Heart valve sealing device and delivery device therefor

Abstract

To provide improved devices and methods for treating a regurgitant valve.SOLUTION: An implantable prosthetic device has a coaption element and at least one anchor. The coaption element is configured to be positioned within a native heart valve orifice to help fill a space where a native valve is regurgitant and form a more effective seal. The coaption element can have a structure that is impervious to blood. The coaption element can be connected to leaflets of the native valve by the anchor.SELECTED DRAWING: Figure 232A

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 744,031, filed Oct. 10, 2018, which is hereby incorporated by reference in its entirety for all purposes.

Background Art

[0002] Natural heart valves (i.e., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play important roles in ensuring proper forward blood supply through the cardiovascular system. These heart valves can be damaged by congenital malformations, inflammatory processes, infectious conditions, diseases, etc., and thus may have reduced effectiveness. Such valve damage can lead to serious cardiovascular disorders or death. Damaged valves can be surgically repaired or replaced during open - heart surgery. However, open - heart surgery is highly invasive and can cause complications. Transvascular techniques for introducing and implanting artificial devices in a much less invasive manner than open - heart surgery can be used. As one example, for instance, a transseptal technique may be used that includes inserting a catheter into the right femoral vein, advancing up the inferior vena cava, inserting it into the right atrium, puncturing the septum, and passing the catheter into the left atrium.

[0003] A healthy heart has a generally conical shape that tapers towards the apex. The heart is divided into four parts, including the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different biological structure from other natural heart valves. The mitral valve includes an annulus portion, which is a circular - shaped portion of the native valve tissue surrounding the mitral valve orifice, and a pair of valve leaflets or cusps that extend downward from the annulus into the left ventricle. The mitral valve annulus can form a cross - sectional shape that is not a perfect circle, such as “D” - shaped, elliptical, or otherwise having a major axis and a minor axis. The anterior cusp is larger than the posterior cusp, and when they are closed together, they can form a generally “C” - shaped boundary between the adjacent sides of the cusps.

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also called "ventricular 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 called "ventricular systole" or "systole"), the increase in blood pressure in the left ventricle pulls both sides of the two valve leaflets together, closing the one-way mitral valve, so that blood cannot flow back into the left atrium and instead is discharged from the left ventricle through the aortic valve. To prevent the two valve leaflets from deviating under pressure and folding back through the mitral annulus towards the left atrium, a plurality of fibrous cords called chordae tendineae connect the valve leaflets to the papillary muscles of the left ventricle.

[0005] During the systolic phase of cardiac contraction, the native mitral valve cannot close properly, and mitral regurgitation occurs when blood flows 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 many different causes, such as leaflet prolapse, malfunctioning papillary muscles, dilation of the mitral annulus due to left ventricular dilation, two or more of these, etc. Mitral regurgitation in the central part of the leaflet can be called central jet mitral regurgitation, and mitral regurgitation closer to one commissure of the leaflet (i.e., the position where the leaflets touch) can be called eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, so the valve does not close and there is regurgitation.

[0006] Techniques for treating mitral and other valve regurgitation in patients may include directly fixing the edges of the native valve leaflets to each other. For example, catheter-delivered clips can be used in an attempt to clip together both sides of the valve leaflet at the tip portion of the valve leaflet. However, significant challenges exist. For example, multiple clips may be required to remove or reduce regurgitation to an acceptable level, but in some situations, this can result in a longer procedure time and may lead to overly restricted flow or undesirable stress on the native biological structure.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Summary of the Invention

Problems to be Solved by the Invention

[0008] Despite these prior arts, there remains a continuing need for improved devices and methods for treating valve regurgitation.

Means for Solving the Problems

[0009] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims unless the claims expressly enumerate those features. Also, the features, components, steps, concepts, etc. described in the examples in this summary and elsewhere in this disclosure can be combined in various ways. The various features and steps described elsewhere in this disclosure can be included in the examples summarized herein.

[0010] An exemplary implantable artificial device has a core capture element (the term core capture element is used throughout this application, but this can also be referred to as a core captation element, spacer, etc.), and at least one anchor. The core capture element is configured to be positioned within a natural heart valve orifice to assist in filling a space where the natural valve backflows and forms a more effective seal. The core capture element can have a structure that is impermeable to blood. The core capture element can be connected to the valve leaflet of the natural valve by an anchor.

[0011] In one exemplary embodiment, a valve repair device for repairing a patient's natural valve includes a strip of material and a pair of paddles. The core capture element is formed from or includes the strip of material. The pair of paddles is formed from or includes the strip of material and is connected to the core capture element. The pair of paddles is movable between an open position and a closed position.

[0012] The "strip of material" in the various embodiments described throughout this disclosure can be one single integral strip or piece of material. However, in some embodiments, the "strip of material" can be formed from a plurality of smaller unobtrusive pieces of material that are combined into a larger composite strip of material.

[0013] In an exemplary method of manufacturing a valve repair device, a strip of material is folded to form a core capture element and a pair of paddles connected to the core capture element. The paddles are movable between an open position and a closed position and are configured to be attached to a patient's native valve. A portion of the strip of material forming the core capture element is attached to a collar. A portion of the strip of material forming the paddles is attached to a cap. When the cap is moved toward the collar, the pair of paddles move to the closed position. When the cap is moved away from the collar, the pair of paddles move to the open position.

[0014] In an exemplary embodiment, a valve repair device for repairing a patient's native valve has a core capture element and a pair of paddles. The core capture element has four layers. The pair of paddles is connected to the core capture element. The paddles are movable between an open position and a closed position and are configured to be attached to a patient's native valve.

[0015] In an exemplary embodiment, a valve repair device for repairing a patient's native valve includes a strip of material and a collar. The core capture element is formed from the strip of material. The collar is connected to the core capture element. The pair of paddles is formed from the strip of material and is connected to the core capture element. The paddles are movable between an open position and a closed position by moving the collar toward and away from the paddles.

[0016] In an exemplary embodiment, a valve repair device for repairing a patient's native valve includes a collar, a core capture element, and a pair of paddles. The collar has a plurality of engagement portions configured to releasably engage a delivery device. The core capture element is attached to the collar. The pair of paddles is connected to the core capture element and is movable between an open position and a closed position. The paddles are circumferentially disposed between the engagement portions. The paddles are configured to be attached to a patient's native valve.

[0017] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a coaptation element, a pair of paddles, and a covering. The pair of paddles is connected to the coaptation element. The paddles are movable between an open position and a closed position. When the paddles are in the open position, a catch point (e.g., a point that may pull or capture a portion of the delivery system and interfere with deployment and / or recapture of the device) is formed by or between at least a portion of the coaptation element and the pair of paddles. A cover connected to the coaptation element and the paddles covers the catch point.

[0018] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a coaptation element, a pair of paddles, a first cover, and a second cover. The pair of paddles is connected to the coaptation element and is movable between an open position and a closed position. The first cover extends from the distal end of the device and covers at least a portion of the paddles. The second cover extends from the proximal end of the device and covers at least a portion of the coaptation element.

[0019] In one exemplary embodiment, a valve repair device for repairing a patient's native valve is made from a strip of material. The strip of material has first and second edges surrounding a central portion. The coaptation element is formed from the strip of material. The pair of paddles is formed from the strip of material. The pair of paddles is connected to the coaptation element. The paddles are movable between an open position and a closed position.

[0020] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a strip of material, a pair of attachment portions, a pair of extension members, and a cap. A core cushioning 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 core cushioning element. The paddles are movable between an open position and a closed position. The paddles are disposed on the extension members. The cap is attached to the paddles. Moving the cap toward the core cushioning element causes the pair of paddles to move to the closed position. Moving the cap away from the core cushioning element causes the pair of paddles to move to the open position. The cap includes a retaining body, a retaining nut, and a retaining bolt. The retaining body has a locking aperture for receiving the attachment portion of the extension member. The retaining nut is inserted into the locking aperture. The retaining bolt secures the retaining nut within the locking aperture.

[0021] In one exemplary method of manufacturing a valve repair device for repairing a patient's native valve, a strip of material is folded to form a core cushioning element and a pair of paddles connected to the core cushioning element. The paddles are movable between an open position and a closed position and are configured to be attached to the patient's native valve. A portion of the strip of material forming the paddles is attached to the cap. Moving the cap toward the core cushioning element causes the pair of paddles to move to the closed position. Moving the cap away from the core cushioning element causes the pair of paddles to move to the open position. The cap includes a retaining body, a retaining nut, and a retaining bolt. The retaining body has a locking aperture for receiving the attachment portion of the extension member. The retaining nut is configured to be inserted into the locking aperture. The retaining bolt secures the retaining nut within the locking aperture. The pair of extension members are attached to the retaining body of the cap via the attachment portions of the extension members such that the paddles are disposed on the extension members. The retaining bolt and the retaining nut are assembled to secure the cap to the strip of material.

[0022] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a strip of material, a cap, and a pair of extension members. The core capture element is formed from the strip of material. A pair of paddles are formed from the strip of material and are connected to the core capture 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 cap is attached to the paddles. Moving the cap toward the core capture element causes the pair of paddles to move to the closed position. Moving the cap away from the core capture element causes the pair of paddles to move to the open position. The pair of extension members are connected to the cap and are movable between an open position and a closed position. In the closed position, the extension members are biased in the closing direction.

[0023] In one exemplary method of 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 jig to form both a core capture element and a pair of paddles connected to the core capture 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 set the shape of the strip of material to the shape of the core capture element and the paddles.

[0024] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a strip of material, a cap, and a pair of extension members. A core capture element is formed from the strip of material. A pair of paddles is formed from the strip of material and connected to the core capture element. The paddles are movable between an open position and a closed position and are configured to be attached to the patient's native valve. The cap is attached to the paddles. Moving the cap toward the core capture element causes the pair of paddles to move to the closed position. Moving the cap away from the core capture element causes the pair of paddles to move to the open position. The pair of extension members is connected to the cap and the paddles. The extension members extend from an attachment portion for attaching the extension members to the cap to an end portion attached to the strip material forming the paddles. The end portion of the extension members extends beyond the strip of material.

[0025] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a main core capture element, at least one auxiliary core capture element, and a pair of paddles. The at least one auxiliary core capture element is connected to the core capture element. The pair of paddles is connected to the main core capture element. The paddles are movable between an open position and a closed position.

[0026] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a core capture element, a pair of paddles connected to the core capture element, and a pair of paddle frames. The paddles are movable between an open position and a closed position. The paddles are configured to be attached to the patient's native valve. The first and second paddle frames have frame portions spaced parallel or substantially parallel when the paddles are in the closed position to form a rectangular valve tip engagement region.

[0027] In one example of a method for repairing a native heart valve, the first and second repair devices are placed on a pair of leaflets of the native heart valve. Each repair device has a frame having a rectangular or substantially rectangular shape. The paddle frames of the placed repair devices are adjacent to each other and are parallel or substantially parallel to each other.

[0028] The foregoing methods and other treatment methods herein can be performed on a living animal or on a simulation such as, for example, a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, tissue, etc.).

[0029] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a pair of paddles and a pair of clasps. The paddles are movable between an open position and a closed position. Each clasp 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 such that the barb support portion bends away from the movable arm.

[0030] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, and in particular, when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.

[0031] To further clarify various aspects of the embodiments of the present disclosure, a more specific description of certain embodiments is made by referring to various aspects of the accompanying drawings. It is understood that these drawings depict only typical embodiments of the present disclosure and are not to be considered as limiting the scope of the present disclosure. Further, while the drawings may be to scale for some embodiments, the drawings are not necessarily to scale for all embodiments. The embodiments of the present disclosure as well as other features and advantages are described and explained using additional specificity and detail through the use of the accompanying drawings.

Brief Description of the Drawings

[0032]

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[0033] The following description refers to the accompanying drawings that illustrate specific embodiments of the present disclosure. Other embodiments having different structures and operations do not depart from the scope of the present disclosure.

[0034] Exemplary embodiments of the present disclosure relate to devices and methods for repairing defective heart valves. Various embodiments of native valve repair devices and delivery systems are disclosed herein, and it should be noted that any combination of these options can be made, unless specifically excluded. In other words, the individual components of the disclosed devices and systems can be combined, except where they are mutually exclusive or physically impossible otherwise.

[0035] As described herein, when one or more components are described as being connected, joined, affixed, linked, attached, or interconnected in another way, such an interconnection may be direct between the components or may be indirect, such as by the use of one or more intermediate components. Also, as described herein, references to "member", "component", or "portion" are not limited to a single structural member, component, or element, but can include a collection of components, members, or elements. Also, as described herein, the terms "substantially" and "about" are defined as being at least near (and including) a given value or state (preferably within 10%, more preferably within 1%, most preferably within 0.1%).

[0036] Figures 1 and 2 are cutaway views of a human heart H during diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV, respectively, i.e., the atrioventricular valves. Further, 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 valve leaflets (e.g., valve leaflets 20, 22 shown in FIGS. 4 and 5) that come together or "coapt" in the flow to form a one-way fluid occluding surface that extends inwardly across the individual valve orifices. The native valve repair system of the present application is described primarily with respect to the mitral valve MV. Accordingly, the anatomical structures of the left atrium LA and the left ventricle LV are described in more detail. It should be understood that the devices described herein can also be used in the repair of other native valves, e.g., the devices can be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0037] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase or diastole, as seen in Figure 1, the blood that has already collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV into the left ventricle LV due to the expansion of the left ventricle LV. During the systolic phase or systole, as seen in Figure 2, the left ventricle LV contracts and pumps 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 into the left atrium LA, and blood is collected into the left atrium from the pulmonary veins. In one exemplary embodiment, the device described by this application is used to repair the function of a defective mitral valve MV. That is, the device is configured to help close the leaflets of the mitral valve to prevent blood from flowing back from the left ventricle LV into the left atrium LA. Different from the prior art that describes the use of sutures or clips, which often require multiple sutures or clips and additional supports to treat large regurgitations, the device described in this application is designed to easily grip and fix the native leaflets around a core occlusion element that acts as a filling agent for the regurgitant orifice.

[0038] Referring now to Figures 1 - 7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, a variably dense fibrous tissue ring that surrounds the leaflets 20, 22. Referring to Figure 3, the mitral valve MV is tethered 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., the 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 function to limit the movement of the mitral valve MV and prevent the mitral valve from prolapsing. In response to pressure changes in the left atrium LA and the left ventricle LV, the mitral valve MV opens and closes. The papillary muscles do not open and close the mitral valve MV. Rather, the papillary muscles support the mitral valve MV against the high pressures necessary to circulate blood throughout the body. The papillary muscles and chordae tendineae are together known as subvalvular tissue, which functions to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed.

[0039] A variety of disease processes can impair the proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastofibroma), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). Further, 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 diseases (e.g., cardiomyopathy) can deform the shape of the native valve, which can cause native valve insufficiency. However, most patients undergoing valve surgery, such as mitral valve MV surgery, suffer from degenerative diseases that cause insufficiency of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), which results in prolapse and regurgitation.

[0040] Generally, native valves can be insufficient in two different ways: (1) valvular stenosis, and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not open fully, thereby causing an obstruction to blood flow. Typically, valvular stenosis is due to the accumulation of calcified material on the leaflets of the valve, which thickens the leaflets and impairs the valve's ability to open fully and allow forward blood flow.

[0041] Valve regurgitation, which is the second type of valve dysfunction, occurs when the valve leaflets do not close completely, thereby allowing blood to leak back into the previous ventricle (e.g., blood leaks from the left ventricle into the left atrium). There are three main mechanisms by which native valves become regurgitant or insufficient, including Carpentier's type I, type II, and type III dysfunctions. Carpentier's type I dysfunction involves dilation of the annulus such that normally functioning leaflets are displaced from each other and cannot form a tight seal (i.e., the leaflets do not appose properly). Included in the dysfunction of the type I mechanism is perforation of the leaflets such as that which exists in endocarditis. Carpentier's type II dysfunction involves displacement of one or more leaflets of the native valve above the plane of coaptation. Carpentier's type III dysfunction involves restriction of the movement of one or more leaflets of the native valve such that the leaflets are abnormally constrained below the plane of the annulus. Restriction of the leaflets can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0042] Referring to FIG. 4, when a healthy mitral valve MV is in the closed position, the anterior leaflet 20 and posterior leaflet 22 appose, which prevents blood from leaking from the left ventricle LV into the left atrium LA. Referring to FIG. 5, regurgitation occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA during systole. Inability to appose in this manner creates a gap 26 between the anterior leaflet 20 and posterior leaflet 22, which allows blood to regurgitate from the left ventricle LV into the left atrium LA during systole. As noted above, there are several different ways in which leaflets (e.g., leaflets 20, 22 of the mitral valve MV) can be dysfunctional and thereby cause regurgitation.

[0043] Referring to FIG. 6, in certain situations, the 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 the closed position (i.e., during systole). For example, the gap 26 can have a width W of about 2.5 mm to about 17.5 mm, such as about 5 mm to about 15 mm, such as about 7.5 mm to about 12.5 mm, such as about 10 mm. In some situations, the gap 26 can have a width W greater than 15 mm. In any of the above situations, a valve repair device that can engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV is desirable.

[0044] Stenosis or regurgitation can affect any valve, but stenosis has been found to mainly affect either the aortic valve AV or the pulmonary valve PV, and regurgitation has been found to mainly affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve 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. The left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is mainly involved in circulating the blood flow throughout the body, and dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening. Therefore, because the pressure on the left side of the heart is substantially higher, dysfunction of the mitral valve MV or the aortic valve AV is often more problematic.

[0045] For natural heart valve dysfunction, either repair or replacement can be performed. Repair typically involves 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 pulmonary valve PV are more prone to stenosis. Since the stenotic lesions sustained by the valve leaflets are irreversible, the most conventional treatment for a stenotic aortic valve or stenotic pulmonary valve is removal of the valve and replacement with a surgically implanted heart valve, or replacement with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to leaflet deformation, which, as described above, prevents the mitral or tricuspid valve from closing properly and allows blood to flow backward or regurgitate from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow regurgitation or backflow from the left ventricle LV into the left atrium LA). Backflow or regurgitation of blood from the ventricle into the atrium results in valvular insufficiency. Deformation of the structure or shape of the mitral valve MV or tricuspid valve TV is often repairable. Additionally, regurgitation can occur when the chordae tendineae 10 malfunction (e.g., the chordae tendineae can stretch or rupture), which allows the anterior leaflet 20 and posterior leaflet 22 to be retracted, thus allowing blood to regurgitate into the left atrium LA. The problems caused by malfunctioning 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).

[0046] The devices and procedures disclosed herein often refer to mitral valve repair for illustrative purposes. 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, referring now to FIG. 7, any 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, septal leaflet 32, and posterior leaflet 34 to prevent the backflow of blood from the right ventricle into the right atrium. Further, any of the devices and concepts provided herein can be used together for all three of the valve leaflets 30, 32, 34 to prevent the backflow of blood from the right ventricle into the right atrium. That is, the valve repair device provided herein can be positioned centrally among the three valve leaflets 30, 32, 34.

[0047] The exemplary implantable artificial device has a core capture element and at least one anchor. The core capture element is configured to be positioned within a native heart valve orifice to assist in filling the space and forming a more effective seal, thereby reducing or preventing the backflow described above. The core capture element is impermeable or resistant to blood and has a structure that allows the native valve leaflets to close around the core capture element during ventricular systole, preventing blood from flowing from the left ventricle or right ventricle into the left atrium or right atrium, respectively. The artificial device can be configured to seal against two or three native valve leaflets, i.e., the device can be used in native mitral (bicuspid) and tricuspid valves. Since the core capture element can fill the space between a native mitral or tricuspid valve that does not close completely and is not functioning properly, the core capture element is sometimes also referred to herein as a spacer.

[0048] The core capture element (e.g., spacer, core capture element, etc.) can have various shapes. In some embodiments, it can have an elongated cylindrical shape with a circular cross-sectional shape. In other embodiments, the core capture element can have an elliptical cross-sectional shape, a crescent-shaped cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. The core capture element can have an atrial portion positioned within or adjacent to the left atrium, a ventricular portion or lower portion positioned within or adjacent to the left ventricle, and a side extending between the natural mitral valve leaflets. In embodiments configured for use with the tricuspid valve, the atrial portion or upper portion is positioned within or adjacent to the right atrium, the ventricular portion or lower portion is positioned within or adjacent to the right ventricle, and the side extends between the natural tricuspid valve leaflets.

[0049] The anchor can be configured to fix the device to one or both of the natural mitral valve leaflets such that the core capture element is positioned between the two natural valve leaflets. In embodiments configured for use with the tricuspid valve, the anchor is configured to fix the device to one, two, or three of the tricuspid valve leaflets such that the core capture element is positioned between the three natural valve leaflets. In some embodiments, the anchor can be attached to the core capture element at a position adjacent to the ventricular portion of the core capture element. In some embodiments, the anchor can be attached to an actuating element such as a shaft or an actuating wire, to which the core capture element is also attached. In some embodiments, the anchor and the core capture element can be positioned independently of each other by moving each of the anchor and the core capture element separately along the longitudinal axis of the shaft or the actuating wire. In some embodiments, the anchor and the core capture element can be positioned simultaneously by moving the anchor and the core capture element together along the longitudinal axis of the shaft or the actuating wire. The anchor can be configured to be positioned behind the natural valve leaflet when implanted such that the valve leaflet is gripped by the anchor.

[0050] The artificial device can be configured to be implanted via a delivery sheath. The core capture element and the anchor can be compressible into a radially compressed state and self-expanding into a radially expanded state when the compression pressure is released. The device can be configured to first expand the anchor radially away from the still-compressed core capture element to create a gap between the core capture element and the anchor. The native valve leaflet can then be positioned within the gap. The core capture element can expand radially to close the gap between the core capture element and the anchor and capture the valve leaflet between the core capture element and the anchor. In some embodiments, the anchor and the core capture element are optionally configured to self-expand. The implantation methods of the various embodiments may vary and are considered more fully below for each embodiment. Additional information regarding these and other delivery methods can be found in Patent Documents 1 to 4, each of which is hereby incorporated by reference in its entirety. These methods can be performed on a living animal or on a simulation such as, for example, a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, tissue, etc.).

[0051] The disclosed artificial device can be configured such that the anchor is connected to the valve leaflet and resists the high systolic pressure that pulls the device toward the left atrium by utilizing the tension from the native chordae tendineae. During diastole, the device can rely on the compressive and holding forces applied to the valve leaflet gripped by the anchor.

[0052] Referring now to FIGS. 8-14, the implantable artificial device 100 is schematically illustrated in various stages of deployment. The device 100 can include any other features related to the implantable artificial device considered in this application, and the device 100 can 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).

[0053] Device 100 is deployed from a delivery sheath or delivery means 102 and includes a core adaptation portion 104 and an anchor portion 106. The core adaptation portion 104 of device 100 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, tricuspid valve, etc.) and includes a core option element or joining means 110 that is slidably attached to an actuating element 112 (e.g., an actuating wire, actuating shaft, actuating tube, etc.). The anchor portion 106 is operable between an open state and a closed state and can take a wide form such as, for example, a paddle, a gripping element, etc. Actuation of the actuating element or actuating means 112 opens and closes the anchor portion 106 of device 100 to grip the native valve leaflets during implantation. The actuating element 112 (e.g., wire, shaft, tube, screw, wire, etc.) can take a wide variety of different forms. For example, the actuating element may have threads such that rotation of the actuating element (e.g., wire, shaft, tube, screw, etc.) moves the anchor portion 106 relative to the core option portion 104. Or, the actuating element may not have threads such that pushing or pulling on the actuating element 112 moves the anchor portion 106 relative to the core option portion 104.

[0054] The anchor portion 106 of device 100 includes an outer paddle 120 and an inner paddle 122 connected between a cap 114 and a core option element or joining means 110 by portions 124, 126, 128. The portions 124, 126, 128 may be articulated to move between all of the positions described below and / or may be flexible. The interconnection of the outer paddle 120, inner paddle 122, core option element or joining means 110, and cap 114 by portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.

[0055] In some embodiments, an actuating element or means 112 (e.g., an actuating wire, an actuating shaft, etc.) extends through the delivery sheath and the core coaptation element or joining means 110 to the cap 114 at the distal connection of the anchor portion 106. Extension and retraction of the actuating element or means 112 respectively increase and decrease the spacing between the core coaptation element or joining means 110 and the cap 114. A collar or other attachment element removably attaches the core coaptation element or joining means 110 to the delivery sheath or delivery means 102, whereby the actuating element or means 112 slides through the collar or other attachment element and the core coaptation element or joining means 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106.

[0056] Referring now to FIG. 11, the anchor portion 106 includes an attachment portion or gripping member. The gripping member shown includes a return clasp 130 that includes a base or fixed arm 132, a movable arm 134, a barb or securing means 136, and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122, and the joint portion 138 is disposed proximate the core portion or joining means 110. The return clasp has a flat surface and does not conform to the recess of the paddle. Rather, the flat portion of the return clasp is disposed against the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed and movable arms 132, 134 of the return clasp 130. The joint portion 138 can be any suitable joint such as a flexible joint, a spring joint, a pivot joint, etc. In certain embodiments, the joint portion 138 is a single piece of flexible material integrally formed with the fixed and movable arms 132, 134. The fixed arm 132 is attached to the inner paddle 122 and remains fixed relative to the inner paddle 122 when the movable arm 134 opens to open the return clasp 130 and expose the return or securing means 136. In some implementations, the return clasp 130 is released by applying tension to an actuating wire 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, flex, or pivot on the joint portion 138. Other actuating mechanisms are also possible.

[0057] During implantation, paddles 120, 122 can be opened and closed, for example, gripping a native valve cusp or a native mitral valve cusp between paddles 120, 122 and a core capture element or engagement means 110. The return clasp 130 can be used to engage the cusp with barb or fixation means 136 and sandwich the cusp between the movable arm 134 and the fixed arm 132 to sandwich and / or further secure the native valve cusp. The return or fixation means 136 of the return clasp 130 may increase friction with the cusp or may pierce the cusp partially or completely. The actuation line 116 can be actuated separately so that each return clasp 130 can be opened and closed separately. By separate operations, one cusp can be gripped at a time, or the clasp 130 on an inadequately gripped cusp can be repositioned without changing the good grip of the other cusp. The return clasp 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 enabling the cusp to be gripped at various positions as required by a particular situation.

[0058] The return clasp 130 can be separately released by pulling on an attached actuation line 116 that extends through the delivery sheath or delivery means 102 to the return clasp 130. The actuation line 116 can take a wide variety of forms, such as, for example, a wire, suture, wire, rod, catheter, etc. In the closed position, the return clasp 130 can be spring-loaded so that it continues to provide a clamping force to the gripped native valve cusp. This clamping force remains constant regardless of the position of the inner paddle 122. The return or fixation means 136 of the return clasp 130 can pierce the native valve cusp to further secure the native valve cusp.

[0059] Referring now to FIG. 8, device 100 is shown in an elongated or fully open state for deployment from the delivery sheath. The fully open position occupies the least amount of space and enables the use of the smallest catheter (or the largest device 100 to be used for a given catheter size), so device 100 is loaded into the delivery sheath in the fully open position. In the elongated state, cap 114 is spaced from core capture element or joining means 110 such that paddles 120, 122 of anchor portion 106 are fully extended. In some embodiments, the angle formed between the interiors of outer and inner paddles 120, 122 is about 180 degrees. Return clasp 130 is held in a closed state during deployment through delivery sheath or delivery means 102, whereby return or securing means 136 (FIG. 11) does not capture or damage the sheath or tissue within the patient's heart.

[0060] Referring now to FIG. 9, device 100 is shown in an elongated unclasped state similar to that of FIG. 8, but return clasp 130 is in a fully open position of about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees between the fixed and movable portions of return clasp 130. It has been found that fully opening paddles 120, 122 and clasp 130 improves the ease of unclasping or detaching from the patient's anatomy during implantation of device 100.

[0061] Referring now to FIG. 10, device 100 is shown in a retracted or fully closed state. The compact size of device 100 in the retracted state allows for easier manipulation and placement within the heart. To move device 100 from the elongated state to the retracted state, actuation element or means 112 is retracted to pull cap 114 toward core capture element or engagement means 110. Joint or flexible connection 126 between outer paddle 120 and inner paddle 122 is such that the compressive force acting on outer paddle 120, which is stored from cap 114 toward core capture element or engagement means 110, causes movement to be restricted such that paddles or gripping elements 120, 122 move radially outward. During movement from the open position to the closed position, outer paddle 120 maintains an acute angle with actuation element or means 112. Outer paddle 120 may optionally be biased toward the closed position. During the same operation, inner paddle 122 moves through a fairly large angle since they are oriented away from core capture element or engagement means 110 in the open state and are folded along both sides of core capture element or engagement means 110 in the closed state. In certain embodiments, inner paddle 122 is thinner and / or narrower than outer paddle 120, and joints or flexible portions 126, 128 connected to inner paddle 122 may be thinner and / or more flexible. For example, this enhanced flexibility may allow for more movement than joint or flexible portion 124 connecting outer paddle 120 to cap 114. In certain other embodiments, outer paddle 120 is narrower than inner paddle 122. Joints or flexible portions 126, 128 connected to inner paddle 122 may be more flexible, for example, to allow for more movement than joint or flexible portion 124 connecting outer paddle 120 to cap 114. In one embodiment, inner paddle 122 may be the same or substantially the same width as the outer paddle (see, e.g., FIG. 65A).

[0062] Referring now to FIGS. 11 - 13, device 100 is shown in a partially open, ready - to - grip state. To transition from the fully closed state to the partially open state, the actuating element or means 112 is extended to push the cap 114 away from the core - option element or joining means 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor portion 106 to be partially expanded. The actuating wire 116 is also drawn in to release the clasp 130, whereby the valve tip can be gripped. In the embodiment shown by FIG. 11, the pair of inner and outer paddles 122, 120 move in unison, not independently, by a single actuating element or means 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, when the paddles 122, 120 close, the clasp also closes.

[0063] FIG. 11A shows an exemplary embodiment where the paddles 120, 122 are independently controllable. The device 100A shown by FIG. 11A includes an actuating element configured as two independent actuating elements 112A, 112B to which the device 100A is connected to two independent caps 114A, 114B, and is similar to the device shown by FIG. 11, except for this. To transition the first inner paddle and the first outer paddle from the fully closed state to the partially open state, the actuating element or means 112A is extended to push the cap 114A away from the core - option element or joining means 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor portion 106 to be partially expanded. To transition the second inner paddle and the second outer paddle from the fully closed state to the partially open state, the actuating element or means 112B is extended to push the cap 114 away from the core - option element or joining means 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor portion 106 to be partially expanded. The independent paddle control shown by FIG. 11A can be implemented in any of the devices disclosed by this application.

[0064] Referring now to FIG. 12, one of the activation lines 116 is extended to enable one of the clasps 130 to close. Referring now to FIG. 13, the other activation line 116 is extended to enable the other clasp 130 to close. Either or both of the activation lines 116 may be actuated repeatedly to repeatedly open and close the return clasp 130.

[0065] Referring now to FIG. 14, the device 100 is shown in a fully closed and deployed state. The delivery sheath or delivery means 102 and the activation element or activation means 112 are retracted, and the paddles 120, 122 and the clasps 130 are still in their fully closed positions. When deployed, the device 100 may be maintained in its fully closed position by a mechanical latch, or may be biased to remain closed by the use of a spring material such as steel, other metals, plastics, composite materials, or a shape memory alloy such as nitinol. For example, the articulation or flexible portions 124, 126, 128, 138, and / or the inner and outer paddles 122, 120, and / or additional biasing components (see component 524 in FIG. 28) may be formed from a metal such as steel or a shape memory alloy such as nitinol (manufactured as a wire, sheet, tube, or laser sintered powder), and may be biased to close and hold the outer paddle 120 around the coaptation element or joining means 110, and the return clasp 130 is clamped around the natural valve tip. Similarly, the fixed and movable arms 132, 134 of the return clasp 130 are biased to clamp the valve tip. In certain embodiments, the attachment or joint portions 124, 126, 128, 138, and / or the inner and outer paddles 122, and / or additional biasing components (see component 524 in FIG. 28) may be formed from any other suitable elastic material such as a metal or polymer material to maintain the device in a closed state after implantation.

[0066] Referring now to FIGS. 226 - 231, the implantable device 100 is shown with the cover 140 provided. The cover 140 can be a cross material such as a fine mesh polyethylene cloth. The cross - cover can provide a blood seal on the surface of the spacer and / or can promote rapid ingrowth of tissue. The cover 140 includes a first cover portion 142 and a second cover portion 144, each covering a different portion of the device 100. In some embodiments, a portion of one of the first and second cover portions 142, 144 overlaps a portion of the other of the first and second cover portions 142, 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 one of the first cover portion 142 and the second cover portion 144.

[0067] Referring now to FIGS. 226 - 229, various arrangements of the first and second cover portions 142, 144 are shown without the overlapping portion 146. Referring next to FIG. 226, the first cover portion 142 (represented by the thin - lined cross - hatching), which can be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the clasp 130. The second cover 144 (represented by the thick - lined cross - hatching), which can be a single piece of material, covers the core - option element or joining means 110.

[0068] Referring next to FIG. 227, the first cover portion 142, which can be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, the fixed arm 132, and the movable arm 134 of the clasp 130. Similar to the cover 140 of FIG. 226, the second cover 144 covers the core - option element or joining means 110.

[0069] Next, referring to FIG. 228, a first cover portion 142 that can be made from a single piece of material extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the clasp 130. A second cover 144 that can be made from a single piece of material covers the core cushioning element or joining means 110 and extends from the core cushioning element or joining means 110 to cover the movable arm 134 of the clasp 130.

[0070] Next, referring to FIG. 229, a first cover portion 142 that can be made from a single piece of material extends from the cap 114 and covers the cap 114 and the outer paddle 120. A second cover 144 that can be made from a single piece of material covers the core cushioning element or joining means 110 and extends from the core cushioning element or joining means 110 to cover the inner paddle 122, the fixed arm 132, and the movable arm 134 of the clasp 130.

[0071] Now referring to FIGS. 230 - 231, the arrangement of the first and second cover portions 142, 144 is shown including an overlapping portion 146. Next, referring to FIG. 230, a first cover portion 142 that can be made from a single piece of material extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, the fixed arm 132, and the movable arm 134 of the clasp 130. A second cover 144 that can be made from a single piece of material covers the core cushioning element or joining means 110 and extends from the core cushioning element or joining means 110 to include an overlapping portion 146 that overlaps a portion of the movable arm 134 covered by the first cover 142.

[0072] Next, referring to FIG. 231, a first cover portion 142 that can be made from a single piece of material extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the clasp 130. A second cover 144 that can be made from a single piece of material covers the core cushioning element or joining means 110 and the movable arm 134 of the clasp 130. The first cover 142 also includes an overlapping portion 146 that extends from the fixed arm 132 and the inner paddle 122, overlaps a portion of the movable arm 134 covered by the second cover 144, and the core cushioning element or joining means 110.

[0073] Referring now to FIGS. 15 - 20, it is shown that the implantable device 100 of FIGS. 8 - 14 has been delivered and implanted within the native mitral valve MV of the heart H. The methods and steps illustrated and / or contemplated can be performed on a living animal or in a simulation such as, for example, a cadaver, a cadaver heart, a simulator (e.g., where a body part, heart, tissue, etc. is being simulated).

[0074] Referring now to FIG. 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. Next, the actuating element or means 112 is retracted to move the device 100 to the fully closed state shown in FIG. 16. As can be seen from FIG. 17, the device 100 moves within the position within the mitral valve MV into the inner chamber LV and partially opens so that the valve leaflets 20, 22 can be grasped. Referring now to FIG. 18, the actuating wire 116 is extended to close one of the clasps 130 and capture the valve leaflet 20. FIG. 19 then shows that the other actuating wire 116 is extended to close the other clasp 130 and capture the remaining valve leaflet 22. As can be seen from FIG. 20, next, the delivery sheath or delivery means 102, and the actuating element or means 112, and the actuating wire 116 are retracted and the device 100 is fully closed and deployed within the native mitral valve MV.

[0075] Referring now to FIG. 21, an exemplary implantable artificial device 200 or its frame is shown. In certain embodiments, device 200 includes an annular spacer member 202, a fiber cover (not shown), and an anchor 204 extending from spacer member 202. The end of each anchor 204 can be coupled to a respective strut of spacer member 202 by a respective sleeve 206 that can be crimped or welded around the connection portion of anchor 204 and the strut of spacer member 202. In one exemplary embodiment, a latch mechanism can couple spacer member 202 to anchor 204 within 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 spacer member 202 and anchor 204 such that the sleeve can frictionally fit into the connection portion. One or more barbs or protrusions 208 can be mounted on the frame of spacer member 202. The free end of the barb or protrusion 208 can include a variety of shapes including rounded, pointed, hooked, or the like. The protrusion 208 can exert a holding force against the natural valve cusp by an anchor 204 shaped to push the natural valve cusp inwardly into spacer member 202.

[0076] Referring now to FIG. 22, an exemplary implantable artificial device 300 or its frame is shown. In certain embodiments, the artificial spacer device 300 includes an annular spacer member 302, a fiber cover (not shown), and an anchor 304 extending from spacer member 302 and can be configured similarly to artificial spacer device 200. One or more barbs or protrusions 306 can be mounted on the frame of spacer member 302. The end of the protrusion 306 can include a stopper 308. The stopper 308 of the protrusion can be configured in a wide variety of different ways. For example, the stopper 308 can be configured to engage and / or penetrate the natural valve cusp and limit the extent of protrusion 306 that can engage and / or penetrate the natural valve cusp, and / or the stopper can be configured to prevent removal of protrusion 306 from the tissue after protrusion 306 has penetrated the tissue.

[0077] The anchor 304 of the artificial spacer device 300 can be configured similarly to the anchor 204 of the artificial spacer device 200, except that the curve of each anchor 304 includes a larger radius than the anchor 204. Thus, the anchor 304 covers a relatively large portion of the spacer member 302 compared to the anchor 204. This can distribute the clamping force of the anchor 304 against the native valve cusp over a relatively larger surface of the native valve cusp, for example, to further protect the native valve cusp tissue.

[0078] Additional details regarding the artificial spacer device can be found, for example, in Patent Documents 4 and 5, which are hereby incorporated by reference. The devices 200, 300 can include any other features related to the implantable artificial devices contemplated in this application, and the devices 200, 300 can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0079] Referring now to FIGS. 23 - 27, an exemplary embodiment of an implantable artificial spacer device 400 and its components is shown. The device 400 can include any other features related to the implantable artificial devices contemplated in this application, and the device 400 can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0080] Referring now to FIG. 23, the artificial spacer or core capture device 400 can include a core capture portion 404 and an anchor portion 406, and the anchor portion 406 can include a plurality of anchors 408. The core capture portion 404 can include a core capture or spacer member 410. The anchor portion 406 can include a plurality of paddles 420 (e.g., two in the illustrated embodiment) and a plurality of clasps 430 (e.g., two in the illustrated embodiment). A first or proximal collar 411 and a second collar or cap 414 are used to move the core capture portion 404 and the anchor portion 406 relative to each other.

[0081] As shown in FIG. 25, a first connection portion 425 of the anchor 408 can be coupled to and extend from a first portion 417 of the core capture or spacer member 410, and a second connection portion 421 of the anchor 408 can be coupled to the second collar 414. The proximal collar 411 can be coupled to a second portion 419 of the core capture member 410.

[0082] The core capture member 410 and the anchor 408 can be connected together in various ways. For example, as shown in the illustrated embodiment, the core capture member 410 and the anchor 408 can be connected together by integrally forming the core capture member 410 and the anchor 408 as a single unitary component. This can be achieved, for example, by forming the core capture member 410 and the anchor 408 from a braided or woven material such as braided or woven nitinol wire. In other embodiments, the core capture member 410 and the anchor 408 can be connected together by welding, fasteners, adhesives, joint connections, sutures, friction fits, swaging, and / or other connection means.

[0083] Referring now to FIG. 24, the anchor 408 can include a first portion or outer paddle 420 and a second portion or inner paddle 422 separated by a joint portion 423. Thus, the anchor 408 is configured similarly to a leg in that the inner paddle 422 is like the upper portion of the leg, the outer paddle 420 is like the lower portion of the leg, and the joint portion 423 is like the knee portion of the leg. In some embodiments, the inner paddle portion 422, the outer paddle portion 420, and the joint portion 423 are formed from a continuous strip of material such as a metallic fiber. In some embodiments, the strip of fiber is a composite strip of fibers.

[0084] The anchor 408 can be configured to move between various configurations by axially moving the cap 414 relative to the proximal collar 411, and thus the anchor 408 relative to the core capture member 410, along the longitudinal axis extending between the first or distal portion and the second or proximal portions 417, 419 of the core capture member 410. For example, the anchor 408 can be positioned in a linear configuration by moving the cap 414 away from the core capture member 410. In the linear configuration, the paddle portions are aligned in the direction of the longitudinal axis of the device or are linear, and the joint portion 423 of the anchor 408 is adjacent to the longitudinal axis of the core capture member 410 (similar to the configuration shown in FIG. 59, for example). From the linear configuration, the anchor 408 can be moved toward the core capture member 410 to move to a fully folded configuration (e.g., FIG. 23). As shown in FIGS. 24-25, initially, as the cap 414 moves toward the core capture 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 core capture member 410 and axially toward the first portion 417 of the core capture member 410. As the cap 414 continues to move toward the core capture member 410, the joint portion 423 moves radially inward relative to the longitudinal axis of the core capture member 410 and axially toward the proximal portion 419 of the core capture member 410, as shown in FIG. 23.

[0085] In some embodiments, the angle between the inner paddle 422 of the anchor 408 and the core capture member 410 can be about 180 degrees when the anchor 408 is in the linear configuration (see, e.g., FIG. 59), and the angle between the inner paddle 422 of the anchor 408 and the core capture member 410 can be about 0 degrees when the anchor 408 is in the fully folded configuration (see, e.g., FIG. 23). 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 core capture member 410 can be about 10-170 degrees or about 45-135 degrees.

[0086] Configuring the artificial spacer device 400 such that the anchor 408 can extend to a linear or substantially linear configuration (e.g., about 120 degrees to 180 degrees relative to the core capture member 410) can provide several advantages. For example, this can reduce the radial crimp profile of the artificial spacer device 400. This can also make it easier to grip the native valve cusp by providing a larger opening for gripping the native valve cusp. Further, the relatively narrow linear configuration can prevent or reduce the possibility that the artificial spacer device 400 becomes entangled within a natural biological structure (e.g., chordae tendineae) when positioning and / or removing the artificial spacer device 400 within the delivery device.

[0087] Referring again to FIG. 24, the clasp 430 can include an attachment or fixed portion 432 and an arm or movable portion 434. The attachment or fixed portion 432 can be connected to the inner paddle 422 of the anchor 408 in various ways such as sutures, adhesives, fasteners, welding, suturing, swaging, friction fitting, and / or other connecting means or fastening.

[0088] In some embodiments, the movable portion 434 can articulate, flex, or pivot relative to the fixed portion 432 between an open configuration (e.g., FIG. 24) and a closed configuration (FIGS. 23 and 25). In some embodiments, the clasp 430 can be biased towards the 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 such that a native valve cusp 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 towards each other, thereby clamping the native valve cusp between the fixed portion 432 and the movable portion 434.

[0089] Referring to FIGS. 26-27, the clasp 430 is shown in a top view and a perspective view. The fixed portion 432 (only one shown in FIGS. 26-27) can include one or more openings 433 (e.g., three in the illustrated embodiment). At least a portion of the openings 433 can be used to connect the fixed portion 432 to the anchor 408. For example, suture and / or fasteners can extend through the openings 433 to connect the fixed portion 432 to the anchor 408, or other attachments such as welding, adhesives, etc. can be used.

[0090] The movable portion 434 can include one or more side beams 431. When two side beams are included as shown, the side beams can form slots 431A with a spacing. The slots 431A can be configured to receive the fixed portion 432. The movable portion 434 can also include a spring portion 434A connected to the fixed portion 432 and a barb support portion 434B disposed on the opposite side of the spring portion 434A.

[0091] The barb support portion 434B can include a gripper or attachment element such as a barb 436 and / or other means for frictionally engaging the natural valve tip tissue. The gripper element can be configured to engage and / or penetrate the natural valve tip tissue to help hold the natural valve tip between the fixed portion 432 and the movable portion 434 of the clasp 430.

[0092] The barb support portion 434B can also include a hole 435 that can be used to connect the barb support portion 434B to an actuating mechanism configured to bend or pivot the movable portion 434 relative to the fixed portion 432. Additional details regarding connecting the clasp 430 to the actuating mechanism are provided below.

[0093] In some embodiments, the clasp 430 can be formed from a shape memory material such as nitinol, stainless steel, and / or a shape memory polymer. In certain embodiments, the clasp 430 can be formed by laser cutting a flat sheet material (e.g., nitinol) or a portion of a tube having the configuration shown in FIG. 26, or a tube of a similar or different configuration, and then setting the shape of the clasp 430 having the configuration shown in FIG. 27.

[0094] Setting the shape of the clasp 430 in this manner can provide several advantages. For example, the clasp 430 can be optionally compressed from the set shape configuration (e.g., FIG. 27) to a planar configuration (e.g., FIG. 26), or another configuration that reduces the radial crimp profile of the clasp 430. For example, the barb can be optionally compressed to a flat configuration. Reducing the radial crimp profile can improve the trackability and retrievability of the artificial spacer device 400 with respect to the catheter shaft of the delivery device because the barb 436 is directed radially inwards towards the anchor 408 when the artificial spacer device 400 is advanced through the catheter shaft or retrieved into the catheter shaft (see, e.g., FIG. 33). This can prevent or reduce the possibility that the clasp 430 can pull on or skip the catheter shaft.

[0095] Furthermore, configuring the clasp 430 in the configuration shown in FIG. 27 can increase the clamping force of the clasp 430 when the clasp 430 is in the closed configuration. This is because the movable part 434 is configured in a first position (e.g., FIG. 27) that exceeds the position that can be achieved when the movable part 434 is attached to the anchor 408 (e.g., FIG. 25) with respect to the fixed part 432, and the anchor 408 prevents the movable part 434 from further moving towards the configured configuration. Thereby, when the clasp 430 is attached to the anchor 408 and is in the closed configuration, the movable part 434 is brought to have a preload (i.e., the clamping force is greater than zero). Therefore, configuring the clasp 430 in the configuration of FIG. 27 can increase the clamping force of the clasp 430 compared to a clasp configured in the closed configuration.

[0096] The magnitude of the preload of the clasp 430 can be changed by adjusting the angle at which the movable part 434 is configured with respect to the fixed part 432. For example, increasing the relative angle between the movable part 434 and the fixed part 432 increases the preload, and decreasing the relative angle between the movable part 434 and the fixed part 432 decreases the preload. Also, it can be adjusted by other means such as based on the configuration of joints, hinges, materials, etc.

[0097] In some embodiments, the proximal collar 411 and / or the core capture member 410 may include a hemostatic seal 413 configured to reduce or prevent blood flow through the proximal collar 411 and / or the core capture member 410. For example, in some embodiments, the hemostatic seal 413 can include a plurality of flexible flaps 413A, as shown in FIG. 23. In some embodiments, the flaps 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 the second collar 414. In one exemplary embodiment, the flaps 413A form a seal around the shaft of the delivery device. When the shaft of the delivery device is removed, the flaps 413A can be configured to return from the open configuration to the sealed configuration.

[0098] Referring now to FIG. 23A, an exemplary embodiment of an implantable artificial spacer device 400A is shown. The device 400A can include any other features related to the implantable artificial devices discussed in this application, and the device 400A can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0099] The artificial spacer or core capture device 400A can include a core capture portion 404A and an anchor portion 406A, and the anchor portion 406A includes a plurality of anchors 408A. The core capture portion 404A includes a core capture member or spacer 410A. The anchor portion 406A includes a plurality of paddles 420A (e.g., two in the illustrated embodiment) and a plurality of clasps 430A (e.g., two in the illustrated embodiment). The first or proximal collar 411A and the second collar or cap 414A are used to move the core capture portion 404A and the anchor portion 406A relative to each other.

[0100] The core capture member 410A extends from a proximal portion 419B assembled to the collar 411A to a distal portion 417A that connects to the anchor 408A. The core capture member 410A and the anchor 408A can be connected together in various ways. For example, as shown in the illustrated embodiment, the core capture member 410A and the anchor 408A can be connected together by integrally forming the core capture member 410A and the anchor 408A as a single integral component. This can be achieved, for example, by forming the core capture member 410A and the anchor 408A from a continuous strip 401A of a braided or woven material such as braided or woven nitinol wire.

[0101] The anchor 408A is attached to the core capture member 410A by a hinge portion 425A and to the cap 414A by a hinge portion 421A. The anchor 408A can include a first portion or outer paddle 420A and a second portion or inner paddle 422A separated by a joint portion 423A. The joint portion 423A is attached to a paddle frame 424A that is hingedly attached to the cap 414A. Thus, the anchor 408A is configured similarly to a leg in that the inner paddle 422A is like the upper portion of the leg, the outer paddle 420A is like the lower portion of the leg, and the joint portion 423A is like the knee portion of the leg. In the illustrated embodiment, the inner paddle portion 422A, the outer paddle portion 420A, and the joint portion 423A are formed from a continuous strip 401A of a material such as a metal fiber.

[0102] 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 the anchor 408A relative to the core capture member 410A, along a longitudinal axis extending between the cap 414A and the proximal collar 411A. For example, the anchor 408 can be positioned in a linear configuration (see FIG. 60A) by moving the cap 414A away from the core capture member 410A. In the linear configuration, the paddle portions 420A, 422A are aligned in the direction of the longitudinal axis of the device or are linear, and the joint portion 423A of the anchor 408A is adjacent to the longitudinal axis of the core capture member 410A (e.g., similar to the configuration shown in FIG. 60A). From the linear configuration, the anchor 408 can move to a fully folded configuration (e.g., FIG. 23A) by moving toward the core capture member 410A. First, as the cap 414A moves toward the core capture member 410A, the anchor 408A bends at the joint portions 421A, 423A, 425A and the joint portion 423A moves radially outward relative to the longitudinal axis of the device 400A and axially toward the distal portion 417A of the core capture member 410A, as shown in FIGS. 53A and 54A. As the cap 414A continues to move toward the core capture 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 core capture member 410A, as shown in FIG. 23A.

[0103] In some embodiments, the angle between the inner paddle 422A of the anchor 408A and the core capture member 410A can be about 180 degrees when the anchor 408A is in a straight configuration (e.g., see FIG. 60A), and the angle between the inner paddle 422A of the anchor 408A and the core capture member 410A can be about 0 degrees when the anchor 408A is in a fully folded configuration (e.g., see FIG. 23A). 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 core capture member 410A can be from about 10 degrees to 170 degrees or from about 45 degrees to 135 degrees.

[0104] Configuring the artificial spacer device 400A such that the anchor 408A can extend to a straight or substantially straight configuration (e.g., about 120 degrees to 180 degrees relative to the core capture member 410A) can provide several advantages. For example, this can reduce the radial crimp profile of the artificial spacer device 400A. This can also make it easier to grip the native valve leaflet by providing a larger opening for gripping the native valve leaflet. Additionally, the relatively narrow straight configuration can prevent or reduce the likelihood that the artificial spacer device 400A will become entangled within the native biological structure (e.g., chordae tendineae) when positioning and / or removing the artificial spacer device 400A within the delivery device.

[0105] The clasp 430A can include an attachment or fixation portion 432C and an arm or movable portion 434C. The attachment or fixation portion 432C can be connected to the inner paddle 422A of the anchor 408A in various ways such as suture, adhesive, fastener, welding, suturing, swaging, friction fitting, and / or other connection means. The clasp 430A is similar to the clasp 430.

[0106] In some embodiments, the movable portion 434C can articulate, flex, or pivot relative to the fixed portion 432C between an open configuration (e.g., FIG. 54A) and a closed configuration (FIG. 53A). In some embodiments, the clasp 430A can be biased toward the closed configuration. In the open configuration, the fixed portion 432C and the movable portion 434C articulate, pivot, or flex away from each other such that a native valve leaflet 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 articulate, pivot, or flex toward each other, thereby clamping the native valve leaflet between the fixed portion 432C and the movable portion 434C.

[0107] The strip 401A is attached to the collar 411A, the cap 414A, the paddle frame 424A, and the clasp 430A to form both the core capture portion 404A and the anchor portion 406A of the device 400A. In the illustrated embodiment, the core capture member 410A, the hinge portions 421A, 423A, 425A, the outer paddle 420A, and the inner paddle 422A are formed from the continuous strip 401A. The continuous strip 401A may be a single layer of material or may include two or more layers. In certain embodiments, one portion of the device 400A has a single layer of the strip 401A of material and other portions are formed from multiple overlapping or stacked layers of the strip 401A of material. For example, FIG. 23A shows a core capture member 410A and an inner paddle 422A formed from multiple overlapping layers of the strip 401A of material. The single continuous strip 401A of material can start and end at various locations of the device 400A. The ends of the strip 401A of material can be at the same or different locations of the device 400A. For example, in the illustrated embodiment of FIG. 23A, the strip of material starts and ends at the location of the inner paddle 422A.

[0108] Referring now to FIG. 30A, an exemplary implantable artificial device 400A is shown covered by a cover 440A. The cover 440A is disposed over a core absorption member 410A, a collar 411A, a cap 414A, paddles 420A, 422A, a paddle frame 424A, and a clasp 430A. The cover 440A can be configured to prevent or reduce blood flow through the artificial spacer device 400A and / or to promote ingrowth of native tissue. In some embodiments, the cover 440A can be a cloth or fiber such as PET, velour, or other suitable fiber. In other embodiments, instead of or in addition to the fiber, the cover 440A can include a coating (e.g., a polymeric material, silicone, etc.) applied to the artificial spacer device 400A.

[0109] Referring now to FIGS. 28 - 30, an exemplary embodiment of an implantable artificial device 500 (e.g., an artificial spacer device) is shown. The implantable device 500 is one of many different configurations that the device 100 schematically illustrated in FIGS. 8 - 20 can take. The device 500 can include any other features related to implantable artificial devices contemplated in this application, and the device 500 can be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0110] The artificial spacer device 500 can include a core absorption element or spacer member 510, a plurality of anchors 508 including outer paddles 520, inner paddles 522, a clasp 530, a first or proximal collar 511, and a second collar or cap 514. These components of the artificial spacer device 500 can be configured the same as or substantially similar to the corresponding components of the artificial spacer device 400.

[0111] The artificial spacer device 500 may also include a plurality of paddle extension members or paddle frames 524. The paddle frame 524 may be configured in a round three-dimensional shape that is connected to and extends from a cap 514 and a second connection portion 528 with a first connection portion 526 disposed on the opposite side of the first connection portion 526. The paddle frame 524 may be configured to extend circumferentially around the core cushioning member 510 more widely than the outer paddle 520. For example, in some embodiments, each of the paddle frames 524 extends around approximately half of the circumference around the core cushioning member 510 (as shown in FIG. 29), and the outer paddle 520 extends around less than half of the circumference around the core cushioning member 510 (as shown in FIG. 28). The paddle frame 524 may also be configured to extend laterally beyond the outer diameter of the core cushioning member 510 (i.e., perpendicular to the longitudinal axis of the core cushioning member 510). In the illustrated example, the inner paddle portion 522 and the outer paddle portion 520 may be formed from a continuous strip of fibers connected to the paddle frame 524. For example, the inner paddle portion and the outer paddle portion may be connected to the connection portion of the paddle frame with a flexible connection between the inner paddle portion and the outer paddle portion.

[0112] The paddle frame 524 can be further configured such that the connection portion 528 of the paddle frame 524 is connected to or axially adjacent to the joint portion 523. The connection portion of the paddle frame 524 may be positioned between the outer paddle 520 and the inner paddle 522, on the outside of the paddle portion 520, on the inside of the inner paddle portion, or on the joint portion 523 when the artificial spacer device 500 is in the folded configuration (e.g., FIGS. 28-30). The connections between the paddle frame 524, the single strip forming the outer paddle 520 and the inner paddle 522, the cap 514, and the core capture element can limit each of these parts to the movements and positions described herein. In particular, the joint portion 523 is limited by its connection between the outer paddle 520 and the inner paddle 522 and by its connection to the paddle frame. Similarly, the paddle frame 524 is limited by its attachment to the joint portion 523 (and thus the inner and outer paddles) and the cap.

[0113] By configuring the paddle frame 524 in this way, the surface area is increased compared to the outer paddle 520 alone. This can, for example, facilitate the grasping and fixation of the native valve leaflet. The increased surface area can also distribute the clamping force of the paddles 520 and the paddle frame 524 against the native valve leaflet over a relatively large surface of the native valve leaflet to further protect the native valve leaflet tissue.

[0114] The increased surface area of the paddle frame 524 may also enable the fixation of the native valve leaflet to the artificial spacer device 500 such that the native valve leaflet is fully joined around the core capture member 510. This can, for example, improve the sealing of the native valve leaflet and thus prevent or further reduce mitral regurgitation.

[0115] Referring to FIG. 30, the artificial spacer device 500 may also include a cover 540. In some embodiments, the cover 540 may be disposed on the core capture member 510, paddles 520, 522, and / or paddle frame 524. The cover 540 may be configured to prevent or reduce blood flow through the artificial spacer device 500 and / or to promote ingrowth of native tissue. In some embodiments, the cover 540 may be a cloth or fiber such as PET, velour, or other suitable fiber. In other embodiments, instead of or in addition to the fiber, the cover 540 may include a coating (e.g., polymeric fiber, silicone, etc.) applied to the artificial device 500.

[0116] FIGS. 31-32 show the implantable artificial device 500 of FIGS. 28 and 29 with the anchor 508 and clasp 530 of the anchor portion 506 in the open position. The device 500 is deployed from a delivery sheath (not shown) and includes a core capture portion 504 and an anchor portion 506. The device 500 is loaded into the delivery sheath in the fully expanded or bailed out position (see FIG. 35) because the fully expanded or bailed out position occupies a minimum amount of space and a minimum catheter can be used. Alternatively, the fully expanded position allows the largest device 500 to be used for a given catheter size. The core capture portion 504 of the device includes a core capture element 510 for implantation between the native leaflets of a native valve (e.g., mitral valve, tricuspid valve, etc.). The insert portion 516A is disposed within the core capture element 510. The insert portion 516A and the core capture element 510 are slidably attached to an actuating element 512 (e.g., an actuating wire, rod, shaft, tube, screw, suture, wire, etc.). 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 core capture element 510. Actuation of the actuating element or means 512 opens and closes the anchor 508 of the device 500 to grip the native valve leaflets during implantation.

[0117] The actuating element 512 extends through a delivery sheath (not shown), a proximal collar 511, a core capture element 510, and an insert portion 516A and extends to a cap 514. Extension and retraction of the actuating element 512 increases and decreases the spacing between the core capture element 510 and the cap 514, respectively. This change in the spacing between the core capture element 510 and the cap 514 moves the anchor portion 506 of the device between different positions.

[0118] 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, the seal closing when the actuating element 512 is removed and blood flow through the interior of the core capture element 510 after implantation closes or substantially closes the proximal end of the device 500. In some embodiments, a coupler or means for connection 2214 (see FIG. 145) removably engages and attaches the proximal collar 511 and the core capture element 510 to the delivery sheath. In some embodiments, the coupler or connection means 2214 is held closed around the proximal collar 511 by the actuating element 512 such that removal of the actuating element 512 allows the fingers of the coupler or connection means 2214 (see FIG. 145) to open while releasing the proximal collar 511.

[0119] The proximal collar 511 and the insert portion 516A within the core capture element 510 slide along the actuating element 512 during operation to open and close the paddles 520, 522 of the anchor 508. Referring to FIGS. 32A and 32B, in some embodiments, the cap 514 optionally includes a sealing projection 516 that sealingly fits within the sealed opening 517 of the insert portion 516A. In one exemplary embodiment, the cap 514 includes a sealed opening and the insert portion 516A includes a sealing projection. The insert portion 516A can sealingly fit within the distal opening 515 of the core capture element 510, which has a hollow interior. Referring to FIG. 32A, the sealing projection 516 of the cap 514 sealingly engages the opening 517 of the insert portion 516A and maintains the distal end of the core capture element 510 in a closed or substantially closed state against blood flow when the device 500 is implanted and / or when in the closed position.

[0120] In one exemplary embodiment, instead of a sealing engagement between the cap 514 and the insert portion 516A, the insert portion 516A can optionally include a seal, such as a collar seal 513 of the proximal collar portion, that forms a seal around the actuating element or means 512 during implantation of the device 500 and closes the seal when the actuating element 512 is removed. Such a seal can close or substantially close the distal end of the core capture element 510 against blood flow after implantation.

[0121] The core capture element 510 and paddles 520, 522 are formed from a flexible material such as metal fibers that can be formed by mesh, weaving, knitting, or any other suitable manner, or a flexible material cut by laser cutting or another method. The material may be a cloth, a wire such as nitinol that provides shape fixation ability, or any other flexible material suitable for implantation into the human body. The paddle frame 524 provides additional clamping force between the inner paddle 522 and the core capture element 510 and assists in wrapping the tip of the valve around the side of the core capture element 510 for better sealing between the core capture element 510 and the valve tip. In some embodiments, the coating 540 shown by FIG. 30 extends around the paddle frame 524.

[0122] The clasp 530 includes a base or fixed arm 532, a movable arm 534, barbs 536, and a joint portion 538. The fixed arm 532 is attached to the inner paddle 522, and the joint portion 538 is disposed proximate to the core capture element 510. The return clasp has a flat surface and does not conform to the recess of the paddle. Rather, the flat portion of the return clasp is disposed against the surface of the inner paddle 522. For example, the fixed arm 532 is attached to the inner paddle 522 with a suture (not shown) through a hole or slot 533. The fixed arm 532 can be attached to the inner paddle 522 or another part of the device by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc. The fixed arm 532 remains stationary or substantially fixed relative to the inner paddle 522 when the movable arm 534 is opened to open the return clasp 530 and expose the barbs 536. The return clasp 530 is opened by applying tension to an actuating wire (not shown) attached to the hole 535 of the movable arm 534, thereby pivoting or flexing the movable arm 534 on the joint portion 538.

[0123] During implantation, the anchor 508 is opened and closed to grip the native valve leaflet between the paddles 520, 522 and the core capture element 510. The return clasp 530 further secures the native valve leaflet by returning the valve tip to engage with 536 and clamping the valve tip between the movable and fixed arms 534, 532. The return 536 of the return clasp 530 may increase friction with the valve tip or may puncture the valve tip partially or completely. The actuation wires may be actuated separately so that each return clasp 530 can be opened and closed separately. By separate operation, one valve tip can be gripped at a time, or the clasp 530 on an inadequately gripped valve tip can be repositioned without changing the good grip of the other valve tip. The return clasp 530 is opened and closed when the inner paddle 522 is not closed, thereby allowing the valve tip to be gripped at various positions where specific circumstances are required.

[0124] Referring now to FIG. 33, an exemplary return clasp 600 for use in an implantable artificial device such as the device described above is shown. However, a wide variety of different return clasps can be used. Examples of return clasps that can be used include, but are not limited to, any of the return clasps disclosed in this application, as well as in any application incorporated herein by reference and / or to which this application claims priority. In the illustrated example, the return clasp 600 is formed from an upper layer 602 and a lower layer 604. The two-layer design of the clasp 600 allows for the use of a thinner sheet of material, thereby improving the flexibility of the clasp 600 relative to a clasp formed from a single thick sheet while maintaining the strength of the clasp 600 necessary to successfully hold the native valve leaflet.

[0125] The return clasp 600 includes a fixed arm 610, a joint portion 620, and a movable arm 630 having a return clasp 640. The upper layer 602 and the lower layer 604 have similar shapes and are attached to each other at the return portion 640 in certain embodiments. However, the upper layer 602 and the lower layer 604 may be attached to each other at other or additional locations. The joint portion 620 is spring-loaded such that when the return clasp 600 is in the closed state, the fixed arm 610 and the movable arm 630 are biased towards each other. When assembled into an implantable artificial device, the fixed arm 610 is attached to a portion of the artificial device. The clasp 600 is opened by pulling on the activation wire attached to the movable arm 630 until the spring force of the joint portion 620 is overcome.

[0126] The fixed arm 610 is formed from a tongue 611 of material extending from the joint 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 such that a force needs to be applied to move the tongue 611 from a neutral position located beyond the side beams 631 to a preloaded position parallel or substantially parallel to the side beams 631. The tongue 611 is held in the preloaded position by any T-shaped crossbar 614 attached to the tongue 611 and extending outwardly to engage the side beam 631. In an exemplary embodiment, the crossbar is omitted and the tongue 611 is attached to the inner paddle 522, and the inner paddle 522 maintains the clasp in the preloaded position. In a two-layer clasp application, the upper layer 602 and the lower layer 604, or only the upper layer, can be attached to the inner paddle. In some embodiments, the angle between the fixed arm 610 and the movable arm 630 when the tongue is in the neutral position is from 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.

[0127] The tongue portion 611 includes a hole 612 for receiving a suture (not shown) that attaches the fixed arm 610 to the implantable device. The fixed arm 610 can be attached to the implantable device using screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc. In certain embodiments, the hole 612 is an elongated slot or oval hole for accommodating the sliding of the layers 602, 604 without damaging the suture that attaches the clasp 600 to the implantable device.

[0128] The joint portion 620 is formed by two beam loops 622 that extend from the tongue portion 611 of the fixed arm 610 to the side beam 631 of the movable arm 630. In certain embodiments, the beam loops 622 are narrower than the tongue portion 611 and the side beam 631 to provide additional flexibility. Each of the beam loops 622 includes a central portion 624 that extends from the tongue portion 611 and an outer portion 626 that extends to the side beam 631. The beam loops 622 are bent in a slightly spiral or helical shape by bending the central portion 624 and the outer portion 626 in opposite directions, thereby forming an offset or step distance 628 between the tongue portion 611 and the side beam 631. The step distance 628 provides space between the arms 610, 630 and accommodates the natural valve leaflet after it is grasped. In certain embodiments, the step distance 628 is from about 0.5 millimeters to about 1 millimeter, or about 0.75 millimeters.

[0129] When viewed in a top plan view, the beam loop has an "omega-like" shape. This shape of the beam loop 622 allows the fixed and movable arms 610, 630 to move a significant distance relative to each other without plastically deforming the clasp material. For example, in certain embodiments, the tongue 611 may be bent or pivoted from a neutral position of more than about 45 degrees from the movable arm 630 to a fully open position of from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or about 180 degrees from the movable arm 630 without plastically deforming the clasp material. In certain embodiments, the clasp material plastically deforms during opening without reducing or substantially reducing the clamping force exerted between the fixed and movable arms in the closed position.

[0130] By preloading the tongue 611, the clasp 600 can maintain a clamping force or crimping force on the native valve tip when closed. The preloading of the tongue 611 provides a significant advantage over prior art clips that provide little or no clamping force when closed. Further, closing the clasp 600 with a spring force allows the clasp 600 to be repeatedly opened and closed to change its position on the valve tip while still maintaining sufficient clamping force when closed, which is a significant improvement over clips that use a one-time locking closure mechanism. Further, the spring-loaded clasp can also facilitate removal of the device over time as compared to a device that locks in the closed position (after tissue implantation). In one exemplary embodiment, both the clasp and paddle are springs that are biased to their closed positions (as opposed to being locked in the closed position), thereby facilitating removal of the device after tissue implantation.

[0131] The return portion 640 of the movable arm 630 includes a hole 642, a barb 644, and a barb support 646. When the return portion of the clasp 600 is positioned toward the end of the movable arm 630, when the clasp 600 is opened, the space between the barb 644 and the fixed arm 610 increases, thereby improving the ability of the clasp 600 to grip the valve tip well during implantation. This distance also enables the barb 644 to more reliably disengage from the valve tip for repositioning. In certain embodiments, the clasps' barbs may be arranged in an alternating longitudinal pattern to further distribute the clamping force and local valve tip stress.

[0132] The barbs 644 are laterally spaced from the joint portion 620 at the same distance, thereby providing an excellent distribution of the clamping force to the valve tip tissue while making the clasp more robust against valve tip gripping than barbs arranged in longitudinal rows. In some embodiments, the barbs 644 may be arranged in an alternating pattern to further distribute the clamping force and local valve tip stress.

[0133] The barbs 644 are formed from the lower layer 604, and the barb support 646 is formed from the upper layer. In certain embodiments, the barbs are formed from the upper layer 602 and the barb support is formed from the lower layer 604. By forming the barbs 644 in only one of the two layers 602, 604, the barbs are made thinner and thus sharper more effectively than barbs formed from the same material having twice the thickness. The barb support 646 extends along the lower portion of the barb 644 to stiffen the barb 644 and further improve the penetration and retention of the valve tip tissue. In certain embodiments, the ends of the barbs 644 are further ground using any suitable grinding means.

[0134] The barb 644 is inclined away from the movable arm 630 so as to easily penetrate the tissue of the natural valve tip using a minimal clamping force or clipping force. The barb 644 extends from the movable arm 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 barb 644 provides an additional benefit in that the force pulling the implant from the natural valve tip promotes further engagement of the barb 644 with the tissue, thereby ensuring better retention. The retention of the valve tip to the clasp 600 can be further improved by the position of the T-shaped crossbar 614 near the barb 644 when the clasp 600 is closed. In this arrangement, the tissue punctured by the barb 644 is clamped against the movable arm 630 at the position of the crossbar 614, thereby forming the tissue into an S-shaped distorted path as it passes through the barb 644. Thus, the force to pull the valve tip away from the clasp 600 promotes the tissue to further engage with the barb 644 before the valve tip can escape. For example, the tension of the valve tip during diastole can be urged to pull the barb towards the end portion of the valve tip. The S-shaped path utilizes the tension of the valve tip during diastole to allow for a closer engagement between the valve tip and the barb.

[0135] Each layer 602, 604 of the clasp 600 is laser cut from a sheet of shape memory alloy such as nitinol. The upper layer 602 is aligned and attached to the lower layer 604. In certain embodiments, the layers 602, 604 are attached to the barb portion 640 of the movable arm 630. For example, the layers 602, 604 may be attached only to the barb portion 640 to allow the remaining portions of the layers to slide relative to each other. Portions of the coupling layers 602, 604 such as the fixed arm 610, the barb 644 and barb support 646, and the beam loop 622 are bent to the desired position. The layers 602, 604 can be bent together to set the shape, or bent separately to set the shape and then joined together. The clasp 600 is then subjected to a shape setting process such that after the internal forces of the material are deformed by an external force, it tends to return to the set shape. After shape setting, the tongue 611 moves to its pre-loaded position so that the cross bar 614 can be attached. In one exemplary embodiment, the clasp 600 can be optionally flattened completely for delivery through a delivery sheath and can expand when deployed within the heart. The clasp 600 is opened and closed by applying and releasing tension to an actuation wire, suture, wire, rod, catheter, or the like (not shown) attached to the movable arm 630. In some embodiments, an actuation wire or suture is inserted through the aperture 642 near the barb 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 created through the aperture and the suture is inserted through the intermediate loop. Alternative embodiments of the intermediate loop can be constructed from a fiber or another material attached to the movable arm instead of a suture loop.

[0136] The intermediate loop of the suture material reduces the friction experienced by the actuation wire / suture compared to the friction between the actuation wire / suture and the clasp material. When the suture is looped through the aperture 642 or the intermediate loop, both ends of the actuation wire / suture extend rearwardly within and through the delivery sheath (e.g., FIG. 8). The suture can be removed by proximally pulling one end of the suture and withdrawing it until the other end of the suture returns through the aperture or intermediate loop into the delivery sheath.

[0137] Referring now to FIG. 34, a close-up view of one of the valve tips 20, 22 grasped by a return clasp such as clasps 430, 530 is shown. The valve tips 20, 22 are grasped between the movable arms 434 and the fixed arms 532 of the clasps 430, 530. As shown in FIG. 34, the tissue of the valve tips 20, 22 is not punctured by the barbs 436, 536, although in some embodiments, the barbs 436, 536 may partially or fully puncture the valve tips 20, 22. The angle and height of the barbs 436, 536 relative to the movable arms 434, 534 serve to fix the valve tips 20, 22 within the clasps 430, 530. In particular, the force pulling the implant from the native valve tip promotes further engagement of the barbs 436, 536 with the tissue, thereby ensuring better retention. The retention of the valve tips 20, 22 in the clasps 430, 530 is further improved by the position of the fixed arms 432, 532 near the barbs 436, 536 when the clasps 430, 530 are closed. In this arrangement, the tissue is formed within an S-shaped distorted path by the fixed arms 432, 532, and the movable arms 434, 534, as well as the barbs 436, 536. Thus, the force to pull the valve tip away from the clasps 430, 530 promotes the tissue to further engage the barbs 436, 536 before the valve tip can escape. For example, as described above, the tension of the valve tip during diastole can be promoted to pull the barb toward the end portion of the valve tip. The S-shaped path utilizes the tension of the valve tip during diastole to allow for a closer engagement between the valve tip and the barb.

[0138] Referring now to FIGS. 35 - 46, an implantable device 500 is shown to be delivered and implanted within the native mitral valve MV of the heart H. The methods and steps illustrated and / or contemplated may be performed on a live animal or in a simulation such as, for example, on a cadaver, cadaver heart, simulator (e.g., where a body part, heart, tissue, etc. is being simulated).

[0139] As described above, the device 500 has a cover 540 (see FIG. 30) over the core capture element 510, clasp 530, inner paddles 522, and / or outer paddles 520. The device 500 is deployed from a delivery sheath 502 and includes a core capture portion 504 and an anchor portion 506 that includes a plurality of anchors 508 (i.e., two in the illustrated embodiment). The core capture portion 504 of the device includes a core capture element 510 for implanting between the leaflets 20, 22 of the native mitral valve MV that is slidably attached to an actuating element or means 512. Actuation of the actuating element or means 512 opens and closes the anchors 508 of the device 500 to grip the mitral valve leaflets 20, 22 during implantation.

[0140] The anchors 508 of the device 500 include outer paddles 520 and inner paddles 522 that are flexibly connected to a cap 514 and the core capture element 510. The actuating element 512 extends through a capture mechanism 503 (see FIG. 41), the delivery sheath 502, and the core capture element 510 to a cap 514 connected to the anchor portion 506. Extension and retraction of the actuating element 512 increases and decreases the spacing between the core capture element 510 and the cap 514, respectively. In the embodiment shown by FIGS. 35 - 46, the pair of inner and outer paddles 522, 520 move in unison, not independently, by a single actuating element 512. Also, the position of the clasp 530 is dependent on the position of the paddles 522, 520. For example, referring to FIG. 45, closure of the paddles 522, 520 causes the clasp to also close. In one exemplary embodiment, the device 500 may be fabricated to controllably and independently move the paddles 520, 522 in the same manner as the embodiment of FIG. 11A.

[0141] The fingers of the capture mechanism 503 removably attach the collar 511 to the delivery sheath 502. The collar 511 and the core insertion element 510 slide along the actuating element 512 during actuation to open and close the anchor 508 of the anchor portion 506. In some embodiments, upon removal of the actuating element 512, the capture mechanism 503 is held in a closed state around the collar 511 by the actuating element 512, allowing the fingers of the capture mechanism 503 to release the collar 511 and thus open the core insertion element 510.

[0142] In some embodiments, the core insertion element 510 and the paddles 520, 522 can be formed of a flexible material such as metal fibers formed in a mesh, woven, knitted, or any other suitable manner, or a flexible material cut by laser cutting or another method. The flexible material can be a cloth, a wire such as nitinol that provides shape fixation capabilities, or any other flexible material suitable for implantation into the human body. Other configurations are also possible.

[0143] The return clasp 530 includes a base or fixed arm 532, a movable arm 534, barbs 536 (see FIG. 41), and a joint portion 538. The fixed arm 532 is attached to the inner paddle 522, and the joint portion 538 is disposed proximate to the core insertion element 510. A suture (not shown) attaches the fixed arm 532 to the inner paddle 522. The fixed arm 532 can be attached to the inner paddle 522 and / or another portion of the device by any suitable means such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc. The fixed arm 532 remains fixed, or substantially fixed, when the movable arm 534 opens to release the return clasp 530 and expose the barbs 536. The return clasp 530 is opened by applying tension to a clasp control member or actuating wire 537 attached to the movable arm 534, thereby pivoting or flexing the movable arm 534 on the joint portion 538.

[0144] During implantation, the anchor 508 is opened and closed to grip the native valve leaflets between the paddles 520, 522 and the coaptation element 510. The outer paddle 520 has a wide curved shape that conforms to the curved perimeter of the coaptation element 510 to more firmly grip the leaflet tips 20, 22. The curved shape and rounded edges of the outer paddle 520 also prevent tearing of the leaflet tissue. The return clasp 530 further secures the native leaflets by engaging the leaflet tips with the barbs 536 and sandwiching the leaflet tips between the movable and fixed arms 534, 532. The barbs 536 of the return clasp 530 may increase friction with the leaflet tips or may puncture the leaflet tips partially or completely. The actuation wires can be actuated separately so that each return clasp 530 can be opened and closed separately. By separate operation, one leaflet tip can be gripped at a time, or the clasp 530 on the inadequately gripped leaflet can be repositioned without changing the good grip of the other leaflet tip. The return clasp 530 can be fully opened and closed when the inner paddle 522 is not closed, thereby allowing the leaflet tips to be gripped at various positions where specific situations require it.

[0145] To enable the fully open or fully deployed position to occupy the least amount of space and use the smallest catheter (or use the largest device 500 for a given catheter size), the device 500 is loaded into the delivery sheath in the fully open or fully deployed position. Referring now to Figure 35, the delivery sheath is inserted into the left atrium LA through the septum, and the device 500 is deployed from the delivery sheath 502 in the fully open state. Next, the actuating element 512 is retracted to move the device 500 to the fully closed state shown in Figures 36 - 37, and then it is moved towards the mitral valve MV as shown in Figure 38. Referring now to Figure 39, when the device 500 is aligned with the mitral valve MV (or other native valve if implanted in another valve), the actuating element 512 is extended to open the paddles 520, 522 to the partially open position, and the clasp control member or actuating wire 537 is retracted to release the return clasp 530 to prepare for grasping the valve leaflets. Next, as shown in Figures 40 - 41, the partially open device 500 is inserted through the mitral valve MV until the valve leaflets 20, 22 are properly positioned between the inner paddle 522 and the coaptation element 510 and inside the open return clasp 530. Figure 42 shows the device 500 with both clasps 530 closed, but the return 536 of one of the clasps 530 has missed one of the valve leaflets 22. As can be seen from Figures 42 - 44, the misaligned clasp 530 is opened and closed again to properly grasp the missed valve leaflet 22. When both valve leaflets 20, 22 are properly grasped, the actuating element 512 is retracted to move the device 500 to the fully closed position shown in Figure 45. When the device 500 is fully implanted into the native mitral valve MV, the actuating element 512 is withdrawn to release the capture mechanism 503 from the proximal collar 511. When deployed, the device 500 may be maintained in the fully closed position using mechanical means such as a latch, or may remain closed through the use of a spring material such as steel and / or a shape memory alloy such as nitinol.For example, paddles 520, 522 can be formed from steel or nitinol shape memory alloy made of wire, sheet, tube, or laser sintered powder, and are biased to hold an outer paddle 520 that closes around an inner paddle 522, a core capture element 510, and a return clasp 530 clamped around natural valve leaflets 20, 22.

[0146] Device 500 can have a wide variety of different shapes and sizes. Referring to FIGS. 6 and 6A - 6E, in an exemplary embodiment, core capture element 510 functions as a gap filler within the backflow orifice of a valve, such as natural valve gap 26 shown in FIG. 6. Referring to FIG. 6A, because core capture element 510 is deployed between two opposing valve leaflets 20, 22, the leaflets do not join with each other within the region of core capture element 510, but instead join to core capture element 510. This reduces the distance that valve leaflets 20, 22 need to approach each other. Reducing the leaflet approach distance can provide several advantages. For example, the core capture element and the resulting reduction in approach can facilitate repair of the anatomical structure of a severely diseased mitral valve, such as a large gap in functional valve disease (see, e.g., FIG. 6). Because core capture element 510 reduces the distance that the natural valve needs to approach, stress in the natural valve can be reduced or minimized. The shorter approach distance of valve leaflets 20, 22 can require less closing force, which can result in less tension on the leaflets and a smaller reduction in annulus diameter. A smaller reduction in annulus (or no reduction in annulus) can result in a smaller reduction in valve orifice area compared to a device without a spacer. As a result, core capture element 510 can reduce the transvalvular gradient.

[0147] In one exemplary embodiment, the paddle frame 524 conforms to the shape of the coaptation element 510. In one example, when the coaptation element 510 is wider than the paddle frame 524, the distance (gap) between the opposing valve leaflets 20, 22 can be created by the device 500. Referring to FIGS. 6A-6E, in one exemplary embodiment, the paddle is configured to conform to the shape or geometric arrangement of the coaptation element 510. As a result, the paddle can mate with both the coaptation element 510 and the native valve. Referring to FIGS. 6D and 6E, in one exemplary embodiment, the paddle 524 surrounds the coaptation element 510. Thus, when the valve leaflets 20, 22 are joined or pressed against the coaptation element 510, the valve leaflets 20, 22 completely surround or "hold" the coaptation element 510 as a whole, thus preventing small leaks on the inner and outer surfaces of the coaptation element 510. FIGS. 6B and 6C show the valve repair device 500 attached to the mitral valve leaflets 20, 22 from the ventricular side of the mitral valve. FIG. 6A shows the valve repair device 500 attached to the mitral valve leaflets 20, 22 from the atrial side of the mitral valve. Referring to FIGS. 6A and 6B, when the paddle has a geometric shape that conforms to the geometric shape of the coaptation element 510, the valve leaflets 20, 22 can be joined around the coaptation element and / or along the length of the spacer. Referring to FIG. 6E, a schematic atrial view / surgeon's view shows a paddle frame (not actually visible from a real atrial view) that conforms to the spacer shape. The opposing valve leaflets 20, 22 (neither of whose ends are visible in a true atrial view) are brought together by the paddle to completely surround or "hold" the coaptation element 510.

[0148] Referring to FIGS. 6B - 6E, since the paddle frame 524 conforms to the shape of the core capture element 510, the valve tips 20, 22 can be joined by the paddle frame 524 to completely surround the core capture element, including on the inner and outer surfaces 601, 603 of the core capture element 510. This core capture of the valve tips 20, 22 with respect to the inner and outer surfaces of the core capture element 510 may seem to conflict with the above in that the presence of the core capture element 510 minimizes the distance that the valve tips need to approach. However, if the core capture element 510 is accurately positioned in the backflow gap and the backflow gap is smaller than the width (inner surface - outer surface) of the core capture element 510, the distance that the valve tips 20, 22 need to approach is still minimized.

[0149] Referring to FIGS. 6A and 6E, the core capture element 510 can take a wide variety of shapes. In one exemplary embodiment, when viewed from above (and / or a cross - section from above, see FIGS. 95 - 102), the core capture element has an oval or elliptical shape. The oval or elliptical shape can enable the paddle frame 524 to conform to the shape of the core capture element and / or can reduce lateral leakage (see FIGS. 65 - 83).

[0150] As described above, the coaptation element 510 can reduce the tension of the opposing leaflets by reducing the distance that the leaflet tips need to approach the coaptation element at positions 601, 603. The reduction of the leaflet tip approach distance at positions 601, 603 can result in a reduction of leaflet stress and gradient. Further, as also described above, the native leaflets 20, 22 can surround or "hold" the coaptation element to prevent lateral leakage. In one exemplary embodiment, the geometric features of the coaptation element can be designed to retain and enhance these two features of the device 500. Referring to FIG. 2A, when viewed from the left ventricular outflow tract (LVOT) view, the biological structure of the leaflets 20, 22 is such that the inner sides of the leaflets join at the free end portion and the leaflets 20, 22 begin to move away from each other or begin to spread. The leaflets 20, 22 spread away in the atrial direction until each leaflet contacts the mitral annulus.

[0151] In one exemplary embodiment, the valve repair device 500 and its coaptation element 510 are designed to conform to the geometric biological structure of the leaflets 20, 22. To achieve valve sealing, the valve repair device 500 can be designed to join the native valve to the coaptation element so as to completely surround the coaptation element including the inner position 601 and the outer position 603 of the coaptation element. Further, the reduction of the force required to contact the leaflet tips with the coaptation element 510 at positions 601, 603 can minimize leaflet stress and gradient. FIG. 2B shows how the tapered or triangular shape of the coaptation element 510 naturally conforms to the native valve geometry and the nature of its expanded leaflets (towards the valve annulus).

[0152] FIG. 6D shows the geometric shapes of the coaptation element 510 and the paddle frame 524 from the perspective of the LVOT. As can be seen from this figure, the coaptation element 510 has a tapered shape that is smaller in dimensions in a region closer to where the inner surfaces of the valve leaflets 20, 22 need to join, and the dimensions increase as the coaptation element extends towards the atrium. The geometric shape of the illustrated native valve is adapted by the geometric shape of the tapered coaptation element. Referring further to FIG. 6D, in conjunction with the shape of the illustrated (annulus-directed) expanded paddle frame 524, the geometric shape of the tapered coaptation element can serve to achieve junction at the lower ends of the valve leaflets, reduce stress, and minimize the transvalvular gradient.

[0153] Referring to FIG. 6C, in one exemplary embodiment, the remaining shapes of the coaptation element 510 and the paddle frame 524 can be defined based on the views of the native valve and the interconnected nerves of the device 500. Two factors for these shapes are the leaflet coaptation to the coaptation element 510 and the reduction of stress on the leaflets by the coaptation. Referring to FIGS. 6C and 67, to join the valve leaflets 20, 22 to the coaptation element 510 and reduce the stress applied to the valve leaflets 20, 22 by the coaptation element 510 and / or the paddle 524, the coaptation element 510 may have a rounded or rounded shape, and the paddle frame 524 may have an overall radius extending from one leg of the paddle to the other leg of the paddle. The circular shape of the coaptation element and / or the fully rounded shape of the illustrated paddle frame distribute stress over a large, curved engagement region 607 to the valve leaflets 20, 22. For example, in FIG. 6C, when the valve leaflet 20 is attempting to open during diastole, the force on the valve leaflets 20, 22 by the paddle frame spreads along the rounded full length of the paddle frame 524.

[0154] Referring to FIG. 67, in one exemplary embodiment, in order to cooperate with the fully rounded shape of the paddle frame 524, and / or to maximize the core ptosis of the valve tip with respect to the core ptosis element 510, and the core ptosis from valve tip to valve tip on the side surfaces 601, 603 of the core ptosis element 510, the shape of the core ptosis element 510 in the internal commissural view follows a rounded shape. Referring to FIG. 67, the rounded shape of the core ptosis element in this figure substantially follows or is close to the shape of the paddle frame 524.

[0155] In one exemplary embodiment, the overall shape of the core ptosis element 510 is an elliptical or oval cross-section (see top view - FIG. 70) when viewed from the surgeon's view, a tapered shape or cross-section (see side view - FIG. 69) when viewed from the LVOT view, and a substantially rounded or rounded shape (see FIG. 68) when viewed from the internal commissural view. In one exemplary embodiment, the combination of these three geometric shapes can result in the three-dimensional shape of the illustrated core ptosis element 510 that achieves the above-described benefits.

[0156] In one exemplary embodiment, the dimensions of the core ptosis element are selected to minimize the number of implants (preferably one) required for a single patient while simultaneously maintaining a low transvalvular gradient. In one exemplary embodiment, the anterior-posterior distance X47B at the top of the spacer is about 5 mm, and the medial-lateral distance X67D of the widest spacer is about 10 mm. In one exemplary embodiment, the overall geometric shape of the device 500 may be based on these two dimensions and the overall shape strategy described above. It is readily apparent that using other anterior-posterior distances X47B and medial-lateral distances X67D as the starting point for the device will result in devices with different dimensions. Further, using other dimensions and shape strategies described above will also result in devices with different dimensions.

[0157] Tables A, B, and C provide examples of device dimensions and values and ranges of device components for some exemplary embodiments. However, the devices can have a wide variety of different shapes and sizes and do not need to have all or any of the dimensional values or dimensional ranges provided in Tables A, B, and C. Table A provides examples of linear dimension X in millimeters and ranges of linear dimensions in millimeters for the device and device components. Table B provides examples of radius dimension R in millimeters and ranges of radius dimensions in millimeters for the device and device components. Table C provides examples of angular dimension α (degrees) and ranges of angular dimensions (degrees) for the device and device components. Each subscript of the dimension indicates the drawing in which the dimension first appears. [Table 1] [Table 2] [Table 3]

[0158] Referring now to FIGS. 47-61, an implantable device 500 is shown in various positions and configurations. The implantable device 500 can include any other features related to implantable artificial devices contemplated in this application, and the device 500 can be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0159] The implantable device 500 has a proximal or attachment portion 505, a core capture element (e.g., a spacer, etc.) 510, an inner anchor portion or inner paddle 522, an outer anchor portion or outer paddle 520, an anchor extension member or paddle frame 524, and a distal portion 507. The inner paddle 522 is attached (e.g., articulately attached, etc.) between the core capture element 510 and the outer paddle 520. The outer paddle 520 is attached (e.g., articulately attached, etc.) between the inner paddle 522 and the distal portion 507. The paddle frame 524 is attached to the cap 514 at the distal portion 507 and extends to the joint portion 523 between the inner and outer paddles 522, 520. In some embodiments, the paddle frame 524 is formed of a material that is more rigid and harder than the material forming the paddles 522, 520 so as to provide support for the paddles 522, 520. In an exemplary embodiment, the inner paddle 522 is hard, relatively hard, rigid, has a rigid portion, and / or is reinforced by a fixed portion of a reinforcement member or clasp 530. The reinforcement of the inner paddle allows the device to move to the various different positions illustrated and described herein. The inner paddle 522, the outer paddle 520, and the core capture can all be interconnected as described herein, whereby the device 500 is constrained to the movements and positions illustrated and described herein.

[0160] Referring now to FIGS. 47-48, the device 500 is shown in a partially open position. When closed, the inner paddle 522 is disposed between the outer paddle 520 and the core capture element 510. In some embodiments, the device 500 includes a clasp or gripping member 530 (FIG. 48) that can open and close to grip the native valve leaflets 20, 22 of the mitral valve MV. The clasp 530 is attached to the inner paddle 522 and moves therewith and is disposed between the inner paddle 522 and the core capture element 510.

[0161] Referring now to FIGS. 49 - 51, device 500 is shown in a partially open position. Device 500 is moved to the partially open position by an actuating element or means 512 that passes through attachment portion 505 and core - option element 510 and can removably engage distal portion 507. As actuating element 512 extends, it extends through attachment portion 505 such that the distance D between attachment portion 505 and distal portion 507 increases. In the embodiments shown by FIGS. 49 - 51, the pair of inner and outer paddles 522, 520 move in unison, not independently, by a single actuating wire 512. Also, the position of clasp 530 is dependent on the position of paddles 522, 520. For example, referring to FIG. 48, closure of paddles 522, 520 causes the clasp to also close. In one exemplary embodiment, device 500 can be made to controllably and independently move paddles 520, 522 in the same manner as the embodiment of FIG. 11A.

[0162] Extension of the actuating element 512 pulls down the outer paddle 520 and the bottom portion of the paddle frame 524. The outer paddle 520 and paddle frame 524 pull down the inner paddle 522, and the inner paddle 522 is connected to the outer paddle 520 and paddle frame 524. Since the attachment portion 505 and core - option element 510 are held in place, the inner paddle 522 is bent or pivoted in the direction of the opening. The inner paddle 522, outer paddle 520, and paddle frame all bend to the position shown in FIG. 49. Opening of paddles 522, 520 and frame 524 creates a gap 520A between the core - option element 510, which can receive and grip the natural valve tip 20, and the inner paddle 522.

[0163] As described above, some embodiments of device 500 include a clasp or gripping member 530. When device 500 is partially open, clasp 530 is exposed. In some embodiments, a closed clasp 530 (FIG. 50) can open (FIG. 51), thereby creating a second opening or gap 530A for receiving and capturing natural valve leaflets 20, 22. The extent of gap 530A within clasp 530 is limited to the extent that inner paddle 522 extends away from coaptation element 510.

[0164] Referring now to FIGS. 52 - 54, device 500 is shown in a laterally extended or open position. Device 500 moves to the laterally extended or open position by continuing to extend activation element 512, thereby increasing the distance D between attachment portion 505 and distal portion 507. By continuing to extend activation element 512, outer paddles 520 and paddle frame 524 are pulled down, thereby spreading inner paddle 522 further away from coaptation element 510. In the laterally extended or open position, inner paddle 522 extends more horizontally than at other positions of device 500 and forms an angle of approximately 90 degrees with coaptation element 510. Similarly, paddle frame 524 is in its most spread position when device 500 is in the laterally extended or open position. The increase in gap 520A formed in the laterally extended or open position allows clasp 530 to open further (FIG. 54) before engaging coaptation element 510, thereby allowing the size of gap 530A to increase.

[0165] Referring now to FIGS. 55 - 57, device 500 is shown in the three - quarters extended position. Device 500 moves to the three - quarters extended position by continuing to extend the operating element 512 as described above, thereby increasing the distance D between the attachment portion 505 and the distal portion 507. By continuing to extend the operating element 512, the outer paddle 520 and the paddle frame 524 are pulled down, thereby spreading the inner paddle 522 further away from the co - option element 510. At the three - quarters extended position, the inner paddle 522 is open at an angle of more than 90 degrees to about 135 degrees with respect to the co - option element 510. The paddle frame 524 has less spread than in the laterally extended position or open position and begins to move inwardly toward the operating element 512 as the operating element 512 extends further. The outer paddle 520 also bends rearwardly toward the operating element 512. As in the case of the laterally extended position or open position, the increase in the gap 520A formed in the laterally extended position or open position causes the clasp 530 to open further (FIG. 57), thereby making it possible to increase the size of the gap 530A.

[0166] Referring now to FIG. 58, device 500 is shown in the substantially fully extended position. Device 500 moves to the substantially fully extended position by continuing to extend the operating element 512 as described above, thereby increasing the distance D between the attachment portion 505 and the distal portion 507. By continuing to extend the operating element 512, the outer paddle 520 and the paddle frame 524 are pulled down, thereby spreading the inner paddle 522 further away from the co - option element 510. In the substantially fully extended position, the inner paddle 522 approaches an angle of about 180 degrees with respect to the co - option element 510. As the inner paddle moves to this position, the outer paddle 520 and the paddle frame 524 do not move or bend at an angle of 90 degrees or more than 90 degrees with respect to the co - option element 510. In the substantially fully extended position, the inner paddle 522 and the outer paddle 520 may have a slightly curved shape.

[0167] Referring now to FIGS. 59 - 61, device 500 is shown in a fully extended position. Device 500 moves to the fully extended position by continuing to extend the operating element 512, thereby increasing the distance D between the attachment portion 505 and the distal portion 507 to the maximum distance allowed by device 500. By continuing to extend the operating element 512, the outer paddle 520 and paddle frame 524 are pulled down, thereby spreading the inner paddle 522 further away from the core capture element 510. The outer paddle 520 and paddle frame 524 are moved to positions closer to the operating element. In the fully extended position, the inner paddle 522 is open at an angle of approximately 180 degrees relative to the core capture element 510. The inner paddle 522 and outer paddle 520 are straight and extended in the fully extended position, forming an angle of approximately 180 degrees between paddles 522, 520. The fully extended position of device 500 provides the maximum size of the gap 520A between the paddles and, in some embodiments, allows the clasp 530 to fully open to approximately 180 degrees between portions of the clasp 530 (FIG. 61). The position of device 500 is the most narrow configuration. Thus, the fully extended position of device 500 may be a desirable position for bailing out device 500 from an attempted implantation or may be a desirable position for placement of the device onto a delivery catheter or the like.

[0168] Referring now to FIGS. 47A, 48A - 48H, 53A - 53C, 54A - 54D, 60A - 60D, and 61A - 61D, the implantable device 500A is shown in various positions and configurations. The implantable device 500A can include any other features related to the implantable artificial device considered in this application, and device 500A can be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0169] The implantable device 500A has a proximal or attachment portion 505A, a core capture element 510A, an inner anchor portion or inner paddle 522A, an outer anchor portion or outer paddle 520A, an anchor extension member or paddle frame 524A, and a distal portion 507A. The inner paddle 522A is attached (e.g., articulately attached) between the core capture element 510A by, for example, a joint portion 525A and the outer paddle 520A by a joint portion 523A. The outer paddle 520A is attached (e.g., articulately attached) between the inner paddle 522A by, for example, a joint portion 523A and the distal portion 507A by a joint portion 521A. The paddle frame 524A is attached to a cap 514A at the distal portion 507A (FIG. 48A) and extends to a joint portion 523A between the inner and outer paddles 522A, 520A. In some embodiments, the paddle frame 524A is formed of a material that is more rigid and harder than the material forming the paddles 522A, 520A so as to provide support for the paddles 522A, 520A. The paddle frame 524A includes an opening or slot 524B for receiving the joint portion 523A (FIG. 65A). In some embodiments, the inner paddle 522A is rigid, relatively rigid, stiff, has a rigid portion, and / or is reinforced by a fixed portion of a reinforcement member or clasp 530C. The reinforcement of the inner paddle allows the device to move to various different positions illustrated and described herein. The inner paddle 522A, the outer paddle 520A, and the core capture element can all be interconnected as described herein, whereby the device 500A is constrained to the movements and positions illustrated and described herein.

[0170] The core engagement element 510A, the inner paddle 522A, and the outer paddle 520A can be attached together by integrally forming the core engagement element 510A and the paddles 520A, 522A as a single integral component. This can be achieved, for example, by forming the core engagement element 510A and the paddles 520A, 522A from a continuous strip 501A of a braided or woven material such as braided or woven Nitinol wire.

[0171] The continuous strip 501A is attached to the color 511D, the cap 514A, the paddle frame 524A, and the clasp 530C. In the illustrated embodiment, the core engagement element 510A, the hinge portions 521A, 523A, 525A, the outer paddle 520A, and the inner paddle 522A are formed from the continuous strip 501A. The continuous strip 501A may be a single layer of material or may include two or more layers. In certain embodiments, a portion of the device 500A has a single layer of the strip 501A of material and other portions are formed from multiple overlapping or stacked layers of the strip 501A of material. For example, FIG. 47A shows a core engagement element 510A and an inner paddle 522A formed from multiple overlapping or stacked layers of the strip 501A of material. As a result, the core engagement element 510A and the inner paddle 522A have increased hardness compared to the outer paddle 520A formed from a single layer of the material 501A. The single continuous strip 501A of material can start and end at various locations of the device 500A. The ends of the strip 501A of material can be at the same or different locations of the device 500A. For example, in the illustrated embodiment of FIG. 47A, the strip of material starts and ends at the location of the inner paddle 522.

[0172] The clasp 530C can include an attachment or fixing portion 532C, an arm or movable portion 534C, a barb 536C, and a joint portion 538C. The attachment or fixing portion 532C can be connected to the inner paddle 522A in various ways, such as sutures, adhesives, fasteners, welding, stitching, swaging, friction fitting, and / or other means for connecting to the joint portion 538C disposed in proximity to the core plug element 510A. The clasp 530C may be similar to the clasp 430.

[0173] The movable portion 534C can pivot or flex relative to the fixed portion 532C between an open configuration (e.g., FIG. 54A) and a closed configuration (FIG. 48A). In some embodiments, the clasp 530C can be biased towards the closed configuration. In the open configuration, the fixed portion 532C and the movable portion 534C pivot or flex away from each other such that a natural valve tip 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 towards each other, thereby clamping the natural valve tip between the fixed portion 532C and the movable portion 534C. The fixed arm 532C remains fixed or substantially fixed when the movable arm 534C opens and returns to release the clasp 530C and expose the barb 536C. The return clasp 530C is released by applying tension to an actuating wire 537A attached to the movable arm 534C, thereby pivoting or flexing the movable arm 534C on the joint portion 538C.

[0174] Referring now to FIGS. 47A and 48A - 48H, device 500A is shown in a closed position. Device 500A is shown in side views of FIGS. 48B, 48C, and 48F, front views of FIGS. 48D, 48E, and 48G, and a bottom view of FIG. 48H. Device 500A is narrower when viewed from the front than from the side. When viewed from the side, device 500A has a generally trapezoidal shape that is rounded and tapered towards the distal portion 507A of device 500A. When viewed from the front, device 500A has a generally rounded rectangular shape that tapers slightly towards the distal portion 507A. As can be seen from the bottom view of device 500A shown in FIG. 48H, device 500A has a generally rounded rectangular shape when viewed from below (and when viewed from above, as seen for example in FIG. 70A).

[0175] In the closed configuration of device 500A, inner paddle 522A is disposed between outer paddle 520A and core occlusion element 510A. In some embodiments, device 500A includes a clasp or gripping member 530C (FIG. 48A) that can be opened and closed to grip the native leaflets 20, 22 of the mitral valve MV. Clasp 530C is attached to and moves with inner paddle 522A and is disposed between inner paddle 522A and core occlusion element 510A.

[0176] Referring now to FIGS. 48B - 48D, device 500A is shown attached to delivery device 502A. Delivery device 502A has an operable member or finger 503A that releasably engages attachment portion 505A. Actuating element 512A extends from delivery device 502A through attachment portion 505A of artificial device 500A and core aspiration element 510A to cap 514A. When actuating element 512A is extended and retracted, device 500A opens and closes as described below. Actuating wire / suture 537A extends from delivery device 502A and is attached to clasp 530C. Tension can be applied to suture 537A to open clasp 530C and release it so that it can be closed. Device 500A is shown separated from delivery device 502A in the deployed state of FIGS. 48F - 48G.

[0177] Referring now to FIGS. 48C and 48E, device 500A is shown with cover 540A. Cover 540A may be formed from a single piece of material or from multiple segments adjacent or joined to each other. In the illustrated embodiment, cover 540A has outer or lower cover 541A and inner or upper cover 543A. Outer cover 541A covers cap 514A, outer paddle 520A, inner paddle 522A, and clasp 530C. Inner cover 543A covers core aspiration element 510A, the proximal end of inner paddle 522A, and clasp 530C where core aspiration element 510A intersects inner paddle 522A and clasp 530C. Cover 540A can be a cross material such as a fine - mesh polyethylene cloth. The cross - cover can provide a blood seal on the surface of the spacer and / or can promote rapid tissue ingrowth.

[0178] Referring now to FIGS. 53A - 53D and FIGS. 54A - 54D, device 500A is shown in a laterally extended or open position. Device 500A is moved to the open position by an actuating element or means 512A that passes through attachment portion 505A and core - capture element 510A and can removably engage distal portion 507A. As actuating element 512A extends, actuating element 512A extends through attachment portion 505A such that the distance D2 between attachment portion 505A and distal portion 507A increases. In the embodiments shown by FIGS. 53A - 53D and FIGS. 54A - 54D, the pair of inner and outer paddles 520A, 522A move in unison, not independently, by a single actuating element 512A. Also, the position of clasp 530C depends on the position of paddles 520A, 522A. For example, referring to FIG. 48A, closure of paddles 520A, 522A causes clasp 530C to also close. In one exemplary embodiment, device 500A can be made to controllably and independently actuate paddles 520A, 522A in the same manner as the embodiment of FIG. 11A.

[0179] Extension of actuating element 512A pulls down the outer paddle 520A and the bottom portion of paddle frame 524A, shifting device 500A from the closed position to a partially open position. The outer paddle 520A and paddle frame 524A pull down the inner paddle 522A, and the inner paddle 522A is connected to the outer paddle 520A and paddle frame 524A. Since attachment portion 505A and core - capture element 510A are held in place, inner paddle 522A pivots or flexes in the direction of the opening. Inner paddle 522A, outer paddle 520A, and the paddle frame all flex to the position shown in FIG. 53A. Opening of paddles 522A, 520A and frame 524 forms a gap 520D between core - capture element 510A, which can receive and grip natural valve tip 20, and inner paddle 522A.

[0180] By continuing to extend the actuating element 512A, the outer paddle 520A and the paddle frame 524A are pulled down, thereby spreading the inner paddle 522A further away from the core aspiration element 510A. In the lateral extension or open position, the inner paddle 522A extends more horizontally than other positions of the device 500A and forms an angle of approximately 90 degrees with the core aspiration element 510A. Similarly, the paddle frame 524A is in its most expanded position when the device 500A is in the lateral extension or open position. The increase in the gap 520D formed in the lateral extension or open position causes the clasp 530C to open further (FIG. 54A) before engaging with the core aspiration element 510A, thereby allowing the size of the gap 530D to be increased compared to the partially open position.

[0181] As described above, some embodiments of the device 500A include a clasp or gripping member 530C. When the device 500A is open, the clasp 530C is exposed. In some embodiments, the closed clasp 530C (FIGS. 53A-53D) opens (FIGS. 54A-54D), thereby creating a second opening or gap 530D for receiving and capturing the native valve leaflets 20, 22. The extent of the gap 530D within the clasp 530C is limited to the extent that the inner paddle 522A is spread away from the core aspiration element 510A.

[0182] Referring now to FIGS. 60A-60D and FIGS. 61A-61D, device 500A is shown in a fully extended position. Device 500A moves to the fully extended position by continuing to extend the actuating element 512A, thereby increasing the distance D2 between the attachment portion 505A and the distal portion 507A to the maximum distance allowed by device 500A. By continuing to extend the actuating element 512A, the outer paddle 520A and paddle frame 524A are pulled down, thereby extending the inner paddle 522A further away from the core aspiration element 510A. The outer paddle 520A and paddle frame 524A move to a position closer to the actuating element. In the fully extended position, the inner paddle 522A is open at an angle of approximately 180 degrees relative to the core aspiration element 510A. The inner paddle 522A and outer paddle 520A are straight or substantially straight when fully extended, forming an angle of approximately 180 degrees between paddles 522A, 520A. The fully extended position of device 500A provides the maximum size of the gap 520D between the paddles and, in some embodiments, also allows the clasp 530C to fully open to approximately 180 degrees between portions of the clasp 530C (FIG. 61A). The position of device 500A is the narrowest configuration. Thus, the fully extended position of device 500A may be a desirable position for the bailout of device 500A from an attempted implantation or may be a desirable position for the placement of the device onto a delivery catheter or the like.

[0183] Referring now to FIGS. 197 - 198, an enlarged view of the portion of FIG. 60C is shown. Referring now to FIG. 197, it can be seen that the inner cover 543A covers the core capture 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 cross material, such as a fine mesh polyethylene cloth (see FIG. 201), folded around the core capture element 510A, and held in place by stitches 545A. Referring now to FIG. 198, it can be seen that the outer cover 541A covers the clasp 530C and the inner paddle 522A. The color portion 548A of the inner cover 543A covers the portions of the clasp 530C and the inner paddle 522A closest to the core capture element 510A. The moving portion 547A of the inner cover 543A extends from the core capture element 510A to the color portion 548A to provide a smooth movement between the core capture element 510A and the clasp 530C and the inner paddle 522A so that natural tissue does not catch on the device 500A during implantation.

[0184] Referring now to FIG. 199, an exploded view of the device 500A is shown. The core capture element 510A, the outer paddle 520A, and the inner paddle 522A are formed from a single strip of material 501A as described above. The color 511D, the cap 514A, the paddle frame 524A, and the clasp 530C are assembled to the strip of material 501A to form the device 500A. The cap 514A includes a retaining body 560A having a locking aperture 561A for receiving a retaining nut 562A having a threaded hole 564A that engages the threaded portion 568A of the retaining bolt 566A. The threaded portion 568A of the retaining bolt 566A is inserted through the opening 527B to engage the retaining body and nut 560A, 562A and attach the cap 514A to the strip of material 501A.

[0185] In one embodiment, the reinforcement member 539C is attached to the inner paddle 522A to reinforce the inner paddle 522A and maintain the inner paddle in a straight or substantially straight configuration as the inner paddle is moved between various positions. The notch 539D of the reinforcement member 539C is shaped to receive the fixed arm 532C of the clasp 530C such that the reinforcement member 539C can fit around the fixed arm 532C when both the reinforcement member 539C and the clasp 530C are attached to the inner paddle 522A. Similar to the fixed arm 532C, the reinforcement member 539C can be connected to the inner paddle 522A in various ways such as suture, adhesive, fastener, welding, stitching, swaging, friction fitting, and / or other connecting means.

[0186] Referring now to FIG. 200, an enlarged view of the collar 511D attached to the proximal portion 519B of the core aspiration element 510A is shown. The collar 511D includes a protrusion 511B for releasably engaging the finger 503A of the delivery device 502A. The aperture 515A of the collar 511D receives the actuating element 512A. The proximal portion 519B of the core aspiration element 510A flares outwardly to form two loops 519D, and the two loops 519D are inserted through the arcuate opening 513A of the collar 511D to attach the collar 511D to the proximal portion 519B of the core aspiration element 510A. The loops 519D are formed by folding a strip 501A of material to form a first layer 581A and a second layer 582A.

[0187] Referring now to FIGS. 201 - 202, an enlarged view and an exploded view of the cap 514A are shown respectively. FIG. 201 shows an enlarged view of the cap 514A attached to the distal portion 527A of the strip 501A of material. The retaining body 560A, the retaining nut 562A, and the retaining bolt 566A cooperate to attach the paddle frame 524A to the distal portion 527A of the strip 501A of material. In particular, the retaining bolt 566A is inserted through the opening 527B of the distal portion 527A (FIG. 202) to prevent movement of the cap 514A along the strip 501A of material. The channel 560B of the retaining body 560A and the flange 567A of the bolt 566A form a passage 514B through the cap 514A of the distal portion 527A.

[0188] Referring now to FIG. 202, the components of the cap 514A are shown in an exploded view to better illustrate the features of the components of the cap 514A and the paddle frame 524A and how those features interlock during assembly of the cap 514A to the distal portion 527A. By forming the cap 514A from a plurality of components that can be assembled around the strip 501A of material, the strip 501A of material is folded to form the core option element 510A and the paddles 520A, 522A, and after being woven through the color 511D and the paddle frame 524A, it becomes possible to attach the cap 514A.

[0189] The retaining body 560A includes a locking aperture 561A for receiving the retaining nut 562A. The locking aperture 561A has a generally rectangular shape and includes two opposing locking channels 561B for receiving the attachment portion 524C of the paddle frame 524A. The lateral locking channel 561C formed at the bottom of the retaining body 560A has the same width as the locking channel 561B. The paddle frame 524A includes a notch 524D of the attachment portion 524C that engages the lateral locking channel 561C to form a hook portion 524E that fixes the paddle frame 524A to the cap 514A.

[0190] The retaining nut 562A includes a rectangular locking body 563A that extends distally from the flange 563B. The locking body 563A is configured to slidably engage with the locking aperture 561A of the retaining body 560A without blocking the locking channel 561B. Thus, the locking body 563A can be inserted into the locking aperture 561A to lock the attachment portion 524C of the paddle frame 524A within the locking channel 561B. The notch 563C of the flange 563B accommodates the attachment portion 524C of the paddle frame 524A. The threaded hole 564A is formed through the retaining nut 562A to receive the retaining bolt 566A.

[0191] The retaining bolt 566A includes a threaded portion 568A that extends from the flange 567A. The threaded portion 568A is inserted through the opening 527B of the distal portion 527A for threaded engagement with the threaded hole 564A of the retaining nut 562A. The flange 567A has a rounded shape that provides a rounded end to the distal portion 507A of the device 500A. The flange 567A includes an opening 567B for receiving a tool (not shown) that engages the bolt 566A such that the bolt 566A can be rotated during assembly to connect the components of the cap 514A together.

[0192] To assemble paddle frame 524A and cap 514A to distal portion 527A, paddle frame 524A is compressed to narrow the width of attachment portion 524C such that attachment portion 524C can be inserted into locking channel 561B of locking aperture 561A. When paddle frame 524A can be expanded, attachment portion 524C expands outward such that notch 524D engages with holding body 560A and hook portion 524E engages with lateral locking channel 561C. Next, retaining nut 562A is inserted into locking aperture 561A in a locked state where locking portion 563A is disposed between two attachment portions 524C of each paddle frame 524A, thereby locking paddle frame 524A in engagement with holding body 560A. The assembled paddle frame 524A, holding body 560A, and retaining nut 562A are placed on distal portion 527A such that threaded hole 564A is aligned with opening 527B and threaded portion 568A of bolt 566A is inserted through opening 527B to threadedly engage with threaded hole 564A. Next, bolt 566A is tightened until flange 567A engages with holding body 560A and cap 514A is firmly assembled to distal portion 527A.

[0193] Referring now to FIGS. 203 and 204, portions of cover 540A are shown cut from a sheet of flat material. Cover 540A includes outer cover 541A and inner cover 543A. Each of covers 541A, 543A includes segments or portions of different shapes for attachment to different portions of device 500A. In particular, covers 541A, 543A are shaped to smooth transitions between portions of device 500A, reduce catch points, and provide a smoother exterior to device 500.

[0194] The various segments of covers 541A, 543A extend from a central portion shaped to be attached to the end of device 500A. In other embodiments, the portions of covers 541A, 543A that are attached to the end of device 500A can be located at the ends of covers 541A, 543A or anywhere between the central and end portions of covers 541A, 543A. The various portions of covers 541A, 543A can be shaped to enclose portions of device 500A. Cover 540A can be made of any suitable material, such as a fine-mesh polyethylene cloth. In certain embodiments, the cover is formed from 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 by any suitable means, such as stitching, adhesives, welding, etc.

[0195] Referring to FIGS. 60C and 204, outer cover 541A extends outwardly from central portion 580 to end portion 588. Central portion 580 is shaped to be attached to cap 514A of device 500A. Outer paddle portion 582 extends from central portion 580 to inner paddle and inner clasp portion 584. Inner paddle portion and inner clasp portion 584 extend from outer paddle portion 582 to outer movable clasp portion 586. Outer movable clasp portion 586 extends from inner paddle portion 584 to end portion 588.

[0196] The outer paddle portion 582 includes a wing portion 583 that extends laterally in a width wider than other portions of the outer cover 541A so that the outer paddle portion 582 can be attached to the outer paddle 520A and the paddle frame 524A of the device 500A. The inner paddle portion 584 is attached to the inner surfaces (the side with barbs) of the inner paddle 522A, the fixed arm 532C, and the movable arm 534C. The outer clasp portion 586 is attached to the outer surface (the side without barbs) of the movable arm 534C of the clasp 530C. The end 588 of the outer cover 541A terminates near the joint portion 538C of the outer clasp 530C of the clasp 530C. The inner paddle and the inner clasp portion 584 include an opening 585 that allows the barb 536C of the clasp 530C to project through the outer cover 541A and engage the tissue of the native heart valve.

[0197] Referring to FIGS. 60C and 203, the inner cover 543A extends outwardly from a central portion 590 to an end portion 598. The central portion 590 is configured to be attached to the collar 511D of the device 500A. The opening 591 of the central portion 590 exposes the protrusion 511E from the collar 511D when the central portion 590 is attached to the collar 511D so that the protrusion 511E can be engaged by the delivery device 502A. The core cushion portion 592 extends from the central portion 590 to the flexible hinge portion 594. The holes 593 along the edge of the core cushion portion 592 allow each of the core cushion portions 592 to be joined together after being folded around the core cushion element 510A, for example, by stitches 545A or the like. The flexible hinge portion 594 extends from the core cushion portion 592 to the transition portion 596. The transition portion 596 extends from the flexible hinge portion 594 to the end portion 598. The holes 597 along the edge of the transition portion 596 allow each of the transition portions 596 to be wound around the ends of the inner paddle 522A and the clasp 530C and fixed to itself by stitches or other suitable fixing means. The flexible hinge portion 594 bridges the gap between the core cushion element 510A and the clasp 530C when the device 500A is opened, as seen in FIG. 198.

[0198] Referring now to FIGS. 62A-64C, an implantable device 700 is shown. The implantable device 700 has a paddle 702 that opens and closes to grip the valve tips 20, 22 against a barb clasp or gripping device 704. The paddle 702 moves in the X direction outwardly, rotates, or pivots to form an opening 706 between the paddle 702 and the gripping device 704, where the valve tips 20, 22 can be gripped. The device 700 can be configured to close the wide gap 26 (FIG. 6) of the native heart valves MV, TV. Further, the implantable device 700 can include any other features related to the devices contemplated in this application, and the device 700 can be positioned to engage the valve leaflets 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The device 700 can include any other features related to the implantable artificial devices contemplated in this application, and the device 700 can 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).

[0199] Referring to FIG. 62A, the paddle 702 of the device 700 moves, rotates, or pivots outwardly in the X direction to form an opening 706 between the paddle 702 and a gripping member 704 having a width W. The width W can be, for example, about 5 mm to about 15 mm, about 7.5 mm to 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.

[0200] Referring to FIG. 62B, paddle 702 of device 700 moves outwardly in the Z direction such that opening 706 has a width H. The width H can be, for example, from about 10 mm to about 25 mm, from about 10 mm to about 20 mm, from about 12.5 mm to about 17.5 mm, about 15 mm, etc. In some embodiments, the width H can be less than 10 mm or greater than 25 mm. In certain embodiments, the ratio between the width H and the width W can be, for example, about 5:1 or less, about 4:1 or less, about 3:1 or less, about 2:1 or less, about 1.5:1 or less, about 1.25:1 or less, about 1:1, etc. The device 700 can be configured such that paddle 702 moves, rotates, or pivots outwardly in the X direction and then moves outwardly in the Z direction to create an opening 706 having a width H between paddle 702 and gripping member 704. Optionally, the device 700 can be configured such that the paddle moves outwardly in the Z direction and then moves or pivots outwardly in the X direction to create a width H between paddle 702 and gripping member 704. Further, the device 700 can be configured such that paddle 702 moves or pivots outwardly in the direction X and simultaneously moves outwardly in the direction Z to create a width H between paddle 702 and gripping member 704.

[0201] Figures 63A - 63C illustrate an implant device 700 in which paddle 702 moves, rotates, or pivots outwardly in the X - direction and then moves outwardly in the Z - direction to create a wider opening 706. Figure 63A shows the implant device 700 in a closed position where paddle 702 engages with gripping member 704. Referring to Figure 63B, paddle 702 moves or pivots outwardly in the X - direction to create an opening 706 having a width W for receiving valve tissue. Referring to Figure 63C, after paddle 702 moves or pivots outwardly in the X - direction, paddle 702 moves outwardly in the Z - direction such that opening 706 has a width H. After valve tissue is received in opening 706 between paddle 702 and gripping member 704, the valve repair device is returned to the closed position (as shown in Figure 63A) to secure implant device 700 to the valve tissue. Implant device 700 can include any other features related to implant devices contemplated in this application, and implant device 700 can be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0202] Figures 64A - 64C illustrate an implant device 700 in which paddle 702 moves outwardly in the Z direction and then moves, extends, or pivots outwardly in the X direction to create a wider opening 706. Figure 64A shows the implant device 700 in a closed position where paddle 702 engages with gripping member 704. Referring to Figure 64B, paddle 702 moves outwardly in the Z direction to create an opening 706 having a width W for receiving valve tissue. Referring to Figure 64C, after paddle 702 has moved outwardly in the Z direction, paddle 702 moves or pivots outwardly in the X direction such that opening 706 has a width H. After valve tissue is received in opening 706 between paddle 702 and gripping member 704, implant device 700 is returned to a closed position (as shown in Figure 64A) to secure implant device 700 to the valve tissue. Implant device 700 can include any other features related to implant devices contemplated in this application, and implant device 700 can be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0203] Figures 63A - 63C illustrate a device 700 in which paddle 702 moves or pivots and then spreads apart, and Figures 64A - 64C illustrate a device 700 in which paddle 702 spreads apart and then moves or pivots, but in alternative embodiments, device 700 can include paddles 702 that can spread apart and move or pivot simultaneously. Further, in certain embodiments, paddles 702 can spread apart and move or pivot independently of each other. That is, in the embodiments of valve repair device 700 shown in Figures 63A - 63C and Figures 64A - 64C, and in embodiments where the spreading and movement or pivoting of each paddle 702 is completed simultaneously, paddles 702 can be controlled independently of each other.

[0204] Referring now to FIGS. 65 - 83, an exemplary implantable device 500 is shown in a closed state. Next, referring to FIGS. 65 - 66, device 500 extends from a proximal portion 505 to a distal portion 507 and includes a core capture portion 510, inner paddles 522, outer paddles 520, and paddle frame 524. In some embodiments, outer paddles 520 can extend toward and / or around paddle frame 524 and have multiple layers for surrounding paddle frame 524. Proximal portion 505 can include a collar 511 for attaching a delivery device (not shown). Distal portion 507 can include a cap 514 that is attached to (e.g., articulately attached to, etc.) outer paddles 520 and is engaged by an actuating element (not shown) to open and close device 500 to facilitate implantation into a native valve as described in this application.

[0205] Referring now to FIGS. 67-68, a front view of device 500 is shown. Device 500 is symmetric or substantially symmetric about a plane 550 that extends from a vertical front side to a rear side, and has a generally narrower shape at distal portion 507 than at proximal portion 505. The shapes of core capture element 510 and paddle frame 524 are rounded or generally rounded to prevent device 500 from catching or snagging heart structures such as chordae tendineae during implantation. For this reason, proximal collar 511 (FIG. 68) and cap 514 (FIG. 68) also have rounded edges. When viewed from the front or rear, paddle frame 524 can be seen to have a rounded or generally rounded shape that extends upward and outward from distal portion 507 so as to generally conform to the shape of core capture element 510 when viewed from the front or rear. Thus, core capture element 510 and paddle frame 524 generally define the shape of device 500 when viewed from the front or rear. Further, the rounded shape of paddle frame 524 and the corresponding rounded shape of the core capture element can distribute cusp stress over a larger surface. In some exemplary embodiments, paddle frame 524 and / or core capture element 510 may have other shapes.

[0206] Referring now to FIG. 69, a side view of device 500 is shown. Similar to the front and rear views (FIGS. 67-68), device 500 has a shape that is symmetric or substantially symmetric about a plane 552 that extends from a vertical lateral side to a lateral side when viewed from the side. Distal portion 507 is also generally narrower than proximal portion 505 when device 500 is viewed from the side. Core capture element 510 also optionally has a tapered or generally tapered shape that narrows toward distal portion 507 of device 500. However, in some exemplary embodiments, the core capture element is not tapered as it extends from the proximal portion of the device to the distal portion of the device.

[0207] The rounded features of the device 500 are further evidenced by the rounded shape of the paddles 520, 522, where the inner paddles 520 and the outer paddles 522 are joined together to form the rounded shape of the paddle frame 524. However, the paddles 520, 522 and the paddle frame 524 can take a wide variety of different forms. For example, the paddles 520, 522 and the paddle frame 524 may be rounded along the upper edge, but are flat or substantially flat on the sides of the paddles 520, 522 and / or the paddle frame. By making the paddles 520, 522 flat or substantially flat on the sides, two devices can be implanted in parallel on the native valve leaflet and the two devices can be placed in the same plane or substantially the same plane relative to each other.

[0208] The closed paddles 520, 522 form a gap 542 between the inner paddle 522 configured to receive native tissue and the coaptation element 510. As seen in FIG. 69, the narrowing of the coaptation element 510 gives the gap 542 a somewhat teardrop shape where the width of the gap 542 increases as it approaches the distal portion 507 of the device. By widening the gap 542 towards the distal portion 507, the paddles 520, 522 can be brought into contact with tissue gripped within the gap 542 closer to the proximal portion 505.

[0209] The paddle frame 524 extends vertically from the distal portion 507 towards the proximal portion 505 up to approximately the central third of the device 500 before the frame 524 bends or spreads outwards such that the connection portion of the frame 524 passes through a gap 544 formed by the inner paddle 522 folded inside the outer paddle 520. However, in other embodiments, the connection of the frame is positioned inside the inner paddle 522 or outside the outer paddle 520. The outer paddle 520 has a rounded shape similar to the shape of the core capture element 510 when viewed from the front or the back (FIGS. 67 - 68). Accordingly, the device 500 has a rounded or substantially rounded shape. The rounded shape of the device 500 is particularly visible when the device 500 is viewed from above (FIGS. 70 - 71) or from below (FIGS. 72 - 73).

[0210] Referring now to FIGS. 70 - 71, a top view of the device 500 is shown. The device 500 has a symmetric or substantially symmetric shape around the rear surface 550 from the front, and is symmetric or substantially symmetric around a plane 552 from side to side when viewed from above. The opening 519A within the core capture element 510 can be seen at the proximal portion 505 of the device 500. As seen in FIG. 70, the core capture element 510 may be hollow inside. The proximal collar 511 shown in FIG. 71 is fixed to the core capture element 510 and can close the core capture element 510.

[0211] In one exemplary embodiment, the core capture element has all curved surfaces, rather than being planar. For example, the core capture element 510 illustrated herein can be formed from a series of mixed surfaces having various different radii of curvature. The core capture element 510 has an elliptical or substantially elliptical shape when viewed from above. However, in some exemplary embodiments, the core capture element 510 can have other shapes when viewed from above. For example, the core capture element can have a rectangular, square, diamond, oval, or any other shape. Each of the paddle frames 224 has an arcuate shape with a radius smaller than that of the core capture element 510 such that the gaps 542 formed between the inner paddle 522 and the paddle frame 524 and the core capture element 510 taper as they approach the left 551 and right 553 sides of the device 500. Thus, natural tissue such as the valve leaflets 20, 22 tends to be pinched between the paddle frame 524 and the core capture element 510 toward the left and right sides 551, 553 of the device 500.

[0212] Referring now to FIGS. 72-73, a bottom view of the device 500 is shown. Similar to the top views (FIGS. 70-71), the device 500 has a symmetric or substantially symmetric shape about the rear surface 550 from front to back and is symmetric or substantially symmetric about the plane 552 from side to side when viewed from the bottom. The cap 514 is shown in FIG. 73 and can be articulately attached to the outer paddle 520 and the paddle frame 524.

[0213] The paddle frame 524 extends outwardly from the distal portion 507 of the device 500 to the left and right sides 551, 553 at a narrow or slight angle from the plane 552 from side to side. The paddle frame 524 extends further away from the plane 552 from side to side as the paddle frame 524 extends toward the proximal portion of the device 500 (FIG. 69) and ultimately forms the arcuate shape seen in FIGS. 70-71.

[0214] Referring now to FIGS. 74 - 83, perspective and cross-sectional views of device 500 are shown. Referring next to FIG. 74, device 500 is shown cut away by cross-sectional plane 75 near the proximal portion of core aspiration element 510. Referring next to FIG. 75, a cross-sectional view of device 500 as seen from cross-sectional plane 75 of FIG. 74 is shown. At the location of plane 75, core aspiration element 510 has a round or substantially round shape with blades disposed along a rearward plane 550 from front to back. Gap 542 between paddle frame 524 and core aspiration element 510 forms a crescent-like shape having a central width 543. As described above, gap 542 narrows as gap 542 approaches left and right side surfaces 551, 553.

[0215] Referring next to FIG. 76, device 500 is shown cut away by cross-sectional plane 77 located approximately three-quarters of the distance between distal portion 507 and proximal portion 505 of core aspiration element 510. Referring next to FIG. 77, a cross-sectional view of device 500 as seen from cross-sectional plane 77 of FIG. 76 is shown. At the location of plane 75, core aspiration element 510 has an oval or substantially oval shape oriented along a plane 552 from side to side. Gap 542 between paddle frame 524 and core aspiration element 510 forms a crescent or crescent-like shape having a central width 543 that is smaller than central width 543 seen in FIG. 75. At the location of plane 77, the width 543 of gap 542 narrows toward the center of the device and widens slightly as gap 542 approaches left and right side surfaces 551, 553 before gap 542 narrows again. Thus, natural tissue is sandwiched at the center of gap 542 for approximately three-quarters of the path over core aspiration element 510.

[0216] Next, referring to FIG. 78, device 500 is shown cut away by a cross-sectional plane 79 located approximately halfway between the distal portion 507 and the proximal portion 505 of the core aspiration element 510. Next, referring to FIG. 79, a cross-sectional view of device 500 as seen from cross-sectional plane 79 of FIG. 78 is shown. At the location of plane 79, the core aspiration element 510 has an elliptical or generally elliptical shape oriented along plane 552 from side to side. The paddle frame 524 can be seen to be very close to or in contact with the core aspiration element 510 near the left side 551 and the right side 553. The gap 542 is crescent-shaped or generally crescent-shaped and is wider than the gap 542 seen along plane 77 (FIG. 77).

[0217] Next, referring to FIG. 80, device 500 is shown cut away by a cross-sectional plane 81 located approximately one-quarter of the distance between the distal portion 507 and the proximal portion 505 of the core aspiration element 510. Next, referring to FIG. 81, a cross-sectional view of device 500 as seen from cross-sectional plane 81 of FIG. 80 is shown. At the location of plane 81, the core aspiration element 510 has an elliptical or generally elliptical shape oriented along plane 552 from side to side that is narrower than the elliptical shape seen in FIG. 77. The paddle frame 524 can be seen to be very close to or in contact with the core aspiration element 510 near the left side 551 and the right side 553. The gap 542 is crescent-shaped or generally crescent-shaped and is wider than the gap 542 seen along plane 79 (FIG. 79).

[0218] Next, referring to FIG. 82, device 500 is shown cut away by a cross-sectional plane 83 positioned near the distal portion 507 of the core capture element 510. Next, referring to FIG. 83, a cross-sectional view of device 500 as seen from cross-sectional plane 83 of FIG. 82 is shown. At the location of plane 83, the core capture element 510 has an elliptical or substantially elliptical shape that is narrower from side to side than the elliptical shape seen in FIG. 79 as the core capture element 510 tapers toward the distal portion 507 of device 500 and is oriented along a plane 552 from side to side. The paddle frame 524 can be seen to be very close to or in contact with the core capture element 510 near the left side surface 551 and the right side surface 553. Although the inner paddle 522 is not visible in FIG. 81, the gap 542 is crescent-shaped or generally crescent-shaped and is wider than the gap 542 seen along plane 81 (FIG. 81).

[0219] Referring now to FIGS. 65A, 66A, 67A, 68A, 70A, 71A, 72A, 73A, 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A, an exemplary implantable device 500A is shown in a closed state. Next, referring to FIGS. 65A-66A, device 500A extends from a proximal portion 505A to a distal portion 507A and includes a core capture portion 510A, an inner paddle 522A, an outer paddle 520A, and a paddle frame 524A. The proximal portion 505A can include a collar 511D for attaching a delivery device (not shown). The distal portion 507A can include a cap 514A that is attached to the outer paddle 520A (e.g., pivotally attached, etc.) and is engaged by an actuating element (not shown) to open and close device 500A to facilitate implantation into a native valve as described in this application.

[0220] Referring now to FIGS. 67A and 68A, a front view of device 500A is shown. Device 500A is symmetric or substantially symmetric about a plane 550A from a vertical front to a back, and has a generally narrower shape at the distal portion 507A than along the paddle frame 524A. The shapes of the core capture element 510A and the paddle frame 524A are generally rounded rectangular shapes to prevent the device 500A from capturing or snagging heart structures such as chordae tendineae during implantation. For this reason, the proximal collar 511D (FIG. 68A) and the cap 514A (FIG. 68A) can also have rounded edges. When viewed from the front or the back, the paddle frame 524A can be seen as having a generally rounded rectangular shape that extends upward and outward from the distal portion 507A into a shape having sides that are wider than and generally parallel to the core capture element 510A when viewed from the front or the back. Thus, the paddle frame 524A generally defines the shape of the device 500A when viewed from the front or the back. Further, the rounded rectangular shape of the paddle frame 524A can distribute cusp stress over a wider surface. In some exemplary embodiments, the paddle frame 524A and / or the core capture element 510A may have other shapes.

[0221] Similar to the front and back views (FIGS. 67A-68A), device 500A has a shape that is symmetric or substantially symmetric about a lateral plane 552A (FIG. 70A) from a vertical lateral direction when viewed from the side (e.g., FIG. 47A). The distal portion 507A is also generally narrower than the proximal portion 505A when device 500A is viewed from the side. In the embodiment shown in FIG. 48B, the core capture element 510A is not tapered because it extends from the proximal portion 505A to the distal portion 507A of device 500A. However, in some exemplary embodiments, the core capture element is tapered because it extends from the proximal portion of the device to the distal portion of the device (e.g., FIG. 47).

[0222] The generally rounded features of device 500A are further evidenced by the rounded shape of paddles 520A, 522A, and inner paddle 520A and outer paddle 522A are joined together. However, paddles 520A, 522A, and paddle frame 524A can take on a wide variety of different forms. For example, paddles 520A, 522A, and paddle frame 524A may be rounded along their upper ends, or may be flat or substantially flat on their sides (e.g., the sides of paddle frame 524A disposed on the front and back sides of device 500A). By making paddles 520A, 522A flat or substantially flat on their sides, two devices can be implanted in parallel on a native valve leaflet and the two devices can be arranged in the same plane or substantially the same plane relative to each other.

[0223] Closed paddles 520A, 522A form a gap 542A between inner paddle 522A configured to receive native tissue and core capture element 510A. As seen in FIGS. 48B and 48F, the proximal end of core capture element 510A has a generally dogbone shape such that gap 542A narrows toward proximal portion 505A as gap 542A approaches distal portion 507A of the device. By narrowing gap 542A toward attachment portion 505A, paddles 520A, 522A can be brought into contact with tissue gripped within gap 542A closer to proximal portion 505A.

[0224] The paddle frame 524A extends vertically from the distal portion 507A towards the proximal portion 505A up to approximately the central one-third of the device 500A before the frame 524A bends or spreads outwards such that the connection portion 524B of the frame 524A passes through a gap 544A formed by the inner paddle 522A folded inside the outer paddle 520A. However, in other embodiments, the connection of the frame is positioned inside the inner paddle 522A or outside the outer paddle 520A. The outer paddle 520A has a rounded rectangular shape that is similar to the shape of the core capture element 510A when viewed from the front or the back (Figs. 67A and 68A). Thus, the device 500A has a rounded rectangular shape. The rounded rectangular shape of the device 500A is particularly visible when the device 500A is viewed from above (Figs. 70A and 71A) or from below (Figs. 72A and 73A).

[0225] Referring now to FIGS. 70A and 71A, a front view of device 500A is shown. Device 500A has a symmetric or substantially symmetric shape around rear surface 550A from the front, and is symmetric or substantially symmetric around plane 552A from side to side when viewed from above. The proximal opening 519C within the core portion element 510A is visible at the proximal portion 505A of device 500A. Actuating element 512A is received through opening 519C such that core portion element 510A is wound around actuating element 512A. In some embodiments, opening 519C is formed by inserting actuating element 512A between folded and overlapping layers of strip 501A of material (described in detail below). In other embodiments, opening 519C is formed by shaping the folded layers of strip 501A of material that forms core portion element 510A around a blank or jig to give core portion element 510A a rounded or substantially rounded shape. The proximal collar 511D shown in FIG. 71A is fixed to core portion element 510A and can close core portion element 510A. Proximal collar 511D includes attachment portion 513A that engages an opening 546A formed by the folded layers of strip 501A of material that forms core portion element 510A. In some embodiments, attachment portion 513A is a hole in collar 511D such that strip 501A of material must be inserted through collar 511D before folding strip 501A of material during assembly of device 500A. In some embodiments, attachment portion 513A is an open slot (e.g., attachment portion 524B of paddle frame 524A) that receives strip 501A of material before or after folding strip 501A of material.

[0226] As described above, the core capture element 510A has a generally rectangular shape when viewed from above. In some exemplary embodiments, the core capture element 510A may have other shapes when viewed from above. For example, the core capture element may have a circular, square, diamond, oval, or any other shape. Each of the paddle frames 224A has a rounded rectangular shape when viewed from above such that the paddle frame 224A surrounds the rectangular core capture element 510A. Thus, natural tissue such as the valve leaflets 20, 22 tends to be evenly sandwiched or compressed within the gap 542A formed between the inner paddle 522A, the paddle frame 524A, and the core capture element 510A.

[0227] Referring now to FIGS. 72A and 73A, a bottom view of the device 500A is shown. Similar to the top views (FIGS. 70A and 71A), the device 500A has a symmetric or substantially symmetric shape about the plane 550A from front to back, and is symmetric or substantially symmetric about the plane 552A from side to side when viewed from the bottom. The distal portion 527A of the strip of material 501A includes an aperture 527B for receiving the cap 514A shown in FIG. 73A.

[0228] The paddle frame 524A extends outwardly from the distal portion 507A of the device 500A at a narrow or slight angle from the plane 552A from side to side to the left and right side surfaces 551A, 553A. The paddle frame 524A extends away from the plane 552A from side to side while maintaining a generally constant distance from the plane 550A from front to back as the paddle frame 524A extends toward the proximal portion 505A of the device 500A (FIG. 65A) and ultimately forms the rounded rectangular shape seen in FIGS. 70A and 71A.

[0229] In one exemplary embodiment, the dimensions of device 500A are selected to minimize the number of implants (preferably one) required for a single patient while simultaneously maintaining a low transvalvular gradient. In one exemplary embodiment, the widest anterior-posterior distance Y47I of device 500A is less than 10 mm, and the widest medial-lateral distance Y67C of its spacers is less than 6 mm. In one exemplary embodiment, the overall geometric shape of device 500A may be based on these two dimensions and the overall shape strategy described above. It is readily apparent that using other anterior-posterior distances Y47I and medial-lateral distances Y67C as a starting point for device 500A will result in devices having different dimensions. Additionally, using other dimensions and shape strategies described above will also result in devices having different dimensions.

[0230] Tables D and E provide examples of values and ranges of dimensions of device 500A and components of device 500A for some exemplary embodiments. However, device 500A can have a wide variety of different shapes and sizes and need not have all or any of the dimension values or dimension ranges provided in Tables D and E. Table D provides examples of linear dimensions Y in millimeters and ranges of linear dimensions in millimeters for device 500A and components of device 500A. Table B provides examples of radius dimensions S in millimeters and ranges of radius dimensions in millimeters for device 500A and components of device 500A. The subscript for each dimension indicates the drawing in which the dimension first appears. [Table 4] [Table 5]

[0231] Referring now to FIGS. 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A, perspective and cross-sectional views of device 500A are shown. Next, referring to FIG. 74A, device 500A is shown cut away by cross-sectional plane 75A near the proximal portion of core aspiration element 510A. Next, referring to FIG. 75A, a cross-sectional view of device 500A as seen from cross-sectional plane 75A of FIG. 74A is shown. At the location of plane 75A, core aspiration element 510A generally has a rounded rectangular shape. Gap 542A between inner paddle 522A and core aspiration element 510A has a width 542B. As described above, gap 542A has a constant or generally constant width.

[0232] Next, referring to FIG. 76A, device 500A is shown cut away by cross-sectional plane 77A located approximately three-quarters of the distance between the distal portion 507A and proximal portion 505A of core aspiration element 510A. Next, referring to FIG. 77A, a cross-sectional view of device 500A as seen from cross-sectional plane 77A of FIG. 76A is shown. As seen in FIGS. 76A and 77A, strip 501A of the material forming device 500A partially overlaps to form four layers in the region of core aspiration element 510A. A single layer of strip 501A of material forms each of inner paddle 522A and outer paddle 520A. At the location of plane 75A, core aspiration element 510A has a generally rectangular shape oriented along plane 552A from side to side. Gap 542A between inner paddle 522A and core aspiration element 510A is visible. Gap 542A between inner paddle 522A and core aspiration element 510A has a width 542B that is greater than width 542B as seen in FIG. 75A. Gap 544A between outer paddle 520A and inner paddle 522A has a consistent or generally consistent width 544B for receiving attachment portion 524B of paddle frame 524A.

[0233] Next, referring to FIG. 78A, device 500A is shown cut away by a cross-sectional plane 79A located approximately halfway between the distal portion 507A and the proximal portion 505A of device 500A. Next, referring to FIG. 79A, a cross-sectional view of device 500A as seen from cross-sectional plane 79A of FIG. 78A is shown. As seen in FIGS. 78A and 79A, the strip 501A of material forming device 500A partially overlaps to form four layers in the region of core aspiration element 510A, two layers in the region of inner paddle 522A, and one layer in the region of outer paddle 520A. At the location of plane 79A, core aspiration element 510A has a generally rectangular shape oriented along plane 552A from side to side. The gap 542A between inner paddle 522A and core aspiration element 510A has the same or approximately the same width 542B as that seen in FIG. 77A.

[0234] Next, referring to FIG. 80A, device 500A is shown cut away by a cross-sectional plane 81A located approximately one-quarter of the distance between the distal portion 507A and the proximal portion 505A of device 500A. Next, referring to FIG. 81A, a cross-sectional view of device 500A as seen from cross-sectional plane 81A of FIG. 80A is shown. As seen in FIGS. 80A and 81A, the strip 501A of material forming device 500A partially overlaps to form four layers in the region of core aspiration element 510A and two layers in the region of inner paddle 522A, and outer paddle 520A is formed by a single layer. At the location of plane 81A, core aspiration element 510A has a generally rectangular shape oriented along plane 552A from side to side. The gap 542A between inner paddle 522A and core aspiration element 510A has a width 542B that is approximately the same as the central width 542B seen in FIG. 79A.

[0235] Next, referring to FIG. 82A, device 500A is shown cut away by a cross-sectional plane 83A located approximately one-fourth of the distance between the distal portion 507A and the proximal portion 505A of device 500A. Next, referring to FIG. 83A, a cross-sectional view of device 500A as seen from cross-sectional plane 83A of FIG. 82A is shown. As seen in FIGS. 82A and 83A, the strip 501A of material forming device 500A partially overlaps to form four layers in the region of the core capture element 510A, two layers in the region of the inner paddle 522A, and a single layer forms the outer paddle 520A. At the location of plane 83A, the core capture element 510A has a generally rectangular shape oriented along plane 552A from side to side. The gap 542A between the inner paddle 522A and the core capture element 510A forms an arcuate shape having a width 542B that is approximately the same as the central width 542B seen in FIG. 81A.

[0236] Now referring to FIGS. 84 - 88, 86A, 87A, and 88A, exemplary implantable devices 100, 500, 500A are shown without a clasp or articulated grasping member. Rather, the exemplary devices 100, 500, 500A shown in FIGS. 84 - 88, 86A, 87A, and 88A have barbs or grasping members 800 / 800A and / or 802 / 802A integrated into the core capture element or paddle portion of the anchor portion of the device to facilitate grasping of native heart valve tissue.

[0237] Now referring to FIG. 84, an exemplary implantable device 100 is shown that does not include an articulated clasp or grasping element. As described above, device 100 is deployed from a delivery sheath or delivery means 102 and includes a core capture portion 104 and an anchor portion 106. The core capture portion 104 of device 100 is adapted to be implanted between the valve leaflets 20, 22 of a native valve (e.g., mitral valve MV, etc.) and is slidably attached to an operating element or shaft 112 that extends through a core capture element or joining means 110 to a distal cap 114.

[0238] The anchor portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the distal cap 114 and the core capture element or joining means 110. The anchor portion 106 is operable between an open state and a closed state and can take a wide variety of forms, such as paddles, gripping elements, etc. Actuation of the actuation element or means 112 opens and closes the anchor portion 106 of the device 100 to grip the native valve leaflets 20, 22 during implantation.

[0239] Rather than an articulated clasp or gripping element, the device 100 shown in FIG. 84 includes a return portion 800 disposed on the core capture element or joining means 110, and each side of the core capture element or joining means 110 has at least one return portion 800. When the anchor portion 106 of the device 100 is closed, tissue gripped between the inner paddle 122 and the core capture element or joining means 110 is pressed against the return portion 800. The return portions 800 can be sharp so that they engage native tissue and, in some embodiments, pierce the native tissue and prevent tissue from being pulled away from the device 100. In some embodiments, the return portions 800 are angled downward to increase engagement with native tissue.

[0240] Referring now to FIG. 85, an exemplary implantable device 100 is shown without a separate articulated clasp. As described above, the device 100 is deployed from a delivery sheath or means 102 and includes a core capture portion 104 and an anchor portion 106. The core capture portion 104 of the device 100 is adapted to be implanted between the leaflets 20, 22 of a native valve or mitral valve MV and is slidably attached to a core capture element or joining means 110 that extends through the core capture element or joining means 110 to the distal cap 114 by an actuation element 112 (e.g., an actuation wire, shaft, rod, suture, thread, etc.).

[0241] The anchor portion 106 of device 100 includes an outer paddle 120 and an inner paddle 122 connected between a distal cap 114 and a core capture element or joining means 110. The anchor portion 106 is operable between an open state and a closed state and can take a wide variety of forms, such as paddles, gripping elements, etc. Activation of the activation element or activation means 112 opens and closes the anchor portion 106 of device 100 to grip the native valve leaflets 20, 22 during implantation.

[0242] Rather than separate articulated clasps or gripping elements, device 100 shown in FIG. 85 includes a barb portion 800 disposed on inner paddle 122, and each inner paddle 122 has at least one barb portion 800. When the anchor portion 106 of device 100 is closed, tissue gripped between inner paddle 122 and the core capture element or joining means 110 is pressed against barb portion 800. Barb portions 800 are sharp such that they engage native tissue and, in some embodiments, pierce the native tissue and prevent tissue from being pulled away from device 100. In some embodiments, barb portions 800 are angled downwardly to increase engagement with native tissue.

[0243] Referring now to FIG. 86, an exemplary implantable device 500 is shown that does not include an articulated clasp or gripping element. As described above, device 500 includes a core capture portion 504 and an anchor portion 506. The core capture portion 504 of device 500 is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and includes a core capture element 510 slidably attached to an activation element or activation means 512 that extends through core capture element 510 to distal cap 514.

[0244] The anchor portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cap 514 and the core capture element 510. The anchor portion 506 is operable between an open state and a closed state and can take a wide variety of forms, such as paddles, gripping elements, etc. Actuation of the actuation element 512 opens and closes the anchor portion 506 of the device 500 to grip the native valve leaflets 20, 22 during implantation.

[0245] Rather than an articulated clasp or gripping element, the device 500 includes a barb portion 800 disposed on the inner paddle 522, and each inner paddle 522 optionally has a plurality of barb portions 800. When the anchor portion 506 of the device 500 is closed, tissue gripped between the inner paddle 522 and the core capture element 510 is pressed against the barb portions 800. The barb portions 800 are sharp such that they engage native tissue and, in some embodiments, pierce the native tissue and prevent tissue from being pulled away from the device 500. In some embodiments, the barb portions 800 are angled downwardly to increase engagement with native tissue.

[0246] Referring now to FIG. 86A, an exemplary implantable device 500A is shown that does not include an articulated clasp or gripping element. As described above, the device 500A 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 means (not shown) that extends through the core capture element 510A to the distal cap 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the core capture element 510A. The device 500A is operable between an open state and a closed state and can take a wide variety of forms, such as paddles, gripping elements, etc. Actuation of the actuation element opens and closes the paddles 520A, 522A of the device 500A to grip the native valve leaflets 20, 22 during implantation.

[0247] Rather than an articulated clasp or gripping element, device 500A includes a return portion 800A disposed on inner paddle 522A, and each inner paddle 522A optionally has a plurality of return portions 800A. When device 500A is closed, tissue gripped between inner paddle 522A and core aspiration element 510A is pressed against return portion 800A. Return portions 800A are sharp so that they engage natural tissue and, in some embodiments, pierce natural tissue and prevent tissue from being drawn away from device 500A. In some embodiments, return portions 800A are angled downward to increase engagement with natural tissue.

[0248] Referring now to FIG. 87, an exemplary implantable device 500 is shown that does not include a separate articulated clasp or gripping element. As described above, device 500 includes a core aspiration portion 504 and an anchor portion 506. The core aspiration portion 502 of device 500 includes a core aspiration element 510 slidably attached to an actuating element or means 512 that is adapted to be implanted between leaflets 20, 22 of a native valve or native mitral valve MV and extends through core aspiration element 510 to distal cap 514.

[0249] The anchor portion 506 of device 500 includes outer paddles 520 and inner paddles 522 connected between distal cap 514 and core aspiration element 510. The anchor portion 506 is operable between an open state and a closed state and can take a wide variety of forms, such as paddles, gripping elements, etc. Actuation of actuating element 512 opens and closes the anchor portion 506 of device 500 to grip native valve leaflets 20, 22 during implantation.

[0250] Rather than a separate articulated clasp or grasping element, the device 500 includes a return portion 800 disposed on the core apposition element 510, and each side of the core apposition element 510 has a plurality of return portions 800. When the anchor portion 506 of the device 500 is closed, the tissue grasped between the inner paddle 522 and the core apposition element 510 is pressed against the return portion 800. The return portions 800 are sharp such that they engage the native tissue and, in some embodiments, pierce the native tissue and prevent the tissue from being pulled away from the device 500. In some embodiments, the return portions 800 are angled downwardly to increase engagement with the native tissue.

[0251] Referring now to FIG. 87A, an exemplary implantable device 500A is shown that does not include an articulated clasp or grasping element. As described above, the device 500A can be adapted to be implanted between the leaflets 20, 22 of a native valve or mitral valve MV and has a core apposition element 510A that is slidably attached to an actuating element or means (not shown) that extends through the core apposition element 510A to the distal cap 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the core apposition element 510A. The device 500A is operable between an open state and a closed state and can take a wide variety of forms, such as paddles, grasping elements, etc. Actuation of the actuating element opens and closes the paddles 520A, 522A of the device 500A to grasp the native valve leaflets 20, 22 during implantation.

[0252] Rather than separate articulated clasps or gripping elements, device 500A includes return portions 800A disposed on core aspiration element 510A, and each side of core aspiration element 510A has a plurality of return portions 800A. When device 500A is closed, tissue gripped between inner paddle 522A and core aspiration element 510A is pressed against return portions 800A. Return portions 800A are sharp so that they engage natural tissue and, in some embodiments, pierce natural tissue and prevent tissue from being pulled away from device 500A. In some embodiments, return portions 800A are angled downward to increase engagement with natural tissue.

[0253] Referring now to FIG. 88, an exemplary implantable device 500 is shown that does not include separate articulated clasps or gripping elements. As described above, device 500 includes a core aspiration portion 504 and an anchor portion 506. The core aspiration portion 504 of device 500 includes a core aspiration element 510 that is slidably attached to an actuating element or means 512 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and extends through core aspiration element 510 to distal cap 514.

[0254] The anchor portion 506 of device 500 includes an outer paddle 520 and an inner paddle 522 connected between distal cap 514 and core aspiration element 510. The anchor portion 506 is operable between an open state and a closed state and can take a wide variety of forms, such as paddles, gripping elements, etc. Actuation of actuating element 512 opens and closes the anchor portion 506 of device 500 to grip native valve leaflets 20, 22 during implantation.

[0255] Rather than an articulating clasp or gripping element, device 500 includes a return portion 800 disposed on core aspiration element 510, and each side of core aspiration element 510 includes at least one return portion 800. Similar to device 1000 described above, device 500 also includes a return portion 802 disposed on inner paddle 522, and each inner paddle 522 has at least one return portion 802.

[0256] When the anchor portion 506 of device 500 is closed, tissue gripped between inner paddle 522 and core aspiration element 510 is pressed against return portions 800, 802. Return portions 800, 802 are sharp so that they engage native tissue and, in some embodiments, pierce the native tissue and prevent the tissue from being withdrawn from device 500. In some embodiments, return portions 800, 802 are angled downwardly to increase engagement with native tissue. The combination of return portion 800 on core aspiration element 510 and return portion 802 on inner paddle 522 forms the gripped tissue into an S-shaped meandering path as it passes through return portions 800, 802. Thus, the force to pull the tissue away from device 500 encourages the tissue to engage further with return portions 800, 802 before the tissue can escape.

[0257] Referring now to FIG. 88A, an exemplary implantable device 500A is shown that does not include an articulated clasp or gripping element. As described above, the device 500A 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 means (not shown) that extends through the core capture element 510A to the distal cap 514A. The device 500A can have a core capture element 510A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the core capture element 510A. The device 500A is operable between an open state and a closed state and can take a wide 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.

[0258] Rather than an articulated clasp or gripping element, the device 500A includes a return portion 800A disposed on the core capture element 510A, and each side surface of the core capture element 510A includes at least one return portion 800A. The device 500A also includes a return portion 802A disposed on the inner paddle 522A, and each inner paddle 522A has at least one return portion 802A.

[0259] When device 500A is closed, the tissue gripped between inner paddle 522A and core aspiration element 510A is pressed against return portions 800A, 802A. Return portions 800A, 802A are sharp such that they engage natural tissue and, in some embodiments, penetrate the natural tissue and prevent tissue from being drawn away from device 500A. In some embodiments, return portions 800A, 802A are angled downwardly to increase engagement with natural tissue. The combination of return portion 800A on core aspiration element 510A and return portion 802A on inner paddle 522A forms the gripped tissue into an S-shaped serpentine path as it passes through return portions 800A, 802A. Thus, the force to pull the tissue away from device 500A encourages the tissue to further engage return portions 800A, 802A before the tissue can escape.

[0260] Referring now to FIGS. 89-102, core aspiration element 510 and paddles 520, 522 of exemplary device 500 are shown. Core aspiration element 510 and the paddles can be made from a wide variety of different materials. Core aspiration element 510 and paddles 520, 522 can be made from a variety of materials such as, for example, metal fibers such as mesh, woven, knitted, electrospun, deposited, or formed in any other suitable manner, materials cut by laser cutting or another method, or one or more of flexible materials. The material can be a cross, a wire such as nitinol to provide shape fixation ability, or any other flexible material suitable for implantation into the human body.

[0261] In one exemplary embodiment, the core aspiration element is made from a braided mesh of metal wire such as a braided mesh of nitinol wire. In one exemplary embodiment, core aspiration element 510 is made from a braid 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.

[0262] The core capture element can be covered with a cross such as a polyethylene cross. The core capture element 510 can be entirely surrounded by a cross cover such as a fine-mesh polyethylene cross. The cross cover can provide a blood seal on the surface of the spacer and / or can promote rapid tissue ingrowth.

[0263] The use of a shape memory material such as a braided nitinol wire mesh for the construction of the core capture element 510 results in a core capture element that can be self-expanding in all directions, can be flexible, and / or can result in low strain when the core capture element is crimped and / or bent. The material can be a single piece, two half pieces joined together, or multiple sections or pieces fixed or joined together in any suitable manner, such as by welding, with an adhesive, etc.

[0264] Referring now to FIGS. 89 - 90, the device 500 extends from a proximal portion 505 to a distal portion 507 and includes a core capture element 510, an inner paddle 522, and an outer paddle 520. The core capture element 510 includes a proximal opening 519A and a distal opening 515 (FIGS. 92 and 94). The proximal opening 519A of the core capture element 510 is formed within the proximal portion 519 of the core capture element 510. The core capture element 510 is articulately connected to the inner paddle 522 by a joint portion 525. The inner paddle 522 is articulately connected to the outer paddle 520 by a joint portion 523. The outer paddle 520 is attached to the distal portion 527 by a joint portion 521 (e.g., articulately attached, etc.). A core capture gap 542 is formed between the inner paddle 522 and the core capture element 510. A paddle gap 544 is formed between the inner paddle 520 and the outer paddle 522 when the paddles 520, 522 are folded, as shown, for example, in FIG. 90.

[0265] Referring now to FIG. 91, a front view of device 500 is shown (a rear view would be similar). Core capture element 510 includes a proximal portion 519, a central portion 518, and a distal portion 517. Proximal portion 519 includes a proximal opening 519A. Distal portion 517 includes a distal opening 515 and is connected to joint portion 525. The shape of core capture element 510 is rounded or generally rounded to prevent device 500 from catching or snagging heart structures such as chordae tendineae during implantation.

[0266] Referring now to FIG. 92, a side view of device 500 is shown. Similar to device 500 as viewed from the front, distal portion 507 of device 500 is generally narrower than proximal portion 505 of device 500 as viewed from the side. Core capture element 510 flares outwardly within proximal portion 519 from proximal opening 519A to central portion 518. Next, core capture element 510 tapers or narrows from proximal portion 519 to distal portion 517 within central portion 518. Distal portion 517 remains narrow and then divides into two joint portions 525. The generally rounded features of device 500 are further demonstrated by the rounded shape of joint portion 523 that articulately connects inner paddle 520 and outer paddle 522, and the outwardly arcuate shape of outer paddle 520.

[0267] Core capture gap 542 formed between inner paddle 522 and core capture element 510 is configured to receive native tissue. The narrowing of core capture element 510 gives gap 542 somewhat of a teardrop shape where the width of gap 542 increases as it approaches distal portion 507 of device 500. By widening gap 542 toward distal portion 507, inner paddle 522 is able to contact tissue gripped within gap 542 closer to proximal portion 505, and the clamping force is the result of a greater mechanical advantage than provided by the length of paddles 520, 522 and other securing or anchoring elements such as those described in this application.

[0268] Referring now to FIG. 93, a top view of device 500 is shown. The proximal opening 519A within the core aspiration element 510 is visible at the proximal portion 505 of the device 500, and the core aspiration element 510 can be seen as having a hollow interior. The core aspiration element 510 has an elliptical or substantially elliptical shape when viewed from above. The paddles 520, 522 appear as protruding rectangular shapes, but the paddles 520, 522 can extend laterally and have an arcuate or crescent shape.

[0269] Referring now to FIG. 94, a bottom view of device 500 is shown. The distal opening 515 within the core aspiration element 510 is visible at the distal portion 507 of the device 500, and the core aspiration element 510 can be seen as having a hollow interior. The core aspiration element 510 has an elliptical or substantially elliptical shape when viewed from above. The paddles 520, 522 appear as protruding rectangular shapes, but the paddles 520, 522 can extend laterally and have an arcuate or crescent shape. The distal portion 517 of the core aspiration element 510 can be seen as split into two for joining with the joint portion 525.

[0270] Referring now to FIGS. 89A, 90A, 91A, 92A, 93A, 94A, 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A, a portion of device 500A formed by material strip 501A (e.g., a single continuous strip of material, a composite strip of material, etc.), i.e., core option element 510A and paddles 520A, 522A, is shown. Core option element 510A and the paddles can be made from a wide variety of different materials. Core option element 510A and paddles 520A, 522A can be materials such as metal fibers in the form of mesh, woven, knitted, electrospun, deposited, or any other suitable manner, materials formed by laser cutting or cut by another method, or materials formed from flexible materials. The material can be a cloth, a wire such as nitinol to provide shape fixation ability, or any other flexible material suitable for implantation into the human body.

[0271] In one exemplary embodiment, core option element 510A, inner paddle 522A, and outer paddle 520A are made from a single continuous strip of material 501A. Material strip 501A can be a material such as metal fibers in the form of mesh, woven, knitted, electrospun, deposited, or any other suitable manner, materials formed by laser cutting or cut by another method, or materials formed from flexible materials. The material can be a cloth, a wire such as nitinol to provide shape fixation ability, or any other flexible material suitable for implantation into the human body. In one exemplary embodiment, material strip 501A is a braid of 25 to 100 strands, e.g., 40 to 85 strands, e.g., 45 to 60 strands, e.g., about 48 nitinol wires, or made from 48 nitinol wires.

[0272] Referring now to FIGS. 205 - 207, an exemplary woven or braided material 4000 that can be used for the strip 501A of material is shown. Referring now to FIG. 205, an enlarged plan view of the material 4000 is shown. The material 4000 extends from a first edge 4002 to a second edge 4004. The edges 4002, 4004 surround a central portion or field 4006. The material 4000 is formed by weaving or braiding with a central strand 4020 such as a nitinol wire. Edge strands 4010 extend longitudinally through the material 4000 along the edges 4002, 4004. The central strand 4020 is woven or braided such that the central strand 4020 is wound around the edge strands 4010. Wrapping the central strand 4020 around the edge strands 4010 makes the material 4000 near the edges 4002, 4004 thicker than the material of the central portion 4006 when viewing the material 4000 from the end, as shown in FIG. 206, forming a leaf - like or dog - bone - like shape. 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 may have similar diameters and may have diameters in the range of about 0.06 millimeters to about 0.18 millimeters. In some embodiments, the edge strands 4010 have a larger diameter than the central strand 4020 and can impart more stiffness or rigidity to the edges 4002, 4004 than to the central portion 4006. For example, the edge strands 4010 may have a diameter in the range of 0.07 millimeters to about 0.27 millimeters, or about 0.17 millimeters, and the central strand 4020 may have a diameter in the range of about 0.04 millimeters to about 0.15 millimeters, or about 0.009 millimeters. 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, such as a metallic material (e.g., nitinol) for the edge strands 4010 and a cross or plastic material (e.g., polyethylene) for the central strand 4020.Alternatively, the edge strands 4010 and the central strand 4020 may be made from the same material that is subjected to different chemical and / or thermal processes that vary the flexibility of the material, such that the central strand 4020 is more flexible than the edge strands 4010.

[0273] Referring now to FIG. 207, the folded portions of the material 4000 are stacked on top of each other to form a section having four layers 4000A, 4000B, 4000C, 4000D. The leaf-like shape of the individual layers having edges 4002, 4004 that are thicker than the central portion 4006 creates three gaps 4001A, 4001B, 4001C between the layers 4000A, 4000B, 4000C, 4000D of the material 4000 at the location of the central portion 4006. The outer gaps 4001A, 4001C are formed between the outer layers 4000A, 4000D and the adjacent intermediate layers 4000B, 4000C.

[0274] As contemplated in the present disclosure, the core deposition element 510A of the device 500A can be formed from four layers of material such as the material 4000. When the layers of the material 4000 are used to form the core deposition element 510A, the actuating element 512A of the device 500A can be inserted through a central gap 4001B formed at the center of the four layers of the material 4000. The actuating element 512A can have a diameter larger than the width of the gap 4001B, such that inserting the actuating element 512A causes the intermediate gap 4001B to stretch the adjacent outer gaps 4001A, 4001C in an open state and reduce their size. In some embodiments, inserting the actuating element 512A causes the central body portion 4006 on both sides to bulge outwardly to a thickness greater than the thickness of the four stacked edge portions 4002, 4004.

[0275] The core capture element 510A and paddles 520A, 522A can be covered with a cloth such as a polyethylene cloth. The core capture 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 spacer and / or can promote rapid tissue ingrowth.

[0276] The use of a shape memory material such as a braided nitinol wire mesh for the construction of the core capture element 510A and paddles 520A, 522A results in a core capture element and paddles that can be self-expanding in all directions, can be flexible, and / or can result in low strain when crimped and / or bent. The material can be a single piece, two halves joined together, or multiple sections or pieces fixed or joined together in any suitable manner, such as by an adhesive, for example, by welding.

[0277] Referring now to FIGS. 89A and 90A, the device 500A extends from a proximal portion 505A to a distal portion 507A and includes a core capture 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 the core capture element 510A, the inner paddle 522A, and the outer paddle 520A. Some portions of the device 500A are formed from multiple layers of the strip of material 501A. For example, the strip of material 501A partially overlaps to form four layers in the region of the core capture element 510A and two layers in the region of the inner paddle 522A.

[0278] The core capture element 510A and paddles 520A, 522A are jointably connected together by a joint portion of the strip of material 501A. The core capture element 510A is jointably connected to the inner paddle 522A by a joint portion 525A. The inner paddle 522A is jointably connected to the outer paddle 520A by a joint portion 523A. The outer paddle 520A is attached (e.g., jointably attached) to the distal portion 527A by a joint portion 521A. An aperture 527B of the distal portion 527A engages a cap 514A.

[0279] When the strip of material 501A is folded into a desired shape, various gaps are formed between portions of the device 500A. A core capture gap 542A is formed between the inner paddle 522A and the core capture element 510A. A paddle gap 544A is formed between the paddles 520A, 522A when the paddles 520A, 522A are folded, e.g., as shown in FIG. 90A, between the inner paddle 520A and the outer paddle 522A. A collar gap 546A is formed when the strip of material 501A is folded to form the proximal portion 519B of the core capture element 510A.

[0280] Referring now to FIG. 91A, a front view of the device 500A is shown (the rear view would be similar). The core capture element 510A includes a proximal portion 519B that extends above the joint portions 523A of the paddles 520A, 522A. The distal portion 517A of the core capture element 510A is hidden by the paddles 520A, 522A when viewed from the front or rear, giving the device 500A a long, narrow, rounded rectangular shape. The shape of the core capture element 510A serves to help prevent the device 500A from catching or snagging on heart structures, such as chordae tendineae, during implantation.

[0281] Referring now to FIG. 92A, a side view of device 500A is shown. The distal end 507A of device 500A forms a generally narrower, generally blunt, and rounded shape when viewed from the side compared to the proximal end 505A of device 500A. The core capture element 510A includes a proximal portion 519B, a central portion 518A, and a distal portion 517A. The proximal portion 519B extends outwardly from the central portion 518A and engages the collar 511D (FIG. 48A). The central portion 518A of the core capture element 510A is straight or substantially straight when viewed from the side. The distal portion 517A is attached to the inner paddle 522A by a joint portion 525A (e.g., attachable in an articulatable manner, etc.). The generally rounded feature of device 500A is further demonstrated by the rounded shape of the joint portion 523A that connects the paddles 520A, 522A in an articulatable manner. The joint portion 521A that connects the outer paddle 520A to the distal portion 527A is also rounded and facilitates the transition in shape from the strip of material 501A to the cap 514A (FIG. 48A) that is assembled to the flat or substantially flat distal portion 527A.

[0282] The core capture gap 542A formed between the inner paddle 522A and the core capture element 510A is configured to receive native tissue. The general linearity of the central portion 518A of the core capture element 510A and the inner paddle 522A provides a consistent or generally consistent width to the gap 542A with the narrow upper end where the proximal portion 519B extends outwardly and engages the collar 511D (FIG. 48A). Thus, the inner paddle 522A contacts tissue gripped within the gap 542A closer to the proximal portion 505A, where the clamping force is the result of a greater mechanical advantage provided by the length of the paddles 520A, 522A, and other securing or anchoring elements such as those described in this application.

[0283] As discussed above, the core suction element 510A and paddles 520A, 522A of 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 color 511D, cap 514A, and paddle frame 524A. The strip of material 501A is shaped after being formed into a desired shape such that the strip of material 501A returns to the desired shape after assembly with other components. In some embodiments, a jig is used during folding and shaping of the strip of material 501A to ensure that the strip of material 501A is folded at the appropriate location with the desired radius.

[0284] Referring back to FIG. 92A, a portion of a jig 570A to assist in folding and shaping the device 500A is shown. The strip 501A of material is shown folded around the jig 570A so that the strip 501A of material forms a desired shape. To fold the strip 501A of material into the shape of the device 500A using the jig 570A, the strip 501A of material is disposed at one of the ends 501B at the position of the inner paddle 522A. The strip 501A extends in the distal direction 507B from the end 501B to form the first layer 581A of the inner paddle 522A, forms the first layer 581A of the hinge portion 525A around the first jig portion 572A, and then in the proximal direction 505B, forms the first layer 581A of the core cushioning element 510A. The first layer 581A of the material forms the core cushioning element 510A that surrounds the side surface of the inner paddle 522A and the core cushioning gap 542A. The strip 501A is then wound around the second jig portion 574A to form one of the proximal portion 519B of the core cushioning element 510A and the opening 546A. The strip 501A then extends in the distal direction 507A along the first layer 581A to form the second layer 582A of the core cushioning element 510A. The strip 501A then rounds and folds back the first jig portion 572A to form the second layer 582A of the hinge portion 525A and returns in the proximal direction 505B to form the second layer 582A of the inner paddle 522A. The strip 501A is then wound around the third jig portion 576A to form the joint portion 523A. The strip 501A then extends in the distal direction 507A along the inner paddle 522A to form the outer paddle 520A and then is folded around the fourth jig portion 578A to form the joint portion 521. The strip 501A then extends laterally to form the distal portion 527. Then, the routing of the strip 501A through the jig 570A is performed in reverse order on the opposite side of the jig 570A to form the second half portion of the device 500A. That is, the strip 501A is then wound around the fourth, third, second, and first jig portions 578A, 576A, 574A, 572A to form the second half portion of the device 500A.Once the strip 501A is wound around the jig portion as described above, a shaping operation is performed. The illustrated jig portion has a rounded or substantially rounded shape, although the portion can have any shape to assist in folding and shaping the strip 501A of material. The jig 570 can have more or fewer portions for engaging the strip 501A of material.

[0285] Referring now to FIG. 93A, a top view of the device 500A is shown. The first and second layers 581A, 582A of each half portion of the device 500A form four layers of the coaption device 510A. The proximal opening 519C of the coaption 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 strip 501A of material after the shaping of the strip 501A of material. In other embodiments, the opening 519C is formed by shaping the folded layers 581A, 582A of the strip 501A of material around an additional jig portion (not shown), giving the coaption element 510A a rounded or generally rounded shape when viewed from above.

[0286] Referring now to FIG. 94A, a bottom view of the device 500A is shown. Similar to the aperture 527B for receiving the cap 514A, the distal portion 527A of the strip 501A of material is shown. The coaption element 510A and the outer paddle 520A have a generally rounded rectangular shape when viewed from below.

[0287] Referring now to FIGS. 95 - 102, perspective and cross-sectional views of device 500 are shown. Referring next to FIG. 95, device 500 is shown cut-away by a cross-sectional plane 96 near the proximal portion of core aspiration element 510. Referring next to FIG. 96, a cross-sectional view of device 500 as seen from cross-sectional plane 96 of FIG. 95 is shown. At the location of plane 96, core aspiration element 510 has an elliptical or substantially elliptical shape with a thicker portion along the sides of core aspiration element 510. Distal opening 515 is visible from the proximal portion and core aspiration element 510 has a hollow interior.

[0288] Referring next to FIG. 97, device 500 is shown cut-away by a cross-sectional plane 98 located approximately halfway between the distal portion 507 and the proximal portion 505 of core aspiration element 510. Referring next to FIG. 98, a cross-sectional view of device 500 as seen from cross-sectional plane 98 of FIG. 97 is shown. At the location of plane 98, core aspiration element 510 has an elliptical or substantially elliptical shape that is larger than the elliptical shape of FIG. 96.

[0289] Referring next to FIG. 99, device 500 is shown cut-away by a cross-sectional plane 100 located approximately one-quarter of the distance between the distal portion 507 and the proximal portion 505 of core aspiration element 510. Referring next to FIG. 99, a cross-sectional view of device 500 as seen from cross-sectional plane 100 of FIG. 99 is shown. At the location of plane 100, core aspiration element 510 has an elliptical or substantially elliptical shape that is narrower than the elliptical shape seen in FIG. 98.

[0290] Next, referring to FIG. 101, device 500 is shown cut away by a cross-sectional plane 102 positioned near the distal portion 507 of core capture element 510. Next, referring to FIG. 102, a cross-sectional view of device 500 as seen from cross-sectional plane 102 of FIG. 101 is shown. At the location of plane 102, core capture element 510 has an elliptical or substantially elliptical shape that is smaller than the elliptical shape seen in FIG. 100 and that divides as core capture element 510 joins joint portion 525.

[0291] Now referring to FIGS. 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A, perspective and cross-sectional views are shown of a portion of device 500A formed by a single continuous strip of material 501A. Next, referring to FIG. 95A, device 500A is shown cut away by a cross-sectional plane 96A near the proximal portion of core capture element 510A. Next, referring to FIG. 96A, a cross-sectional view of device 500A as seen from cross-sectional plane 96A of FIG. 95A is shown. At the location of plane 96A, core capture element 510 has a rectangular or substantially rectangular shape. In some embodiments, when an actuating element (not shown) is inserted between layers 582A of core capture element 510A, core capture element 510A remains straight when viewed from the side but bends outwardly to form a rounded or substantially rounded shape when viewed from cross-sectional plane 96A.

[0292] Next, referring to FIG. 97A, device 500A is shown cut away by cross-sectional plane 98A near the proximal portion of core aspiration element 510A. Next, referring to FIG. 98A, a cross-sectional view of device 500A as seen from cross-sectional plane 98A of FIG. 97A is shown. At the location of plane 98A, core aspiration element 510 has a rectangular or substantially rectangular shape. In some embodiments, when an actuating element (not shown) is inserted between layers 582A of core aspiration element 510A, core aspiration element 510A remains straight when viewed from the side but bends outwardly to form a rounded or substantially rounded shape when viewed from cross-sectional plane 98A.

[0293] Next, referring to FIG. 99A, device 500A is shown cut away by cross-sectional plane 100A near the proximal portion of core aspiration element 510A. Next, referring to FIG. 100A, a cross-sectional view of device 500A as seen from cross-sectional plane 100A of FIG. 99A is shown. At the location of plane 100A, core aspiration element 510 has a rectangular or substantially rectangular shape. In some embodiments, when an actuating element (not shown) is inserted between layers 582A of core aspiration element 510A, core aspiration element 510A remains straight when viewed from the side but bends outwardly to form a rounded or substantially rounded shape when viewed from cross-sectional plane 100A.

[0294] Next, referring to FIG. 101A, device 500A is shown cut away by cross-sectional plane 102A near the proximal portion of core aspiration element 510A. Next, referring to FIG. 102A, a cross-sectional view of device 500A as seen from cross-sectional plane 102A of FIG. 101A is shown. At the location of plane 102A, core aspiration element 510 has a rectangular or substantially rectangular shape. In some embodiments, when an actuating element (not shown) is inserted between layers 582A of core aspiration element 510A, core aspiration element 510A remains straight when viewed from the side but bends outwardly to form a rounded or substantially rounded shape when viewed from cross-sectional plane 102A.

[0295] Referring now to FIGS. 103 - 105, the exemplary implantable device 100 is shown having a covered portion and an uncovered portion. The device 100 is shown implanted in the native mitral valve MV and secured to the native valve leaflets 20, 22. As described above, the device 100 includes a core capture 110, paddles 120, clasps 130, and core capture elements or means of the cap 114. The paddles 120 and clasps 130 are in a closed position for securing the device 100 to the grasped native valve leaflets 20, 22 of the mitral valve MV. The proximal portion 105 of the device 100 is exposed to the left atrium LA, and the distal portion 107 of the device 100 is exposed to the left ventricle LV.

[0296] Next, referring to FIG. 103, the device 100 is shown having a cover 900 that covers the entire core capture element or engagement means 110 and cap 114. In some embodiments, the cover 900 can be a polymer such as a cross or fiber, or PET, velour, electrospan, deposit, or other suitable material. In other embodiments, instead of or in addition to the fiber, the cover can include an artificial spacer device and / or a coating (e.g., a polymer) applied to a mechanical sealing mechanism such as silicone and interlocking joints. The cover 900 can be formed from metallic fibers such as in a mesh, woven, knitted, or any other suitable manner, or from a flexible material cut in another way. The cover 900 can be a cross, a wire such as nitinol to provide shape fixation capabilities, or any other flexible material suitable for implantation into the human body. The cover 900 prevents blood flow through the core capture element or engagement means 110 at the proximal portion 105 and also provides a seal between the device 100 and the valve leaflets 20, 22. Thus, the cover 900 helps prevent blood flow through the native valve at the location of the device 100. The cover 900 also prevents recirculation of blood flow from entering the device 100 from the distal portion 107.

[0297] Next, referring to FIG. 104, device 100 is shown with a cover 1000 that partially covers core capture element or joining means 110 from the proximal portion 105 of device 100 to the portion of core capture element or joining means 110 that engages natural valve leaflets 20, 22. In some embodiments, the cover can be a cross or fiber such as PET, velour, or other suitable fiber. In other embodiments, instead of or in addition to the fiber, the cover can include a coating (e.g., a polymer) applied to the artificial spacer device. Cover 1000 can be formed from metal fibers such as in a mesh, woven, knitted, or any other suitable fashion, or from a flexible material cut by laser or another method. Cover 1000 can be a cross, a wire such as nitinol to provide shape fixation capabilities, or any other flexible material suitable for implantation into the human body. Thus, cover 1000 impedes blood flow through core capture element or joining means 110 at proximal portion 105.

[0298] Next, referring to FIG. 105, device 100 is shown with a cover 1100 that partially covers the core capture element or joining means 110, extending from a portion of the core capture element or joining means 110 that engages the native valve leaflets 20, 22 toward the distal portion 107. Cover 1100 also covers cap 114. In some embodiments, the cover can be a cloth or fiber such as PET, velour, or other suitable fiber. In other embodiments, instead of or in addition to the fiber, the cover can include a coating (e.g., a polymer) applied to the artificial spacer device. Cover 1100 can be formed in a mesh, woven, knitted, or any other suitable manner. Cover 1100 can be a cloth, polymer, silicone, electrospun material, deposited material, and / or a shape memory alloy wire such as nitinol for providing shape fixation capabilities, or any other flexible material suitable for implantation into the human body. Thus, blood flow can enter the core capture element or joining means 110, but is prevented from passing through the device by cover 1100 disposed toward the distal portion 107. Cover 1100 also prevents recirculation of blood flow from entering device 100 from distal portion 107.

[0299] Referring now to FIGS. 106 - 109, an exemplary core option element 1200 for an implantable artificial device is shown. The core option element 1200 can be used in combination with any of the implantable artificial devices described in this application. Referring to FIG. 106, the core option element 1200 has a cylindrical or substantially cylindrical shape that extends between two caps 1201. However, the core option element 1200 can have any shape, such as any of the shapes disclosed herein. In one exemplary embodiment, the expansion direction of the core option element 1200 can be controlled. For example, the width / size of the core option element in the forward to rearward direction (when implanted), the inward to lateral direction (when implanted), or both, can be expanded (or contracted) in a controlled manner. The core option element can be made from a mesh 1200 of material. Referring now to FIG. 107, the mesh wall of the generally cylindrical core option element 1200 extends outwardly from the caps 1201 by a distance 1204. Referring now to FIG. 108, an axial force 1208 is applied to the caps 1201 of the core option element 1200, whereby the core option element 1200 is compressed axially. When the core option element 1200 is compressed axially, the core option element 1200 expands or bulges in the outward direction 1210 such that the distance 1204 increases.

[0300] The core option element 1200 can be compressed in a variety of different ways. For example, a screw connection can be used to pull the two ends of the core option element together or push the two ends of the core option element apart. For example, collars can be provided on each end of the core option element. One of the collars can be threadedly engaged with a threaded shaft and the other collar is 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.

[0301] By incorporating the core aspiration element 1200 into the implantable artificial device of the present application, the core aspiration element can be expanded to push outwardly against the tissue grasped between the core aspiration element and the paddle and / or the grasping member.

[0302] Referring now to FIGS. 106A, 108A, 106B, and 108B, an exemplary core aspiration element 1200 is shown that is similar to the embodiments illustrated by FIGS. 106-109 for an implantable artificial device. The core aspiration element 1200 can be used in combination with any of the implantable artificial devices described in the present application. Referring to FIG. 106A, the core aspiration element 1200 has a cylindrical or substantially cylindrical shape that extends between two caps 1201. However, the core aspiration element 1200 can have any shape, such as any of the shapes disclosed herein. In the examples illustrated by FIGS. 106A and 108A, the core aspiration element 1200 includes a tube 1203 having slots 1205. For example, the tube 1203 may be made of a shape memory alloy such as nitinol, and the slots may be cut into the tube by laser cutting or the like. The slots can be cut into the material forming the tube before the material is formed into the tube.

[0303] In one exemplary embodiment, the expansion direction of the core capture element 1200 can be controlled. For example, the configuration of the slots 1205 and / or the shaping of the tube can be selected to control the shape of the expanded core capture element 1200. For example, the configuration of the slots 1205 and / or the shaping can determine the width / size of the core capture element in the forward-to-backward direction and / or the inward-to-lateral expansion (and / or contraction). Referring to FIG. 106A, the tube wall of the generally cylindrical core capture element 1200 extends outward from the cap 1201 by a distance 1204. Referring now to FIG. 108A, an axial force 1208 and / or a rotational force 1209 are applied to the cap 1201 of the core capture element 1200, enabling the core capture element 1200 to expand from the configuration illustrated by FIG. 106A to the configuration illustrated by FIG. 108A. In the illustrated example, when the core capture element 1200 is axially compressed and the core capture element 1200 is twisted, it expands or bulges in the outward direction 1210 such that the distance 1204 increases.

[0304] Referring to FIGS. 106B and 108B, the core capture element 1200 can be compressed in a wide variety of different ways. For example, a screw connection 1221 can be used to pull the two ends of the core capture element together and twist the core capture element in a first direction, or to push the two ends of the core capture element apart and twist the core capture element in a second direction. For example, collars can be provided on each end of the core capture element. One of the collars can be threadedly engaged with a threaded shaft, and the other collar can be fixedly connected to the shaft. Rotating the shaft in one direction pulls the collars together and rotates the collars relative to each other in a first direction. Rotating the shaft in the opposite direction moves the collars apart and rotates the collars relative to each other in a second direction. The pitch of the threaded connection can be selected to set the ratio of the distance by which the core capture element 1200 is compressed to the angle by which the core capture element is twisted.

[0305] By incorporating the core aspiration element 1200 illustrated by FIGS. 106A, 108A, 106B, and 108B into the implantable artificial device of the present application, the core aspiration element can be expanded to push outwardly against the tissue grasped between the core aspiration element and the paddle and / or the grasping member.

[0306] FIGS. 106C and 108C show an exemplary embodiment of a controllably expandable core aspiration element 1200 for an implantable artificial device. The core aspiration element 1200, by itself, can have a coating or be used inside any of the core aspiration elements described herein (for expanding the core aspiration element). The core aspiration element 1200 can be used in combination with any of the implantable artificial devices described in the present application. Referring to FIG. 106C, the core aspiration element 1200 has a pair of pivotally connected arms 1231. Each of the pair of pivotally connected arms 1231 extends between two caps 1201 and is pivotally connected to the two caps 1201. In the illustrated example, there are two pairs of pivotally connected arms 1231. However, there may be one, three, four, or any number of pairs of pivotally connected arms.

[0307] In one exemplary embodiment, the expansion direction of the core aspiration element 1200 can be controlled. For example, two pairs of pivotally connected arms (such as those illustrated) can be included to change the width / size of the core aspiration element in only one of the front-to-back direction and / or the in-to-lateral direction. Four pairs of pivotally connected arms 1231 can be included to change the width / size of the core aspiration element in both the front-to-back direction and the in-to-lateral direction. When four pairs of pivotally connected arms 1231 are included, the arms can have different lengths and / or pivot point locations to expand (or contract) the core aspiration element 1200 separately in different directions. For example, the length of the arms can be selected to expand more in the in-to-lateral direction than in the front-to-back direction.

[0308] Referring now to FIG. 108C, the axial force 1208 is applied to the cap 1201 of the core capture element 1200, enabling the core capture element 1200 to expand from the configuration illustrated by FIG. 106C to the configuration illustrated by FIG. 108C. In the illustrated example, when the pivotally connected arm 1231 is axially compressed, the pivot connection 1233 or knee spreads in the outward direction 1210 such that the distance 1204 increases.

[0309] Referring to FIGS. 106C and 108C, the core capture element 1200 can be compressed in a wide variety of different ways. For example, a screw connection 1221 can be used to pull the two ends of the core capture element together or push the two ends of the core capture element apart. For example, collars can be provided on each end of the core capture element. One of the collars can threadedly engage a threaded shaft, and the other collar is 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.

[0310] By incorporating the core capture element 1200 illustrated by FIGS. 106C and 108C into the implantable artificial device of the present application, the core capture element can be expanded to push outwardly against tissue gripped between the core capture element and the paddle and / or gripping member.

[0311] Figures 106D and 108D show exemplary embodiments of an expandable core option element 1200 for an implantable artificial device. The core option element 1200, as such, has a coating (see FIGS. 106E and 108E) or can be used inside any of the core option elements described herein (to expand the core option element). The core option element 1200 can be used in combination with any of the implantable artificial devices described in this application. Referring to FIG. 106C, the core option element 1200 has a central support member 1243, one or more pivotably connected arms 1241, and connection lines 1245. Each arm 1241 extends from the pivot connection to the central support member 1243. Each connection line 1245 is connected to the central support member 1243 and the pivotably connected arm 1241. The length of the connection line 1245 sets the extent to which the connecting arm pivots away from the central support member 1243. In the illustrated example, there are two pivotably connected arms 1241. However, there may be one, three, four, or any number of pivotably connected arms.

[0312] In one exemplary embodiment, the expansion direction of the core option element 1200 can be controlled. For example, two pivotably connected arms can be included to change the width / size of the core option element in only one of the front-to-back direction and / or the in-to-lateral direction. Four pivotably connected arms 1241 can be included to change the width / size of the core option element in both the front-to-back direction and the in-to-lateral direction. When four pivotably connected arms 1241 are included, the arms and / or connection lines 1245 can have different lengths and / or pivot point locations to expand (or contract) the core option element 1200 separately in different directions. For example, the length of the arms and / or connection lines can be selected to expand more in the in-to-lateral direction than in the front-to-back direction.

[0313] The arm 1241 can move from a contracted position (FIG. 106D) to an extended position (FIG. 108D). For example, the arm 1241 can be biased toward the extended position by a spring or other biasing means. In the illustrated example, a restraint 1247, such as a suture, holds the arm 1241 in the contracted position. The restraint 1247 can be removed or broken, thereby allowing the core capture element 1200 to expand from the configuration illustrated by FIG. 106D to the configuration illustrated by FIG. 108D.

[0314] FIGS. 106E and 108E show exemplary embodiments similar to the embodiments illustrated by FIGS. 106D and 108D, except that the core capture element includes a cover material 1253. The cover material 1253 can extend from the central support member 1243 to each arm 1241. The cover material 1253 can be used with the connecting wire 1245, or the cover material can eliminate the need for the connecting wire 1245.

[0315] Referring now to FIG. 106F, an exemplary core capture element 1200 is shown that is similar to the embodiments illustrated by FIGS. 106-109 for an implantable artificial device. The core capture element 1200 can be used in combination with any of the implantable artificial devices described in this application. Referring to FIG. 106F, the core capture element 1200 is defined by a coil 1263 that extends between two caps 1201. The core capture element 1200 can have any shape, such as any of the shapes disclosed herein. The coil 1263 can be made from a shape memory alloy such as nitinol.

[0316] In one exemplary embodiment, the expansion direction of the core capture element 1200 can be controlled. For example, the shape setting of the coil 1263 can be selected to control the shape of the expanded core capture element 1200. For example, the configuration of the shape setting can determine the manner of the width / size of the core capture element in the forward-to-backward direction and / or the inward-to-lateral expansion (and / or contraction). Referring, the axial force 1208 and / or the rotational force 1209 are applied to the cap 1201 of the core capture element 1200, enabling the core capture element 1200 to expand or contract from the configuration illustrated by FIG. 106F. In the illustrated example, extending the coil 1263 axially and twisting the coil 1263 contracts the coil in the inward direction 1211, compressing the coil 1263 axially, and twisting the coil in the opposite direction expands or inflates the coil in the outward direction.

[0317] Referring to FIG. 106F, the core capture element 1200 can be compressed in a wide variety of different ways. For example, the screw connection 1221 can be used to pull the two ends of the core capture element together and twist the core capture element in a first direction, or push the two ends of the core capture element apart and twist the core capture element in a second direction. For example, collars can be fixedly connected to each end of the coil 1263. One of the collars can be threadedly engaged with a threaded shaft, and the other collar is fixedly connected to the shaft. Rotating the shaft in one direction pulls the collars together and rotates the collars in a first direction relative to each other. Rotating the shaft in the opposite direction moves the collars apart and rotates the collars in a second direction relative to each other. The pitch of the threaded connection can be selected to set the ratio of the distance by which the core capture element 1200 is compressed to the angle by which the core capture element is twisted.

[0318] By incorporating the core aspiration element 1200 illustrated by FIG. 106F into the implantable artificial device of the present application, the core aspiration element can be expanded to outwardly push against the tissue grasped between the core aspiration element and the paddle and / or grasping member.

[0319] FIGS. 106G-106I show exemplary embodiments of an expandable core aspiration element 1200. In the examples illustrated by FIGS. 106G-106I, the core aspiration element is expanded by a fluid medium to expand the core aspiration element. The fluid medium can take a wide variety of different forms. Examples of fluids that can be used to expand the core aspiration element 1200 include, but are not limited to, air, gels, water, blood, foaming materials, and the like. The core aspiration element 1200 can be used in combination with any of the implantable artificial devices described in the present application.

[0320] Referring to FIG. 106G, the core aspiration element 1200 can have an outer layer 1271 (e.g., any of the core aspiration elements 110, 510 disclosed herein), and an inner layer 1273 or balloon. The core aspiration element 1200 can h...

Claims

**Claim 1** A valve repair device for repairing a patient's native valve, the valve repair device comprising: a core capture element; a pair of paddles connected to the core capture element, the paddles being movable between an open position and a closed position; a first cover portion extending from a distal end of the valve repair device and covering at least a portion of the paddles; a second cover portion extending from a proximal end of the valve repair device and covering at least a portion of the core capture element; comprising; A valve repair device, wherein the paddles are configured to be attached to the native valve of the patient. **Claim 2** The valve repair device according to claim 1, wherein the first cover portion completely covers the paddles. **Claim 3** The valve repair device according to claim 1 or 2, wherein the second cover portion completely covers the core capture element. **Claim 4** The valve repair device according to any one of claims 1 to 3, further comprising a gripping member, wherein the first cover portion covers a portion of the gripping member. **Claim 5** The valve repair device according to claim 4, wherein the second cover portion includes an opening for a barb extending from the gripping member. **Claim 6** The valve repair device according to any one of claims 1 to 5, wherein the first cover portion extends outwardly from a central portion to an end portion. **Claim 7** a shaft; a collar through which the shaft extends; a cap attached to the shaft such that the cap can move away from the collar by the shaft; further comprising a base assembly including; the pair of paddles being attached to the cap; The valve repair device according to any one of claims 1 to 6, wherein movement of the cap towards the collar moves the pair of paddles to the closed position, and movement of the cap away from the collar moves the pair of paddles to the open position. **Claim 8** The valve repair device according to claim 7, wherein the second cover portion includes an opening exposing an engaging portion of the collar. **Claim 9** The valve repair device according to any one of claims 1 to 8, wherein the paddles are disposed on an extension member, and the first cover portion is attached to the extension member. **Claim 10** The valve repair device according to claim 9, wherein the extension member includes a hoop. **Claim 11** The valve repair device according to any one of claims 1 to 10, wherein the core capture element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

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