Heart Valve Repair Devices

Abstract

A valve repair device for repairing a patient's native valve. The valve repair device has one or more adjustable width paddle frame sections. The adjustable width paddle frame sections have a forward section extending from an interior side of the device to an exterior side of the device and a rearward section extending from an interior side of the device opposite the forward section to an exterior side of the device. The forward and rearward sections are formed as a unitary frame member integrally joined by link sections on the interior side of the device and the exterior side of the device. The connector includes an attachment section that connects to the link sections for attaching the adjustable width frame sections to the connector.

Description

[Background technology]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 310,557, filed February 15, 2022, which is incorporated by reference in its entirety herein.

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring the forward flow of blood to be properly delivered through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc., and therefore can be less effective. Such damage to the valves can lead to severe cardiovascular disorders or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and complications can occur. Transvascular techniques can be used to introduce and implant devices to treat the heart in a much less invasive manner than open-heart surgery. As one example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, ascending the inferior vena cava, and into the right atrium). The septum is then punctured and the catheter passed into the left atrium. A similar transvascular technique may be used, beginning as the transseptal technique but not going as far as puncturing the septum, and instead implanting a device inside the tricuspid valve that pivots the delivery catheter into the right atrium toward the tricuspid valve.

[0003] A healthy heart has a generally conical shape that tapers toward the apex and base. The heart is a four-chambered structure, including the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure than other native heart valves. The mitral valve includes an annulus portion, which is a circular portion of native valve tissue that surrounds the mitral valve opening, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle. The mitral valve annulus may form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape with major and minor axes. The anterior leaflet may be larger than the posterior leaflet, and when closed together, form a generally "C" shaped boundary between the abutting sides of the leaflets.

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

[0005] Valve regurgitation involves a valve inappropriately allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of heart contraction, allowing blood to flow from the left ventricle to the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as prolapse of the leaflets, insufficient papillary muscles, stretching of the mitral annulus from dilation of the left ventricle, or a combination of these. Mitral regurgitation in the central portion of the leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the commissures of the leaflets (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, and therefore the valve does not close and regurgitation is present. Tricuspid regurgitation can be similar, except on the right side of the heart. Summary of the Invention

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

[0007] In some implementations, an implantable device or implant (such as, for example, an implantable device) is provided that is configured to be positioned within the native heart valve so that the native heart valve can form a more effective seal.

[0008] In some implementations, the implantable device or implant includes an anchor portion, each anchor including a plurality of paddles, each movable between an open position and a closed position.

[0009] In some implementations, an exemplary valve repair device includes a pair of paddles movable between open and closed positions for attaching the valve repair device to a patient's native valve, and one or more paddle frames configured to open and close the pair of paddles. The paddle frame can have an optional inner frame portion extending from a proximal portion of the device to a distal portion of the device, and an adjustable width frame portion having a forward portion extending from the inside of the device to the outside of the device, and a rearward portion extending from the inside of the device opposite the forward portion to the outside of the device.

[0010] In some implementations, the front and rear sections are formed as a single frame member joined together at link portions on the inside of the device and on the outside of the device.

[0011] In some implementations, the connector extends from the distal portion toward the proximal portion along both the inside of the device and the outside of the device. The connector includes an attachment portion that connects to the link portion for attaching the adjustable width frame portion to the connector.

[0012] In some implementations, the link portion is configured as a closed end protrusion.

[0013] In some implementations, each of the mounting portions of the connector includes an aperture through which a respective one of the closed end projections is received.

[0014] In some implementations, the front and rear portions of the adjustable width frame portion are attached to the inner frame portion and one or both of the pair of paddles at the proximal portion of the device.

[0015] In some implementations, the adjustable width frame portion comprises a shape memory alloy.

[0016] In some implementations, the adjustable width frame portion is symmetrical.

[0017] In some implementations, an exemplary valve repair device includes a pair of paddles movable between an open position and a closed position. The pair of paddles is configured to attach the valve repair device to a patient's native valve. The one or more paddle frames may include an optional inner frame portion that extends from a proximal portion of the device to a distal portion of the device. The inner frame portion is connected to the pair of paddles at a proximal portion.

[0018] In some implementations, the first adjustable width frame portion of the valve repair device has a first anterior portion extending from an interior side of the device to adjacent the device and a first posterior portion extending from an interior side of the device opposite the first anterior portion to adjacent the midline of the device, hi some embodiments, the second adjustable width frame portion has a second anterior portion extending from an exterior side of the device to adjacent the midline of the device and a second posterior portion extending from an exterior side of the device opposite the second anterior portion to adjacent the midline of the device.

[0019] In some implementations, the first forward portion and the first rearward portion are integrally joined at a first link portion on the inside of the device, and the second forward portion and the second rearward portion are integrally joined at a second link portion on the outside of the device.

[0020] In some implementations, the connector extends along both the inside of the device and the outside of the device from the distal portion toward the proximal portion, hi some implementations, the connector includes a first attachment portion that connects to the first link portion and a second attachment portion that connects to the second link portion for attaching the adjustable width frame portion to the connector.

[0021] In some implementations, the first and second link portions are configured as closed end projections.

[0022] In some implementations, the first and second mounting portions of the connector include an aperture through which a respective one of the closed end projections is received.

[0023] In some implementations, the first forward portion and the first rearward portion are attached to one or both of the inner frame portion and the pair of paddles at a proximal end of the device.

[0024] In some embodiments, the first adjustable width frame portion and the second adjustable width frame portion each comprise a shape memory alloy.

[0025] In some embodiments, the first adjustable width frame portion is symmetrical.

[0026] In some implementations, an exemplary valve repair device includes a pair of paddles movable between an open position and a closed position. The pair of paddles is configured to attach the valve repair device to a patient's native valve. The one or more paddle frames may include an optional inner frame portion that extends from a proximal portion of the device to a distal portion of the device. The optional inner frame portion may be connected to the pair of paddles at a proximal portion.

[0027] In some implementations, the inner adjustable width frame portion is formed as a closed loop extending from the inside of the device to the outside of the device, and the rear adjustable width frame portion is formed as a closed loop extending from the inside of the device to the outside of the device and is opposite the front adjustable width frame portion.

[0028] In some implementations, the connector extends from the distal portion toward the proximal portion along both the front side of the device and the rear side of the device. The connector includes a first attachment portion that connects to a front distal portion of the front adjustable width frame portion. The connector includes a second attachment portion that connects to a rear distal portion of the rear adjustable width frame portion.

[0029] In some implementations, the anterior distal portion of the anterior adjustable-width frame portion and the posterior distal portion of the posterior adjustable-width frame portion are laterally extending straight sections.

[0030] In some implementations, the first mounting portion of the connector includes an aperture through which the rear distal portion is received.

[0031] In some implementations, the front adjustable width frame portion and the rear adjustable width frame portion are attached to the inner frame portion and one or both of the pair of paddles at a proximal portion of the device.

[0032] In some implementations, the front adjustable width frame portion and the rear adjustable width frame portion each include a shape memory alloy.

[0033] In some implementations, the front adjustable width frame portion and the rear adjustable width frame portion are symmetrical.

[0034] In some implementations, the inner frame portion includes a front inner frame portion and a rear inner frame portion separate from the front inner frame portion.

[0035] In some implementations, the front inner frame portion is integrally formed with the front adjustable width frame portion.

[0036] In some implementations, the front inner frame portion is integrally connected to a front adjustable width frame portion adjacent the proximal portion of the device.

[0037] In some implementations, the valve repair device can include an inner paddle and an outer paddle. The first attachment portion can connect to a forward distal portion of the anterior adjustable width frame portion at a forward outer location of the outer paddle.

[0038] In some implementations, the device can include an inner paddle and an outer paddle, and the first attachment portion can connect to a forward distal portion of the forward adjustable width frame portion at a location forward outer of the inner paddle and forward inner of the outer paddle.

[0039] Any of the above systems, assemblies, devices, instruments, components, etc. can be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for patient use, and any of the methods herein can include (or additional methods can include or consist of) sterilization (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, instruments, components, etc. described herein.

[0040] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals and in which:

[0041] To further clarify various aspects of the implementation of the present disclosure, certain embodiments and implementations will be described in more detail by reference to various aspects of the accompanying drawings. These drawings depict only exemplary implementations of the present disclosure and are therefore not to be considered as limiting the scope of the present disclosure. Furthermore, the drawings may be drawn to scale for some embodiments, but not necessarily to scale for all embodiments. The embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0042] [Figure 1] FIG. 1 shows a cross-section of a human heart in diastole. [Diagram 2] FIG. 2 shows a cross-section of a human heart during systole. [Diagram 3] FIG. 3 shows a cross-section of a human heart during systole, showing mitral valve regurgitation. [Figure 4] FIG. 4 is a cross-sectional view of FIG. 3, annotated to show the natural shape of the mitral valve leaflets during systole. [Diagram 5] FIG. 5 shows a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Figure 6]FIG. 6 shows an incompetent mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] FIG. 8 illustrates one embodiment of an implantable device or implant at one stage of deployment. [Figure 9] FIG. 9 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 10] FIG. 10 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 11] FIG. 11 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 12] FIG. 12 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 13] FIG. 13 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 14] FIG. 14 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 15] FIG. 15 illustrates one embodiment of an implantable device or implant similar to the device illustrated in FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16] FIG. 16 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 17] FIG. 17 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 18] FIG. 18 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 19] FIG. 19 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 20] FIG. 20 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 21] FIG. 21 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 22] FIG. 22 shows a perspective view of an exemplary implantable device or implant in a closed position. [Diagram 23] FIG. 23 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 24] FIG. 24 illustrates an exemplary valve repair device with the paddles in the open position. [Figure 25A] FIG. 25A shows another exemplary valve repair device with the paddles in a closed position. [Figure 25B] FIG. 25B shows a top view of an exemplary valve repair device. [Figure 26] FIG. 26 shows a perspective view of an exemplary implantable device having paddles with adjustable width. [Figure 27] FIG. 27 is a cross-sectional view of the implantable device of FIG. 26, where the implantable device is bisected. [Figure 28] 28 is another cross-sectional view of the implantable device of FIG. 26, where the implantable device is bisected along a plane perpendicular to the plane shown in FIG. [Figure 29] FIG. 29 is a schematic diagram of an exemplary implant catheter assembly coupled to an implantable device, where the actuation elements are coupled to the paddle actuation controls and driver head of the implantable device. [Diagram 30] FIG. 30 is a view of the assembly of FIG. 29 with the implantable device rotated 90 degrees to show the paddle width adjustment element coupled to the inner end of the implantable device connector and coupled to the paddle width control. [Diagram 31] FIG. 31 shows a perspective view of an exemplary implantable device having paddles with adjustable width. [Figure 32A]32A shows a perspective view of an exemplary adjustable width frame member that can be used as part of the implantable device of FIG. [Figure 32B] FIG. 32B shows a top view of the adjustable width frame member of FIG. 32A in a flat planar configuration. [Diagram 33] FIG. 33 shows a top view of the adjustable width frame member of FIG. 32A. [Diagram 34] FIG. 34 shows a front view of the adjustable width frame member of FIG. 32A. [Diagram 35] 35 shows a top view of the adjustable width frame member of FIG. 32A connected to an exemplary connector of the implantable device of FIG. [Diagram 36] FIG. 36 shows a front view of the adjustable width frame member and connector of FIG. [Figure 37] FIG. 37 shows a perspective view of an exemplary adjustable width frame member that can be used as part of the implantable device of FIG. [Figure 38] FIG. 38 shows a perspective view of an exemplary implantable device having paddles with adjustable width. [Figure 39] FIG. 39 shows a perspective view of an exemplary adjustable width frame member that can be used as part of the implantable device of FIG. [Diagram 40] FIG. 40 shows a top view of the adjustable width frame member of FIG. [Diagram 41] FIG. 41 shows a front view of the adjustable width frame member of FIG. [Diagram 42] FIG. 42 shows a perspective view of an adjustable width frame member and a connector which may be the same as or similar to the connector of FIG. [Diagram 43] FIG. 43 shows a perspective view of an exemplary implantable device having paddles with adjustable width. [Diagram 44] FIG. 44 shows a front view of the implantable device of FIG. [Diagram 45] FIG. 45 shows a side view of the implantable device of FIG. [Diagram 46]FIG. 46 shows a front view of an exemplary implantable device having paddles with adjustable width. [Figure 47] FIG. 47 shows a perspective view of an exemplary paddle frame that can be used as part of an implantable device. [Figure 48] FIG. 48 shows a side view of the paddle frame of FIG. [Figure 49] FIG. 49 shows a front view of the paddle frame of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] In the following description, reference is made to the accompanying drawings which illustrate example implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0044] Some implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, some implementations of valve repair devices, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, the individual components of the disclosed devices and systems can be combined unless mutually exclusive or physically impossible. Furthermore, the techniques and methods herein can be performed on live animals, or on simulations such as cadavers, cadaver hearts, simulators (e.g., where body parts, hearts, tissues, etc. are simulated), fictional subjects (e.g., shown in the air with a fictional heart), etc.

[0045] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection may be direct, such as between the components, or may be indirect, such as through the use of one or more intermediate components. Also, references to a "member," "component," or "portion" described herein are not limited to a single structural member, component, or element, but may include an assembly of components, members, or elements. Also, as described herein, the terms "substantially" and "about" are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0046] 1 and 2 are cross-sectional views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figs. 3-6 and leaflets 30, 32, 34 shown in Fig. 7) that extend inwardly across their respective openings, which come together or "coapt" in flow to form a unidirectional fluid occlusion surface. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and the left ventricle LV will be described in more detail. However, the devices described herein may also be used in the repair of other native valves, for example, the devices may be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0047] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase or diastole, seen in FIG. 1, blood already collected in the left atrium LA (during systole) moves through the mitral valve MV to the left ventricle LV due to the expansion of the left ventricle LV. During the contraction phase or systole, seen in FIG. 2, the left ventricle LV contracts to pump blood through the aortic valve AV and the ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV to the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described in this application is used to restore the function of a defective mitral valve MV. That is, the device is configured to assist in the closure of the leaflets of the mitral valve to prevent, inhibit, or reduce blood from flowing back from the left ventricle LV to the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation element or spacer that beneficially acts as a filler in the regurgitant opening to prevent or reduce backflow or regurgitation during systole, although this is not required.

[0048] Referring now to Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see Figure 5), which is a variably dense fibrous ring of tissue that surrounds the leaflets 20, 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located in the wall of the left ventricle LV at the base of the chordae tendineae CT) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from everting. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the leaflets 20, 22 against the high pressures required to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular apparatus, which function to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in Figure 3, the anatomy of the leaflets 20, 22 is such that the inner surfaces of the leaflets coapt at their free ends and the leaflets 20, 22 begin to retract or spread apart from one another. The leaflets 20, 22 spread apart toward the atrium until each leaflet contacts the mitral valve annulus.

[0049] Various disease processes can impair the proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or right ventricle RV due to a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathies, etc.) can distort the geometry of the native valve, which can cause the native valve to malfunction. However, the majority of patients who undergo valve surgery, such as mitral valve MV surgery, suffer from a degenerative disease that causes malfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0050] In general, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely, thereby causing impaired blood flow. Typically, valve stenosis is due to the accumulation of calcified material on the leaflets of the valve, which thickens the leaflets and impairs the ability of the valve to open completely and allow forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely, causing blood to leak back into the previous heart chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0051] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier's Type I, II, and III insufficiencies. Carpentier's Type I insufficiency involves dilatation of the valve annulus, so that normally functioning leaflets move apart and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in the insufficiency of the Type I mechanism is leaflet perforation, as occurs in endocarditis. Carpentier's Type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier's Type III insufficiency involves restricted movement of one or more leaflets of the native valve, so that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or ventricular dilatation.

[0052] With reference to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 are coapted, thereby preventing blood from leaking from the left ventricle LV to the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA during systole, so that the edges of the leaflets 20, 22 do not contact each other. Such malcoaptation creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back from the left ventricle LV to the left atrium LA during systole, as shown by the mitral regurgitation MR flow path in FIG. 3. With reference to FIG. 6, the gap 26 may have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 may have a width W of greater than 15 mm or even greater than 17.5 mm. As discussed above, there are several different ways in which a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) may become incompetent, causing valve regurgitation.

[0053] In any of the above situations, a valve repair device or implant that can engage the anterior leaflets 20 and posterior leaflets 22 and close the gap 26 to prevent or inhibit backflow of blood through the mitral valve MV is desirable. As can be seen from FIG. 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the leaflets 20, 22 such that backflow does not occur during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, etc.) of the device 10 have a generally tapered or triangular shape that naturally matches the geometry of the native valve and its tendency to expand (towards the annulus). In this application, terms such as spacer, coaption element, coaptation element and gap filler are used interchangeably and refer to elements that fill a portion of the space between the leaflets of the native valve and / or are configured to engage or "coapt" the leaflets of the native valve (e.g., so that the leaflets coapt not only to each other but also to the coaptation element, spacer, etc.). Coaptation elements or spacers are optional in any of the valve repair devices disclosed herein.

[0054] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve AV or the pulmonary valve PV, and regurgitation has been found to primarily affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the burden on the heart H and, if left untreated, can lead to extremely serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating blood flow throughout the body. Thus, since pressures are substantially higher in the left side of the heart, insufficiency of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening.

[0055] Dysfunctional native heart valves can be either repaired or replaced. Repair typically involves maintaining and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because the stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or pulmonary valve can be removal of the valve and replacing it with a surgically implanted heart valve, or replacing it with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to deformation of the leaflets and / or surrounding tissue, which, as described above, prevents the mitral valve MV or tricuspid valve TV from closing properly and allows regurgitation or backflow of blood from the ventricle to the atrium (e.g., a deformed mitral valve MV can allow regurgitation or backflow from the left ventricle LV to the left atrium LA, as shown in FIG. 3). Regurgitation or backflow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. In addition, regurgitation can occur due to incompetence of the chordae tendineae CT (e.g., the chordae tendineae CT can stretch or rupture), allowing the anterior leaflet 20 and the posterior leaflet 22 to evertate, resulting in blood flowing back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be ameliorated by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0056] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it is understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit backflow of blood from the left ventricle to the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent or inhibit backflow of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets 30, 32, 34 together to prevent or inhibit backflow of blood from the right ventricle to the right atrium. That is, the valve repair device or implant provided herein can be centrally located between the three leaflets 30, 32, 34.

[0057] An exemplary implantable device or implant may optionally have a coaptation element (e.g., a spacer, coaptation element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, an implantable device or implant may have any combination or subcombination of the features disclosed herein without a coaptation element. When included, the coaptation element (e.g., a coaptation element, a spacer, etc.) is configured to be positioned within the native heart valve opening to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting the above-mentioned backflow. The coaptation element may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the native leaflets to close around the coaptation element during ventricular systole, thereby blocking backflow of blood from the left or right ventricle into the left or right atrium, respectively. The device or implant may be configured to seal against two or three native valve leaflets, i.e., the device may be used with native mitral (bicuspid) and native tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element may fill the space between dysfunctional native valve leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely.

[0058] The optional coaptation elements (spacers, coaptation elements, gap fillers, etc.) may have a variety of shapes. In some implementations, the coaptation elements may have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation elements may have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or a variety of other non-cylindrical shapes. In some implementations, the coaptation elements may have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the native leaflets. In some implementations configured for use with a tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid leaflets.

[0059] In some implementations, the anchors can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between two native leaflets. In some implementations configured for use with a tricuspid valve, the anchors are configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between three native leaflets. In some implementations, the anchors can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchors can be attached to an actuation element (e.g., actuation shaft, actuation tube, actuation wire, etc.) to which the coaptation element is also attached. In some implementations, the anchors and coaptation elements can be independently positioned relative to one another by separately moving each of the anchors and coaptation elements along a longitudinal axis of the actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some implementations, the anchors and coaptation elements can be simultaneously positioned by moving the anchors and coaptation elements together along a longitudinal axis of the actuation element (e.g., shaft, actuation wire, etc.). The anchors can be configured to be positioned behind the native valve leaflets when implanted such that the leaflets are grasped by the anchors.

[0060] The device or implant may be configured to be implanted via a delivery system or other delivery means. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The coaptation element and anchor may be compressible to a radially compressed state and may be self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured such that the anchor is expanded radially away from the coaptation element, which is initially still compressed, to create a gap between the coaptation element and the anchor. The native leaflet may then be positioned within the gap. The coaptation element may be expanded radially, closing the gap between the coaptation element and the anchor to capture the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to be self-expanding. The implantation method for some implementations may vary and is described more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, which are incorporated by reference in their entirety for all purposes. These methods can be performed, mutatis mutandis, on live animals or can be performed on simulations, such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0061] The disclosed device or implant may be configured such that anchors are connected to the leaflets and utilize tension from the natural chordae tendineae to resist high systolic pressures that urge the device toward the left atrium. During diastole, the device may rely on compressive and retaining forces exerted on the leaflets that are gripped by the anchors.

[0062] 8-15, a schematic representation of an implantable device or implant 100 (e.g., an implantable prosthetic device, prosthetic spacer device, valve repair device, etc.) is shown in various stages of deployment. The device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated by reference in their entireties. The device 100 may include any other features of an implantable device or implant described in this application or the applications cited above, and the device 100 may be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system / device disclosed in this application or the applications cited above).

[0063] The device or implant 100 is deployed from a delivery system 102. The delivery system 102 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, etc. The device or implant 100 includes a joint portion 104 and an anchor portion 106.

[0064] In some implementations, the interface portion 104 of the device or implant 100 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes an interface element 110 slidably attached to an actuation element 112 (e.g., an actuation wire, an actuation shaft, an actuation tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, a paddle, a gripping element, or the like. When the actuation element 112 is actuated, the anchor portion 106 of the device 100 opens and closes to grip the leaflets of the native valve during implantation. The actuation element 112 (as well as other actuation elements disclosed herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As one example, the actuating element can be threaded such that when the actuating element is rotated, the anchor portion 106 moves relative to the interface portion 104. Alternatively, the actuating element can be unthreaded such that pushing or pulling the actuating element 112 moves the anchor portion 106 relative to the interface portion 104.

[0065] The anchor portion 106 and / or anchor of the device 100, in some implementations, includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the interface element 110 by portions 124, 126, 128. The portions 124, 126, 128 may be articulated and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, interface element 110, and cap 114 by portions 124, 126, 128 may constrain the device to the positions and movements shown herein.

[0066] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuating element 112 (e.g., an actuating wire, an actuating shaft, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuating element 112 extends through the delivery catheter and the interface element 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuating element 112 increases and decreases, respectively, the spacing between the interface element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion). In some implementations, a collar or other attachment element (e.g., a coupler, clamp, removable fastener, clip, etc.) removably attaches, either directly or indirectly, the interface element 110 to the delivery system 102 such that the actuation element 112 slides through the collar or other attachment element, and in some implementations, through the interface element 110 during actuation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0067] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member. The illustrated gripping member may include a catch 130 including a base or fixed arm 132, a movable arm 134, optional friction enhancing elements, other securing structures 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and an interface portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the interface portion 138 disposed proximate to the interface element 110. The interface portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the catch 130. The interface portion 138 may be any suitable interface, such as a flexible interface, a spring interface, a pivot interface, or the like. In some implementations, interface 138 is a flexible piece of material integrally formed with fixed arm 132 and movable arm 134. Fixed arm 132 is attached to inner paddle 122 and remains stationary or substantially stationary relative to inner paddle 122 when movable arm 134 is in an open state, opening clasp 130 and exposing optional barbs or other optional friction enhancing elements 136.

[0068] In some implementations, the clasp 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend or pivot on a joint 138. The actuation line 116 extends through the delivery system 102 (e.g., through the steerable catheter and / or the implant catheter). Other actuation mechanisms are also possible.

[0069] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be spring loaded so that the clasp 130 continues to provide a clamping force to the grasped native leaflet in the closed position. Optional barbs or frictional reinforcement elements 136 of the clasp 130 can grasp, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0070] During implantation, the paddles 120, 122 may be opened and closed, for example, to grip the native leaflets (e.g., leaflets of a native mitral valve, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element 110 (e.g., spacer, plug, membrane, etc.). The clasps 130 may be used to grip and / or further secure the native leaflets by engaging the leaflets with optional barbs or other optional friction enhancing elements 136 and clamping the leaflets between the movable arm 134 and the fixed arm 132. The barbs or other friction enhancing elements 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) of the clasps 130 may increase friction with the leaflets or partially or completely puncture the leaflets. The actuation lines 116 may be actuated separately such that each clasp 130 may be opened and closed separately. Acting separately allows one leaflet to be grasped at a time, or the clasp 130 to be repositioned on a leaflet that was not adequately grasped without changing the good grip on the other leaflets. The clasp 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), allowing the leaflets to be grasped in various positions as the particular situation requires.

[0071] 8, the device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of a delivery system 102. The device 100 is placed at the end of the catheter of the delivery system 102 in the fully open position. In the extended state, the cap 114 is spaced apart from the interface element 110 such that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 can be held closed during deployment through the delivery system. The actuation line 116 can extend to and be attached to a movable arm 134.

[0072] 9, device 100 is shown in an extended state similar to FIG. 8, but with clasp 130 in a range of about 140 degrees to about 200 degrees, in a range of about 170 degrees to about 190 degrees, or in a fully open position of about 180 degrees between fixed portion 132 and movable portion 134 of clasp 130.

[0073] 10, the device 100 is shown in a contracted or fully closed state. To move the device 100 from the extended state to the contracted state, the actuation element 112 is retracted, pulling the cap 114 towards the interface element 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained from moving, so that the compressive force acting on the outer paddle 120 from the cap 114 retracting towards the interface element 110 moves the paddle or gripping element radially outward. The outer paddle 120 maintains an acute angle with the actuation element 112 during movement from the open position to the closed position. The outer paddle 120 can optionally be biased towards the closed position. The inner paddle 122 moves over a very large angle and crushes along the side of the closed interface element 110 because it is oriented away from the open interface element 110 during the same movement.

[0074] 11-13, the device 100 is shown in a partially open, ready-to-grasp state. To move from a fully closed state to a partially open state, an actuation element (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation element 110, thereby pulling the outer paddle 120 and then the inner paddle 122, causing the anchor or anchor portion 106 to partially unfold. The actuation line 116 is also retracted to open the clasp 130 so that the leaflets can be grasped. In some implementations, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation element 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 also closes the clasp. In some implementations, the paddles 120, 122 can be independently controllable. In the embodiment shown in FIG. 15, the device 100 may have two actuating elements 111, 113 and two independent caps 115, 117 (or other mounting parts), such that one independent actuating element (e.g., wire, shaft, etc.) and cap (or other mounting part) is used to control one paddle and the other independent actuating element and cap (or other mounting part) is used to control the other paddle.

[0075] 12, one of the actuation lines 116 can be extended to close one of the clasps 130. Now, referring to FIGURE 13, the other actuation line 116 can be extended to close the other clasp 130. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0076] 14, the device 100 is shown in a fully closed and deployed state. The delivery system 102 and actuation element 112 are retracted and the paddles 120, 122 and clasp 130 remain in a fully closed position. Once deployed, the device 100 may be maintained in the fully closed position by a mechanical latch or may be biased to remain closed by the use of a spring material such as steel, other metals, plastics, composites, or a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from a metal such as steel or from a shape memory alloy such as Nitinol that is fabricated into a wire, sheet, tube, or laser sintered powder and biased to hold the outer paddle 120 closed around the interface element 110 and the clasp 130 in a clamped state around the native leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the valve leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0077] Figure 15 shows an embodiment in which the paddles 120, 122 are independently controllable. The device 101 shown in Figure 15 is similar to the device shown in Figure 11, except that the device 101 of Figure 15 includes an actuation element configured as two independent actuation elements 111, 113 coupled to two independent caps 115, 117. The actuation element 111 is extended to push the cap 115 away from the interface element 110 to transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor 108 to partially expand. The actuation element 113 is extended to push the cap 115 away from the spacer or mating element 110 to transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially expand. The independent paddle control shown in Figure 15 can be implemented in any of the devices disclosed in this application. For comparison, in the embodiment shown in Figure 11, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation element 112.

[0078] 16-21, the implantable device 100 of Figures 8-14 is shown delivered and implanted within the native mitral valve MV of the heart H. With reference to Figure 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as shown in Figure 16. The actuating element 112 is then retracted, moving the implant / device to a fully closed state as shown in Figure 17.

[0079] As can be seen from Figure 18, the implant / device can be moved into position within the mitral valve MV and into the ventricle LV and partially opened to grasp the leaflets 20, 22. For example, the steerable catheter can be advanced and steered or bent to position the steerable catheter as Figure 18 shows. An implant catheter connected to the implant / device can be advanced from within the steerable catheter to position the implant as Figure 18 shows.

[0080] 19, the implant catheter may be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasps 130. The actuating line 116 is extended to close one of the clasps 130, capturing the leaflet 20. FIG. 20 shows the other actuating line 116 then being extended to close the other clasp 130, capturing the remaining leaflet 22. Finally, as can be seen from FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuating element 112 and actuating line 116 are then retracted and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0081] Any of the features disclosed herein may be used in a wide variety of different valve repair devices. Figures 22-24 show examples of valve repair devices that may be modified to include any of the features disclosed herein. Any combination or subcombination of the features disclosed herein may be combined with, substituted for, and / or added to any combination or subcombination of the features of the valve repair devices shown in Figures 8-24.

[0082] 22, an embodiment of an implantable device or implant 200 is shown. The implantable device 200 is one of many different configurations that the device 100, shown generally in FIGS. 8-14, may take. The device 200 may include any of the other features of an implantable device or implant described herein, and the device 200 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system, such as any of the valve repair systems disclosed herein. The device / implant 200 may be an artificial spacer device, a valve repair device, or another type of implant that is attached to the leaflets of a native valve.

[0083] In some implementations, the implantable device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaptation element, plug, membrane, sheet, gap filler, etc.) for implantation between the leaflets of the native valve. In some implementations, the anchor portion 206 includes multiple anchors 208. The anchors may be configured in a variety of ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension or frame 224, and a clasp 230. In some implementations, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism of a delivery system. The delivery system for device 200 may be the same as or similar to delivery system 102 described above and may comprise one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, and the like.

[0084] In some implementations, the joint elements 210 and paddles 220, 222 are formed from a flexible material, which may be a metal fabric formed as a mesh, woven fabric, braided fabric, or the like, or in any other suitable manner, or a flexible material that is laser cut or otherwise cut. The material may be a fabric, a shape memory alloy wire, such as Nitinol, to provide shape setting capabilities, or any other flexible material suitable for implantation within the human body.

[0085] An actuating element (e.g., an actuating shaft, actuating rod, actuating tube, actuating wire, actuating line, etc.) may extend from the delivery system and engage the implantable device or implant 200 to enable actuation thereof. In some implementations, the actuating element extends through the proximal collar 211 and the spacer or interface element 210 and engages the cap 214 of the distal portion 207. The actuating element may be configured to releasably engage the cap 214, such as with a threaded connection, such that the actuating element may be disengaged and removed from the device 200 after implantation.

[0086] The coaptation element 210 extends from a proximal collar 211 (or other attachment element) to an inner paddle 222. In some implementations, the coaptation element 210 has a generally elongated, circular shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above, a tapered shape or cross-section when viewed from the front, and a circular shape or cross-section when viewed from the side. A mixture of these three geometries may result in the illustrated three-dimensional shape of the coaptation element 210 that achieves the benefits described herein. The round shape of the coaptation element 210 may also be seen to substantially follow or approximate the shape of the paddle frame 224 when viewed from above.

[0087] The size and / or shape of the coaptation element 210 may be selected to minimize the number of implants required per patient (preferably one) while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation element is about 5 mm, and the medial-lateral distance at the widest point of the coaptation element is about 10 mm. In some implementations, the overall geometry of the device 200 may be based on these two dimensions and the overall shape plan described above. It will be readily apparent that using other anterior-posterior and medial-lateral distances as a starting point for the device will result in a device with different dimensions. Additionally, using other dimensions and the shape plan described above will also result in a device with different dimensions.

[0088] In some implementations, the outer paddle 220 is joinably attached to the cap 214 of the distal portion 207 by connecting portion 221 and to the inner paddle 222 by connecting portion 223. The inner paddle 222 is joinably attached to the joint element by connecting portion 225. In this manner, the anchor 208 is configured similar to a leg, in that the inner paddle 222 is like an upper portion of a leg, the outer paddle 220 is like a lower portion of a leg, and the connecting portion 223 is like a knee portion of a leg.

[0089] In some implementations, the inner paddle 222 is hard, relatively hard, rigid, has a rigid portion, and / or is rigidified by a stiffening member (e.g., a bar, post, etc.) or a fixed portion of the clasp 230. The inner paddle 222, the outer paddle 220, and the interface elements may all be interconnected as described herein.

[0090] In some implementations, the paddle frame 224 is attached to the cap 214 at the distal portion 207 and extends to a connection portion 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a material that is stiffer and harder than the material forming the paddles 222, 220 such that the paddle frame 224 provides support to the paddles 222, 220.

[0091] The paddle frame 224 may provide additional clamping force between the inner paddle 222 and the coaptation element 210 and may help wrap the leaflets around the sides of the coaptation element 210. That is, the paddle frame 224 may be configured with a rounded three-dimensional shape that extends from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer and inner paddles 220 and 222, the cap 214, and the coaptation element 210 may constrain each of these components to the movements and positions described herein. In particular, the connecting portion 223 is constrained by its connections between the outer and inner paddles 220 and 222, and by its connections to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus the inner and outer paddles 222 and 220) and by its attachment to the cap 214.

[0092] Configuring the paddle frame 224 in this manner widens the surface area, as compared to only the inner paddle 222. The increased surface area may also distribute the clamping force of the paddles 220 and paddle frame 224 against the native leaflet over a larger area of ​​the native leaflet to further protect the native leaflet tissue.

[0093] Additional features of the device 200, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215). Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) is incorporated herein by reference in its entirety.

[0094] 23, there is shown one embodiment of an implantable device or implant 300. The implantable device 300 is one of many different configurations that the device 100 may assume, as shown generally in Figures 8-14. The device 300 may include any of the other features of an implantable device or implant described herein, and the device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0095] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a coaptation portion 304, which optionally includes a coaptation element 310 (e.g., spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 may include, for example, an outer paddle 320, an inner paddle 322, a paddle extension member (e.g., leaf spring, shape setting wire, etc.), or one or more paddles of a paddle frame 324. The anchors may also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging a capture mechanism of a delivery system.

[0096] The anchors 308 may be attached to other portions of the device and / or to each other in a variety of different manners (e.g., directly, indirectly, by welding, by sutures, by adhesive, by links, by latches, by integral formation, by combinations of any or all of these, etc.) In some implementations, the anchors 308 are attached to the interface element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0097] The anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. The connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached to the cap 314 or other mounting portion. In this manner, the anchor 308 is configured similar to a leg, in that the inner paddle 322 is like an upper portion of a leg, the outer paddle 320 is like a lower portion of a leg, and the connecting portion 323 is like a knee portion of a leg.

[0098] In some implementations including the interface element 310, the interface element 310 and the anchor 308 may be coupled together in a variety of ways. As shown in the illustrated embodiment, the interface element 310 and the anchor 308 may be coupled together by integrally forming the interface element 310 and the anchor 308 as a single, unitary component. This may be accomplished, for example, by forming the interface element 310 and the anchor 308 from a continuous piece 301 of braided or woven material, such as braided or interwoven Nitinol wire. In the illustrated embodiment, the interface element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous piece of fabric 301.

[0099] Similar to the anchor 208 of the implantable device or implant 200 described above, the anchor 308 may be configured to move between various configurations by axially moving a distal end of the device (e.g., cap 314, etc.) relative to a proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement may be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device.

[0100] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the spacer or coaptation element 310. From the straight configuration, the anchor 308 can be moved to a fully collapsed configuration (e.g., FIG. 23), for example, by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device.

[0101] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 330 includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and an interface portion 338. The fixed arm 332 is attached to the inner paddle 322 with the interface portion 338 disposed proximate to the interface element 310. The interface portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is in a closed state.

[0102] The fixed arm 332 is attached to the inner paddle 322 by sutures through a hole or slot. The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, welding, adhesive, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened to open the clasp 330 and expose the optional barb 336. The clasp 330 is opened by applying tension to an actuation line attached to the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or bend on the interface 338.

[0103] In summary, the implantable device or implant 300 is similar in construction and operation to the implantable device or implant 200 described above, except that the joint element 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed from a single piece of material 301. In some implementations, the piece of material 301 is attached to the proximal collar 311, the cap 314, and the paddle frame 324 by weaving or inserting through openings in the proximal collar 311, in the cap 314, and in the paddle frame 324 that are configured to receive the continuous piece of material 301. The continuous piece 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of material 301, and other portions are formed from multiple overlapping or overlapping layers of the piece of material 301.

[0104] For example, Figure 23 shows a joining element 310 and inner paddle 322 formed from multiple overlapping layers of material strips 301. The single continuous piece of material 301 may begin and end at various locations on the apparatus 300. The ends of the piece of material 301 may be at the same location or at different locations on the apparatus 300. For example, in the illustrated embodiment of Figure 23, the piece of material 301 begins and ends at the location of the inner paddle 322.

[0105] As with the implantable device or implant 200 described above, the size of the coaptation element 310 may be selected to minimize the number of implants required per patient (preferably one), while at the same time maintaining a low transvalvular gradient. Notably, by forming many of the components of the device 300 from a single piece of material 301, the device 300 may be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance at the widest point of the device 300 (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is approximately 5 mm.

[0106] Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) is incorporated herein by reference in its entirety.

[0107] 24 illustrates another example of one of many valve repair systems 40056 for repairing a patient's native valve to which the concepts of the present application may be applied. The valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0108] The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656, and a pair of gripping members 40856 (e.g., clasps, clips, arms, etc.). In one embodiment, the paddles 40656 may be integrally formed with the base assembly. For example, the paddles 40656 may be formed as an extension of a link of the base assembly. In the illustrated embodiment, the base assembly 40456 of the valve repair device 40256 includes a shaft 40356, a coupler 40556 configured to move along the shaft, and a lock 40756 configured to lock the coupler in a stationary position on the shaft. The coupler 40556 is mechanically connected to the paddles 40656 such that movement of the coupler 40556 along the shaft 40356 moves the paddles between an open position and a closed position. In this manner, the couplers 40556 function as a means for mechanically coupling the paddles 40656 to the shaft 40356 and for moving the paddles 40656 between their open and closed positions as they move along the shaft 40356.

[0109] In some implementations, the gripping member 40856 is pivotally connected to the base assembly 40456 (e.g., the gripping member 40856 can be pivotally connected to the shaft 40356, or any other suitable member of the base assembly) such that the gripping member can be moved to adjust the width of the opening 41456 between the paddle 40656 and the gripping member 40856. The gripping member 40856 can include an optional barbed portion 40956 for attaching the gripping member to the valve tissue when the valve repair device 40256 is attached to the valve tissue. When the paddle 40656 is in a closed position, the paddle engages the gripping member 40856 such that when the valve tissue is attached to the barbed portion 40956 of the gripping member, the paddle secures the valve repair device 40256 to the valve tissue. In some implementations, the gripping member 40856 is configured to engage the paddle 40656 such that the barbed portion 40956 engages the valve tissue and the paddle 40656 to secure the valve repair device 40256 to the valve tissue. For example, in certain circumstances it may be advantageous to have the paddle 40656 maintain an open position and move the gripping member 40856 outwardly toward the paddle 40656 to engage the valve tissue and the paddle 40656.

[0110] Although the embodiment depicted in FIG. 24 shows a pair of paddles 40656 and a pair of gripping members 40856, it will be understood that the valve repair device 40256 can include any suitable number of paddles and gripping members.

[0111] In some implementations, the valve repair system 40056 includes a placement shaft 41356 that is removably attached to the shaft 40356 of the base assembly 40456 of the valve repair device 40256. The placement shaft 41356 is detached from the shaft 40356 to remove the valve repair device 40256 from the remainder of the valve repair system 40056 after the valve repair device 40256 is secured to the valve tissue such that the valve repair device 40256 can remain attached to the valve tissue and the delivery device 40156 can be removed from the patient's body.

[0112] The valve repair system 40056 may also include a paddle control mechanism 41056 (e.g., a relatively movable tube, shaft, etc.), a gripper control mechanism 41156 (e.g., a wire, line, suture, etc.), and a lock control mechanism 41256 (e.g., a relatively movable tube, shaft, wire, line, suture, etc.). The paddle control mechanism 41056 is mechanically attached to the coupler 40556 to move the coupler along the shaft, which causes the paddle 40656 to move between an open position and a closed position. The paddle control mechanism 41056 may take any suitable form, such as, for example, a shaft or rod. For example, the paddle control mechanism may include a hollow shaft and a catheter tube or sleeve that fits over the mounting shaft 41356 and the shaft 40356 and is connected to the coupler 40556.

[0113] The gripper control mechanism 41156 is configured to move the gripping member 40856 such that the width of the opening 41456 between the gripping member and the paddle 40656 may be altered. The gripper control mechanism 41156 may take any suitable form, such as, for example, a line, suture or wire, a rod, a catheter, etc.

[0114] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 locks the coupler 40556 in a stationary position relative to the shaft 40356 and can take a wide variety of different forms, and the type of lock control mechanism 41256 can be determined by the type of lock used. In examples in which the lock 40756 includes a pivotable plate, the lock control mechanism 41256 is configured to engage the pivotable plate to move the plate between a tilted position and a substantially non-tilted position. The lock control mechanism 41256 can be, for example, a rod, suture, wire, or any other member that can move the pivotable plate of the lock 40756 between a tilted position and a substantially non-tilted position.

[0115] The valve restoration device 40256 is movable from an open position to a closed position. The base assembly 40456 includes a link that is moved by a coupler 40556. The coupler 40556 is movably attached to a shaft 40356. To move the valve restoration device from the open position to the closed position, the coupler 40556 is moved along the shaft 40356, thereby moving the link.

[0116] The gripper control mechanism 41156 moves the gripping members 40856 to provide a wider or narrower gap at the opening 41456 between the gripping members and the paddle 40656. In the illustrated embodiment, the gripper control mechanism 41156 includes a line, such as a suture, wire, or the like, that is connected to an opening in the end of the gripper member 40856. When the line is pulled, the gripping members 40856 move inward, causing the opening 41456 between the gripping members and the paddle 40656 to become wider.

[0117] To move the valve restoration device 40256 from an open position to a closed position, the lock 40756 is moved to an unlocked state by the lock control mechanism 41256. Once the lock 40756 is in the unlocked state, the coupler 40556 can be moved along the shaft 40356 by the paddle control mechanism 41056.

[0118] After the paddle 40656 has been moved to the closed position, the lock 40756 is moved to a locked state by the lock control mechanism 41256 to maintain the valve repair device 40256 in the closed position. After the valve repair device 40256 is maintained in the locked state by the lock 40756, the valve repair device 40256 is removed from the delivery device 40156 by decoupling the shaft 40356 from the mounting shaft 41356. In addition, the valve repair device 40256 is disengaged from the paddle control mechanism 41056, the gripper control mechanism 41156, and the lock control mechanism 41256.

[0119] Additional features of the device 40256, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) is incorporated herein by reference in its entirety.

[0120] The clasp or leaflet grasping device disclosed herein can take a wide variety of different forms. An example of a clasp is disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Any combination or subcombination of the features disclosed by this application can be combined with any combination or subcombination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201) is incorporated herein by reference in its entirety.

[0121] 25A and 25B, an exemplary implementation of the valve repair device 40256 includes a coaptation element 3800. The valve repair device 40256 may have the same configuration as the valve repair device shown in FIG. 24 with the addition of the coaptation element. The coaptation element 3800 may take a wide variety of different shapes. The coaptation element 3800 may be compressible and / or expandable. For example, the coaptation element may be compressed to fit within one or more catheters of a delivery system, may expand when moved out of one or more catheters, and / or may be compressed by a paddle 40656 to adjust the size of the spacer or coaptation element. In the embodiment shown in FIG. 25A and 25B, the size of the coaptation element 3800 may be decreased by squeezing the coaptation element with the paddle 40656 and increased by moving the paddle 40656 away from each other. The coaptation element 3800 may extend beyond the outer edge 4001 of the gripping member or clasp 40856 as illustrated to provide additional surface area for closing the mitral valve gap.

[0122] The coaptation element 3800 may be coupled to the valve repair device 40256 in a variety of different ways. For example, the coaptation element 3800 may be fixed to the shaft 40356, slidably disposed about the shaft, connected to the coupler 40556, connected to the lock 40755, and / or connected to a central portion of the catch or gripping member 40856. In some implementations, the coupler 40556 may take the form of the coaptation element 3800. That is, a single element may be used as the coupler 40556, which moves the paddle 40656 between the open and closed positions, and the coaptation element 3800, which closes the gap between the leaflets 20, 22 when the valve repair device 40256 is attached to the leaflets.

[0123] The interface element 3800 can be disposed about one or more of the shaft or other control elements of the valve repair system 40056. For example, the interface element 3800 can be disposed about the shaft 40356, the shaft 41356, the paddle control mechanism 41056, and / or the lock control mechanism 41256.

[0124] The valve repair device 40256 may include any other features for the valve repair device discussed in this application, and the valve repair device 40256 may be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additional features of the device 40256, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904).

[0125] 26-30 show another embodiment of one of many valve repair systems for repairing a patient's native valve to which the concepts of the present application may be applied. With reference to FIGS. 29 and 30, the valve repair system includes an implant catheter assembly 1611 and an implantable valve repair device 8200. With reference to FIGS. 26-28, the implantable device 8200 includes a proximal or attachment portion 8205, a paddle frame 8224, and a distal portion 8207. The attachment portion 8205, the distal portion 8207, and the paddle frame 8224 may be configured in a variety of ways.

[0126] 26, the paddle frame 8224 may be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 8224 is not symmetrical about the axis YY. Further, with reference to FIG. 26, the paddle frame 8224 may include an outer or adjustable width frame portion 8256 and an optional inner frame portion 8260.

[0127] In some implementations, the connector 8966 (e.g., a molded metal component, molded plastic component, tether, wire, post, line, cord, suture, etc.) is attached to the outer or adjustable width frame portion 8256 at an outer end or connection portion 8266 of the connector 8966 and to the coupler 8972 at an inner end 8968 of the connector 8966 ( FIG. 28 ). Between the connector 8966 and the attachment portion 8205, the outer or adjustable width frame portion 8256 forms a curved shape. In the illustrated example, the shape of the outer or adjustable width frame portion 8256 resembles an apple shape, with the outer or adjustable width frame portion 8256 being wider toward the attachment portion 8205 and narrower toward the distal portion 8207. However, in some implementations, the outer frame portion 8256 may be shaped in other ways.

[0128] 26 , an outer or adjustable width frame member 8256 (e.g., a wire frame, a metal frame, etc.) includes front and rear frame members 8967. The front and rear frame members 8967 are connected to a connecting portion 8266 of a connector 8966. In the illustrated embodiment, the connector 8966 is attached to both of the adjustable width frame members 8967 via two joints, such as suture joints. However, in some implementations, the connector 8966 may be attached to both the front and rear frame members 8967 in any suitable manner.

[0129] The inner frame portion 8260 extends from the mounting portion 8205 toward the distal portion 8207. The inner frame portion 8260 then extends inwardly to form a retaining portion 8272 that is attached to the actuation cap 8214. The retaining portion 8272 and the actuation cap 8214 can be configured to be attached in any suitable manner.

[0130] In some implementations, the optional inner frame portion 8260 is a rigid frame portion while the outer or adjustable width frame portion 8256 is a flexible frame portion. The proximal end of the outer frame portion 8256 may be connected to or integrally formed with the proximal end of the inner frame portion 8260, as shown in FIG.

[0131] A width adjustment element 8211 (e.g., a width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt, etc.) is configured to move the outer frame portion 8256 from an expanded position to a narrowed position by pulling the inner end 8968 ( FIG. 28 ) and a portion of the connector 8266 on the actuation cap 8214. The actuation element 8102, according to some implementations disclosed herein, is configured to move the inner frame portion 8260 to open and close the paddles.

[0132] As shown in FIGS. 27 and 28 , the connector 8966 has an inner end 8968 that engages with the width adjustment element 8211 such that a user can move the inner end 8968 inside the receiver 8912 (e.g., an internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a cylinder, a raceway, etc.) to move the outer frame portion 8256 between a constricted position and an expanded position. In the illustrated embodiment, the inner end 8968 includes a post 8970 that attaches the outer portion 8266 of the connector 8966 to a coupler 8972. The coupler 8972 is configured to be attached to and detached from both the width adjustment element 8211 and the receiver 8912. The coupler 8972 can take a wide variety of different forms. For example, the coupler 8972 can include one or more of a threaded connection, a mechanism that mates with a thread, an outwardly biased arm, a detent connection such as a wall, or other portion. When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver 8912. When the coupler 8972 is removed from the width adjustment element 8211, the coupler is secured to the receiver 8912. However, the inner end 8968 of the connector may be configured in a variety of ways. Any configuration may be used that can suitably attach the outer frame portion 8256 to the coupler so that the width adjustment element 8211 can move the outer frame portion 8256 between the constricted and expanded positions. The coupler may be similarly configured in a variety of ways and may be a separate component or may be integrated with another portion of the device, such as the connector or the inner end of the connector.

[0133] The width adjustment element 8211 allows a user to expand or contract the outer frame portion 8256 of the implantable device 8200. In the embodiment shown in FIGS. 27 and 28 , the width adjustment element 8211 includes a male threaded end that screws into the coupler 8972. The width adjustment element 8211 moves the coupler into the receiver 8912 to adjust the width of the outer frame portion 8256. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages the inner surface of the receiver 8912 to set the width of the outer frame portion 8256.

[0134] In some implementations, the receiver 8912 may be integrally formed with the distal cap 8214. Moving the cap 8214 relative to the body of the mounting portion 8205 opens and closes the paddle. In the illustrated example, the receiver 8912 slides inside the body of the mounting portion. When the coupler 8972 is removed from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to the body of the mounting portion 8205. Moving the cap may open and close the device in the same manner as some implementations disclosed above.

[0135] In the illustrated embodiment, the driver head 8916 is disposed at a proximal end of the actuating element 8102. The driver head 8916 removably couples the actuating element 8102 to the receiver 8912. In the illustrated embodiment, the width adjustment element 8211 extends through the actuating element 8102. The actuating element is advanced axially in the opposite direction to the Y direction to move the distal cap 8214. As shown by the arrows in FIG. 27, movement of the distal cap 8214 relative to the mounting portion 8205 is effective to open and close the paddle. That is, when the distal cap 8214 is moved in the Y direction, the device is closed, and when the distal cap is moved in the opposite direction to the Y direction, the device is opened.

[0136] 27 and 28, the width adjustment element 8211 extends through the actuation element 8102, the driver head 8916, and the receiver 8912 and engages a coupler 8972 attached to the inner end 8968. When the outer frame portion 8256 is moved to the constricted position, the device or implant 8200 may be easily maneuvered into position for implantation into the heart by reducing contact and / or friction between the native structures of the heart (e.g., chordae tendineae) and the device 8200. When the outer frame portion 8256 is moved to the expanded position, the anchor portions of the device or implant 8200 are provided with a larger surface area to engage and capture the leaflets of the native heart valve.

[0137] 29 and 30, an example of an implant catheter assembly 1611 is shown in which the clasp actuation line 624 extends through the handle 1616, the actuation element 8102 is coupled to a paddle actuation control 1626, and the width adjustment element 8211 is coupled to a paddle width control 1628. A proximal end portion 1622a of the shaft or catheter of the implant catheter assembly 1611 may be coupled to the handle 1616, and a distal end portion 1622b of the shaft or catheter may be coupled to the implantable device 8200. The actuation element 8102 may extend distally from the paddle actuation control 1626, through the handle 1616, through the delivery shaft or catheter of the implant catheter assembly 1611, and through the proximal end of the device 8200, where the actuation element couples with a driver head 8916. The actuation element 8102 may be axially movable relative to the outer shaft of the implant catheter assembly 1611 and handle 1616 to open and close the device.

[0138] The width adjustment element 8211 may extend distally from the paddle width control 1628, through the paddle actuation control 1626, through the actuation element 8102 (and consequently through the handle 1616, the outer shaft of the implant catheter assembly 1611, and the device 8200), where the width adjustment element couples with the movable coupler 8972. The width adjustment element 8211 may be axially movable relative to the actuation element 8102, the outer shaft of the implant catheter assembly 1611, and the handle 1616. The clasp actuation line 624 may extend through and be axially movable relative to the handle 1616 and the outer shaft of the implant catheter assembly 1611. The clasp actuation line 624 may also be axially movable relative to the actuation element 8102.

[0139] 29 and 30, the width adjustment element 8211 can be removably coupled to the coupler 8972 of the device 8200. The width adjustment element 8211 is advanced and retracted via the paddle width control 1628 to increase or decrease the width of the paddle. The actuation element 8102 is advanced and retracted via the paddle width control 1626 to open and close the paddle of the device.

[0140] 29 and 30, the catheter or shaft of the implant catheter assembly 1611 is an elongate shaft extending axially between a proximal end portion 1622a that is coupled to the handle 1616 and a distal end portion 1622b that is coupled to the device 8200. The outer shaft of the implant catheter assembly 1611 may also include an intermediate portion 1622c disposed between the proximal end portion 1622a and the distal end portion 1622b.

[0141] 31 illustrates an exemplary valve repair system for repairing a patient's native valve to which the concepts of the present application may be applied, which may include the same or similar features as other valve repair systems described. With reference to FIG. 31, the valve repair system may include an implantable valve repair device 9200 having a proximal or attachment portion 9205, a paddle frame 9224, an inner paddle 9225, an outer paddle 9226, and a distal portion 9207. The proximal portion 9205, the distal portion 9207, and the paddle frame 9224 may be configured in a variety of ways.

[0142] The exemplary valve repair device 9200 shown in FIG. 31 may be substantially similar to the valve repair device 8200 of FIG. 26. For example, the paddle frame 9224 may be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 9224 is not symmetrical about the longitudinal axis YY. The paddle frame 9224 includes one or more outer frame members 9256 (e.g., wire frame portions, metal frame portions, etc.) and optional one or more inner frame members 9260 (e.g., wire frame portions, metal frame portions, etc.).

[0143] The outer frame member 9256 is flexibly attached to the connector 9266. Between the connector 9266 and the proximal portion 9205, the outer frame member 9256 forms a curved shape. For example, in the illustrated embodiment, the shape of the outer frame member 9256 resembles that of an apple in that the outer frame member 9256 is wider toward the proximal portion 9205 and narrower toward the distal portion 9207. However, in some implementations, the outer frame member 9256 can be other shapes.

[0144] The inner frame member 9260 extends from the proximal portion 9205 towards the distal portion 9207. The inner frame member 9260 then extends inwardly to form a retaining portion 9272 that is attached to the actuation cap 9214 in the same or similar manner as described in connection with any of the implementations of the implantable valve repair device described herein. The retaining portion 9272 and the actuation cap 9214 can be configured to be attached in any suitable manner.

[0145] In some implementations, the inner frame member 9260 is a rigid frame portion while the outer frame member 9256 is a flexible frame portion. The proximal end of the outer frame member 9256 connects to the proximal end of the inner frame member 9260 at or adjacent to the proximal portion 9205 of the device.

[0146] The implantable valve repair device 9200 is configured to move the outer frame member 9256 from an expanded position to a stenosed position by pulling portions of the connector 9266 on the actuation cap 9214. The implantable valve repair device 9200 is also configured, according to some implementations disclosed herein, to move the inner frame member 9260 to open and close the paddles (e.g., the outer paddle 320 and the inner paddle 322 of FIG. 23 ).

[0147] 26, the outer frame member 8256 includes a pair of adjustable width frame members 8967 (e.g., wire frame portions, metal frame portions, etc.), one disposed anteriorly and the other disposed posteriorly, that connect to the connector 8266 via suture joints. In some implementations, such as the exemplary valve repair device 9200 of FIG. 31, the valve repair device 9200 includes adjustable width frame members 9267 (e.g., wire frame, metal frame, etc.) that connect to the connector portion 9266 and are formed as a single, integral piece, as shown in FIGS. 32-34.

[0148] The adjustable width frame member 9267 (e.g., wire frame member, metal frame member, etc.) may be configured in a variety of ways, including different shapes and sizes, and may be used in a variety of valve repair systems / devices (e.g., the valve repair systems / devices of FIGS. 22-26 may be adapted to include adjustable width paddle and frame member 9267). With reference to FIGS. 31-36, in the illustrated embodiment, the adjustable width frame member 9267 includes a proximal portion 9270 and a distal portion 9271 opposite the proximal portion 9270. The adjustable width frame member 9267 includes a forward portion 9280 and a rearward portion 9282 opposite the forward portion 9280. In the illustrated embodiment, the forward portion 9280 is a mirror image of the rearward portion 9282 such that the adjustable width frame member 9267 is symmetrical about axis WW (FIG. 33) and axis ZZ (FIG. 34). However, in other embodiments, the shape of the forward portion 9280 may differ from the shape of the rearward portion 9282 such that the adjustable width frame member 9267 is not symmetrical.

[0149] In addition to connecting to a proximal end of the inner frame member 9260 (e.g., a wire frame portion, a metal frame portion, etc.), the proximal portion 9270 of each of the forward portion 9280 and rearward portion 9282 may also include an opening 9284 for receiving a paddle (e.g., inner and outer paddles), as shown in FIG. 32. As shown in FIGS. 32A and 34, the forward portion 9280 and rearward portion 9282 of the adjustable width frame member 9267 flare or taper away from each other toward the proximal portion 9270 such that the distance between the forward portion 9280 and rearward portion 9282 is greatest at the proximal portion 9270.

[0150] The distal portion 9271 of the adjustable width frame member 9267 is connected to a proximal portion 9286 of the connector 9266 (FIG. 36). The distal portion 9271 of the adjustable width frame member 9267 may be connected to the proximal portion 9286 of the connector 9266 in a variety of ways. In the illustrated embodiment, the front portion 9280 and the rear portion 9282 of the adjustable width frame member 9267 are integrally connected to one another at the distal portion 9271 to form a link portion. As shown in FIGS. 32 and 34, the front portion 9280 and the rear portion 9282 converge toward one another at the distal portion 9271 to form a pair of closed end projections 9287, one on the inside and the other on the outside of the adjustable width frame member 9267.

[0151] The connector 9266 includes a proximal portion 9286 adjacent the distal portion 9271 of each of the forward and rearward portions 9280, 9282 of the adjustable width frame member 9267. The proximal portion 9286 of the connector 9266 includes an attachment portion 9290 for connecting to the distal portion 9271 of the adjustable width frame member 9267. The attachment portion 9290 may be configured in a variety of ways. In the illustrated embodiment, each attachment portion 9290 includes a loop or hole through which the respective closed end projection 9287 passes.

[0152] In the example of FIG. 31 , the connector 9266 includes two or more layers of material. In some implementations, to connect one of the closed end projections 9287 to one of the attachment portions 9290, the layers can be separated to temporarily open the attachment portion 9290 at the proximal portion 9286 to receive the closed end projection 9287. For example, the closed hole shown in FIG. 31 can be temporarily opened. Once the closed end projection 9287 is properly positioned (e.g., the connector 9266 is centered relative to the adjustable width frame member 9267 or the closed end projection 9287 is coaxial with the connecting portion 9266), the layers can retract together and surround the distal portion 9271. As a result, the attachment points between the adjustable width frame member 9267 and the connector 9266 act as hinges that allow free rotation or pivoting between the adjustable width frame member 9267 and the connector 9266 at the attachment points, resulting in reduced stress and tension on the delivery system and device.

[0153] The adjustable width frame member 9267 may be formed as a single, integral piece in any suitable manner. For example, the adjustable width frame member 9267 may include a shape memory alloy, such as Nitinol, to provide shape setting capabilities. The adjustable width frame member 9267 may be shape set into an assembled state or may be assembled in a flat state or profile. For example, with reference to FIG. 32B, the adjustable width frame member 9267 is shown in a flat planar state. The adjustable width frame member 9267 may be, for example, laser cut and shape set into a flat planar configuration or otherwise bent or biased into the configuration shown in FIG. 32A about axis VV (FIG. 32B). Thus, the closed end protrusion 9287 is created during formation of the adjustable width frame member 9267, such that the adjustable width frame member 9267 bends at or near the proximal portion 9270 when deployed.

[0154] FIG. 37 illustrates an example of an adjustable width frame member 9367 that can be used as part of various valve repair systems or devices (e.g., valve repair device 9200, other valve repair systems and devices herein, etc.) for repairing a patient's native valve, to which the concepts of the present application may be applied. The adjustable width frame member 9367 is formed as a single, integral piece that connects to a lower or distal frame member (e.g., connector 9266, FIG. 31). The adjustable width frame member 9367 may be formed as a single, integral piece in any suitable manner. For example, the adjustable width frame member 9367 may include a shape memory alloy, such as Nitinol, to provide shape setting capabilities. The adjustable width frame member 9367 may be shape set into an assembled state or may be assembled in a flat state or contour.

[0155] The adjustable width frame member 9367 (e.g., wire frame portion, metal frame portion, etc.) may be configured in a variety of ways, including different shapes and sizes. In the illustrated embodiment of FIG. 37, the adjustable width frame member 9367 includes a proximal portion 9370 and a distal portion 9371 opposite the proximal portion 9370. The adjustable width frame member 9367 includes a forward portion 9380 and a rearward portion 9382 opposite the forward portion 9380. In the illustrated embodiment, the forward portion 9380 is a mirror image of the rearward portion 9382 such that the adjustable width frame member 9367 is symmetrical. However, in other embodiments, the shape of the forward portion 9380 may differ from the shape of the rearward portion 9382 such that the adjustable width frame member 9367 is not symmetrical.

[0156] The forward portion 9380 and the rearward portion 9382 of the adjustable width frame member 9367 extend away from each other toward the proximal portion 9370 such that the distance between the forward portion 9380 and the rearward portion 9382 is greatest at the proximal portion 9370. While the adjustable width frame member 9267 of FIG. 34 forms a Y-shape or V-shape having a flared proximal portion 9270 with a rounded contour, the shape of the adjustable width frame member 9367 of FIG. 37 forms a T-shape with a squarer contour at the proximal portion 9270.

[0157] The distal portion 9371 of the adjustable width frame member 9367 is configured to connect to a proximal end of a connector. The distal portion 9371 of the adjustable width frame member 9367 may connect to the connector in a variety of ways. In the illustrated embodiment, the front portion 9380 and the rear portion 9382 of the adjustable width frame member 9367 are integrally connected to one another at the distal portion 9371 to form a link portion. As shown in FIG. 37 , the front portion 9380 and the rear portion 9382 converge toward one another at the distal portion 9371 to form a pair of closed end projections 9387, one on the inside and the other on the outside of the adjustable width frame member 9367.

[0158] FIG 38 illustrates one embodiment of a valve repair system for repairing a patient's native valve to which the concepts of the present application may be applied. With reference to FIG 38, the valve repair system includes an implantable valve repair device 9400 having a proximal or attachment portion 9405, a paddle frame 9424, an inner paddle 9425, an outer paddle 9426, and a distal portion 9407. The proximal portion 9405, the distal portion 9407, and the paddle frame 9424 may be configured in a variety of ways.

[0159] The exemplary valve repair device 9400 shown in FIG. 31 may be similar to the valve repair device 9200 of FIG. 31. For example, the paddle frame 9424 may be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 9424 is not symmetrical about the longitudinal axis YY. The paddle frame 9424 includes one or more outer frame members 9456 (e.g., wire frame portions, metal frame portions, etc.) and one or more inner frame members 9460 (e.g., wire frame portions, metal frame portions, etc.).

[0160] In some implementations, the outer frame member 9456 is flexibly attached to the connector 9466. In some implementations, between the connector 9466 and the proximal portion 9405, the outer frame member 9456 forms a curved convex shape. For example, in the illustrated example, the shape of the outer frame member 9456 resembles an apple shape in that the outer frame member 9456 is wider toward the proximal portion 9405 and narrower toward the distal portion 9407. However, in some implementations, the outer frame member 9456 can be other shapes.

[0161] The inner frame member 9460 extends from the proximal portion 9405 toward the distal portion 9407. The inner frame member 9460 then extends inwardly to form a retention portion 9472 that is attached to the actuation cap 9414 in the same or similar manner as described in connection with any of the implementations of the implantable valve repair device described herein. The retention portion 9472 and the actuation cap 9414 may be configured to be attached in any suitable manner.

[0162] In some implementations, the inner frame member 9460 is a rigid frame portion while the outer frame member 9456 is a flexible frame portion. The proximal end of the outer frame member 9456 connects to the proximal end of the inner frame member 9460 at or adjacent to the proximal portion 9405 of the device.

[0163] The implantable valve repair device 9400 is configured to move the outer frame member 9456 from an expanded position to a stenosed position by pulling portions of the connector 9466 on the actuation cap 9414. The implantable valve repair device 9400 is also configured, according to some implementations disclosed herein, to move the inner frame member 9460 to open and close the paddles (e.g., the outer paddle 320 and the inner paddle 322 of FIG. 23 ).

[0164] In the exemplary valve repair device 8200 shown in FIG. 26, the outer frame member 8256 includes a pair of adjustable width frame members 8967, one disposed anteriorly and the other disposed posteriorly, with the lower or distal frame member 8966 formed at least in part by a connecting portion 8266 and connected to the connector 8256 via a suture joint. However, in the exemplary valve repair device 9400 of FIGS. 38-42, the valve repair device 9400 includes a pair of adjustable width frame members 9467, one disposed medially and the other disposed externally. In particular, the valve repair device 9400 includes an inner adjustable width frame member 9474 (e.g., a wire frame portion, a metal frame portion, etc.) and an outer adjustable width frame member 9476 (e.g., a wire frame portion, a metal frame portion, etc.) that connect to the connector 9466.

[0165] The inner adjustable width frame member 9474 and the outer adjustable width frame member 9476 may be formed in any suitable manner. For example, the inner adjustable width frame member 9474 and the outer adjustable width frame member 9476 may include a shape memory alloy, such as Nitinol, to provide shape setting capabilities. Each of the inner adjustable width frame member 9474 and the outer adjustable width frame member 9476 may be shape set into an assembled state or may be assembled in a flat state or contour. In the illustrated example, the inner adjustable width frame member 9474 and the outer adjustable width frame member 9476 are identical. Thus, the following description of the inner adjustable width frame member 9474 applies equally to the outer adjustable width frame member 9476. However, in some implementations, the inner adjustable width frame member 9474 and the outer adjustable width frame member 9476 may be configured differently.

[0166] The medial adjustable width frame member 9474 may be configured in a variety of ways, including different shapes and sizes, and may be used in a variety of valve repair systems (e.g., the valve repair systems / devices of FIGS. 22-26 may be adapted to include adjustable width paddles and frame member 9474). With reference to FIGS. 39-41, in the illustrated embodiment, the medial adjustable width frame member 9474 includes a proximal portion 9470 and a distal end 9471 opposite the proximal portion 9470. The medial adjustable width frame member 9474 includes a forward portion 9480 and a rearward portion 9482 opposite the forward portion 9480. In the illustrated embodiment, the forward portion 9480 is a mirror image of the rearward portion 9482 such that the medial adjustable width frame member 9474 is symmetrical about axis WW (FIG. 40) and axis ZZ (FIG. 41). However, in other embodiments, the shape of the forward portion 9480 may differ from the shape of the rearward portion 9482 such that the inner adjustable width frame member 9474 is not symmetrical.

[0167] In addition to connecting to the proximal end of the inner frame member 9460, the proximal portion 9470 of each of the forward portion 9480 and rearward portion 9482 may also include a recess or hole 9484 for receiving a portion of a paddle (e.g., the inner and outer paddles), as shown in Figures 39 and 40. As best shown in Figure 41, the forward portion 9480 and rearward portion 9482 of the adjustable width frame member 9467 flare or taper away from each other toward the proximal portion 9470 such that the distance between the forward portion 9480 and rearward portion 9482 is greatest at the proximal portion 9470, and the inner adjustable width frame member 9474 forms a Y- or V-shape.

[0168] The distal end 9471 of the inner adjustable width frame member 9474 is connected to the proximal portion 9486 of the connector 9466 (FIGS. 38 and 42). The distal end 9471 of the inner adjustable width frame member 9474 may be connected to the proximal portion 9486 of the connector 9468 in a variety of ways. In the illustrated embodiment, the front portion 9480 and the rear portion 9482 of the inner adjustable width frame member 9474 are integrally connected to one another at the distal end 9471 to form a link portion. As shown in FIGS. 39 and 41, the front portion 9480 and the rear portion 9482 converge toward one another at the distal end 9471 to form a closed end projection 9487.

[0169] The connector 9466 includes a proximal portion 9486 adjacent the distal end 9471 of the forward portion 9480 and the rear portion 9482 of the medial adjustable width frame member 9474. The proximal portion 9486 of the connector 9466 includes an attachment portion 9490 for connecting to the distal end 9471 of the medial adjustable width frame member 9474. The attachment portion 9490 can be configured in a variety of ways. In the illustrated example, the attachment portion 9490 includes a loop or hole through which the closed end protrusion 9487 passes. In another implementation, the layers of the connector 9466 can be pulled apart to allow the frame members 9474, 9476 to be inserted into the attachment portion 9490. In this alternative implementation, the illustrated material bridge of the attachment portion 9490 is not included such that the hole is not completely closed.

[0170] 38 embodiment, the connector 9466 includes two or more layers of material. To connect the closed end projection 9487 to the attachment portion 9490, the layers can be separated to temporarily open the attachment portion 9490 at the proximal portion 9486 to receive the closed end projection 9487. Once the closed end projection 9487 is properly positioned (e.g., the connector 9466 is centered with respect to the adjustable width frame member 9467 and / or the closed end projection 9487 is coaxial with the connector 9466), the layers can be retracted together to enclose the distal end 9471.

[0171] The outer adjustable width frame member 9476 may connect to the connector 9468 in the same manner as the inner adjustable width frame member 9474. As a result, the attachment points between the adjustable width frame member 9467 and the connector 9468 act as hinges that allow free rotation or pivoting between the adjustable width frame member 9467 and the connector 9468 at the attachment points, resulting in reduced stress and tension on the delivery system and device.

[0172] 43-45 show another embodiment of one of many valve repair systems for repairing a patient's native valve to which the concepts of the present application may be applied. The valve repair system includes an implantable valve repair device 9500 having a proximal or attachment portion 9505, a paddle frame 9524, an inner paddle 9525, an outer paddle 9526, and a distal portion 9507. The proximal portion 9505, the distal portion 9507, the paddle frame 9524, and the paddles 9525, 9526 may be configured in a variety of ways, such as any of the configurations disclosed herein.

[0173] The exemplary valve repair device 9500 shown in Figures 43-45 may be similar to the valve repair device 9200 of Figure 31. For example, the paddle frames 9524, 9525 may be symmetrical along the longitudinal axis YY (Figure 44). However, in some implementations, the paddle frame 9524 is not symmetrical about the longitudinal axis YY. The paddle frame 9524 includes one or more outer frame members 9556 (e.g., wire frame portions, metal frame portions, etc.) and one or more inner frame members 9560 (e.g., wire frame portions, metal frame portions, etc.).

[0174] The outer frame member 9556 is flexibly attached to a connector 9566 at a distal portion 9507. Between the connector 9566 and the proximal portion 9505, the outer frame member 9556 forms a curved shape. For example, in the illustrated embodiment, the shape of the outer frame member 9556 resembles an oval shape as shown in FIG. 45. However, in some implementations, the outer frame member 9556 can be other shapes.

[0175] The inner frame member 9560 extends from the proximal portion 9505 towards the distal portion 9507. The inner frame member 9560 then extends inwardly to form a retaining portion 9572 that is attached to the actuation cap 9514 in the same or similar manner as described in connection with any of the implementations of the implantable valve repair device described herein. The retaining portion 9572 and the actuation cap 9514 can be configured to be attached in any suitable manner.

[0176] In some implementations, the inner frame member 9560 is a rigid frame portion while the outer frame member 9556 is a flexible frame portion. The proximal end of the outer frame member 9556 may connect to the proximal end of the inner frame member 9560 at or adjacent to the proximal portion 9505 of the device. In some implementations, as shown in FIGS. 43-45 , the proximal ends of the outer frame member 9556 and the proximal ends of the inner frame member 9560 are positioned to connect to the paddles 9525, 9526 at spaced apart locations.

[0177] The implantable valve repair device 9500 is configured to move the outer frame member 9556 from an expanded position to a stenosed position by pulling on a portion of the connector 9566 against the actuation cap 9514. The implantable valve repair device 9500 is also configured to move the inner frame member 9560 to open and close the paddles 9525, 9526, according to some implementations disclosed herein.

[0178] In the exemplary valve repair device 9400 of FIGS. 38-42, the valve repair device 9400 includes a pair of adjustable width frame members 9467, one disposed on the inside and the other disposed on the outside. Each of the pair of adjustable width frame members 9467 includes a forward portion 9480 and a rearward portion 9482 integrally connected to one another at a distal end 9471, forming a closed end projection 9487 that connects to a connector 9466, one disposed on the inside and the other disposed on the outside. In the exemplary valve repair device 9500 of FIGS. 44-47, the valve repair device 9500 includes a pair of adjustable width frame members 9567, one disposed on the inside and the other disposed on the rearward. In particular, the valve repair device 9500 includes a forward adjustable width frame member 9574 and a rearward adjustable width frame member 9576, both of which connect to the connector 9566. In the valve repair device 9500, the connectors 9566 are arranged to extend anteriorly and posteriorly, as opposed to medially and laterally, similar to the valve repair device 9400 of Figures 38-42.

[0179] The front adjustable width frame member 9574 and the rear adjustable width frame member 9576 may be formed in any suitable manner. For example, the front adjustable width frame member 9574 and the rear adjustable width frame member 9576 may include a shape memory alloy, such as Nitinol, to provide shape setting capabilities. Each of the front adjustable width frame member 9574 and the rear adjustable width frame member 9576 may be shape set into an assembled state or may be assembled in a flat state or contour. In the illustrated example, the front adjustable width frame member 9574 and the rear adjustable width frame member 9576 are identical. Thus, the following description of the front adjustable width frame member 9574 applies equally to the rear adjustable width frame member 9576. However, in some implementations, the front adjustable width frame member 9574 and the rear adjustable width frame member 9576 may be configured differently.

[0180] The forward adjustable width frame member 9574 (e.g., wire frame portion, metal frame portion, etc.) can be configured in a variety of ways, including different shapes and sizes. With reference to FIGS. 43-45, in the illustrated embodiment, the forward adjustable width frame member 9574 is formed as a closed loop having a proximal portion 9570, a distal portion 9571 opposite the proximal portion 9570, an inner portion 9578 extending between the proximal portion 9570 and the distal portion 9571, and an outer portion 9580 extending between the proximal portion 9570 and the distal portion 9571 and opposite the inner portion 9578. However, in some implementations, the forward adjustable width frame member 9574 can be open ended, such as at the proximal portion 9570.

[0181] The proximal portion 9570 of the anterior adjustable width frame member 9574 may also include one or more recesses or holes 9584 (FIGS. 43 and 45) for receiving a portion of one of the paddles (e.g., the medial and lateral paddles). The distal portion 9571 is connected to the proximal portion 9586 of the connector 9566 at or adjacent to the midplane of the device 9500. The distal portion 9571 of the anterior adjustable width frame member 9574 may be connected to the proximal portion 9586 of the connector 9568 in a variety of ways. In the illustrated embodiment, the distal portion 9571 is a straight segment that extends across the valve repair device 9500 between the medial and lateral sides.

[0182] The connector 9566 includes a proximal portion 9586 adjacent to the distal portion 9571 of the forward adjustable width frame member 9574. The proximal portion 9586 includes an attachment portion 9590 for connecting to the distal portion 9571. The attachment portion 9590 can be configured in a variety of ways. In the illustrated embodiment, the attachment portion 9590 includes a loop or hole through which the distal portion 9571 passes.

[0183] The connector 9566 may include two or more layers of material. To connect the distal portion 9571 to the attachment portion 9590, the layers may be separated to temporarily open the attachment portion 9590 at the proximal portion 9586 to receive the distal portion 9571. Once the distal portion 9571 is properly positioned, the layers may be retracted together to enclose the distal portion 9571. The illustrated material bridge and resulting closed hole are optional.

[0184] 43-45, when the distal portion 9571 of the forward adjustable width frame member 9574 is attached to the connector 9566 by the attachment portion 9590 at the proximal portion 9586, the distal portion 9571 is positioned outside (i.e., further forward) of the outer paddle 9526. However, in some implementations, the distal portion 9571 may be positioned inside (i.e., not further forward than) the outer paddle 9526.

[0185] For example, Figure 46 shows an example of an implantable valve repair device 9500' having a proximal or mounting portion 9505', a paddle frame 9524', an inner paddle 9525', an outer paddle 9526', and a distal portion 9507'. The valve repair device 9500' can be configured substantially identically to the valve repair device 9500 of Figures 43-45. Thus, the description of the valve repair device 9500 applies equally to the valve repair device 9500'. However, for the valve repair device 9500', when the distal portion 9571' of the adjustable width frame members 9574', 9576' is attached to the proximal portion 9586' of the connector 9566' by the attachment portion 9590', the distal portion 9571' is positioned between the inner paddle 9525' and the outer paddle 9526' (i.e., in front of the inner paddle 9525' and on the outside of the outer paddle 9526). The connector 9566' extends through an opening or cutout in the outer paddle 9526'. The connecting portion 9590' is also positioned between the inner paddle 9525' and the outer paddle 9526' (i.e., in front of the inner paddle 9525' and on the outside of the outer paddle 9526). As shown in FIG. 46, the distance between connecting portions 9566' is less (ie, narrower extent) than the distance (ie, wider extent) between connecting portions 9566 of device 9500 of FIGS.

[0186] 43-45, the posterior adjustable width frame member 9576 may connect to the connector 9566 in the same manner as the anterior adjustable width frame member 9574. The attachment points between the adjustable width frame member 9567 and the connector 9566 act as hinges that allow free rotation or pivoting between the adjustable width frame member 9567 and the connector 9566 at the attachment points, resulting in reduced stress and tension on the delivery system and device. Additionally, by arranging the attachment points between the adjustable width frame and the distal outer frame anterior and posterior, rather than medial and lateral, the attachment points do not limit the depth to which the leaflets of the mitral valve may be inserted into the paddle. Thus, the leaflets may be fully received by the paddle.

[0187] 47-49 illustrate one embodiment of a paddle frame 9624 that may be used in various valve repair systems and devices (e.g., valve repair device 9500, other valve repair systems and devices herein, etc.) for repairing a patient's native valve to which the concepts of the present application may be applied. The paddle frame 9624 includes one or more adjustable width frame members 9667 and one or more inner frame members 9660 formed as a single, integral piece. The one or more adjustable width frame members 9667 connect to a lower or distal frame member (e.g., connector 9566 of FIG. 43).

[0188] The paddle frame 9624 may be formed as a single, integral piece in any suitable manner. For example, the paddle frame 9624 may include a shape memory alloy, such as Nitinol, to provide shape setting capabilities. The paddle frame 9624 may be shape set into an assembled state or may be assembled in a flat state or contour. The paddle frame 9624 may be symmetrical along the longitudinal axis YY ( FIG. 48 ). However, in some implementations, the paddle frame 9624 is not symmetrical about the longitudinal axis YY. The paddle frame 9624 includes a proximal portion 9605 and a distal portion 9607 opposite the proximal portion 9605.

[0189] An inner frame member 9660 (e.g., a wire frame portion, a metal frame portion, etc.) extends from the proximal portion 9605 toward the distal portion 9607. The inner frame member 9660 at the distal portion 9607 extends inward to form a retention portion 9672 that is attached to an actuation cap (e.g., actuation cap 9514 of FIG. 43) in the same or similar manner as described in connection with any of the implementations of the implantable valve repair device described herein. The retention portion 9672 can be configured to be attached in any suitable manner. In some implementations, the inner frame member 9660 is a rigid frame portion while the outer frame portion 9667 is a flexible frame portion. The adjustable width frame member 9667 can be integrally connected to the inner frame member 9660 at or adjacent to the proximal portion 9605 of the paddle frame 9624. The proximal portion 9605 may also include one or more recesses or holes 9684 (FIGS. 47 and 48) for receiving a portion of one of the paddles (eg, the inner and outer paddles).

[0190] The adjustable width frame member 9667 is flexibly attached to a connecting portion of a connector (e.g., connecting portion 9566 of connector 9568 in FIGS. 43-45). The adjustable width frame member 9667 can be configured in a variety of ways, including different shapes and sizes. In the illustrated embodiment, the adjustable width frame member 9667 is formed as a closed loop having a proximal portion 9605 and an opposing distal portion 9671, an inner portion 9678 extending between the proximal portion 9505 and the distal portion 9671, and an outer portion 9680 extending between the proximal portion 9605 and the distal portion 9671 and opposite the inner portion 9678.

[0191] The distal portion 9671 is configured to connect to a proximal end of a connector (e.g., proximal portion 9586 of connector 9566 of FIGS. 43-45) at or adjacent to the midplane of the device. The distal portion 9671 may connect to the proximal end of the connector in a variety of ways. In the illustrated embodiment, the distal portion 9671 is a straight segment that extends across the valve repair device between the inside and outside and is configured to be received through a loop or hole in the connecting portion in the same manner as the device of FIGS. 43-45.

[0192] Between the proximal portion 9605 and the distal portion 9671, the adjustable width frame member 9667 forms a curved shape. For example, in the illustrated embodiment, in the view shown in FIG. 478, the shape of the adjustable width frame member 9667 resembles a rectangle with the proximal portion 9605 being curved or domed. However, in some implementations, the outer frame member 9667 can be other shapes.

[0193] The implantable valve repair device is configured to move the adjustable width frame member 9667 from an expanded position to a narrowed position by pulling portions of the connector on the actuation cap in a manner similar to the connector 9566 and actuation cap 9514 of Figure 43. The implantable valve repair device is also configured to move the inner frame member 9660 to open and close paddles (e.g., outer paddle 320 and inner paddle 322 of Figure 23) according to some implementations disclosed herein.

[0194] Therapeutic techniques, methods, operations, steps, etc. described or suggested herein may be performed on living subjects (e.g., humans, other animals, etc.) or may be performed on non-living subjects (e.g., simulations such as cadavers, cadaver hearts, simulators, anthropomorphic phantoms, etc.). When performed in a simulation, the body parts, e.g., hearts, tissues, valves, etc., may optionally be referred to as "simulations" (e.g., simulated hearts, simulated tissues, simulated valves, etc.) and may include, for example, computerized and / or physical representations of the body parts, tissues, etc.

[0195] Any of the various systems, assemblies, devices, equipment, etc. in this disclosure may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on a patient, and the methods described herein may include (or additional methods may include or consist of) sterilization of the associated systems, devices, equipment, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0196] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in the embodiments herein, these various aspects, concepts, and features may be used in many alternatives, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Still further, although various alternatives for the various aspects, concepts, and features of the present disclosure may be described herein, such as alternative materials, alternative structures, alternative configurations, alternative methods, alternative devices, alternative components, alternatives in form, alternatives in fit, alternatives in function, and the like, such descriptions are not intended to be a complete or exhaustive list of available alternatives, whether currently known or later developed. Those skilled in the art may readily incorporate one or more of the aspects, concepts, or features of the present invention into additional embodiments and applications within the scope of the present application, even if such embodiments are not expressly disclosed herein.

[0197] Additionally, although some features, concepts, or aspects of the present disclosure may be described herein as being preferred configurations or methods, such description is not intended to imply that such features are essential or essential unless expressly stated.Furthermore, while exemplary or representative values, and even exemplary or representative ranges, may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be critical values ​​or ranges only if so expressly stated.

[0198] Moreover, although various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the disclosure, such identification is not intended to be exclusive; rather, there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a particular disclosure, the disclosure being instead defined in the appended claims. Descriptions of exemplary methods or processes are not limited to the inclusion of every step as essential in all cases, nor is the order in which steps are presented construed as essential or essential unless expressly stated. Terms used in the claims are to be given their full ordinary meaning and are not to be limited in any way by the description of the examples herein.

Claims

1. 1. A valve repair device for repairing a native heart valve, comprising: a pair of paddles movable between an open position and a closed position and configured to attach the valve repair device to the native valve; one or more paddle frames configured to open and close the pair of paddles, an inner frame portion extending from a proximal portion of the device to a distal portion of the device and connected to the pair of paddles at the proximal portion; one or more paddle frames comprising: an adjustable width frame portion having a forward portion extending from an inside of the device to an outside of the device and a rearward portion extending from the inside of the device opposite the forward portion to the outside of the device, the forward portion and the rearward portion being formed as a single frame member integrally joined at link portions on the inside of the device and the outside of the device; a connector extending from the distal portion toward the proximal portion along both an inside of the device and an outside of the device; The connector includes an attachment portion that connects to the link portion for attaching the adjustable width frame portion to the connector.

2. The valve repair device of claim 1 , wherein the link portion is configured as a closed end protrusion.

3. 3. The valve repair device of claim 2, wherein each of the mounting portions of the connectors includes an aperture through which a respective one of the closed end projections is received.

4. The valve repair device of any one of claims 1 to 3, wherein the anterior and posterior portions of the adjustable width frame portion are attached to one or both of the inner frame portion and the pair of paddles at the proximal portion of the device.

5. The valve repair device of any one of claims 1 to 4, wherein the adjustable width frame portion comprises a shape memory alloy.

6. The valve repair device of any one of claims 1 to 5, wherein the adjustable width frame portion is symmetrical.

7. 1. A valve repair device for repairing a native valve in a patient, comprising: a pair of paddles movable between an open position and a closed position and configured to attach the valve repair device to the patient's native valve; one or more paddle frames configured to open and close the pair of paddles, an inner frame portion extending from a proximal end of the device to a distal portion of the device and connected to the pair of paddles at the proximal end; a first adjustable width frame portion having a first anterior portion extending from an inner side of the device to adjacent a midline of the device, and a first posterior portion extending from the inner side of the device opposite the first anterior portion to adjacent the midline of the device; a second adjustable width frame portion having a second anterior portion extending from an exterior side of the device to adjacent the midline of the device and a second posterior portion extending from the exterior side of the device opposite the second anterior portion to adjacent the midline of the device; one or more paddle frames, the first forward section and the first aft section being integrally joined at a first link section on the inside of the device and the second forward section and the second aft section being integrally joined at a second link section on the outside of the device; a connector extending from the distal portion toward the proximal end along both an inside of the device and an outside of the device; The connector includes a first mounting portion that connects to the first link portion and a second mounting portion that connects to the second link portion for attaching the adjustable width frame portion to the connector.

8. The valve repair device of claim 7 , wherein the first and second link portions are configured as closed end projections.

9. 9. The valve repair device of claim 8, wherein the first and second mounting portions of the connector include an aperture through which a respective one of the closed end projections is received.

10. The valve repair device of any one of claims 7 to 9, wherein the first anterior portion and the first posterior portion are attached to one or both of the inner frame portion and the pair of paddles at the proximal end of the device.

11. The valve repair device of any one of claims 7 to 10, wherein the first adjustable width frame portion and the second adjustable width frame portion each comprise a shape memory alloy.

12. The valve repair device of any one of claims 7 to 11, wherein the first adjustable width frame portion is symmetrical.

13. 1. A valve repair device for repairing a native valve in a patient, comprising: a pair of paddles movable between an open position and a closed position and configured to attach the valve repair device to the patient's native valve; one or more paddle frames configured to open and close the pair of paddles, an inner frame portion extending from a proximal portion of the device to a distal portion of the device and connected to the pair of paddles at the proximal portion; a front adjustable width frame portion formed as a closed loop extending from an inner side of the device to an outer side of the device; one or more paddle frames comprising: a rear adjustable width frame portion formed as a closed loop extending from the inner side of the device to the outer side of the device and opposite the front adjustable width frame portion; a connector extending from the distal portion toward the proximal portion along both a front side of the device and a rear side of the device; the connector includes a first attachment portion that connects to a forward distal portion of the forward adjustable-width frame portion; The connector includes a second attachment portion that connects to a rear distal portion of the rear adjustable width frame portion.

14. The valve repair device of claim 13 , wherein the anterior distal portion of the anterior adjustable-width frame portion and the posterior distal portion of the posterior adjustable-width frame portion are laterally extending straight sections.

15. The valve repair device of claim 14 , wherein the first attachment portion of the connector includes an aperture through which the rear distal portion is received.

16. 14. The valve repair device of claim 13, wherein the anterior adjustable width frame portion and the posterior adjustable width frame portion are attached to one or both of the inner frame portion and the pair of paddles at the proximal portion of the device.

17. The valve repair device of claim 13 , wherein the anterior adjustable width frame portion and the posterior adjustable width frame portion each comprise a shape memory alloy.

18. The valve repair device of claim 13 , wherein the anterior adjustable width frame portion and the posterior adjustable width frame portion are symmetrical.

19. The valve repair device of claim 13 , wherein the inner frame portion includes a front inner frame portion and a rear inner frame portion separate from the front inner frame portion.

20. 20. The valve repair device of claim 19, wherein the anterior inner frame portion is integrally formed with the anterior adjustable width frame portion.

21. 21. The valve repair device of claim 20, wherein the anterior inner frame portion is integrally connected to the anterior adjustable width frame portion adjacent the proximal portion of the device.

22. 14. The valve repair device of claim 13, further comprising an inner paddle and an outer paddle, the first attachment portion connecting to the anterior distal portion of the anterior adjustable width frame portion at a forward lateral location of the outer paddle.

23. 14. The valve repair device of claim 13, further comprising an inner paddle and an outer paddle, the first attachment portion connecting to the anterior distal portion of the anterior adjustable width frame portion at a location anterior-lateral to the inner paddle and anterior-medial to the outer paddle.

24. The valve repair device of any one of claims 1 to 23, wherein the device is sterilized.

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