HEART VALVE REPAIR DEVICE AND DELIVERY DEVICE THEREFOR - Patent application

Abstract

The implantable device or implant is configured to be positioned inside the native heart valve so that the native heart valve may form a more effective seal. The device may include a contoured clasp that approximates the shape of the native valve when the clasp is in a closed position. The device may include a coaptation element with a body portion including a plurality of struts and openings that define a lattice structure. The device may be deployed from a delivery system that includes an actuation wire that may be decoupled from the device by energizing one or more electrodes. One or more surfaces of one or more components of the device may be coated to improve visibility of the device during deployment and implantation.

Description

[Background technology]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 327,121, filed April 4, 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, up the inferior vena cava, and into the right atrium). The septum is then punctured and the catheter threaded into the left atrium. A similar transvascular technique can 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 rotates the delivery catheter toward the tricuspid valve in the right atrium.

[0003] A healthy heart has a generally conical shape that tapers toward the apex and base. The heart is a four-chamber 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 ring-shaped 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 they are 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 conditions 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, a valve repair device for repairing a patient's native valve includes a pair of paddles and a pair of contoured clasps movable between an open position and a closed position, the contoured clasps approximating a shape of the native valve when the valve repair device is deployed within the native valve and the contoured clasps are in the closed position.

[0010] In some implementations, each contoured clasp includes a contoured movable arm and a fixed arm.

[0011] In some implementations, the fixed arm has a contour that is a mirror image of the contoured movable arm.

[0012] In some implementations, the contour clasp includes one or more barbs.

[0013] In some implementations, each paddle includes an inner paddle and an outer paddle.

[0014] In some implementations, the device includes an interface element disposed between the contour clasps.

[0015] In some implementations, the interface element includes a plurality of posts and a plurality of openings that define a lattice structure.

[0016] In some implementations, one or more components of the device include a coating that reduces the number of waveforms that echo back when using imaging techniques.

[0017] In some implementations, the system includes a valve repair device coupled to one or more catheters.

[0018] In some implementations, one or more of the valve repair device and / or catheter are sterilized.

[0019] In some implementations, a valve repair device for repairing a patient's native valve includes an anchor portion with a pair of anchors and an interface portion including a coaptation element, the coaptation element including a body portion with a plurality of struts and a plurality of openings that define a lattice structure.

[0020] In some implementations, the lattice structure defines a wing portion of a body portion of the interface element.

[0021] In some implementations, the lattice structure defines substantially the entire body portion of the interface element.

[0022] In some implementations, the posts are compressed when subjected to a force applied to the body portion of the joint element.

[0023] In some implementations, the posts return to an uncompressed position when the force is removed from the body portion of the joint element.

[0024] In some implementations, the clasps of the anchor portion approximate the shape of the mitral valve when the valve repair device is deployed within the native valve and the contour clasp is in the closed position.

[0025] In some implementations, the device includes a coating that reduces the number of waveforms that echo back when using imaging techniques.

[0026] In some implementations, the system includes a valve repair device coupled to one or more catheters.

[0027] In some implementations, one or more of the valve repair device and / or catheter are sterilized.

[0028] In some implementations, a method for implanting a valve repair device to repair a patient's native valve includes deploying the valve repair device from a delivery system in the patient's native heart; actuating the valve repair device with an actuation element; applying tension to an actuation wire coupled to an actuation loop of the valve repair device to open a clasp of the device; reducing the tension to close the clasp to engage the native valve; energizing an electrode at a distal end of the actuation wire to decouple the actuation wire from the actuation loop; and retracting the actuation wire and delivery system from the native heart.

[0029] In some implementations, the actuation wire includes insulation.

[0030] In some implementations, the actuation wire includes a protector.

[0031] In some implementations, the electrodes are energized by an energy source.

[0032] In some implementations, the handle controls the flow of energy to the electrodes.

[0033] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, a virtual person, a simulator, etc.). In a simulation, the body parts may optionally be referred to as "simulations" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, computerized and / or physical representations.

[0034] In some implementations, one or more of the valve repair device, the delivery system, the actuation element, the actuation wire, the actuation loop, the clasp, and the electrodes are sterilized.

[0035] Any of the above systems, assemblies, devices, equipment, components, etc. may be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for patient use, and the above methods may include (or the additional methods may include or consist of) sterilization (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, equipment, components, etc. described herein.

[0036] 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 elements bear like reference numerals and in which:

[0037] To further clarify various aspects of the implementations 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 embodiments 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]

[0038] [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 shows one embodiment of an implantable device or implant similar to the device shown in FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16] FIG. 16 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 17] FIG. 17 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 18] FIG. 18 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 19] FIG. 19 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 20] FIG. 20 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 21] FIG. 21 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 22] FIG. 22 shows a perspective view of an exemplary implantable device or implant in a closed position. [Diagram 23] FIG. 23 shows a 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 illustrates an 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 a 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 is a schematic cross-sectional view of the geometry of the mitral valve leaflets. [Diagram 32] FIG. 32 illustrates an exemplary valve repair device with the paddles in a closed position. [Diagram 33] FIG. 33 shows a side view of an exemplary implantable device or implant in a closed position. [Diagram 34] FIG. 34 illustrates a side view of an exemplary implantable device or implant in an extended position with the clasps in a closed position. [Diagram 35] FIG. 35 shows a side view of the implantable device or implant of FIG. 34 with the clasp in the open position. [Diagram 36] FIG. 36 illustrates one embodiment of an implantable device or implant at one stage of deployment. [Figure 37] FIG. 37 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 38] FIG. 38 illustrates one embodiment of an implantable device or implant at one stage of deployment. [Figure 39] FIG. 39 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Diagram 40] FIG. 40 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 41A] FIG. 41A shows a schematic diagram of an exemplary deployment system for an implantable device or implant. [Figure 41B] FIG. 41B shows a schematic diagram of an exemplary deployment system for an implantable device or implant. [Figure 42A] FIG. 42A shows a schematic diagram of an exemplary deployment system for an implantable device or implant. [Figure 42B] FIG. 42B shows a schematic diagram of an exemplary deployment system for an implantable device or implant. [Figure 43A] FIG. 43A shows a schematic diagram of an exemplary deployment system for an implantable device or implant. [Figure 43B] FIG. 43B shows a schematic diagram of an exemplary deployment system for an implantable device or implant. [Figure 44A] FIG. 44A shows a schematic diagram of an exemplary deployment system for an implantable device or implant. [Figure 44B] FIG. 44B shows a schematic diagram of an exemplary deployment system for an implantable device or implant. [Diagram 45] FIG. 45 shows a perspective view of an exemplary spacer or coaptation element for an implantable device or implant. [Diagram 46] FIG. 46 shows various views of an implantable device or implant incorporating the spacer or coaptation element of FIG. [Figure 47] FIG. 47 shows various views of an implantable device or implant incorporating the spacer or coaptation element of FIG. [Figure 48] FIG. 48 shows various views of an implantable device or implant incorporating the spacer or coaptation element of FIG. [Figure 49] FIG. 49 shows a schematic diagram of an exemplary method for treating components of an implantable device or implant. [Figure 50] FIG. 50 shows the surfaces of components of an implantable device or implant following the treatment method of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] The following description refers to the accompanying drawings, which illustrate examples of the present disclosure. Some implementations having different structure and operation do not depart from the scope of the present disclosure.

[0040] Examples of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, implementations of valve repair devices, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and unless specifically excluded, any combination of these options can be made. In other words, individual components in the disclosed devices and systems can be combined unless they are mutually exclusive or physically impossible.

[0041] 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%).

[0042] The treatment techniques, methods, operations, steps, etc. described or suggested in this specification or the references incorporated herein may be performed on living animals (e.g., humans, other animals, etc.) or on non-living simulations such as cadavers, cadaver hearts, simulators, virtual persons, 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.

[0043] The term "simulation" encompasses use on cadavers, computer simulators, virtual people (eg, simply demonstrating in air on a virtual heart), and the like.

[0044] 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 valve openings, which come together or "coapt" in flow to form a unidirectional fluid occlusion surface. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and the left ventricle LV will be described in more detail. However, the devices described herein may also be used in the repair of other native valves, for example, the devices may be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0045] 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.

[0046] 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 now 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.

[0047] 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.

[0048] 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).

[0049] 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.

[0050] 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.

[0051] 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 are configured to fill a portion of the space between the leaflets of the native valve and / or to cause the leaflets of the native valve to engage or "coapt" (e.g., so that the native leaflets coapt not only to each other but also to the coaptation element, spacer, etc.).

[0052] 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.

[0053] 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).

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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 International Publication No. WO 2020 / 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.

[0059] 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.

[0060] 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 WO 2018 / 195215, WO 2020 / 076898, and WO 2019 / 139904, which are incorporated by reference in their entireties. The device 100 may include any other features of another 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 disclosed in this application or the applications cited above).

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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 the spacing between the interface element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some implementations, a collar or other attachment element removably attaches, either directly or indirectly, the interface element 110 to the delivery system 102 such that an actuation means or element 112 slides through the collar or other attachment 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.

[0065] 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 a joint 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 joint portion 138 disposed proximate to the mating element 110. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the catch 130. The joint portion 138 may be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 138 is a flexible piece of material integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary relative to the inner paddle 122 when the movable arm 134 is in an open state, opening the clasp 130 and exposing the optional barb or other friction enhancing element 136.

[0066] 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 portion 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.

[0067] 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.

[0068] 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 optional 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 friction enhancing elements 136 and clamping the leaflets between the movable arm 134 and the fixed arm 132. The optional barbs, friction enhancing elements or other fixation structures 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.

[0069] 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.

[0070] 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.

[0071] 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 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 through 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.

[0072] 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.

[0073] 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.

[0074] 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, joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from a metal such as steel or 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 coaptation 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, joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0075] 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 100 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.

[0076] 16-21, the implantable device 100 of FIGS. 8-14 is shown delivered and implanted within the native mitral valve MV of the heart H. With reference to FIG. 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as shown in FIG. 16. The actuating element 112 is then retracted, moving the implant / device to a fully closed state as shown in FIG. 17.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] In some implementations, the implantable device or implant 200 includes an optional interface portion 204, a proximal or attachment portion 209, an anchor portion 206, and a distal portion 207. In some implementations, the interface portion 204 of the device optionally includes an interface element 210 (e.g., a spacer, interface element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some implementations, the anchor portion 206 includes multiple anchors 208. The anchors may be configured in a variety of ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, the attachment portion 209 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism (e.g., a coupler, clamp, tether, etc.) 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.

[0082] 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.

[0083] An actuation element (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) may extend from a delivery system (not shown) and engage the implantable device or implant 200 to enable actuation thereof. In some implementations, the actuation element extends through the proximal collar 211 and the spacer or interface element 210 and engages a cap 214 of the distal portion 207. The actuation element may be configured to releasably engage the cap 214, such as with a threaded connection, such that the actuation element may be disengaged and removed from the device 200 after implantation.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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 plate, bar, sheet, etc.) or a fixed portion of the fastener 230. The inner paddle 222, the outer paddle 220, and the interface elements may all be interconnected as described herein.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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 (Publication No. WO 2018 / 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 (Publication No. WO 2018 / 195215). Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (Publication No. WO 2018 / 195215) is incorporated herein by reference in its entirety.

[0092] 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, shown generally in FIGS. 8-14, may take. 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, such as any of the valve repair systems disclosed herein.

[0093] 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 an optional interface portion 304, which optionally includes an interface 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 multiple anchors 308. In some implementations, each anchor 308 can include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors can also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging a capture mechanism (e.g., a coupler, clamp, tether, etc.) of a delivery system.

[0094] 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.

[0095] 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.

[0096] In some implementations with the optional 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.

[0097] 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.

[0098] 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.

[0099] 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 a joint portion 338. The fixed arm 332 is attached to the inner paddle 322 with the joint portion 338 disposed proximate to the mating element 310. The joint 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.

[0100] 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 a joint portion 338.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] 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 (WO 2020 / 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 (WO 2020 / 076898). Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (WO 2020 / 076898) is incorporated herein by reference in its entirety.

[0105] 24 illustrates one embodiment 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.

[0106] 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, gripping arms, etc.). In one embodiment, the paddles 40656 may be formed integrally 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.

[0107] 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 the closed position, the paddle engages the gripping member 40856 such that when the valve tissue is attached to the optional 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 optional 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.

[0108] 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.

[0109] 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 after the valve repair device 40256 is secured to the valve tissue, removing the valve repair device 40256 from the remainder of the valve repair system 40056 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.

[0110] The valve repair system 40056 can also include a paddle control mechanism 41056, a gripper control mechanism 41156, and a lock control mechanism 41256. The paddle control mechanism 41056 is mechanically attached to the coupler 40556 to drive the paddle 40656 between the open and closed positions by driving the coupler along the shaft. The paddle control mechanism 41056 can take any suitable form, such as, for example, a shaft or rod. For example, the paddle control mechanism can include a hollow shaft and a catheter tube or sleeve that fits over the mounting shaft 41356 and the shaft 40356 and connects to the coupler 40556.

[0111] 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.

[0112] 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 embodiments 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 the tilted position and the 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 the tilted position and the substantially non-tilted position.

[0113] 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.

[0114] 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 gripping members 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.

[0115] 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 may be moved along the shaft 40356 by the paddle control mechanism 41056.

[0116] After the paddle 40656 is 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 deployment 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.

[0117] 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 (WO 2019 / 139904). 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 (WO 2019 / 139904). Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (WO 2019 / 139904) is incorporated herein by reference in its entirety.

[0118] 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 (Publication No. WO 2018 / 195201). 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 (Publication No. WO 2018 / 195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (Publication No. WO 2018 / 195201) is incorporated herein by reference in its entirety.

[0119] 25A and 25B, an exemplary implementation of the valve repair device 40256 has an optional coaptation element 3800. The valve repair device 40256 can have the same configuration as the valve repair device shown in FIG. 24 with the addition of the coaptation element. The coaptation element 3800 can take a wide variety of different shapes. The coaptation element 3800 can be compressible and / or expandable. For example, the coaptation element can be compressed to fit within one or more catheters of a delivery system, can expand when moved out of the one or more catheters, and / or can be compressed by a paddle 40656 to adjust the size of the coaptation element. In the example shown in FIG. 25A and 25B, the size of the coaptation element 3800 can 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.

[0120] 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 40756, 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 coupler that moves the paddle 40656 between the open and closed positions and the coaptation element 3800 that closes the gap between the leaflets 20, 22 when the valve repair device 40256 is attached to the leaflets.

[0121] The interface element 3800 can be disposed about one or more of the shafts, rods, tubes, 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.

[0122] 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 (WO 2019 / 139904). 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 (WO 2019 / 139904).

[0123] 26-30 show one 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.

[0124] 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 includes an outer frame portion 8256 and an inner frame portion 8260.

[0125] In some implementations, the connector 8266 (e.g., a shaped metal component, a shaped plastic component, a tether, wire, post, line, cord, suture, etc.) is attached to the outer frame portion 8256 at an outer end of the connector 8266 and to the coupler 8972 at an inner end 8968 of the connector 8266 (see FIG. 28 ). Between the connector 8266 and the attachment portion 8205, the outer frame portion 8256 forms a curved shape. For example, in the illustrated embodiment, the shape of the outer frame member 8256 resembles an apple shape, with the outer frame member 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.

[0126] 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.

[0127] In some implementations, the inner frame portion 8260 is a rigid frame portion while the outer frame portion 8256 is a flexible frame portion. As shown in FIG. 26 , a proximal end of the outer frame portion 8256 connects to a proximal end of the inner frame portion 8260.

[0128] 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.

[0129] As shown in FIGS. 27 and 28 , the connector 8266 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 is attached to the outer frame portion 8256 and a coupler 8972 that extends from the post 8970. 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 may 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. 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 position and the expanded position. 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 another portion of the inner end of the connector.

[0130] 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.

[0131] 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 the other examples disclosed above.

[0132] 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.

[0133] 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.

[0134] 29 and 30, an implementation 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.

[0135] 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.

[0136] 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.

[0137] 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.

[0138] 31-35, a schematic representation of an implantable or valve repair device 400 (e.g., an implantable prosthetic device, prosthetic spacer device, valve repair device, etc.) is shown in various stages of deployment. The device or implant 400 may include any of the other features of an implantable device, implant, or valve repair device described in this application or the applications cited above, and the device 400 may be positioned to engage valve tissue (e.g., leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above). The device 400 may be sized, shaped, or otherwise configured to approximate the shape and configuration of the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) when the device 400 is implanted, such as when the device 400 engages the leaflets 20, 22, 30, 32, 34.

[0139] FIG. 31 shows a side schematic view of two leaflets 20, 22 of the mitral valve MV. As described above, the leaflets 20, 22 extend radially inward from an annulus 24 that surrounds the leaflets 20, 22. As shown, the leaflets 20, 22 form a tapered or funnel-shaped opening that descends from the annulus 24. As the leaflets 20, 22 extend radially inward from the annulus 24, they curve downward at an increasingly increasing angle toward the opening of the mitral valve MV. Thus, the distance between the leaflets 20, 22 gradually decreases from the annulus 24 to the opening, forming a curved or contoured shape.

[0140] 32-35, implantable device or valve repair device 400 may be configured in a variety of ways such that when device 400 engages the leaflets 20, 22 of the mitral valve MV, one or more contours of device 400 conform to the shape and geometry of the leaflets 20, 22. For example, mounting portions or gripping members, clasps, coaptation elements, and / or paddles of device 400 may be curved, contoured, or otherwise shaped to approximate the shape and geometry of the native leaflets 20, 22 in the mitral valve MV.

[0141] As shown in Figure 32, in one implementation, the device 400 is a valve repair device configured to approximate the shape and geometry of the leaflets 20, 22 of the mitral valve when the device 400 is implanted in the mitral valve. The device 400 may include any other features of the valve repair device described above in this application, such as the valve repair device 40256 of Figure 24 or the valve repair device 40256 of Figures 25A and 25B, and the device 400 may be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed in this application).

[0142] The device 400 includes a base 402, a pair of paddles 420, and a pair of clasps or gripping members 430. In one embodiment, the paddles 420 may be integrally formed with the base 402. For example, the paddles 420 may be formed as an extension of a link or other portion of the base 402. In some implementations, the gripping members 430 are pivotally connected to the base 402 such that the gripping members 430 may be moved to adjust the width of the opening between the paddles 420 and the gripping members 430. Each gripping member 430 may include barbs, friction enhancing elements, or other fixation structures 436 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) for attaching the gripping members 430 to engage valve tissue (e.g., leaflets 20, 22) when the device 400 is attached to the valve tissue. When the paddle 420 is in the closed position, the paddle 420 engages the gripping member 430 such that when the valve tissue is attached to the gripping member 430, the paddle 420 fixes the relative positions of the leaflets 20, 22. In some implementations, the gripping member 430 is configured to engage the paddle 420 such that the optional barbed portion 436 engages the valve tissue and the paddle 420 to secure the valve repair device 400 to the valve tissue. For example, in certain circumstances it may be advantageous to have the paddle 420 maintain an open position and move the gripping member 430 outwardly toward the paddle 420 to engage the valve tissue and the paddle 420. The paddle 420 and / or the gripping member 430 may be moved between the open and closed positions by any means as described in FIGS. 24, 25A, and 25B.

[0143] In some implementations, the gripping members 430 may be sized, shaped, or otherwise configured to approximate the shape and geometry of the native tissue (e.g., leaflets 20, 22) when the device 400 is implanted in a native valve (e.g., mitral valve). For example, a proximal portion of the gripping members 430 (e.g., the portion of the gripping members 430 furthest from the base 402) may be outwardly curved, contoured, or flared to approximate the shape or geometry of the native tissue (e.g., leaflets 20, 22). Thus, when the gripping members 430 engage the native tissue (e.g., leaflets 20, 22), the native tissue may substantially retain its natural shape without additional bending or shear forces. In the illustrated example, the paddles 420 are substantially straight. However, the paddle 420 may also be outwardly curved, contoured, or flared so as to approximate the shape or geometry of the natural tissue (e.g., valve leaflets 20, 22) such that when the natural tissue is engaged between the paddle 420 and the gripping member 430, the paddle 420 and the gripping member 430 substantially approximate the shape or geometry of the natural tissue (e.g., valve leaflets 20, 22).

[0144] Although the embodiment shown in FIG. 32 shows a pair of paddles 420 and a pair of gripping members 430, it will be understood that the valve repair device 400 may include any suitable number of paddles and gripping members.

[0145] As shown in Figures 33-35, in other implementations, device 400 is an implantable device or implant configured to approximate the shape and geometry of the leaflets 20, 22 of the mitral valve when device 400 is implanted in the mitral valve. Device 400 may include any of the features of any of the implantable devices or implants disclosed herein above, such as device 100 in Figures 8-21, device 200 in Figure 22, or device 300 in Figure 23, device 8200 in Figures 26-30, and device 400 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 in the present application).

[0146] In some implementations, the device or implant 400 includes an optional interface portion 404 and an anchor portion 406. The interface portion 404 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 410 that is slidably attached to an actuation element 412 (e.g., an actuation wire, an actuation shaft, an actuation tube, etc.). The anchor portion 406 includes one or more anchors 408 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 grasping element (e.g., a clasp), or the like. Upon actuation of the actuation element 412, the anchor portion 406 of the device 400 opens and closes to grasp the native leaflets (e.g., leaflets 20, 22) during implantation. The actuating element 412 (as well as other actuating elements disclosed herein) may take a wide variety of different forms (e.g., wires, rods, shafts, tubes, threads, sutures, lines, strips, combinations thereof, etc.), may be made from a variety of different materials, and may have a variety of configurations.

[0147] The anchor portion 406 and / or anchor of the device 400, in some implementations, includes an outer paddle 420 and an inner paddle 422 that are connected between the cap 414 and the interface element 410 by portions (portions 124, 126, 128 as shown in FIGS. 8-15). The portions may be articulated and / or flexible to move between any suitable positions. The interconnection of the outer paddle 420, inner paddle 422, interface element 410, and cap 414 by portions may constrain the position and movement of the device 400 to the positions and movements shown in FIGS. 8-15, and the like.

[0148] In some implementations, the anchor portion 406 and / or the anchor 408 may include an attachment portion or gripping member. The illustrated gripping member may include a catch 430 including a base or fixed arm 432, a movable arm 434, optional barbs, friction enhancing elements or other fastening structures 436 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and a joint portion 438. The fixed arm 432 is attached to the inner paddle 422. In some implementations, the fixed arm 432 is attached to the inner paddle 422 with the joint portion 438 disposed proximate to the spacer or interface element 410. The joint portion 438 provides a spring force between the fixed arm 432 and the movable arm 434 of the catch 430. The joint portion 438 may be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 438 is a flexible piece of material integrally formed with the fixed arm 432 and the movable arm 434. The fixed arm 432 is attached to the inner paddle 422 and remains stationary or substantially stationary relative to the inner paddle 422 when the movable arm 434 is in an open state, opening the clasp 430 and exposing the optional barb, friction enhancing element, or fixation structure 436. The clasp 430 may be opened or actuated by any method described herein. For example, the clasp 430 may be opened by an actuation line extending from the delivery system (e.g., through the steerable catheter and / or the implant catheter).

[0149] In some implementations, the gripping member or catch 430, the fixed arm 432, the movable arm 434, and / or the joint portion 438 may be sized, shaped, or otherwise configured to approximate the shape and geometry of the natural tissue (e.g., leaflets 20, 22) when the device 400 is implanted in a native valve (e.g., mitral valve). For example, a distal portion of the movable arm 434 (e.g., the portion of the movable arm 434 furthest from the cap 414 when the movable arm 434 is in the open position) may be curved, contoured, or flared outwardly to approximate the shape or geometry of the natural tissue (e.g., leaflets 20, 22). Additionally, a corresponding portion of the fixed arm 432 (e.g., the portion of the fixed arm 432 closest to the cap 414) may be curved, contoured, or flared to be a mirror image of the curve, contour, or flare of the respective movable arm 434. When the catch 430 is moved to the closed position and the arms 432, 434 engage the natural tissue (e.g., leaflets 20, 22), the region of engagement of the natural tissue between the fixed arm 432 and the movable arm 434 substantially approximates the shape and geometry of the natural tissue (e.g., leaflets 20, 22). Thus, when the catch 430 engages the natural tissue (e.g., leaflets 20, 22) (FIG. 33), the natural tissue can substantially retain its shape.

[0150] Additionally, the contours of the clasp 430, fixed arm 432, movable arm 434, and / or joint portion 438 can facilitate deployment or tracking of the device 400 from a delivery system. For example, the contour of the movable arm 434 can prevent or inhibit the distal portion of the movable arm 434 and / or barb 436 from catching on the delivery device or natural tissue during deployment. The contour of the clasp 430 can also improve extension of the device 400 in the open position.

[0151] Although the embodiment shown in FIG. 32 illustrates a pair of clasps 430 including a pair of fixed arms 432 and a pair of movable arms 434, it should be understood that the implantable device 400 may include any suitable number of clasps, fixed arms, and movable arms.

[0152] 36 and 37, one implementation is shown illustrating how an implantable device or implant (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, etc.) is controlled by a delivery system (e.g., a steerable catheter or an implant catheter) during deployment and implantation. In the illustrated implementation, the device 100 of FIGS. 8-15 is deployed from a delivery system 102. However, it will be understood that the attachment method may be used with any suitable valve repair system (e.g., any of the valve repair systems disclosed in this application or the applications cited above), and that the delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, a clasp control element (e.g., a line, a suture, a wire, etc.), combinations thereof, and the like.

[0153] 36-39, one or more actuating elements 116 may extend through the delivery system 102 and may be attached to or disposed about components of the device 100. Each actuating element 116 may be a line, suture, tether, wire, etc., and may include fabric, polymer, or other bio-inert material. The actuating elements 116 may be attached to or coupled to a movable arm 134 of the device 100 to open or close the movable arm 134. Each actuating element 116 may extend through the delivery system 102 and connect to an actuating loop 119 that is connected to the movable arm 134 of the clasp. The actuating element 116 may connect, tie, or otherwise secure the loop to the actuating loop 119 that is connected to the movable arm 134). In this manner, the actuating line 116 may be controlled to open and close the clasp during deployment and implantation.

[0154] As described above, the clasp 130 of the device 100 is opened by applying tension to the actuation element 116 attached to the movable arm 134, thereby causing the movable arm to articulate, bend, or pivot on a joint portion 138. The clasp 130 may be spring loaded such that the clasp 130 continues to provide a clamping force to the grasped native leaflet in the closed position. Optional barbs, friction enhancing elements, or other fixation structures 136 of the clasp 130 may grab, pinch, and / or pierce the native leaflet to further secure it.

[0155] As detailed above (e.g., FIGS. 8-15), the paddles 120, 122 may be opened and closed to compress 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 spacer or coaptation element 110 (e.g., spacer, plug, membrane, etc.) by, for example, actuating the paddle actuating element 112. Tension may be applied to each of the actuating loops 119 via the actuating element 116 (e.g., line, suture, wire, etc.) to open the respective clasps 130, and tension may be removed from the actuating element 116 to allow the respective clasps 130 to be released. The actuating elements 116 may be actuated separately such that each clasp 130 may be opened and closed separately. Actuating separately allows one leaflet at a time to be grasped, or allows the clasp 130 to be repositioned over a leaflet that was not adequately grasped without altering 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), thereby allowing the leaflets to be grasped in various positions as the particular situation requires.

[0156] 8-21 show an embodiment in which, after deployment and implantation of the device 100, the clasp actuation lines 116 can be decoupled from the clasps of the device 100 by pulling one end of each of the actuation lines 116 through the delivery system 102. In some implementations, pulling the actuation lines 116 out of the delivery system 102 causes the actuation lines 116 to float or loosen from their attachment to the moveable arm 134, decoupling the clasps from the delivery system 102. In some implementations, the actuation lines 116 can be pulled through the actuation loops 119 (see FIGS. 36 and 37), thereby decoupling the actuation lines 116 from the actuation loops 119.

[0157] 38-43B, an example of a method is illustrated in which the clasps of an implantable device or implant (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, etc.) are controlled by a delivery system (e.g., a steerable catheter, an implant catheter, a clasp control element, etc.) during deployment and implantation. In the illustrated example, the device 100 of FIGS. 8-15 is deployed from a delivery system 102. However, it will be understood that the control and release implementations of FIGS. 38-43B may be used with any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited herein). The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, and / or a combination of these clasp control elements, etc. For example, the control and release implementations of Figures 38-43B may be used with the valve repair device 40256 of Figure 24 or the implantable valve repair device 8200 of Figures 29 and 30 as part of any suitable valve repair system disclosed in this application or the above-cited applications.

[0158] In the example shown in FIGS. 38-43B, the device 100 includes an actuation loop 119 on each of the movable arms 134. The actuation loop 119 is a circle, coil, eyelet, loop hole, knot, noose, circle, or other loop of material attached to or disposed through a portion of the movable arm 134. The actuation loop 119 may comprise fabric, polymer, and / or bio-inert material. In the illustrated implementation, the actuation loop 119 is disposed at an outer end of the movable arm 134. However, the actuation loop 119 may be in any suitable location on the movable arm 134 that allows the movable arm 134 to be opened or closed by increasing or decreasing tension applied to the actuation loop 119.

[0159] In the implementation shown in FIGS. 38-43B, the actuating element 116 comprises one or more actuating wires 516 extending through the delivery system 102. The actuating wires 516 can be metal wires or similar materials capable of conducting voltage and / or current. Each actuating wire 516 includes one or more electrodes 520 at a distal end 518. The electrodes 520 can generate a thermal output from the voltage and / or current provided by the actuating wires 516. The distal end 518 of each actuating wire 516 can be attached or secured to one of the actuating loops 119 of the device 100. The distal end 518 of the actuating wires 516 can be tied, secured, coupled, or otherwise secured to the actuating loops 119, or each actuating loop 119 can be looped or otherwise secured around a portion of the distal end 518 of the actuating wire 516.

[0160] 41A and 41B, one or more energy sources 522 can be attached to a proximal end of each actuation wire 516 and can provide a voltage and / or current, such as a radio frequency current, through the actuation wire 516 to one or more electrodes 520 at a distal end 518 of the actuation wire 516. For example, in some implementations shown in FIGS. 41A, 42A, and 43A, the actuation wires 516 can be connected to a single energy source 522 that can provide a voltage and / or current, such as a radio frequency current, through each actuation wire 516 to each electrode 520. For example, in some implementations shown in FIGS. 41B, 42B, and 43B, each actuation wire 516 can be connected to a separate energy source 522 that can provide a voltage and / or current, such as a radio frequency current, to the connected actuation wire 516 and respective electrode 520. The energy source 522 can be any suitable device capable of generating and / or providing a voltage and / or current. For example, the energy source 522 can be a battery, a battery pack, a power bank, or a generator, a connection to a power outlet or power source, or any combination thereof. In some implementations, the proximal end of each actuation wire 516 is also connected to a handle 524 that can control the movement, deployment, and position of the one or more actuation wires 516. For example, in some implementations shown in FIGS. 41A, 42A, and 43A, the actuation wires 516 can be connected to a single handle 524 that can control the movement, deployment, and position of each of the actuation wires 516. For example, in some implementations shown in FIGS. 41B, 42B, and 43B, each actuation wire 516 can be connected to a separate handle 524 that can control the movement, deployment, and position of the connected actuation wire 516. In some implementations, the one or more handles 524 can also control the flow of voltage and / or current from the energy source 522 to the respective actuation wires 516 and electrodes 520.

[0161] 38-40, the movable arm 134 may be opened or closed by increasing or decreasing tension applied to the actuation loop 119 via an actuation wire 516, similar to the actuation line 116 described in FIGS. 8-15. During deployment from the delivery system 102, the clasp 130 of the device 100 may be released by applying tension to one or more actuation wires 516 that transmit tension to the actuation loop 119 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend or pivot on the joint portion 138. The clasp 130 may be spring loaded such that in the closed position, the clasp 130 continues to provide a clamping force to the grasped native leaflet. Optional barbs, friction enhancing elements, or other fixation structures 136 of the clasp 130 may grip, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0162] During implantation, the paddles 120, 122 may be opened and closed, for example, to compress 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 spacer or coaptation element 110 (e.g., spacer, plug, membrane, etc.). The clasp 130 may be used to grasp and / or further secure the native leaflets by barbing the leaflets and engaging the friction enhancing elements or fixation structures 136 to clamp the leaflets between the movable arm 134 and the fixed arm 132. The barbs, friction enhancing elements, or other fixation means 136 (e.g., barbs, projections, ridges, grooves, textured surfaces, adhesives, etc.) of the clasp or barbed clasp 130 may increase friction with the leaflets or partially or fully puncture the leaflets. The actuation wires 516 may optionally be separately actuated to allow each clasp 130 to be opened and closed separately, such as by separately actuating each actuation wire 516 with one or more handles 524. Separate actuation allows one leaflet to be grasped at a time, or allows 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 may be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing the leaflets to be grasped in various positions as the particular situation requires. After deployment and implantation of the device 100, the actuation wires 516 may remain attached to the actuation loop 119 disposed on the movable arm 134 of the device 100.

[0163] In the illustrated implementation, the device 100 and the actuating wires 516 are both deployed from the same passageway (e.g., a catheter) of the delivery system 102. However, the device 100 and the actuating wires 516 may be deployed in other manners. For example, the device 100 may be deployed from a separate passageway from one or more actuating wires 516, such as a separate catheter or a separate passageway or lumen within the same catheter, or the actuating wires 516 may extend outwardly from a radial opening that extends through a side of the delivery system 102 near the distal end of the delivery system 102.

[0164] As shown in FIG. 40, after the device 100 has been deployed and implanted, such as in a native valve of the heart, the actuation wires 516 may be decoupled from the device 100. One or more energy sources 522 may be activated or energized to provide a voltage and / or current to the one or more actuation wires 516. For example, each handle 524 may include a switch that, when activated, allows the flow of current and / or voltage to the one or more actuation wires 516. The current and / or voltage may flow through one or more of the actuation wires 516, energizing one or more electrodes 520. The energized electrodes 520 may then heat, ablate, cauterize, sear, scorch, or otherwise burn the actuation loop 119 secured to the moveable arm 134 of the device 100. The energized electrodes 520 may separate, disrupt, or detach the actuation loop 119 such that the actuation wires 516 are decoupled or otherwise separated from the device 100. A portion of the actuation loop 119 may remain secured to the device 100. Each electrode 520 may be energized separately to separate, disrupt, or detach the respective working loop 119, or the electrodes 520 may be energized simultaneously to separate, disrupt, or detach the working loops 119. After each of the working wires 516 is decoupled from the device 100, each working wire 516, along with the working element 112, may be retracted or withdrawn into the delivery system 102, and the delivery system 102 may be retracted from the native valve of the heart. Each working wire 516 may be decoupled separately from the device 100 and retracted or withdrawn into the delivery system 102, or all of the working wires 516 may be decoupled from the device 100 and retracted or withdrawn into the delivery system 102 simultaneously. Although the energized electrodes 520 have been described as severing or separating the working loops 119 by heat generated from thermal or electrical energy, the energized electrodes 520 may be capable of severing or separating the working loops 119 by other suitable means. For example, the energized electrode 520 may vibrate at a high frequency, such as ultrasonically, to cut or separate the working loop 119 .

[0165] 42A-43B, each actuation wire 516 can include an insulator 526 disposed about the actuation wire 516 and extending along the length of the actuation wire 516 to a distal end 518. The insulator 526 can prevent or reduce the flow of electrical current and / or voltage and generate heat radially outward from the actuation wire 516. The insulator 526 can include clay, ceramic, porcelain, plastic, rubber, mica, polymers such as Teflon, polytetrafluoroethylene, perfluoroalkoxy, or any combination thereof.

[0166] 43A and 43B, each actuating wire 516 may also include a protector 528 that may prevent or inhibit the actuating wire 516 and / or electrode 520 from contacting and / or providing heat, vibration energy, current and / or voltage, etc., to natural tissue of the heart or to undesirable portions or components of the implantable device or implant. The protector 528 may include the same material as the insulator 526 and may prevent or reduce the flow of voltage and / or current or heat from the actuating wire 516 and / or electrode 520. In the illustrated implementation, the protector 528 is disposed on a radial side of the electrode 520 and extends distally beyond the electrode 520. However, the protector 528 may have any suitable shape, position, or configuration. For example, the protector 528 may be disposed on multiple sides of the electrode 520, may extend less than the length of the electrode 520, may substantially surround the electrode 520, may curve distally around the electrode 520, or any combination thereof.

[0167] As shown in FIGS. 44A and 44B, instead of or in addition to electrodes, the actuation wires 516 may include one or more blades or cutters 530 at the distal end 518 of each actuation wire 516. The blades or cutters 530 may be sharpened and / or serrated to cut or tear the actuation loops 119 disposed on the implantable device or implant. The actuation wires 516 may operate substantially similarly to the actuation wires 516 described in FIGS. 38-43, or the cutters may be configured to simply cut the loops 119. For example, in some implementations shown in FIG. 44A, the actuation wires 516 may be connected to a single energy source 522 that can provide a voltage and / or current through the actuation wires 516, and the proximal end of each actuation wire 516 is also connected to a single handle 524 that can control the movement, deployment, and position of each of the actuation wires 516. 44B , each actuation wire 516 may be connected to a separate energy source 522 that can provide a voltage and / or current to the connected actuation wires 516, and the proximal end of each actuation wire 516 is connected to a separate handle 524 that can control the movement, deployment, and position of the connected actuation wires 516. The one or more energy sources 522, such as via the one or more handles 524, may energize the one or more actuation wires 516 and / or actuate the blades or cutters 530 at the distal ends of the respective actuation wires 516. The one or more energy sources 522 and the one or more handles 524 may actuate each of the blades or cutters 530 separately or may actuate each of the blades or cutters 530 simultaneously. A distal end 518 of each actuation wire 516 may be attached or coupled to an actuation loop 119 (see FIGS. 38-40) of device 100, and the actuation wires 516 may be used to open and close the clasp 130 of device 100, as described. In some implementations, one or more of the actuation wires 516 may include insulation and / or protectors, such as shown in FIGS. 42A-43B.

[0168] After device 100 has been deployed and implanted, such as in a native heart valve, actuation wire 516 may be decoupled from the device. Energy source 522 and / or handle 524 may be activated, energized, moved, or otherwise controlled to cause cutter 530 to sever, sever, or otherwise separate working loop 119 such that actuation wire 516 is decoupled or otherwise separated from device 100. For example, energy source 522 may provide a current and / or voltage through actuation wire 516 to actuate, rotate, oscillate, or otherwise move cutter 530 to cut, shear, tear, or sever working loop 119, or handle 524 may be controlled or manipulated to move or rotate cutter 530 to cut, shear, tear, or sever working loop 119. After the actuation wire 516 is decoupled from the device 100, the actuation wire 516 may be retracted or withdrawn within the delivery system 102, and the delivery system 102 may be retracted from the native valve of the heart.

[0169] 45-48, the optional coaptation element 610 may be configured in various ways to be compressible, reduce density, improve visibility, reduce radiopacity, increase volume, increase compliance when deployed in the native heart, and / or promote tissue ingrowth once deployed in the native valve of the heart. For example, the coaptation element 610 described above may be compressible so that it can fit within, be moved through, and / or be deployed from a delivery catheter or the like. The coaptation element 610 may incorporate any of the features described herein above, such as the coaptation element 610 described in FIG. 4, the coaptation element 110 described in FIGS. 8-21, the coaptation element 210 described in FIG. 22, the coaptation element 310 described in FIG. 23, the coaptation element 3800 described in FIGS. 25A and 25B, or the coaptation element 410 described in FIGS. 33-35. Additionally, each of the interface elements may be used with any of the devices described herein above (e.g., 10, 100, 101, 200, 300, 400, 8200, 40256). Each of the interface elements may be made of a flexible and / or compressible material, such as, for example, rubber, foam, plastic, silicone, or other suitable material, or any combination thereof.

[0170] The coaptation element 610 extends from a proximal end 611 to a distal end 612 and has a generally elongated and rounded shape. In some implementations, the coaptation element 610 has an oval shape or cross-section when viewed from above ( FIG. 46 ) and a tapered rectangular shape or cross-section when viewed from the front ( FIG. 45 ). A central opening 613 extends through a body portion 614 of the coaptation element 610 from the proximal end 611 to the distal end 612. The central opening 613 has a size that is approximately the same as or slightly larger than the size of a main shaft or body of an implantable device or implant such that the main shaft can be received within the central opening 613 of the coaptation element 610.

[0171] The coaptation element 610 has a plurality of struts 615 disposed throughout the body portion 614 creating a plurality of gaps or openings 617 in the body portion 614 between the struts 615. The struts 615 and openings 617 may form a lattice structure throughout at least a portion of the body 614 of the coaptation element 610. The struts 615 may be sized, shaped, and oriented in a variety of ways. For example, the struts 615 may be thin, reducing the weight or mass of the coaptation element 610, increasing the compressibility of the coaptation element 610, increasing the flexibility of the coaptation element 610, and / or configured to promote tissue ingrowth within the coaptation element 610 when the coaptation element 610 is deployed or otherwise disposed within the native heart. In the illustrated implementation, the struts 615 form a substantially hexagonal lattice structure with openings 617 therebetween. However, it will be understood that the struts 615 may be arranged, shaped, oriented, or otherwise configured in any suitable manner to be compressible, reduce density, improve visibility, reduce radiopacity, increase volume, increase compliance when deployed in the native heart, and / or promote tissue ingrowth once deployed in the native valve of the heart. For example, the struts 615 may form a triangular lattice structure, a rectangular lattice structure, a circular lattice structure, an oval lattice structure, any combination of these lattice structures, or a lattice structure of any other shape, or the struts 615 may extend in multiple directions, such as in a non-uniform manner.

[0172] The lattice structure of the coaptation element 610 formed by the struts 615 and the openings 617 may facilitate the deployment of the coaptation element 610 through a delivery catheter while maximizing the volume of the coaptation element 610 when deployed in the native heart. For example, the struts 615 may provide flexible support to the coaptation element 610 such that the coaptation element 610 may bend or compress by a compressive force applied to the coaptation element 610 and the openings 617 may reduce the mass of the coaptation element 610 without reducing the volume of the coaptation element 610. The compressible struts 615 may also increase the engagement or fixation of the coaptation element 610 in the native heart because the compressible struts 615 and the openings 617 allow the coaptation element 610 to conform to various spaces and geometries and compensate for anatomical variances. Additionally, the struts 615 may resist plastic deformation such that the struts 615 may return to their normal position when the compressive force is removed.

[0173] The lattice structure formed by the struts 615 and openings 617 of the coaptation element 610 can also increase or enhance visibility using imaging techniques during delivery and deployment of the implantable device or implant. For example, the lattice structure formed by the struts 615 and openings 617 can increase the articulation of the implant and reduce shadows seen during echocardiography by limiting the overall material density of the coaptation element 610. The lattice structure formed by the struts 615 and openings 617 of the coaptation element 610 can further promote tissue ingrowth when the coaptation element 610 is deployed in a native heart. For example, tissue can grow into and around the openings 617 and struts 615 of the coaptation element 610 when the coaptation element 610 is deployed in a native heart.

[0174] A force can be applied to the outside of the body portion 614 of the coaptation element 610 such that the struts 615 compress or bend and the size of the openings 617 between the struts 615 decreases. Thus, the overall size of the coaptation element 610 is reduced. In some implementations, any inward force applied to the body portion 614 of the coaptation element 610 can reduce the overall size of the coaptation element 610. However, it will be appreciated that the struts 615 and openings 617 can be configured such that the coaptation element 610 can be compressed in a variety of ways. For example, the struts 615 and openings 617 can be configured such that the coaptation element 610 can only compress radially from an inward force, or such that the coaptation element 610 can only compress longitudinally from an upward or downward force.

[0175] The struts 615 may be made from a flexible and / or compressible material, such as, for example, foam, rubber, plastic, silicone or other suitable material or combinations thereof. In some implementations, the struts 615 may be made from a material that can bend or compress when subjected to a force and return to its original shape when the force is removed. The struts 615 may be formed from any suitable method. For example, the struts 615 may be formed from 3D printing, additive manufacturing, additive layer manufacturing, material extrusion, directed energy deposition, powder bed fusion, vat polymerization, injection molding, overmolding, chemical molding, machining, liquid silicone molding, computer numerically controlled machine tooling, laser printing, or any combination thereof.

[0176] In the illustrated implementation, the entire right and left wing portions of the body portion 614 of the coaptation element 610 include struts 615 and openings 617 that define a lattice structure, and a central portion of the body portion 614 surrounding the central opening 613 is substantially solid. However, it will be understood that the coaptation element 610 can have a variety of configurations. For example, in some implementations, the entire body portion 614 of the coaptation element 610 can include struts 615 and openings 617 that define a lattice structure. In some implementations, only one or more portions of the coaptation element 610 can include struts 615 and openings 617 to facilitate capture and / or engagement of natural tissue and / or to increase the compressibility of the coaptation element 610, to facilitate deployment of the coaptation element 610, etc. For example, the struts 615 and openings 617 may only define a lattice structure on an outer portion or periphery of the body portion 614 to promote tissue ingrowth when the coaptation element 610 is deployed into the native heart, while a core unit made of a harder, more solid material may comprise the center of the body portion 614 to facilitate deployment of the coaptation element 610 through a delivery device. In some implementations, the struts 615 and openings 617 may only define a lattice structure within the core of the body portion 614 to reduce the overall density of the coaptation element 610, while an outer unit made of a harder, more solid material may comprise the outer portion or periphery of the body portion 614 to facilitate capture of the leaflets of the native heart valve.

[0177] The coaptation element 610 may be sized, shaped, and configured to fit the natural anatomy of the patient receiving the implant. The coaptation element 610 may be sized, shaped, and configured specifically for the natural anatomy of the patient receiving the implant. The size of the coaptation element 610 may be selected to minimize the number of implants required per patient (preferably one), while at the same time maintaining a low transvalvular gradient. In some implementations, the struts 615 and openings 617 of the coaptation element 610 may be sized, shaped, or otherwise configured such that the coaptation element 610 may be compressible and / or expandable to be deployed in any native heart. In some implementations, the surgeon performing the procedure may have a variety of coaptation elements 610 available to the surgeon during the procedure. The surgeon may select a coaptation element 610 with a desired size, shape, and configuration that corresponds to the natural anatomy of the patient receiving the implant. In some implementations, the coaptation element 610 is manufactured specifically for the particular patient receiving the implant. For example, the size and shape of a patient's native valve and / or the area where regurgitation occurs can be measured and spacer 610 can be manufactured with a size and / or shape that accommodates the measured parameters, i.e., each coaptation element can be tailored to any individual patient.

[0178] In some implementations, the coaptation element 610 may be removable or otherwise replaceable on the implantable device or implant such that the surgeon performing the procedure can remove one coaptation element 610 from the implantable device or implant and place the coaptation element 610 on the implantable device or implant of the size, shape, and configuration desired for the patient. In some implementations, the anterior-posterior distance at the top of the spacer or coaptation element is about 5 mm, and the medial-lateral distance at the widest point of the spacer or coaptation element is about 10 mm.

[0179] In some implementations, the joining element 610 may also include a coating to facilitate expansion of the joining element 610 and / or to facilitate deployment of the joining element 610 from a delivery catheter. The coating may be a polymer or any other suitable material or composition. For example, the coating may be a biocompatible polymer that reduces friction exerted on the joining element 610 when the joining element 610 is deployed and expanded from a compressed configuration in a delivery catheter.

[0180] As shown in Figures 46-48, the coaptation element 610 may be attached to or incorporated into an implantable device or implant 600. The implantable device 600 is one of many different configurations that the device 100 shown generally in Figures 8-14 may assume. The device 600 may include any of the features of any of the implantable devices or valve repair devices disclosed herein above, such as the device 100 shown in Figures 8-21, the device 200 shown in Figure 22, the device 300 shown in Figure 23, the valve repair device 40256 shown in Figures 24, the valve repair device 40256 of Figures 25A and 25B, the device 8200 shown in Figures 26-30, or the device 400 shown in Figures 32-35, and the device 600 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 in the present application). The device / implant 600 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.

[0181] The implantable device or implant 600 may be similar in configuration and operation to the implantable devices or implants 200, 300 described above. In some implementations, the implantable device or implant 600 includes a coaptation portion 604, a proximal or attachment portion 605, an anchor portion 606, and a distal portion 607. A coaptation element 610 may be included in or disposed on the coaptation portion 604 for implantation between the leaflets of a native valve. For example, the coaptation element 610 may be disposed on a main shaft of the device 600, such as having the main shaft extend through a central opening 613 of the coaptation element 610. In some implementations, the anchor portion 606 includes multiple anchors 608. The anchors 608 may be configured in a variety of ways. In some implementations, each anchor 608 includes an outer paddle 620, an inner paddle 622, a paddle extension member or frame 625, and a clasp 630. In some implementations, the attachment portion 605 includes a first or proximal collar 651 (or other attachment element) for engaging a capture mechanism (e.g., a coupler, clamp, tether, etc.) of a delivery system. The delivery system for the device 600 may be the same as or similar to the 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.

[0182] In some implementations, the paddles 620, 622 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, a shape memory alloy sheet material such as Nitinol, or any other flexible material suitable for implantation in the human body.

[0183] An actuation element (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) may extend from a delivery system (not shown) and engage the implantable device or implant 600 to enable actuation thereof. In some implementations, the actuation element extends through the proximal collar 651 and the interface element 610 and engages a cap 654 on the distal portion 607. The actuation element may be configured to releasably engage the cap 654, such as with a threaded connection, such that the actuation element may be disengaged and removed from the device 600 after implantation.

[0184] The coaptation element 610 extends from the proximal collar 651 (or other attachment element) to the inner paddle 622. The outer paddle 620, inner paddle 622, frame 625, clasp 430, and cap 654 may be formed, shaped, and attached in any manner or configuration described herein, similar to device 200 in FIG. 22, device 300 in FIG. 23, or device 8200 in FIG. 26. The coaptation element 610, outer paddle 620, inner paddle 622, frame 625, and / or clasp 430 may engage native valve tissue (e.g., leaflets 20, 22) by any method discussed in this application or the applications cited above.

[0185] 49 and 50, one or more surfaces of an implantable device or implant, valve repair device, or valve repair system may be coated or treated to improve visibility of the device or system during deployment and implantation. For example, one or more portions of the device may be coated with a coating, material, or substance to increase or enhance visualization of the device or implant during deployment and implantation, such as when viewed using echocardiographic, ultrasound, electromagnetic, or other similar imaging techniques. The coating or treatment may be implemented on any of the components of any of the devices described herein above (e.g., 10, 100, 101, 200, 300, 400, 600, 8200, 40256), or on an implantable device or valve repair system having any combination of the features disclosed herein.

[0186] As shown in Figure 49, a part or component 700 of the implantable device or valve repair system may be at least partially coated or covered with a material or coating 702 that can increase or improve the visibility of the implantable device or valve repair system when viewed using imaging techniques. The coating 702 may include titanium, hydroxyapatite, ceramic, carbide, silicide, nitride, cermet, or any combination thereof. The part or component 700 may be any metallic surface of the implantable device or valve repair system. For example, the coating 702 may be used to form joints or connections (e.g., 124, 126, 128, 138, 221, 223, 225, 321, 323, 325, 338, 438, 8266), paddles (e.g., 120, 122, 220, 222, 320, 322, 420, 422, 620, 622, 8256, 40656), anchors (e.g., 208, 308, 408, 608), paddle frames (e.g., 224, 324, 62 5, 8224), clasps or gripping members (e.g., 130, 230, 330, 430, 630, 40856), arms (e.g., 132, 134, 332, 334, 432, 434), interface elements (e.g., 210, 310, 410, 610, 3800), collars (e.g., 211, 311, 651), caps (e.g., 214, 314, 414, 654, 8214), and / or any other suitable components.

[0187] Coating 702 may be applied or deposited on component 700 using plasma spraying, plasma arc spraying, sputtering, or additive material deposition methods to increase the texture of the surface of component 700, such as by providing nanostructures on the surface of component 700. Texture added to the surface of component 700 may increase the visibility of the device or repair system during deployment and implantation because the added texture may increase the effective scattering of echocardiographic, ultrasonic, electromagnetic, or other waveforms used to visualize or image the deployment and implantation of the device or repair system, such as during echocardiogram visualization. For example, texture added to the surface of component 700 may reduce the acoustic or return of echocardiographic, ultrasonic, electromagnetic, or other waveforms used for visualization or imaging to reduce ring-down and / or shadow artifacts of the visualization method, thereby allowing a clearer image of the deployment and implantation of the device or repair system.

[0188] As shown in FIG. 49, droplets 704 containing the material of the coating 702 are formed. The droplets 704 may be formed from a powder, wire, liquid, suspension, etc., containing the desired material of the coating 702. The droplets 704 may be melted, vaporized, ionized, energized, or otherwise heated into a liquid, gas, or plasma. In some implementations, the droplets 704 are heated with a device such as a plasmatron, plasma torch, or similar device that converts electrical energy into thermal energy that can generate high temperatures, such as temperatures of at least 10,000 K. The liquid, gas, or plasma droplets 704 are then sprayed, propelled, or otherwise deposited onto the surface of the component 700. For example, the droplets 704 may be deposited onto the surface of the component 700 by a plasma jet. The coating 702 may solidify on the surface of the component 700 to form a coating 702 that increases the texture and / or surface mechanical strength of the surface of the component 700. In some implementations, the droplets 704 may be deposited on the component 700 in a vacuum, such as in high vacuum conditions and / or under an inert gas.

[0189] As shown in FIG. 50, an exemplary surface of component 700 is shown after coating 702 has been applied. Coating 702 increases the texture of the surface of component 700, thereby decreasing the smoothness of the surface of component 700. For example, coating 702 may include lamellae, plates, flakes, or particles of similar material that increase the texture of the surface of component 700. When the surface of component 700 is subjected to an echocardiographic, ultrasound, electromagnetic, or other similar imaging technique, the waveforms scatter when they are acoustic or reflective, thereby decreasing the amount and / or intensity of the waveforms that echo back to the imaging device. Thus, coating 702, when applied to an implantable device or valve repair system, can increase the visibility of the device repair system when viewed using an echocardiographic, ultrasound, electromagnetic, or other similar imaging technique by decreasing the intensity of the reflected waveforms and providing a clearer image of the implantable device or valve repair system.

[0190] 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.).

[0191] 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.

[0192] 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.

[0193] 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. An implantable valve repair device for repairing a patient's natural valve, A pair of paddles, It comprises a pair of contour fasteners that are movable between an open position and a closed position, A valve repair device in which, when the valve repair device is deployed within the natural valve and the pair of contour fasteners are in the closed position, the proximal portion of each contour fastener is curved outward or flared to approximate the natural shape of the natural valve leaflet, thereby enabling the natural valve leaflet to substantially retain its natural shape.

2. The embeddable valve repair device according to claim 1, wherein each contoured retainer includes a contoured movable arm and a fixed arm.

3. The embeddable valve repair device according to claim 1, wherein the fixed arm has a contour that is a mirror image of the contoured movable arm.

4. The embeddable valve repair device according to claim 1, wherein each of the pair of contour fasteners includes one or more finials.

5. The embeddable valve repair device according to claim 1, wherein each paddle includes an inner paddle and an outer paddle.

6. The embeddable valve repair device according to claim 1, further comprising a connecting element positioned between the pair of contour fasteners.

7. The embeddable valve repair device according to claim 6, wherein the connecting element includes a plurality of support columns and a plurality of openings defining a lattice structure.

8. The implantable valve repair device according to claim 1, further comprising a covering that reduces the number of waveforms to be echoed back when using imaging technology.

9. The embeddable valve repair device according to claim 6, wherein the joining element is compressible and / or expandable.

10. The implantable valve repair device according to claim 6, wherein the joint element has a central opening that extends through the body portion of the joint element from its proximal end to its distal end, and the central opening is sized to be slightly larger than the size of the main shaft of the implantable valve repair device, so that the main shaft can be received within the central opening of the joint element.

11. The embeddable valve repair device according to any one of claims 1 to 10, further comprising a proximal mounting portion including a collar for engaging with a capture mechanism of a delivery system, wherein the joining element extends from the proximal collar to an internal paddle of the valve repair device.

12. A valve repair system, An implantable valve repair device, A pair of paddles, It comprises a pair of contour fasteners that are movable between an open position and a closed position, Each of the pair of contour retainers approximates the shape of the natural valve when the valve repair device is deployed inside the natural valve and the pair of contour retainers are in the closed position. A valve repair system comprising one or more catheters coupled to the valve repair device.

13. The valve repair system according to claim 12, wherein each contoured retainer includes a contoured movable arm and a fixed arm.

14. The valve repair system according to claim 12, wherein the fixed arm has a contour that is a mirror image of the contoured movable arm.

15. The valve repair system according to claim 12, wherein each of the pair of contour fasteners includes at least one return.

16. The valve repair system according to claim 12, wherein each paddle includes an inner paddle and an outer paddle.

17. The valve repair system according to claim 12, further comprising a joining element positioned between the pair of contour fasteners.

18. The valve repair system according to claim 17, wherein the connecting element includes a plurality of support columns and a plurality of openings defining a lattice structure.

19. The valve repair system according to claim 12, further comprising a covering that reduces the number of echoed waveforms when using imaging technology.

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