Heart valve sealing device and delivery device thereof

Abstract

The invention relates to a heart valve sealing device and a delivery device thereof. An example implantable prosthetic device has a mating element and at least one anchor. The involution element is configured to be positioned within a native heart valve orifice to help fill the space of native valve backflow and create a more efficient seal. The involution element may have a blood impermeable structure. The involution element may be connected to a leaflet of the native valve by the anchor.

Description

[0001] This application is a divisional application. The application date of the original application is October 9, 2019, the application number is 201980067067.8, and the name of the invention is "Heart valve sealing device and delivery device thereof", which is incorporated herein by reference in its entirety.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 744,031, filed October 10, 2018, which is incorporated herein by reference for all purposes. Technical Field

[0004] The present application relates generally to heart valve sealing devices and delivery devices thereof. Background Art

[0005] The natural heart valves (i.e., the aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play a key role in ensuring an adequate forward flow of blood through the cardiovascular system. These heart valves may be damaged due to congenital malformations, inflammatory processes, infectious conditions, disease, and therefore reduced effectiveness. Such damage to the valves can lead to serious cardiovascular damage or death. Damaged valves can be surgically repaired or replaced during open heart surgery. However, open heart surgery is highly invasive and complications may occur. Transvascular techniques can be used to introduce and implant prosthetic devices in a much less invasive manner than open heart surgery. As an example, a transseptal technique can be used, for example, comprising inserting a catheter into the right femoral vein, up along the inferior vena cava and into the right atrium, piercing the septum, and passing the catheter into the left atrium.

[0006] A healthy heart is typically conical in shape, tapering to a lower apex. The heart is four-chambered and includes a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has an anatomical structure that is quite different from other natural heart valves. The mitral valve includes an annular portion, which is an annular portion of natural valve tissue surrounding the mitral valve orifice, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle. The mitral valve annulus can form a "D"-shaped, oval, or otherwise out-of-round cross-sectional shape having a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, thereby forming a roughly "C"-shaped boundary between their adjacent sides when the two are closed together.

[0007] When operating correctly, the anterior and posterior leaflets act together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expand (also known as "diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as "systole" or "systole"), the increased blood pressure in the left ventricle pushes the sides of the two leaflets together, thereby closing the one-way mitral valve, so that blood cannot flow back into the left atrium and is instead expelled from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding in half through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0008] During the systolic phase of heart contracture, mitral regurgitation occurs when the native mitral valve fails to close properly, and blood flows back from the left ventricle into the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral annulus caused by left ventricular dilation, more than one of these, and the like. Mitral regurgitation at the central portion of the leaflet can be referred to as central jet mitral regurgitation, while mitral regurgitation near one of the leaflets (i.e., the location 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 there is regurgitation.

[0009] One technique for treating mitral and other valve regurgitation in patients can involve directly securing the edges of the native valve leaflets to each other. For example, catheter-delivered clips have been used to attempt to clamp the sides of the leaflets together at their end portions. However, significant challenges exist. For example, multiple clips may be required to eliminate or reduce regurgitation to an acceptable level, but in some cases, this can result in longer procedures and may result in overly restricted flow or undesirable stress on the native anatomy.

[0010] Despite this prior art, there remains a need for improved devices and methods for treating valvular regurgitation. Summary of the Invention

[0011] The present disclosure 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 in the present disclosure is not required for the claims unless the claims explicitly recite these features. In addition, the features, components, steps, concepts, etc. described in the examples in the present disclosure and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples outlined here.

[0012] An exemplary implantable prosthetic device includes a coaptation element (although the term coaptation element is used throughout this application, this may also be referred to as a coaptation element, a spacer, etc.) and at least one anchor. The coaptation element is configured to be positioned within the orifice of a native heart valve to help fill the space where the native valve is regurgitated and form a more effective seal. The coaptation element may have a blood-impermeable structure. The coaptation element may be connected to the leaflets of the native valve via the anchor.

[0013] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a strip of material and a pair of paddles. The apposition element is formed from or includes the strip of material. The pair of paddles are formed from or include the strip of material and are connected to the apposition element. The pair of paddles are movable between an open position and a closed position.

[0014] The "strip of material" in the various embodiments described throughout this disclosure can be a single, unitary strip of material or piece of material. However, in some embodiments, a "strip of material" can be formed from multiple smaller discrete pieces of one or more materials that are combined into a larger composite material strip.

[0015] In one example method for manufacturing a valve repair device, a strip of material is folded to form an apposition element and a pair of paddles connected to the apposition element. The paddles are movable between an open position and a closed position and are configured to attach to a patient's native valve. A portion of the strip of material forming the apposition element is attached to a backing ring. A portion of the strip of material forming the paddles is attached to a cover. Movement of the cover toward the backing ring causes the pair of paddles to move to the closed position. Movement of the cover away from the backing ring causes the pair of paddles to move to the open position.

[0016] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes an apposition element and a pair of paddles. The apposition element has four layers. The pair of paddles are connected to the apposition element. The paddles are movable between an open position and a closed position and are configured to attach to the patient's native valve.

[0017] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a strip of material and a collar. An apposition element is formed from the strip of material. The collar is connected to the apposition element. A pair of paddles are formed from the strip of material and connected to the apposition element. The paddles can be moved between an open position and a closed position by moving the collar toward and away from the paddles.

[0018] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a collar, an apposition element, and a pair of paddles. The collar has a plurality of engagement portions configured to releasably engage a delivery device. The apposition element is attached to the collar. The pair of paddles are connected to the apposition element and are movable between an open position and a closed position. The paddles are circumferentially disposed between the engagement portions. The paddles are configured to attach to the patient's native valve.

[0019] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes an apposition element, a pair of paddles, and a covering. The pair of paddles are connected to the apposition element. The paddles are movable between an open position and a closed position. When the paddles are in the open position, a stop (e.g., a point that could snag or hook on a portion of a delivery system and interfere with deployment and / or recapture of the device) is formed by or between a portion of the apposition element and at least one of the pair of paddles. A covering connected to the apposition element and the paddles covers the stop.

[0020] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes an apposition element, a pair of paddles, a first cover, and a second cover. The pair of paddles are connected to the apposition element and are movable between an open position and a closed position. The first cover extends from a distal end of the device and covers at least a portion of the paddles. The second cover extends from a proximal end of the device and covers at least a portion of the apposition element.

[0021] In one exemplary embodiment, a valve repair device for repairing a patient's native valve is formed from a strip of material. The strip of material has a first edge and a second edge surrounding a central portion. An apposition element is formed from the strip of material. A pair of paddles are formed from the strip of material. The pair of paddles are connected to the apposition element. The paddles are movable between an open position and a closed position.

[0022] In one exemplary embodiment, a valve repair device for repairing a patient's natural valve includes a strip of material, a pair of attachment portions, a pair of extension members, and a cover. The mate element is formed from the strip of material. The pair of extension members have attachment portions. A pair of paddles are formed from the strip of material. The pair of paddles are connected to the mate element. The paddles are movable between an open position and a closed position. The paddles are arranged above the extension members. The cover is attached to the paddles. Movement of the cover toward the mate element causes the pair of paddles to move to the closed position. Movement of the cover away from the mate element causes the pair of paddles to move to the open position. The cover includes a retaining body, a retaining nut, and a retaining bolt. The retaining body has a locking opening for receiving the attachment portion of the extension member. The retaining nut is inserted into the locking opening. The retaining bolt secures the retaining nut within the locking opening.

[0023] In one exemplary method for manufacturing a valve repair device for repairing a patient's natural valve, a strip of material is folded to form an apposition element and a pair of paddles connected to the apposition element. The paddles are movable between an open position and a closed position and are configured to attach to the patient's natural valve. A portion of the strip of material forming the paddles is attached to a cover. Movement of the cover toward the apposition element causes the pair of paddles to move to the closed position. Movement of the cover away from the apposition element causes the pair of paddles to move to the open position. The cover includes a retaining body, a retaining nut, and a retaining bolt. The retaining body has a locking opening for receiving an attachment portion of an extension member. The retaining nut is configured to be inserted into the locking opening. The retaining bolt secures the retaining nut within the locking opening. A pair of extension members are attached to the retaining body of the cover via the attachment portions of the extension members, such that the paddles are positioned above the extension members. The retaining bolt and retaining nut are assembled to secure the cover to the strip of material.

[0024] In one exemplary embodiment, a valve repair device for repairing a patient's natural valve includes a strip of material, a cover, and a pair of extension members. The apposition element is formed from the strip of material. A pair of paddles are formed from the strip of material and connected to the apposition element. The paddles are movable between an open position and a closed position and are configured to attach to the patient's natural valve. The cover is attached to the paddles. Movement of the cover toward the apposition element causes the pair of paddles to move to the closed position. Movement of the cover away from the apposition element causes the pair of paddles to move to the open position. A pair of extension members are connected to the cover and are movable between an open position and a closed position. In the closed position, the extension members are biased in a closing direction.

[0025] In one example method for manufacturing a valve repair device for repairing a patient's native valve, a strip of material formed from a shape memory alloy is folded around a fixture to form an apposition element and a pair of paddles connected to the apposition element. The paddles are movable between an open position and a closed position and are configured to attach to the patient's native valve. The strip of shape memory material is heat treated to shape the strip into the shape of the apposition element and the paddles.

[0026] In one exemplary embodiment, a valve repair device for repairing a patient's natural valve includes a strip of material, a cover, and a pair of extension members. The apposition element is formed from the strip of material. A pair of paddles are formed from the strip of material and connected to the apposition element. The paddles are movable between an open position and a closed position and are configured to attach to the patient's natural valve. The cover is attached to the paddles. Movement of the cover toward the apposition element causes the pair of paddles to move to the closed position. Movement of the cover away from the apposition element causes the pair of paddles to move to the open position. The pair of extension members are connected to the cover and the paddles. The extension members extend from an attachment portion for attaching the extension members to the cover to an end portion of the paddles attached to the strip of material. The end portion of the extension member extends beyond the strip of material.

[0027] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a primary coaptation element, at least one auxiliary coaptation element, and a pair of paddles. The at least one auxiliary coaptation element is coupled to the coaptation element. The pair of paddles is coupled to the primary coaptation element. The paddles are movable between an open position and a closed position.

[0028] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes an apposition element, a pair of paddles connected to the apposition element, and a pair of paddle frames. The paddles are movable between an open position and a closed position. The paddles are configured to attach to the patient's native valve. The first paddle frame and the second paddle frame have spaced-apart frame portions that are parallel or substantially parallel when the paddles are in the closed position to form a rectangular leaflet coaptation region.

[0029] In one exemplary method for repairing a native heart valve, a first prosthetic device and a second prosthetic device are mounted on a pair of leaflets of a native heart valve. Each prosthetic device has a rectangular or substantially rectangular frame. The paddle frames of the mounted prosthetic devices are adjacent to each other and parallel or substantially parallel to each other.

[0030] The foregoing methods and other treatment methods herein can be performed on a living animal or on a mimetic, such as a cadaver, a cadaver heart, a mimetic (eg, utilizing simulated body parts, tissues, etc.), and the like.

[0031] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a pair of paddles and a pair of hooks. The paddles are movable between an open position and a closed position. Each hook has at least one barb, a barb support portion, a movable arm, and a flexible portion between the barb support portion and the movable arm. The flexible portion is configured to allow the barb support portion to flex away from the movable arm.

[0032] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] To further illustrate various aspects of the embodiments of the present disclosure, certain embodiments will be described in more detail with reference to various aspects of the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the present disclosure and, therefore, should not be considered to limit the scope of the present disclosure. In addition, although the drawings may be drawn to scale for certain embodiments, they are not necessarily drawn to scale for all embodiments. Through the use of the accompanying drawings, embodiments and other features and advantages of the present disclosure will be described and explained in conjunction with additional specificity and details, wherein:

[0034] Figure 1 shows a cross-sectional view of a human heart in diastole;

[0035] Figure 2 shows a cross-sectional view of a human heart in the systolic phase;

[0036] Figure 2A is another cross-sectional view of the human heart during the systolic phase;

[0037] Figure 2B yes Figure 2A a cross-sectional view of a mitral valve leaflet annotated to illustrate the natural shape of the mitral valve leaflet during systole;

[0038] Figure 3 shows a cross-sectional view of a human heart in diastole, with chordae tendineae shown attaching the leaflets of the mitral and tricuspid valves to the ventricular wall;

[0039] Figure 4 Shown is a healthy mitral valve with leaflet closure viewed from the atrial side of the mitral valve;

[0040] Figure 5 A dysfunctional mitral valve with visible gaps between the leaflets is shown as viewed from the atrial side of the mitral valve;

[0041] Figure 6 The mitral valve is shown with a wide gap between the posterior and anterior leaflets;

[0042] Figure 6A showing the coaptation elements in the interspace of the mitral valve as viewed from the atrial side of the mitral valve;

[0043] Figure 6B shows a valve repair device attached to a mitral valve leaflet as viewed from the ventricular side of the mitral valve, with the coaptation element in the interspace of the mitral valve;

[0044] Figure 6C is a perspective view of a valve repair device attached to a mitral valve leaflet shown from the ventricular side of the mitral valve with the coaptation element in the interspace of the mitral valve;

[0045] Figure 6D is a schematic diagram illustrating the path of a mitral valve leaflet along each side of an apposition element of an example mitral valve repair device;

[0046] Figure 6E is a top schematic diagram illustrating the path of mitral valve leaflets around coaptation elements of an example native valve repair device;

[0047] Figure 7 The tricuspid valve is shown as viewed from the atrial side of the tricuspid valve;

[0048] Figures 8 to 14 illustrates an example embodiment of an implantable prosthetic device in various stages of deployment;

[0049] Figure 11A An exemplary embodiment of an implantable prosthetic device is shown, which is similar to Figure 11 The arrangement shown, but in which the paddles are independently controllable;

[0050] Figures 15 to 20 Shown being delivered and implanted within a native valve Figures 8 to 14 implantable prosthetic devices;

[0051] Figure 21 Illustrative embodiments of implantable prosthetic devices or frames for implantable prosthetic devices are shown;

[0052] Figure 22 Illustrative embodiments of implantable prosthetic devices or frames for implantable prosthetic devices are shown;

[0053] Figures 23 to 25 Illustrative embodiments of components of an implantable prosthetic device or implantable medical device are shown;

[0054] Figure 23A An exemplary embodiment of an implantable prosthetic device is shown, which is similar to Figure 23 The device shown, but in which at least the commissure elements and the paddles are formed from strips of material;

[0055] Figure 26 and 27 An example embodiment of a barbed hook for use in an implantable prosthetic device is shown;

[0056] Figures 28 to 32 An example embodiment of an implantable prosthetic device is shown;

[0057] Figure 30A Shown with a cover provided thereon Figure 23A An exemplary embodiment of an implantable prosthetic device is shown;

[0058] Figure 32A and 32B yes Figures 28 to 32 a perspective view of a cap and an apposition element insert of an implantable prosthetic device in sealed and spaced-apart positions, respectively;

[0059] Figure 33 A barbed hook is shown for use in an implantable prosthetic device;

[0060] Figure 34 A portion of native valve tissue is shown grasped by the barbed hook;

[0061] Figures 35 to 46An example embodiment of an implantable prosthetic device is shown being delivered and implanted within a native valve;

[0062] Figure 47 A side view of an example implantable prosthetic device without barbed hooks is shown in a closed position;

[0063] Figure 47A A side view of an example implantable prosthetic device without barbs is shown in a closed position;

[0064] Figure 48 A side view of an example implantable prosthetic device with a barbed hook is shown in a closed position;

[0065] Figure 48A A side view of an example implantable prosthetic device with a barbed hook is shown in a closed position;

[0066] Figure 48B A side view of an example implantable prosthetic device having a barbed hook is shown in a closed position, the device being coupled to a deployment device;

[0067] Figure 48C Show the basis Figure 48B a side view of an example implantable prosthetic device having a cover;

[0068] Figure 48D Show the basis Figure 48B a front view of an example implantable prosthetic device attached to a deployment device;

[0069] Figure 48E Show the basis Figure 48D a front view of an example implantable prosthetic device having a cover;

[0070] Figure 48F Show the basis Figure 48B a side view of an example implantable prosthetic device having a barbed hook in a closed position;

[0071] Figure 48G Show the basis Figure 48F a front view of an example implantable prosthetic device;

[0072] Figure 48H Show the basis Figure 48F a bottom view of an example implantable prosthetic device;

[0073] Figure 49 A side view of an example implantable prosthetic device without barbed hooks is shown in a partially open position;

[0074] Figure 50showing a side view of an example implantable prosthetic device in a partially open position with the barbed hook in a closed position;

[0075] Figure 51 showing a side view of an example implantable prosthetic device in a partially open position with the barbed hook in an open position;

[0076] Figure 52 A side view of an example implantable prosthetic device without a barbed hook is shown in a semi-open position;

[0077] Figure 53 A side view of an example implantable prosthetic device is shown in a semi-open position with the barbed hook in a closed position;

[0078] Figure 53A A side view of an example implantable prosthetic device is shown in a semi-open position with the barbed hook in a closed position;

[0079] Figure 53B Show the basis Figure 53A a front view of an example implantable prosthetic device;

[0080] Figure 53C Show the basis Figure 53A a side view of an example implantable prosthetic device provided with a cover;

[0081] Figure 53D Show the basis Figure 53A a front view of an example implantable prosthetic device provided with a cover;

[0082] Figure 54 A side view of an example implantable prosthetic device is shown in a semi-open position with the barbed hook in an open position;

[0083] Figure 54A A side view of an example implantable prosthetic device is shown in a semi-open position with the barbed hook in an open position;

[0084] Figure 54B Show the basis Figure 54A a front view of an example implantable prosthetic device;

[0085] Figure 54C Show the basis Figure 54A a side view of an example implantable prosthetic device having a cover;

[0086] Figure 54D Show Figure 54A a front view of an example implantable prosthetic device having a cover;

[0087] Figure 55A side view of an example implantable prosthetic device without a barbed hook is shown in a three-quarters open position;

[0088] Figure 56 showing a side view of an example implantable prosthetic device in a three-quarter open position with the barbed hook in a closed position;

[0089] Figure 57 showing a side view of an example implantable prosthetic device in a three-quarter open position with the barbed hook in the open position;

[0090] Figure 58 A side view of an example implantable prosthetic device without a barbed hook is shown near a fully salvaged position or near a fully open position;

[0091] Figure 59 A side view of an example implantable prosthetic device without a barbed hook is shown in a fully salvaged or fully open position;

[0092] Figure 60 A side view of an example implantable device is shown in a fully salvaged position with the barbed hooks in a closed position;

[0093] Figure 60A A side view of an example implantable device is shown in a fully salvaged position with the barbed hooks in a closed position;

[0094] Figure 60B Show the basis Figure 60A a front view of an example implantable prosthetic device;

[0095] Figure 60C Show the basis Figure 60A a side view of an example implantable prosthetic device provided with a cover;

[0096] Figure 60D Show the basis Figure 60A a front view of an example implantable prosthetic device having a cover;

[0097] Figure 61 A side view of an example implantable device is shown in a fully salvaged position with the barbed hooks in an open position;

[0098] Figure 61A A side view of an example implantable device is shown in a fully salvaged position with the barbed hooks in an open position;

[0099] Figure 61B Show the basis Figure 61A a front view of an example implantable prosthetic device;

[0100] Figure 61C Show the basis Figure 61A a side view of an example implantable prosthetic device provided with a cover;

[0101] Figure 61D Show the basis Figure 61A a front view of an example implantable prosthetic device having a cover;

[0102] Figures 62A to 62B illustrates movement of a paddle of an example embodiment of an implantable prosthetic device;

[0103] Figures 63A to 63C illustrates movement of a paddle of an example embodiment of an implantable prosthetic device;

[0104] Figures 64A to 64C illustrates movement of a paddle of an example embodiment of an implantable prosthetic device;

[0105] Figure 65 showing a perspective view of an example implantable prosthetic device in a closed position;

[0106] Figure 65A showing a perspective view of an example implantable prosthetic device in a closed position;

[0107] Figure 66 Show Figure 65 A perspective view of an implantable prosthetic device;

[0108] Figure 66A Show Figure 65A A perspective view of an implantable prosthetic device;

[0109] Figure 67 Show Figure 65 A front view of an implantable prosthetic device;

[0110] Figure 67A Show Figure 65A A front view of an implantable prosthetic device;

[0111] Figure 68 Shown with additional components Figure 65 A front view of an implantable prosthetic device;

[0112] Figure 68A Shown with additional components Figure 65A A front view of an implantable prosthetic device;

[0113] Figure 69 Show Figure 65 A side view of an implantable prosthetic device;

[0114] Figure 70 Show Figure 65 A top view of an implantable prosthetic device;

[0115] Figure 70A Show Figure 65A A top view of an implantable prosthetic device;

[0116] Figure 71 Shown with a bushing component Figure 65 A top view of an implantable prosthetic device;

[0117] Figure 71A Shown with a bushing component Figure 65A A top view of an implantable prosthetic device;

[0118] Figure 72 Show Figure 65 A bottom view of an implantable prosthetic device;

[0119] Figure 72A Show Figure 65A A bottom view of an implantable prosthetic device;

[0120] Figure 73 Shown with a cover member Figure 65 A bottom view of an implantable prosthetic device;

[0121] Figure 73A Shown with a cover member Figure 65A A bottom view of an implantable prosthetic device;

[0122] Figure 74 Shown is a cross-sectional view taken through a cross-sectional plane 75. Figure 65 A cutaway perspective view of an implantable prosthetic device;

[0123] Figure 74A Shown is a cross-sectional view taken along cross-sectional plane 75A. Figure 65A A cutaway perspective view of an implantable prosthetic device;

[0124] Figure 75 Show Figure 74 a top cross-sectional view of an example prosthetic device is shown;

[0125] Figure 75A Show Figure 74A a top cross-sectional view of an example prosthetic device is shown;

[0126] Figure 76 Shown is a cross-sectional view taken by cross-sectional plane 77. Figure 65 A cutaway perspective view of an implantable prosthetic device;

[0127] Figure 76A Shown is a cross-sectional view taken along cross-sectional plane 77A. Figure 65A A cutaway perspective view of an implantable prosthetic device;

[0128] Figure 77 Show Figure 76a top cross-sectional view of an example prosthetic device is shown;

[0129] Figure 77A Show Figure 76A a top cross-sectional view of an example prosthetic device is shown;

[0130] Figure 78 Shown is a cross-sectional view taken by cross-sectional plane 77. Figure 65 A cutaway perspective view of an implantable prosthetic device;

[0131] Figure 78A Shown is a cross-sectional view taken along cross-sectional plane 77A. Figure 65A A cutaway perspective view of an implantable prosthetic device;

[0132] Figure 79 Show Figure 78 a top cross-sectional view of an example prosthetic device is shown;

[0133] Figure 79A Show Figure 78A a top cross-sectional view of an example prosthetic device is shown;

[0134] Figure 80 Shown is a cross-sectional view taken from a cross-sectional plane 81. Figure 65 A cutaway perspective view of an implantable prosthetic device;

[0135] Figure 80A Shown is a cross-sectional view taken along cross-sectional plane 81A. Figure 65A A cutaway perspective view of an implantable prosthetic device;

[0136] Figure 81 Show Figure 80 a top cross-sectional view of an example prosthetic device is shown;

[0137] Figure 81A Show Figure 80A a top cross-sectional view of an example prosthetic device is shown;

[0138] Figure 82 Shown is a cross-sectional view taken by cross-sectional plane 83. Figure 65 A cutaway perspective view of an implantable prosthetic device;

[0139] Figure 82A Shown is a cross-sectional view taken along cross-sectional plane 83A. Figure 65A A cutaway perspective view of an implantable prosthetic device;

[0140] Figure 83 Show Figure 82 a top cross-sectional view of an example prosthetic device is shown;

[0141] Figure 83A Show Figure 82Aa top cross-sectional view of an example prosthetic device is shown;

[0142] Figure 84 An exemplary embodiment of an implantable prosthetic device having integral barbs is shown;

[0143] Figure 85 An exemplary embodiment of an implantable prosthetic device having integral barbs is shown;

[0144] Figure 86 An exemplary embodiment of an implantable prosthetic device having integral barbs is shown;

[0145] Figure 86A An exemplary embodiment of an implantable prosthetic device having integrated barbs is shown;

[0146] Figure 87 An exemplary embodiment of an implantable prosthetic device having integral barbs is shown;

[0147] Figure 87A An exemplary embodiment of an implantable prosthetic device having integrated barbs is shown;

[0148] Figure 88 An exemplary embodiment of an implantable prosthetic device having integral barbs is shown;

[0149] Figure 88A An exemplary embodiment of an implantable prosthetic device having integrated barbs is shown;

[0150] Figure 89 Show Figure 65 a perspective view of the apposed portion and the paddle portion of the implantable prosthetic device shown;

[0151] Figure 89A Show Figure 65A a perspective view of the apposed portion and the paddle portion of the implantable prosthetic device shown;

[0152] Figure 90 Show Figure 65 a perspective view of the apposed portion and the paddle portion of the implantable prosthetic device shown;

[0153] Figure 90A Show Figure 65A a perspective view of the apposed portion and the paddle portion of the implantable prosthetic device shown;

[0154] Figure 91 Show Figure 65 A front view of the apposed and paddle portions of the implantable prosthetic device is shown;

[0155] Figure 91A Show Figure 65AA front view of the apposed and paddle portions of the implantable prosthetic device is shown;

[0156] Figure 92 Show Figure 65 a side view of the apposed portion and the paddle portion of the implantable prosthetic device shown;

[0157] Figure 92A Show Figure 65A a side view of the apposed portion and the paddle portion of the implantable prosthetic device shown;

[0158] Figure 93 Show Figure 65 a top view of the apposed portion and the paddle portion of the implantable prosthetic device;

[0159] Figure 93A Show Figure 65A a top view of the apposed portion and the paddle portion of the implantable prosthetic device;

[0160] Figure 94 Show Figure 65 a bottom view of the illustrated apposition portion and paddle portion of the implantable prosthetic device;

[0161] Figure 94A Show Figure 65A a bottom view of the illustrated apposition portion and paddle portion of the implantable prosthetic device;

[0162] Figure 95 Show Figure 65 A cutaway perspective view of the apposed and paddle portions of the implantable prosthetic device is shown, wherein the section is taken through plane 96;

[0163] Figure 95A Show Figure 65A A cutaway perspective view of the apposition and slurry portions of the implantable prosthetic device is shown, wherein the section is taken through plane 96A;

[0164] Figure 96 Show Figure 95 a cross-sectional view of the commissure portion and the blade portion;

[0165] Figure 96A Show Figure 95A a cross-sectional view of the commissure portion and the blade portion;

[0166] Figure 97 Show Figure 65 A cutaway perspective view of the apposed and paddle portions of the implantable prosthetic device is shown, wherein the section is taken through plane 98;

[0167] Figure 97A Show Figure 65AA cutaway perspective view of the apposition and slurry portions of the implantable prosthetic device is shown, wherein the section is taken through plane 98A;

[0168] Figure 98 Show Figure 97 a cross-sectional view of the commissure portion and the blade portion;

[0169] Figure 98A Show Figure 97A a cross-sectional view of the commissure portion and the blade portion;

[0170] Figure 99 Show Figure 65 A cutaway perspective view of the apposed and paddle portions of an implantable prosthetic device is shown, wherein the section is taken through plane 100;

[0171] Figure 99A Show Figure 65A A cutaway perspective view of the apposed and paddle portions of the implantable prosthetic device is shown, wherein the section is taken through plane 100A;

[0172] Figure 100 Show Figure 99 a cross-sectional view of the commissure portion and the blade portion;

[0173] Figure 100A Show Figure 99A a cross-sectional view of the commissure portion and the blade portion;

[0174] Figure 101 Show Figure 65 A cutaway perspective view of the apposed and paddle portions of an implantable prosthetic device is shown, wherein the section is taken through plane 102;

[0175] Figure 101A Show Figure 65A A cutaway perspective view of the apposed and paddle portions of the implantable prosthetic device is shown, wherein the section is taken through plane 102A;

[0176] Figure 102 Show Figure 101 a cross-sectional view of the commissure portion and the blade portion;

[0177] Figure 102A Show Figure 101A a cross-sectional view of the commissure portion and the blade portion;

[0178] Figure 103 An example embodiment of an implantable prosthetic device is shown;

[0179] Figure 104 An example embodiment of an implantable prosthetic device is shown;

[0180] Figure 105An example embodiment of an implantable prosthetic device is shown;

[0181] Figure 106 A side view illustrating an example embodiment of an expandable apposition element in an unexpanded state;

[0182] Figure 106A A side view illustrating an example embodiment of an expandable apposition element in an unexpanded state;

[0183] Figure 106B A side view illustrating an example embodiment of an expandable apposition element in an unexpanded state;

[0184] Figure 106C A side view illustrating an example embodiment of an expandable apposition element in an unexpanded state;

[0185] Figure 106D A side view illustrating an example embodiment of an expandable apposition element in an unexpanded state;

[0186] Figure 106E A side view illustrating an example embodiment of an expandable apposition element in an unexpanded state;

[0187] Figure 106F An example embodiment of an expandable involute element is shown;

[0188] Figure 106G An example embodiment of an expandable involute element is shown;

[0189] Figure 106H An example embodiment of an expandable involute element is shown;

[0190] Figure 106I An example embodiment of an expandable involute element is shown;

[0191] Figure 107 Show Figure 106 An end view of an expandable involute element;

[0192] Figure 108 Shown in expanded state Figure 106 Scalable involution elements;

[0193] Figure 108A Shown in expanded state Figure 106A Scalable involution elements;

[0194] Figure 108B Shown in expanded state Figure 106B Scalable involution elements;

[0195] Figure 108C Shown in expanded state Figure 106C Scalable involution elements;

[0196] Figure 108D Shown in expanded state Figure 106D Scalable involution elements;

[0197] Figure 108E Shown in expanded state Figure 106E Scalable involution elements;

[0198] Figure 109 Show Figure 108 an end view of the mating element;

[0199] Figure 110 shows a side view of an example embodiment of an implantable prosthetic device;

[0200] Figure 111 Shown is a view taken along line 111 Figure 110 End view of an apposing element of an example prosthetic device.

[0201] Figures 112 to 114 Shown for Figure 65 A perspective view of an example embodiment of a paddle frame of an implantable prosthetic device is shown;

[0202] Figure 112A Shown for Figure 65A A perspective view of an example embodiment of a paddle frame of an implantable prosthetic device;

[0203] Figure 114A Show Figure 112A A side view of a blade frame;

[0204] Figure 115 Show Figures 112 to 114 A front view of the blade frame;

[0205] Figure 115A Show Figure 112A A top view of a blade frame;

[0206] Figure 116 Show Figure 112 and Figure 114 A top view of a blade frame;

[0207] Figure 116A Show Figure 112A A front view of the blade frame;

[0208] Figure 117 Show Figure 112 and Figure 114 A side view of a blade frame;

[0209] Figure 117A Show Figure 112A Rear view of the blade frame;

[0210] Figure 118 Show Figure 112 and Figure 114 A bottom view of the blade frame;

[0211] Figure 118A Show Figure 112A A bottom view of the blade frame;

[0212] Figure 119 Show Figures 112 to 114 A front view of the blade frame;

[0213] Figure 120 Shown in compressed state within delivery device Figures 112 to 114 A front view of the blade frame;

[0214] Figure 121 showing a side view of an example embodiment of an implantable prosthetic device in a closed state;

[0215] Figure 122 Show Figure 121 A front view of a paddle frame of an example prosthetic device;

[0216] Figure 123 Shows the open state Figure 121 a side view of the implantable prosthetic device shown;

[0217] Figure 124 Show Figure 123 a front view of an opened paddle frame of a prosthetic device;

[0218] Figure 125 showing a side view of an example embodiment of an implantable prosthetic device in a closed state;

[0219] Figure 126 Show Figure 125 A front view of a paddle frame of an example prosthetic device;

[0220] Figure 127 Shown in closed state Figure 125 A side view of an implantable prosthetic device;

[0221] Figure 128 Show Figure 127 a front view of an opened paddle frame of a prosthetic device;

[0222] Figure 129 An example embodiment of an implantable prosthetic device is shown;

[0223] Figures 130 to 131 An example embodiment of an implantable prosthetic device is shown;

[0224] Figure 132An example embodiment of an implantable prosthetic device is shown;

[0225] Figures 133 to 134 An example embodiment of an implantable prosthetic device is shown;

[0226] Figures 135 to 136 An example embodiment of an implantable prosthetic device is shown;

[0227] Figure 137 An example embodiment of an implantable prosthetic device is shown;

[0228] Figures 138 to 143 illustrates the use of an example embodiment of an implantable prosthetic device;

[0229] Figure 144 An example embodiment of a delivery assembly including a delivery device and an example prosthetic device is shown;

[0230] Figure 145 showing a perspective view of an example embodiment of an implantable prosthetic device releasably coupled to a delivery device;

[0231] Figure 146 Show Figure 145 An embodiment wherein the implantable prosthetic device is released from a delivery device;

[0232] Figure 147 Show Figure 145 A cross-sectional view of a connector;

[0233] Figure 148 Show Figure 144 a perspective view of a delivery assembly of FIG. 1 , wherein a prosthetic device is shown in partial cross-section and certain components of the delivery apparatus are schematically shown;

[0234] Figure 149 Show Figure 144 a plan view of the axis of the delivery device;

[0235] Figure 150 Show Figure 144 a side view of a proximal end portion of a delivery device;

[0236] Figure 151 Show Figure 144 The proximal end portion of the delivery device is along Figure 150 a cross-sectional view taken along line 151-151 as shown;

[0237] Figure 152 Show Figure 144 an exploded view of a proximal end portion of a delivery device;

[0238] Figures 153 to 160 An example procedure for repairing a native valve of a heart is shown, which is partially illustrated;

[0239] Figure 161 Shown for Figure 144 Example embodiments of a handle of a delivery device;

[0240] Figure 162 yes Figure 161 Exploded view of the handle;

[0241] Figure 163 Shown for Figure 144 Example embodiments of a coupler and a proximal collar of a delivery assembly of FIG, showing the coupler releasably coupled to the proximal collar;

[0242] Figure 164 Show Figure 163 A perspective view of a coupling and a proximal collar showing the coupling released from the proximal collar;

[0243] Figure 165 Shown for Figure 144 Example embodiments of a cover, an actuating element or actuating instrument, and a release wire of a delivery assembly of the invention are shown, showing a cover releasably coupled to an actuating element or a device actuated by a release wire.

[0244] Figure 166 Show Figure 163 a perspective view of a cover, an actuating element or an actuating device, and a release wire showing the cover and the release wire released from the actuating element or the actuating device;

[0245] Figure 167 Show Figure 144 Example embodiments of a coupler, proximal collar, cap, and actuation element or actuation instrument of a delivery assembly of

[0246] Figure 168 Show Figure 167 A perspective view of the coupling and proximal collar;

[0247] Figure 169 Show Figure 144 Example embodiments of a hook control member of a delivery device;

[0248] Figure 170 Shown from Figure 169 The perspective shown Figure 170 The intercepted Figure 169 Detailed view of the hook control member;

[0249] Figure 171 Shown for Figure 169 Example embodiments of guide rails of hook control members;

[0250] Figure 172 Show Figure 144 Example embodiments of a shaft of a delivery device;

[0251] Figure 173 Illustrative embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0252] Figure 174 Illustrative embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0253] Figure 174A Embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0254] Figure 175 Illustrative embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0255] Figure 175A Embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0256] Figure 176 Illustrative embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0257] Figures 177 to 178 An example embodiment of a coupler for an example implantable prosthetic device is shown;

[0258] Figures 179 to 181 An example embodiment of a coupler for an example implantable prosthetic device is shown;

[0259] Figures 182 to 183 An example embodiment of a coupler for an example implantable prosthetic device is shown;

[0260] Figures 184 to 185 An example embodiment of a coupler for an example implantable prosthetic device is shown;

[0261] Figure 186 shows an example embodiment of an actuating element or actuating instrument for an example prosthetic device;

[0262] Figure 187 An actuation mechanism for an example prosthetic device is shown;

[0263] Figure 188 An actuation mechanism for an example prosthetic device is shown;

[0264] Figure 188A An actuation mechanism of an example prosthetic device is shown;

[0265] Figure 189 An actuation mechanism for an example prosthetic device is shown;

[0266] Figure 190 An actuation mechanism for an example prosthetic device is shown;

[0267] Figure 191 is a perspective view of a blank for making a blade frame;

[0268] Figure 192 yes Figure 191 A perspective view of a blank being bent to form a blade frame;

[0269] Figure 193 is a perspective view of a shaped paddle frame attached to a cover of a valve repair device;

[0270] Figure 194 yes Figure 193 a perspective view of a blade frame flexed and attached to the inner and outer blades in a closed position;

[0271] Figure 195 yes Figure 112A A perspective view of two blade frames showing the blade frames in a shaped position;

[0272] Figure 196 yes Figure 195 A perspective view of a blade frame showing the blade frame in a stowed position;

[0273] Figure 197 yes Figure 60C an enlarged side view of the device showing the cover;

[0274] Figure 198 yes Figure 60C an enlarged side view of the illustrated device showing the cover;

[0275] Figure 199 shows an exploded view of an example prosthetic device;

[0276] Figure 200 an enlarged perspective view showing a bushing of an example prosthetic device;

[0277] Figure 201 an enlarged perspective view showing a cover of an example prosthetic device;

[0278] Figure 202 Show Figure 206 Exploded view of the cover;

[0279] Figure 203 shows a plan view of an inner cover for an example prosthetic device;

[0280] Figure 204 showing a plan view of an outer cover of an example prosthetic device;

[0281] Figure 205 shows an enlarged view of a strip of material used in an example prosthetic device;

[0282] Figure 206 Show Figure 205 an end view of the material;

[0283] Figure 207 Shown arranged in multiple layers Figure 205 an end view of the material;

[0284] Figure 208A An example implantable prosthetic device is shown in the interspace of a native valve as viewed from the atrial side of the native valve during diastole with an example expandable spacer in a deflated state;

[0285] Figure 208B Shown during contraction Figure 208A The device, wherein the example expandable spacer is in a deflated state;

[0286] Figure 209A Shown during diastole Figure 208A The device, wherein the example expandable spacer is in an expanded state;

[0287] Figure 209B Shown during contraction Figure 208A The device, wherein the example expandable spacer is in an expanded state;

[0288] Figure 210A An example expandable spacer is shown in a compressed state;

[0289] Figure 210B Shown in expanded state Figure 210A Expandable spacers;

[0290] Figure 211A An example implantable prosthetic device is shown with an example expandable spacer in a deflated state;

[0291] Figure 211B Show Figure 211B The device, wherein the example expandable spacer is in an expanded state;

[0292] Figure 212A is a side view of an example implantable prosthetic device;

[0293] Figure 212B for Figure 212A Front / rear view of the device;

[0294] Figure 213A is used to attach to Figure 212A A top view of an example auxiliary spacer of a device;

[0295] Figure 213B yes Figure 213A a side view of a spacer;

[0296] Figure 214 Is assembled to Figure 212A 、 212B The device Figure 213A 、 213B a side view of a spacer;

[0297] Figure 215A Is assembled to Figure 212A 、 212B On the device Figure 213A 、 213B a side view of a spacer;

[0298] Figure 215B yes Figure 215A A top view of the component;

[0299] Figure 216A is a side view of an example implantable prosthetic device;

[0300] Figure 216B for Figure 216A Front / rear view of the device;

[0301] Figure 217A is used to attach to Figure 216A A top view of an example auxiliary spacer of a device;

[0302] Figure 217B yes Figure 217A a side view of a spacer;

[0303] Figure 218 is an example auxiliary spacer;

[0304] Figure 219A is a top view of an example implantable prosthetic device;

[0305] Figure 219B is a side view of an example implantable prosthetic device;

[0306] Figure 220A is a top view of an example auxiliary spacer;

[0307] Figure 220B is a top view of an example auxiliary spacer;

[0308] Figure 220C is a top view of an example auxiliary spacer;

[0309] Figure 220D is a top view of an example auxiliary spacer;

[0310] Figure 220E is a top view of an example auxiliary spacer;

[0311] Figure 221 is a plan view of an example implantable prosthetic device cut from a flat sheet;

[0312] Figure 222 yes Figure 221 A perspective view of the device;

[0313] Figure 223 Shows the gap in the native valve when viewed from the atrial side of the native valve. Figures 221 to 222 device;

[0314] Figure 224 is a plan view of an example implantable prosthetic device cut from a flat sheet;

[0315] Figure 225 yes Figure 224 A perspective view of the device;

[0316] Figure 226 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0317] Figure 227 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0318] Figure 228 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0319] Figure 229 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0320] Figure 230 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0321] Figure 231 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0322] Figure 232A is a front view of an implantable prosthetic device including a barbed hook and substantially parallel paddle frame members according to an example embodiment;

[0323] Figure 232B It is along Figure 232A A cross-sectional view taken along the plane indicated by line 232B-232B;

[0324] Figure 233A is with Figure 232A A similar view, noting the spaces between the substantially parallel sections of the blade frame elements;

[0325] Figure 233B It is along Figure 233A A cross-sectional view taken along the plane indicated by line 233B-233B;

[0326] Figure 234A is with Figure 232A A similar view showing the engagement of a portion of a native leaflet between substantially parallel paddle frame elements;

[0327] Figure 234B It is along Figure 234A a cross-sectional view taken along a plane indicated by line 234B-234B;

[0328] Figure 235A For Figure 234A a similar view showing misaligned native valve leaflets;

[0329] Figure 235B It is along Figure 235A A cross-sectional view taken along the plane indicated by line 235B-235B;

[0330] Figure 236 is a side view of an implantable prosthetic device according to an example embodiment;

[0331] Figure 237 is a side view of two adjacent implantable prosthetic devices according to an example embodiment;

[0332] Figure 238A is a side view of an implantable prosthetic device installed on a native valve according to an example embodiment;

[0333] Figure 238B It is along Figure 238A A cross-sectional view taken along the plane indicated by line 238B-238B;

[0334] Figure 239A is a side view of two adjacent implantable prosthetic devices installed on a mitral valve according to an example embodiment;

[0335] Figure 239B It is along Figure 239A A cross-sectional view taken along the plane indicated by line 239B-239B;

[0336] Figure 240A is similar to Figure 239A , showing two adjacent but misaligned implantable prosthetic devices;

[0337] Figure 240B It is along Figure 240A A cross-sectional view taken along the plane shown by line 240B-240B;

[0338] Figure 241 is a perspective view of a portion of a hook having a flexible barb support according to an example embodiment;

[0339] Figure 242 yes Figure 241 a portion of a hook, wherein the barb support is bent rearwardly to illustrate the flexible nature of the barb support in the example embodiment;

[0340] Figures 243A to 243H yes Figure 242 Schematic diagram of a hook with a flexible barbed support being released from a valve leaflet;

[0341] Figures 244A to 244E is a schematic diagram of an implantable prosthetic device with hooks and flexible barbed supports released from valve leaflets;

[0342] Figures 245A to 245E is an illustration of an implantable prosthetic device with hooks and flexible barb supports released from valve leaflets; and

[0343] Figure 246 is an illustration of an implantable device applying force on a single leaflet to illustrate a situation in which the hooks can be released from the native valve leaflet. DETAILED DESCRIPTION

[0344] The following description refers to the accompanying drawings, which illustrate specific embodiments of the present disclosure. Other embodiments having different structures and operations do not depart from the scope of the present disclosure.

[0345] Example embodiments of the present disclosure relate to devices and methods for repairing defective heart valves. It should be noted that various embodiments of native valve repair devices and systems for delivery are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, the various components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.

[0346] As described herein, when one or more components are described as being connected, coupled, attached, coupled, attached, or otherwise interconnected, such interconnection may be a direct interconnection between the components or may be an indirect interconnection (such as through the use of one or more intermediate components). Also as described herein, references to "member," "component," or "portion" should not be limited to a single structural member, component, or element, but may include an assembly of components, components, or elements. Also as described herein, the terms "substantially" and "approximately" are defined as at least approaching (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0347] Figure 1 and Figure 2Figures 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., Figure 4 and Figure 5 , 22) with flexible leaflets extending inwardly across respective orifices that meet or "comb" in the flow stream to form a one-way flow-blocking surface. The native valve repair system of the present application is primarily described with respect to the mitral valve MV. Therefore, the anatomy of the left atrium LA and left ventricle LV will be explained in more detail. It will be understood that the device described herein can also be used to repair other native valves, for example, the device can be used to repair the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0348] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase or relaxation, as Figure 1 As shown, blood that was previously collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV and enters the left ventricle LV through the expansion of the left ventricle LV. Figure 2 As shown, the left ventricle LV contracts to force blood into the body through the aortic valve AV and the ascending aorta AA. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV and back into the left atrium LA, and blood collects in the left atrium from the pulmonary veins. In an example embodiment, the devices described in this application are used to repair the function of a defective mitral valve MV. That is, these devices are configured to help close the leaflets of the mitral valve to prevent blood from flowing back from the left ventricle LV and back into the left atrium LA. Unlike prior art techniques that describe the use of sutures or clips, which typically require multiple sutures or clips and additional supports to handle large regurgitations, the devices described in this application are designed to easily grasp and secure the native leaflets around the apposition element, which acts as a filler in the regurgitation orifice.

[0349] Now refer to Figures 1 to 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, which is a variably dense fibrous ring of tissue surrounding the leaflets 20, 22. Figure 3, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae 10. The chordae tendineae 10 are cord-like tendons that connect the papillary muscles 12 (i.e., muscles located at the base of the chordae tendineae and within the wall of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles 12 serve to limit the movement of the mitral valve MV and prevent mitral valve reversal. 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 cannot open or close the mitral valve MV. Instead, the papillary muscles support the mitral valve MV against the high pressures required to circulate blood throughout the body. Together, the papillary muscles and chordae tendineae are referred to as the subvalvular structures, which serve to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed.

[0350] Various disease processes can impair the normal function of one or more native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic defects), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy) can distort the geometry of the native valve, which can cause native valve dysfunction. However, the vast majority of patients who undergo valve surgery (such as surgery on the mitral valve MV) suffer from a degenerative disease that causes dysfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), which leads to prolapse and regurgitation.

[0351] Generally speaking, native valves can malfunction in two different ways: (1) valvular stenosis and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not open fully, thereby causing blood flow obstruction. Typically, valvular stenosis is caused by the accumulation of calcified material in the valve leaflets, which causes the leaflets to thicken and impairs the valve's ability to fully open to allow forward blood flow.

[0352] The second type of valve dysfunction, valvular regurgitation, occurs when the leaflets of the valve do not close completely, causing blood to leak back into the previous chamber (for example, causing blood to leak from the left ventricle to the left atrium). There are three main mechanisms by which a native valve becomes regurgitant (or incompetent), including Carpentier Type I, Type II, and Type III dysfunction. Carpentier Type I dysfunction involves dilation of the annulus, causing the normally functioning leaflets to separate from each other and fail to form a tight seal (i.e., the leaflets cannot properly appose). Type I mechanism dysfunction includes leaflet perforation present in endocarditis. Carpentier Type II dysfunction involves prolapse of one or more leaflets of the native valve above the plane of apposition. Carpentier Type III dysfunction involves restriction of movement of one or more leaflets of the native valve, causing the leaflets to be abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilatation (IIIb).

[0353] refer to Figure 4 When the healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Figure 5 Regurgitation occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV displace into the left atrium LA during systole. This failure to coapt creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow from the left ventricle LV back into the left atrium LA during systole. As described above, there are several different ways that leaflets (e.g., leaflets 20, 22 of the mitral valve MV) can malfunction, resulting in regurgitation.

[0354] refer to Figure 6 In some cases, a patient's mitral valve MV may have a wide gap 26 between the anterior leaflet 20 and the posterior leaflet 22 when the mitral valve is in a closed position (i.e., during the systolic phase). For example, the gap 26 may have a width W between about 2.5 mm and about 17.5 mm, such as between about 5 mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm (such as about 10 mm). In some cases, the gap 26 may have a width W greater than 15 mm. In any of the above cases, there is a need for a valve repair device that can engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent blood from flowing back through the mitral valve MV.

[0355] Although stenosis or regurgitation can affect any valve, stenosis is primarily found to affect the aortic valve AV or the pulmonary valve PV, and regurgitation is primarily found to affect the mitral valve MV or the tricuspid valve TV. Both valvular stenosis and valvular regurgitation increase the workload of the heart H and, if left untreated, can lead to very serious conditions; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Since the left side of the heart (i.e., the left atrium LA, left ventricle LV, mitral valve MV, and aortic valve AV) is primarily responsible for circulating blood throughout the body, malfunction of the mitral valve MV or aortic valve AV is particularly problematic and often life-threatening. Therefore, due to the significantly higher pressures on the left side of the heart, dysfunction of the mitral valve MV or aortic valve AV tends to be more problematic.

[0356] Dysfunctional natural heart valves can be repaired or replaced. Repair typically involves the preservation and correction of the patient's natural valve. Replacement typically involves replacing the patient's natural valve with a biological or mechanical substitute. Typically, the aortic valve AV and the pulmonary valve PV are more prone to stenosis. Because the stenotic damage maintained by the leaflets is irreversible, the most conventional treatment for a stenotic aortic valve or a stenotic pulmonary valve is to remove the valve and replace it with a surgically implanted heart valve, or to replace the above valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to leaflet deformation, which, as described above, prevents the mitral valve or tricuspid valve from closing correctly and allows backflow or reverse flow of blood from the ventricles to the atria (for example, a deformed mitral valve MV can allow backflow or reverse flow from the left ventricle LV to the left atrium LA). Backflow or reverse flow of blood from the ventricles to the atria leads to valvular insufficiency. Deformation of the structure or shape of the mitral valve MV or the tricuspid valve TV is typically repairable. Additionally, backflow may occur because the chordae tendineae 10 become dysfunctional (e.g., the chordae may stretch or rupture), which allows the anterior and posterior leaflets 20, 22 to reverse, allowing blood to flow back into the left atrium LA. Problems caused by dysfunctional chordae tendineae 10 can be repaired by repairing the chordae tendineae or the structure of the mitral valve (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0357] For purposes of illustration, the devices and procedures disclosed herein generally relate to repairing the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve and any component of a native valve. For example, reference is now made to Figure 7Any of the devices and concepts provided herein can be used to repair the tricuspid valve TV. For example, 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 blood from flowing back from the right ventricle to the right atrium. In addition, any of the devices and concepts provided herein can be used together on all three leaflets 30, 32, 34 to prevent blood from flowing back from the right ventricle to the right atrium. In other words, the valve repair device provided herein can be located centrally between the three leaflets 30, 32, 34.

[0358] An example implantable prosthetic device has an apposition element and at least one anchor. The apposition element is configured to be positioned within a native heart valve orifice to help fill the space and form a more effective seal, thereby reducing or preventing the above-mentioned backflow. The apposition element can have a structure that is impermeable to blood or resistant to blood and allows the native leaflets to close around the apposition element during ventricular contraction to prevent blood from flowing back from the left ventricle or right ventricle into the left atrium or right atrium, respectively. The prosthetic device can be configured to seal against two or three native valve leaflets; that is, the device can be used for native mitral (or bicuspid) and tricuspid valves. The apposition element is sometimes referred to as a spacer in this article because the apposition element can fill the space between the dysfunctional native mitral or tricuspid valve leaflets that are not fully closed.

[0359] The apposition elements (e.g., spacers, apposition elements, etc.) can have various shapes. In some embodiments, the apposition element can have an elongated cylindrical shape having a circular cross-sectional shape. In other embodiments, the apposition element can have an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. The apposition element can have an atrial portion positioned in or adjacent to the left atrium, a ventricular portion or lower portion positioned in or adjacent to the left ventricle, and a side surface extending between the natural mitral valve leaflets. In an embodiment constructed for the tricuspid valve, the atrial portion or upper portion is positioned in or adjacent to the right atrium, and the ventricular portion or lower portion is positioned in or adjacent to the right ventricle, and the side surface extends between the natural tricuspid valve leaflets.

[0360] The anchor can be configured to secure the device to one or two of the natural mitral valve leaflets, such that the coaptation element is positioned between the two natural leaflets. In embodiments configured for the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid valve leaflets, such that the coaptation element is positioned between the three natural leaflets. In some embodiments, the anchor can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some embodiments, the anchor can be attached to an actuating element, such as a shaft or an actuating wire, to which the coaptation element is also attached. In some embodiments, the anchor and the coaptation element can be positioned independently relative to each other by moving each of the anchor and the coaptation element separately along the longitudinal axis of the shaft or the actuating wire. In some embodiments, the anchor and the coaptation element can be positioned simultaneously by moving the anchor and the coaptation element together along the longitudinal axis of the shaft or the actuating wire. The anchor can be configured to be positioned behind the natural leaflet upon implantation, such that the leaflet is grasped by the anchor.

[0361] The prosthetic device can be configured to be implanted via a delivery sheath. The apposition element and the anchoring member can be compressed to a radially compressed state and can self-expand to a radially expanded state when the compression pressure is released. The device can be configured to initially radially expand the anchoring member away from the still compressed apposition element so as to create a gap between the apposition element and the anchoring member. The natural leaflet can then be positioned in the gap. The apposition element can radially expand, thereby closing the gap between the apposition element and the anchoring member and capturing the leaflet between the apposition element and the anchoring member. In some embodiments, the anchoring member and the apposition element can optionally be configured to self-expand. The implantation methods for various embodiments can be different, and will be discussed more fully below for each embodiment. Additional information about these and other delivery methods can be found in U.S. Patent No. 8,449,599 and U.S. Patent Application Publication Nos. 2014 / 0222136 and 2014 / 0067052, 2016 / 0331523, each of which is incorporated herein by reference in its entirety. These methods can be performed on a live animal or on a simulated object, such as a cadaver, a cadaver heart, a simulated body (eg, utilizing simulated body parts, tissues, etc.), or the like.

[0362] The disclosed prosthetic device can be configured such that the anchors are connected to the leaflets, thereby utilizing tension from the natural chordae tendineae to resist high systolic pressures that urge the device toward the left atrium. During diastole, the device can rely on compressive and retaining forces exerted on the leaflets grasped by the anchors.

[0363] Now refer to Figures 8 to 14, shows a schematically illustrated implantable prosthetic device 100 at various stages of deployment. Device 100 may include any other features used in the implantable prosthetic devices discussed herein, and device 100 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0364] The device 100 is deployed from a delivery sheath or apparatus for delivery 102 and includes an apposition portion 104 and an anchoring portion 106. The apposition portion 104 of the device 100 includes an apposition element or apparatus for apposition 110 adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, tricuspid valve, etc.) and slidably attached to an actuating element 112 (e.g., an actuating wire, an actuating shaft, an actuating tube, etc.). The anchoring portion 106 is actuable between an open state and a closed state and can take a variety of forms such as a paddle, a gripping element, etc. Actuation of the actuating element or apparatus for actuation 112 opens and closes the anchoring portion 106 of the device 100 to grip the native valve leaflets during implantation. The actuating element 112 (e.g., a wire, a shaft, a tube, a screw, a wire, etc.) can take a variety of different forms. For example, the actuation element can be threaded, such that rotation of the actuation element (e.g., a wire, shaft, tube, screw, etc.) moves the anchor portion 106 relative to the apposing portion 104. Alternatively, the actuation element can be unthreaded, such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the apposing portion 104.

[0365] The anchoring portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122, which are connected between the cover 114 and the apposition element or device for apposition 110 via portions 124, 126, and 128. Portions 124, 126, and 128 can be connected and / or flexible to allow movement between all positions described below. The interconnection of the outer paddle 120, the inner paddle 122, the apposition element or device for apposition 110, and the cover 114 via portions 124, 126, and 128 can constrain the device to the positions and movements shown herein.

[0366] In some embodiments, an actuation element or instrument for actuation 112 (e.g., an actuation wire, an actuation shaft, etc.) extends through the delivery sheath and the apposition element or instrument for actuation 110 to a cover 114 at the distal connection of the anchoring portion 106. Extending and retracting the actuation element or instrument for actuation 112 increases and decreases the spacing, respectively, between the apposition element or instrument for actuation 110 and the cover 114. A collar or other attachment element removably attaches the apposition element or instrument for actuation 110 to the delivery sheath or instrument for delivery 102 such that during actuation to open and close the paddles 120, 122 of the anchoring portion 106, the actuation element or instrument for actuation 112 slides through the collar or other attachment element and through the apposition element or instrument for actuation 110.

[0367] Now refer to Figure 11 , anchoring portion 106 includes an attachment portion or gripping member. The illustrated gripping member includes a barbed hook 130, which includes a base or fixed arm 132, a movable arm 134, a barb or device for securing 136, and a joint portion 138. Fixed arm 132 is attached to inner paddle 122, with joint portion 138 positioned adjacent to engagement element or device for securing 110. The barbed hook has a flat surface and does not fit within a recess in the paddle. Instead, the flat portion of the barbed hook rests against the surface of inner paddle 122. Joint portion 138 provides a spring force between fixed arm 132 and movable arm 134 of barbed hook 130. Joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In certain embodiments, joint portion 138 is a flexible sheet of material integrally formed with fixed arm 132 and movable arm 134. The fixed arms 132 are attached to the inner paddle 122 and remain stationary relative to the inner paddle 122 as the movable arms 134 open to open the barbed hooks 130 and expose the barbs or means for securing 136. In some embodiments, the barbed hooks 130 are opened by applying tension to an actuation wire 116 attached to the movable arms 134, causing the movable arms 134 to articulate, flex, or pivot on the joint portion 138. Other actuation mechanisms are also possible.

[0368] During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp the native leaflet or native mitral valve leaflet between the paddles 120, 122 and the apposition element or device 110. The barbed hooks 130 can be used to grasp and / or further secure the native leaflet by engaging the leaflet with the barbs or device 136 and squeezing the leaflet between the movable arm 134 and the fixed arm 132. The barbs or device 136 of the barbed hooks 130 increase friction with the leaflet or can partially or completely pierce the leaflet. The actuation wires 116 can be actuated individually so that each barbed hook 130 can be opened and closed individually. The individual operations allow grasping of one leaflet at a time or allow repositioning of the hook 130 on a leaflet that is not adequately grasped without changing the successful grasping of another leaflet. The barbed hook 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in the open position), thereby allowing the leaflet to be grasped in a variety of positions depending on the needs of the particular situation.

[0369] The barbed hooks 130 can be opened individually by pulling an actuation wire 116 extending through the delivery sheath or the device for delivery 102 to the attachment of the barbed hooks 130. The actuation wire 116 can take a variety of forms, such as a thread, suture, wire, rod, catheter, etc. The barbed hooks 130 can be spring-loaded so that in the closed position, the barbed hooks 130 continue to provide a compressive force on the grasped native leaflet. This compressive force remains constant regardless of the position of the inner paddle 122. The barbs of the barbed hooks 130 or the device for securing 136 can perforate the native leaflet to further secure it.

[0370] Now refer to Figure 8 , the device 100 is shown in an elongated or fully open state for deployment from a delivery sheath. The device 100 is loaded into the delivery sheath in the fully open position because the fully open position takes up the least space and allows the smallest catheter to be used (or the largest device 100 for a given catheter size to be used). In the elongated state, the cover 114 is spaced apart from the apposition element or device for apposition 110 so that the paddles 120, 122 of the anchoring portion 106 are fully extended. In some embodiments, the angle formed between the outer paddle 120 and the interior of the inner paddle 122 is approximately 180 degrees. During deployment through the delivery sheath or device for delivery 102, the barbed hook 130 remains in the closed state so that the barb or device for securing 136 ( Figure 11 ) will not snag or damage the sheath or tissue in the patient's heart.

[0371] Now refer to Figure 9 , the apparatus 100 is shown in a state similar to Figure 8The device 100 is in an elongated, untangled state, but with the barbed hook 130 in a fully open position, with a range of from about 140 degrees to about 200 degrees to about 170 degrees to about 190 degrees, or about 180 degrees between the fixed portion and the movable portion of the barbed hook 130. It has been discovered that fully opening the paddles 120, 122 and the hook 130 can improve the ease of untangling or disengaging from the patient's anatomy during implantation of the device 100.

[0372] Now refer to Figure 10 , the device 100 is shown in a shortened or fully closed state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement within the heart. To move the device 100 from the elongated state to the shortened state, the actuating element or apparatus for actuation 112 is retracted to pull the cover 114 toward the apposition element or apparatus for apposition 110. The joint or flexible connector 126 between the outer paddles 120 and the inner paddles 122 is constrained from movement such that the compressive force exerted on the outer paddles 120 by the cover 114 being retracted toward the apposition element or apparatus for apposition 110 causes the paddles or gripping elements 120, 122 to move radially outward. During movement from the open position to the closed position, the outer paddles 120 maintain an acute angle with the actuating element or apparatus for actuation 112. The outer paddles 120 may optionally be biased toward the closed position. During the same movement, the inner paddles 122 move through a substantial angle as they are oriented away from the apposition element or apparatus for apposition 110 in the open state and collapsed along the sides of the apposition element or apparatus for apposition 110 in the closed state. In some embodiments, the inner paddles 122 are thinner and / or narrower than the outer paddles 120, and the joints or flexible portions 126, 128 connected to the inner paddles 122 can be thinner and / or more flexible. For example, this increased flexibility can allow for more movement than the joints or flexible portions 124 connecting the outer paddles 120 to the cover 114. In certain other embodiments, the outer paddles 120 are narrower than the inner paddles 122. The joints or flexible portions 126, 128 connected to the inner paddles 122 can be more flexible, for example, to allow for more movement than the joints or flexible portions 124 connecting the outer paddles 120 to the cover 114. In one embodiment, the inner paddles 122 can have the same or substantially the same width as the outer paddles (e.g., see Figure 65A ).

[0373] Now refer to Figures 11 to 13, the device 100 is shown in a partially open, ready-to-grasp state. To transition from the fully closed state to the partially open state, the actuating element or means for actuating 112 is extended to push the cover 114 away from the apposition element or means for apposition 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the anchoring portion 106 to partially deploy. The actuating wire 116 also retracts to open the catch 130 so that the leaflet can be grasped. Figure 11 In the example shown, the pair of inner and outer blades 122, 120 are moved in unison rather than independently by a single actuating element or means for actuation 112. Likewise, the position of the hook 130 depends on the position of the blades 122, 120. For example, referring to Figure 10 , closing the blades 122, 120 also closes the hook.

[0374] Figure 11A An example embodiment is shown in which the blades 120 , 122 are independently controllable. Figure 11A The device 100A shown is similar to Figure 11 The device is shown, except that device 100A includes an actuating element configured as two separate actuating elements 112A, 112B coupled to two separate covers 114A, 114B. To transition the first inner and outer paddles from a fully closed state to a partially open state, actuating element or means for actuating 112A extends to push cover 114A away from the apposition element or means for actuating 110, thereby pulling outer paddle 120, which in turn pulls inner paddle 122, causing the first anchoring portion 106 to partially deploy. To transition the second inner and outer paddles from a fully closed state to a partially open state, actuating element or means for actuating 112B extends to push cover 114 away from the apposition element or means for actuating 110, thereby pulling outer paddle 120, which in turn pulls inner paddle 122, causing the second anchoring portion 106 to partially deploy. Figure 11A The illustrated independent blade control may be implemented on any of the devices disclosed herein.

[0375] Now refer to Figure 12 , one of the actuating wires 116 extends to allow one of the hooks 130 to close. Figure 13 , the other actuation wire 116 extends to allow the other hook 130 to close. Any one or both of the actuation wires 116 can be repeatedly actuated to repeatedly open and close the barbed hooks 130.

[0376] Now refer to Figure 14, the device 100 is shown in a fully closed and deployed state. The delivery sheath or device for delivery 102 and the actuating element or device for actuation 112 are retracted and the paddles 120, 122 and the hook 130 are maintained in the fully closed position. Once deployed, the device 100 can be held in the fully closed position with a mechanical latch or can be biased to remain closed using a spring material such as steel, other metals, plastics, composite materials, etc., or a shape memory alloy such as Nitinol. The connecting or flexible portions 124, 126, 128, 138 and / or the inner and outer paddles 122 and / or additional biasing components (see Figure 28 The components 524 in (see Figure 524) can be formed of a metal, such as steel or a shape memory alloy (such as Nitinol in wire, sheet, tubing, or laser sintered powder), and are biased to hold the outer paddle 120 closed around the apposition element or device for apposition 110 and the barbed hook 130 pressed around the native leaflet. Similarly, the fixed arm 132 and movable arm 134 of the barbed hook 130 are biased to compress the leaflet. In certain embodiments, the attachment or joint portions 124, 126, 128, 138 and / or the inner and outer paddles 122, 120 and / or additional biasing components (see Figure 524) can be formed of a metal, such as steel or a shape memory alloy (such as Nitinol in wire, sheet, tubing, or laser sintered powder) ... Figure 28 Component 524 in the device may be formed from any other suitably resilient material, such as a metal or polymer material, to maintain the device in a closed state after implantation.

[0377] Now refer to Figure 226 and 231 , the implantable device 100 is shown as being provided with a cover 140. The cover 140 can be a cloth, such as a fine mesh polyethylene cloth. The cloth cover can provide a blood seal on the surface of the spacer and / or promote rapid tissue ingrowth. The cover 140 includes a first cover portion 142 and a second cover portion 144, each of which covers a different portion of the device 100. In some embodiments, a portion of one of the first cover portion 142 and the second cover portion 144 overlaps with a portion of the other of the first cover portion 142 and the second cover portion 144. The first cover portion 142 and the second cover portion 144 can be arranged in various ways, and in some embodiments, can include an overlapping portion 146 that overlaps with one of the first cover portion 142 and the second cover portion 144.

[0378] Now refer to Figures 226 to 229 , showing various arrangements of first cover portion 142 and second cover portion 144 without overlapping portion 146. Referring now to Figure 226A first cover portion 142 (indicated by thin cross-hatching), which may be formed from a single piece of material, extends from the cover 114 to cover the cover 114, the outer paddle 120, the inner paddle 122, and the securing arm 132 of the hook 130. A second cover 144 (indicated by thick cross-hatching), which may be formed from a single piece of material, covers the mate element or the device for mate 110.

[0379] Now refer to Figure 227 A first cover portion 142 , which may be made of a single piece of material, extends from the cover 114 to cover the cover 114 , the outer paddle 120 , the inner paddle 122 , the fixed arm 132 of the hook 130 , and the movable arm 134 . Figure 226 Like the first cover 140 , the second cover 144 covers the engaging element or the device 110 for engaging.

[0380] Now refer to Figure 228 A first cover portion 142, which may be formed from a single piece of material, extends from the cover 114 to cover the cover 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the hook 130. A second cover 144, which may be formed from a single piece of material, covers the mate element or the device for mate 110 and extends from the mate element or the device for mate 110 to cover the movable arm 134 of the hook 130.

[0381] Now refer to Figure 229 A first cover portion 142, which may be formed from a single piece of material, extends from cover 114 to cover cover 114 and outer paddle 120. A second cover 144, which may be formed from a single piece of material, covers the mate member or device for mate 110 and extends from the mate member or device for mate 110 to cover inner paddle 122 and fixed arm 132 and movable arm 134 of hook 130.

[0382] Now refer to Figures 230 to 231 , showing an arrangement of a first cover portion 142 and a second cover portion 144 including an overlapping portion 146. Referring now to Figure 230 A first cover portion 142, which may be formed from a single piece of material, extends from the cover 114 to cover the cover 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 and the movable arm 134 of the hook 130. A second cover 144, which may be formed from a single piece of material, covers the mate element or the device for mate 110 and includes an overlapping portion 146 that extends from the mate element or the device for mate 110 to overlap a portion of the movable arm 134 covered by the first cover 142.

[0383] Now refer to Figure 231A first cover portion 142, which may be formed from a single piece of material, extends from the cover 114 to cover the cover 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the hook 130. A second cover 144, which may be formed from a single piece of material, covers the engaging element or device for engaging 110 and the movable arm 134 of the hook 130. The first cover 142 also includes an overlapping portion 146 extending from the fixed arm 132 and the inner paddle 122 to overlap a portion of the movable arm 134 and the engaging element or device for engaging 110 covered by the second cover 144.

[0384] Now refer to Figures 15 to 20 , Figures 8 to 14 The implantable device 100 is shown as being delivered and implanted within the native mitral valve MV of the heart H, and the methods and steps shown and / or discussed can be performed on a living animal or on a simulator, such as a cadaver, a cadaver heart, a simulator (e.g., utilizing a simulated body part, tissue, etc.), etc.

[0385] Now refer to Figure 15 The delivery sheath is inserted through the septum into the left atrium LA and the device 100 is deployed from the delivery sheath in a fully open state. The actuating element or means for actuation 112 is then retracted to move the device 100 to the Figure 16 As shown in the fully closed state. Figure 17 As can be seen in FIG, the device 100 is moved into position within the mitral valve MV, into the ventricle LV and is partially opened so that the leaflets 20, 22 can be grasped. Referring now to FIG. Figure 18 , the actuation wire 116 extends to close one of the hooks 130 , thereby capturing the leaflet 20 . Figure 19 Another actuation wire 116 is shown, which then extends to close another hook 130, thereby capturing the remaining leaflet 22. Figure 20 As shown, the delivery sheath or instrument for delivery 102 and actuation element or instrument for actuation 112 and actuation wire 116 are then retracted, and the device 100 is fully closed and deployed in the native mitral valve MV.

[0386] Now refer to Figure 21, illustrates an example implantable prosthetic device 200 or its framework. In certain embodiments, the device 200 includes an annular spacer member 202, a fabric cover (not shown), and anchors 204 extending from the spacer member 202. The ends of each anchor 204 can be coupled to a corresponding strut of the spacer member 202 via a corresponding sleeve 206, which can be crimped or welded around the connecting portion of the anchor 204 and the strut of the spacer member 202. In one example embodiment, a latching mechanism can constrain the spacer member 202 to the anchor 204 within the sleeve 206. For example, the sleeve can be machined to have an internal shape that matches or is slightly smaller than the external shape of the ends of the spacer member 202 and the anchor 204, so that the sleeve can be friction-fitted over the connecting portion. One or more barbs or protrusions 208 can be mounted on the frame of the spacer member 202. The free ends of the barbs or protrusions 208 can include various shapes, including rounded, pointed, barbed, etc. The protrusions 208 can exert a retaining force on the native leaflets against the anchors 204 , which are shaped to force the native leaflets inwardly into the spacer member 202 .

[0387] Now refer to Figure 22 , showing an example implantable prosthetic device 300 or a frame thereof. In certain embodiments, the prosthetic spacer device 300 includes an annular spacer member 302, a fabric cover (not shown), and an anchor 304 extending from the spacer member 302, and can be constructed similarly to the prosthetic spacer device 200. One or more barbs or protrusions 306 can be mounted on the frame of the spacer member 302. The ends of the protrusions 306 can include stops 308. The stops 308 of the protrusions can be constructed in a variety of different ways. For example, the stops 308 can be configured to limit the extent to which the protrusions 306 can engage and / or penetrate the native leaflet, and / or the stops can be configured to prevent the protrusions 306 from being removed from the tissue after the protrusions 306 have penetrated the tissue.

[0388] The anchors 304 of the prosthetic spacer device 300 can be configured similarly to the anchors 204 of the prosthetic spacer device 200, except that the curvature of each anchor 304 has a larger radius than that of the anchor 204. Thus, the anchors 304 cover a relatively larger portion of the spacer 302 than the anchors 204. This can, for example, distribute the clamping force of the anchors 304 against the native leaflet over a relatively larger surface of the native leaflet to further protect the native leaflet tissue.

[0389] Additional details regarding prosthetic spacer devices can be found, for example, in U.S. Patent Application Publication No. 2016 / 0331523 and U.S. Provisional Application No. 62 / 161,688, which are incorporated herein by reference. Devices 200, 300 can include any other features used in the implantable prosthetic devices discussed herein, and devices 200, 300 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0390] Now refer to Figures 23 to 27 , an example embodiment of an implantable prosthetic spacer device 400 and its components is shown. Device 400 may include any other features used in the implantable prosthetic devices discussed in this application, and device 400 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0391] Now refer to Figure 23 , a prosthetic spacer or apposition device 400 can include an apposition portion 404 and an anchoring portion 406, wherein the anchoring portion 406 includes a plurality of anchors 408. The apposition portion 404 includes an apposition member or spacer member 410. The anchoring portion 406 includes a plurality of paddles 420 (e.g., two in the embodiment shown) and a plurality of hooks 430 (e.g., two in the embodiment shown). A first or proximal collar 411 and a second collar or cap 414 are used to move the apposition portion 404 and the anchoring portion 406 relative to each other.

[0392] like Figure 25 As shown, the first connection portion 425 of the anchor 408 can be coupled to and extend from the first portion 417 of the apposition member or spacer member 410, and the second connection portion 421 of the anchor 408 can be coupled to the second collar 414. The proximal collar 411 can be coupled to the second portion 419 of the apposition member 410.

[0393] The apposition member 410 and the anchor 408 can be coupled together in various ways. For example, as shown in the illustrated embodiment, the apposition member 410 and the anchor 408 can be coupled together by integrally forming the apposition member 410 and the anchor 408 as a single, unitary component. For example, this can be achieved by forming the apposition member 410 and the anchor 408 from a braided or woven material, such as a braided or woven nitinol wire. In other embodiments, the apposition member 410 and the anchor 408 can be coupled together by welding, fasteners, adhesives, joint connections, sutures, friction fits, swaging, and / or other means for coupling.

[0394] Now refer to Figure 24 , anchor 408 may include a first portion or outer paddle 420 and a second portion or inner paddle 422 separated by a joint portion 423. In this manner, anchor 408 is configured to resemble a leg, as inner paddle 422 resembles an upper portion of a leg, outer paddle 420 resembles a lower portion of a leg, and joint portion 423 resembles a knee portion of a leg. In some embodiments, inner paddle portion 422, outer paddle portion 420, and joint portion 423 are formed from a continuous strip of fabric, such as a metallic fabric. In some embodiments, the fabric strip is a composite fabric strip.

[0395] The anchor 408 can be configured to move between various configurations by axially moving the cap 414 relative to the proximal collar 411, and therefore relative to the apposition member 410, along a longitudinal axis extending between a first or distal portion 417 and a second or proximal portion 419 of the apposition member 410. For example, the anchor 408 can be positioned in a straight configuration by moving the cap 414 away from the apposition member 410. In the straight configuration, the paddle portion is aligned or straight in the direction of the longitudinal axis of the device, and the joint portion 423 of the anchor 408 is adjacent the longitudinal axis of the apposition member 410 (e.g., similar to the longitudinal axis of the apposition member 410). Figure 59 By moving toward the apposition member 410, the anchor member 408 can be moved from the straight configuration to the fully folded configuration (e.g., Figure 23 Initially, as the cap 414 moves toward the apposition member 410, the anchor 408 bends at the joint portions 423, 425, 421, and the joint portion 423 moves radially outward relative to the longitudinal axis of the apposition member 410 and axially toward the first portion 417 of the apposition member 410, as shown. Figures 24 and 25 As the cap 414 continues to move toward the apposition member 410, the joint portion 423 moves radially inward relative to the longitudinal axis of the apposition member 410 and axially toward the proximal portion 419 of the apposition member 410, as shown. Figure 23 shown.

[0396] In some embodiments, when the anchor 408 is in the straight configuration (see, e.g., Figure 59 ), the angle between the inner paddle 422 of the anchor 408 and the apposition member 410 can be approximately 180 degrees, and when the anchor 408 is in the fully folded configuration (see, e.g., Figure 23 ), the angle between the inner paddle 422 of the anchor 408 and the apposition member 410 can be approximately 0 degrees. The anchor 408 can be positioned in various partially folded configurations such that the angle between the inner paddle 422 of the anchor 408 and the apposition member 410 can be approximately 10 to 170 degrees or approximately 45 to 135 degrees.

[0397] Configuring the prosthetic spacer device 400 so that the anchor 408 can extend to a straight or nearly straight configuration (e.g., approximately 120 to 180 degrees relative to the apposition member 410) can provide several advantages. For example, this can reduce the radial crimping profile of the prosthetic spacer device 400. By providing a larger opening in which to grasp the natural leaflet, it can also make it easier to grasp the natural leaflet. In addition, the relatively narrow straight configuration can prevent or reduce the possibility that the prosthetic spacer device 400 will become entangled in the natural anatomical structure (e.g., chordae tendineae) when the prosthetic spacer device 400 is positioned and / or retracted into the delivery device.

[0398] Reference again Figure 24 , the hook 430 can include an attachment or fixed portion 432 and an arm or movable portion 434. The attachment or fixed portion 432 can be coupled to the inner paddle 422 of the anchor 408 in various ways, such as by sutures, adhesives, fasteners, welding, stitching, swaging, friction fit, and / or other means for coupling or fastening.

[0399] In some embodiments, the movable portion 434 can be in an open configuration (e.g., Figure 24 ) and closed configuration ( Figure 23 and Figure 25 ). In some embodiments, the hook 430 can be biased to a closed configuration. In some embodiments, in the open configuration, the fixed portion 432 and the movable portion 434 flex or pivot away from each other so that the native leaflets can be positioned between the fixed portion 432 and the movable portion 434. In some embodiments, in the closed configuration, the fixed portion 432 and the movable portion 434 flex or pivot toward each other, thereby clamping the native leaflets between the fixed portion 432 and the movable portion 434.

[0400] refer to Figures 26 to 27 , showing the hook 430 in top view and perspective view. The fixing portion 432 ( Figures 26 to 27 The anchor 408 may include one or more openings 433 (e.g., three in the illustrated embodiment). At least some of the openings 433 may be used to connect the fixation portion 432 to the anchor 408. For example, sutures and / or fasteners may extend through the openings 433 to couple the fixation portion 432 to the anchor 408, or other attachment means such as welding, adhesives, etc. may be used.

[0401] The movable portion 434 may include one or more side beams 431. When two side beams are included as shown, the side beams may be spaced apart to form a slot 431A. The slot 431A may be configured to receive the fixed portion 432. The movable portion 434 may also include a spring portion 434A coupled to the fixed portion 432 and a barb support portion 434B disposed opposite the spring portion 434A.

[0402] The barb support portion 434B can include a gripper or attachment element, such as a barb 436 and / or other means for frictionally engaging native leaflet tissue. The gripper element can be configured to engage and / or penetrate native leaflet tissue to help retain the native leaflet between the fixed portion 432 and the movable portion 434 of the hook 430.

[0403] Barb support portion 434B may also include an eyelet 435 that may be used to couple barb support portion 434B to an actuation mechanism configured to flex or pivot movable portion 434 relative to fixed portion 432. Additional details regarding coupling hook 430 to an actuation mechanism are provided below.

[0404] In some embodiments, the hook 430 can be formed from a shape memory material, such as nitinol, stainless steel, and / or a shape memory polymer. In certain embodiments, the hook 430 can be formed by laser cutting a flat sheet (e.g., nitinol) or in a Figure 26 The configuration shown or a tube of similar or different configuration is then formed into the hook 430. Figure 27 The configuration shown is formed.

[0405] Shaping the hook 430 in this manner can provide several advantages. For example, the hook 430 can optionally be shaped from a fixed configuration (e.g., Figure 27 ) is compressed to a flat configuration (e.g., Figure 26 ), or another configuration that reduces the radial crimping profile of the hook 430. For example, the barb can be optionally compressed into a flat configuration. Reducing the radial crimping profile can improve the followability and retractability of the prosthetic spacer device 400 relative to the catheter shaft of the delivery device because the barb 436 points radially inwardly toward the anchor 408 when the prosthetic spacer device 400 is advanced through or retracted into the catheter shaft (see, e.g., FIG. Figure 33 This can prevent or reduce the possibility that the hook 430 may snag or scrape the catheter shaft.

[0406] Furthermore, when the hook 430 is in the closed configuration, the hook 430 is shaped Figure 27 The illustrated configuration can increase the clamping force of the hook 430. This is because the movable portion 434 is shaped relative to the fixed portion 432 to a first position (e.g., Figure 27), the first position is beyond the position when the hook 430 is attached to the anchor 408 (e.g., Figure 25 ) The position that the movable portion 434 can achieve is because the anchor 408 prevents the movable portion 434 from moving further toward the shaped configuration. This results in the movable portion 434 having a preload (i.e., a clamping force greater than zero) when the hook 430 is attached to the anchor 408 and in the closed configuration. Therefore, compared to the hook being shaped in the closed configuration, Figure 27 The shaped hook 430 in the structure can increase the clamping force of the hook 430.

[0407] The preload of the hook 430 can be varied by adjusting the angle of the movable portion 434 relative to the fixed portion 432. For example, increasing the relative angle between the movable portion 434 and the fixed portion 432 increases the preload, while decreasing the relative angle between the movable portion 434 and the fixed portion 432 decreases the preload. The preload can also be adjusted in other ways, such as based on the configuration of the joint, hinge, material, etc.

[0408] In some embodiments, the proximal collar 411 and / or the apposition member 410 may include a hemostatic seal 413 configured to reduce or prevent blood flow through the proximal collar 411 and / or the apposition member 410. For example, in some embodiments, the hemostatic seal 413 may include a plurality of flexible flaps 413A, such as Figure 23 In some embodiments, flap 413A can be configured to pivot from a sealed configuration to an open configuration to allow the shaft of the delivery device to extend through second collar 414. In one example embodiment, flap 413A forms a seal around the shaft of the delivery device. When the shaft of the delivery device is removed, flap 413A can be configured to return from the open configuration to the sealed configuration.

[0409] Now refer to Figure 23A , an example embodiment of an implantable prosthetic spacer device 400A is shown. Device 400A may include any other features used in the implantable prosthetic devices discussed herein, and device 400A may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0410] The prosthetic spacer or apposition device 400A can include an apposition portion 404A and an anchoring portion 406A, wherein the anchoring portion 406A includes a plurality of anchors 408A. The apposition portion 404A includes an apposition member or spacer 410A. The anchoring portion 406A includes a plurality of paddles 420A (e.g., two in the embodiment shown) and a plurality of hooks 430A (e.g., two in the embodiment shown). A first or proximal collar 411A and a second collar or cap 414A are used to move the apposition portion 404A and the anchoring portion 406A relative to each other.

[0411] The apposition member 410A extends from a proximal portion 419B assembled to the collar 411A to a distal portion 417A connected to the anchor 408A. The apposition member 410A and the anchor 408A can be coupled together in various ways. For example, as shown in the illustrated embodiment, the apposition member 410A and the anchor 408A can be coupled together by integrally forming the apposition member 410A and the anchor 408A as a single, unitary component. For example, this can be achieved by forming the apposition member 410A and the anchor 408A from a continuous strip 401A of braided or woven material, such as a braided or woven nitinol wire.

[0412] Anchor 408A is attached to mate member 410A via hinge portion 425A and to cover 414A via hinge portion 421A. Anchor 408A may include a first portion, or outer paddle 420A, and a second portion, or inner paddle 422A, separated by a joint portion 423A. Joint portion 423A is attached to paddle frame 424A, which is hingeably attached to cover 414A. In this manner, anchor 408A is configured to resemble a leg, with inner paddle 422A resembling the upper portion of a leg, outer paddle 420A resembling the lower portion of a leg, and joint portion 423A resembling the knee portion of a leg. In the example shown, inner paddle portion 422A, outer paddle portion 420A, and joint portion 423A are formed from a continuous strip of fabric 401A, such as a metallic fabric.

[0413] The anchor 408A can be configured to move between various configurations by axially moving the cap 414A relative to the proximal collar 411A, and thus relative to the apposition member 410A, along a longitudinal axis extending between the cap 414A and the proximal collar 411A. For example, the anchor 408A can be positioned in a straight configuration (see FIG. 1 ) by moving the cap 414A away from the apposition member 410A. Figure 60A In the straight configuration, the paddle portions 420A, 422A are aligned or straight in the direction of the longitudinal axis of the device, and the joint portion 423A of the anchor 408A is adjacent the longitudinal axis of the apposition member 410A (e.g., similar to Figure 60A By moving toward the apposition member 410A, the anchor member 408 can be moved from the straight configuration to the fully folded configuration (e.g., Figure 23A Initially, as cap 414A moves toward apposition member 410A, anchor 408A bends at joint portions 421A, 423A, 425A, and joint portion 423A moves radially outward relative to the longitudinal axis of device 400A and axially toward distal portion 417A of apposition member 410A, as shown. Figure 53A and Figure 54A As the cap 414A continues to move toward the apposition member 410A, the joint portion 423A moves radially inward relative to the longitudinal axis of the device 400A and axially toward the proximal portion 419A of the apposition member 410A, as shown. Figure 23A shown.

[0414] In some embodiments, when the anchor 408A is in the straight configuration (see Figure 60A ), the angle between the inner paddle 422A of the anchor 408A and the apposition member 410A can be approximately 180 degrees, and when the anchor 408A is in the fully folded configuration (see Figure 23A ), the angle between the inner paddle 422A of the anchor 408A and the apposition member 410A can be approximately 0 degrees. The anchor 408A can be positioned in various partially folded configurations such that the angle between the inner paddle 422A of the anchor 408A and the apposition member 410A can be approximately 10 to 170 degrees or approximately 45 to 135 degrees.

[0415] Configuring the prosthetic spacer device 400A so that the anchor 408A can extend to a straight or nearly straight configuration (e.g., approximately 120 to 180 degrees relative to the apposition member 410A) can provide several advantages. For example, this can reduce the radial crimping profile of the prosthetic spacer device 400A. By providing a larger opening in which to grasp the natural leaflet, it can also make it easier to grasp the natural leaflet. In addition, the relatively narrow straight configuration can prevent or reduce the possibility that the prosthetic spacer device 400A will be entangled in the natural anatomical structure (e.g., chordae tendineae) when the prosthetic spacer device 400A is positioned and / or retracted into the delivery device.

[0416] Hook 430A may include an attachment or fixed portion 432C and an arm or movable portion 434C. Attachment or fixed portion 432C may be coupled to inner paddle 422A of anchor 408A in various ways, such as by sutures, adhesives, fasteners, welding, stitching, swaging, friction fit, and / or other means for coupling. Hook 430A is similar to hook 430.

[0417] In some embodiments, the movable portion 434C can be in an open configuration (e.g., Figure 54A ) and closed configuration ( Figure 53A ). In some embodiments, the hook 430A can be biased to a closed configuration. In the open configuration, the fixed portion 432C and the movable portion 434C are hinged, pivoted, or flexed away from each other so that the native leaflets can be positioned between the fixed portion 432C and the movable portion 434C. In the closed configuration, the fixed portion 432C and the movable portion 434C are hinged, pivoted, or flexed toward each other, thereby clamping the native leaflets between the fixed portion 432C and the movable portion 434C.

[0418] 406A of the device 400A. Figure 23A The juxtaposition member 410A and the inner paddle 422A are shown formed from multiple overlapping layers of the material strip 401A. The single continuous material strip 401A can start and end at various locations on the device 400A. The ends of the material strip 401A can be at the same location or at different locations on the device 400A. For example, at Figure 23A In the illustrated embodiment, the strip of material begins and ends at the location of the inner blade 422A.

[0419] Now refer to Figure 30A , an example implantable prosthetic device 400A is shown covered with a cover 440A. The cover 440A is arranged on the apposition member 410A, the collar 411A, the cover 414A, the paddles 420A, 422A, the paddle frame 424A and the hook 430A. The cover 440A can be configured to prevent or reduce blood flow through the prosthetic spacer device 400A and / or promote natural tissue ingrowth. In some embodiments, the cover 440A can be a cloth or fabric, such as PET, velvet or other suitable fabric. In other embodiments, instead of or in addition to the fabric, the cover 440A may include a coating (e.g., a polymeric material, silicone, etc.) applied to the prosthetic spacer device 400A.

[0420] Now refer to Figures 28 to 30, showing an example embodiment of an implantable prosthetic device 500 (e.g., a prosthetic spacer device). The implantable device 500 is Figures 8 to 20 1 is one of many different configurations that device 100 can take. Device 500 may include any other features used in the implantable prosthetic devices discussed herein, and device 500 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0421] Prosthetic spacer device 500 may include an apposition element or spacer member 510, a plurality of anchors 508 including an outer paddle 520, an inner paddle 522, a hook 530, a first or proximal collar 511, and a second collar or cap 514. These components of prosthetic spacer device 500 may be configured the same as or substantially similar to corresponding components of prosthetic spacer device 400.

[0422] The prosthetic spacer device 500 may also include a plurality of paddle extension members or paddle frames 524. The paddle frames 524 may be configured to have a circular three-dimensional shape, wherein a first connecting portion 526 is coupled to and extends from the cover 514, and a second connecting portion 528 is disposed opposite the first connecting portion 526. The paddle frames 524 may be configured to extend circumferentially further around the apposition member 510 than the outer paddles 520. For example, in some embodiments, each paddle frame 524 extends about halfway around the circumference of the apposition member 510 (e.g., Figure 29 ), and the outer blades 520 extend around less than half of the circumference of the commissure member 510 (as shown in FIG. Figure 28 ). The blade frame 524 can also be configured to extend transversely (i.e., perpendicular to the longitudinal axis of the bisector member 510) beyond the outer diameter of the bisector member 510. In the example shown, the inner blade portion 522 and the outer blade portion 520 can be formed from a continuous fabric strip connected to the blade frame 524. For example, the inner and outer blade portions can be connected to the connecting portion of the blade frame at a flexible connection between the inner and outer blade portions.

[0423] The paddle frame 524 can also be configured such that the connecting portion 528 of the paddle frame 524 is connected to or axially adjacent to the joint portion 523. Figures 28 to 30), the connecting portion of blade frame 524 can be located between outer blade 520 and inner blade 522, on the outside of blade portion 520, on the inside of inner blade portion, or on top of joint portion 523. The connection between blade frame 524, the single strap forming outer blade 520 and inner blade 522, cover 514, and the mate element can constrain each of these components to the movements and positions described herein. In particular, joint portion 523 is constrained by its connection between outer blade 520 and inner blade 522 and by its connection to the blade frame. Similarly, blade frame 524 is constrained by its attachment to mate portion 523 (and therefore to the inner and outer blades) and the cover.

[0424] Configuring paddle frame 524 in this manner provides increased surface area compared to individual outer paddles 520. This can, for example, make it easier to grasp and secure the native leaflet. The increased surface area can also distribute the clamping force of paddle 520 and paddle frame 524 against the native leaflet over a relatively larger surface area of ​​the native leaflet, further protecting the native leaflet tissue.

[0425] The increased surface area of ​​paddle frame 524 may also allow the native leaflets to be clamped to prosthetic spacer device 500 such that the native leaflets are fully apposed around apposition member 510. This may, for example, improve sealing of the native leaflets and thereby prevent or further reduce mitral regurgitation.

[0426] refer to Figure 30 , the prosthetic spacer device 500 may further include a covering 540. In some embodiments, the covering 540 may be disposed on the apposition member 510, the paddles 520, 522, and / or the paddle frame 524. The covering 540 may be configured to prevent or reduce blood flow through the prosthetic spacer device 500 and / or promote natural tissue ingrowth. In some embodiments, the covering 540 may be a cloth or fabric, such as PET, velvet, or other suitable fabric. In other embodiments, the covering 540 may include a coating (e.g., a polymer, silicone, etc.) applied to the prosthetic device 500 instead of or in addition to the fabric.

[0427] Figures 31 to 32 Show Figure 28 and 29 The implantable prosthetic device 500 is shown in FIG. 5 , wherein the anchor 508 and the hook 530 of the anchoring portion 506 are in an open position. The device 500 is deployed from a delivery sheath (not shown) and includes the apposition portion 504 and the anchoring portion 506. The device 500 is loaded into the delivery sheath in a fully extended or rescue position because the fully extended or rescue position occupies minimal space and allows the use of the smallest catheter (see FIG. 5 ). Figure 35). Alternatively, the fully extended position allows the largest device 500 to be used for a given catheter size. The apposition portion 504 of the device includes an apposition element 510 for implantation between the native leaflets of a native valve (e.g., a mitral valve, a tricuspid valve, etc.). An insert 516A is disposed within the apposition element 510. The insert 516A and the apposition element 510 are slidably attached to an actuating element 512 (e.g., an actuating wire, rod, shaft, tube, screw, suture, thread, etc.). The anchor 508 of the device 500 includes an outer paddle 520 and an inner paddle 522 that are flexibly connected to the cover 514 and the apposition element 510. Actuation of the actuating element or the instrument for actuation 512 opens and closes the anchor 508 of the device 500 to grasp the native valve leaflets during implantation.

[0428] The actuation element 512 extends through the delivery sheath (not shown), the proximal collar 511, the apposition element 510, the insert 516A, and to the cap 514. Extending and retracting the actuation element 512 increases and decreases, respectively, the spacing between the apposition element 510 and the cap 514. This change in spacing between the apposition element 510 and the cap 514 causes the anchoring portion 506 of the device to move between different positions.

[0429] The proximal collar 511 optionally includes a collar seal 513 that forms a seal around the actuating element or actuating means 512 during implantation of the device 500 and seals closed when the actuating element 512 is removed to close or substantially close the proximal end of the device 500 after implantation to allow blood flow through the interior of the apposition element 510. In some embodiments, the coupler or means for coupling 2214 (see Figure 145 ) removably engages and attaches the proximal collar 511 and the apposition element 510 to the delivery sheath. In some embodiments, the coupler or means for coupling 2214 is held closed about the proximal collar 511 by the actuation element 512, such that removal of the actuation element 512 allows the fingers of the coupler or means for coupling 2214 (see Figure 145 ) opens, thereby releasing the proximal liner 511.

[0430] During actuation to open and close the paddles 520, 522 of the anchor 508, the proximal collar 511 and the insert 516A in the apposition element 510 slide along the actuation element 512. Figure 32A and 32BIn some embodiments, the cover 514 optionally includes a sealing protrusion 516 that sealingly fits within a sealing opening 517 of the insert 516A. In one example embodiment, the cover 514 includes a sealing opening, and the insert 516A includes a sealing protrusion. The insert 516A can be sealingly fitted within a distal opening 515 of the apposition element 510, which has a hollow interior. Figure 32A , the sealing protrusion 516 of the cover 514 sealingly engages the opening 517 in the insert 516A to maintain the distal end of the apposition element 510 closed or substantially closed to blood flow when the device 500 is implanted and / or in the closed position.

[0431] In one exemplary embodiment, instead of a sealing engagement between the cap 514 and the insert 516A, the insert 516A may optionally include a seal, such as a proximal collar seal 513, that forms a seal around the actuating element or instrument for actuation 512 during implantation of the device 500 and seals closed when the actuating element 512 is removed. Such a seal may close or substantially close the distal end of the apposition element 510 to blood flow after implantation.

[0432] The apposition element 510 and paddles 520, 522 are formed of a flexible material, which may be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable manner, or formed from a flexible material that is laser cut or otherwise cut. The material is cloth, a shape memory alloy wire (such as Nitinol) to provide shape holding capability, or any other flexible material suitable for implantation in a human body. The paddle frame 524 provides additional compressive force between the inner paddle 522 and the apposition element 510 and helps wrap the leaflets around the sides of the apposition element 510 to obtain a better seal between the apposition element 510 and the leaflets. In some embodiments, Figure 30 Cover 540 is shown extending around blade frame 524 .

[0433] Hook 530 includes a base or fixed arm 532, a movable arm 534, a barb 536, and a connector portion 538. Fixed arm 532 is attached to inner paddle 522, with connector portion 538 positioned proximate to mating element 510. The barbed hook has a flat surface and does not fit within a recessed portion of the paddle. Instead, the flat portion of the barbed hook rests against a surface of inner paddle 522. For example, fixed arm 532 is attached to inner paddle 522 via hole or slot 533 using suture (not shown). Fixed arm 532 can be attached to inner paddle 522 or another portion of the device using any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, and the like. When movable arm 534 is opened to open barbed hook 530 and expose barb 536, fixed arm 532 remains fixed or substantially stationary relative to inner paddle 522. The barbed hook 530 is opened by applying tension to an actuation wire (not shown) attached to a hole 535 in the movable arm 534 , causing the movable arm 534 to pivot or flex on the joint portion 538 .

[0434] During implantation, anchor 508 is opened and closed to grasp the native valve leaflet between paddles 520, 522 and apposition element 510. Barbed hooks 530 further secure the native leaflet by engaging the leaflet with barbs 536 and squeezing the leaflet between movable arm 534 and fixed arm 532. The barbs 536 of barbed hooks 530 increase friction with the leaflet or can partially or completely pierce the leaflet. The actuation wires can be actuated individually, allowing each barbed hook 530 to be opened and closed individually. Separate manipulation allows grasping of one leaflet at a time or repositioning the hook 530 on a leaflet that is not adequately grasped without affecting the successful grasp of another leaflet. When the inner paddle 522 is not closed, the barbed hooks 530 can be opened and closed, allowing the leaflet to be grasped in a variety of positions depending on the specific situation.

[0435] Now refer to Figure 33 , an example barbed hook 600 for use with an implantable prosthetic device, such as those described above, is shown. However, a variety of different barbed hooks may be used. Examples of barbs that may be used include, but are not limited to, any barb disclosed in this application and any application incorporated herein by reference and / or claiming priority from this application. In the example shown, the barbed hook 600 is formed from a top layer 602 and a bottom layer 604. The two-layer design of the hook 600 allows for the use of thinner sheets of material, thereby increasing the flexibility of the hook 600 relative to a hook formed from a single, thicker sheet, while maintaining the strength of the hook 600 required to successfully retain the native valve leaflets.

[0436] The barbed hook 600 includes a fixed arm 610, a connecting portion 620, and a movable arm 630 having a barbed portion 640. The top layer 602 and the bottom layer 604 have similar shapes and, in certain embodiments, are attached to each other at the barbed portion 640. However, the top layer 602 and the bottom layer 604 can be attached to each other at other or additional locations. The connecting portion 620 is spring-loaded so that when the barbed hook 600 is in a closed state, the fixed arm 610 and the movable arm 630 are offset from each other. When assembled into an implantable prosthetic device, the fixed arm 610 is attached to a portion of the prosthetic device. The hook 600 is opened by pulling an actuation wire connected to the movable arm 630 until the spring force of the connecting portion 620 is overcome.

[0437] The fixed arm 610 is formed from a tongue 611 of material extending from a mating portion 620 between two side beams 631 of the movable arm 630. The tongue 611 is biased between the side beams 631 by the joint portion 620, so that force must be applied to move the tongue 611 from a neutral position located outside the side beams 631 to a preloaded position parallel or substantially parallel to the side beams 631. The tongue 611 is retained in the preloaded position by an optional T-shaped crossbar 614, which is connected to the tongue 611 and extends outward to engage the side beams 631. In one exemplary embodiment, the crossbar is omitted, and the tongue 611 is attached to the inner paddle 522, which holds the hook in the preloaded position. In a two-layer hook application, both the top layer 602 and the bottom layer 604, or only the top layer, can be attached to the inner paddle. In some embodiments, when the tongue is in a neutral position, the angle between the fixed arm 610 and the movable arm 630 is about 30 degrees to about 100 degrees, 30 degrees to about 90 degrees, or about 30 degrees to about 60 degrees, or about 40 degrees to about 50 degrees, or about 45 degrees.

[0438] Tongue 611 includes a hole 612 for receiving a suture (not shown) that connects fixation arm 610 to the implantable device. Fixation arm 610 can be attached to the implantable device using, for example, screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc. In some embodiments, hole 612 is an elongated slot or oval hole to accommodate sliding of layers 602, 604 without damaging the suture that attaches hook 600 to the implantable device.

[0439] The apposition portion 620 is formed by two beam rings 622 extending from the tongue 611 of the fixed arm 610 to the side beams 631 of the movable arm 630. In certain embodiments, the beam rings 622 are narrower than the tongue 611 and the side beams 631 to provide additional flexibility. Each beam ring 622 includes a central portion 624 extending from the tongue 611 and an outer portion 626 extending to the side beams 631. By bending the central and outer portions 624, 626 in opposite directions, the beam rings 622 are bent into a slight spiral or helical shape, thereby forming an offset or step 628 between the tongue 611 and the side beams 631. The step 628 provides space between the arms 610, 630 to accommodate the native leaflets of the native valve after they are grasped. In certain embodiments, the step 628 is approximately 0.5 mm to approximately 1 mm, or approximately 0.75 mm.

[0440] When viewed in a top plan view, the beam ring has an "Ω-like" shape. This shape of the beam ring 622 allows the fixed arm 610 and the movable arm 630 to move significantly relative to each other without plastically deforming the hook material. For example, in some embodiments, the tongue 611 can flex or pivot from a neutral position approximately 45 degrees beyond the movable arm 630 to a fully open position within a range of about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees relative to the movable arm 630 without plastically deforming the hook material. In some embodiments, the hook material plastically deforms during opening without reducing or substantially reducing the compressive force applied between the fixed arm and the movable arm in the closed position.

[0441] Preloading the tongue 611 enables the hook 600 to maintain a squeezing or clamping force on the native leaflet when closed. Preloading the tongue 611 provides a significant advantage over prior art clips, which provide little or no squeezing force when closed. Additionally, closing the hook 600 with a spring force is a significant improvement over clips that use a one-time locking closure mechanism because the hook 600 can be repeatedly opened and closed to be repositioned on the leaflet while still maintaining sufficient squeezing force when closed. Furthermore, the spring-loaded hook also allows for easier removal of the device over time compared to devices that are locked in the closed position (after tissue ingrowth). In one example embodiment, both the hook and paddle are spring biased to their closed position (as opposed to being locked in the closed position), which can allow for easier removal of the device after tissue ingrowth.

[0442] The barbed portion 640 of the movable arm 630 includes an eyelet 642, a barb 644, and a barb support 646. Positioning the barbed portion of the hook 600 toward the end of the movable arm 630 increases the space between the barb 644 and the fixed arm 610 when the hook 600 is open, thereby improving the ability of the hook 600 to successfully grasp the leaflet during implantation. This distance also allows the barb 644 to more reliably disengage from the leaflet for repositioning. In certain embodiments, the barbs of the hook can be staggered longitudinally to further distribute compressive forces and localized leaflet stress.

[0443] The barbs 644 are laterally spaced the same distance from the connector portion 620, providing excellent distribution of compressive forces on the leaflet tissue while also allowing the hooks to have a more secure grip on the leaflet than if the barbs were arranged in longitudinal rows. In some embodiments, the barbs 644 can be staggered to further distribute compressive forces and localized leaflet stresses.

[0444] Barbs 644 are formed from the bottom layer 604, and barb supports 646 are formed from the top layer. In some embodiments, the barbs are formed from the top layer 602, while the barb supports are formed from the bottom layer 604. Forming barbs 644 in only one of the two layers 602, 604 allows the barbs to be thinner and, therefore, more effectively sharpened than barbs formed from twice as thick a material. Barb supports 646 extend along the lower portion of barbs 644 to stiffen barbs 644, further improving penetration and retention of leaflet tissue. In some embodiments, the ends of barbs 644 are further sharpened using any suitable sharpening device.

[0445] The barbs 644 are angled away from the movable arms 630 so that they easily penetrate the tissue of the native leaflet with minimal squeezing or clamping force. The barbs 644 extend from the movable arms at an angle of about 45 degrees to about 75 degrees, or about 45 degrees to about 60 degrees, or about 48 degrees to about 56 degrees, or about 52 degrees. The angle of the barbs 644 provides an additional benefit because the force pulling the implant away from the native leaflet will encourage the barbs 644 to further engage the tissue, thereby ensuring better retention. When the hook 600 is closed, the retention of the leaflet in the hook 600 can be further improved by positioning the T-shaped crossbar 614 near the barbs 644. In this arrangement, the tissue pierced by the barbs 644 is pressed against the movable arms 630 at the location of the crossbar 614, thereby forcing the tissue into an S-shaped curved path as it passes through the barbs 644. Thus, the force pulling the leaflet away from the hook 600 will cause the tissue to further engage the barb 644 before the leaflet can disengage. For example, leaflet tension during diastole can encourage the barb to be pulled toward the end portion of the leaflet. The S-shaped path can take advantage of leaflet tension during diastole to more tightly engage the leaflet with the barb.

[0446] Each layer 602, 604 of the hook 600 is laser-cut from a sheet of shape-memory alloy, such as Nitinol. The top layer 602 is aligned with and attached to the bottom layer 604. In certain embodiments, the layers 602, 604 are attached to the barbed portion 640 of the movable arm 630. For example, the layers 602, 604 may be attached only to the barbed portion 640, allowing the remaining layers to slide relative to each other. The combined layers 602, 604, such as the fixed arm 610, the barbs 644, the barb supports 646, and the beam ring 622, are bent into the desired position. The layers 602, 604 can be bent and shaped together, or they can be bent and shaped separately and then joined together. The hook 600 is then subjected to a shaping process, so that the internal forces of the material tend to return to the set shape after being deformed by external forces. After shaping, the tongue 611 is moved to its preloaded position, allowing the crossbar 614 to be attached. In one exemplary embodiment, the hook 600 can optionally be completely flattened for delivery through a delivery sheath and allowed to expand once deployed within the heart. The hook 600 is opened and closed by applying and releasing tension on an actuation wire, suture, wire, rod, catheter, etc. (not shown) attached to the movable arm 630. In some embodiments, the actuation wire or suture is inserted through an eyelet 642 near the barbed portion 640 of the movable arm 630 and wrapped around the movable arm 630 before returning to the delivery sheath. In certain embodiments, an intermediate suture loop is made through the eyelet and the suture is inserted through the intermediate suture loop. An alternative embodiment of the intermediate loop can be made of fabric or other material that is attached to the movable arm instead of a suture loop.

[0447] The intermediate loop of suture material reduces the friction experienced by the actuation wire / suture relative to the friction between the actuation wire / suture and the hook material. When the suture is looped through the eyelet 642 or the intermediate loop, both ends of the actuation wire / suture extend back into the delivery sheath and through the delivery sheath (e.g., Figure 8 The suture can be removed by pulling one end of the suture proximally until the other end of the suture is pulled through the eyelet or intermediate collar and back into the delivery sheath.

[0448] Now refer to Figure 34 , shows a close-up view of one of the leaflets 20, 22 being grasped by a barbed hook, such as hook 430, 530. The leaflet 20, 22 is grasped between the movable arm 434 and the fixed arm 532 of the hook 430, 530. Figure 34As shown in FIG, the tissue of the leaflets 20, 22 is not pierced by the barbs 436, 536, but in some embodiments, the barbs 436, 536 may partially or completely pierce the leaflets 20, 22. The angle and height of the barbs 436, 536 relative to the movable arms 434, 534 help to secure the leaflets 20, 22 within the hooks 430, 530. In particular, the force pulling the implant away from the native leaflets will encourage the barbs 436, 536 to further engage the tissue, thereby ensuring better retention. When the hooks 430, 530 are closed, the retention of the leaflets 20, 22 in the hooks 430, 530 is further enhanced by the position of the fixed arms 432, 532 close to the barbs 436, 536. In this arrangement, the tissue is formed into an S-shaped curved path by the fixed arms 432, 532 and the movable arms 434, 534 and the barbs 436, 536. Thus, the force pulling the leaflet away from the hooks 430, 530 will cause the tissue to further engage the barbs 436, 536 before the leaflet can disengage. For example, as described above, leaflet tension during diastole can promote the barbs to be pulled toward the end portions of the leaflet. The S-shaped path can take advantage of leaflet tension during diastole to more tightly engage the leaflet with the barbs.

[0449] Now refer to Figures 35 to 46 , the implantable device 500 is shown as being delivered and implanted within the native mitral valve MV of the heart H, and the methods and steps shown and / or discussed can be performed on a living animal or on a simulator, such as a cadaver, a cadaver heart, a simulator (e.g., utilizing a simulated body part, tissue, etc.), etc.

[0450] As described above, the device 500 has a covering 540 (see FIG. 5 ) on the engaging element 510, the hook 530, the inner paddle 522, and / or the outer paddle 520. Figure 30 ). The device 500 is deployed from a delivery sheath 502 and includes an apposition portion 504 and an anchoring portion 506 including a plurality of anchors 508 (i.e., two in the illustrated embodiment). The apposition portion 504 of the device includes an apposition element 510 for implantation between the leaflets 20, 22 of the native mitral valve MV, slidably attached to an actuation element or instrument for actuation 512. Actuation of the actuation element or instrument for actuation 512 opens and closes the anchors 508 of the device 500 to grasp the mitral valve leaflets 20, 22 during implantation.

[0451] The anchor 508 of the device 500 includes an outer paddle 520 and an inner paddle 522 that are flexibly connected to the cap 514 and the engagement element 510. The actuation element 512 extends through the capture mechanism 503 (see Figure 41), the delivery sheath 502 and the apposition element 510 reach the cover 514 connected to the anchor portion 506. Extending and retracting the actuation element 512 increases and decreases the spacing between the apposition element 510 and the cover 514, respectively. Figures 35 to 46 In the example shown, the pair of inner and outer blades 522, 520 are moved in unison rather than independently by a single actuating element 512. Likewise, the position of the hook 530 depends on the position of the blades 522, 520. For example, referring to Figure 45 In one exemplary embodiment, the device 500 may be provided with a plurality of paddles 522, 520, each of which is provided with a plurality of paddles 522, 520. Figure 11A The paddles 520, 522 are independently controllable in the same manner as in the embodiment.

[0452] The fingers of the capture mechanism 503 removably attach the collar 511 to the delivery sheath 502. The collar 511 and the apposition element 510 slide along the actuation element 512 during actuation to open and close the anchors 508 of the anchor portion 506. In some embodiments, the capture mechanism 503 is held closed around the collar 511 by the actuation element 512, such that removal of the actuation element 512 allows the fingers of the capture mechanism 503 to open, thereby releasing the collar 511 and, therefore, the apposition element 510.

[0453] In some embodiments, the apposition element 510 and the paddles 520, 522 are formed from a flexible material, which can be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable manner, or formed from a flexible material that is laser cut or otherwise cut. The flexible material can be cloth, a shape memory alloy wire (such as Nitinol) to provide shape-holding capabilities, or any other flexible material suitable for implantation in the human body. Other configurations are also possible.

[0454] The barbed hook 530 includes a base or fixed arm 532, a movable arm 534, a barb 536 (see Figure 41 ) and a joint portion 538. The securing arm 532 is attached to the inner paddle 522, wherein the joint portion 538 is disposed proximate to the engaging element 510. A suture (not shown) attaches the securing arm 532 to the inner paddle 522. The securing arm 532 can be attached to the inner paddle 522 and / or another portion of the device by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, etc. The securing arm 532 remains stationary or substantially stationary as the movable arm 534 opens to open the barbed hook 530 and expose the barb 536. The barbed hook 530 is opened by applying tension to a hook control member or actuation wire 537 attached to the movable arm 534, causing the movable arm 534 to pivot or flex on the joint portion 538.

[0455] During implantation, anchor 508 opens and closes to grasp the native valve leaflets between paddles 520, 522 and apposition element 510. The outer paddle 520 has a wide, curved shape that fits around the curved shape of apposition element 510 to more securely grasp leaflets 20, 22. The curved shape and rounded edges of the outer paddle 520 also prevent tearing of leaflet tissue. Barbed hooks 530 further secure the native leaflets by engaging the leaflets with barbs 536 and squeezing them between movable arm 534 and fixed arm 532. The barbs 536 of barbed hooks 530 increase friction with the leaflets or can partially or completely pierce them. The actuation wires can be actuated individually, allowing each barbed hook 530 to be opened and closed individually. Individual manipulation allows for grasping one leaflet at a time or repositioning a hook 530 on an inadequately grasped leaflet without altering successful grasping of another leaflet. When the inner paddle 522 is not closed, the barbed hook 530 can be fully opened and closed, allowing the leaflet to be grasped in a variety of positions depending on the particular situation.

[0456] The device 500 is loaded into the delivery sheath in a fully open or fully extended position because the fully open or fully extended position takes up the least space and allows the smallest catheter to be used (or the largest device 500 for a given catheter size to be used). Figure 35 , the delivery sheath is inserted through the septum into the left atrium LA, and the device 500 is deployed from the delivery sheath 502 in a fully open state. The actuating element 512 is then retracted to move the device 500 to Figures 36 to 37 The fully closed state shown, then Figure 38 MV manipulation towards the mitral valve is shown. Figure 39 When the device 500 is aligned with the mitral valve MV (or other native valve if implanted in another valve), the actuation element 512 is actuated to open the paddles 520, 522 to a partially open position, and the hook control member or actuation wire 537 is retracted to open the barbed hooks 530 in preparation for leaflet grasping. Figures 40 to 41 As shown, the partially opened device 500 is inserted through the mitral valve MV until the leaflets 20 , 22 are properly positioned between the inner paddle 522 and the apposition element 510 and within the opened barbed hooks 530 . Figure 42 The device 500 is shown with both hooks 530 closed, although the barb 536 of one hook 530 has missed one of the leaflets 22. Figures 42 to 44 As shown, the out-of-place hook 530 opens and closes again to properly grasp the missing leaflet 22. When both leaflets 20, 22 are properly grasped, the actuator 512 retracts to move the device 500 to the position indicated by the arrows. Figure 45510 and 511. The fully closed position is shown. With the device 500 fully implanted in the native mitral valve MV, the actuating element 512 is withdrawn to release the capture mechanism 503 from the proximal collar 511. Once deployed, the device 500 can be maintained in the fully closed position by a mechanical device, such as a latch, or can be biased to maintain closure using a spring material, such as steel and / or a shape memory alloy, such as Nitinol. For example, the paddles 520, 522 can be formed of steel or a Nitinol shape memory alloy (such as Nitinol made from wire, sheet, tubing, or laser sintered powder) and biased to maintain the outer paddle 520 closed around the inner paddle 522, the apposition element 510, and the barbed hook 530 that presses against the native leaflets 20, 22.

[0457] The device 500 can have a variety of shapes and sizes. Figure 6 and Figures 6A to 6E In an exemplary embodiment, the apposition element 510 serves as a gap filler in the valve regurgitation orifice, such as by Figure 6 The gap 26 in the native valve is shown. Figure 6A Since the coaptation element 510 is deployed between the two opposing valve leaflets 20, 22, the leaflets will not be apposed against each other in the region of the coaptation element 510, but rather will be apposed against the coaptation element 510. This reduces the distance that the leaflets 20, 22 need to be approximated. The reduction in the distance that the leaflets need to be approximated can provide several advantages. For example, the coaptation element and the resulting reduced approximation can facilitate the repair of severe mitral valve anatomy, such as large gaps in functional valve disease (see, e.g., Figure 6 Because the coaptation element 510 reduces the distance that the native valve must approximate, stresses in the native valve can be reduced or minimized. A shorter approximation distance of the valve leaflets 20, 22 can require less approximation force, which can result in less tensioning of the leaflets and a smaller diameter reduction of the valve annulus. A smaller reduction in the valve annulus (or no reduction in the valve annulus) can result in a smaller reduction in the valve orifice area compared to a device without a spacer. Thus, the coaptation element 510 can reduce the transvalvular gradient.

[0458] In an exemplary embodiment, the paddle frame 524 conforms to the shape of the engagement element 510. In an example, if the engagement element 510 is wider than the paddle frame 524, the device 500 can create a distance (gap) between the opposing leaflets 20, 22. Figures 6A to 6E In one example embodiment, the paddle is configured to conform to the shape or geometry of the coaptation element 510. Thus, the paddle can cooperate with both the coaptation element 510 and the native valve. Figure 6D and Figure 6EIn one exemplary embodiment, the paddles 524 surround the apposition element 510. Thus, when the leaflets 20, 22 are apposed or pressed against the apposition element 510, the leaflets 20, 22 completely surround or "hug" the entirety of the apposition element 510, thereby preventing small leaks on both the medial and lateral sides of the apposition element 510. Figure 6B and 6C The valve repair device 500 is shown attached to the native valve leaflets 20, 22 from the ventricular side of the mitral valve. Figure 6A The valve repair device 500 is shown attached to the mitral valve leaflets 20, 22 from the atrial side of the mitral valve. Figure 6A and Figure 6B , when the paddles have a geometry that conforms to the geometry of the apposition element 510, the leaflets 20, 22 can apposition around the apposition element and / or along the length of the spacer. Figure 6E , the schematic atrial view / surgeon's view depicts the paddle frame conforming to the septum geometry (which would not actually be visible from a true atrial view). The opposing leaflets 20, 22 (the ends of which would also not be visible in a true atrial view) are approximated by the paddles to completely surround or "hug" the apposition element 510.

[0459] refer to Figures 6B to 6E Because the paddle frame 524 conforms to the shape of the apposition element 510, the leaflets 20, 22 can be completely apposed by the paddle frame 524 around the apposition element, including on the lateral side 601 and the medial side 603 of the apposition element 510. This apposition of the leaflets 20, 22 against the lateral and medial sides of the apposition element 510 would appear to contradict the statement above that the presence of the apposition element 510 minimizes the distance the leaflets need to approximate. However, if the apposition element 510 is precisely placed at the regurgitation gap and the regurgitation gap is less than the width (medial-lateral) of the apposition element 510, the distance the leaflets 20, 22 need to approximate is still minimized.

[0460] refer to Figure 6A and 6E , the apposition element 510 can take a variety of different shapes. In one exemplary embodiment, when viewed from the top (and / or in cross-section from the top, see Figures 95 to 102 ), the mating element has an oval shape or an elliptical shape. The oval or elliptical shape can allow the blade frame 524 to conform to the shape of the mating element and / or can reduce lateral leakage (refer to Figures 65 to 83 ).

[0461] As described above, the apposition element 510 can reduce tension on the opposing leaflets by reducing the distance the leaflets need to be approximated to the apposition element 510 at locations 601, 603. The reduction in the distance the leaflets need to be approximated at locations 601, 603 can result in a reduction in leaflet stress and gradients. Additionally, as described above, the native valve leaflets 20, 22 can surround or "hug" the apposition element to prevent lateral leakage. In an exemplary embodiment, the geometric properties of the apposition element can be designed to preserve and enhance both of these properties of the device 500. Reference Figure 2A As viewed from the left ventricular outflow tract (LVOT), the anatomy of the leaflets 20, 22 is such that the inner sides of the leaflets coapt at their free end portions and the leaflets 20, 22 begin to recede or unfold relative to one another. The leaflets 20, 22 unfold in an atrial direction until each leaflet meets the mitral annulus.

[0462] In one exemplary embodiment, the valve repair device 500 and its apposition element 510 are designed to conform to the geometric anatomy of the valve leaflets 20, 22. To achieve a valve seal, the valve repair device 500 can be designed to apposition the native leaflets to the apposition element completely around the apposition element, including at locations inside 601 and outside 603 of the apposition element 510. Additionally, reducing the force required to bring the leaflets into contact with the apposition element 510 at locations 601, 603 can minimize leaflet stresses and gradients. Figure 2B It illustrates how the tapered or triangular shape of the apposition element 510 will naturally adapt to the native valve geometry and its expanded leaflet nature (towards the annulus).

[0463] Figure 6D The geometry of the coaptation element 510 and the paddle frame 524 is shown from the perspective of the LVOT. As can be seen from this view, the coaptation element 510 has a tapered shape that is smaller in the area near the inner surfaces of the leaflets 20, 22 where coaptation is desired and increases in size as the coaptation element extends toward the atrium. The depicted native valve geometry is accommodated by the tapered coaptation element geometry. Still referring to Figure 6D The tapered coaptation element geometry, along with the illustrated expanded paddle frame 524 shape (toward the annulus) can help achieve coaptation of the inferior ends of the leaflets, reduce stress, and minimize transvalvular gradients.

[0464] refer to Figure 6C In one example embodiment, the remaining shapes of the coaptation element 510 and paddle frame 524 can be defined based on an internal view of the commissures of the native valve and the device 500. Two factors in these shapes are the coaptation of the leaflets against the coaptation element 510 and the reduction of stress on the leaflets due to coaptation. Figure 6C and Figure 67In order to appose the valve leaflets 20, 22 against the apposition element 510 and reduce the stress applied to the valve leaflets 20, 22 by the apposition element 510 and / or the paddle 524, the apposition element 510 can have a circular or rounded shape and the paddle frame 524 can have a full radius spanning from one leg of the paddle to the other leg of the paddle. The circular shape of the apposition element and / or the fully rounded shape of the paddle frame shown will distribute the stress on the leaflets 20, 22 over the large curved coaptation area 607. For example, in Figure 6C In FIG. 5 , the forces exerted by the paddle frame on the leaflets 20 , 22 as the leaflets 20 attempt to open during the diastolic cycle are dispersed along the entire rounded length of the paddle frame 524 .

[0465] refer to Figure 67 In one example embodiment, to mate with the fully circular shape of paddle frame 524 and / or to maximize leaflet coaptation against and leaflet-to-leaflet coaptation at sides 601, 603 of coaptation element 510, the shape of the coaptation element follows a circular shape in an internal commissural view. Figure 67 , in this view, the circular shape of the juxtaposition elements substantially follows or approximates the shape of the blade frame 524.

[0466] In one example embodiment, when viewed from the surgeon's perspective (top view - see Figure 70 ) the overall shape of the apposition element 510 is an elliptical or oval cross section when viewed from the LVOT view (side view - see Figure 69 ) is conical in shape or cross-section and is conical in shape or cross-section when viewed from the commissural view (see Figure 68 ) is a generally circular shape or a circular shape. In an exemplary embodiment, the combination of these three geometric shapes can produce the three-dimensional shape of the illustrated integrative element 510 that achieves the above-mentioned benefits.

[0467] In an example embodiment, the size of the apposition element is selected to minimize the number of implants (preferably one) that a single patient will need while maintaining a low transvalvular gradient. In an example embodiment, the front-back distance X47B at the top of the septum is approximately 5mm, and the inside-outside distance X67D of the septum at the widest point of the septum is approximately 10mm. In an example embodiment, the overall geometry of device 500 can be based on these two sizes and the above-mentioned overall shape strategy. It should be readily understood that using other front-back distances X47B and inside-outside distances X67D as the starting point of the device will result in the device having different sizes. In addition, using other sizes and the above-mentioned shape strategy will also result in devices having different sizes.

[0468] Tables A, B, and C provide examples of values ​​and ranges for dimensions of devices and components of devices according to some example embodiments. However, the device can have a variety of different shapes and sizes and need not have all or any of the dimensional values ​​or dimensional ranges provided in Tables A, B, and C. Table A provides examples of linear dimensions X in millimeters and linear dimension ranges in millimeters for devices and components of devices. Table B provides examples of radial dimensions R in millimeters and radial dimension ranges in millimeters for devices and components of devices. Table C provides examples of angles α in degrees and ranges of angles α in degrees for devices and components of devices. The subscript for each dimension indicates the figure in which the dimension first appears.

[0469]

[0470]

[0471] Now refer to Figures 47 to 61 , showing implantable device 500 in various positions and configurations. Implantable device 500 can include any other features used in the implantable prosthetic devices discussed herein, and device 500 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0472] Implantable device 500 has a proximal or attachment portion 505, an apposition element 510 (e.g., a spacer, etc.), an inner anchoring portion or inner paddle 522, an outer anchoring portion or outer paddle 520, an anchor extension member or paddle frame 524, and a distal portion 507. Inner paddle 522 is attached (e.g., engageably attached, etc.) between apposition element 510 and outer paddle 520. Outer paddle 520 is attached (e.g., engageably attached, etc.) between inner paddle 522 and distal portion 507. Paddle frame 524 is attached to cap 514 at distal portion 507 and extends to a joint portion 523 between inner paddle 522 and outer paddle 520. In some embodiments, paddle frame 524 is formed of a material that is more rigid and stiffer than the material forming paddles 522, 520, such that paddle frame 524 provides support for paddles 522, 520. In one exemplary embodiment, inner paddle 522 is hard, relatively hard, rigid, has a rigid portion, and / or is hardened by a hardening member or fixed portion of hook 530. The hardening of the inner paddle allows the device to move to the various positions shown and described herein. Inner paddle 522, outer paddle 520, and the counter-joint can all be interconnected as described herein such that device 500 is constrained to the movements and positions shown and described herein.

[0473] Now refer to Figures 47 and 48, the device 500 is shown in a closed position. When closed, the inner paddle 522 is disposed between the outer paddle 520 and the apposition element 510. In some embodiments, the device 500 includes a hook or gripping member 530 ( Figure 48 The hook 530 is attached to the inner blade 522 and moves along with the inner blade, and is disposed between the inner blade 522 and the engaging element 510 .

[0474] Now refer to Figures 49 to 51 , the device 500 is shown in a partially open position. The device 500 is moved to the partially open position by an actuating element or instrument for actuation 512, which passes through the attachment portion 505 and the apposition element 510 and can removably engage the distal portion 507. The actuating element 512 extends through the attachment portion 505 such that the distance between the attachment portion 505 and the distal portion 507 increases as the actuating element 512 extends. Figures 49 to 51 In the example shown, the pair of inner and outer blades 522, 520 are moved in unison rather than independently by a single actuating element 512. Likewise, the position of the hook 530 depends on the position of the blades 522, 520. For example, referring to Figure 48 In one exemplary embodiment, the device 500 may be provided with a plurality of paddles 522, 520, each of which is provided with a plurality of paddles 522, 520. Figure 11A The paddles 520, 522 are independently controllable in the same manner as in the embodiment.

[0475] Extending actuating element 512 pulls downward on the bottom portion of outer paddle 520 and paddle frame 524. Outer paddle 520 and paddle frame 524 pull downward on inner paddle 522, to which inner paddle 522 is connected. Because attachment portion 505 and engaging element 510 are held in place, inner paddle 522 is caused to flex or pivot in the opening direction. Inner paddle 522, outer paddle 520, and paddle frame all flex to the opening position. Figure 49 Opening the paddles 522, 520 and the paddle frame 524 creates a gap 520A between the apposition element 510 and the inner paddle 522 that can receive and grasp the native leaflet 20.

[0476] As described above, some embodiments of the device 500 include a hook or gripping member 530. When the device 500 is partially opened, the hook 530 is exposed. In some embodiments, the closed hook 530 ( Figure 50 ) can be opened ( Figure 51), thereby creating a second opening or gap 530A for receiving and capturing the native leaflets 20, 22. The extent of the gap 530A in the hook 530 is limited to the extent that the inner paddle 522 has been deployed away from the apposition element 510.

[0477] Now refer to Figures 52 to 54 , the device 500 is shown in a laterally extended or open position. By continuing to extend the above-mentioned actuating element 512, the device 500 is moved to the laterally extended or open position, thereby increasing the distance D between the attachment portion 505 and the distal portion 507. Continuing to extend the actuating element 512 pulls the outer paddle 520 and the paddle frame 524 downward, causing the inner paddle 522 to further deploy from the mating element 510. In the laterally extended or open position, the inner paddle 522 extends more horizontally than in other positions of the device 500 and forms an angle of approximately 90 degrees with the mating element 510. Similarly, when the device 500 is in the laterally extended or open position, the paddle frame 524 is in its maximum extended position. The increased gap 520A formed in the laterally extended or open position allows the hook 530 to open further ( ) before engaging the mating element 510. Figure 54 ), thereby increasing the size of gap 530A.

[0478] Now refer to Figures 55 to 57 , the device 500 is shown in a three-quarter extended position. By continuing to extend the above-mentioned actuating element 512, the device 500 is moved to the three-quarter extended position, thereby increasing the distance D between the attachment portion 505 and the distal portion 507. Continuing to extend the actuating element 512 pulls the outer paddle 520 and the paddle frame 524 downward, causing the inner paddle 522 to further deploy from the mating element 510. In the three-quarter extended position, the inner paddle 522 is opened more than 90 degrees and is at an angle of approximately 135 degrees to the mating element 510. The paddle frame 524 is less extended than in the laterally extended or open position and begins to move inward toward the actuating element 512 as the actuating element 512 is further extended. The outer paddle 520 also flexes rearwardly toward the actuating element 512. As with the laterally extended or open position, the increased gap 520A formed in the laterally extended or open position allows the hook 530 to open further ( Figure 57 ), thereby increasing the size of gap 530A.

[0479] Now refer to Figure 58, device 500 is shown in an almost fully extended position. By continuing to extend the aforementioned actuating element 512, device 500 is moved to the almost fully extended position, thereby increasing the distance D between the attachment portion 505 and the distal portion 507. Continuing to extend actuating element 512 pulls the outer paddle 520 and paddle frame 524 downward, thereby causing the inner paddle 522 to further deploy from the mating element 510. In the almost fully extended position, the inner paddle 522 begins to approach an angle of approximately 180 degrees with respect to the mating element 510. Although the inner paddle moves to this position, the outer paddle 520 and paddle frame 524 never move or flex to or beyond a ninety-degree angle relative to the mating element 510. In the almost fully extended position, the inner paddle 522 and outer paddle 520 may have a slightly curved shape.

[0480] Now refer to Figures 59 to 61 , the device 500 is shown in a fully extended position. By further extending the actuating element 512, the device 500 is moved to the fully extended position, thereby increasing the distance D between the attachment portion 505 and the distal portion 507 to the maximum distance allowed by the device 500. Continuing to extend the actuating element 512 pulls the outer paddle 520 and the paddle frame 524 downward, causing the inner paddle 522 to further deploy from the mating element 510. The outer paddle 520 and the paddle frame 524 move to their positions close to the actuating element. In the fully extended position, the inner paddle 522 is opened to an angle of approximately 180 degrees with respect to the mating element 510. In the fully extended position, the inner paddle 522 and the outer paddle 520 are stretched straight to form an angle of approximately 180 degrees between the paddles 522, 520. The fully extended position of the device 500 provides the maximum size of the gap 520A between the blades and, in some embodiments, allows the gap 530 between the portions of the hook 530 to also fully open to approximately 180 degrees ( Figure 61 ). The position of the device 500 is the narrowest configuration. Thus, the fully extended position of the device 500 can be a desired position for salvaging the device 500 from an attempted implant, or can be a desired position for placing the device in a delivery catheter, etc.

[0481] Now refer to Figure 47A 、 48A -48H, 53A-53C, 54A-54D, 60A-60D, and 61A-61D, show implantable device 500A in various positions and configurations. Implantable device 500A can include any other features used in implantable prosthetic devices discussed herein, and device 500A can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0482] Implantable device 500A has a proximal or attachment portion 505A, apposition elements 510A, an inner anchoring portion or inner paddle 522A, an outer anchoring portion or outer paddle 520A, an anchor extension member or paddle frame 524A, and a distal portion 507A. Inner paddle 522A is attached (e.g., engageably attached, etc.) between apposition elements 510A, for example, via apposition portions 525A, and is attached (e.g., engageably attached, etc.) between outer paddle 520A via apposition portions 523A. Outer paddle 520A is attached (e.g., engageably attached, etc.) between inner paddle 522A (e.g., via engagement portions 523A) and distal portion 507A (via engagement portions 521A). Paddle frame 524A is attached to cap 514A (e.g., at distal portion 507A). Figure 48A ) and extends to a joint portion 523A between the inner and outer blades 522A, 520A. In some embodiments, blade frame 524A is formed of a material that is more rigid and harder than the material forming blades 522A, 520A, so that blade frame 524A provides support for blades 522A, 520A. Blade frame 524A includes a portion for receiving joint portion 523A ( Figure 65A ) opening or slot 524B. In some embodiments, inner paddle 522A is hard, relatively hard, rigid, has a rigid portion, and / or is hardened by a hardening member or fixed portion of hook 530C. The hardening of the inner paddle allows the device to move into the various positions shown and described herein. Inner paddle 522A, outer paddle 520A, and the engaging element can all be interconnected as described herein so that device 500A is constrained to the movement and positions shown and described herein.

[0483] The apposing element 510A, inner paddle 522A, and outer paddle 520A can be attached together by integrally forming the apposing element 510A and paddles 520A, 522A as a single, unitary component. For example, this can be achieved by forming the apposing element 510A and paddles 520A, 522A from a continuous strip 501A of braided or woven material, such as braided or woven Nitinol wire.

[0484] Continuous strip 501A is attached to collar 511D, cover 514A, paddle frame 524A, hook 530C. In the embodiment shown, abutment element 510A, hinge portions 521A, 523A, 525A, outer paddle 520A, and inner paddle 522A are formed from continuous strip 501A. Continuous strip 501A can be a single layer of material or can include two or more layers. In some embodiments, portions of device 500A have a single layer of strip 501A and other portions are formed from multiple overlapping or superimposed layers of strip 501A. For example, Figure 47AThe juxtaposed element 510A and inner paddle 522A are shown formed from multiple overlapping or stacked layers of material strip 501A. Thus, the juxtaposed element 510A and inner paddle 522A have increased stiffness relative to outer paddle 520A formed from a single layer of material 501A. A single continuous strip of material 501A may begin and end at various locations on the device 500A. The ends of the material strip 501A may be at the same location or at different locations on the device 500A. For example, at Figure 47A In the embodiment shown, the strip of material begins and ends at the location of the inner paddle 522.

[0485] Hook 530C may include an attachment or fixed portion 532C, an arm or movable portion 534C, a barb 536C, and a connector portion 538C. Attachment or fixed portion 532C may be coupled to inner paddle 522A in various ways, such as by sutures, adhesives, fasteners, welding, stitching, swaging, friction fit, and / or other means for coupling with connector portion 538C disposed adjacent to mating element 510A. Hook 530C may be similar to hook 430.

[0486] The movable portion 534C can be in an open configuration (e.g., Figure 54A ) and closed configuration ( Figure 48A ) pivots or flexes between the barbed hooks 530C and the movable portion 534C. In some embodiments, the hook 530C can be biased to a closed configuration. In the open configuration, the fixed portion 532C and the movable portion 534C pivot or flex away from each other so that the natural leaflet can be positioned between the fixed portion 532C and the movable portion 534C. In the closed configuration, the fixed portion 532C and the movable portion 534C pivot or flex toward each other, thereby clamping the natural leaflet between the fixed portion 532C and the movable portion 534C. When the movable arm 534C opens to open the barbed hook 530C and expose the barb 536C, the fixed arm 532C remains stationary or substantially stationary. The barbed hook 530C is opened by applying tension to the actuation wire 537A attached to the movable arm 534C, causing the movable arm 534C to pivot or flex on the joint portion 538C.

[0487] Now refer to Figure 47A and Figures 48A-48H , the device 500A is shown in a closed position. A side view of the device 500A is shown in Figure 48B 、 48C and 48F, the front view is shown in Figure 48D 、 48E and 48G, the bottom view is shown in Figure 48HWhen viewed from the front, the device 500A is narrower than from the side. From the side, the device 500A has a generally inverted trapezoidal shape that is rounded and tapers toward the distal portion 507A of the device 500A. From the front, the device 500A has a generally rounded rectangular shape that tapers slightly toward the distal portion 507A. Figure 48H The bottom view of the device 500A shown can be seen when viewed from below (and when viewed from above, as can be seen in, for example, Figure 70A ), device 500A has a generally rounded rectangular shape.

[0488] In the closed configuration of the device 500A, the inner paddle 522A is disposed between the outer paddle 520A and the apposition element 510A. In some embodiments, the device 500A includes a hook or gripping member 530C ( ) that can be opened and closed to grip the native leaflets 20, 22 of the mitral valve MV. Figure 48A The hook 530C is attached to the inner blade 522A and moves with the inner blade, and is disposed between the inner blade 522A and the engaging element 510A.

[0489] Now refer to Figures 48B to 48D , the device 500A is shown connected to a delivery device 502A. The delivery device 502A has an actuatable member or finger 503A that releasably engages the attachment portion 505A. An actuating element 512A extends from the delivery device 502A through the attachment portion 505A and the engagement element 510A of the prosthetic device 500A to 514A. As described below, extending and retracting the actuating element 512A causes the device 500A to open and close. An actuating wire / suture 537A extends from the delivery device 502A to attach to the hook 530C. Tension can be applied to the suture 537A to open the hook 530C, and the tension can be released to close the hook 530C. In Figures 48F to 48G , device 500A is shown separated from delivery device 502A in a deployed state.

[0490] Now refer to Figure 48C and 48E, device 500A is shown as having a cover 540A. Cover 540A can be formed from a single piece of material or from multiple parts that are adjacent or connected to each other. In the illustrated embodiment, cover 540A has an outer or lower cover 541A and an inner or upper cover 543A. Outer cover 541A covers cap 514A, outer paddle 520A, inner paddle 522A, and hook 530C. Inner cover 543A covers apposition element 510A and the proximal end of inner paddle 522A and hook 530C, wherein apposition element 510A intersects with inner paddle 522A and hook 530C. Cover 540A can be a cloth such as a fine mesh polyethylene cloth. The cloth cover can provide a blood seal on the surface of the septum and / or promote rapid tissue ingrowth.

[0491] Now refer to Figures 53A-53D and Figures 54A-54D , the device 500A is shown in a laterally extended or open position. The device 500A is moved to the open position by an actuating element or instrument for actuation 512A, which passes through the attachment portion 505A and the engaging element 510A and can removably engage the distal portion 507A. The actuating element 512A extends through the attachment portion 505A such that the distance D2 between the attachment portion 505A and the distal portion 507A increases as the actuating element 512A extends. Figures 53A-53D and Figures 54A-54D In the example shown, the pair of inner and outer blades 520A, 522A are moved in unison by a single actuating element 512A rather than independently. Likewise, the position of the hook 530C depends on the position of the blades 520A, 522A. For example, referring to Figure 48A , closing the paddles 520A, 522A also closes the hook 530C. In one exemplary embodiment, the device 500A may be provided with Figure 11A The paddles 520A, 522A are independently controllable in the same manner as in the embodiment.

[0492] Extending actuating element 512A pulls downward on the bottom of outer paddle 520A and paddle frame 524A to transition device 500A from the closed position to the partially open position. Outer paddle 520A and paddle frame 524A pull down on inner paddle 522A, to which inner paddle 522A is connected. Because attachment portion 505A and engaging element 510A are held in place, inner paddle 522A is caused to pivot or flex in the opening direction. Inner paddle 522A, outer paddle 520A, and paddle frame all flex to the closed position. Figure 53A Opening the paddles 522A, 520A and the frame 524 creates a gap 520D between the apposition element 510A and the inner paddle 522A, which can receive and grasp the native leaflet 20.

[0493] Continued extension of actuating element 512A pulls outer paddle 520A and paddle frame 524A downward, causing inner paddle 522A to deploy further from mating element 510A. In the laterally extended or open position, inner paddle 522A extends more horizontally than in other positions of device 500A and forms an angle of approximately 90 degrees with mating element 510A. Similarly, when device 500A is in the laterally extended or open position, paddle frame 524A is in its most extended position. The increased gap 520D formed in the laterally extended or open position allows hook 530C to open further (before mating element 510A) Figure 54A ), thereby increasing the size of gap 530D compared to the partially open position.

[0494] As described above, some embodiments of the device 500A include a hook or gripping member 530C. When the device 500A is open, the hook 530C is exposed. In some embodiments, the closed hook 530C ( Figures 53A to 53D ) can be opened ( Figures 54A to 54D ), thereby creating a second opening or gap 530D for receiving and capturing the native leaflets 20, 22. The extent of the gap 530D in the hook 530C is limited to the extent to which the inner paddle 522A has extended away from the apposition element 510A.

[0495] Now refer to Figures 60A-60D and Figures 61A-61D , device 500A is shown in a fully extended position. By further extending the aforementioned actuating element 512A, device 500A is moved to the fully extended position, thereby increasing the distance D2 between the attachment portion 505A and the distal portion 507A to the maximum distance allowed by device 500A. Continuing to extend actuating element 512A pulls the outer paddle 520A and paddle frame 524A downward, thereby extending the inner paddle 522A further away from the mating element 510A. The outer paddle 520A and paddle frame 524A move to their positions adjacent to the actuating element. In the fully extended position, the inner paddle 522A is opened to an angle of approximately 180 degrees relative to the mating element 510A. In the fully extended position, the inner paddle 522A and the outer paddle 520A are stretched straight or substantially straight to form an angle of approximately 180 degrees between the paddles 522A, 520A. The fully extended position of the device 500A provides the maximum size of the gap 520D between the blades and, in some embodiments, allows the hook 530C to also fully open to approximately 180 degrees ( Figure 61A ). The position of the device 500A is the narrowest configuration. Thus, the fully extended position of the device 500A can be a desired position for salvaging the device 500A from an attempted implant, or can be a desired position for placing the device in a delivery catheter, etc.

[0496] Now refer to Figures 197 to 198 , showing Figure 60C Now refer to Figure 197 , it can be seen that the inner cover 543A covers the apposition element 510A from the proximal portion 519B to the distal portion 517A. In some embodiments, the inner cover 543A is formed from a flat sheet of fabric material such as a fine mesh polyethylene fabric (see FIG. Figure 201 ) is formed and folded around the apposition element 510A and held in place by suture 545A. Figure 198 , outer cover 541A covering hook 530C and inner paddle 522A can be seen. A collar portion 548A of inner cover 543A covers the portion of hook 530C and inner paddle 522A closest to abutment element 510A. A transition portion 547A of inner cover 543A extends from abutment element 510A to collar portion 548A to provide a smooth transition between abutment element 510A and hook 530C and inner paddle 522A, thereby preventing native tissue from becoming trapped on device 500A during implantation.

[0497] Now refer to Figure 199 , shows an exploded view of device 500A. As described above, mating element 510A, outer paddle 520A, and inner paddle 522A are formed from a single strip of material 501A. Bushing 511D, cover 514A, paddle frame 524A, and hook 530C are assembled onto strip 501A to form device 500A. Cover 514A includes a retaining body 560A having a locking aperture 561A for receiving a retaining nut 562A having a threaded aperture 564A that engages a threaded portion 568A of a retaining bolt 566A. Threaded portion 568A of retaining bolt 566A is inserted through opening 527B to engage retaining body and nuts 560A, 562A, thereby attaching cover 514A to strip 501A.

[0498] In some embodiments, stiffening member 539C is attached to inner blade 522A to stiffen inner blade 522A to maintain the inner blade in a straight or substantially straight configuration as the inner blade moves between various positions. Cutout 539D in stiffening member 539C is shaped to receive securing arm 532C of hook 530C, such that stiffening member 539C can fit around securing arm 532C when both stiffening member 539C and hook 530C are attached to inner blade 522A. Similar to securing arm 532C, stiffening member 539C can be coupled to inner blade 522A in various ways, such as by sutures, adhesives, fasteners, welding, stitching, swaging, friction fit, and / or other means for coupling.

[0499] Now refer to Figure 200 , shows an enlarged view of collar 511D attached to proximal portion 519B of apposition element 510A. Collar 511D includes protrusions 511B for releasably engaging fingers 503A of delivery device 502A. Openings 515A in collar 511D receive actuating element 512A. Proximal portion 519B of apposition element 510A flares outward to form two loops 519D, which are inserted through arcuate openings 513A in collar 511D to attach collar 511D to proximal portion 519B of apposition element 510A. Loops 519D are formed by folding material strip 501A to form first layer 581A and second layer 582A.

[0500] Now refer to Figures 201 to 202 , respectively showing an enlarged and exploded view of the cover 514A. Figure 201 An enlarged view of cap 514A attached to distal portion 527A of strip of material 501A is shown. Retaining body 560A, retaining nut 562A, and retaining bolt 566A cooperate to connect paddle frame 524A to distal portion 527A of strip of material 501A. In particular, retaining bolt 566A is inserted through opening 527B ( Figure 202 ) to prevent the cover 514A from moving along the strip of material 501 A. The channel 560B in the retaining body 560A and the flange 567A of the bolt 566A form a passage 514B through the cover 514A for the distal portion 527A.

[0501] Now refer to Figure 202 , the components of cover 514A are shown in an exploded view to better illustrate features of the components of cover 514A and paddle frame 524A and to illustrate how these features interlock during assembly of cover 514A to distal portion 527A. Forming cover 514A from multiple components that can be assembled around material strip 501A allows cover 514A to be attached after material strip 501A has been folded to form appositive element 510A and paddles 520A, 522A and has been woven through collar 51 ID and paddle frame 524A.

[0502] Retaining body 560A includes a locking aperture 561A for receiving a retaining nut 562A. Locking aperture 561A has a generally rectangular shape and includes two opposing locking channels 561B that receive attachment portion 524C of paddle frame 524A. Transverse locking channel 561C formed in the bottom of retaining body 560A has the same width as locking channel 561B. Paddle frame 524A includes a notch 524D formed in attachment portion 524C that engages hook portion 524E of transverse locking slot 561C to secure paddle frame 524A to cover 514A.

[0503] Retaining nut 562A includes a rectangular locking body 563A extending distally from flange 563B. Locking body 563A is configured to slidably engage locking aperture 561A of retaining body 560A while leaving locking channel 561B unobstructed. Thus, locking body 563A can be inserted into locking aperture 561A to lock attachment portion 524C of paddle frame 524A within locking channel 561B. Recess 563C in flange 563B accommodates attachment portion 524C of paddle frame 524A. Threaded hole 564A is formed through retaining nut 562A to receive retaining bolt 566A.

[0504] Retaining bolt 566A includes a threaded portion 568A extending from flange 567A. Threaded portion 568A is inserted through opening 527B in distal portion 527A to threadably engage threaded hole 564A of retaining nut 562A. Flange 567A has a circular shape that provides a rounded end to distal portion 507A of device 500A. Flange 567A includes an opening 567B for receiving a tool (not shown) that engages bolt 566A, allowing bolt 566A to be rotated during assembly to couple the components of cover 514A together.

[0505] To assemble paddle frame 524A and cover 514A to distal portion 527A, paddle frame 524A is squeezed to narrow the width of attachment portion 524C, enabling attachment portion 524C to be inserted into locking channel 561B of locking aperture 561A. When paddle frame 524A is allowed to expand, attachment portion 524C expands outward, causing notch 524D to engage retaining body 560A and hook portion 524E to engage transverse locking channel 561C. Retaining nut 562A is then inserted into locking aperture 561A, with locking portion 563A disposed between the two attachment portions 524C of each paddle frame 524A, thereby locking paddle frame 524A into engagement with retaining body 560A. Assembled paddle frame 524A, retaining body 560A, and retaining nut 562A are placed on distal portion 527A so that threaded hole 564A is aligned with opening 527B, and threaded portion 568A of bolt 566A is inserted through opening 527B to threadably engage threaded hole 564A. Bolt 566A is then tightened until flange 567A engages retaining body 560A, and cap 514A is securely assembled to distal portion 527A.

[0506] Now refer to Figure 203 and Figure 204, showing a portion of a cover 540A cut from a flat sheet. Cover 540A comprises an outer cover 541A and an inner cover 543A. Each of covers 541A, 543A comprises differently shaped segments or portions for attachment to different portions of device 500A. In particular, covers 541A, 543A are shaped to smooth transitions between portions of device 500A, reducing sticking points and providing a smoother exterior for device 500A.

[0507] The various segments of the covers 541A, 543A extend from a middle portion shaped to be attached to the ends of the device 500A. In other embodiments, the portion of the covers 541A, 543A that is attached to the ends of the device 500A is located at the ends of the covers 541A, 543A or can be located anywhere between the middle and the ends of the covers 541A, 543A. The various portions of the covers 541A, 543A can be shaped to wrap around portions of the device 500A. The cover 540A can be made of any suitable material, such as a fine mesh polyethylene fabric. In certain embodiments, the cover is formed of a single piece of material. In other embodiments, the cover can be formed of any number of pieces of material that are attached to the device and / or joined together in any suitable manner, such as by stitching, adhesives, welding, etc.

[0508] refer to Figure 60C and Figure 204 , outer cover 541A extends outwardly from middle portion 580 to end portion 588. Middle portion 580 is shaped to attach to 514A of device 500A. Outer paddle portion 582 extends from middle portion 580 to inner paddle and inner hook portion 584. Inner hook and inner hook portion 584 extend from outer hook portion 582 to outer movable hook portion 586. Outer movable hook portion 586 extends from inner hook portion 584 to end portion 588.

[0509] The outer paddle portion 582 includes wings 583 that extend laterally to a greater width than the rest of the outer cover 541A, allowing the outer paddle portion 582 to be attached to the outer paddle 520A and paddle frame 524A of the device 500A. The inner paddle portion 584 is connected to the inner paddle 522A, the fixed arm 532C, and the inner surface (the side with the barbs) of the movable arm 534C. The outer hook portion 586 is attached to the outer surface (the side without the barbs) of the movable arm 534C of the hook 530C. The end 588 of the outer cover 541A terminates on the exterior of the hook 530C near the joint portion 538C of the hook 530C. The inner paddle and inner hook portion 584 include openings 585 that allow the barbs 536C of the hook 530C to protrude through the outer cover 541A to engage the tissue of the native heart valve.

[0510] refer to Figure 60C and Figure 203 , inner cover 543A extends outwardly from middle portion 590 to end portion 598. Middle portion 590 is configured to attach to collar 511D of device 500A. When middle portion 590 is attached to collar 511D, opening 591 in middle portion 590 exposes protrusion 511E from collar 511D, allowing protrusion 511E to be engaged by delivery device 502A. Apposition portions 592 extend from middle portion 590 to flexible hinge portions 594. Apertures 593 along the edges of apposition portions 592 allow each of apposition portions 592 to be joined together, for example, by sutures 545A, after being folded around apposition element 510A. Flexible hinge portions 594 extend from apposition portions 592 to transition portions 596. Transition portions 596 extend from flexible hinge portions 594 to end portion 598. Holes 597 along the edges of the transition portions 596 allow each transition portion 596 to be wrapped around the ends of the inner paddle 522A and the hook 530C and secured to itself by sutures or other suitable securing means. When the device 500A is opened, the flexible hinge portion 594 bridges the gap between the engaging element 510A and the hook 530C, as shown in FIG. Figure 198 As shown in .

[0511] Now refer to Figures 62A to 64C , showing an implantable device 700. The implantable device 700 has paddles 702 that open and close to grasp the leaflets 20, 22 against barbed hooks or gripping devices 704. The paddles 702 move to form openings 706 between the paddles 702 and the gripping devices 704, in which the leaflets 20, 22 can be grasped. The device 700 can be configured to close the wide gaps 26 ( Figure 6 ). Additionally, implantable device 700 may include any other features for the devices discussed herein, and device 700 may be positioned to engage valve leaflets 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein). Device 700 may include any other features for the implantable prosthetic devices discussed herein, and device 700 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0512] refer to Figure 62A, the paddle 702 of the device 700 moves, rotates, or pivots outwardly in the X direction to form an opening 706 having a width W between the paddle 702 and the gripping member 704. The width W can be, for example, between about 5 mm and about 15 mm, such as between 7.5 mm and about 12.5 mm, such as about 10 mm. In alternative embodiments, the width W can be less than 5 mm or greater than 15 mm.

[0513] refer to Figure 62B , paddle 702 of device 700 moves outward in direction Z so that opening 706 has a width H. Width H can be, for example, between about 10 mm and about 25 mm, such as between about 10 mm and about 20 mm, such as between about 12.5 mm and about 17.5 mm, or about 15 mm. In some embodiments, width H can be less than 10 mm or greater than 25 mm. In certain embodiments, the ratio between width H and width W can be about 5:1 or less, such as about 4:1 or less, such as about 3:1 or less, such as about 2:1 or less, such as about 1.5:1 or less, such as about 1.25:1 or less, or about 1:1. Device 700 can be configured such that paddle 702 moves, rotates, or pivots outward in the X direction and then moves outward in the Z direction to form opening 706 having width H between paddle 702 and gripping element 704. Alternatively, device 700 can be configured to move the paddle outward in the Z direction and then move or pivot outward in the X direction to form a width H between paddle 702 and gripping member 704. Additionally, device 700 can be configured to move or pivot paddle 702 outward in the X direction and simultaneously move outward in the Z direction to form a width H between paddle 702 and gripping member 704.

[0514] Figures 63A to 63C Implantable device 700 is shown with paddles 702 moved, rotated, or pivoted outward in the X-direction and then moved outward in the Z-direction to form a wider opening 706 . Figure 63A Implantable device 700 is shown in a closed position such that paddle 702 is engaged with gripping member 704. Figure 63B , the paddle 702 moves or pivots outwardly along direction X to form an opening 706 having a width W for receiving valve tissue. Figure 63C After the paddle 702 moves or pivots outwardly along the direction X, the paddle 702 moves outwardly along the direction Z so that the opening 706 has a width H. After the valve tissue is received in the opening 706 between the paddle 702 and the grasping member 704, the valve repair device moves back to the closed position (e.g., Figure 63A) to secure valve repair device 700 to valve tissue. Implantable device 700 may include any other features used for implantable devices discussed herein, and implantable device 700 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0515] Figures 64A to 64C Implantable device 700 is shown with paddles 702 moved outward in direction Z and then moved, extended, or pivoted outward in direction X to form a wider opening 706 . Figure 64A Implantable device 700 is shown in a closed position such that paddle 702 is engaged with gripping member 704. Figure 64B , the paddle 702 moves outward along the Z direction to form an opening 706 with a width W for receiving valve tissue. Figure 64C After the paddles 702 move outward in direction Z, the paddles 702 move or pivot outward in direction X so that the opening 706 has a width H. After the valve tissue is received in the opening 706 between the paddles 702 and the gripping member 704, the implantable device 700 moves back to the closed position (e.g., Figure 64A ) to secure the implantable device 700 to the valve tissue. The implantable device 700 may include any other features used for the implantable devices discussed herein, and the implantable device 700 may be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0516] Although Figures 63A to 63C shows the device 700 in which the paddles 702 are moved or pivoted and then deployed, Figures 64A to 64C The device 700 is shown in which the paddles 702 are deployed and then moved or pivoted, but in alternative embodiments, the device 700 can include paddles 702 that can be deployed and moved or pivoted simultaneously. Furthermore, in certain embodiments, the paddles 702 can be deployed and moved or pivoted independently of each other. That is, in Figures 63A-63C and Figures 64A-64C In the embodiment of valve repair device 700 shown, and in embodiments where deployment and movement or pivoting of each paddle 702 are performed simultaneously, paddles 702 can be controlled independently of one another.

[0517] Now refer to Figures 65 to 83 , the example implantable device 500 is shown in a closed state. Referring now to Figures 65 to 66, device 500 extends from a proximal portion 505 to a distal portion 507 and includes an apposition portion 510, an inner paddle 522, an outer paddle 520, and a paddle frame 524. In some embodiments, the outer paddle 520 extends to and / or around the paddle frame 524 and may have more than one layer to surround the paddle frame 524. The proximal portion 505 may include a collar 511 for attaching a delivery device (not shown). The distal portion 507 may include a cap 514 that is attached (e.g., engageably attached, etc.) to the outer paddle 520 and is engaged by an actuation element (not shown) to open and close the device 500 for implantation into a native valve as described herein.

[0518] Now refer to Figures 67 to 68 , showing a front view of device 500. Device 500 has a symmetrical or substantially symmetrical shape about a vertical anterior-posterior plane 550 and is generally narrower at the distal portion 507 than at the proximal portion 505. The shapes of the apposition element 510 and the paddle frame 524 are circular or substantially circular to prevent the device 500 from snagging or snagging on cardiac structures, such as chordae tendineae, during implantation. To this end, the proximal collar 511 ( Figure 68 ) and cover 514( Figure 68 ) also has rounded edges. When viewed from the front or rear, paddle frame 524 can be seen as having a circular or substantially circular shape, extending upward and outward from distal portion 507 to generally conform to the shape of apposition element 510 when viewed from the front or rear. Thus, apposition element 510 and paddle frame 524 generally define the shape of device 500 when viewed from the front or rear. Additionally, the circular shape of paddle frame 524 and the corresponding circular shape of the apposition element can distribute leaflet stress over a wider surface. In some example embodiments, paddle frame 524 and / or apposition element 510 can have other shapes.

[0519] Now refer to Figure 69 , showing a side view of the device 500. As in the front and rear views ( Figures 67 to 68 ), when viewed from the side, the device 500 has a symmetrical or substantially symmetrical shape about a vertical side-to-side plane 552. When the device 500 is viewed from the side, the distal portion 507 is also generally narrower than the proximal portion 505. The apposition element 510 optionally also has a tapered or substantially tapered shape that narrows toward the distal portion 507 of the device 500. However, in some example embodiments, the apposition element does not taper as it extends from the proximal portion of the device to the distal portion of the device.

[0520] The circular nature of device 500 is further illustrated by the circular shape of the paddles 520, 522, which join the inner and outer paddles 520, 522, and the circular shape of the paddle frame 524. However, paddles 520, 522 and paddle frame 524 can take a variety of different forms. For example, paddles 520, 522 and paddle frame 524 can be rounded along the top edges, but flat or substantially flat on the sides of the paddles 520, 522 and / or paddle frame. By making paddles 520, 522 flat or substantially flat on the sides, two devices can be implanted side by side on a native valve leaflet, with the two devices positioned flush or substantially flush with each other.

[0521] The closed paddles 520, 522 form a gap 542 between the inner paddle 522 and the apposition element 510, which is configured to receive natural tissue. Figure 69 As shown, the narrowing of the apposition element 510 gives the gap 542 a slight teardrop shape that increases in width as the gap 542 approaches the distal portion 507 of the device. The widening of the gap 542 toward the distal portion 507 allows the paddles 520, 522 to contact tissue grasped in the gap 542 closer to the proximal portion 505.

[0522] The paddle frame 524 extends vertically from the distal portion 507 toward the proximal portion 505 to approximately the middle third of the device 500, then bends or flares outwardly so that the connected portion of the frame 524 passes through the gap 544 formed by the inner paddle 522 folded inside the outer paddle 520. However, in other embodiments, the connection of the frame is located inside the inner paddle 522 or outside the outer paddle 520. The outer paddle 520 has a circular shape that is similar to the circular shape of the apposition element 510 when viewed from the front or back ( Figures 67 to 68 ). Thus, the device 500 has a circular shape or a substantially circular shape. When viewed from the top ( Figures 70 to 71 ) or bottom ( Figures 72 to 73 )When viewing device 500, the circular shape of device 500 is particularly visible.

[0523] Now refer to Figures 70 to 71 , shows a top view of the device 500. When viewed from the top, the device 500 has a shape that is symmetrical or substantially symmetrical about the anterior-posterior plane 550 and also symmetrical or substantially symmetrical about the lateral-lateral plane 552. The opening 519A in the apposition element 510 is visible at the proximal portion 505 of the device 500. Figure 70 As can be seen in FIG, the engaging element 510 may be hollow inside. Figure 71 The proximal collar 511 shown in FIG. 5 can be secured to the apposition element 510 to close the apposition element 510 .

[0524] In one exemplary embodiment, the apposition element is not planar and has all curved surfaces. For example, the apposition element 510 shown herein can be formed by a series of mixed surfaces with various different radii of curvature. The apposition element 510 has an oval or substantially oval shape when viewed from the top. However, in some exemplary embodiments, the apposition element 510 can have other shapes when viewed from the top. For example, the apposition element can have a rectangular, square, diamond, elliptical, or any other shape. The paddle frames 224 each have an arc shape with a radius smaller than the apposition element 510, so that the gap 542 formed between the inner paddle 522 and the paddle frame 524 and the apposition element 510 gradually decreases as they approach the left side 551 and right side 553 of the device 500. Therefore, natural tissue such as the leaflets 20, 22 tends to be grasped between the paddle frame 524 and the apposition element 510 toward the left side 551 and right side 553 of the device 500.

[0525] Now refer to Figures 72 to 73 , showing a bottom view of the device 500. and a top view ( Figures 70 to 71 ), when viewed from the bottom, the device 500 is symmetrical or substantially symmetrical about the front-to-back plane 550 and also symmetrical or substantially symmetrical about the side-to-side plane 552. Figure 73 Cover 514 is shown in FIG, and may be engageably attached to outer blade 520 and blade frame 524 .

[0526] The paddle frame 524 extends outwardly from the distal portion 507 of the device 500 to the left side 551 and the right side 553 at a narrow or slight angle to the side-to-side plane 552. As the paddle frame 524 extends toward the proximal portion of the device 500 ( Figure 69 ), the blade frame 524 further extends away from the side-side plane 552 to ultimately form Figures 70 to 71 The arc shape seen in .

[0527] Now refer to Figures 74 to 83 , which shows a perspective view and a cross-sectional view of the device 500. Now referring to Figure 74 , the device 500 is shown cut through a cross-sectional plane 75 near the proximal portion of the apposition element 510. Referring now to Figure 75 , showing that from Figure 74 FIG. 5 shows a cross-sectional view of device 500 as viewed along cross-sectional plane 75 in FIG. At the location of plane 75, engaging element 510 has a circular or substantially circular shape with petal-like projections arranged along front-back plane 550. A gap 542 between paddle frame 524 and engaging element 510 forms a crescent-like shape having a central width 543. As described above, gap 542 narrows as it approaches left side 551 and right side 553.

[0528] Now refer to Figure 76 , the device 500 is shown cut through a cross-sectional plane 77 positioned approximately three-quarters of the way between the distal portion 507 and the proximal portion 505 of the apposition element 510. Referring now to Figure 77 , showing that from Figure 76 FIG. 5 shows a cross-sectional view of the device 500 viewed through the cross-sectional plane 77 in FIG. At the location of the plane 75, the engaging element 510 has an oval or substantially oval shape oriented along the side-to-side plane 552. The gap 542 between the blade frame 524 and the engaging element 510 forms a central width 543 less than Figure 75 543 as seen in FIG. At the location of plane 77, the width 543 of gap 542 is narrower toward the center of the device, then slightly wider as gap 542 approaches left side 551 and right side 553 before narrowing again. Thus, the native tissue is compressed in the center of gap 542 to approximately three-quarters of the way up the apposition element 510.

[0529] Now refer to Figure 78 , the device 500 is shown cut through by cross-sectional plane 79, which is located approximately halfway between the distal portion 507 and the proximal portion 505 of the apposition element 510. Referring now to Figure 79 , showing that from Figure 78 FIG. 5 shows a cross-sectional view of device 500 as viewed through cross-sectional plane 79 in FIG. At the location of plane 79, engaging element 510 has an oval or substantially oval shape oriented along side-to-side plane 552. Blade frame 524 can be seen proximate left side 551 and right side 553, very close to or in contact with engaging element 510. Gap 542 is crescent-shaped or substantially crescent-shaped and is wider than gap 542 as viewed from plane 77 ( FIG. 5 shows a cross-sectional view of device 500 as viewed through cross-sectional plane 79 in FIG. 5 shows a cross-sectional view of device 500 as viewed from plane 77 ( FIG. 5 shows a cross-sectional view of device 500 as viewed from plane 79). At the location of plane 79, engaging element 510 has an oval or substantially oval shape oriented along side-to-side plane 552. Blade frame 524 can be seen proximate left side 551 and right side 553, very close to or in contact with engaging element 510. Gap 542 is crescent-shaped or substantially crescent-shaped and is wider than gap 542 ( FIG. 5 shows a cross-sectional view of device 500 as viewed from plane 7 ... Figure 77 ).

[0530] Now refer to Figure 80 , the device 500 is shown cut through by a transverse cross-sectional plane 81 positioned approximately one quarter of the way between the distal portion 507 and the proximal portion 505 of the apposition element 510. Referring now to Figure 81 , showing that from Figure 80 5. A cross-sectional view of the device 500 as viewed from the cross-sectional plane 81 in FIG. At the location of the plane 81, the apposition element 510 has an oval or substantially oval shape oriented along the side-to-side plane 552, which is larger than the side-to-side plane 552. Figure 77 The oval shape seen in FIG. 5 is narrow. It can be seen that the blade frame 524 is close to the left side 551 and the right side 553, very close to or in contact with the mate element 510. The gap 542 is crescent-shaped or approximately crescent-shaped and is wider than the gap 542 when viewed from the plane 79 ( Figure 79 ).

[0531] Now refer to Figure 82, the device 500 is shown cut through a cross-sectional plane 83 positioned near the distal portion 507 of the apposition element 510. Referring now to Figure 83 , showing that from Figure 82 83 in the cross-sectional view of the device 500. At the location of plane 83, the apposition element 510 has an oval or substantially oval shape oriented along the side-to-side plane 552, which is larger than the side-to-side plane 552. Figure 79 The oval shape seen in FIG is narrow because the engaging element 510 tapers toward the distal portion 507 of the device 500. The paddle frame 524 can be seen near the left side 551 and the right side 553, very close to or in contact with the engaging element 510. Although the inner paddle 522 is Figure 81 , but gap 542 is crescent-shaped or substantially crescent-shaped and is wider than gap 542 when viewed along plane 81 ( Figure 81 ).

[0532] Now refer to Figure 65A 、 66A , 67A, 68A, 70A, 71A, 72A, 73A, 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A and 83A, the example implantable device 500A is shown in a closed state. Figure 65A and Figure 66A , device 500A extends from a proximal portion 505A to a distal portion 507A and includes an apposition portion 510A, an inner paddle 522A, an outer paddle 520A, and a paddle frame 524A. Proximal portion 505A may include a collar 511D for connecting to a delivery device (not shown). Distal portion 507A may include a cap 514A that is attached (e.g., engageably attached, etc.) to outer paddle 520A and engaged by an actuation element (not shown) to open and close device 500A, thereby facilitating implantation into a native valve as described herein.

[0533] Now refer to Figure 67A and Figure 68A , showing a front view of device 500A. Device 500A has a symmetrical or substantially symmetrical shape about a vertical anterior-posterior plane 550A and is narrower at distal portion 507A than along paddle frame 524A. The shapes of apposition element 510A and paddle frame 524A are generally rounded rectangular to prevent device 500A from snagging or snagging on cardiac structures, such as chordae tendineae, during implantation. To this end, proximal collar 511D ( Figure 68A ) and 514A( Figure 68A) can also have rounded edges. When viewed from the front or rear, paddle frame 524A can be seen to have a generally rounded rectangular shape, extending upward and outward from distal portion 507A to a plan view having a shape 510A that is wider than the apposing element and substantially parallel to the sides of the apposing element. Thus, when viewed from the front or rear, paddle frame 524A generally defines the shape of device 500A. Additionally, the rounded rectangular shape of paddle frame 524A can distribute leaflet stress over a wider surface. In some example embodiments, paddle frame 524A and / or apposing element 510A can have other shapes.

[0534] Like the front and back views ( Figure 67A and 68A ), when viewed from the side (e.g. Figure 47A ), the device 500A has a vertical side-to-side plane 552A ( Figure 70A ) symmetrical or substantially symmetrical shape. When the device 500A is viewed from the side, the distal portion 507A is also generally narrower than the proximal portion 505A. Figure 48B In the illustrated embodiment, the apposition element 510A is not tapered as it extends from the proximal portion 505A of the device 500A to the distal portion 507A of the device 500A. However, in some example embodiments, the apposition element does taper (e.g., Figure 47 ).

[0535] The generally circular nature of device 500A is further indicated by the circular shape of paddles 520A, 522A where inner and outer paddles 520A, 522A join together. However, paddles 520A, 522A and paddle frame 524A can take a variety of different forms. For example, paddles 520A, 522A and paddle frame 524A can be rounded along the top edges and flat or substantially flat on the sides (e.g., the sides of paddle frame 524A disposed on the front and back sides of device 500A). By making the sides of paddles 520A, 522A flat or substantially flat, two devices can be implanted side by side on a native valve leaflet so that the two devices are flush or substantially flush with each other.

[0536] The closed paddles 520A, 522A form a gap 542A between the inner paddle 522A and the apposition element 510A, which is configured to receive natural tissue. Figure 48B and Figure 48F5A, the proximal end of the apposition element 510A has a dog-bone-like shape so that as the gap 542A approaches the distal portion 507A of the device, the gap 542A narrows toward the proximal portion 505A. The narrowing of the gap 542A toward the attachment portion 505A allows the paddles 520A, 522A to contact tissue grasped in the gap 542A closer to the proximal portion 505A.

[0537] Paddle frame 524A extends vertically from distal portion 507A toward proximal portion 505A to approximately the middle third of device 500A, then bends or flares outward so that connection portion 524B of frame 524A passes through gap 544A formed by inner paddle 522A folded inside outer paddle 520A. However, in other embodiments, the connection of the frame is located inside inner paddle 522A or outside outer paddle 520A. When viewed from the front or back ( Figure 67A and 68A ), the outer blade 520A has a rounded rectangular shape similar to the mating element 510A. Therefore, the device 500A has a rounded rectangular shape. When viewed from the top ( Figure 70A and Figure 71A ) or bottom ( Figure 72A and Figure 73A )When viewing device 500A, the rounded rectangular shape of device 500A is particularly visible.

[0538] Now refer to Figure 70A and Figure 71A , showing a top view of the device 500A. When viewed from the top, the device 500A has a shape that is symmetrical or substantially symmetrical about the front-to-back plane 550A and also symmetrical or substantially symmetrical about the side-to-side plane 552A. The proximal opening 519C in the apposition element 510A is visible at the proximal portion 505A of the device 500A. The actuating element 512A is received through the opening 519C so that the apposition element 510A wraps around the actuating element 512A. In some embodiments, the opening 519C is formed by inserting the actuating element 512A between the folded and overlapping layers of the material strip 501A (described in detail below). In other embodiments, the opening 519C is formed by shaping the folded layers of material 501A forming the apposition element 510A around a blank or fixture to give the apposition element 510A a circular or substantially circular shape. Figure 71A1A and 1B , the proximal collar 511D shown in FIG. 1A can be secured to the apposition element 510A to enclose the apposition element 510A. The proximal collar 511D includes an attachment portion 513A that engages with an opening 546A formed by the folded layer of material 501A forming the apposition element 510A. In some embodiments, the attachment portion 513A is a hole in the collar 511D such that, during assembly of the device 500A, the material strip 501A must be inserted through the collar 511D before the material strip 501A is folded. In some embodiments, the attachment portion 513A is an open slot (e.g., the attachment portion 524B of the paddle frame 524A) that receives the material strip 501A before or after the material strip 501A is folded.

[0539] As described above, when viewed from the top, the apposition element 510A has a generally rectangular shape. In some exemplary embodiments, when viewed from the top, the apposition element 510A can have other shapes. For example, the apposition element can have a circular, square, diamond-shaped, oval, or any other shape. When viewed from the top, the paddle frames 224A each have a rounded rectangular shape, such that the paddle frames 224A surround the rectangular apposition element 510A. As a result, natural tissue, such as leaflets 20, 22, tends to be evenly grasped or compressed in the gap 542A formed between the inner paddle 522A and the paddle frames 524A and the apposition element 510A.

[0540] Now refer to Figure 72A and Figure 73A , showing a bottom view of the device 500A. and a top view ( Figure 70A and Figure 71A ), when viewed from the bottom, the device 500A has a shape that is symmetrical or substantially symmetrical about the front-back plane 550A and also symmetrical or substantially symmetrical about the side-side plane 552A. The distal portion 527A of the strip of material 501A includes a Figure 73A Opening 527B of cover 514A is shown.

[0541] The paddle frame 524A extends outwardly from the distal portion 507A of the device 500A to the left side 551A and the right side 553A at a narrow or slight angle to the side-to-side plane 552A. Figure 65A ), the blade frame 524A extends further away from the side-side plane 552A while maintaining a substantially constant distance relative to the front-rear plane 550A to ultimately form Figure 70A and 71A The rounded rectangular shape seen in .

[0542] In one example embodiment, the size of device 500A is selected to minimize the number of implants required for a single patient (preferably one) while maintaining a low transvalvular gradient. In one example embodiment, the widest front-to-back distance Y47I of device 500A is less than 10 mm, and the widest inside-outside distance Y67C of the spacer is less than 6 mm. In one example embodiment, the overall geometry of device 500A can be based on these two dimensions and the above-mentioned overall shape strategy. It should be easily understood that using other front-to-back distances Y47I and inside-outside distances Y67C as the starting point of device 500A will result in devices with different sizes. In addition, using other dimensions and the above-mentioned shape strategy will also result in devices with different sizes.

[0543] Tables D and E provide examples of values ​​and ranges for dimensions of the device 500A and components of the device 500A according to some example embodiments. However, the device 500A can have a variety of different shapes and sizes and need not have all or any of the dimensional values ​​or dimensional ranges provided in Tables D and E. Table D provides examples of linear dimensions Y in millimeters and linear dimension ranges in millimeters for the device 500A and components of the device 500A. Table B provides examples of radial dimensions S in millimeters and radial dimension ranges in millimeters for the device 500A and components of the device 500A. The subscript for each dimension indicates the figure in which the dimension first appears.

[0544]

[0545] Now refer to Figure 74A 、 75A , 76A, 77A, 78A, 79A, 80A, 81A, 82A and 83A, which show perspective and cross-sectional views of the device 500A. Figure 74A , the device 500A is shown cut through a cross-sectional plane 75A near the proximal portion of the apposition element 510A. Referring now to Figure 75A , showing that from Figure 74A FIG. 5 shows a cross-sectional view of device 500A viewed through cross-sectional plane 75A. At the location of plane 75A, engaging element 510A has a generally rounded rectangular shape. Gap 542A between inner paddle 522A and engaging element 510A has a width 542B. As described above, gap 542A has a uniform or generally uniform width.

[0546] Now refer to Figure 76A , the device 500A is shown cut through a cross-sectional plane 77A positioned approximately three-quarters of the way between the distal portion 507A and the proximal portion 505A of the apposition element 510A. Referring now to Figure 77A , showing that from Figure 76AA cross-sectional view of the device 500A as viewed through the cross-sectional plane 77A in FIG. Figure 76A and Figure 77A As shown, the strips of material 501A forming the device 500A overlap in the region of the mating element 510A to form four layers. A single layer of the strip of material 501A forms each of the inner paddle 522A and the outer paddle 520A. At the location of plane 75A, the mating element 510A has a generally rectangular shape oriented along a side-to-side plane 552A. A gap 542A between the inner paddle 522A and the mating element 510A is visible. The width 542B of the gap 542A between the inner paddle 522A and the mating element 510A is greater than Figure 75A The gap 544A between the outer blade 520A and the inner blade 522A has a uniform or substantially uniform width 544B for receiving the attachment portion 524B of the blade frame 524A.

[0547] Now refer to Figure 78A , the device 500A is shown cut through by cross-sectional plane 79A, which is located approximately halfway between the distal portion 507A and the proximal portion 505A of the device 500A. Figure 79A , showing that from Figure 78A A cross-sectional view of the device 500A as viewed through the cross-sectional plane 79A in FIG. Figure 78A and 79A As shown in FIG, the strips of material 501A forming the device 500A overlap to form four layers in the region of the counter element 510A, two layers in the region of the inner paddle 522A, and one layer in the region of the outer paddle 520A. At the location of plane 79A, the counter element 510A has a generally rectangular shape oriented along the side-to-side plane 552A. The gap 542A between the inner paddle 522A and the counter element 510A has a substantially rectangular shape. Figure 77A The width 542B seen in FIG. 5 is the same or approximately the same as the width 542B.

[0548] Now refer to Figure 80A , the device 500A is cut by cross-sectional plane 81A, which is located approximately one-quarter of the way between the distal portion 507A and the proximal portion 505A of the device 500A. Figure 81A , showing that from Figure 80A A cross-sectional view of the device 500A as viewed through the cross-sectional plane 81A. Figure 80A and 81AAs shown, the strips of material 501A forming device 500A overlap to form four layers in the area of ​​juxtaposition element 510A, two layers in the area of ​​inner paddle 522A, and outer paddle 520A is formed from a single layer. At the location of plane 81A, juxtaposition element 510A has a generally rectangular shape oriented along side-to-side plane 552A. Gap 542A between inner paddle 522A and juxtaposition element 510A has a substantially rectangular shape oriented along side-to-side plane 552A. Figure 79A The center width 542B seen in is approximately the same width 542B.

[0549] Now refer to Figure 82A , the device 500A is cut by cross-sectional plane 83A, which is located approximately one-quarter of the way between the distal portion 507A and the proximal portion 505A of the device 500A. Figure 83A , showing that from Figure 82A A cross-sectional view of the device 500A as viewed through the cross-sectional plane 83A. Figure 82A and 83A As shown in FIG, the strips of material 501A forming the device 500A overlap to form four layers in the area of ​​the juxtaposition element 510A, two layers in the area of ​​the inner paddle 522A, and a single layer forming the outer paddle 520A. At the location of plane 83A, the juxtaposition element 510A has a generally rectangular shape oriented along the side-to-side plane 552A. The gap 542A between the inner paddle 522A and the juxtaposition element 510A forms an arcuate shape having a width 542B that is approximately the same as the width of the outer paddle 522A. Figure 81A The center width 542B seen in is approximately the same.

[0550] Now refer to Figures 84 to 88 , 86A, 87A and 88A, show example implantable devices 100, 500, 500A without hooks or hingeable gripping elements. Figures 84-88 The example devices 100, 500, 500A shown in Figures 86A, 87A and 88A have barbs or grasping members 800 / 800A and / or 802 / 802A integrated into the mate elements or paddle portions of the anchoring portion of the device to facilitate grasping tissue of the native heart valve.

[0551] Now refer to Figure 84 , shows an example implantable device 100 that does not include an articulatable hook or gripping element. As described above, the device 100 is deployed from a delivery sheath or instrument for delivery 102 and includes an apposition portion 104 and an anchoring portion 106. The apposition portion 104 of the device 100 includes an apposition element or instrument for apposition 110 adapted to be implanted between the leaflets 20, 22 of a native valve (e.g., a mitral valve MV, etc.) and is slidably attached to an actuating element or shaft 112 that extends through the apposition element or instrument for apposition 110 to a distal cap 114.

[0552] The anchoring portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the distal cap 114 and the apposition element or means for apposition 110. The anchoring portion 106 is actuable between an open state and a closed state and can take a variety of forms such as a paddle, a gripping element, etc. Actuation of the actuation element or means for actuation 112 opens and closes the anchoring portion 106 of the device 100 to grip the native valve leaflets 20, 22 during implantation.

[0553] Figure 84 The device 100 shown in FIG includes barbed portions 800 disposed on an apposition element or device for apposition 110, rather than an articulatable hook or gripping element, wherein each side of the apposition element or device for apposition 110 has at least one barbed portion 800. When the anchoring portion 106 of the device 100 is closed, tissue captured between the inner paddle 122 and the apposition element or device for apposition 110 is pressed against the barbed portions 800. The barbed portions 800 can be sharp so that they engage native tissue and, in some embodiments, pierce the native tissue and prevent tissue from retracting from the device 100. In some embodiments, the barbed portions 800 are angled downward to increase engagement with the native tissue.

[0554] Now refer to Figure 85 , the example implantable device 100 is shown without a separate articulated hook. As described above, the device 100 is deployed from a delivery sheath or instrument for delivery 102 and includes an apposition portion 104 and an anchoring portion 106. The apposition portion 104 of the device 100 includes an apposition element or instrument for apposition 110 adapted to be implanted between the leaflets 20, 22 of the native valve or mitral valve MV and is slidably attached to an actuation element 112 (e.g., an actuation wire, shaft, rod, suture, thread, etc.) extending through the apposition element or instrument for apposition 110 to a distal cap 114.

[0555] The anchoring portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the distal cap 114 and the apposition element or means for apposition 110. The anchoring portion 106 is actuable between an open state and a closed state and can take a variety of forms such as a paddle, a gripping element, etc. Actuation of the actuation element or means for actuation 112 opens and closes the anchoring portion 106 of the device 100 to grip the native valve leaflets 20, 22 during implantation.

[0556] Figure 85The illustrated device 100 includes barbed portions 800 disposed on the inner paddles 122, rather than separate articulatable hooks or gripping elements, with each inner paddle 122 having at least one barbed portion 800. When the anchoring portion 106 of the device 100 is closed, tissue captured between the inner paddles 122 and the apposition element or instrument for apposition 110 is pressed against the barbed portions 800. The barbed portions 800 are sharp so that they engage, and in some embodiments, pierce, native tissue and prevent retraction of the tissue from the device 100. In some embodiments, the barbed portions 800 are angled downward to increase engagement with the native tissue.

[0557] Now refer to Figure 86 , shows an example implantable device 500 that does not include an articulatable hook or gripping element. As described above, the device 500 includes an apposition portion 504 and an anchoring portion 506. The apposition portion 504 of the device 500 includes an apposition element 510 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuation element or instrument for actuation 512 that extends through the apposition element 510 to a distal cover 514.

[0558] The anchoring portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cap 514 and the apposition element 510. The anchoring portion 506 is actuable between an open state and a closed state and can take a variety of forms such as a paddle, a gripping element, etc. Actuation of the actuating element 512 opens and closes the anchoring portion 506 of the device 500 to grip the native valve leaflets 20, 22 during implantation.

[0559] The device 500 includes barbed portions 800 disposed on the inner paddles 522, rather than articulatable hooks or gripping elements, wherein each inner paddle 522 optionally has more than one barbed portion 800. When the anchoring portion 506 of the device 500 is closed, tissue gripped between the inner paddles 522 and the apposition element 510 is pressed against the barbed portions 800. The barbed portions 800 are sharp so that they engage, and in some embodiments, pierce, native tissue and prevent tissue from retracting from the device 500. In some embodiments, the barbed portions 800 are angled downward to increase engagement with native tissue.

[0560] Now refer to Figure 86A, shows an example implantable device 500A that does not include an articulated hook or gripping element. As described above, the device 500A includes an apposition element 510A, which is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuating element or an instrument for actuation (not shown) that extends through the apposition element 510A to a distal cover 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cover 514A and the apposition element 510A. The device 500A is actuable between an open state and a closed state and can take a variety of forms such as paddles, gripping elements, etc. Actuation of the actuating element opens and closes the paddles 520A, 522A of the device 500A to grip the native valve leaflets 20, 22 during implantation.

[0561] Device 500A includes barbed portions 800A disposed on inner paddles 522A, rather than articulatable hooks or gripping elements, wherein each inner paddle 522A optionally has more than one barbed portion 800A. When device 500A is closed, tissue captured between inner paddles 522A and apposition element 510A is pressed against barbed portions 800A. Barbed portions 800A are sharp so that they engage and, in some embodiments, pierce native tissue and prevent tissue from retracting from device 500A. In some embodiments, barbed portions 800A are angled downward to enhance engagement with native tissue.

[0562] Now refer to Figure 87 , shows an example implantable device 500 that does not include a separate articulated hook or gripping element. As described above, the device 500 includes an apposition portion 504 and an anchoring portion 506. The apposition portion 502 of the device 500 includes an apposition element 510 that is adapted to be implanted between the leaflets 20, 22 of the native valve or native mitral valve MV and is slidably attached to an actuation element or instrument for actuation 512 that extends through the apposition element 510 to a distal cover 514.

[0563] The anchoring portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cap 514 and the apposition element 510. The anchoring portion 506 is actuable between an open state and a closed state and can take a variety of forms such as a paddle, a gripping element, etc. Actuation of the actuating element 512 opens and closes the anchoring portion 506 of the device 500 to grip the native valve leaflets 20, 22 during implantation.

[0564] The device 500 includes barbed portions 800 disposed on the apposition element 510 rather than separate articulatable hooks or gripping elements, with each side of the apposition element 510 having more than one barbed portion 800. When the anchoring portion 506 of the device 500 is closed, tissue captured between the inner paddle 522 and the apposition element 510 is pressed against the barbed portions 800. The barbed portions 800 are sharp so that they engage, and in some embodiments, pierce, native tissue and prevent tissue from retracting from the device 500. In some embodiments, the barbed portions 800 are angled downward to increase engagement with native tissue.

[0565] Now refer to Figure 87A , shows an example implantable device 500A that does not include a hingeable hook or gripping element. As described above, the device 500A may have an apposition element 510A that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuating element or an instrument for actuation (not shown) that extends through the apposition element 510A to a distal cover 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cover 514A and the apposition element 510A. The device 500A can be actuated between an open state and a closed state and can take a variety of forms such as paddles, gripping elements, etc. Actuation of the actuating element opens and closes the paddles 520A, 522A of the device 500A to grip the native valve leaflets 20, 22 during implantation.

[0566] Device 500A includes a barbed portion 800A disposed on engaging element 510A, with each side of engaging element 510A having more than one barbed portion 800A, rather than a single articulated hook or gripping element. When device 500A is closed, tissue captured between inner paddle 522A and engaging element 510A is pressed against barbed portion 800A. Barbed portion 800A is sharp, so that it engages and, in some embodiments, pierces native tissue and prevents tissue from retracting from device 500A. In some embodiments, barbed portion 800A is angled downward to enhance engagement with native tissue.

[0567] Now refer to Figure 88 , shows an example implantable device 500 that does not include a separate articulated hook or gripping element. As described above, the device 500 includes an apposition portion 504 and an anchoring portion 506. The apposition portion 504 of the device 500 includes an apposition element 510 that is adapted to be implanted between the leaflets 20, 22 of the native valve or native mitral valve MV and is slidably attached to an actuation element or instrument for actuation 512 that extends through the apposition element 510 to a distal cover 514.

[0568] The anchoring portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cap 514 and the apposition element 510. The anchoring portion 506 is actuable between an open state and a closed state and can take a variety of forms such as a paddle, a gripping element, etc. Actuation of the actuating element 512 opens and closes the anchoring portion 506 of the device 500 to grip the native valve leaflets 20, 22 during implantation.

[0569] The device 500 includes a barbed portion 800 disposed on the mating element 510 instead of an articulatable hook or gripping element, wherein each side of the mating element 510 includes at least one barbed portion 800. Similar to the device 1000 described above, the device 500 also includes a barbed portion 802 disposed on the inner paddles 522, wherein each inner paddle 522 has at least one barbed portion 802.

[0570] When the anchoring portion 506 of the device 500 is closed, tissue captured between the inner paddle 522 and the engaging element 510 is pressed against the barbed portions 800, 802. The barbed portions 800, 802 are sharp, so that they engage and, in some embodiments, pierce native tissue and prevent the tissue from retracting from the device 500. In some embodiments, the barbed portions 800, 802 are angled downward to increase engagement with native tissue. The combination of the barbed portions 800 on the engaging element 510 and the barbed portions 802 on the inner paddle 522 forces the captured tissue into an S-shaped curved path as it passes through the barbed portions 800, 802. Thus, the force pulling the tissue away from the device 500 will cause the tissue to further engage the barbed portions 800, 802 before it can disengage.

[0571] Now refer to Figure 88A , shows an example implantable device 500A that does not include a hingeable hook or gripping element. As described above, the device 500A may have an apposition element 510A that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuating element or an instrument for actuation (not shown) that extends through the apposition element 510A to a distal cover 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cover 514A and the apposition element 510A. The device 500A can be actuated between an open state and a closed state and can take a variety of forms such as paddles, gripping elements, etc. Actuation of the actuating element opens and closes the paddles 520A, 522A of the device 500A to grip the native valve leaflets 20, 22 during implantation.

[0572] The device 500A includes a barbed portion 800A disposed on the mating element 510A, rather than an articulatable hook or gripping element, wherein each side of the mating element 510A includes at least one barbed portion 800A. The device 500A also includes a barbed portion 802A disposed on the inner paddles 522A, wherein each inner paddle 522A has at least one barbed portion 802A.

[0573] When the device 500A is closed, the tissue held between the inner paddle 522A and the apposition element 510A is pressed against the barbed portions 800A, 802A. The barbed portions 800A, 802A are sharp, so that they engage the natural tissue and, in some embodiments, pierce the natural tissue and prevent the tissue from retracting from the device 500A. In some embodiments, the barbed portions 800A, 802A are angled downward to increase engagement with the natural tissue. The combination of the barbed portion 800A on the apposition element 510A and the barbed portion 802A on the inner paddle 522A forms an S-shaped curved path when the tissue being grasped passes through the barbed portions 800A, 802A. Therefore, the force pulling the tissue away from the device 500A will cause the tissue to further engage the barbed portions 800A, 802A before the tissue can detach.

[0574] Now refer to Figures 89 to 102 , showing an apposition element 510 and paddles 520, 522 of an example device 500. The apposition element 510 and paddles 520, 522 can be made of a variety of different materials. The apposition element 510 and paddles 520, 522 can be formed from one or more of a variety of materials, such as a metal fabric, such as a mesh, woven, braided, electrospun, deposited, or formed in any other suitable manner, a material cut by a laser or otherwise, or a flexible material. The material can be cloth, a shape memory alloy wire (such as Nitinol) to provide shape-holding capabilities, or any other flexible material suitable for implantation in the human body.

[0575] In one exemplary embodiment, the apposition element is made of a braided mesh of metal wires, such as a braided mesh of nickel-titanium alloy wires. In one exemplary embodiment, the apposition element 510 is made of a braided mesh of 25 to 100 wires, such as 40 to 85 wires, such as 45 to 60 wires, such as about 48 nitinol wires or 48 nitinol wires.

[0576] The apposition element can be covered in cloth, such as polyethylene cloth. The apposition element 510 can be entirely surrounded by a cloth cover, such as a fine mesh polyethylene cloth. The cloth cover can provide a blood seal on the surface of the septum and / or promote rapid tissue ingrowth.

[0577] The use of a shape memory material, such as a braided nitinol wire mesh, to construct the apposition element 510 results in an apposition element that is self-expandable, flexible in all directions, and / or results in low strain when the apposition element is crimped and / or bent. The material can be a single piece, two halves joined together, or multiple sections or pieces fastened or joined together in any suitable manner, such as by welding, using an adhesive, etc.

[0578] Now refer to Figures 89 to 90 , the device 500 extends from a proximal portion 505 to a distal portion 507 and includes an apposition element 510, an inner paddle 522, and an outer paddle 520. The apposition element 510 includes a proximal opening 519A and a distal opening 515 ( Figure 92 and 94 ). A proximal opening 519A of the mate element 510 is formed in a proximal portion 519 of the mate element 510. The mate element 510 is engageably connected to the inner paddle 522 via the mate portion 525. The inner paddle 522 is engageably connected to the outer paddle 520 via the mate portion 523. The outer paddle 520 is attached (e.g., engageably attached, etc.) to the distal portion 527 via the mate portion 521. An mate gap 542 is formed between the inner paddle 522 and the mate element 510. When the paddles 520, 522 are folded, a paddle gap 544 is formed between the inner paddle 520 and the outer paddle 522, e.g., as Figure 90 shown.

[0579] Now refer to Figure 91 , shows a front view of the device 500 (the rear view will be the same). The apposition element 510 includes a proximal portion 519, a middle portion 518, and a distal portion 517. The proximal portion 519 includes a proximal opening 519A. The distal portion 517 includes a distal opening 515 and is connected to the connector portion 525. The shape of the apposition element 510 is circular or substantially circular to prevent the device 500 from snagging or snagging on cardiac structures, such as chordae tendineae, during implantation.

[0580] Now refer to Figure 92 , shows a side view of device 500. Similar to device 500 viewed from the front, when device 500 is viewed from the side, distal portion 507 of device 500 is generally narrower than proximal portion 505 of device 500. Apposition element 510 flares outward from proximal opening 519A in proximal portion 519 to intermediate portion 518. Apposition element 510 then tapers or narrows in intermediate portion 518 from proximal portion 519 to distal portion 517. Distal portion 517 remains narrow and then splits into two joint portions 525. The generally circular nature of device 500 is further illustrated by the circular shape of apposition portion 523 that engageably connects inner paddle 520 and outer paddle 522, and the outwardly bowed shape of outer paddle 520.

[0581] The engagement gap 542 formed between the inner paddle 522 and the apposition element 510 is configured to receive native tissue. The narrowing of the apposition element 510 gives the gap 542 a slightly teardrop shape that increases in width as the gap 542 approaches the distal portion 507 of the device 500. The widening of the gap 542 toward the distal portion 507 allows the inner paddle 522 to contact tissue grasped in the gap 542 closer to the proximal portion 505, where the compressive force is greater due to the mechanical advantage provided by the length of the paddles 520, 522 and other fixation or anchoring elements (such as those described in this application).

[0582] Now refer to Figure 93 , showing a top view of device 500. Proximal opening 519A in apposition element 510 is visible at proximal portion 505 of device 500, and apposition element 510 can be seen to be internally hollow. Apposition element 510 has an oval or generally oval shape when viewed from the top. While paddles 520, 522 appear to be protruding rectangular shapes, paddles 520, 522 can extend laterally and have an arcuate or crescent-shaped shape.

[0583] Now refer to Figure 94 , showing a bottom view of the device 500. A distal opening 515 in the apposition element 510 is visible at the distal portion 507 of the device 500, and it can be seen that the apposition element 510 is hollow internally. The apposition element 510 has an oval or generally oval shape when viewed from the top. While the paddles 520, 522 appear to be protruding rectangular shapes, the paddles 520, 522 can extend laterally and have an arcuate or crescent-shaped shape. The distal portion 517 of the apposition element 510 can be seen to be split in two to engage with the joint portion 525.

[0584] Now refer to Figure 89A 、 90A , 91A, 92A, 93A, 94A, 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A illustrate portions of a device 500A formed from a strip of material 501A (e.g., a single, continuous strip of material, a composite material strip, etc.), namely, an apposition element 510A and paddles 520A, 522A. The apposition element 510A and paddles 520A, 522A can be made from a variety of different materials. The apposition element 510A and paddles 520A, 522A can be formed from a material that can be a metal fabric, such as a mesh, woven, braided, electrospun, deposited, or formed in any other suitable manner, a material that can be laser cut or otherwise cut, or a flexible material. The material can be cloth, a shape memory alloy wire (such as Nitinol) to provide shape-holding capabilities, or any other flexible material suitable for implantation in the human body.

[0585] In one exemplary embodiment, the apposition element 510A, the inner paddle 522A, and the outer paddle 520A are made from a single continuous strip of material 501A. The strip of material 501A can be formed from a material that can be a metal fabric, such as a mesh, woven, braided, electrospun, deposited, or formed in any other suitable manner, a material that is cut by a laser or otherwise, or a flexible material. The material is cloth, a shape memory alloy wire (such as Nitinol) to provide shape-holding capabilities, or any other flexible material suitable for implantation in the human body. In one exemplary embodiment, the strip of material 501A is made from a braided mesh having 25 to 100 strands, such as 40 to 85 strands, such as 45 to 60 strands, such as approximately 48 Nitinol wires or 48 Nitinol wires.

[0586] Now refer to Figures 205 to 207 , an example woven or braided material 4000 that may be used for the strip of material 501A is shown. Referring now to Figure 205 , shows an enlarged plan view of material 4000. Material 4000 extends from a first edge 4002 to a second edge 4004. The edges 4002, 4004 surround a central portion or region 4006. Material 4000 is formed by braiding or weaving together central strands 4020, such as nitinol wire. Edge strands 4010 extend longitudinally through the material 4000 along the edges 4002, 4004. The central strands 4020 are woven or braided such that the central strands 4020 wrap around the edge strands 4010. Wrapping the central strands 4020 around the edge strands 4010 causes the material 4000 near the edges 4002, 4004 to be thicker than the material in the central portion 4006, forming a flap-like or dog-bone-like shape when the material 4000 is viewed from the end, as shown. Figure 206. Thus, the edges 4002, 4004 of the material 4000 are less flexible than the central portion 4006. The edge strands 4010 and the central strand 4020 can be similar in diameter and can have a diameter ranging from about 0.06 mm to about 0.18 mm. In some embodiments, the edge strands 4010 can have a larger diameter than the central strands 4020 so that the edges 4002, 4004 have a greater hardness or stiffness than the central portion 4006. For example, the edge strands 4010 can have a diameter ranging from 0.07 mm to about 0.27 mm or about 0.17 mm, and the central strand 4020 can have a diameter ranging from about 0.04 mm to about 0.15 mm or about 0.009 mm. In some embodiments, the edges 4002, 4004 are made less flexible than the central portion 4006 by using different materials for the edge strands 4010 and the central strand 4020, for example, a metal material such as nitinol for the edge strands 4010 and a cloth or plastic material such as polyethylene for the central strand 4020. Alternatively, the edge strands 4010 and the central strand 4020 can be made of the same material that undergoes different chemical and / or thermal treatments that alter the flexibility of the material, making the central strand 4020 more flexible than the edge strands 4010.

[0587] Now refer to Figure 207 The folded portions of material 4000 are stacked on top of each other to form a portion having four layers 4000A, 4000B, 4000C, and 4000D. The petal-like shape of each layer, having edges 4002 and 4004 thicker than a central portion 4006, creates three gaps 4001A, 4001B, and 4001C between the layers 4000A, 4000B, 4000C, and 4000D of material 4000 at the location of the central portion 4006. The outer gaps 4001A and 4001C are formed between the outer layers 4000A and 4000D and the adjacent middle layers 4000B and 4000C.

[0588] As discussed in the present disclosure, the apposition element 510A of the device 500A can be formed from four layers of material, such as material 4000. When layers of material 4000 are used to form the apposition element 510A, the actuating element 512A of the device 500A can be inserted through the central gap 4001B formed in the center of the four layers of material 4000. The actuating element 512A can have a diameter that is larger than the width of the gap 4001B, such that inserting the actuating element 512A causes the central gap 4001B to stretch open and adjacent the outer gaps 4001A, 4001C to reduce its size. In some embodiments, inserting the actuating element 512A causes the central body portion 4006 on either side to bulge outward to a thickness greater than the thickness of the four stacked edge portions 4002, 4004.

[0589] The apposition element 510A and paddles 520A, 522A can be covered in cloth, such as polyethylene cloth. The apposition element 510A and paddles 520A, 522A can be entirely surrounded by a cloth cover (e.g., cover 540A), such as a fine mesh polyethylene cloth. The cloth cover can provide a blood seal on the surface of the septum and / or promote rapid tissue ingrowth.

[0590] The use of a shape memory material, such as a braided nitinol wire mesh, to construct the apposition element 510A and paddles 520A, 522A results in an apposition element and paddle that is self-expandable, flexible in all directions, and results in low strain when the apposition element is crimped and / or bent. The material can be a single piece, two halves joined together, or multiple sections or pieces fastened or joined together in any suitable manner, such as by welding, using adhesives, etc.

[0591] Now refer to Figure 89A and Figure 90A , device 500A extends from proximal portion 505A to distal portion 507A and includes an apposition element 510A, an inner paddle 522A, and an outer paddle 520A. A single continuous strip of material 501A extends between two ends 501B and is folded to form apposition element 510A, inner paddle 522A, and outer paddle 520A. Some portions of device 500A are formed from multiple layers of strip of material 501A. For example, strip of material 501A is overlapped to form four layers in the region of apposition element 510A and two layers in the region of inner paddle 522A.

[0592] The mate element 510A and the paddles 520A, 522A are mateably connected together by the mate portion of the material strip 501A. The mate element 510A is mateably connected to the inner paddle 522A by the mate portion 525A. The inner paddle 522A is mateably connected to the outer paddle 520A by the mate portion 523A. The outer paddle 520A is attached (e.g., mateably attached, etc.) to the distal portion 527A by the mate portion 521A. The opening 527B in the distal portion 527A engages with the cap 514A.

[0593] When the strip of material 501A is folded into a desired shape, a plurality of gaps are formed between the various portions of the device 500A. A mate gap 542A is formed between the inner paddle 522A and the mate element 510A. When the paddles 520A, 522A are folded, a paddle gap 544A is formed between the inner paddle 520A and the outer paddle 522A, e.g., Figure 90A When the strip of material 501A is folded to form the proximal portion 519B of the abutting element 510A, a collar gap 546A is formed.

[0594] Now refer to Figure 91A , shows a front view of device 500A (a rear view would be identical). Apposition element 510A includes a proximal portion 519B that extends above a joint portion 523A of paddles 520A, 522A. When viewed from the front or rear, distal portion 517A of apposition element 510A is hidden by paddles 520A, 522A, giving device 500A a long, narrow, rounded rectangular shape. The shape of apposition element 510A helps prevent device 500A from snagging or snagging on cardiac structures, such as chordae tendineae, during implantation.

[0595] Now refer to Figure 92A , showing a side view of the device 500A. When the device 500A is viewed from the side, the distal end 507A of the device 500A is generally narrower than the proximal end 505A of the device 500A, thereby forming a generally blunt and rounded shape. The engaging element 510A includes a proximal portion 519B, a middle portion 518A, and a distal portion 517A. The proximal portion 519B flares outward from the middle portion 518A to engage with the distal portion 511D ( Figure 48A ). When viewed from the side, the middle portion 518A of the mate element 510A is straight or substantially straight. The distal portion 517A is attached (e.g., engageably attached, etc.) to the inner paddle 522A by a joint portion 525A. The generally circular nature of the device 500A is further indicated by the circular shape of the connecting portion 523A that engageably connects the paddles 520A, 522A. The connecting portion 521A connecting the outer paddle 520A to the distal portion 527A is also circular and facilitates assembly from the strip of material 501A to the cover 514A ( Figure 48A ) shape transition.

[0596] The apposition gap 542A formed between the inner paddle 522A and the apposition element 510A is configured to receive natural tissue. The generally straight nature of the intermediate portion 518A of the apposition element 510A and the inner paddle 522A provides the gap 542A with a uniform or substantially uniform width, with a narrow upper end and a proximal portion 519B flaring outward to engage the collar 511D ( Figure 48A Thus, inner paddle 522A contacts tissue grasped in gap 542A closer to proximal portion 505A, where the compressive force is greater due to the mechanical advantage provided by the length of paddles 520A, 522A and other securing or anchoring elements, such as those described herein.

[0597] As described above, the mating element 510A and paddles 520A, 522A of the device 500A are formed by folding a strip of material 501A. The strip of material 501A is then unfolded and assembled with other components, such as a collar 511D, a cover 514A, and a paddle frame 524A. After being formed into the desired shape, the strip of material 501A is shaped so that the strip of material 501A returns to the desired shape after being assembled with the other components. In some embodiments, a jig is used during the folding and shaping of the strip of material 501A to ensure that the strip of material 501A is folded in the proper position and at the desired radius.

[0598] Reference again Figure 92A, showing a portion of a jig 570A to assist in folding and shaping device 500A. A strip of material 501A is shown folded around jig 570A to form the desired shape. To fold the strip of material 501A into the shape of device 500A using jig 570A, the strip of material 501A is positioned so that one of the ends 501B is positioned at the location of inner paddle 522A. The strip 501A extends from end 501B in a distal direction 507B to form a first layer 581A of inner paddle 522A, extends around first jig portion 572A to form a first layer 581A of hinge portion 525A, and then extends in a proximal direction 505B to form a first layer 581A of mate element 510A. This first layer 581A forms the sides of inner paddle 522A and mate element 510A surrounding mate gap 542A. The strip 501A is then wrapped around the second clamp portion 574A to form the proximal portion 519B and one of the openings 546A of the apposition element 510A. The strip 501A is then extended in the distal direction 507A along the first layer 581A to form the second layer 582A of the apposition element 510A. The strip 501A is then wrapped rearwardly around the first clamp portion 524A to form the second layer 582A of the hinge portion 525A, and is then wrapped rearwardly in the proximal direction 505B to form the second layer 582A of the inner paddle 522A. The strip 501A is then wrapped around the third clamp portion 576A to form the joint portion 523A. The strip 501A is then extended in the distal direction 507A along the inner paddle 522A to form the outer paddle 520A, and then folded around the fourth clamp portion 578A to form the apposition portion 521. The strip 501A is then extended laterally to form the distal portion 527. The strip 501A is then routed through the jig 570A in the reverse order on the opposite side of the jig 570A to form the second half of the device 500A. That is, the strip 501A is then wrapped around the fourth jig portion 578A, the third jig portion 576A, the second jig portion 574A, and the first jig portion 572A to form the second half of the device 500A. Once the strip 501A is wrapped around the jig portions as described above, the shaping operation is performed. While the jig portions shown have a circular or substantially circular shape, the portions may have any shape to facilitate folding and shaping the strip of material 501A. The jig 570 may have more or fewer portions for joining the strip of material 501A.

[0599] Now refer to Figure 93A, showing a top view of the device 500A. The first layer 581A and the second layer 582A of each half of the device 500A form the four layers of the juxtaposition device 510A. The proximal end opening 519C of the juxtaposition device 510A is formed between the two second layers 582A. In some embodiments, the opening 519C is formed by inserting an actuating element 512A (not shown) between the folded and overlapping layers of the material 501A after the material 501A has been shaped. In other embodiments, the opening 519C is formed by shaping the folded layers 581A, 582A of the material strip 501A around another clamp portion (not shown) to give the juxtaposition element 510A a circular or substantially circular shape when viewed from the top.

[0600] Now refer to Figure 94A , shows a bottom view of the device 500A. The distal portion 527A of the strip of material 501A is shown, as well as the opening 527B for receiving the cap 514A. When viewed from below, the mate element 510A and the outer paddle 520A have a generally rounded rectangular shape.

[0601] Now refer to Figures 95 to 102 , which shows a perspective view and a cross-sectional view of the device 500. Now referring to Figure 95 , the device 500 is shown cut through a cross-sectional plane 96 near the proximal portion of the apposition element 510. Referring now to Figure 96 , showing that from Figure 95 96. At the location of plane 96, the apposition element 510 has an oval or substantially oval shape with thicker portions along the sides of the apposition element 510. A distal opening 515 is visible from the proximal portion, and the apposition element 510 has a hollow interior.

[0602] Now refer to Figure 97 , the device 500 is shown cut by cross-sectional plane 98, which is located approximately halfway between the distal portion 507 and the proximal portion 505 of the apposition element 510. Referring now to Figure 98 , showing that from Figure 97 FIG. 5 is a cross-sectional view of the device 500 viewed from the cross-sectional plane 98 in FIG. At the location of the plane 98, the juxtaposition element 510 has a Figure 96 Oval shape, large oval or roughly oval shape.

[0603] Now refer to Figure 99 , the device 500 is shown cut through by a transverse cross-sectional plane 100, which is positioned approximately one quarter of the way between the distal portion 507 and the proximal portion 505 of the apposition element 510. Referring now to Figure 99 , showing that from Figure 99A cross-sectional view of the device 500 is shown in FIG. 1 . At the location of plane 100, the juxtaposition element 510 has a greater Figure 98 A narrow oval or roughly oval shape as seen in the elliptical.

[0604] Now refer to Figure 101 , the device 500 is shown cut through a cross-sectional plane 102 positioned near the distal portion 507 of the apposition element 510. Referring now to Figure 102 , showing that from Figure 101 FIG. 5 shows a cross-sectional view of the device 500 viewed from the cross-sectional plane 102 in FIG. At the location of the plane 102, the apposition element 510 has an oval or substantially oval shape that is smaller than Figure 100 and are separated when the mate element 510 mates the portion 525.

[0605] Now refer to Figure 95A 、 96A , 97A, 98A, 99A, 100A, 101A and 102A, which show perspective and cross-sectional views of a portion of a device 500A formed from a single continuous strip of material 501A. Referring now to Figure 95A , the device 500A is shown cut through a cross-sectional plane 96A near the proximal portion of the apposition element 510A. Referring now to Figure 96A , showing that from Figure 95A FIG. 5 shows a cross-sectional view of the device 500A viewed through cross-sectional plane 96A in FIG. At the location of plane 96A, the engaging element 510 has a rectangular or substantially rectangular shape. In some embodiments, when the actuating element (not shown) is inserted between the layers 582A of the engaging element 510A, the engaging element 510A remains straight when viewed from the side, but bends outward to form a circular or substantially circular shape when viewed in cross-section 96A.

[0606] Now refer to Figure 97A , the device 500A is shown cut through a cross-sectional plane 98A near the proximal portion of the apposition element 510A. Referring now to Figure 98A , showing that from Figure 97A FIG. 5 shows a cross-sectional view of the device 500A viewed through cross-sectional plane 98A in FIG. At the location of plane 98A, the engaging element 510 has a rectangular or substantially rectangular shape. In some embodiments, when the actuating element (not shown) is inserted between the layers 582A of the engaging element 510A, the engaging element 510A remains straight when viewed from the side, but bends outward to form a circular or substantially circular shape when viewed in cross-section 98A.

[0607] Now refer to Figure 99A, the device 500A is shown cut through a cross-sectional plane 100A near the proximal portion of the apposition element 510A. Referring now to Figure 100A , showing that from Figure 99A FIG2 is a cross-sectional view of the device 500A viewed through the cross-sectional plane 100A in FIG2 . At the location of the plane 100A, the engaging element 510 has a rectangular or substantially rectangular shape. In some embodiments, when the actuating element (not shown) is inserted between the layers 582A of the engaging element 510A, the engaging element 510A remains straight when viewed from the side, but bends outward to form a circular or substantially circular shape when viewed in the cross-sectional plane 100A.

[0608] Now refer to Figure 101A , the device 500A is shown cut through a cross-sectional plane 102A near the proximal portion of the apposition element 510A. Referring now to Figure 102A , showing that from Figure 101A FIG2 is a cross-sectional view of the device 500A viewed through the cross-sectional plane 102A in FIG2 . At the location of the plane 102A, the engaging element 510 has a rectangular or substantially rectangular shape. In some embodiments, when the actuating element (not shown) is inserted between the layers 582A of the engaging element 510A, the engaging element 510A remains straight when viewed from the side, but bends outward to form a circular or substantially circular shape when viewed in cross-section 102A.

[0609] Now refer to Figures 103 to 105 , shows an example implantable prosthetic device 100 having a covered portion and an uncovered portion. The device 100 is shown implanted in a native mitral valve MV and secured to the native leaflets 20, 22. As described above, the device 100 includes an apposition element or instrument for apposition 110, a paddle 120, a hook 130, and a cover 114. The paddle 120 and the hook 130 are in a closed position to secure the device 100 to the grasped native leaflets 20, 22 of the mitral valve MV. The proximal portion 105 of the device 100 is exposed to the left atrium LA, while the distal portion 107 of the device 100 is exposed to the left ventricle LV.

[0610] Now refer to Figure 103, the device 100 is shown having a covering 900 that covers the entirety of the apposition element or the device for apposition 110 and the cover 114. In some embodiments, the covering 900 can be a cloth or fabric or polymer, such as PET, velvet, a material formed by electrospinning, deposition, or other suitable material. In other embodiments, instead of or in addition to the fabric, the covering may include a coating (e.g., a polymer) applied to the prosthetic spacer device and / or mechanical sealing mechanism, such as silicone, and interlocking joints may be used. The covering 900 can be formed from a metal fabric, such as a mesh, woven, braided, or formed in any other suitable manner, or from a flexible material that is laser cut or otherwise cut. The covering 900 can be cloth, a shape memory alloy wire (such as nitinol) to provide shape-holding capability, or any other flexible material suitable for implantation in the human body. The covering 900 prevents blood from flowing through the apposition element or the device for apposition 110 at the proximal portion 105, and also provides a seal between the device 100 and the leaflets 20, 22. Thus, the covering 900 helps prevent blood from flowing through the native valve at the location of the device 100. The covering 900 also prevents recirculating blood from entering the device 100 from the distal portion 107.

[0611] Now refer to Figure 104 , the device 100 is shown having a covering 1000 that partially covers the apposition element or device for apposition 110 from the proximal portion 105 of the device 100 to the portion of the apposition element or device for apposition 110 that engages the natural leaflets 20, 22. In some embodiments, the covering can be cloth or fabric, such as PET, velvet, or other suitable fabric. In other embodiments, the covering can include a coating (e.g., a polymer) applied to the prosthetic spacer device instead of or in addition to the fabric. The covering 1000 can be formed from a metal fabric, such as a mesh, woven, braided, or formed in any other suitable manner, or from a flexible material that is laser cut or otherwise cut. The covering 1000 can be cloth, a shape memory alloy wire (such as Nitinol) to provide shape-holding capabilities, or any other flexible material suitable for implantation in the human body. Thus, the covering 1000 prevents blood from flowing through the apposition element or device for apposition 110 at the proximal portion 105.

[0612] Now refer to Figure 105, the device 100 is shown having a covering 1100 that partially covers the apposition element or the instrument for apposition 110 extending from the portion of the apposition element or the instrument for apposition 110 that engages the natural leaflets 20, 22 toward the distal portion 107. The covering 1100 also covers the cap 114. In some embodiments, the covering can be a cloth or fabric, such as PET, velvet, or other suitable fabric. In other embodiments, instead of or in addition to the fabric, the covering can include a coating (e.g., a polymer) applied to the prosthetic spacer device. The covering 1100 can be formed from a mesh, woven, braided, or formed in any other suitable manner. The covering 1100 can be a cloth, a polymer, a silicone, an electrospun material, a deposited material, and / or a shape memory alloy wire (such as nitinol) to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body. Thus, blood flow can enter the apposition element or the instrument for apposition 110, but is prevented from passing through the device by the covering 1100 arranged toward the distal portion 107. The covering 1100 also prevents recirculating blood flow from entering the device 100 from the distal portion 107 .

[0613] Now refer to Figures 106 to 109 , shows an example apposition element 1200 for an implantable prosthetic device. The apposition element 1200 can be used with any implantable prosthetic device described in this application. Figure 106 , the apposition element 1200 has a cylindrical or substantially cylindrical shape extending between the two covers 1201. However, the apposition element 1200 can have any shape, such as any shape disclosed herein. In an exemplary embodiment, the direction of expansion of the apposition element 1200 can be controlled. For example, the width / dimension of the apposition element in the anterior-posterior direction (when implanted), the lateral-lateral direction (when implanted), or both can be expanded (or contracted) in a controlled manner. The apposition element can be made of a web of material 1200. Now referring to Figure 107 , the walls of the generally cylindrical mate element 1200 extend outwardly from the cover 1201 a distance 1204. Figure 108 , an axial force 1208 is applied to the cap 1201 of the apposition element 1200, causing the apposition element 1200 to compress in the axial direction. Axial compression of the apposition element 1200 causes the apposition element 1200 to expand or bulge in an outward direction 1210, causing the distance 1204 to increase.

[0614] The juxtaposition element 1200 can be compressed in a variety of ways. For example, a threaded connection can be used to pull the two ends of the juxtaposition element together or push the two ends of the juxtaposition element apart. For example, a collar can be provided on each end of the juxtaposition element. One collar can threadably engage a threaded shaft, while the other collar can be rotatably connected to the shaft. Rotating the shaft in one direction pulls the collars together. Rotating the shaft in the opposite direction moves the collars apart.

[0615] Incorporating the apposition element 1200 into the implantable prosthetic device of the present application allows the apposition element to expand to press outwardly against tissue grasped between the apposition element and the paddle and / or grasping member.

[0616] Now refer to Figure 106A 、 108A , 106B and 108B, showing an example apposition element 1200 for an implantable prosthetic device, which is similar to Figures 106 to 109 The embodiment shown. The apposition element 1200 can be used with any implantable prosthetic device described in this application. Figure 106A , the mate element 1200 has a cylindrical or substantially cylindrical shape extending between the two covers 1201. However, the mate element 1200 can have any shape, such as any shape disclosed herein. Figure 106A and 108A In the example shown, the apposition element 1200 includes a tube 1203 having a groove 1205. For example, the tube 1203 can be made of a shape memory alloy such as Nitinol, and the groove can be cut, such as by laser cutting, into the tube. The groove can be cut into the material forming the tube before the material is formed into the tube.

[0617] In one exemplary embodiment, the direction of expansion of the apposition element 1200 can be controlled. For example, the configuration of the groove 1205 and / or the shape of the tube can be selected to control the shape of the expanded apposition element 1200. For example, the configuration of the groove 1205 and / or the shape can determine how the width / size of the apposition element expands (and / or contracts) in the anterior-posterior direction and / or the lateral-medial direction. Figure 106A The wall of the generally cylindrical mate element 1200 may extend outwardly from the cover 1201 by a distance 1204. Figure 108A , an axial force 1208 and / or a rotational force 1209 may be applied to the cover 1201 of the mating element 1200, thereby causing the mating element 1200 to rotate from Figure 106A The configuration shown expands to Figure 108A In the example shown, the apposition elements 1200 are axially compressed and twisted to expand or bulge in an outward direction 1210 such that the distance 1204 increases.

[0618] refer to Figure 106B and Figure 108B, the coupling element 1200 can be compressed in a variety of different ways. For example, the threaded connection 1221 can be used to pull the two ends of the coupling element together and twist the coupling element in a first direction, or to push the two ends of the coupling element apart and twist the coupling element in a second direction. For example, a bushing can be provided on each end of the coupling element. One bushing can be threadably engaged with a threaded shaft, while the other bushing is fixedly connected to the shaft. Rotating the shaft in one direction draws the bushings together and causes the bushings to rotate relative to each other in a first direction. Rotating the shaft in the opposite direction moves the bushings apart and causes the bushings to rotate relative to each other in a second direction. The pitch of the threaded connection can be selected to set the ratio between the distance the coupling element 1200 is compressed and the angle by which the coupling element is twisted.

[0619] Will Figure 106A 、 108A Incorporation of the apposition element 1200 shown in Figures 106B, 108B into the implantable prosthetic device of the present application allows the apposition element to expand to press outwardly against tissue grasped between the apposition element and the paddle and / or grasping member.

[0620] Figure 106C and 108C An example embodiment of a controllably expandable apposition element 1200 for an implantable prosthetic device is shown. The apposition element 1200 can be used alone, with a covering, or within any of the apposition elements described herein (to expand the apposition element). The apposition element 1200 can be used with any of the implantable prosthetic devices described in this application. Figure 106C , the mating element 1200 has a pair of pivotally connected arms 1231. Each of the pair of pivotally connected arms 1231 extends between the two covers 1201 and is pivotally connected to the two covers. In the example shown, there are two pairs of pivotally connected arms 1231. However, there can be one, three, four, or any number of pairs of pivotally connected arms.

[0621] In one exemplary embodiment, the direction of expansion of the apposition element 1200 can be controlled. For example, two pairs of pivotally connected arms (as shown) can be included to change the width / size of the apposition element in only one of the front-to-back direction and / or the inside-outside direction. Four pairs of pivotally connected arms 1231 can be included to change the width / size of the apposition element in the front-to-back direction and the inside-outside direction. When four pairs of pivotally connected arms 1231 are included, the arms can have different lengths and / or pivot point locations so that the apposition element 1200 expands (or contracts) differently in different directions. For example, the length of the arms can be selected to expand more in the inside-outside direction than in the front-to-back direction.

[0622] Now refer to Figure 108C, an axial force 1208 can be applied to the cover 1201 of the mating element 1200, thereby causing the mating element 1200 to move from Figure 106C The configuration shown expands to Figure 108C In the example shown, axial compression of the pivotally connected arm 1231 causes the pivotal connection 1233 or knee to expand in an outward direction 1210 such that the distance 1204 increases.

[0623] refer to Figure 106C and Figure 108C The compressing element 1200 can be compressed in a variety of ways. For example, threaded connector 1221 can be used to pull the two ends of the compressing element together or push them apart. For example, a bushing can be provided on each end of the compressing element. One bushing can threadably engage a threaded shaft, while the other bushing can be rotatably connected to the shaft. Rotating the shaft in one direction pulls the bushings together. Rotating the shaft in the opposite direction moves the bushings apart.

[0624] Will Figure 106C and 108C Incorporation of the illustrated apposition element 1200 into the implantable prosthetic device of the present application allows the apposition element to expand to press outwardly against tissue grasped between the apposition element and the paddle and / or grasping member.

[0625] Figure 106D and 108D An exemplary embodiment of an expandable apposition element 1200 for an implantable prosthetic device is shown. The apposition element 1200 can be used alone, with a covering (see Figure 106E and Figure 108E ), or used within any of the apposition elements described herein (to expand the apposition element). The apposition element 1200 can be used with any implantable prosthetic device described in this application. Figure 106C , the coaptation element 1200 has a central support member 1243, one or more pivotally connected arms 1241, and connecting wires 1245. Each arm 1241 extends from a pivot connection to the central support member 1243. Each connecting wire 1245 is connected to the central support member 1243 and the pivotally connected arm 1241. The length of the connecting wire 1245 determines the extent to which the connecting arm pivots away from the central support member 1243. In the example shown, there are two pivotally connected arms 1241. However, there can be one, three, four, or any number of pivotally connected arms.

[0626] In one exemplary embodiment, the direction of expansion of the apposition element 1200 can be controlled. For example, two pivotally connected arms can be included to change the width / size of the apposition element in only one of the front-to-back direction and / or the inside-outside direction. Four pivotally connected arms 1241 can be included to change the width / size of the apposition element in the front-to-back direction and the inside-outside direction. When four pivotally connected arms 1241 are included, the arms and / or connecting lines 1245 can have different lengths and / or pivot point locations to allow the apposition element 1200 to expand (or contract) differently in different directions. For example, the length of the arms and / or connecting lines can be selected to expand more in the inside-outside direction than in the front-to-back direction.

[0627] The arm 1241 can be moved from a retracted position ( Figure 106D ) to the extended position ( Figure 108D ). For example, the arms 1241 may be biased toward the expanded position by a spring or other biasing means. In the example shown, a restraint 1247, such as a suture, holds the arms 1241 in the retracted position. The restraint 1247 may be removed or broken to allow the apposition element 1200 to be retracted. Figure 106D The configuration shown expands to Figure 108D Configuration shown.

[0628] Figure 106E and Figure 108E Shown with Figure 106D and Figure 108D The embodiment shown is similar to the exemplary embodiment, except that the mate elements include a covering material 1253. The covering material 1253 can extend from the central support member 1243 to each arm 1241. The covering material 1253 can be used in conjunction with the connecting wire 1245, or the covering material can eliminate the need for the connecting wire 1245.

[0629] Now refer to Figure 106F , showing an example apposition element 1200 for an implantable prosthetic device, which is similar to Figures 106 to 109 The embodiment shown. The apposition element 1200 can be used with any implantable prosthetic device described in this application. Figure 106F , the apposition element 1200 is defined by a coil 1263 extending between the two covers 1201. The apposition element 1200 can have any shape, such as any shape disclosed herein. The coil 1263 can be made of a shape memory alloy, such as Nitinol.

[0630] In one example embodiment, the direction of expansion of the apposition element 1200 can be controlled. For example, the shaping of the coil 1263 can be selected to control the shape of the expanded apposition element 1200. For example, the configuration of the shaping can determine the manner in which the width / size of the apposition element expands (and / or contracts) in the anterior-posterior direction and / or the lateral-lateral direction. With reference to the axial force 1208 and / or the rotational force 1209, these can be applied to the cap 1201 of the apposition element 1200 to cause the apposition element 1200 to expand (and / or contract). Figure 106F In the example shown, axially extending the coil 1263 and twisting the coil 1263 contracts the coil in the inward direction 1211, and axially compressing the coil 1263 and twisting the coil in the opposite direction expands or bulges the coil in the outward direction.

[0631] refer to Figure 106F , the coupling element 1200 can be compressed in a variety of different ways. For example, the threaded connection 1221 can be used to pull the two ends of the coupling element together and twist the coupling element in a first direction, or to push the two ends of the coupling element apart and twist the coupling element in a second direction. For example, a bushing can be fixedly connected to each end of the coil 1263. One bushing can be threadably engaged with a threaded shaft, while the other bushing is fixedly connected to the shaft. Rotating the shaft in one direction draws the bushings together and causes the bushings to rotate relative to each other in a first direction. Rotating the shaft in the opposite direction moves the bushings apart and causes the bushings to rotate relative to each other in a second direction. The pitch of the threaded connection can be selected to set the ratio between the distance the coupling element 1200 is compressed and the angle the coupling element is twisted.

[0632] Will Figure 106F Incorporation of the illustrated apposition element 1200 into the implantable prosthetic device of the present application allows the apposition element to expand to press outwardly against tissue grasped between the apposition element and the paddle and / or grasping member.

[0633] Figures 106G to 106I An example embodiment of an expandable involute element 1200 is shown. Figures 106G to 106I In the illustrated example, the apposition element is expanded by a fluid medium. The fluid medium can take a variety of different forms. Examples of fluids that can be used to expand the apposition element 1200 include, but are not limited to, air, gel, water, blood, foam, etc. The apposition element 1200 can be used with any implantable prosthetic device described herein.

[0634] refer to Figure 106G, the apposition element 1200 can have an outer layer 1271 (e.g., any of the apposition elements 110, 510 disclosed herein) and an inner layer 1273 or balloon. The apposition element 1200 can have any shape, such as any shape disclosed herein. Figure 106G In the example shown in FIG1086 , inner layer 1273 is disposed within outer layer 1271 and can have the same or substantially the same shape as the inner surface of the outer layer. The inner layer can be made of an expandable material, such as rubber or other materials conventionally used to manufacture balloons and angioplasty devices. Outer layer 1271 can be made of a shape memory alloy, such as Nitinol.

[0635] refer to Figure 106H and Figure 106I In one example embodiment, the expansion direction of the involute element 1200 can be controlled. Figure 106H In the example shown, the inner layer 1273 includes two balloons that are optionally connected together. However, any number of balloons can be used. For example, the inner layer can include 3, 4, or any number of balloons. The balloons can be expanded individually to control the expanded shape of the apposition element 1200. When the balloons are connected together, the connection also affects the shape of the expansion. In the example shown in 106H, the balloons are connected together along a plane 1275 or area. Due to the connection 1275, the expansion of the inner layer 1273 in direction 1277 will be less than the expansion in direction 1279. Thus, in this example, the expansion caused by the expansion can be limited to or substantially limited to expansion along the inside-out direction.

[0636] The use of multiple balloons and the configuration of any connections between the balloons can determine the manner in which the width / size of the apposition elements expands (and / or contracts) in the anterior-posterior and / or lateral-medial directions.

[0637] exist Figure 106I In the example shown, the inner layer 1273 includes one or more supports 1281 or struts. One support 1281 is shown, but any number can be used. For example, the inner layer can include 2, 3, 4, or any number of supports. The supports 1281 can divide the inner layer into multiple independently expandable chambers, or the supports may not seal the independent chambers, and an inflation fluid applied to any chamber will fill all of the chambers. When independently expandable chambers are present, the chambers can be individually inflated to control the expanded shape of the apposition element 1200. The supports also affect the shape of the expansion. In the case of a Figure 106I In the example shown, support members 1281 will reduce or eliminate expansion of inner layer 1273 in direction 1277. Thus, in this example, expansion due to expansion can be limited or substantially limited to expansion along the in-out direction.

[0638] The use of multiple independently expandable chambers and / or the configuration of the support member 1281 can determine how the width / size of the apposition element expands (and / or contracts) in the anterior-posterior direction and / or lateral-lateral direction.

[0639] Will Figures 106G to 106I Incorporation of the illustrated apposition element 1200 into the implantable prosthetic device of the present application allows the apposition element to expand to press outwardly against tissue grasped between the apposition element and the paddle and / or grasping member.

[0640] Now refer to Figures 110 to 111 , an example implantable prosthetic device 1300 is shown. Device 1300 is similar to device 100 described above and includes an apposition element 1310, a paddle 1320, and a hook or gripping member 1330. Referring now to Figure 111 , showing a top view of the mating element 1310. Figure 111 As shown in FIG, the apposition element 1310 has an oval or substantially oval cross-section. The apposition element 1310 does not include a central opening and can be formed from a solid block of material, such as foam. Forming the apposition element 1310 from a solid block of foam prevents blood from flowing through the center of the apposition element 1310, thereby substantially eliminating a location where blood can be trapped. The device 1300 may include any other features used in the implantable prosthetic devices discussed in this application, and the device 1300 may be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The prosthetic device 1300 can be opened and closed in a variety of different ways. For example, a sleeve can be slidably disposed on the apposition element to engage and open the paddle. Alternatively, the paddle can be opened by pulling a thread or suture that opens a hook, and the movement of the hook can open the paddle. However, any mechanism for opening and closing the device 1300 can be used.

[0641] Now refer to Figure 112 and 128 , an example paddle frame 1400 for an implantable prosthetic device is shown. Paddle frame 1400 can be used with any of the implantable prosthetic devices described herein. Paddle frame 1400 is formed from a piece of material 1402, such as nitinol or any other suitable material. Paddle frame 1400 extends from a cover attachment portion 1410 to a paddle connection portion 1420 and has a proximal portion 1422, a middle portion 1424, and a distal portion 1426. In some embodiments, paddle frame 1400 includes a cover for attaching a paddle to a paddle. Figure 30), inner paddle 522 and / or outer paddle 520 are secured to attachment portion 1440 of paddle frame 1400. In some embodiments, paddle frame 1400 is thinner at the location of fifth curve 1438 to facilitate bending of the sides of paddle frame 1400 toward center plane 1404, for example, during crimping of the device.

[0642] Paddle frame 1400 extends in a circular three-dimensional shape from first attachment portion 1412 through proximal portion 1422, middle portion 1424, and distal portion 1426, and back to second attachment portion 1414. To form the circular three-dimensional shape, blade frame 1400 bends or curves in multiple locations as it extends between first attachment portion 1412 and second attachment portion 1414. Attachment portions 1412, 1414 include notches 1416, 1418, respectively, for attachment to a cover. Blade frame 1400 flexes at region 1419. Region 1419 may include a wider portion 1417 to distribute the stresses generated by bending blade frame 1400 over a larger area. Similarly, notches 1416, 1418 may include radial notches 1415 at each end of the notch. Radiating notches 1415 serve as strain relief for the bend region 1419 and the area where blade frame 1400 connects to the cover.

[0643] Blade frame 1400 is away from middle or center plane 1404 at first curve 1430 ( Figure 115 ) is bent to widen the shape of the blade frame 1400. Figure 117 As shown, paddle frame 1400 further curves away from frontal plane 1406 at first curve 1430. Paddle frame 1400 bends in an outward direction away from first curve 1430 at second curve 1432 to form the sides of frame 1400. Paddle frame continues to tilt away from frontal plane 1406 at second curve 1432. In some embodiments, second curve 1432 has a larger radius than first curve 1430. When viewed from frontal plane 1406, as paddle frame 1400 continues to bend in the arc of second curve 1432, paddle frame 1400 curves away from frontal plane 1406 at third curve 1434. This curvature at third curve 1434 causes frame 1400, and therefore the native valve leaflets, to gradually deviate from centerline 1406. This deviation from the centerline causes the leaflet tissue to stretch toward the valve annulus, which can result in less stress on the leaflet tissue. As frame 1400 continues to bend away from frontal plane 1406, blade frame 1400 bends toward lateral plane 1404 at fourth curve 1436. The circular three-dimensional shape of blade frame 1400 is closed by fifth curve 1438 connecting the two sides of blade frame 1400. Figure 116 and 118As shown, paddle frame 1400 has an arcuate or substantially arcuate shape as it extends from attachment portion 1420 to closure portion 1424. Frame mid-portion 1424 is closer to frontal plane 1406 than closure portion 1426, thereby imparting a rounded, wing-like shape to the sides of mid-portion 1424 that acts as a curved surface of an apposition element (not shown) during gripping of natural tissue between a paddle (not shown) and an apposition element (not shown) of an implantable device of the present invention.

[0644] refer to Figure 191 In an exemplary embodiment, the flat blank 1403 of the blade frame 1400 can be cut, for example, laser cut, from a flat sheet. Figure 192 , the cut blank 1403 can then be bent to form the three-dimensional shape of the blade frame 1400.

[0645] refer to Figure 193 and 194 In one example embodiment, paddle frame 1400 may be shaped to provide increased clamping force against or toward mate element 510 when paddles 520, 522 are in the closed configuration. This is because paddle frame 1400 is shaped relative to the closed position (e.g., Figure 194 ) is shaped to a first position (e.g., Figure 193 ), the first position being beyond the position where the inner blade 522 will engage the mating element, such as beyond the center plane 552 of the device 500, such as beyond the outer blade on the opposite side of the mating element. Figure 194 , blade frame 1400 is bent and connected to inner blade 522 and outer blade 520, for example, by sewing. This results in the blade frame having a preload (i.e., a clamping force against or toward the abutting elements greater than zero) when blade frame 1400 is in the closed configuration. Figure 194 ) compared to Figure 193 The configured shaped blade frame 1400 may increase the clamping force of the blade frame 1400 .

[0646] The amount of preload on blade frame 1400 can be varied by adjusting the degree to which blade frame 1400 is shaped relative to mate element 510. The further...

Claims

1. A valve repair device for repairing a patient's natural valve, the valve repair device comprising: Strips of material; a mating element formed from the strip of material; as well as a pair of paddles formed from the strip of material and connected to the mating element, wherein the paddles are movable between an open position and a closed position; Wherein the paddle is configured to attach to the native valve of the patient.

2. The valve repair device of claim 1, wherein the strip of material comprises metal strands woven together.

3. A valve repair device as described in any of the preceding claims, wherein the strip of material comprises an electrospun material.

4. A valve repair device as claimed in any one of the preceding claims, wherein the strip of material comprises electrospun metal fibers.

5. The valve repair device of any one of the preceding claims, wherein the paddle comprises an inner paddle portion and an outer paddle portion.

6. A valve repair device as claimed in any one of the preceding claims, wherein the strip of material is folded to form the apposition element and the pair of paddles.

7. A valve repair device as claimed in any one of the preceding claims, wherein the strip of material is folded to form a plurality of layers.

8. The valve repair device of claim 7, wherein the apposition element is formed from four layers of the material strip.

9. The valve repair device of claim 7, wherein the paddle comprises an inner paddle portion and an outer paddle portion, and the inner paddle portion is formed by two layers of folded material strips.

10. The valve repair device of any one of the preceding claims, wherein the paddle is disposed above the extension member.

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