Natural valve repair device and program

Abstract

The invention relates to a native valve repair device and program. A valve repair device for repairing a native valve of a patient includes a pair of paddles, a pair of clamping members, and a spacer element. The paddle is movable between an open position and a closed position. The paddle and the clamping member are configured to attach to a native valve of a patient. The spacer element is configured to close a gap in a native valve of a patient when the valve repair device is attached to the native valve.

Description

[0001] This application is a divisional application. The application date of the original application is January 8, 2019, the application number is 2019800076637, and the name of the invention is “Natural valve repair device and procedure”.

[0002] Related Applications

[0003] This application claims the benefit of U.S. Provisional Application Serial No. 62 / 615,213, filed on January 9, 2018, entitled “Native Valve Repair Devices and Procedures,” which is incorporated herein by reference in its entirety. Technical Field

[0004] The present application relates generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. Background Art

[0005] Natural heart valves (i.e., aortic valve, pulmonary valve, tricuspid valve and mitral valve) play a key role in ensuring that an adequate supply of blood flows forward through the cardiovascular system. These heart valves may be damaged by congenital malformations, inflammatory processes, infectious conditions, or diseases, thereby reducing their efficiency. Such damage to the valve can lead to severe cardiovascular damage or death. For many years, the definitive treatment for such damaged valves has been surgical repair or replacement of the valve during open heart surgery. However, open heart surgery is highly invasive and prone to many complications. Therefore, elderly and frail patients with defective heart valves often do not receive treatment. Recently, transvascular techniques have been developed for introducing and implanting prosthetic devices in a much less invasive manner than open heart surgery. A specific transvascular technique for accessing the natural mitral valve and aortic valve is the transseptal technique. The transseptal technique includes inserting a catheter into the right femoral vein, up along the inferior vena cava and into the right atrium. The septum is then pierced and the catheter is passed into the left atrium.

[0006] A healthy heart has a generally conical shape, tapering to a lower apex. The heart is a four-chambered heart and includes a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The anatomical structure of the mitral valve is quite different from other natural heart valves. The mitral valve includes a valve ring portion, which is an annular portion of natural valve tissue surrounding the mitral valve orifice, and a pair of cusps or leaflets extending downward from the valve ring into the left ventricle. The mitral valve ring can form a "D" shape, an elliptical, or other non-circular cross-sectional shape with a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, thereby forming a roughly "C" shaped boundary between the adjacent free edges of the leaflets when the leaflets are closed together.

[0007] When functioning properly, the anterior and posterior leaflets act together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expand (also known as "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 known as "ventricular systole" or "systole"), the increased blood pressure in the left ventricle forces the two leaflets together, closing the one-way mitral valve so that blood cannot flow back into the left atrium, but instead is discharged from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral valve annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0008] Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of contraction. Mitral regurgitation is the most common form of valvular heart disease. There are different causes of mitral regurgitation, such as leaflet prolapse, papillary muscle dysfunction, and / or left ventricular dilatation leading to stretching of the mitral annulus. Mitral regurgitation at the central portion of the leaflet may be referred to as central jet mitral regurgitation, while mitral regurgitation closer to one of the commissures of the leaflets (i.e., where the leaflets meet) may be referred to as eccentric jet mitral regurgitation. With central jet regurgitation, the edges of the leaflets do not converge in the middle. Therefore, the valve does not close and regurgitation occurs.

[0009] Some prior art techniques for treating mitral regurgitation in patients involve surgically suturing the edges of the native mitral valve leaflets directly to one another. Like the surgical suturing method, catheter-delivered clamps have been used in an attempt to clamp the edges of the leaflets together. However, such clamps are disadvantageous in that they can only be used to clamp the middle edges of the leaflets, where the leaflets overlap by 2 mm or more. Alternatively, attempts have been made to use multiple clamps on the commissures of the mitral valve, where there is more overlap. This can result in longer surgical procedures and can cause the patient's leaflets to become ligated at the edges, thereby restricting blood flow. Both surgical and clamp treatments are believed to place stress on the patient's leaflets.

[0010] Despite the prior art, there remains a need for improved devices and methods for treating mitral valve regurgitation. Summary of the invention

[0011] An exemplary valve repair device for repairing a patient's natural valve includes a pair of paddles, a pair of gripping members, and a spacer element. The paddles are movable between an open position and a closed position. The paddles and gripping members are configured to be attached to the patient's natural valve. The spacer element is configured to close a gap in the patient's natural valve when the valve repair device is attached to the natural valve.

[0012] A further understanding of the nature and advantages of the present invention will be set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts have like reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] In order to further illustrate various aspects of the embodiments of the present disclosure, certain embodiments will be described in more detail by referring to various aspects of the accompanying drawings. It should be understood that these drawings only depict typical embodiments of the present disclosure and should not be considered to limit the scope of the present disclosure. In addition, although the drawings can be drawn to scale for certain embodiments, they are not necessarily drawn to scale for all embodiments. By using the accompanying drawings, the embodiments of the present disclosure will be described and explained with additional specificity and detail.

[0014] Figure 1 illustrates a cross-sectional view of a human heart in diastole;

[0015] Figure 2 illustrates a cross-sectional view of a human heart in systole;

[0016] Figure 3 An example of a healthy mitral valve with closed leaflets as viewed from the atrial side of the mitral valve;

[0017] Figure 4 An example of a dysfunctional mitral valve with visible gaps between the leaflets as viewed from the atrial side of the mitral valve is shown;

[0018] Figure 4A An illustration of the tricuspid valve as viewed from the atrial side of the tricuspid valve is shown;

[0019] Figure 5 illustrates a cross-sectional view of a human heart in diastole, with chordae tendineae shown attaching the leaflets of the mitral and tricuspid valves to the ventricular wall;

[0020] Figure 6 A valve repair device is illustrated with the paddle in an open position;

[0021] Figure 7 Example Figure 6 The valve repair device of claim 1, wherein the paddle is in an open position and the clamping member is moved to create a larger gap between the clamping member and the paddle;

[0022] Figure 8 Example Figure 6 A valve repair device, wherein the valve repair device is in Figure 7 the position shown, wherein valve tissue is disposed between the clamping member and the paddle;

[0023] Fig. 9 Example Figure 6 The valve repair device of claim 1, wherein the clamping member is moved to reduce the gap between the clamping member and the paddle;

[0024] Figures 10A-10B Example Figure 6 movement of a paddle of a valve repair device from an open position to a closed position;

[0025] Fig.11 Example of a closed position Figure 6 The valve repair device of claim 1, wherein the clamping member engages valve tissue;

[0026] Fig.12 The valve is shown after being separated from the delivery device and attached to the valve tissue. Figure 6 A valve repair device, wherein the valve repair device is in a closed condition and a locked condition;

[0027] Fig.13A illustrates an exemplary embodiment of a valve repair device attached to anterior and posterior leaflets of a patient's mitral valve shown from the left atrium of the patient's heart, with the valve repair device and leaflet tissue on the ventricular side shown in phantom;

[0028] Fig. 13B yes Fig.13A A larger version of

[0029] Fig.14A is another exemplary embodiment of a valve repair device attached to anterior and posterior leaflets of a mitral valve of a patient, wherein the valve repair device and leaflet tissue on the ventricular side are shown in phantom;

[0030] Fig. 14B is another exemplary embodiment of a valve repair device attached to anterior and posterior leaflets of a mitral valve of a patient, wherein the valve repair device includes a paddle that flexes to place less stress on mitral valve tissue, wherein the valve repair device and leaflet tissue on the ventricular side are shown in phantom;

[0031] Figures 15A-15B Another exemplary embodiment of a valve repair device is illustrated, wherein the valve repair device includes a paddle that flexes along its length to place less stress on the valve tissue when the valve repair device is attached to the valve tissue;

[0032] Figures 16A-16F Another exemplary embodiment of a valve repair device is illustrated, wherein the valve repair device includes a compressible paddle including an exemplary embodiment of a wire loop;

[0033] Figures 16G-16H Another exemplary embodiment of a valve repair device is illustrated, wherein the valve repair device includes a compressible paddle including another exemplary embodiment of a wire loop;

[0034] Figures 16I-16J Another exemplary embodiment of a valve repair device is illustrated, wherein the valve repair device includes a compressible paddle including another exemplary embodiment of a wire loop;

[0035] Figures 17A-17F Another exemplary embodiment of a valve repair device is illustrated, wherein the valve repair device includes a compressible paddle having a horseshoe shape;

[0036] Figures 18A-18D Another exemplary embodiment of a valve repair device is illustrated, wherein the valve repair device includes a compressible paddle having a horseshoe shape;

[0037] Fig.18E and 18F An example similar to Fig.18C and 18D A compressible paddle of the type shown in , except that the legs of the paddle are not crossed when the paddle is loaded into the catheter;

[0038] Figures 19A-19DAnother exemplary embodiment of a valve repair device is illustrated, wherein the valve repair device includes a compressible mesh paddle;

[0039] Figures 20A-20B Exemplary embodiments of a paddle for a valve repair device are illustrated, wherein the paddle is compressible;

[0040] Figures 21A-21B Another exemplary embodiment of a valve repair device is illustrated, wherein a paddle of the valve repair device is extendable;

[0041] Fig. 22 Another exemplary embodiment of a valve repair assembly is illustrated, wherein a gripper control mechanism is configured to independently control each gripper member of a valve repair device;

[0042] Figures 22A-22D Another exemplary embodiment of a valve repair assembly is illustrated in which an exemplary embodiment of a clamp control mechanism is configured to control four clamp members of an exemplary embodiment of a valve repair device independently of one another.

[0043] Fig.23 Another exemplary embodiment of a valve repair assembly is illustrated, wherein the clamp control mechanism is configured to independently control each clamp member of the valve repair device;

[0044] Fig.24 This example shows the placement shaft and Fig.23 an exemplary embodiment of a connection between a paddle control mechanism shaft of a valve repair device of the present invention, wherein the clamp control mechanism is attached to the valve repair device at the connection between the placement shaft and the paddle control mechanism shaft;

[0045] Figures 24A-24B This example shows how to place the axis and Fig.23 An exemplary embodiment of a connection between a paddle control mechanism and a shaft of a valve repair device, wherein the clamp control mechanism is attached to the valve repair device at the connection between the placement shaft and the shaft of the valve repair device;

[0046] Fig.25 Another exemplary embodiment of a valve repair assembly is illustrated, wherein the clamp control mechanism is configured to control each clamp member of the valve repair device independently of each other;

[0047] Fig.25AAnother exemplary embodiment of a clamp control mechanism configured to control each clamp member of a valve repair device independently of one another is illustrated;

[0048] Fig.26 Another exemplary embodiment of a valve repair assembly is illustrated, wherein the clamp control mechanism is configured to control each clamp member of the valve repair device independently of each other;

[0049] Figures 27A-27C Another exemplary embodiment of a valve repair device is illustrated, wherein each paddle of the valve repair device is independently movable from an open position to a closed position;

[0050] Figures 28A-28F Another exemplary embodiment of a valve repair device is illustrated, wherein each paddle of the valve repair device is independently movable from an open position to a closed position;

[0051] Figures 29A-29B Another exemplary embodiment of a valve repair device is illustrated, wherein each paddle of the valve repair device is movable from an open position to a closed position independently of one another;

[0052] Fig.30 A mitral valve with a wide gap between the posterior and anterior leaflets is illustrated;

[0053] Figures 31A-31B Another exemplary embodiment of a valve repair device is illustrated, wherein a paddle of the valve repair device expands to create a wide gap for receiving valve tissue;

[0054] Figures 32A-32C Another exemplary embodiment of a valve repair device is illustrated, wherein the valve repair device is configured so that a paddle of the valve repair device expands by pivoting and spreading to create a wide gap for receiving valve tissue;

[0055] Figures 33A-33C Another exemplary embodiment of a valve repair device is illustrated, wherein the valve repair device is configured such that a paddle of the valve repair device expands by unfolding and pivoting to create a wide gap for receiving valve tissue;

[0056] Figures 34A-34B Another exemplary embodiment of a valve repair device is illustrated, wherein a "W" shaped mechanism causes a paddle of the valve repair device to expand to create a wide gap;

[0057] Figures 34C-34D Another exemplary embodiment of a valve repair device is illustrated, wherein a "W" shaped mechanism causes a paddle of the valve repair device to expand to create a wide gap;

[0058] Figures 35A-35B Another exemplary embodiment of a valve repair device is illustrated, wherein a "W" shaped mechanism expands the paddles of the valve repair device to create a wide gap for receiving valve tissue;

[0059] Figures 36A-36B Another exemplary embodiment of a valve repair device is illustrated, wherein a "W" shaped mechanism causes a paddle of the valve repair device to expand to create a wide gap;

[0060] Fig.36C Example for Figures 36A-36B An exemplary embodiment of a paddle control mechanism of a valve repair device;

[0061] Figures 36D-36E Another exemplary embodiment of a valve repair device is illustrated, wherein a "W" shaped mechanism causes a paddle of the valve repair device to expand to create a wide gap;

[0062] Figures 37A-37D Another exemplary embodiment of a valve repair device having a mesh paddle and an internal cam for deploying the mesh paddle to create a wide gap for the spaced apart valve tissue is illustrated;

[0063] Figures 37E-37F Another exemplary embodiment of a valve repair device having a mesh paddle and an internal cam for deploying the mesh paddle to create a wide gap for the spaced apart valve tissue is illustrated;

[0064] Fig.38 An exemplary embodiment of a valve repair device is illustrated, the valve repair device including an exemplary embodiment of a spacer element, wherein the valve repair device is attached to a mitral valve;

[0065] Fig.39 Another exemplary embodiment of a valve repair device is illustrated, the valve repair device comprising an exemplary embodiment of a spacer element, and wherein the valve repair device is attached to a mitral valve;

[0066] Figures 40A-40B Another exemplary embodiment of a valve repair device is illustrated, the valve repair device including an exemplary embodiment of a spacer element, wherein the spacer element is attached to a shaft of the valve repair device;

[0067] Figures 41A-41D Another exemplary embodiment of a valve repair device is illustrated, the valve repair device including an exemplary embodiment of a spacer element having a first portion attached to a first clamping member of the valve repair device and a second portion of the spacer element attached to a second clamping member of the valve repair device;

[0068] Figures 42A-42C Example Figures 40A-40B A valve repair device, wherein the spacer element has various shapes;

[0069] Figures 43A-43C Example Figures 41A-41B A valve repair device, wherein the spacer element has various shapes;

[0070] Figures 44A-44B Another exemplary embodiment of a valve repair device having a paddle and an expandable spacer element that stretches wider is illustrated;

[0071] Figures 45A-45C Another exemplary embodiment of a valve repair device having an increased bailout angle for removal of the valve repair device is illustrated.

[0072] Figures 46A-46D Another exemplary embodiment of a valve repair device having an increased relief angle for removal of the valve repair device is illustrated;

[0073] Figures 47A-47B Another exemplary embodiment of a valve repair device having an attachment member for connecting a paddle to a clamp when the valve repair device is in a closed position is illustrated;

[0074] Fig.48 Another exemplary embodiment of a valve repair device having a spring member configured to bias a paddle of the valve repair device to a closed position is illustrated;

[0075] Fig.49 Another exemplary embodiment of a valve repair device having a threaded mechanism for moving the valve repair device between an open position and a closed position is illustrated;

[0076] Fig.50 Another exemplary embodiment of a valve repair device having a clamping member attached to a paddle is illustrated;

[0077] Fig.51 Another exemplary embodiment of a valve repair device having a clamping member having a single row of barbs is illustrated;

[0078] Figures 51A-51E Another exemplary embodiment of a valve repair system having a valve repair assembly having a valve repair device having a clamping member configured to place a tensioning force on valve tissue when the valve repair device is attached to the valve tissue is illustrated;

[0079] Figures 51F-51H Another exemplary embodiment of a valve repair assembly having a clamping member configured to place a tensioning force on valve tissue when a valve repair device is attached to the valve tissue is illustrated;

[0080] Fig.52 Another exemplary embodiment of a valve repair device having a gripping member extendable in length is illustrated;

[0081] Figures 53A-53B Another exemplary embodiment of a valve repair device having a gripping member that is flexible is illustrated; and

[0082] Fig.54 Another exemplary embodiment of a valve repair device is illustrated in which a clamping member is attached to a separate spring member. DETAILED DESCRIPTION

[0083] The following description refers to the accompanying drawings, which illustrate specific embodiments of the present invention. Other embodiments having different structures and operations do not depart from the scope of the present invention.

[0084] Exemplary embodiments of the present disclosure relate to devices and methods for repairing defective heart valves. It should be noted that various embodiments of native valve repair devices and systems for delivery are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, the individual components of the disclosed devices and systems can be combined unless mutually exclusive or physically impossible.

[0085] Figure 1 and 2 are cross-sectional views of a human heart H in 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, respectively, by the tricuspid valve TV and the mitral valve MV (i.e., the atrioventricular valves). In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., Figure 3 and 4 ), the flexible leaflets extend inwardly across their respective orifices, meeting or "joining" in the flowstream to form a one-way fluid-occlusive surface. The native valve repair system of the present application is described primarily with respect to the mitral valve MV. Therefore, the anatomical structures of the left atrium LA and the left ventricle LV will be explained in more detail. It should be understood that the device described herein can also be used to repair other native valves, for example, the device can be used to repair the tricuspid valve TV, the aortic valve AV and the pulmonary valve PV.

[0086] The left atrium LA receives oxygenated blood from the lungs. Figure 1 During the systolic phase (as shown in Figure 1), blood previously collected in the left atrium LA (during systole) moves through the mitral valve MV and into the left ventricle LV by the expansion of the left ventricle LV. Figure 2 ), the left ventricle LV contracts to force blood into the body through the aortic valve AV and the ascending aorta AA. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV and into the left atrium LA, and blood is collected in the left atrium from the pulmonary veins. In an exemplary embodiment, the device described in the present 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 and into the left atrium LA.

[0087] refer to Figure 1-5 , the mitral valve MV includes two leaflets: an anterior leaflet 302 and a posterior leaflet 304. The mitral valve MV also includes an annulus 306, which is a dense and variable fibrous ring of tissue surrounding the leaflets 302, 304. Figure 5 , the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae 501. The chordae tendineae 501 are rope-like tendons that connect the papillary muscles 503 (i.e., muscles located at the base of the chordae tendineae and within the wall of the left ventricle) to the leaflets 302, 304 of the mitral valve MV. The papillary muscles serve to limit the movement of the mitral valve MV and prevent the mitral valve from reverting. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles do not open or close the mitral valve MV. Instead, the papillary muscles support the mitral valve MV against the high pressures required to circulate blood throughout the body. The papillary muscles and chordae tendineae are collectively referred to as the subvalvular apparatus, which acts to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed.

[0088] Various disease processes may impair the normal function of one or more native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic dysfunction), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy) can distort the geometry of the native valve, which can cause the native valve to malfunction. However, the vast majority of patients who undergo valve surgery (such as surgery on the mitral valve MV) suffer from a degenerative disease that causes the leaflets (e.g., leaflets 302, 304) of the native valve (e.g., mitral valve MV) to malfunction, which leads to prolapse and regurgitation.

[0089] Typically, native valves can malfunction in two different ways. One possible malfunction is valvular stenosis, which occurs when the native valve does not open fully and therefore results in blood flow occlusion. Generally speaking, valvular stenosis is caused by the accumulation of calcified material on the valve leaflets, which causes the leaflets to thicken and impairs the valve's ability to open fully to allow positive blood flow.

[0090] Another possible dysfunction is valve regurgitation, which occurs when the valve leaflets do not close completely, causing blood to leak back into the previous chamber (for example, causing blood to leak from the left ventricle to the left atrium). Three mechanisms by which native valves become regurgitant or incompentent include Carpenter's Type I, Type II, and Type III dysfunctions. Carpenter's Type 1 dysfunction includes expansion of the annulus, causing normally functioning leaflets to disperse from each other and fail to form a tight seal (i.e., not properly engaged). Type I mechanism dysfunction includes perforation of the leaflets (such as in endocarditis). Carpenter's Type II dysfunction involves prolapse of one or more leaflets of the native valve above the plane of engagement. Carpenter's Type III dysfunction involves restriction of the movement of one or more leaflets of the native valve, causing the leaflets to be abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilatation (IIIb).

[0091] refer to Figure 3 , when the healthy mitral valve MV is in the closed position, the anterior leaflet 302 and the posterior leaflet 304 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Figure 4, regurgitation occurs when the anterior leaflet 302 and / or the posterior leaflet 304 of the mitral valve MV displace into the left atrium LA during systole. This failure to coapt results in a gap 408 between the anterior leaflet 302 and the posterior leaflet 304, which allows blood to flow from the left ventricle LV back into the left atrium LA during systole. As described above, there are several different ways that a leaflet (e.g., the leaflets 302, 304 of the mitral valve MV) can malfunction, which in turn can lead to regurgitation.

[0092] Although stenosis or regurgitation can affect any valve, stenosis is found primarily to affect the aortic valve AV or the pulmonary valve PV, while regurgitation is found primarily to affect the mitral valve MV or the tricuspid valve TV. Both valvular stenosis and valvular regurgitation increase the workload of the heart H and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium LA, left ventricle LV, mitral valve MV, and aortic valve AV) is primarily responsible for circulating blood throughout the body, dysfunction of the mitral valve MV or aortic valve AV is particularly problematic and often life-threatening. Therefore, since the pressure on the left side of the heart is significantly higher, dysfunction of the mitral valve MV or aortic valve AV is more problematic.

[0093] Dysfunctional natural heart valves can be repaired or replaced. Repair generally involves preserving and correcting the patient's natural valve. Replacement generally involves replacing the patient's natural valve with a biological substitute or a mechanical substitute. In general, the aortic valve AV and the pulmonary valve PV are more susceptible to stenosis. Since the stenotic damage sustained by the leaflets is irreversible, the most conventional treatment for stenotic aortic valves or stenotic pulmonary valves is to remove the valves and replace the valves with surgically implanted heart valves, or to displace the valves with transcatheter heart valves. The mitral valve MV and the tricuspid valve TV are more susceptible to leaflet deformation, which, as described above, prevents the mitral valve or tricuspid valve from closing normally and allows blood to flow back or reflux from the ventricles to the atria (e.g., a deformed mitral valve MV may allow reflux or reflux from the left ventricle LV to the left atrium LA). Reflux or reflux of blood from the ventricles to the atria causes valvular insufficiency. Deformation of the structure or shape of the mitral valve MV or the tricuspid valve TV is usually repairable. Additionally, regurgitation may occur as the chordae 501 become dysfunctional (e.g., the chordae may stretch or rupture), which allows the anterior leaflet 302 and the posterior leaflet 304 to rotate back, allowing blood to flow back into the left atrium LA. Problems that occur due to dysfunctional chordae 501 may be repaired by repairing the chordae or the structure of the mitral valve (e.g., by fixing the leaflets 302, 304 at the affected portion of the mitral valve).

[0094] The devices and procedures disclosed herein relate to repairing the structure of the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve and any component of a native valve. Figure 4A , any device and concept provided herein can be used to repair tricuspid valve TV. For example, any device and concept provided herein can be used between any two of the anterior leaflet 4011, the septal leaflet 4012, and the posterior leaflet 4013 to prevent blood from flowing back from the right ventricle to the right atrium. In addition, any device and concept provided herein can be used together on all three leaflets 4011, 4012, 4013 to prevent blood from flowing back from the right ventricle to the right atrium. That is, the valve repair device provided herein can be centrally positioned between the three leaflets 4011, 4012, 4013.

[0095] Figure 6-13B A valve repair system 600 for repairing a patient's natural valve is illustrated. The valve repair system 600 includes a delivery device 601 and a valve repair device 602, wherein the delivery device is configured to deliver the valve repair device to the patient's natural valve, and wherein the valve repair device is configured to attach to the leaflets of the natural valve to repair the patient's natural valve. The delivery device 601 can take any suitable form capable of delivering the valve repair device 602 to the patient's natural valve. In certain embodiments, the valve repair system 600 is configured to deliver the valve repair device 602 to the patient's natural valve during a non-open heart procedure. A suitable delivery device for percutaneously delivering the valve repair system 600 in a minimally invasive procedure can be a delivery sleeve or a delivery catheter, which can be inserted through a small incision in the patient's skin and, for example, advanced to the implantation site along an intravascular (e.g., transfemoral) path or a transapical path.

[0096] The valve repair device 602 includes a base assembly 604, a pair of paddles 606, and a pair of clamping members 608. In an exemplary embodiment, the paddle 606 may be formed integrally with the base assembly. For example, the paddle 606 may be formed as an extension of the links of the base assembly. In the illustrated example, the base assembly 604 of the valve repair device 602 has an axis 603, a coupler 605 configured to move along the axis, and a locking member 607 configured to lock the coupler in a fixed position on the axis. The coupler 605 is mechanically connected to the paddle 606 so that the movement of the coupler 605 along the axis 603 moves the paddle between an open position and a closed position. In this way, the coupler 605 acts as a device for mechanically coupling the paddle 606 to the axis 603 and moving the paddle 606 between its open position and a closed position when moving along the axis 603. In certain embodiments, the clamping member 608 is pivotally connected to the base assembly 604 (e.g., the clamping member 608 can be pivotally connected to the shaft 603, or any other suitable member of the base assembly) so that the clamping member can be moved to adjust the width of the opening 614 between the paddle 606 and the clamping member 608. The clamping member 608 can include a barbed portion 609 for attaching the clamping member to the valve tissue when the valve repair device 602 is attached to the valve tissue. The clamping member 608 forms a device for clamping the valve tissue (particularly the tissue of the valve leaflets) using a sticking device or portion such as the barbed portion 609. When the paddle 606 is in the closed position, the paddle engages the clamping member 608 so that when the valve tissue is attached to the barbed portion 609 of the clamping member, the paddle acts as a holding or fixing device that holds the valve tissue on the clamping member and fixes the valve repair device 602 to the valve tissue. In some embodiments, clamping member 608 is configured to engage paddle 606 such that barbed portion 609 engages the valve tissue member and paddle 608 to secure valve repair device 602 to the valve tissue member. For example, in some cases, it may be advantageous to maintain paddle 606 in an open position and move clamping member 608 outward toward paddle 606 to engage the valve tissue member and paddle 606.

[0097] although Figure 6-13BThe illustrated embodiment illustrates a pair of paddles 606 and a pair of clamping members 608, but it should be understood that the valve repair device 602 may include any suitable number of paddles and clamping members. In certain embodiments, the valve repair system 600 includes a placement shaft 613 that is removably attached to the shaft 603 of the base assembly 604 of the valve repair device 602. After the valve repair device 602 is secured to the valve tissue, the placement shaft 613 is removed from the shaft 603 to remove the valve repair device 602 from the rest of the valve repair system 600, so that the valve repair device 602 can remain attached to the valve tissue, and the delivery device 601 can be removed from the patient's body.

[0098] The valve repair system 600 may also include a paddle control mechanism 610, a clamp control mechanism 611, and a lock control mechanism 612. The paddle control mechanism 610 is mechanically attached to the connector 605 to move the connector along the axis, which moves the paddle 606 between the open position and the closed position. The paddle control mechanism 610 can take any suitable form, such as, for example, a shaft or a rod. For example, the paddle control mechanism may include a hollow shaft, a catheter, or a sleeve that fits over the placement shaft 613 and the shaft 603 and is connected to the connector 605. The clamp control mechanism 611 is configured to move the clamping member 608 so that the width of the opening 614 between the clamping member and the paddle 606 can be changed. The clamp control mechanism 611 can take any suitable form, such as, for example, a wire, a suture or wire, a rod, a catheter, etc.

[0099] The lock control mechanism 612 is configured to lock and unlock the lock. The lock 607 acts as a locking device for locking the connector 605 in a fixed position relative to the shaft 603 and can take a wide variety of different forms, and the type of lock control mechanism 612 can depend on the type of lock used. In one embodiment, the lock 607 takes the form of a lock commonly used in caulking guns. That is, the lock 607 includes a pivotable plate having a hole, wherein the shaft 603 of the valve repair device 602 is arranged in the hole of the pivotable plate. In this embodiment, when the pivotable plate is in an inclined position, the pivotable plate engages the shaft 603 to maintain its position on the shaft 603, but when the pivotable plate is in a substantially non-inclined position, the pivotable plate can be moved along the shaft (which allows the connector 605 to move along the shaft 603). In other words, when the pivotable plate of the lock 607 is in the inclined (or locked) position, the connector 605 is prevented from moving along the shaft 603 in the direction Y (such as Fig. 10A) is moved, while the coupler is allowed to move along axis 603 in direction Y when the pivotable plate is in a substantially non-tilted (or unlocked) position. In embodiments where the lock 607 includes a pivotable plate, the lock control mechanism 612 is configured to engage the pivotable plate to move the plate between a tilted position and a substantially non-tilted position. The lock control mechanism 612 can be, for example, a rod, a suture, a wire, or any other member capable of moving the pivotable plate of the lock 607 between a tilted position and a substantially non-tilted position. In certain embodiments, the pivotable plate of the lock 607 is biased to a tilted (or locked) position, and the lock control mechanism 612 is used to move the plate from the tilted position to a substantially non-tilted (or unlocked) position. In other embodiments, the pivotable plate of the lock 607 is biased to a substantially non-tilted (or unlocked) position, and the lock control mechanism 612 is used to move the plate from a substantially non-tilted position to a tilted (or locked) position.

[0100] Figures 10A-10B Example from the open position (such as Fig. 10A ) moves to a closed position (as shown in Fig. 10B 602 of a valve repair device (shown in FIG. 604). The base assembly 604 includes a first link 1021 extending from point A to point B, a second link 1022 extending from point A to point C, a third link 1023 extending from point B to point D, a fourth link 1024 extending from point C to point E, and a fifth link 1025 extending from point D to point E. The coupler 605 is movably attached to the shaft 603, and the shaft 603 is fixed to the fifth link 1025. The first link 1021 and the second link 1022 are pivotally attached to the coupler 605 at point A, so that movement of the coupler 605 along the shaft 603 moves the position of point A, and thus moves the first link 1021 and the second link 1022. The first link 1021 and the third link 1023 are pivotally attached to each other at point B, and the second link 1022 and the fourth link 1024 are pivotally attached to each other at point C. One paddle 606a is attached to the first link 1021 so that movement of the first link 1021 moves the paddle 606a, and the other paddle 606b is attached to the second link 1022 so that movement of the second link 1022 moves the paddle 606b. Alternatively, the paddles 606a, 606b may be connected to the links 1023, 1024 or may be extensions of the links 1023, 1024.

[0101] To move the valve repair device from an open position (eg Fig. 10A ) moves to a closed position (as shown in Fig. 10B), the connector 605 is moved in the direction Y along the axis 603, which moves the pivot point A of the first link 1021 and the second link 1022 to a new position. The movement of the connector 605 (and the pivot point A) in the direction Y causes the portion of the first link 1021 near point A to move in the direction H, and the portion of the first link 1021 near point B to move in the direction J. The paddle 606a is attached to the first link 1021 so that the movement of the connector 605 in the direction Y causes the paddle 606a to move in the direction Z. In addition, the third link 1023 is pivotally attached to the first link 1021 at point B so that the movement of the connector 605 in the direction Y causes the third link 1023 to move in the direction K. Similarly, movement of the coupler 605 (and pivot point A) in direction Y causes the portion of the second link 1022 near point A to move in direction L, while the portion of the second link 1022 near point C moves in direction M. The paddle 606b is attached to the second link 1022 such that movement of the coupler 605 in direction Y causes the paddle 606b to move in direction V. Additionally, the fourth link 1024 is pivotally attached to the second link 1022 at point C such that movement of the coupler 605 in direction Y causes the fourth link 1024 to move in direction N. Fig. 10B The example of the connector 605 is as follows Fig. 10A The final position of valve repair device 602 after movement is shown in FIG.

[0102] refer to Figure 7 , valve repair device 602 is shown in an open position (similar to Fig. 10A ), and the clamp control mechanism 611 is shown moving the clamping member 608 to provide a wider gap at the opening 614 between the clamping member and the paddle 606. In the illustrated embodiment, the clamp control mechanism 611 includes a thread, such as a suture, wire, etc., threaded through the opening in the end of the clamping member 608. Both ends of the thread extend through the delivery opening 716 of the delivery device 601. When the thread is pulled through the delivery opening 716 in the direction Y, the clamping member 608 moves inward in the direction X, which causes the opening 614 between the clamping member and the paddle 606 to become wider.

[0103] refer to Figure 8 , the valve repair device 602 is shown such that the valve tissue 820 is disposed in the opening 614 between the clamping member 608 and the paddle 606. Fig. 9, after arranging valve tissue 820 between clamping member 608 and paddle 606, clamp control mechanism 611 is used to reduce the width of opening 614 between clamping member and paddle. That is, in the illustrated embodiment, the wire of clamp control mechanism 611 is released or pushed out from opening 716 of delivery member in direction H, which allows clamping member 608 to move in direction D to reduce the width of opening 614. Although clamp control mechanism 611 is shown moving clamping member 608 to increase the width of opening 614 between clamping member and paddle 606 ( Figure 8 ), but it should be understood that the clamping member may not have to move to position the valve tissue in the opening 614. However, in some cases, the opening 614 between the paddle 606 and the clamping member 608 may need to be wider in order to receive the valve tissue.

[0104] refer to Fig.11 , the valve repair device 602 is in a closed position and fixed to the valve tissue 820. The valve repair device 602 is fixed to the valve tissue 820 by the paddles 606a, 606b and the clamping members 608a, 608b. Specifically, the valve tissue 820 is attached to the valve repair device 602 by the barbed portion 609 of the clamping members 608a, 608b, and the paddles 606a, 606b engage the clamping members 608 to fix the valve repair device 602 to the valve tissue 820. In order to move the valve repair device 602 from the open position to the closed position, the lock 607 is moved to the unlocked state (such as the unlocked state) by the lock control mechanism 612. Fig.11 ). Once locking member 607 is in the unlocked state, coupler 605 can be moved along shaft 603 by paddle control mechanism 610. In the illustrated embodiment, paddle control mechanism 610 moves coupler 605 along shaft in direction Y, which moves one paddle 606a in direction X and the other paddle 606b in direction Z. Movement of paddles 606a, 606b in directions X and Z causes the paddles to engage clamping members 608a, 608b and secure valve repair device 602 to valve tissue 820.

[0105] refer to Fig.12 After moving paddle 606 to a closed position to secure valve repair device 602 to valve tissue 820 (eg, Fig.11 ), through the locking member control mechanism 611 ( Fig.11 ) moves the locking member 607 to the locked state to maintain the valve repair device 602 in the closed position. After the valve repair device 602 is maintained in the locked state by the locking member 607, the shaft 603 is moved to the placement shaft 613 ( Fig.11) to remove the valve repair device 602 from the delivery device 601. In addition, the valve repair device 602 is separated from the paddle control mechanism 610 ( Fig.11 )、Clamp control mechanism 611( Fig.11 ) and the lock control mechanism 612 are disengaged. Removing the valve repair device 602 from the delivery device 601 allows the valve repair device to remain secured to the valve tissue 820 when the delivery device 601 is removed from the patient.

[0106] refer to Figures 13A-13B , shows a patient's mitral valve 1300 with a valve repair device 602 attached to the anterior leaflet 1301 and the posterior leaflet 1302 of the mitral valve. Figures 13A-13B 13 is a view of the atrial side of the mitral valve 1300, wherein a portion of the valve repair device 602 and mitral leaflet tissue captured on the ventricular side of the mitral valve are depicted in dashed lines. Figure 1 ), blood collected in the left atrium of the heart enters the mitral valve 1300 through the expansion of the left ventricle of the heart. The anterior leaflet 1301 and the posterior leaflet 1302 open to allow blood to travel from the left atrium to the left ventricle. During systole (as shown in FIG. Figure 2 ), the left ventricle contracts to force blood through the aortic valve and the ascending aorta and into the body. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back into the left atrium LA. As described above, when the anterior leaflet 1301 and the posterior leaflet 1302 are not completely closed so that a gap exists between the anterior leaflet and the posterior leaflet, blood backflow from the left ventricle to the left atrium through the mitral valve occurs. In order to repair the mitral valve 1300 to prevent blood from flowing back through the mitral valve, a valve repair device 602 is connected to the anterior leaflet 1301 and the posterior leaflet 1302 to close the gap.

[0107] refer to Fig.13A , from the left atrium of the patient's heart (e.g., from Figure 5 The mitral valve 1300 is shown in the perspective indicated by line AA in FIG. 1 . In the illustrated embodiment, the mitral valve 1300 is shown in an open position (i.e., the position of the mitral valve during diastole). The valve repair device 602 is attached to the anterior leaflet 1301 and the posterior leaflet 1302 of the mitral valve 1300 in the left ventricle of the patient's heart, and Figures 13A-13B The dotted line is shown in FIG. 1 to indicate the position of the valve repair device relative to the mitral valve. Figures 13A-13BAs shown in , the valve repair device 602 engages the anterior leaflet 1301 and the posterior leaflet 1302 and causes the anterior leaflet and the posterior leaflet to engage with each other (i.e., the valve repair device closes a portion of the gap between the anterior leaflet and the posterior leaflet). The valve repair device 602 can be placed in a position where there is a gap between the anterior leaflet 1301 and the posterior leaflet 1302 when the mitral valve 1301 is in a closed position (i.e., the position of the mitral valve during systole), so that the valve repair device will prevent the gap from occurring. The illustrated embodiment shows the mitral valve 1300 and the valve repair device 602 during diastole. That is, during diastole, the valve repair device 602 will keep a portion of the mitral valve closed, but the portion of the mitral valve not engaged by the valve repair device will open, so that a gap 1303 is created to allow blood to flow from the left atrium to the left ventricle.

[0108] refer to Fig. 13B , the valve repair device 602 is attached to both the anterior leaflet 1301 and the posterior leaflet 1302. Specifically, a portion 1301a of the anterior leaflet 1301 is fixed between a paddle 606a and a clamping member 608a of the valve repair device 602, and a portion 1302b of the posterior leaflet 1302 is fixed between another paddle 606b and another clamping member 608b of the valve repair device. For example, Figure 6-12 As shown in , valve repair device 602 is secured and locked to mitral valve 1300.

[0109] Figures 14A-14B An exemplary embodiment of a valve repair device 602 is illustrated as being attached to the anterior leaflet 1301 and the posterior leaflet 1302 of a mitral valve 1300. Figure 5 The mitral valve 1300 is shown in FIG. 1300 from the perspective indicated by line AA in FIG. Figures 14A-14B , the valve repair device 602 includes a first paddle 606a, a second paddle 606b, a first clamping member 608a and a second clamping member 608b. A portion 1301a of the front leaflet 1301 is fixed between the first paddle 606a and the first clamping member 608a of the valve repair device 602, and a portion 1302b of the rear leaflet 1302 is fixed between the second paddle 606b and the second clamping member 608b of the valve repair device. The first paddle 606a and the second paddle 606b include a main portion 1404 and side portions 1405. Fig.14A, the valve repair device 602 is configured so that the portions 1301a, 1302b of the mitral valve 1300 match or substantially match the shape of the paddles 606a, 606b. That is, the valve leaflet portions 1301a, 1302b are pressed into the paddles by the clamping members 608a, 608b so that the valve leaflet portions 1301a, 1301b are arranged along the main portion 1404 and the side portion 1405 of the paddles 606a, 606b. Fig.14A In the embodiment of the valve repair device 602 shown in FIG. 6 , the paddles 606a , 606b may be made of a rigid material, such as steel, molded plastic, or the like.

[0110] exist Fig. 14B In the illustrated exemplary embodiment, the paddles 606a, 606b of the valve repair device 602 are configured to flex. Due to this flexure, when the valve repair device is attached to the mitral valve 1300, the mitral valve tissue portions 1301a, 1302b cause the side portions 1405 of the paddles to move as indicated by arrows 1450, which is consistent with the Fig.14A Compared to the illustrated embodiment, the stress placed on the mitral valve by the valve repair device is reduced. That is, the flexure causes the paddle to more gradually contour to the mitral valve tissue while still firmly attaching the valve repair device 602 to the mitral valve tissue. Fig. 14B In the embodiment of valve repair device 602 shown in FIG. 6 , paddles 606a , 606b may be made from a variety of different flexible materials or a rigid material that is cut or otherwise processed to provide flexibility.

[0111] Figures 15A-15B Another exemplary embodiment of a valve repair device 602 is illustrated. Fig.15A , the valve repair device 602 is in an open position and is about to engage the valve tissue 820 (eg, the leaflets of the mitral valve). Fig. 15B , the valve repair device 602 is in a closed position and secured to the valve tissue 820. The valve repair device 602 can take any suitable form, for example, any form described in the present application. The valve repair device 602 can be moved between an open position and a closed position and can be attached to the valve tissue 820 by a valve repair system, such as, for example, any valve repair system described in the present application. In the illustrated embodiment, the valve repair device 602 includes a paddle 606 and a clamping member 608. The clamping member 608 includes a barbed portion 609 for attaching the clamping member to the valve tissue 820. Reference Fig.15A , when valve repair device 602 is in the open position, paddle 606 maintains its original form. Fig. 15B, upon engagement with valve tissue 820, paddle 606 flexes along its length L. That is, a portion of paddle 606 flexes in an inward direction X, while another portion of the paddle extends in an outward direction Z. This flexing of paddle 606 allows the paddle to conform to the shape of the valve tissue, which places less stress on the valve tissue.

[0112] refer to Figures 16A-16F , another exemplary embodiment of the valve repair device 602 includes a paddle 606 having a wire loop 1601. The wire loop 1601 can be made of, for example, any suitable metal material, a laser cut ring of a nitinol sheet, a nitinol tube, or any other suitable material. In some embodiments, the wire loop 1601 can have varying sizes throughout the length of the wire loop 1601 to optimize the paddle pinch force and the paddle crimp force on the valve tissue when the paddle engages the valve tissue. For example, certain sections of the wire loop 1601 can be thinner than other sections of the wire loop 1601. In some embodiments, the wire loop 1601 of the paddle 606 is compressible, which allows the paddle 606 to be arranged in a delivery device 601 (e.g., a catheter) with a small diameter (e.g., a catheter). Fig.16E ), for delivering the valve repair device 602 to the patient's native valve, and also allowing the paddle 606 to expand after leaving the delivery device 601 (as shown in Figures 16A-16D ), so that paddle 606 has a larger surface area for engaging the patient's native valve. Valve repair device 602 can take any suitable form, such as, for example, any form described in this application. Valve repair device 602 can be moved between an open position and a closed position by a valve repair system, such as, for example, any valve repair system described in this application, and can be attached to a native valve.

[0113] Figures 16A-16B illustrates a valve repair device 602 in an open position, Figures 16C-16D The valve repair device is illustrated in a closed position. Figures 16A-16B When valve repair device 602 is in the expanded and open position, paddle 606 extends outward to create a wide opening 614 between paddle 606 and clamping member 608 of valve repair device 602. Figures 16C-16D, when the valve repair device 602 is in an expanded and closed position, the paddle 606 engages the clamping member 608 so that the valve tissue can be fixed between the paddle and the clamping member. The paddle 606 includes a curved surface 1603, which is configured to place less stress on the valve tissue when the valve repair device 602 is attached to the valve tissue. When the paddle 606 is in an expanded state, the paddle has a width W. The width W can be, for example, between about 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In some embodiments, the width W can be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, the width W can be less than 5 mm. In some embodiments, paddle 606 includes material 1605 disposed on loop 1601 to create a contact area for the paddle to engage valve tissue. Material 1605 can be any suitable material, such as, for example, a braided material, an electrospun material, or a material that can promote tissue ingrowth and protect delivery device 601 during tracking. Figure 6 ) lining. In some embodiments, material 1605 can be blood-impermeable cloth (such as PET cloth or biocompatible covering material, such as fabric treated with a blood-impermeable coating), polyester, or processed biomaterial (such as pericardium).

[0114] refer to Fig.16E , when the paddle is arranged in the delivery device 601, the paddle 606 is in a compressed state. When the paddle 606 is in the compressed state, the paddle has a width H. The width H can be, for example, between about 4 mm and about 7 mm, such as, between about 5 mm and about 6 mm. In optional embodiments, the width H can be less than 4 mm or greater than 7 mm. In certain embodiments, the width H of the compressed paddle 606 is substantially equal to the width D of the delivery opening 716 of the delivery device 601. The ratio between the width W of the paddle in the expanded state and the width H of the paddle in the compressed state can be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In optional embodiments, the ratio between the width W and the width H may be greater than 4 to 1. Reference Fig.16F , paddle 606 is moved from an expanded state to a compressed state by compressing the paddle in direction Y and extending the length of the paddle in direction X.

[0115] Figures 16G-16HAnother exemplary embodiment of a valve repair device 602 is illustrated in an open position, wherein the valve repair device includes a paddle 606 having a wire loop 1601. In the illustrated embodiment, the paddle 606 is shown having a wire loop 1601 including three lobes 1611. Figures 16I-16J Another exemplary embodiment of a valve repair device 602 includes a paddle 606 having a wire loop 1601 having two lobes 1611. Figures 16G-16H The embodiments shown in FIGS. 16I-16J show a wire ring 1601 with a paddle 606 having three lobes and two lobes, respectively, but it should be understood that the valve repair device 602 may include a paddle 606 with a wire ring 1601 having any suitable number of lobes 1611, such as, for example, two or more lobes, three or more lobes, four or more lobes, five or more lobes, etc. A paddle 606 having a wire ring 1601 with lobes is advantageous because a paddle with lobes allows the chordae tendineae to assume their natural position more easily than a single wire ring without lobes. That is, the chordae tendineae can move into the space between the multiple rings.

[0116] Figures 16G-16H The embodiments of the valve repair device 602 shown in Figures 16I-16J may include the above reference Figures 16A-16F Any features described. For example, Figures 16G-16H The embodiments of the valve repair device 602 shown in 16I-16J may include a width W, wherein the width W may be, for example, between about 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In some embodiments, the width W may be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, the width W may be less than 5 mm. Figures 16G-16H The embodiments of the paddle 606 shown in Figures 16I-16J may also include a material disposed on the wire loop 1601 to create a contact area for the paddle to engage the valve tissue. The material may be any suitable material, such as, for example, a braided material, an electrospun material, or a material that promotes tissue ingrowth and protects the delivery device 601 during tracking. Figure 6 ) lining. In some embodiments, material 1605 can be blood-impermeable cloth (such as PET cloth or biocompatible covering material, such as fabric treated with a blood-impermeable coating), polyester, or processed biomaterial (such as pericardium). Figures 16G-16H and Figures 16I-16JThe embodiment of the paddle 606 shown in FIG. 606 may also be compressed when deployed in the delivery device 601 (e.g., as in FIG. Fig.16E About Figures 16A-16B ). The ratio between the width W of paddle 606 in the expanded state and the width of paddle 606 in the compressed state can be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In alternative embodiments, the ratio between width W and width H can be greater than 4 to 1.

[0117] refer to Figures 17A-17F Another exemplary embodiment of a valve repair device 602 includes a paddle 606 having a horseshoe shape 1701. In some embodiments, the horseshoe shape 1701 of the paddle 606 is compressible, which allows the paddle 606 to be arranged in a delivery device 601 (e.g., a catheter) with a small diameter (e.g., Fig.17F ), for delivering the valve repair device 602 to the patient's native valve, and also allowing the paddle 606 to expand after leaving the delivery device 601 (as shown in Figures 17A-17D ), so that paddle 606 has a larger surface area for engaging the patient's native valve. Valve repair device 602 can take any suitable form, such as, for example, any form described in this application. Valve repair device 602 can be moved between an open position and a closed position by a valve repair system, such as, for example, any valve repair system described in this application, and can be attached to a native valve.

[0118] Figures 17A-17C The valve repair device 602 is illustrated in an open position. Figures 17A-17B When the valve repair device 602 is in the expanded and open position, the paddle 606 extends outward to create a wide opening 614 between the paddle 606 and the clamping member 608 of the valve repair device 602. In the illustrated embodiment, the horseshoe shape 1701 of the paddle 606 includes side members 1707 extending from the base 1706 of the paddle 606, and a center member 1709 extending from the base 1706 and connected to the base assembly 604 of the valve repair device 602, wherein the side members 1707 are formed as shown. Fig. 17C In some embodiments, paddle 606 includes material 1705 disposed on horseshoe shape 1701 to create a contact area for the paddle to engage valve tissue. Material 1705 can be any suitable material, such as, for example, a woven material, an electrospun material, or a material that can promote tissue ingrowth and protect delivery device 601 during tracking. Figure 6) lining. In some embodiments, material 1605 can be blood-impermeable cloth (such as PET cloth or biocompatible covering material, such as fabric treated with a blood-impermeable coating), polyester, or processed biomaterial (such as pericardium).

[0119] In various embodiments, paddle 606 is configured to flex when valve repair device 602 is attached to valve tissue, thereby placing less stress on the valve tissue. When paddle 606 is in an expanded state, paddle 606 has a width W. Width W can be, for example, between about 4 mm and about 21 mm, such as between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In certain embodiments, width W can be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, width W can be less than 5 mm. Reference Fig.17D In some embodiments, the thickness T of the paddle is, for example, between about 0.3 mm and about 0.46 mm, such as between about 0.32 mm and about 0.44 mm, such as between about 0.34 mm and about 0.42 mm, such as between about 0.36 mm and about 0.40 mm, such as about 0.38 mm. In alternative embodiments, the thickness T of the paddle can be less than 0.3 mm or greater than 0.46 mm.

[0120] refer to Fig.17E , when the paddle is arranged in the delivery device 601, the paddle 606 is in a compressed state. When the paddle 606 is in the compressed state, the paddle has a width H. The width H can be, for example, between about 4 mm and about 7 mm, such as, between about 5 mm and about 6 mm. In optional embodiments, the width H can be less than 4 mm or greater than 7 mm. In certain embodiments, the width H of the compressed paddle 606 is equal to the width D of the delivery opening 716 of the delivery device 601. The ratio between the width W of the paddle in the expanded state and the width H of the paddle in the compressed state can be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In optional embodiments, the ratio between the width W and the width H can be greater than 4 to 1. Reference Fig.17F , paddle 606 is moved from an expanded state to a compressed state by compressing the paddle in direction Y and extending the length of the paddle in direction X. In the illustrated embodiment, when paddle is in the compressed state, the length of side members 1707 of paddle 606 is extended, but the length of center member 1709 remains the same length.

[0121] refer to Figures 18A-18DAnother exemplary embodiment of the valve repair device 602 includes a paddle 606 having another horseshoe shape 1801. In some embodiments, the horseshoe shape 1801 of the paddle 606 is compressible, which allows the paddle 606 to be arranged in a delivery device 601 (e.g., a catheter) with a small diameter (e.g., Fig.18C ), for delivering the valve repair device 602 to the patient's native valve, and also allowing the paddle 606 to expand after leaving the delivery device 601 (as shown in Figures 18A-18B ), so that paddle 606 has a larger surface area for engaging the patient's native valve. Valve repair device 602 can take any suitable form, such as, for example, any form described in this application. Valve repair device 602 can be moved between an open position and a closed position and attached to a native valve by a valve repair system, such as, for example, any valve repair system described in this application.

[0122] Figures 18A-18B The valve repair device 602 is illustrated in an open position. When the valve repair device 602 is in the open position, the paddle 606 extends outward to create a wide opening 614 between the paddle 606 and the clamping member 608 of the valve repair device 602. In the illustrated embodiment, the horseshoe shape 1801 of the paddle 606 includes side members 1807 extending from the base 1806 of the paddle 606, and the base 1806 is attached to the base assembly 604 of the valve repair device 602. In some embodiments, the paddle 606 includes a material 1805 arranged on the horseshoe shape 1801 to create a contact area for the paddle to engage the valve tissue. The material 1805 can be any suitable material, such as, for example, a braided material, an electrospun material, or a material that can promote tissue ingrowth and protect the delivery device 601 ( during tracking). Figure 6 ) lining. In some embodiments, material 1605 can be blood-impermeable cloth (such as PET cloth or biocompatible covering material, such as fabric treated with a blood-impermeable coating), polyester, or processed biomaterial (such as pericardium).

[0123] In various embodiments, paddle 606 is configured to flex when valve repair device 602 is attached to valve tissue, thereby placing less stress on the valve tissue. When paddle 606 is in an expanded state, paddle has a width W. Width W can be, for example, between about 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In certain embodiments, width W can be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, width W can be less than 5 mm.

[0124] refer to Fig.18C , when the paddle is arranged in the delivery device 601, the paddle 606 is in a compressed state. When the paddle 606 is in the compressed state, the paddle has a width H. The width H can be, for example, between about 4 mm and about 7 mm, such as, between about 5 mm and about 6 mm. In optional embodiments, the width H can be less than 4 mm or greater than 7 mm. In certain embodiments, the width H of the compressed paddle 606 is equal to the width D of the delivery opening 716 of the delivery device 601. The ratio between the width W of the paddle in the expanded state and the width H of the paddle in the compressed state can be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In optional embodiments, the ratio between the width W and the width H can be greater than 4 to 1. Reference Fig.18D , paddle 606 is moved from an expanded state to a compressed state by compressing the paddle in direction Y and extending the length of the paddle in direction X. In the illustrated embodiment, the length of side members 1807 of paddle 606 is extended when the paddle is in the compressed state. Fig.18C In certain embodiments, when the paddle 606 is disposed in the delivery device 601 and in a compressed state, the side members 1807 of the paddle cross over one another.

[0125] refer to Figures 19A-19D Another exemplary embodiment of the valve repair device 602 includes a paddle 606 having a mesh structure 1901. In some embodiments, the mesh structure 1901 of the paddle 606 is compressible, which allows the paddle 606 to be arranged in a delivery device 601 (e.g., a catheter) with a small diameter (e.g., Fig.19C ), for delivering the valve repair device 602 to the patient's native valve, and also allowing the paddle 606 to expand after leaving the delivery device 601 (as shown in Figures 19A-19B), so that paddle 606 has a larger surface area to engage the patient's native valve. Valve repair device 602 can take any suitable form, such as, for example, any form described in this application. Valve repair device 602 can be moved between an open position and a closed position by a valve repair system, such as, for example, any valve repair system described in this application, and can be attached to a native valve.

[0126] Figures 19A-19B The valve repair device 602 is illustrated in an open position. When the valve repair device 602 is in the expanded and open position, the paddle 606 extends outward to create a wide opening 614 between the paddle 606 and the clamping member 608 of the valve repair device 602. In some embodiments, the paddle 606 includes a material disposed on the mesh structure 1901, such as, for example, a woven material, an electrospun material, or a material that can promote tissue ingrowth and protect the delivery device 601 during tracking. Figure 6 ) lining. In some embodiments, material 1605 can be blood-impermeable cloth (such as PET cloth or biocompatible covering material, such as fabric treated with a blood-impermeable coating), polyester, or processed biomaterial (such as pericardium).

[0127] In various embodiments, paddle 606 is configured to flex when valve repair device 602 is attached to valve tissue, thereby placing less stress on the valve tissue. When paddle 606 is in an expanded state, paddle has a width W. Width W can be, for example, between about 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In certain embodiments, width W can be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, width W can be less than 5 mm.

[0128] refer to Fig.19C, when the paddle is arranged in the delivery device 601, the paddle 606 is in a compressed state. When the paddle 606 is in the compressed state, the paddle has a width H. The width H can be, for example, between about 4 mm and about 7 mm, such as, between about 5 mm and about 6 mm. In optional embodiments, the width H can be less than 4 mm or greater than 7 mm. In certain embodiments, the width H of the compressed paddle 606 is equal to the width D of the delivery opening 716 of the delivery device 601. The ratio between the width W of the paddle in the expanded state and the width H of the paddle in the compressed state can be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In optional embodiments, the ratio between the width W and the width H can be greater than 4 to 1. Reference Fig.19D , paddle 606 is moved from an expanded state to a compressed state by compressing the paddle in direction Y and extending the length of the paddle in direction X.

[0129] refer to Figures 20A-20B Another exemplary embodiment of a valve repair device includes a compressible paddle 606, which allows the paddle 606 to be deployed in a delivery device 601 (eg, a catheter) with a small diameter (eg, Fig. 20A ) for delivering the valve repair device to the patient's native valve and also allowing the paddle 606 to expand after leaving the delivery device 601 (as shown in Fig. 20B ), so that paddle 606 has a larger surface area for engaging the patient's native valve. Paddle 606 can be included on valve repair device 602 in any suitable form, such as, for example, any of the forms described in this application. The valve repair device (and paddle 606) can be attached to the native valve by a valve repair system, such as, for example, any of the valve repair systems described in this application.

[0130] Fig. 20A Paddle 606 is illustrated in a compressed state within delivery device 601. Paddle includes opening 2001 that allows a portion of the paddle to expand after deployment from delivery device 601. In the compressed state, the width H of paddle 606 can be, for example, between about 4 mm and about 7 mm, such as between about 5 mm and about 6 mm. In alternative embodiments, width H can be less than 4 mm or greater than 7 mm. In certain embodiments, the width H of compressed paddle 606 is equal to the width D of delivery opening 716 of delivery device 601. Fig. 20BThe paddle 606 in an expanded state is illustrated. In the expanded state, the paddle 606, for example, may have a width W between about 4 mm and about 21 mm, such as between about 5 mm and about 20 mm, such as between about 7.5 mm and about 17.5 mm, such as between about 10 mm and about 15 mm. In certain embodiments, the width W may be, for example, 5 mm or more, such as about 7.5 mm or more, such as about 10 mm or more, such as about 15 mm or more, such as about 20 mm or more. In other embodiments, the width W may be less than 5 mm. The ratio between the width W of the paddle in the expanded state and the width H of the paddle in the compressed state may be, for example, about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. In optional embodiments, the ratio between the width W and the width H may be greater than 4 to 1. Reference Fig. 20B , paddle 606 is moved from an expanded state to a compressed state by compressing the paddle in direction Y. In various embodiments, paddle 606 is configured to flex when valve repair device 602 is attached to valve tissue, thereby placing less stress on the valve tissue. In some embodiments, paddle 606 includes a material disposed on paddle 606, such as, for example, to promote tissue ingrowth and protect delivery device 601 ( Figure 6 ) lining. In certain embodiments, the material can be blood-impermeable cloth (such as PET cloth or biocompatible covering material, such as fabric treated with a blood-impermeable coating), polyester, or processed biomaterial (such as pericardium).

[0131] Figures 21A-21B Another exemplary embodiment of a valve repair system 600 is illustrated, wherein the valve repair system 600 includes a valve repair device 602 having an expandable paddle. The valve repair system 600 can take any suitable form, such as, for example, any of the forms described in the present application. In the illustrated embodiment, the valve repair device 602 includes a telescoping paddle 606 so that the length L of the paddle can be changed. That is, the paddle 606 includes a main portion 2110 and an extendable portion 2112. The extendable portion 2112 can be accommodated within the main portion 2110 to produce a paddle having a shorter length L (e.g., Fig.21A ), and the extendable portion 2112 can extend beyond the main portion to create a paddle having a longer length L (as shown in Fig.21B The shorter length L (as shown in Fig.21A ) and a longer length L (as shown in Fig.21B) can be, for example, 1.25 to 1 or greater, such as 1.5 to 1 or greater, such as 2 to 1 or greater, such as 2 to 1 or greater, such as 4 to 1 or greater, such as 5 to 1 or greater.

[0132] In one embodiment, the main portion 2110 is a hollow conduit having an opening, and the extendable portion 2112 is a rod or conduit configured to be received in the opening of the hollow member. In certain embodiments, the extendable portion 2112 is spring loaded so that the extendable portion 2112 is biased toward the extended position, and the latch member is arranged in the locked position, thereby maintaining the extendable portion 2112 contained in the main portion 2110 in a non-extended position. The movement of the latch member from the locked position to the unlocked position causes the spring loaded extendable portion 2112 to move out of the main portion 2110 and into the extended position. In addition, the extendable portion 2112 can move back within the main portion 2110, and the latch member can move from the unlocked position to the locked position, thereby moving the paddle from the extended position to the retracted position. The latch member can be moved between the locked position and the unlocked position by any suitable means (such as, for example, a rod that engages the latch member to move the latch member between the locked position and the unlocked position). In an alternative embodiment, a suture or wire extends through the main portion 2110 and engages the extendable portion 2112 to maintain the extendable portion 2112 in a non-extended position, while removal of the suture or wire allows the spring-loaded extendable portion to move out of the main portion 2110 and into the extended position.

[0133] refer to Fig.21A , shows valve repair device 602 with paddle 606 in a non-extended position and the valve repair device positioned to engage valve tissue 820. Fig.21BAfter the valve repair device 602 is placed in the appropriate position to engage the valve tissue 820, the extendable portion 2112 of the paddle 606 is extended so that the paddle has a larger surface area for engaging the valve tissue. After the paddle 606 is extended to the desired length L, the valve repair device 602 is closed to secure the valve repair device to the valve tissue 820, and the valve repair device is removed from the valve repair system 600. In some embodiments, the valve repair device 602 is configured so that after the valve repair device is secured to the valve tissue 820, the extendable portion 2112 of the paddle can be extended or retracted so that the tension on the valve tissue can be increased or decreased, depending on the patient and the procedural circumstances. For example, in an embodiment where the valve tissue 820 is the patient's mitral valve, a valve with excess leaflet material or damaged chordae tendineae may require greater tension to adequately seal the mitral valve, or a valve with short, non-engaged leaflets may require less tension to adequately seal the mitral valve. The valve repair device may be moved from the open position to the closed position and removed from the valve repair system 600 in any suitable manner, such as, for example, any of the manners described herein.

[0134] refer to Figure 22-26 In some embodiments, clamp control mechanism 611 is configured to control each of clamp members 608 independently of one another. Independent control of each of clamp members 608 is advantageous because when valve repair device 602 is attached to valve tissue (e.g., a patient's mitral valve), opening 614 between paddle 606 and the clamp members can be independently adjusted. Additionally, independent clamp control would also be advantageous in situations where one of clamp members 608 and paddle 606 adequately secures valve repair device 602 to a first portion of valve tissue, but another clamp member and another paddle do not connect the valve repair device to a second portion of valve tissue. In this case, the clamp control mechanism 611 can be used to control only the clamping member 608 that is not connected to the valve tissue to create an opening 614 for receiving the second portion of the valve tissue, and after the second portion of the valve tissue is arranged in the opening, the unattached clamping member and the unattached paddle can be closed to secure the valve repair device 602 to the second portion of the valve tissue.

[0135] Still refer to Figure 22-26, an exemplary embodiment of a valve repair system 600 includes a delivery device 601 and a valve repair device 602, wherein the delivery device is configured to deliver the valve repair device to a patient's native valve, and wherein the valve repair device is configured to attach to a leaflet of a native valve to repair the patient's native valve. The delivery device 601 can take any suitable form capable of delivering the valve repair device 602 to a patient's native valve, such as, for example, any form described in the present application. The valve repair device 602 is similar to the valve repair device previously described, and includes a base assembly 604, a pair of paddles 606, and a pair of clamping members 608. The base assembly 604 of the valve repair device 602 has a shaft 603, a connector 605 configured to move along the shaft, and a locking member 607 configured to lock the connector in a fixed position on the shaft. The valve repair device 602 can take any suitable form, such as, for example, any form described in the present application. The valve repair system 600 may also include a paddle control mechanism 610, a clamp control mechanism 611, and a lock control mechanism 612. The paddle control mechanism 610 is mechanically attached to the connector 605 to move the connector along the axis 603, which moves the paddle 606 between an open position and a closed position. The paddle control mechanism 610 may take any suitable form, such as, for example, any form described in this application. The lock control mechanism 612 is configured to move the connector 605 between a locked state and an unlocked state. The lock control mechanism 612 may take any suitable form, such as, for example, any form described in this application.

[0136] refer to Fig. 22 , an exemplary embodiment of the clamp control mechanism 611 includes a first clamp control member 2202 and a second clamp control member 2204. The first clamp control member 2202 is configured to move the clamp member 608a in a direction X, while the second clamp control member 2204 is configured to move the clamp member 608b in a direction Z. Movement of the clamp member 608a in the direction X will adjust the width W of the opening 614a between the clamp member 608a and the paddle 606a, while movement of the clamp member 608b in the direction Z will adjust the width H of the opening between the clamp member 608b and the paddle 606b. The clamp control members 2202, 2204 may take any suitable form that is capable of independently moving the clamp members 608a, 608b. In the illustrated embodiment, the clamp control members 2202, 2204 are wires, such as sutures, wires, etc., which are removably attached to each of the clamp members 608a, 608b, respectively, with both ends of the wire extending through the delivery opening 716 of the delivery device 601. The clamp control members 2202, 2204 can be independently pulled into the catheter and cast from the catheter to independently control the position of the clamp members 608a, 608b.

[0137] refer to Figures 22A-22D , shows another exemplary embodiment of a valve repair system 600, wherein another embodiment of a clamp control mechanism 611 is used to control the clamping members 608a-d of another exemplary embodiment of a valve repair device 602. For illustration purposes, Figures 22A-22D The paddle 606 of the valve repair device 602 is not shown, but it should be noted that the valve repair device 602 also includes a paddle 606 that interacts with the clamping members 608a-d to secure the valve repair device 602 to the valve tissue, and the paddle 606 can take any suitable form, such as, for example, any form described in the present application. Fig.22A The valve repair system 600 is illustrated in which each of the four clamping members 608a-d is in a first position and Fig. 22C The valve repair system 600 is illustrated wherein one of the clamping members 608a is moved to a second position. Fig. 22B is a top view of the valve repair system 600 (eg Fig.22A 22B-22B in FIG. 2 ), wherein each of the clamping members 608a-d is arranged in a first position. Fig.22D is a cross-sectional view of the valve repair system 600 (eg Fig. 22C ), wherein the clamping member 608a is arranged in the second position. Each of the four clamping members can be independently moved in the same manner as exemplified by the clamping member 608a.

[0138] The valve repair device 602 includes a first clamping member 608a, a second clamping member 608b, a third clamping member 608c, and a fourth clamping member 608d. Each of the clamping members 608a-d includes a barb portion 609a-d for fixing the clamping members 608a-d to the valve tissue. The clamp control mechanism 611 includes a first clamp control member 2202a configured to control the first clamp member 608a, a second clamp control member 2202b configured to control the second clamp member 608b, a third clamp control member 2202c configured to control the third clamp member 608c, and a fourth clamp control member 2202d configured to control the fourth clamp member 608d. Specifically, the first clamp control member 2202a is configured to move the clamp member 608a in the direction X, while the second clamp control member 2202b is configured to move the second clamp member 608b in the direction X. In addition, the third clamp control member 2202c is configured to move the clamp member 608c in the direction Z, while the fourth clamp control member 2202d is configured to move the fourth clamp member 608d in the direction Z. Movement of the clamp members 608a-b in the direction X will adjust the width of the opening between the clamp members 608a-b and the corresponding paddle 606, while movement of the clamp members 608c-d in the direction Z will adjust the width of the opening between the clamp members 608c-d and the corresponding paddle. The clamp control mechanism 611 is configured to move each of the clamp members 608a-d independently of each other. The clamp control members 2202a-d may take any suitable form that is capable of independently moving the clamp members 608a-d. In the illustrated embodiment, the clamp control members 2202a-d are wires, such as sutures, wires, etc., which are removably attached to each of the clamp members 608a-d, respectively, with both ends of the wire extending through the delivery opening 716 of the delivery device 601. The clamp control members 2202a-d can be independently pulled into and released from the catheter, thereby independently controlling the position of the clamp members 608a-d.

[0139] refer to Fig.22A and 22B , each of the clamping members 608a-d is shown in an expanded position. Fig. 22C and 22D , showing the first clamping member 608a, after the first clamping control member 2202a of the clamping control mechanism is pulled into the catheter, the first clamping member 608a is moved inwardly toward the axis 603 in the direction X, while the other clamping members 608b-d are still in Fig.22A and 22B In other words, Figures 22A-22DThe illustrated embodiment shown in FIG. 6 shows a first clamping member 608a being independently controlled relative to the other clamping members 608b-d. Although the illustrated embodiment shows the first clamping member 608a being independently controlled, it should be understood that each of the clamping members 608a-d can be independently controlled by a corresponding clamping member 2202a-d of the clamping control mechanism 611. In addition, although Figures 22A-22D The illustrated embodiment of the embodiment illustrates a valve repair assembly 600 having four clamping members 608a-d and four clamp control members 2202a-d, but it should be understood that any suitable number of clamping members and clamp control members can be used, and any number of clamping members can be independently controlled by the clamp control mechanism. In addition, each of the clamping members 608a-608d can have any configuration disclosed in the present application, and each of the control mechanisms 2202a-2202d can have any form disclosed in the present application.

[0140] refer to Fig.23 , another exemplary embodiment of the clamp control mechanism 611 includes a single line 2302, such as a suture or wire, which is removably attached to the clamping members 608a, 608b and removably secured between the placement axis 613 and the 603 axis of the valve repair device. The connection 615 between the placement axis 613 and the 603 axis of the valve repair device can be in a variety of different positions. In the illustrated example, the connection 615 is aligned or substantially aligned with the ends of the clamping members 608a, 608b. However, in other embodiments, the connection 615 can be more distal, such as at the most proximal position that the connector 605 can reach (see, for example Fig.45C and 46D606a). A single wire 2302 is connected between shaft 613 and shaft 603 so that the single wire 2302 can independently control clamping members 608a, 608b. That is, movement of a first portion 2303 of wire 2302 in direction Y will adjust the width W between clamping member 608a and paddle 606a, but will not adjust the width H between clamping member 608b and paddle 606b. Similarly, movement of a second portion 2305 of wire 2302 in direction M will adjust the width H between clamping member 608b and paddle 606b, but will not adjust the width W between clamping member 608a and paddle 606a. After valve repair device 602 is in a closed position and secured to valve tissue, shaft 613 is placed and separated from shaft 603 of valve repair device 602. Separation of shaft 603 from shaft 613 releases the wire. The wire 2302 can then be retracted into the catheter by pulling one end of the wire 2302 into the catheter to release the clamping members 608a, 608b. Pulling one end of the wire into the catheter pulls the other end of the wire through the clamping members 608a, 608b and then into the catheter. Any wire described herein can be retracted in this manner.

[0141] refer to Fig.24 In some embodiments, the placement shaft 613 and the shaft 603 of the device 602 can be a hollow fitting on the coupling shaft 2400 that holds the shafts 613, 603 together. The shaft 603 of the device 602 can include a protruding portion 2406 and a recessed receiving portion 2408. The positioning shaft 613 can include a protruding portion 2407 and a recessed receiving portion 2409. When the shafts 613, 603 are coupled, the protruding portion 2406 of the shaft 603 is disposed in the receiving portion 2409 of the shaft 613, and the protruding portion 2407 of the shaft 613 is disposed in the receiving portion 2408 of the shaft 603. The shafts 613, 603 can be connected in a variety of different ways. For example, the shaft 613 can include a hole or channel 2411, and when the protruding portions 2406, 2407 are disposed in the receiving portions 2408, 2409, respectively, the hole or channel 2411 is aligned with the hole or channel 2413 of the shaft 602. When the openings 2411, 2413 are aligned and the retaining shaft 2400 is placed into the openings 2411, 2413 in the direction X, the shafts 613, 603 are held together. When the placement shaft is removed from the openings 2411, 2413 in the direction Z, the protrusions 2406, 2407 can be removed from the receiving portions 2408, 2409, so that the device 602 is separated from the placement shaft 613.

[0142] Still refer to Fig.24, when the shafts 613, 603 are fixed to each other, a hole 2415 is created at the interface 2417 between the shafts 613, 603. The hole 2415 is configured to fix the wire 2302 between the shafts 613, 603, thereby allowing independent control of the clamping members 608a, 608b. That is, the hole 2415 is configured so that when the shafts 613, 603 are attached, the wire 2302 does not move relative to the hole 2416. After the shafts 613, 603 are separated, the wire 2302 is released from the hole 2415 and can be removed from the valve repair device 602. The wire 2302 can then be retracted into the catheter as described above to release the clamping member.

[0143] refer to Fig.23 and 24A -24B, in an alternative embodiment, the wire 2302 of the clamp control mechanism 610 is fixed between the placement shaft 613 and the shaft 603 through a threaded connection, thereby independently controlling the clamp members 608a, 608b. Fig.24A , the placement shaft 613 includes an external thread member 2419, and the shaft 603 includes an internal thread member 2421 configured to receive the external thread member 2419 of the placement shaft 613. However, the external thread and the internal thread can be reversed. The placement shaft 613 is fixed to the shaft 603 by inserting the external thread member 2419 into the internal thread member 2421 of the shaft 603. The wire 2302 of the clamp control mechanism 611 is arranged between the placement shaft 613 and the shaft 603, so that when the placement shaft 613 is fixed to the shaft 603, the wire 2302 is compressed (as shown in the figure mark M) between the placement shaft 613 and the shaft 603. When the wire 2302 controls the clamping members 608a, 608b, the compression M of the wire 2302 between the placement shaft 613 and the shaft 603 does not move the wire 2302 relative to the placement shaft 613, the joint 2423 between the shaft 603 and the wire 2302. Thus, the compression M and resulting retention of the wire 2302 allows the wire 2302 to independently control the clamping members 608a, 608b.

[0144] refer to Fig.25, another exemplary embodiment of the clamp control mechanism 611 includes a first clamp control member 2502 and a second clamp control member 2504. The first clamp control member 2502 is configured to bi-directionally move the clamp member 608a in the direction X, and the second clamp control member 2504 is configured to bi-directionally move the clamp member 608b in the direction Z. Movement of the clamp member 608a in the direction X will adjust the width W of the opening 614a between the clamp member 608a and the paddle 606a, while movement of the clamp member 608b in the direction Z will adjust the width H of the opening between the clamp member 608b and the paddle 606b. In the illustrated embodiment, the clamp control members 2202, 2204 include push / pull links 2503, 2505, such as, for example, a catheter, a flexible rod, or a rigid wire, and couplers 2506, 2507. Each push / pull link 2503, 2505 extends from the delivery device 601 and is removably attached to a corresponding clamping member 608a, 608b via connectors 2506, 2507. Link 2503 is configured to push and pull in direction Y. Movement of link 2503 in direction Y causes clamping member 608a to move in direction X. Similarly, link 2505 is configured to push and pull in direction M, and movement of catheter 2505 in direction M causes catheter 2505 to move clamping member 608b in direction H.

[0145] Fig.25A Another embodiment of the clamp control mechanism 611 is shown in FIG. In this embodiment, the clamp control members 2202, 2204 include sutures 2511, 2513 and flexible wires 2503, 2505. In this embodiment, the first flexible wire 2503 includes a loop 2517 for receiving the first suture 2511 and for engaging the clamping member 608a ( Fig.25 ), and the second flexible wire 2505 includes a loop 2519 for receiving the second suture 2513 and for engaging the clamping member 608b ( Fig.25 ). Sutures 2517, 2519 are removably attached to each of the clamping members 608a, 608b, respectively, with both ends of the lines extending through the delivery device 601 as described above. Each of the wires 2503, 2505 extends from the delivery device 601, and the loops 2517, 2519 of the respective wires 2503, 2505 are movable along the corresponding sutures 2511, 2513 so that the loops 2517, 2519 can engage the corresponding clamping elements 608a, 608b, thereby moving the clamping members (e.g., as described with respect to Fig.25Wires 2503, 2505 may be made of, for example, steel, nickel-titanium alloy, or other wires, or plastic materials. In certain embodiments, the diameter of wires 2503, 2505 may be between about 0.1 mm and 0.35 mm, such as between about 0.15 mm and 0.3 mm, such as between about 0.2 mm and 0.25 mm.

[0146] refer to Fig.26 , another exemplary embodiment of a clamp control mechanism 611 includes a first conduit 2603, a second conduit 2605, and a single wire 2604, such as a wire or suture. The first conduit 2603 and wire 2604 are configured to move the clamping member 608a in a direction X, while the second conduit 2605 and wire 2604 are configured to move the clamping member 608b in a direction Z. Movement of the clamping member 608a in the direction X will adjust the width W of the opening 614a between the clamping member 608a and the paddle 606a, while movement of the clamping member 608b in the direction Z will adjust the width H of the opening between the clamping member 608b and the paddle 606b. The wire 2604 extends from the delivery device 601 through the conduits 2603, 2605, and through the openings in both the clamping members 608a, 608b. Each conduit 2603, 2605 is configured to engage and move a corresponding clamping member 608a, 608b. Specifically, conduit 2603 is configured to be pushed in direction Y when wire 2604 is paid out of conduit 2603 or tension in the wire is reduced. Conduit 2603 is configured to be pulled in direction Y when wire 2604 is pulled into conduit 2603 or tension in the wire is increased. Movement of conduit 2603 in direction Y causes conduit 2603 to move clamping member 608a in direction X. Similarly, conduit 2605 is configured to be pushed in direction M when wire 2604 is paid out of conduit 2605 or tension in the wire is reduced. Conduit 2605 is configured to be pulled in direction M when wire 2604 is pulled into conduit 2605 or tension in the wire is increased. Movement of the catheter 2505 in the direction M causes the catheter 2505 to move the clamping member 608b in the direction H. In an alternative embodiment, the above reference Fig.26 The described clamp control mechanism 611 may include a first flexible wire having a loop (e.g., Fig.25A ) and a second flexible wire having a loop (e.g., Fig.25A 2505 having a hoop 2519 as shown in FIG, and a single wire 2604 extends through the hoop 2517, 2519 of each of the wires 2503.

[0147] refer to Figures 27A-29BIn some embodiments, valve repair device 602 and paddle control mechanism 610 for valve repair device 602 are configured so that each of paddles 606 can be controlled independently of each other. Independent control of each of paddles 606 is advantageous because when valve repair device 602 is attached to valve tissue (e.g., a patient's mitral valve), opening 614 between paddles and clamping member 608 can be independently adjusted. Additionally, independent paddle control would also be advantageous in situations where one of clamping members 608 and one of paddles 606 adequately secure valve repair device 602 to a first portion of valve tissue, but another clamping member and another of paddles do not connect the valve repair device to a second portion of valve tissue. In this case, the paddle control mechanism 610 can be used to control only the paddle 606 that is not connected to the valve tissue to create an opening 614 for receiving the second portion of the valve tissue, and after the second portion of the valve tissue is arranged in the opening, the unattached clamping member and the unattached paddle can be closed to secure the valve repair device 602 to the second portion of the valve tissue.

[0148] refer to Figures 27A-27C , the base assembly 604 of the valve repair device 602 includes a first shaft 603a, a second shaft 603b, a first coupler 605a and a second coupler 605b. In addition, the paddle control mechanism 610 includes a first paddle control mechanism 2702 and a second paddle control mechanism 2704. The first paddle control mechanism 2702 is configured to move the first coupler 605a along the shaft 603a, and the second paddle control mechanism 2704 is configured to move the second coupler 605b along the shaft 603b. The movement of the first coupler 605a along the shaft 603a moves the paddle 606a between the open position and the closed position, and the movement of the second coupler 605b along the shaft 603b moves the paddle 606b between the open position and the closed position. In an optional embodiment, the base assembly 604 may include a single shaft, a first coupler 605a attached to the single shaft, and a second coupler 605b attached to the single shaft. In this optional embodiment, the paddle control mechanism 610 may include a first paddle control mechanism 2702 configured to move the first connector 605a along a single axis to move the paddle 606a between an open position and a closed position, and a second paddle control mechanism 2704 configured to move the second connector 605b along a single axis to move the paddle 606b between an open position and a closed position.

[0149] Figures 27A-27CThe paddle of the valve repair device that moves between an open position and a closed position is illustrated. The base assembly 604 of the valve repair device 602 includes a first link 2721 extending from point A to point B, a second link 2722 extending from point B to point C, a third link 2723 extending from point C to point D, a fourth link 2724 extending from point D to point E, and a fifth link 2725 extending from point E to point F. The coupler 605a is movably attached to the shaft 603a, the coupler 605b is movably attached to the shaft 603b, and the shafts 603a, 603b are fixed to the third link 2723. The first link 2721 is pivotally attached to the coupler 605a at point A, so that movement of the coupler 605a along the shaft 603a moves the position of point A, and thus moves the first link 2721. Similarly, the fifth link 2725 is pivotally attached to the coupler 605b at point F, such that movement of the coupler 605b along the axis 603b moves the position of point F and, therefore, moves the fifth link 2725. The first link 2721 and the second link 2722 are pivotally attached to each other at point B, while the fifth link 2725 and the fourth link 2724 are pivotally attached to each other at point E. One paddle 606a is attached to the first link 2721, such that movement of the first link 2721 moves the paddle 606a, while the other paddle 606b is attached to the fifth link 2725, such that movement of the fifth link 2725 moves the paddle 606b.

[0150] refer to Fig.27A , paddles 606a, 606b are in the open position. Fig.27A and 27B When the second paddle control mechanism 2704 moves the second coupler 605b along the axis 603b in the direction Y, which moves the portion of the fifth link 2725 near point F in the direction H and moves the portion of the fifth link 2725 near point E in the direction J, the paddle 606b moves from the open position (eg, Fig.27A ) moves to a closed position (as shown in Fig.27B ). Paddle 606b is attached to fifth link 2725 such that movement of second coupler 605b in direction Y moves paddle 606b in direction Z. Additionally, fourth link 2724 is pivotally attached to fifth link 2725 at point E such that movement of second coupler 605b in direction Y moves fourth link 2724 in direction K. Fig.27B, paddle 606b moves in direction Q when moving from the open position to the closed position. In an alternative embodiment where the pivot connection at point E between fourth link 2724 and fifth link 2725 is significantly lower than the pivot connection at point F between fifth link 2725 and second coupler 605b, when closing paddle 606b, movement of paddle 606b from the open position to the closed position will be as follows: Fig.27A , except that fourth link 2724 will initially move in a direction substantially opposite to direction K. In any of the above embodiments, second paddle control mechanism 2704 may take any suitable form for moving second coupler 605b along axis 603b, such as, for example, any of the forms of paddle control mechanisms described herein.

[0151] refer to Fig.27A and 27C When the first paddle control mechanism 2702 moves the first coupler 605a along the axis 603a in the direction N, which moves the portion of the first link 2721 near point A in the direction L and moves the portion of the first link 2721 near point B in the direction I, the paddle 606a moves from the open position (such as Fig.27A ) moves to a closed position (as shown in Fig.27C ). Paddle 606a is attached to first link 2721 such that movement of first coupler 605a in direction N moves paddle 606a in direction V. Additionally, second link 2722 is pivotally attached to first link 2721 at point B such that movement of first coupler 605a in direction N moves second link 2722 in direction R. Fig.27C , paddle 606a moves in direction T when moving from the open position to the closed position. In an alternative embodiment where the pivot connection at point B between first link 2721 and second link 2722 is significantly lower than the pivot connection at point A between first link 2721 and first coupler 605a, when closing paddle 606b, movement of paddle 606a from the open position to the closed position will be as follows: Fig.27A , except that second link 2722 will initially move in a direction substantially opposite to direction R. In any of the above embodiments, first paddle control mechanism 2702 may take any suitable form for moving first coupler 605a along axis 603a, such as, for example, any of the forms of paddle control mechanisms described herein.

[0152] refer to Figures 28A-28CIn some embodiments, the paddle control mechanism 610 includes a rack-and-pinion mechanism 2802 configured to selectively couple and decouple the paddles 606a, 606b to the shaft 603. The rack-and-pinion mechanism 2802 includes a first member 2804 attached to the shaft 603 and a toothed member 2806a, 2806b attached to each of the paddles 606a, 606b and pivotally connected to the base member 2801 at connection points A, B. The first member 2804 is configured so that the paddles 606a, 606b can move independently of each other between an open position and a closed position. In the illustrated embodiment, the first member 2804 has a ribbed portion 2805 and an opening portion 2807. When the toothed members 2806a, 2806b(s) are aligned with the rib portion 2805 of the first member 2804, the toothed members 2806a, 2806b(s) are configured to engage the rib portion 2805 such that movement of the shaft in the direction Y relative to the base member 2801 causes the toothed member 2806a to pivot about the connection point A in the direction M, thereby moving the paddle 606a in the direction H between the open position and the closed position, and causes the toothed member 2806b to pivot about the connection point B in the direction N, thereby moving the paddle 606b in the direction Z between the open position and the closed position. When the opening portion 2807 of the first member 2804 is aligned with either of the toothed members 2806a or 2806b, the toothed member aligned with the opening portion 2807 is not engaged by the rib portion 2805 of the paddle 606a or 606b. Thus, movement of shaft 603 in direction Y does not affect the position of paddles 606a or 606b.

[0153] Figures 28A-28B The corkscrew mechanism 2802 is illustrated in a first position. In the first position, the toothed members 2806a, 2806b of both paddles 606a, 606b are aligned with the rib portion 2805 of the first member 2804. Fig.28A When the shaft 603 is moved in the direction Y, both toothed members 2806a, 2806b engage the rib portion 2805 of the first member, which moves both paddles 606a, 606b between the open position and the closed position. Figures 28C-28D The spiral mechanism 2802 is illustrated in a second position. In the second position, the toothed member 2806a is aligned with the open portion 2807 of the first member 2804, and the toothed member 2806b is aligned with the rib portion 2806 of the first member 2804. Fig.28CWhen the shaft 603 is moved in the direction Y, the toothed member 2806b engages with the rib portion 2805 of the first member 2804, which causes the paddle 606b to move between the open position and the closed position, while the toothed member 2806a does not engage with the first member, which causes the paddle 606a to remain in the current position. Figures 28E-28F The spiral mechanism 2802 is illustrated in a third position. In the third position, the toothed member 2806b is aligned with the opening portion 2807 of the first member 2804, and the toothed member 2806a is aligned with the rib portion 2806 of the first member 2804. Fig.28E When the shaft 603 is moved in the direction Y, the toothed member 2806a engages the rib portion 2805 of the first member 2804, which moves the paddle 606a between the open position and the closed position, while the toothed member 2806b does not engage the first member, which keeps the paddle 606b in the current position. In some embodiments, by rotating the shaft 603, the rack-and-pinion mechanism 2802 is rotated. Figures 28A-28F In various embodiments, rack-and-pinion mechanism 2802 includes a mechanism that is configured to maintain paddles 606a, 606b in a desired position when the paddles are aligned with open portion 2807 of first member 2804, but is also configured to allow the paddles to move when the paddles are aligned with rib portion 2805 of first member 2804. The mechanism can take any suitable form, such as, for example, a clutch mechanism, a biasing member, a friction element, etc.

[0154] refer to Figures 29A-29B , the paddle control mechanism 610 is configured to move the coupling 605 along the axis 603, thereby moving the paddles 606a, 606b between an open position and a closed position (similar to Figure 6-12 ), and the locking mechanism 207 is configured to lock the coupling 605 to the shaft 603, thereby maintaining the paddles 606a, 606b in the desired position. In certain embodiments, such as Figures 29A-29BAs shown in FIG. 6 , each of the paddles 606a, 606b includes a pin 2902a, 2902b and a slot 2904a, 2904b. The pin 2902a is configured to move in the slot 2904a, while the pin 2902b is configured to move in the slot 2904b. The pins 2902a, 2902b are also configured to lock in the slots 2904a, 2904b. When the pins 2902a, 2902b are unlocked in the slots 2904a, 2904b, the corresponding paddles 606a, 606b remain in the current position when the paddle control mechanism 610 moves the coupling 605 along the shaft 603. When pins 2902a, 2902b are locked in slots 2904a, 2904b, corresponding paddles 606a, 606b move between open and closed positions when paddle control mechanism 610 moves coupler 605 along shaft 603.

[0155] Fig.29A Valve repair device 602 is illustrated with paddles 606a, 606b in an open position. Fig.29B Valve repair device 602 is illustrated with pin 2902a unlocked in slot 2904a and pin 2902b locked in slot 2904b. Fig.29B , locking member 607 is in an unlocked state, allowing coupler 605 to move along axis 603. Movement of coupler 605 along axis 603 in direction Y causes paddle 606b to pivot about locked pin 2902b, causing paddle 606b to move in direction Z to a closed position. Additionally, because pin 2902a is in an unlocked state in slot 2904a, movement of coupler 605 in direction Y does not cause paddle 606a to move. Instead, movement of coupler 605 in direction Y causes pin 2902a to move in slot 2904a. Alternatively, pin 2902a may be locked in slot 2904a, while pin 2902b may be unlocked in slot 2904b, such that movement of coupler 605 in direction Y will cause paddle 606a to move to a closed position, while leaving paddle 606b still in an open position (by pin 2902b moving in slot 2904b). Additionally, pin 2902a may be locked in slot 2904a, and pin 2902b may be locked in slot 2904b, such that movement of coupler 605 in direction Y will move both paddles 606a, 606b to the closed position. Pins 2902a, 2902b may be locked in slots 2904a, 2904b by any suitable means, such as, for example, any of the means described herein with respect to lock 607.

[0156] refer to Fig.30In some cases, the patient's mitral valve 3001 may have a wide gap 3002 between the anterior leaflet 3003 and the posterior leaflet 3004 when the mitral valve is in a closed position (i.e., during systole). For example, the gap 3002 may have a width W between about 2.5 mm and about 17.5 mm, such as between about 5 mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm, such as about 10 mm. In some cases, the gap 3002 may have a width W greater than 15 mm. In any of the above situations, a valve repair device is desired that is capable of engaging the anterior leaflet 3003 and the posterior leaflet 3004 to close the gap 3002 and prevent blood from flowing back through the mitral valve 3001.

[0157] Figures 31A-37D A wide gap 3002 ( Fig.30 ) Various embodiments of the closed valve repair device 602. Figures 31A-31B , an exemplary embodiment of the valve repair device 602 includes a paddle 606 and a clamping member 608. In addition, the valve repair device 602 may include any other components for the valve repair devices discussed in this application, and the valve repair device 602 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application) may be positioned to engage valve tissue 820. Reference Fig.31A , the paddle 606 of the valve repair device 602 is pivoted outward in the direction X to create an opening 614 having a width W between the paddle 606 and the clamping member 608. The width W can be, for example, between about 5 mm and about 15 mm, such as between 7.5 mm and about 12.5 mm, such as about 10 mm. In alternative embodiments, the width W can be less than 5 mm or greater than 15 mm. Fig.31B, the paddle 606 of the valve repair device 602 is moved outward in the direction Z so that the opening 614 has a width H. The width H can be, for example, between about 10 mm and about 25 mm, such as between about 10 mm and about 20 mm, such as between about 12.5 mm and about 17.5 mm, such as about 15 mm. In alternative 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 about 5 to 1 or less, such as about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1 or less, such as about 1.25 to 1 or less, such as about 1 to 1. The valve repair device 602 can be configured so that the paddle 606 is pivoted outward in the direction X and then moved outward in the direction Z, thereby creating an opening 614 having a width H between the paddle 606 and the clamping member 608. Alternatively, valve repair device 602 may be configured such that paddle 606 is moved outward in direction Z and then pivoted outward in direction X, thereby creating width H between paddle 606 and clamping member 608. Additionally, valve repair device 602 may be configured such that paddle 606 is pivoted outward in direction X and simultaneously moved outward in direction Z, thereby creating width H between paddle 606 and clamping member 608.

[0158] Figures 32A-32C Valve repair device 602 is illustrated with paddles 606 pivoting outward in direction X and then moving outward in direction Z to create a wider opening 614 . Fig.32A Valve repair device 602 is illustrated in a closed position such that paddle 606 engages clamping member 608. Fig.32B , causing the paddle 606 to pivot outwardly in the direction X to create an opening 614 having a width W for receiving valve tissue. Fig.32C After pivoting paddle 606 outward in direction X, paddle 606 is moved outward in direction Z so that opening 614 has width H. After valve tissue is received in opening 614 between paddle 606 and clamping member 608, valve repair device 602 is moved back to the closed position (eg, Fig.32A ) to secure valve repair device 602 to valve tissue. Valve repair device 602 may include any other components for valve repair devices discussed in this application, and valve repair device 602 may be positioned to engage valve tissue 820 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0159] Figures 33A-33C Valve repair device 602 is illustrated wherein paddles 606 move outward in direction Z and then pivot outward in direction X to create a wider opening 614 . Fig.33AValve repair device 602 is illustrated in a closed position such that paddle 606 and clamping member 608 are engaged. Fig.33B , causing the paddle 606 to move outward in the direction Z to create an opening 614 having a width W for receiving valve tissue. Fig.33C After moving paddle 606 outward in direction Z, paddle 606 is pivoted outward in direction X so that opening 614 has a width H. After valve tissue is received in opening 614 between paddle 606 and clamping member 608, the valve repair device is moved back to the closed position (eg, Fig.33A ) to secure valve repair device 602 to valve tissue. Valve repair device 602 may include any other components for valve repair devices discussed in this application, and valve repair device 602 may be positioned to engage valve tissue 820 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0160] although Figures 32A-32C illustrates a valve repair device 602 in which paddles 606 are pivoted and then spread apart, and Figures 33A-33C The valve repair device 602 is illustrated as one in which the paddle 606 is extended and then pivoted, but in an alternative embodiment, the valve repair device 602 may include a paddle 606 that can be extended and pivoted at the same time. In addition, in some embodiments, the paddle 606 can be extended and pivoted independently of each other. Figures 32A-32C 33A-33C and in embodiments where the extension and pivoting of each paddle 606 are performed simultaneously, the paddles 606 may be controlled independently of one another.

[0161] refer to Figures 34A-34B , is configured so that a wide gap 3002 ( Fig.30 ) Another exemplary embodiment of a valve repair device 602 with a closed valve includes a W-shaped mechanism. Specifically, the valve repair device 602 includes a connector 605 configured to move along an axis 603 and a paddle 606 pivotally attached to the connector 605. The paddle 606 includes an inner link 3402 and an outer link 3404. The inner link 3402 of each paddle 606 is pivotally attached to the connector 605, and the outer link 3404 of each paddle 606 is pivotally attached to the corresponding inner link 3402. Fig.34A , the valve repair device 602 is shown in a closed position. Fig.34B, movement of the coupler 605 in the direction Y causes the inner link 3402 of the paddle 606 to extend in the outward direction X. In the illustrated example, the inner link 3402 engages the cam member 3403, which forces the inner link 3402 to open in the direction X. Although the illustrated embodiment shows the valve repair device 602 with generally linear links 3402, 3404 that create a W-shaped mechanism, it should be understood that the links 3402, 3404 may be of a variety of configurations that allow the valve repair device 602 to be as flexible as possible. Figures 34A-34B In embodiments where the links 3402, 3404 are nonlinear (e.g., curved), the valve repair device may not have a W-shaped mechanism, however, the valve repair device may include a similar connection portion so that the valve repair device will function as shown in FIG. Figures 34A-34B Functions as shown in .

[0162] The outer link 3404 may be moved in the direction Z to the illustrated more open position in a variety of different ways. For example, the outer link may be moved using any of the clasp control arrangements described herein. Figure 22-26 3404. In one embodiment, the outer link 3404 may be controlled by any of the buckling control devices shown in FIG. 3404 and / or any of the paddle control devices described herein. Figures 34C-34D , link 3411 is attached to the pivot connection between inner link 3402 and coupler 605 and to the pivot connection between inner link 3402 and outer link 3404, so that movement of coupler 605 in direction Y causes first end 3413 of link 3411 to rotate in direction M through pivot connection 3475, which causes second end 3415 of link 3411 to rotate in direction N through pivot connection 3477. Rotation of second end 3415 of link 3411 in direction N causes outer link 3404 to move in direction Z to the open position.

[0163] For illustration purposes, Figures 34C-34D The embodiment shown in shows a link 3411 for one of the paddles 606, however, it should be understood that the other link 3411 interacts with the other paddle in the same manner as described above to move the outer link 3404 of the other paddle in the direction Z to the open position. In an alternative embodiment, a four-bar linkage may be used to move the paddle 606 to the open position. In another alternative embodiment, a suture may be removably attached to the outer link 3404 of the paddle 606, and the suture may be controlled to move the outer link 3404 of the paddle 606 in the direction Z to the open position.

[0164] In some embodiments, valve repair device 602 includes a biasing member 3410 (eg, a spring) that attaches inner links 3402 of paddle 606 to each other. Biasing member 3410 maintains inner links 3402 in a closed position (eg, Fig.34A and 34C ), until the inner link 3402 engages the cam member 3403 (as shown in Fig.34B and 34D ). Valve repair device 602 may include any of the other components for valve repair devices discussed herein, and valve repair device 602 may be positioned to engage valve tissue 820 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0165] refer to Figures 35A-35B , is configured so that a wide gap 3002 ( Fig.30 ) Another exemplary embodiment of a closed valve repair device 602 includes a W-shaped mechanism. Specifically, the valve repair device 602 includes a connector 605 configured to move along an axis 603 and a paddle 606 pivotally attached to the axis and the connector 605. The lower end 3501 of each paddle 606 of the valve repair device 602 is pivotally connected to the axis at point A. Each of the paddles 606 includes an intermediate member 3502 that pivotally attaches the paddle to the connector 605 at a pivot point B. Fig.35A , the valve repair device 602 is shown in a closed position. Fig.35B , movement of coupler 605 in direction Y pivots intermediate member 3502 of paddle 606 such that lower end 3503 of intermediate member 3502 extends in outward direction X, which moves paddle 606 to an open position in direction Z. Valve repair device 602 may include any of the other components for valve repair devices discussed herein, and valve repair device 602 may be positioned to engage valve tissue 820 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0166] refer to Figures 36A-36B , is configured so that a wide gap 3002 ( Fig.30)Another exemplary embodiment of a valve repair device 602 that is closed includes a W-shaped mechanism. Specifically, the valve repair device 602 includes a paddle 606, and the paddle 606 has a linkage mechanism 3602, which pivotally attaches the paddle 606 to the shaft 603 of the valve repair device 602. The linkage mechanism 3602 includes an inner link 3603 and an outer link 3605. The inner link 3603 is pivotally attached to the shaft 603 and pivotally attached to the outer link 3605. The outer link 3605 is pivotally attached to the inner link 3603 and pivotally attached to the paddle 606. The paddle 606 is also attached to the linkage 3608 of the valve repair device 602. Paddle control mechanism 610 is configured to move the pivot connection at point A between inner link 3603 and outer link 3605 of linkage 3602 in direction Y, which causes paddle 606 to move in an open position (eg, Fig.36B ) and the closed position (as shown in Fig.36A ) between the

[0167] Still refer to Fig.36A and 36B Although the paddle control mechanism is shown attached at pivot connection point A, it should be understood that the paddle control mechanism 610 may be attached to one or more of any of the links of the valve repair device 602. For example, the paddle control mechanism 610 may be coupled to the paddle 606, the link 3605, and / or the link 3603. The paddle control mechanism 610 may take any suitable form, such as, for example, a control wire or any other form described herein. For example, the paddle control device 610 may take Figure 6-8 and any of the clamp control devices shown in 22-26. Valve repair device 602 may include any of the other components for valve repair devices discussed in this application.

[0168] refer to Fig.36C , Fig.36A and 36B The paddle control mechanism 610 of the illustrated embodiment may include a spool 3620 and a wire 3622 (e.g., suture, wire, etc.), and the wire is attached to and wound around the spool. In this embodiment, a force is generated on the wire 3622 in direction Z, causing the spool 3620 to rotate and unwind the wire 3622 from the spool. In this embodiment, the rotation of the spool 3620 causes the paddle control mechanism 610 to move in direction Y and move the valve repair device 602 to an open position (e.g., Fig.36B ).

[0169] refer to Figures 36D-36E , is configured so that a wide gap 3002 ( Fig.30) Another exemplary embodiment of a valve repair device 602 with a closed valve includes a semi-rigid W-shaped mechanism. Specifically, the valve repair device 602 has a linkage mechanism 3602 that flexibly attaches a paddle 606 to the shaft 603 of the valve repair device 602. The linkage mechanism 3602 includes a rigid inner link 3603 and an outer rigid link 3605. The inner rigid link 3603 is flexibly attached to the shaft 603 through a flexible member or flexible portion 3613 and is flexibly attached to the outer rigid link 3605 through a flexible member or flexible portion 3611, while the outer rigid link 3506 is flexibly attached to the paddle 606 through a flexible member or flexible portion 3615. The paddle 606 is also flexibly attached to the link 3608 of the valve repair device 602 through a flexible member or flexible portion 3617. Rigid links 3603, 3605 may be made of, for example, steel or Nitinol. Flexible members 3611, 3613, 3615, 3617 may be made of, for example, Nitinol. Paddle control mechanism 610 is configured to move the pivot connection at point A between inner link 3603 and outer link 3605 of linkage mechanism 3602 in direction Y, which moves paddle 606 in an open position (e.g., Fig.36D ) and the closed position (as shown in Fig.36C ) between the paddle control mechanism 610 and the paddle control mechanism 610. However, the paddle control mechanism 610 may be attached to one or more of any of the links of the valve repair device. For example, the paddle control mechanism 610 may be coupled to the paddle 606, the link 3605, and / or the link 3603. The paddle control mechanism 610 may take any suitable form, such as, for example, a control wire or any other form described in the present application. For example, the paddle control device 610 may take Figure 6-8 and any of the clamp control devices shown in 22-26. Valve repair device 602 may include any of the other components for valve repair devices discussed in this application.

[0170] refer to Figures 37A-37D , is configured so that a wide gap 3002 ( Fig.30 Another exemplary embodiment of a valve repair device 602 with a closed valvular portion includes a wire mesh paddle 606 and an inner cam 3702 configured to push the mesh paddle 606 apart. The inner cam 3702 is rotatably attached to the shaft 603 so that the cam can be in a first position (eg, Figures 37A-37B ) and a second position (as shown in Figures 37C-37D ) between the Fig.37B is along Fig.37A Line BB in exemplifies a top view of the inner cam 3702 in the first position. Fig.37D is along Fig.37CLine DD in exemplifies a top view of the inner cam 3702 in the second position.

[0171] refer to Fig.37A and 37B , when the inner cam 3702 is in the first position, the inner cam does not engage the paddle 606 and the valve repair device is maintained in the closed position. Fig.37C and 37D When the inner cam 3702 is in the second position, the inner cam engages the paddle 606 to move the paddle, thereby moving the paddle to the open position in the outward direction X. By moving the inner cam 3702 from the second position to the first position, the valve repair device 602 is moved from the open position to the closed position.

[0172] In some embodiments, reference Figures 37E-37F , the paddle 606 of the valve repair device may include a flexible member or flexible portion 3711 that biases the paddle to a closed position or an open position. The flexible member or flexible portion 3711 may be configured to flex after being engaged by the cam 3702, thereby allowing the paddle 606 to move to the open position. The flexible member or flexible portion 3711 is also configured to widen the reach of the paddle 606 when the paddle is in the open position. When the paddle is in the open position, any other suitable mechanism may be used to bias the paddle in the closed position and / or widen the reach of the paddle 606, such as, for example, a spring-loaded mechanism. The valve repair device 602 may include any other components for the valve repair devices discussed in the present application, and the valve repair device 602 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application) may be positioned to engage the valve tissue 820. The mesh paddle 606 may be made of any suitable material that can be expanded by the inner cam 3702, such as, for example, nitinol, stainless steel, or any woven or electrospun material.

[0173] refer to Figure 38-39 In some cases, the patient's mitral valve 3001 may have a wide gap 3002 between the anterior leaflet 3003 and the posterior leaflet 3004 when the mitral valve is in a closed position (i.e., during systole). For example, the gap 3002 may have a width W between about 2.5 mm and about 17.5 mm, such as between about 5 mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm, such as about 10 mm. In some cases, the gap 3002 may have a width W greater than 15 mm. In any of the above situations, it is desirable to have a valve repair device that fills sufficient volume to close or fill the gap 3002 without placing a large amount of strain on the leaflets 3003, 3004. For example, the valve repair device may include a spacer element 3800.

[0174] refer to Fig.39 In some embodiments, spacer element 3800 is attached to valve repair device 602 such that when paddle 606 and clamping member 608 secure valve repair device 602 to mitral valve 3001, spacer element 3800 is disposed in gap 3002 between anterior leaflet 3003 and posterior leaflet 3004. Spacer element 3800 can be made of any suitable material, such as, for example, a woven mesh, a fabric, a biocompatible material, a foam, pericardial tissue, any material disclosed herein, etc.

[0175] refer to Figures 40A-40B , an exemplary embodiment of a valve repair device 602 has a spacer element 3800 attached to a shaft 603 of the valve repair device. As illustrated, the spacer element 3800 can extend past an outer edge 4001 of the clamping member 3800 to provide a gap 3002 ( Figure 38-39 ) additional surface area to be closed. In an alternative embodiment, the coupler member 605 can take the form of a spacer element 3800. That is, a single element can be used as the coupler member 605, which moves the paddle 606 between the open position and the closed position, and the spacer element 3800, which closes the gap between the leaflets 3003, 3004 when the valve repair device 602 is attached to the leaflets. The valve repair device 602 can include any of the other components for the valve repair devices discussed in this application, and the valve repair device 602 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application) can be positioned to engage the valve tissue 820.

[0176] refer to Figures 42A-42C , Figures 40A-40B The spacer element 3800 shown in FIG. 3 may take a variety of different shapes. Fig.42A , an exemplary embodiment of the spacer element 3800 includes: a body 4210a extending between the clamping members 608 and passing the edge 4201 of the clamping members; and an extension portion 4212a extending from the body 4210a. When the valve repair device is in the closed position, the extension portion 4212a allows the portion of the gap 3002 of the mitral valve between the anterior leaflet 3003 and the posterior leaflet 3004 and adjacent to the valve repair device 602 ( Figure 38-39) is filled. That is, when the valve repair device 602 is attached to the mitral valve to prevent blood from flowing back through the mitral valve, the portion of the mitral valve proximal to the valve repair device may include an opening from the tissue of the mitral valve extending around the valve repair device. The extension portion 4212a is configured to fill or plug the opening adjacent to the valve repair device 602. In the illustrated embodiment, the length L of the extension portion 4212a is greater than the width W of the extension portion.

[0177] refer to Fig.42B , another exemplary embodiment of the spacer element 3800 includes a body 4210b extending between the clamping members 608 and an extension portion 4212b extending from the body 4210b. In the illustrated embodiment, the extension portion 4212b has a semicircular shape. As the tissue of the mitral valve extends around the valve repair device, the extension portion 4212b is configured to fill the opening adjacent to the valve repair device 602.

[0178] refer to Fig.42C , another exemplary embodiment of the spacer element 3800 includes a main base component 4210c extending between the clamping members 608, a first extension portion 4212c extending from the main body 4210c, and a second extension portion 4214c extending from the first extension portion 4212c. In the illustrated embodiment, the first extension portion 4212c has a semicircular shape, and the length L of the second extension portion 4214c is greater than its width W. As the tissue of the mitral valve extends around the valve repair device, the extension portion 4212b is configured to fill the opening adjacent to the valve repair device 602.

[0179] refer to Figures 41A-41D , another exemplary embodiment of a valve repair device 602 has a spacer element 3800 attached to clamping members 608a, 608b of the valve repair device. The spacer element 3800 includes a first portion 4102 attached to one clamping member 608a and a second portion 4104 attached to the other clamping member 608b. Fig.41C , showing the valve repair device 602 in a closed position. When the valve repair device 602 is in the closed position, the first portion 4102 of the spacer element 3800 and the second portion 4104 of the spacer element 3800 engage with each other and surround the axis 603 (eg, Fig.41B ). Fig.41D, the valve repair device 602 is shown in an open position, with the first portion 4102 of the spacer element 3800 moving with the clamping member 608a, and the second portion 4104 of the spacer element 3800 moving with the clamping member 608b. The spacer element 3800 having multiple portions 4102, 4104 allows the clamping members 608a, 608b to move to adjust the width of the opening between the paddle 606 and the clamping members, which is advantageous in attaching the valve repair device 602 to the valve tissue 820. Fig.41B , the spacer element 3800 extends past the outer edge 4001 of the clamping member 3800 to provide a gap 3002 ( Figure 38-39 ) additional surface area. Valve repair device 602 may include any of the other components for valve repair devices discussed in this application, and valve repair device 602 may be positioned to engage valve tissue 820 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0180] refer to Figures 43A-43C , Figures 41A-41D The spacer element 3800 shown in FIG. 3 can take a variety of different shapes. Fig.43A , an exemplary embodiment of the spacer element 3800 in the closed position includes: a body 4310a extending between the clamping members 608 and passing the edge 4201 of the clamping members; and an extension portion 4312a extending from the body 4310a. When the valve repair device is in the closed position, the extension portion 4312a allows the portion of the gap 3002 of the mitral valve between the anterior leaflet 3003 and the posterior leaflet 3004 and adjacent to the valve repair device 602 ( Figure 38-39 ) is filled. That is, when the valve repair device 602 is attached to the mitral valve to prevent blood from regurgitating through the mitral valve, the portion of the mitral valve proximal to the valve repair device may include an opening from the tissue of the mitral valve extending around the valve repair device. The extension portion 4312a is configured to fill the opening adjacent to the valve repair device 602. In the illustrated embodiment, the length L of the extension portion 4312a is greater than the width W of the extension portion.

[0181] refer to Fig.43B Another exemplary embodiment of the spacer element 3800 in the closed position includes a body 4310b extending between the clamping members 608 and an extension portion 4312b extending from the body 4310b. In the illustrated embodiment, the extension portion 4312b has a semicircular shape. As the tissue of the mitral valve extends around the valve repair device, the extension portion 4312b is configured to fill the opening adjacent to the valve repair device 602.

[0182] refer to Fig.43C , another exemplary embodiment of the spacer element 3800 includes a main base component 4310c extending between the clamping members 608, a first extension portion 4312c extending from the main body 4310c, and a second extension portion 4314c extending from the first extension portion 4312c. In the illustrated embodiment, the first extension portion 4312c has a semicircular shape, and the length L of the second extension portion 4314c is greater than its width W. As the tissue of the mitral valve extends around the valve repair device, the extension portion 4312b is configured to fill the opening adjacent to the valve repair device 602.

[0183] refer to Figures 44A-44B In some embodiments, an expanding spacer element 3800 is integrated with the valve repair device 602. The expanding spacer element 3800 is configured to expand when the paddle 606 is closed (eg, Fig.44B ). Fig.44A , the valve repair device 602 is in an open position so that valve tissue can be received in the opening 614 between the expandable spacer element 3800 and the paddle 606. Fig.44B , the valve repair device 602 is in a closed position, wherein the paddle 606 and the expanded spacer element 3800 engage to secure the valve repair device to the valve tissue. When the spacer element 3800 engages the paddle 606, the spacer element 3800 expands to provide a larger surface area for the gap 3002 (between the anterior leaflet 3003 and the posterior leaflet 3004 of the mitral valve 3001) Fig.38 In the illustrated embodiment, the valve repair device 602 is used Figures 35A-35B 820. However, any valve repair device 602 described in the present application may include an expandable spacer element 3800. The valve repair device 602 may include any other components for the valve repair devices discussed in the present application, and the valve repair device 602 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application) may be positioned to engage valve tissue 820.

[0184] refer to Figures 45A-46D In some cases, the valve repair device 602 needs to be detached from the native valve and removed from the patient. In these cases, it is advantageous to have a valve repair device that can be narrowed and repositioned (to a relief position) so that the valve repair device will be more easily removed from the patient without disturbing any valve tissue of the patient's heart. Figures 45A-45C, the base assembly 604 of the exemplary embodiment of the valve repair device 602 includes a first link 4521 extending from point A to point B, a second link 4522 extending from point A to point C, a third link 4523 extending from point B to point D, a fourth link 4524 extending from point C to point E, and a fifth link 4525 extending from point D to point E. The coupler 605 is movably attached to the shaft 603, and the shaft 603 is fixed to the fifth link 4525. The first link 4521 and the second link 4522 are pivotally attached to the coupler 605 at point A, so that movement of the coupler 605 along the shaft 603 moves the position of point A and thus moves the first link 4521 and the second link 4522. The first link 4521 and the third link 4523 are pivotally attached to each other at point B, and the second link 4522 and the fourth link 4524 are pivotally attached to each other at point C. One paddle 606a is attached to first link 4521 such that movement of first link 4521 moves paddle 606a, and the other paddle 606b is attached to second link 4522 such that movement of second link 4522 moves paddle 606b.

[0185] To move valve repair device 602 from a closed position (eg Fig.45A ) to the relief position (as shown in Fig.45C ), the connector 605 moves along the axis 603 in the direction Y, which moves the pivot point A of the first link 4521 and the second link 4522 to a new position. Fig.45A , valve repair device 602 is shown in a closed position with an angle α between paddle 606 and shaft 603. Angle α can be, for example, between about 0 degrees and about 45 degrees, such as between about 5 degrees and about 40 degrees, such as between about 15 degrees and about 30 degrees, such as between about 20 degrees and about 25 degrees. Fig.45B , the valve repair device 602 is moved to the open position by moving the coupling 605 along the axis 603 in the direction Y. The movement of the coupling 605 in the direction Y causes the first link 4521 to pivot about the point A, so that the first link 4521 and the second link 4522 move outward in the direction Z, which causes the paddles 606a, 606b to move downward and outward in the direction H. Fig.45C , the valve repair device 602 is moved to the relief position by continuing to move the connector 605 along the axis 603 in the direction Y. The continued movement of the connector 605 in the direction Y causes the first link 4521 and the second link 4522 to move inward in the direction M, which causes the paddles 606a 606b to move downward and inward in the direction N. Still referring to Fig.45CIn the relief position, valve repair device 602 has an angle β between paddle 606 and shaft 603. Angle β can be, for example, greater than or equal to 120 degrees, such as greater than or equal to 130 degrees, such as greater than or equal to 140 degrees, such as greater than or equal to 150 degrees, such as greater than or equal to 160 degrees.

[0186] refer to Figures 46A-46D , a base assembly 604 of another exemplary embodiment of a valve repair device 602 includes a first link 4621 extending from point A to point B, a second link 4622 extending from point A to point C, a third link 4623 extending from point B to point D, a fourth link 4624 extending from point C to point E, a fifth link 4625 extending from point D to F, and a sixth link 4626 extending from point E to F. A coupler 605 is movably attached to the shaft 603, and the shaft 603 is attached to the fifth link 4625 and the sixth link 4626 at point F. The first link 4621 and the second link 4622 are pivotally attached to the coupler 605 at point A, so that movement of the coupler 605 along the shaft 603 moves the position of point A, and thus moves the first link 4621 and the second link 4622. The fifth link 4625 and the sixth link 4626 are pivotally attached to the shaft at point F, so that movement of the shaft moves the position of point F and thus moves the fifth link 4625 and the sixth link 4626. The locking element 4631 is configured to selectively lock the fifth link 4625 and the sixth link 4626 to the shaft at point F, so that when the locking member 4631 is in the locked position, the fifth link 4625 and the sixth link 4626 cannot pivot relative to the shaft 603. However, when the locking member 4631 is in the unlocked position, the fifth link 4625 and the sixth link 4626 can pivot around the shaft 603 when the shaft moves the position of point F (as described above). The first link 4621 and the third link 4623 are pivotally attached to each other at point B, and the second link 4622 and the fourth link 4624 are pivotally attached to each other at point C. One paddle 606a is attached to first link 4621 such that movement of first link 4621 moves paddle 606a, and the other paddle 606b is attached to second link 4622 such that movement of second link 4622 moves paddle 606b.

[0187] To move valve repair device 602 from a closed position (eg Fig.46A ) to the relief position (as shown in Fig.46C ), the locking element 4631 is maintained in the locked position and the coupler 605 is moved along the axis 603 in the direction Y, which moves the pivot point A of the first link 4621 and the second link 4622 to a new position. To move the valve repair device 602 from the relief position to the collapsed relief position (as shown in FIG. Fig.46D), moving the locking element 4631 to the unlocked position and moving the shaft 603 in direction D, which moves the pivot point F of the fifth link 4625 and the sixth link 4626 to a new position - causing the fifth link 4625 and the sixth link 4626 to pivot around the shaft 603.

[0188] refer to Fig.46A , valve repair device 602 is shown in a closed position with an angle α between paddle 606 and shaft 603. Angle α can be, for example, between about 0 degrees and about 45 degrees, such as between about 5 degrees and about 40 degrees, such as between about 15 degrees and about 30 degrees, such as between about 20 degrees and about 25 degrees. Fig.46B , the valve repair device 602 is moved to the open position by moving the coupling 605 along the axis 603 in the direction Y. The movement of the coupling 605 in the direction Y causes the first link 4621 and the second link 4622 to move outward in the direction Z, which causes the paddles 606a, 606b to move downward and outward in the direction H. When the valve repair device 602 is moved from the closed position (such as Fig.46A ) to the open position (as shown in Fig.46B ), the locking member 4631 is maintained in the locked position.

[0189] refer to Fig.46C , the valve repair device 602 is moved to the relief position by continuing to move the connector 605 along the axis 603 in the direction Y. The continued movement of the connector 605 in the direction Y causes the first link 4621 and the second link 4622 to move inward in the direction M, which causes the paddles 606a 606b to move downward and inward in the direction N. Still referring to Fig.45C In the relief position, valve repair device 602 has an angle β between paddle 606 and shaft 603. Angle β can be, for example, greater than or equal to 120 degrees, such as greater than or equal to 130 degrees, such as greater than or equal to 140 degrees, such as greater than or equal to 150 degrees, such as greater than or equal to 160 degrees. Fig.46B ) to the relief position (as shown in Fig.46C ), the locking element 4631 is maintained in the locked position.

[0190] refer to Fig.46D , the valve repair device 602 is moved from the relief position to the folded position - by moving the locking element 4631 to the unlocked position and moving the shaft 603 in the direction D, which causes the fifth link 4625 and the sixth link 4626 to pivot about the connection point F and move upward in the direction J, causing the third link 4623 and the fourth link 4624 to move inward and downward in the direction Q, causing the paddles 606a, 606b to move downward and inward in the direction Q. Still referring to Fig.46D, in the creased, relieved position, valve repair device 602 has an angle μ between paddle 606 and shaft 603. Angle μ can be, for example, greater than or equal to 120 degrees, such as greater than or equal to 130 degrees, such as greater than or equal to 140 degrees, such as greater than or equal to 150 degrees, such as greater than or equal to 160 degrees, such as greater than or equal to 170 degrees.

[0191] It would be advantageous to have a valve repair device that includes features that ensure that the valve repair device remains in a closed position after the valve repair device is attached to the patient's native valve. In other words, it would be advantageous to have a valve repair device that includes features that prevent the valve repair device from separating from the patient's native valve after the valve repair device is placed in the patient's body, which could cause problems (e.g., blood regurgitation through the mitral valve). Figures 47A-49 An example of additional components for preventing separation of a valve repair device from a native valve is shown in .

[0192] refer to Figures 47A-47B , an exemplary embodiment of the valve repair device 602 includes a latch member 4701 attached to the paddle 606, wherein the latch member 4701 is configured to attach the paddle 606 to the clamping member 608 when the valve repair device is in the closed position. The valve repair device 602 may include any other components for the valve repair devices discussed in this application, and the valve repair device 602 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application) may be positioned to engage the valve tissue 820. In the illustrated embodiment, the valve repair device 602 includes an optional lock 607 that is configured to maintain the coupler 605 in a locked state on the shaft 603. However, if the optional lock 607 fails, the coupler 605 may move on the shaft 603 and move the valve repair device to the open position. Latch member 4701 is configured to maintain valve repair device 602 in a closed position if lock 607 fails.

[0193] refer to Fig.47A , valve repair device 602 is in an open position, wherein valve tissue 820 is disposed in opening 614 between paddle 606 and clamping member 608. Fig.47B, the valve repair device 602 is moved to the closed position so that the valve tissue 820 is fixed between the paddle 606 and the clamping member 608 of the valve repair device. The valve repair device 602 can be moved to the closed position by any suitable means, such as, for example, any means described in the present application. When the valve repair device 602 is moved to the closed position, the latch member 4701 pierces the valve tissue 820 and the clamping member 608, thereby fixing the paddle to the clamping member. The latch member 4701 can take any suitable form capable of fixing the paddle 606 to the clamping member 608, such as, for example, metal, plastic, etc.

[0194] refer to Fig.48 , another exemplary embodiment of a valve repair system 600 includes a delivery device 601 and a valve repair device 602, wherein the delivery device is configured to deliver the valve repair device to a patient's native valve, and wherein the valve repair device is configured to attach to a leaflet of a native valve to repair the patient's native valve. The delivery device 601 can take any suitable form capable of delivering the valve repair device 602 to a patient's native valve, such as, for example, any form described in the present application. The valve repair device 602 includes a base assembly 604, a pair of paddles 606, and a pair of clamping members 608. The base assembly 604 of the valve repair device 602 has an axis 603 and a connector 605 configured to move along the axis. The connector 605 is mechanically connected to the paddle so that movement of the connector along the axis 603 moves the paddle between an open position and a closed position. In the closed position, paddle 606 and clamping member 608 engage valve tissue and each other to secure valve repair device 602 to the valve tissue. Valve repair device 602 also includes a biasing member 4807 (e.g., a spring) configured to bias coupler 605 on the shaft so that valve repair device 602 is in the closed position.

[0195] In certain embodiments, the valve repair system 600 includes a placement shaft 613 that is removably attached to the shaft 603 of the base assembly 604 of the valve repair device 602. After the valve repair device 602 is secured to the valve tissue, the placement shaft 613 is removed from the shaft 603 to remove the valve repair device 602 from the valve repair system 600, so that the valve repair device 602 can still be attached to the valve tissue, and the delivery device 601 can be removed from the patient's body. After the valve repair device 602 is attached to the valve tissue and the valve repair system 600 is removed from the patient's body, the biasing member 4807 maintains the valve repair device in a closed position to prevent the valve repair device from separating from the valve tissue. The valve repair device 602 can include any other components for the valve repair devices discussed in the present application, and the valve repair device 602 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application) can be positioned to engage the valve tissue 820.

[0196] refer to Fig.49 Another exemplary embodiment of a valve repair system 600 includes a delivery device 601 and a valve repair device 602, wherein the delivery device is configured to deliver the valve repair device to a patient's natural valve, and wherein the valve repair device is configured to attach to the leaflets of the natural valve to repair the patient's natural valve. The delivery device 601 can take any suitable form capable of delivering the valve repair device 602 to the patient's natural valve, such as, for example, any form described in the present application. The valve repair device 602 includes a base assembly 604, a pair of paddles 606, and a pair of clamping members 608. The base assembly 604 of the valve repair device 602 has a shaft 603 and a connector 605 configured to move along the shaft. In the illustrated embodiment, the shaft 603 includes a threaded portion 4902, and the connector 605 is configured to move along the threaded portion 4902 of the shaft. That is, the shaft 603 is rotated to move the connector 605 up and down along the shaft 603. Coupler 605 is mechanically connected to the paddle so that movement of the coupler along shaft 603 moves the paddle between an open position and a closed position. In the closed position, paddle 606 and clamping member 608 engage valve tissue and each other to secure valve repair device 602 to the valve tissue.

[0197] In certain embodiments, the valve repair system 600 includes a placement shaft 613 that is removably attached to the shaft 603 of the base assembly 604 of the valve repair device 602. After the valve repair device 602 is secured to the valve tissue, the placement shaft 613 is removed from the shaft 603 to remove the valve repair device 602 from the valve repair system 600, so that the valve repair device 602 can remain attached to the valve tissue and the delivery device 601 can be removed from the patient's body. After the valve repair device 602 is attached to the valve tissue and the valve repair system 600 is removed from the patient's body, the valve repair device is prevented from being separated from the valve tissue because the connector can only be moved by rotating the shaft 603. The valve repair device 602 can include any other components for the valve repair devices discussed in the present application, and the valve repair device 602 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application) can be positioned to engage the valve tissue 820.

[0198] refer to Figure 50-54 , an embodiment of a valve repair system 600 includes a delivery device 601 and a valve repair device 602, wherein the delivery device is configured to deliver the valve repair device to a patient's natural valve, and wherein the valve repair device is configured to attach to the leaflets of the natural valve to repair the patient's natural valve. The delivery device 601 can take any suitable form capable of delivering the valve repair device 602 to the patient's natural valve, such as, for example, any form described in the present application. The valve repair device 602 is similar to the valve repair device described above and includes a base assembly 604, a pair of paddles 606, and a pair of clamping members 608. The base assembly 604 of the valve repair device 602 has an axis 603 and a connector 605 configured to move along the axis. The connector 605 is mechanically connected to the paddle so that movement of the connector along the axis 603 causes the paddle to move between an open position and a closed position. In some embodiments, valve repair device 602 includes a locking member 607 configured to lock coupler 605 on the shaft in a desired position (eg, Figure 50-53B In an alternative embodiment, valve repair device 602 includes biasing member 4807 configured to maintain coupler 605 on shaft 603 in a desired position (eg, Fig.54). In the closed position, the paddle 606 and the clamping member 608 engage the valve tissue and engage each other to secure the valve repair device 602 to the valve tissue. In certain embodiments, the valve repair system 600 includes a placement shaft 613 that is removably attached to the shaft 603 of the base assembly 604 of the valve repair device 602. After the valve repair device 602 is secured to the valve tissue, the placement shaft 613 is removed from the shaft 603 to remove the valve repair device 602 from the valve repair system 600, so that the valve repair device 602 can remain attached to the valve tissue and the delivery device 601 can be removed from the patient's body. The valve repair device 602 may include any other components for the valve repair devices discussed in this application, and the valve repair device 602 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application) may be positioned to engage the valve tissue 820.

[0199] refer to Fig.50 In some embodiments, a clamping member 608 is attached to the paddle 606. Fig.50 In the illustrated example, the clamping member 608 includes an attachment portion 5010, a hinge portion or flexure portion 5012, and a clamping portion or barb portion 5014. The attachment portion 5010 can take any form that allows the clamping member to be attached to the paddle 606. The hinge portion or flexure portion 5012 can take a variety of different forms. For example, the hinge portion or flexure portion can be configured to bias the clamping portion or barb portion 5014 toward the attachment portion 5010. In an exemplary embodiment, the hinge portion or flexure portion 5012 biases the clamping portion or barb portion 5014 to a fully closed position in which the clamping portion or barb portion engages the attachment portion 5010 and / or the paddle 606. When valve tissue is positioned between the paddle 606 and the clamping portion 5014, the hinge portion or flexure portion biases the clamping portion 5014 to clamp the valve tissue between the clamping portion or barb portion 5014 and the paddle. Fig.50 The illustrated clamping member 608 moves with the paddle 606. The hinge portion or flexure portion 5012 allows the clamping portion 5014 to move in the direction indicated by arrow 5020 and can allow the clamping portion to be pulled in the direction indicated by arrow 5022.

[0200] In certain embodiments, it may be advantageous to arrange the barbed portion 609 towards the proximal end of the clamping member 608 as it will make it easier to release the clamping member 608 from the valve tissue. Fig.51In one embodiment, the clamping member 608 includes a single row of barbs 5102 configured to engage valve tissue and the paddle 606 to secure the valve repair device to the valve tissue. The single row of barbs 5102 makes it easier for the clamping portion 5014 to be released from the valve tissue. In an alternative embodiment, the clamping member 608 may include two or more rows of barbs 5102 arranged at the proximal end of the clamping member 608. In other embodiments, the barbs 5102 may be arranged at the proximal end of the clamping member 608 in any other suitable configuration that makes it easier for the clamping member 608 to be released from the valve tissue.

[0201] In some embodiments, Figures 51A-51E As shown in , the clamping member 608 is configured to place a tensioning force on the valve tissue when the valve repair device (e.g., any valve repair device 602 described in the present application) is attached to the valve tissue. The clamping member 608 is slidably connected to the paddle 606 so that the clamping member 608 can move along the paddle in the direction X. For example, the clamp control mechanism 611 can be used to move the clamping member 608 along the paddle 606 in the direction X, and the clamp control mechanism 611 can also be used to clamp the clamping member 608 in the closed position (e.g., Fig.51A ) and the open position (as shown in Fig.51B ). The clamp control mechanism 611 can take any form described in this application. In some embodiments, the valve repair device 602 includes an optional biasing member 5122 (e.g., a spring) configured to maintain the clamping member 608 in a desired position along the paddle 606 (e.g., Fig.51A and 51E In the illustrated embodiment, the clamping member 608 includes a single row of barbs 609 at the proximal end of the clamping member (e.g., Fig.51 ), however, it should be understood that the present invention is not limited to the embodiment of the valve repair device 602 shown in FIG. Figures 51A-51E The described components may be used with any of the embodiments of the valve repair devices described in this application.

[0202] refer to Fig.51A , the clamping member 608 is shown on the paddle 606 in a first position and a closed position. Fig.51B , shows the clamping member 608 after it has been moved in the direction Z to the open position by the clamp control mechanism 611. Fig.51C, shows the clamping member 608 after it has been moved along the paddle 606 in the direction D to the second position. In certain embodiments, the clamping member 608 is moved along the paddle in the direction D by the clamp control mechanism 611 or a separate mechanism. In embodiments including the biasing member 5122, sufficient force needs to be applied to the clamping member 608 to move the clamping member in the direction D, which will cause the biasing member to expand and create a tensioning force on the clamping member 608 in the direction B. Although the illustrated embodiment shows that the clamping member 608 is moved along the paddle 606 in the direction D to the second position (such as Fig.51C ) before moving to the open position (as shown in Fig.51B ), but it should be understood that the clamping member 608 can be moved in the direction D to the second position before the clamping member 608 is moved in the direction Z to the open position, or can be moved simultaneously. Fig.51D The clamping member 608 is moved to a closed position in the direction Y by the clamp control mechanism 611, thereby fixing the barbed portion 609 of the clamping member 608 to the valve tissue (not shown). Fig.51D In the position shown, the biasing member 5122 is maintained in the extended position (e.g., due to the force applied to the clamping member 608 by the clamp control mechanism (or another mechanism) to maintain the clamping member in the second position), which means that the biasing member 5122 is placing tension on the clamping member 608 in the direction B. Fig.51E After the barbed portion 609 of the clamping member 608 is secured to the valve tissue, the force that maintains the clamping member 608 in the second position is released, which allows the tensioning force applied by the biasing member 5122 to move the clamping member 608 along the paddle 606 in the direction M. The movement of the clamping member 608 in the direction M causes the barbed portion 609 to generate a tensioning force on the valve tissue in the direction T. This tensioning force on the valve tissue allows the valve repair device 602 to maintain a secure connection with the valve tissue.

[0203] In another embodiment, Figures 51F-51GAs shown in , the clamping member 608 includes a barbed portion 609 and a weakened portion or flexure 5103. The barbed portion 609 is arranged on a first side 5111 of the weakened portion or flexure 5103. In the illustrated embodiment, the barbed portion 609 includes a single row of barbs, but it should be understood that any suitable configuration of barbs may be used, such as, for example, any configuration described in the present application. The weakened portion or flexure 5103 can be, for example, a cutout in the clamping member, a different material than the rest of the clamping member 608, or can take any other suitable form that allows the weakened portion or flexure 5103 to be weaker and / or more flexible than the rest of the clamping member 608. However, in other embodiments, the weaker and more flexible portion 5103 is omitted, and the connecting rod 5107 and wire 5105 described below can still enable Figures 51F-51H The barbs shown are partially deflected.

[0204] refer to Figures 51F-51H , the clamp control mechanism 611 includes a wire 5105 (e.g., a suture) and a push / pull link 5107 configured to receive the wire 5105. For example, the push / pull link 5107 can be a catheter, a wire with a loop (e.g., a Fig.25A ), or any other link capable of receiving the wire 5105 and pushing / pulling the clamping member 608. The first end 5125 of the wire 5105 extends from a delivery device (e.g., any delivery device 601 described herein) and is removably attached to the clamping member 608 at a first connection point A on a first side 5111 of the weakened or flexible portion 5103. The wire 5105 also extends from the connection point A and is removably attached to the clamping member 608 at a second connection point B on a second side 5113 of the weakened or flexible portion 5103. Additionally, the wire 5105 extends from the second connection point B and passes through the push / pull link 5107.

[0205] refer to Fig.51F , shows the clamping member 608 in an open position, wherein the valve tissue member 820 is disposed in the opening 614 between the clamping member 608 and the paddle (not shown). The clamping member can be moved to the open position by pulling the wire 5105. Figure 51G , the link 5107 and wire 5105 of the clamp control mechanism 611 are used to move the clamping member 608 to the closed position in the direction X and to flex the portion 609 in the direction Y. Pulling the first end 5125 of the wire 5105 in the direction Y causes the first side 5111 of the clamping member 608 to pivot or flex about the weakened portion 5103. This flexure causes the barbed portion 609 to move in the directions U and Y to the flexed position. Still referring to Figure 51G, moving the link 5107 and the wire 5105 so that the barbed portion 609 pierces the valve tissue 820 when the barbed portion 609 is in the flexed position.

[0206] refer to Fig.51H , wire 5105 is released, which causes first end 5111 of clamping member 608 to pivot about weakened or flexible portion 5103. This causes barbed portion 609 to move through valve tissue 820 in direction D—causing barbed portion 609 of valve repair device to generate tension on valve tissue 820 in direction D. Fig.51H ), the connecting rod 5107 and the wire 5105 are removed from the clamping member 608.

[0207] refer to Fig.52 In various embodiments, the clamping member 608 includes an extendable portion 5202, thereby allowing movement in direction 5204. Movement in direction 5204 allows for clean disengagement from the valve tissue. In some embodiments, the extendable portion 5202 is configured to move so that the barbs 5102 leave the valve tissue in a direction substantially opposite to the direction in which the barbs entered the valve tissue. Alternatively, the clamping member 608 can be extended in other ways to allow disengagement from the valve tissue without tearing the valve tissue. For example, as described above, the hinge portion 5012 can be configured to allow the clamping portion 5014 of the clamping member 608 to be pulled in direction 5204.

[0208] refer to Figures 53A-53B In some embodiments, the clamping member 608 is made of a flexible material. Fig.53A , the valve repair device 602 is shown in a closed position and secured to the valve tissue 820. Fig.53B , the clamping member 608 is shown being moved by the clamp control mechanism 611 to remove the clamping member 608 from the valve tissue 820. Specifically, the movement of the clamp control mechanism 611 in direction Y causes the clamping member 608 to peel back from the valve tissue in direction Z. The flexible material of the clamping member 608 allows the clamping member 608 to peel back when the clamping member is removed from the valve tissue 820. The peeling back of the clamping member 608 is advantageous because it helps the clamping member to be pulled out of the valve tissue 820 without damaging the valve tissue. In some embodiments, the flexible clamping member 608 allows the barbed portion 609 of the clamping member 608 to be removed from the valve tissue in a direction substantially opposite to the direction in which the barbs entered the valve tissue.

[0209] refer to Fig.54In some embodiments, the clamping members 608 are connected to each other by a separate biasing member 5410 (e.g., a spring) that is configured to maintain the clamping members in a desired position such that when the paddle 606 is in the open position, a width W exists between the paddle and the clamping members. The width W can be adjusted by engaging the clamping members 608 with the clamp control mechanism 611. That is, movement of the clamp control mechanism 611 into the delivery device in a direction Z will cause the biasing member 5410 to flex and move the paddle in an inward direction X. Disengagement of the clamping members by the clamp control mechanism 611 will cause the biasing member 5410 to move to a desired position (e.g., Fig.54 ). The clamp control mechanism 611 may take any suitable form for controlling the clamping member 608, such as, for example, any form described in this application. In addition, when the paddle 606 is moved to the closed position, the paddle will engage the clamping member 608, which will cause the biasing member to flex and move the clamping member in the inward direction X. The paddle 608 can be moved from the open position to the closed position in any suitable manner, such as, for example, any manner described in this application. Although the various devices described in this application mention engaging and repairing the mitral valve, it should be understood that these devices can be used to repair any other natural valve (e.g., tricuspid valve, pulmonary valve, aortic valve) or any other part of the heart. In addition, it should be understood that the various components of the various embodiments of the devices described herein can be used in conjunction with each other.

[0210] While the foregoing is a complete description of the preferred embodiment of the invention, various alternatives, modifications and equivalents may be used. In addition, it is apparent that certain other modifications may be made within the scope of the appended claims.

Claims

1. A valve repair device (602) for repairing a natural valve of a patient, the valve repair device comprising: a base assembly (604) comprising a plurality of pivot links (605) and an axle (603), wherein the pivot links are moved by the axle; a pair of paddles (606) attached to the base assembly, wherein movement of the pivot link (605) moves the paddles (606) between an open position and a closed position; a pair of clamping members (608) attached to the base assembly (604), wherein the paddle (606) and the clamping member (608) are each configured to be movable toward each other to attach to the patient's valve leaflets, and the clamping members (608a, 608b) each have a distal portion, the clamping members being connected to each other at their distal portions by distal connecting portions (608, 5410); at least one spacer element (3800) surrounding the shaft (603) and disposed between the pair of clamping members (608); wherein when the paddle (606) is in the closed position, the spacer element (3800) fills the space between the clamping members (608); Wherein, when viewed in a plan view of the atrial side of the native valve, the spacer element (3800) extends past one or more side edges of the clamping member (608) when the paddle (606) and the clamping member (608) are attached to the patient's valve leaflet.

2. The valve repair device according to claim 1, wherein the base assembly (604) of the valve repair device further comprises: a coupling (605) movably attached to the shaft so that the coupling can move along the shaft (603); wherein the pair of paddles (606) are pivotally attached to the coupler (605); Wherein movement of the connector (605) along the axis (603) in a first direction moves the pair of paddles (606) to the closed position, and movement of the connector in a second direction moves the pair of paddles to the open position.

3. A valve repair device according to claim 1, wherein the spacer element (3800) includes a first spacer member (4102) attached to a first clamping member (608a) of the pair of clamping members and a second spacer member (4104) attached to a second clamping member (608b) of the pair of clamping members.

4. A valve repair device according to claim 1, wherein the spacer element (3800) includes a main portion (4210a, 4210b, 4210c) extending between the clamping members (608) and an extension portion (4212a, 4212b, 4212c) extending through the side edges of the clamping members (608).

5. The valve repair device according to claim 4, wherein the extension portion (4212b) has a semicircular shape.

6. The valve repair device of claim 1, wherein the spacer element (3800) is configured to fill at least a portion of a gap in a mitral valve leaflet of the patient.

7. The valve repair device according to claim 1, wherein the spacer element (3800) is made of at least one material, and the at least one material is selected from the group consisting of a woven mesh, a fabric, a biocompatible material, a foam and a pericardial tissue.

8. The valve repair device according to any one of claims 1-7, wherein the distal connecting portion (608) extends perpendicular to the axis (603).

9. The valve repair device according to any one of claims 1-8, wherein the distal connecting portion (608) and the clamping member (608) are arranged in a U-shape.

10. The valve repair device according to any one of claims 1-9, wherein the distal connecting portion (608) is slidably connected to the shaft (603).

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