made of 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 natural valve tip, an indicator arm that drops to or beyond the fixed arm of the fastener indicates that the valve tip is not positioned within the fastener to the depth indicated by that particular indicator arm. The T-bar does not affect the function of the indicator arms, and the indicator arms operate in the same manner as in the exemplary embodiments described in FIGS. 70 - 75, as described below.

[0246] The indicator arms 4954, 4956, 4958 are actuated separately from the movable arm 4930 and can facilitate the detection of the depth of engagement of the natural valve tip between the movable arm 4930 and the fixed arm 4910 of the fastener 4900. In the illustrated embodiment, the indicator arms 4954, 4956, 4958 are narrower than the movable arm 4930 and have lengths that are each smaller than the distance from the bent or hinge portion 4920 to the return portion 4940. The first indicator arm 4954 has a length of from about 75 percent to about 100 percent of the distance between the bent or hinge portion 4920 and the return portion 4940. The second indicator arm 4956 has a length of from about 65 percent to about 85 percent of the length between the bent or hinge portion 4920 and the return portion 4940. The third indicator arm 4958 has a length of from about 50 percent to about 70 percent of the distance between the bent or hinge portion 4920 and the return portion 4940. As long as the length continues to decrease for each successive indicator arm, any combination of indicator arm lengths can be used to provide an indication of the depth to which the valve tip is positioned within the fastener. A fourth indicator arm (not shown) or any number of indicator arms can also be present.

[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 return portion 4940 ensures that the return portion 4940 engages the valve tip positioned at the minimum engagement depth as indicated by the first indicator arm 4954. That is, when the first indicator arm 4954 is actuated, if the natural valve tip positioned within the fastener 4900 is engaged by the first indicator arm 4954, the valve tip will be engaged by the return portion 4940 of the movable arm 4930. The opposite is also true. That is, when the first indicator arm is actuated, if the natural valve tip positioned within the fastener 4900 is not engaged by the first indicator arm 4954, the valve tip will not be fully engaged by the return portion 4940 of the movable arm 4930.

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

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

[0250] Referring now to FIG. 81, the indicator arms 4954, 4956, 4958 are shown in the released condition. Since the valve tips 42, 44 are inserted into the opening 4906 of the fastener 4900 approximately midway between the return portion 4940 and the flexible or hinged portion 4920, the first indicator arm 4954 is engaged with the valve tip, while the second and third indicator arms 4956, 4958 have escaped or slipped off the valve tips 42, 44 and are moving to the fully actuated position at or beyond the fixed arm 4910. The second and third indicator arms 4956, 4958 form a predetermined shape together with the fixed arm, which can be seen via an imaging device used to monitor the implantation and retention of the prosthesis device. Additionally, or alternatively, the indicator arm 4954 engaged with the valve tip bounces or pulsates when the heart beats, while the arms 4956, 4958 do not. This bounce or pulsation can be seen on imaging. Thus, the depth of engagement can be determined from the number of visible shapes formed by the indicator arms 4954, 4956, 4958 and the fixed arm 4910, and / or the ratio of the number of indicator arms that bounce or pulsate to the number that do not.

[0251] Referring now to FIG. 82, the indicator arms 4954, 4956, 4958 are retracted by applying tension to the actuating lines connected to the indicator arm 4958 having the T-bar 7610, and the fastener 4900 is repositioned so that the valve tips 42, 44 are inserted deeper into the opening 4906 of the fastener 4900. (In the explanatory drawing, 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 placed on the T-bar 7610 and there is no space.) However, in some cases, engagement by only some of the indicator arms can indicate the correct valve tip positioning. The indicator arms 4954, 4956, 4958 are then actuated by releasing the tension applied to an actuating line (not shown) attached to the indicator arm 4958 or the T-bar 7610, as can be seen in FIG. 83. Since the valve tips 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 clamp the valve tips 42, 44 against the fixed arm 4910. Engagement with the valve tips 42, 44 prevents the indicator arms 4954, 4956, 4958 from passing through the fixed 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 the imaging device that the valve tips 42, 44 are inserted into the opening 4906 beyond the depth established by at least the third indicator arm 4958.

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

[0253] Referring now to FIGS. 123 and 124, an exemplary fastener 5000 for use in an implantable prosthesis device (e.g., devices 100, 200, 300, etc. as described above) shown as a reversible fastener is shown. Similar to the fastener 3500 described above, the fastener 5000 includes a fixed arm 5010, a flexure or hinge portion 5020, and a movable arm 5030 having a return portion 5040 (although other friction enhancing portions may also be used). The movable arm 5030 also includes an optional first indicating lever 1241 disposed at a distance from the flexure or hinge that is greater than the distance to the return 5040. The movable arm 5030 also includes a second indicating lever 1242 disposed at a distance from the flexure or hinge portion 5020 that is less than the distance between the return portion 5040 and the flexure or hinge portion 5020. The indicating levers 1241, 1242 deform when native valve leaflet tissue is pressed against the fixed arm 5010 by the movable arm 5030, indicating the depth of engagement reached by the valve leaflet tissue. The first indicating lever 1241 deforms when the native valve leaflet is partially inserted into the fastener. The second indicating lever 1242 deforms when the native valve leaflet reaches the minimum desired depth of engagement. The fastener is not limited to two indicating levers and may have additional indicating levers disposed between the first and second indicating levers (as described in Patent Document 5 filed on Feb. 14, 2019, which is hereby 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 valve leaflets 42, 44 have reached the desired depth of engagement until the valve leaflets 42, 44 are inserted at or beyond the location of the second indicating lever 1242.When the valve tips 42, 44 reach the desired engagement depth, the actuation of the movable arm 5030 compresses the valve tip tissue 42, 44 against the indicating lever 1242, flattening or bending the indicating lever 1242 against the valve tips, thereby indicating that the valve tips 42, 44 have been inserted into the fastener 5000 at or beyond the desired engagement depth. The fastener 5000 can be used in any of the implantable prosthesis devices of the present application and can include any or combination of features of the other fasteners described herein.

[0254] Referring now to FIGS. 125, 126, and 127, an exemplary fastener 5000 is shown disposed within the natural valve 40 for securing an implantable device (not shown) (e.g., devices 100, 200, 300, etc. described above) to one of the natural valve tips 42, 44. Referring now to FIG. 125, the fastener 5000 is shown in the open condition with the natural valve tips 42, 44 partially inserted into the opening of the fastener 5000 formed between the fixed arm 5010 and the movable arm 5030. With the fastener in the open condition, neither of the indicating levers 1241, 1242 is bent or flattened. To determine whether the valve tips 42, 44 have reached the desired engagement depth, the movable arm 5030 is actuated via an actuation line (not shown) as shown in FIGS. 126-127.

[0255] Referring now to FIG. 126, when the movable arm 5030 is actuated to push the valve tips 42, 44 against the fixed arm 5010, the valve tips 42, 44 may contact a portion of the movable arm 5030 and, when the engagement depth of the valve tips 42, 44 is less than the desired minimum engagement depth, contact only the first indicating lever 1241 and not the second indicating lever 1242. As can be seen in FIG. 126, when the valve tips 42, 44 are partially inserted into the fastener 5000 and when the valve tips 42, 44 are pressed against the first indicating lever 1241 by the fixed arm 5010, the first indicating lever 1241 is bent so as not to interfere with the movable arm due to contact with the valve tips 42, 44. That is, the first indicating lever 1241 is deformed by the valve tips 42, 44, indicating that the valve tips 42, 44 have been partially inserted into the fastener. In some embodiments, actuation of the movable arm 5030 also engages and secures the return portion 5040 with the valve tips 42, 44 within the return fastener 5000. Since the second indicating lever 1242 is not bent and / or flattened, this indicates to the operator that the valve tips have not been inserted into the fastener at or beyond the minimum engagement depth. If the indicating lever 1242 indicates that the valve tips 42, 44 have not been inserted to the desired depth, the fastener 5000 may be opened to allow repositioning of the valve tips 42, 44.

[0256] Referring now to FIG. 127, when the movable arm 5030 is actuated to push the valve tips 42, 44 against the fixed arm 5010, the valve tips 42, 44 may contact a portion of the movable arm 5030 and, when the engagement depth of the valve tips 42, 44 is greater than or equal to the desired minimum engagement depth, contact the first indicating lever 1241 and the second indicating lever 1242. As can be seen in FIG. 127, when the valve tips 42, 44 are inserted into the fixture 5000 at or beyond the minimum engagement depth and when the valve tips 42, 44 are pressed against both the first indicating lever 1241 and the second indicating lever 1242 by the fixed arm 5010, both the first indicating lever 1241 and the second indicating lever 1242 are bent so as not to interfere with the movable arm due to contact with the valve tips 42, 44. That is, the first indicating lever 1241 and the second indicating lever 1242 are each deformed by the valve tips 42, 44, indicating that the valve tips 42, 44 have been inserted into the fixture at or beyond the minimum engagement depth. In some embodiments, actuation of the movable arm 5030 also engages and secures the return portion 5040 with the valve tips 42, 44 within the return fixture 5200. The indicating lever 1241 is optional and in some exemplary embodiments there is no indicating lever 1241 positioned above the return 5040.

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

[0258] When the tip ends 42, 44 reach the desired engagement depth, the actuation of the movable arm 5030 compresses the tip tissues 42, 44 against at least one indicating lever 1242, flattening or bending the indicating lever 1242 against the tip ends, thereby indicating that the tip ends 42, 44 have been inserted into the fastener 5000 at or beyond the desired engagement depth. Also, the indicating lever 1242 can be used to indicate whether the tip ends 42, 44 have been inserted too far into the fastener. For example, if the indicating lever 1242 closest to the bent or hinged portion 5020 is deformed, this can indicate to the operator that the tip end has been inserted too far into the fastener.

[0259] Referring now to FIGS. 125A, 126A, and 127A, an exemplary fastener 5000 is shown disposed within a natural valve 40 for securing an implantable device (not shown) (e.g., devices 100, 200, 300, etc. described above) to one of the natural tip ends 42, 44. Referring now to FIG. 125A, the fastener 5000 is shown in an open condition, with the natural tip ends 42, 44 partially inserted into the opening of the fastener 5000 formed between the fixed arm 5010 and the movable arm 5030. With the fastener in the open condition, neither of the indicating levers 1241, 1242 is bent or flattened. To determine whether the tip ends 42, 44 have reached the desired engagement depth, the movable arm 5030 is actuated as shown in FIGS. 126A and 127A.

[0260] Referring now to FIG. 126A, when the movable arm 5030 is actuated to push the valve tips 42, 44 against the fixed arm 5010, the valve tips 42, 44 may contact a portion of the movable arm 5030. When the engagement depth of the valve tips 42, 44 is less than the minimum desired engagement depth, they contact only the first indicating lever 1241 and do not contact any of the plurality of indicating levers 1242. As can be seen in FIG. 126A, when the valve tips 42, 44 are partially inserted into the fastener 5000 and the valve tips 42, 44 are pressed against the first indicating lever 1241 by the fixed arm 5010, the first indicating lever 1241 is bent so as not to interfere with the movable arm due to contact with the valve tips 42, 44. That is, the first indicating lever 1241 is deformed by the valve tips 42, 44, indicating that the valve tips 42, 44 have been partially inserted into the fastener. In some embodiments, the actuation of the movable arm 5030 also engages and secures the return portion 5040 with the valve tips 42, 44 within the return fastener 5000. The fact that not all of the indicating levers 1242 are bent and / or flattened indicates to the operator that the valve tips are not inserted into the fastener at or beyond the minimum engagement depth. If the indicating lever 1242 indicates that the valve tips 42, 44 have not been inserted to the desired depth, the fastener 5000 can be reopened to allow repositioning of the valve tips 42, 44.

[0261] Referring now to FIG. 127A, this is a time when the movable arm 5030 is actuated to push the valve tips 42, 44 against the fixed arm 5010. In FIG. 127A, the valve tips 42, 44 are in contact with the first indicating lever 1241 and the two indicating levers 1242. This indicates that the depth of the valve tips 42, 44 is greater than or equal to the desired engagement depth at its minimum. In FIG. 127A, the two indicating levers 1242 closest to the bending region or hinge region 5020 are not deformed, which can indicate to the operator that the valve tips are not inserted too far into the fastener. If the valve tips are inserted too far into the fastener, the fastener can be opened again and the valve tips can be repositioned. In some embodiments, the actuation of the movable arm 5030 also engages and secures the return portion 5040 with the valve tips 42, 44 within the return fastener 5200. The indicating lever 1241 is optional, and in some exemplary embodiments, there is no indicating lever 1241 positioned above the return 5040.

[0262] Referring now to FIGS. 128 - 129, an exemplary fastener 5200 for use in an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above) shown as a returnable fastener is illustrated. Similar to the fastener 3500 described above, the fastener 5200 includes a fixed arm 5210, a flexure or hinge portion 5220, and a movable arm 5230 having a return portion 5240 (although other friction enhancing portions may be used). The fixed arm 5210 also includes an indicating spring 5212, and the indicating spring 5212 is disposed at a distance from the flexure or hinge portion that is less than the distance between the return portion 5240 and the flexure or hinge portion 5220. In an exemplary embodiment, the movable arm 5230 also includes an indicating spring 5212, and the indicating spring 5212 is disposed at a distance from the flexure or hinge portion that is less than the distance between the return portion 5240 and the flexure or hinge portion 5220. The indicating spring is schematically illustrated 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 a closed end and / or can be covered by a cloth or other material to prevent damage to the valve tip tissue. The indicating spring 5212 deforms when the native valve tip tissue is pressed against the indicating spring 5212 by the movable arm 5230, indicating that the valve tip tissue has reached a minimum desired engagement depth. Thus, the indicating spring 5212 will not indicate that the native valve tips 42, 44 have reached the desired engagement depth until the valve tips 42, 44 are inserted at or beyond the location of the indicating spring 5212.When the valve tips 42, 44 reach the desired engagement depth, the actuation of the movable arm 5230 compresses the valve tip tissue 42, 44 against the indicating spring 5212 of the fixed arm 5210, flattening the indicating spring 5212, thereby indicating that the valve tips 42, 44 have been inserted into the fastener 5200 at or beyond the desired engagement depth. The fastener 5200 can be used in any of the implantable prosthesis devices of the present application and can include any or any combination of the features of the other fasteners described herein.

[0263] Referring now to FIGS. 130 - 132, an exemplary fastener 5200 is shown disposed within a natural valve 40 for securing an implantable device (not shown) (e.g., devices 100, 200, 300, etc. described above) to one of the natural valve tips 42, 44. Referring now to FIG. 130, the fastener 5200 is shown in the open condition with the natural valve tips 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 valve tips 42, 44 have reached the desired engagement depth, the movable arm 5230 is actuated via an actuation line (not shown) as shown in FIGS. 131 - 132.

[0264] Referring now to FIG. 131, when the movable arm 5230 is actuated to push the valve tips 42, 44 against the fixed arm 5210, the valve tips 42, 44 may contact a portion of the fixed arm 5210 without contacting the indicating spring 5212 when the engagement depth of the valve tips 42, 44 is less than the desired engagement depth where the engagement depth is minimized. As can be seen in FIG. 132, when the valve tips 42, 44 are inserted into the fastener 5200 at or beyond the minimum engagement depth, and when the valve tips 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 valve tips 42, 44. That is, the indicating spring 5212 is deformed by the valve tips 42, 44, indicating that the valve tips 42, 44 have been inserted at or beyond the minimum engagement depth. In some embodiments, the actuation of the movable arm 5230 also engages and secures the return portion 5240 with the valve tips 42, 44 within the return fastener 5200. If the indicating spring 5212 indicates that the valve tips 42, 44 have not been inserted to the desired depth, the fastener 5200 can be opened to allow repositioning of the valve tips 42, 44.

[0265] Referring now to FIGS. 129B - 129C, additional views and configurations of the fastener 5200 and the indicator spring 5212 are illustrated. FIG. 129B illustrates the indicator spring 5212 attached to the fixed arm 5210. The spring 5212 can be pushed down by a force as indicated by arrow 5214. Arrow 5214 represents the force of the valve tips 42, 44 pressed 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] Referring now to FIGS. 129D-129F, an exemplary fastener 5200 having a conical indicator spring 5213 is illustrated. FIG. 129D illustrates the fastener 5200 in an open configuration having a conical indicator spring 5213 attached to the fixed arm 5210. In some exemplary embodiments, the conical indicator spring 5213 may be attached to the movable arm 5230. FIG. 129E illustrates the conical indicator spring 5213 in a compressed configuration. Arrow 5214 represents the force of the valve tip pressed against the spring. The outermost widest diameter ring of the conical indicator spring 5213 can be seen. The remaining portion of the ring (where the diameter decreases for each successive ring, forming a conical shape) is nested within each other, forming concentric circular shapes as seen in the top view of the spring 5213 of FIG. 129F. As a result, the spring 5212 is flat or substantially flat. In FIGS. 129D-129F, the conical indicator spring 5213 is positioned on the fixed arm 5230, but in some exemplary embodiments, it may be fixed on the movable arm.

[0267] Referring now to FIGS. 129G - 129H, an exemplary embodiment of a fastener having a supplemental indicator element 5315 on a conical indicator spring 5213 is illustrated. Referring to FIGS. 129G and 129H, the indicator element 5315 can be attached to the conical 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 downwardly from the free end of the spring 5213 towards the fixed arm 5210. As shown in FIG. 129H, when in the compressed configuration due to the force as indicated by arrow 5214, the spring 5213 becomes flat and the indicator element 5315 extends through an opening 1291 in the fixed arm such that the indicator element 5315 can be seen on the outer side of the fixed arm 5210.

[0268] Referring now to FIGS. 129I and 129J, an exemplary embodiment of the indicator element 5315 is illustrated. In FIG. 129I, the indicator element 5315a is a conical spring or a conical spring portion, which has a coil of its maximum diameter attached to the free end of the conical indicator spring 5213 and a coil of its minimum diameter positioned closest to the fixed arm 5210. In one exemplary embodiment, the spring 5213 and the conical spring indicator element 5315a are formed from a single piece of material (such as a single piece of wire, etc.). In the example illustrated by FIG. 129J, the indicator element 5315b is a piece of material fixed to the free end of the conical indicator spring. The indicator element 5315b can take a wide variety of different forms. The indicator element 5315b can be a U-shaped, cup-shaped, or rod-shaped piece of radiopaque material fixed to the free end of the conical indicator spring. In the example illustrated, the bottom curve of the "U" extends downward toward the fixed arm, and the free end of the "U" is attached to the conical indicator spring 5213. In some exemplary embodiments, the indicator element 5315 can be attached to a spring indicator having coils of the same diameter, and / or the spring indicator 5213 can be attached to a movable arm. The indicator element 5315 can be wrapped with a radiopaque material, made of a radiopaque material, covered in a radiopaque fabric sheath, and / or printed with a radiopaque ink.

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

[0270] Referring now to FIGS. 133-134, an exemplary fastener 5200 having an indicator on a fixed arm is shown. The fastener may be used within an implantable prosthesis device (e.g., devices 100, 200, 300, etc. described above). The fastener 5200 includes a fixed arm 5210, a flexure or hinge portion 5220, and a movable arm 5230 having a return portion 5240 (although other friction enhancing portions may be used). Further, the fixed arm 5210 includes an indicating spring 5212, and the indicating spring 5212 is disposed at a distance between the flexure or hinge portion 5220 and the return portion 5240. The indicating spring 5212 depicted in FIGS. 133-134 has a coil that is aligned such that the spring extends longitudinally along the fixed arm. The indicating spring is schematically illustrated and can take on a wide 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 by a cloth or other material to prohibit damage to the valve tip tissue. The indicating spring 5212 deforms when the native valve tip tissue is pressed against the indicating spring 5212 by the movable arm 5230, indicating that the valve tip tissue has reached a minimum desired engagement depth. Thus, the indicating spring 5212 will not indicate that the native valve tips 42, 44 have reached the desired engagement depth until the valve tips 42, 44 are inserted at or beyond the location of the indicating spring 5212.When the valve tips 42, 44 reach the desired engagement depth, the actuation of the movable arm 5230 compresses the valve tip tissue 42, 44 against the indicating spring 5212 of the fixed arm 5210 or a portion of the indicating spring, flattening the indicating spring 5212 or a portion of the indicating spring, thereby indicating that the valve tips 42, 44 have been inserted into the fastener 5200 at or beyond the desired engagement depth. Further, the indicating spring 5212 can provide a precise visual indication of the valve tip insertion. This is because the amount by which the indicating spring is depressed is directly related to the amount of valve tip insertion. The fastener 5200 can be used in any of the implantable prosthesis devices of the present application and can include any or a combination of the features of the fasteners described herein.

[0271] Referring now to FIGS. 135 - 137, an exemplary fastener 5200 is shown disposed within a natural valve 40 for securing an implantable device (not shown) (e.g., devices 100, 200, 300, etc. described above) to one of the natural valve tips 42, 44. Referring now to FIG. 135, the fastener 5200 is shown in the open condition with the natural valve tips 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 valve tips 42, 44 have reached the desired engagement depth, the movable arm 5230 is actuated via an actuation line (not shown) as shown in FIGS. 136 - 137. 【027...

Claims

1. A fixed arm; A movable arm having a return portion, the movable arm being movable between an open position and a closed position; A hinge portion that hinge-connects the movable arm to the fixed arm; An indicator configured to indicate capture of the tip of a natural valve, the indicator comprising a sensor having a stimulating electrode and a reference electrode; Comprising; The sensor is configured to generate a biphasic current between the stimulating electrode and the reference electrode, a fastener assembly for a heart valve repair device.

2. The sensor is disposed on the fixed arm, the fastener assembly according to claim 1.

3. The sensor is disposed on the movable arm, the fastener assembly according to claim 1.

4. The sensor is disposed on the fixed arm, and a second sensor is disposed on the movable arm, the fastener assembly according to claim 1.

5. The fastener assembly according to any one of claims 1 to 4, further comprising a communication line extending from the sensor.

6. The sensor is capable of sensing one or more of electrical characteristics, pressure characteristics, position characteristics, and optical characteristics, the fastener assembly according to any one of claims 1 to 5.

7. The sensor is an electrical sensor capable of sensing one or more of resistance, capacitance, current, pressure, contact, and voltage, the fastener assembly according to any one of claims 1 to 5.

8. The sensor is configured to provide a signal in response to the distance between the sensor and the tip of the natural valve, the fastener assembly according to any one of claims 1 to 7.

9. A valve repair device for repairing a patient's natural valve, A core capture element; A plurality of paddles connected to the core capture element, the paddles being movable between an open position and a closed position; A fastener attached to each of the plurality of paddles; The fastener is A fixed arm attached to the paddle; A movable arm; A fastener hinge portion that hinge-connects the movable arm to the fixed arm; Comprising, a fastener; An insertion depth indicator attached to the fixed arm of each fastener to indicate whether the tip of the natural valve is inserted into the opening of the fastener or the valve tip receiving area formed between the fixed arm and the movable arm to at least a minimum desired insertion depth, the insertion depth indicator comprising a sensor; A communication line connected to the sensor and extending from the sensor through the core portion; A valve repair device comprising:

10. The valve repair device according to claim 9, wherein a second sensor is disposed on the movable arm.

11. The valve repair device according to claim 9 or 10, wherein the sensor is capable of sensing one or more of electrical characteristics, pressure characteristics, position characteristics, and optical characteristics.

12. The valve repair device according to any one of claims 9 to 11, wherein the sensor is an electrical sensor capable of sensing one or more of resistance, capacitance, current, pressure, contact, and voltage.

13. The valve repair device according to any one of claims 9 to 12, wherein the sensor is configured to provide a signal in response to the distance between the sensor and the tip of the natural valve.

14. The valve repair device according to any one of claims 9 to 13, wherein each paddle has an inner portion connected to the outer portion by a flexible connection portion.

15. The valve repair device according to any one of claims 9 to 14, wherein the movable arm has a friction enhancing portion.

16. The valve repair device according to any one of claims 9 to 15, wherein the plurality of paddles comprises a pair of paddles.

17. The valve repair device according to any one of claims 9 to 16, wherein the sensor comprises a stimulating electrode and a reference electrode, and the sensor is configured to generate a biphasic current between the stimulating electrode and the reference electrode.

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