Native valve repair devices

Abstract

Valve repair device for repairing a patient's native valve, the valve repair device comprising: a basic arrangement comprising several pivotable links and a shaft, wherein the pivotable links are moved by the shaft; a pair of paddles attached to the base assembly, wherein the movement of the pivoting links moves the paddles between an open position and a closed position; a pair of gripping elements attached to the base assembly, the paddles and gripping elements being configured to be attached to the patient's valve leaflets; at least one spacer element that surrounds the shaft and is arranged between the pair of gripping elements; wherein the spacer element is made of at least one material selected from the group of materials consisting of woven mesh, fabric, biocompatible material, foam and pericardial fabric; the spacer element fills a space between the gripping elements when the paddles are in the closed position.

Description

AREA OF INVENTION

[0001] The present disclosure relates generally to prosthetic devices for helping to seal native heart valves and prevent or reduce regurgitation through them, and to devices for implanting such prosthetic devices. The methods described herein serve to better understand the invention defined in the claims. No methods are claimed. BACKGROUND OF THE INVENTION

[0002] The native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) have crucial functions in ensuring an adequate supply of blood through the cardiovascular system. These heart valves can be damaged and thus impaired by congenital malformations, inflammatory processes, infectious diseases, or other illnesses. Such valve damage can lead to severe cardiovascular complications or death. For many years, the definitive treatment for such damaged valves consisted of surgical repair or replacement during open-heart surgery. However, open-heart surgery is highly invasive and associated with numerous complications. Consequently, elderly and frail patients with defective heart valves often went untreated.More recently, transvascular techniques have been developed that allow prosthetic devices to be introduced and implanted in a manner that is significantly less invasive than open-heart surgery. One particular transvascular technique used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves inserting a catheter into the right femoral vein, up the inferior vena cava, and into the right atrium. The septum is then punctured, and the catheter is advanced into the left atrium.

[0003] A healthy heart generally has a conical shape, tapering towards a lower apex. The heart has four chambers: the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve consists of an annulus, a ring-shaped section of native valve tissue that surrounds the mitral valve orifice, and a pair of cusps, or leaflets, that extend downward from the annulus into the left ventricle. The mitral valve annulus can have a D-shaped, oval, or otherwise non-circular cross-sectional shape, with a major and a minor axis.The anterior sail may be larger than the posterior sail, so that a generally "C"-shaped boundary is formed between the abutting free edges of the sails when they are closed.

[0004] When functioning properly, the anterior and posterior leaflets of the mitral valve work together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expands (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 compresses the two leaflets, closing the one-way mitral valve. This prevents blood from flowing back into the left atrium, forcing it to flow out of the left ventricle through the aortic valve.To prevent the two leaflets from collapsing under pressure and folding back through the annulus of the mitral valve towards the left atrium, the leaflets are attached to the papillary muscles of the left ventricle by several fibrous cords, the chordae tendineae.

[0005] Mitral regurgitation occurs when the native mitral valve does not close properly, allowing blood to flow from the left ventricle into the left atrium during the systolic phase of heart contraction. Mitral regurgitation is the most common form of valvular heart disease. It has various causes, such as leaflet prolapse, papillary muscle dysfunction, and / or dilation of the mitral valve annulus due to left ventricular enlargement. Mitral regurgitation in a central portion of the leaflets may be called central jet mitral regurgitation, while regurgitation near a commissure (the point where the leaflets meet) is called eccentric jet mitral regurgitation. In central jet mitral regurgitation, the leaflet edges do not meet in the center. Therefore, the valve does not close, resulting in regurgitation (insufficiency).

[0006] Some earlier techniques for treating mitral regurgitation in patients include direct surgical suturing of the edges of the native mitral valve leaflets. Attempts have been made to clamp the leaflet edges together using a catheter-delivered clip, similar to surgical suturing. However, this clip has limitations, as it can only clamp the mid-margins of the leaflets if they overlap by 2 mm or more. Alternatively, attempts have been made to use multiple clips at the mitral valve commissures, where greater overlap can occur. This results in a longer operating time, and the patient's leaflets are joined at the sides, restricting blood flow. Both surgical and clip treatments are thought to place stress on the patient's leaflets.

[0007] Despite these existing techniques, there is still a need for improved devices to treat mitral valve regurgitation. SUMMARY

[0008] An example of a valve repair device for repairing a patient's native valve comprises a pair of paddles, a pair of gripping elements, and a spacer. The paddles are movable between an open and a closed position. The paddles and gripping elements are configured to be attached to the patient's native valve. The spacer is configured to close any gap (cleft) in the patient's native valve when the valve repair device is attached.

[0009] A further understanding of the nature and advantages of the present invention will result from the following description and the claims, in particular when viewed in conjunction with the accompanying drawings, in which identical parts have the same reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] To further clarify various aspects of the embodiments of the present disclosure, a more detailed description of certain embodiments is given with reference to various aspects of the accompanying drawings. It is assumed that these drawings represent only typical embodiments of the present disclosure and are therefore not to be considered limiting to the scope of the disclosure. Furthermore, while the figures may be drawn to scale for some embodiments, they are not necessarily drawn to scale for all embodiments. Embodiments of the present disclosure are described and explained with additional specificity and detail with reference to the accompanying drawings. Fig. Figure 1 shows a cross-sectional view of the human heart in a diastolic phase; Fig. Figure 2 shows a cross-sectional view of the human heart during a systolic phase; Fig. Figure 3 shows a healthy mitral valve with closed leaflets, as seen from the atrial side of the mitral valve; Fig. Figure 4 shows a dysfunctional mitral valve with a visible gap between the leaflets, as seen from the atrial side of the mitral valve; Fig. 4A shows a tricuspid valve as seen from an atrial side of the tricuspid valve; Fig. Figure 5 shows a cross-sectional view of the human heart in a diastolic phase, showing the chordae tendineae, which attach the leaflets of the mitral and tricuspid valves to the ventricular walls; Fig. Figure 6 shows a flap repair device with paddles in an open position; Fig. Figure 7 shows the flap repair device of Fig. 6, in which the paddles are in the open position and the gripping elements are moved so that a larger gap is created between the gripping elements and the paddles; Fig. Figure 8 shows the flap repair device of Fig. 6, in which the flap repair device is located in the Fig. 7 is located in the position shown, with flap fabric arranged between the gripping elements and the paddles; Fig. Figure 9 shows the flap repair device of Fig. 6, in which the gripping elements are moved to reduce the distance between the gripping elements and the paddles; Fig. Figures 10A-10B show the movement of the paddles of the flap repair device of Fig. 6 from an open position to a closed position; Fig. Figure 11 shows the flap repair device of Fig. 6 in a closed position in which the gripping elements grasp the flap fabric; Fig. Figure 12 shows the flap repair device of Fig. 6, after it has been separated from a feeding device and attached to the flap fabric, the flap repair device being in a closed and locked state; Fig. Figure 13A shows an exemplary embodiment of a valve repair device attached to the anterior and posterior leaflets of the mitral valve of a patient, shown from the left atrium of the patient's heart, with the valve repair device and the leaflet tissue on the ventricular side shown in hidden lines; Fig. 13B is an enlarged version of Fig. 13A; Fig. 14A is another exemplary embodiment of a valve repair device attached to the anterior and posterior leaflets of a patient's mitral valve, the valve repair device and the valve leaflet tissue on the ventricular side being shown in hidden lines; Fig. Figure 14B is another exemplary embodiment of a valve repair device attached to the anterior and posterior leaflets of a patient's mitral valve, wherein the valve repair device comprises paddles that bend to reduce stress on the mitral valve tissue, the valve repair device and leaflet tissue on the ventricular side being shown in hidden lines; Fig. Figures 15A-15B show another exemplary embodiment of a flap repair device, wherein the flap repair device has paddles which bend along their length to reduce stress on the flap fabric when the flap repair device is attached to the flap fabric; Fig. Figures 16A-16F show a further exemplary embodiment of a flap repair device, wherein the flap repair device comprises compressible paddles which include an exemplary embodiment of a wire loop; Fig. Figures 16G-16H show a further exemplary embodiment of a flap repair device, wherein the flap repair device comprises compressible paddles which comprise a further exemplary embodiment of a wire loop; Fig. 16I-16J show a further exemplary embodiment of a flap repair device, wherein the flap repair device comprises compressible paddles which comprise a further exemplary embodiment of a wire loop; Fig. Figures 17A-17F show another exemplary embodiment of a flap repair device, in which the flap repair device has compressible paddles which have a horseshoe shape; Fig. Figures 18A-18D show another exemplary embodiment of a flap repair device, wherein the flap repair device has compressible paddles which have a horseshoe shape; Fig. 18E and Fig. 18F features a compressible paddle, similar to the one in the Fig. 18C and Fig. The compressible paddle shown in Figure 18D is similar, except that the legs of the paddle do not cross when the paddle is loaded into a catheter; Fig. Figures 19A-19D show another exemplary embodiment of a flap repair device, in which the flap repair device includes compressible paddles made of mesh fabric; Fig. Figures 20A-20B show an exemplary embodiment of a paddle for a flap repair device in which the paddle is compressible; Fig. Figures 21A-21B show another exemplary embodiment of a flap repair device in which the paddles of the flap repair device are extendable; Fig. Figure 22 shows another exemplary embodiment of a flap repair arrangement in which a gripper control mechanism is configured to control each gripper element of a flap repair device independently; Fig. Figures 22A-22D show a further exemplary embodiment of a flap arrangement in which an exemplary embodiment of a gripper control mechanism is configured to control four gripper elements of an exemplary embodiment of a flap repair device independently of each other; Fig. Figure 23 shows another exemplary embodiment of a flap arrangement in which a gripper control mechanism is configured to control each gripper element of a flap repair device independently; Fig. Figure 24 shows an exemplary embodiment of a connection between a placement shaft and a paddle control mechanism shaft of the flap repair device of Fig. 23, in which the gripper control mechanism is attached to the connection between the placement shaft and the paddle control mechanism shaft on the flap repair device; Fig. Figures 24A-24B show an exemplary embodiment of a connection between a placement shaft and a paddle control mechanism shaft of the flap repair device of Fig. 23, in which the gripper control mechanism is attached to the flap repair device at the connection between the placement shaft and the shaft of the flap repair device. Fig. Figure 25 shows another exemplary embodiment of a flap repair arrangement in which a gripper control mechanism is configured to control each gripper element of a flap repair device independently of the others; Fig. Figure 25A shows another exemplary embodiment of a gripper control mechanism configured to control each gripper element of a flap repair device independently of the others; Fig. Figure 26 shows another exemplary embodiment of a flap repair arrangement in which a gripper control mechanism is configured to control each gripper element of a flap repair device independently of the others; Fig. Figures 27A-27C show another exemplary embodiment of a flap repair device in which each paddle of the flap repair device can be moved to a closed position independently of an open position; Fig. 28A-28F show another exemplary embodiment of a flap repair device in which each paddle of the flap repair device can be moved to a closed position independently of an open position; Fig. Figures 29A-29B show another exemplary embodiment of a flap repair device in which each paddle of the flap repair device can be moved to a closed position independently of an open position; Fig. Figure 30 shows a mitral valve with a wide gap between the posterior leaflet and the anterior leaflet; Fig. Figures 31A-31B show another exemplary embodiment of a flap repair device in which the paddles of the flap repair device expand to create a wide gap for receiving flap tissue; Fig. Figures 32A-32C show another exemplary embodiment of a flap repair device in which the flap repair device is configured such that the paddles of the flap repair device expand by pivoting and spreading apart to create a wide gap for receiving flap tissue; Fig. Figures 33A-33C show another exemplary embodiment of a flap repair device in which the flap repair device is configured such that the paddles of the flap repair device expand by spreading apart and pivoting to create a wide gap for receiving flap tissue; Fig. Figures 34A-34B show another exemplary embodiment of a flap repair device in which a “W”-shaped mechanism expands the paddles of the flap repair device to create a wide gap; Fig. Figures 35A-35B show another exemplary embodiment of a flap repair device in which a “W”-shaped mechanism expands the paddles of the flap repair device to create a wide gap for receiving flap tissue; Fig. Figures 36A-36B show another exemplary embodiment of a flap repair device in which a “W”-shaped mechanism expands the paddles of the flap repair device to create a wide gap; Fig. Figure 36C shows an exemplary embodiment of a paddle control mechanism for the flap repair device of the Fig. 36A-36B; Fig. Figures 36D-36E show another exemplary embodiment of a flap repair device in which a “W”-shaped mechanism expands the paddles of the flap repair device to create a wide gap; Fig. Figures 37A-37D show another exemplary embodiment of a flap repair device with paddles made of mesh fabric and an internal cam for spreading apart the paddles made of mesh fabric to create a wide gap for spaced flap fabric; Fig. Figure 38 shows an exemplary embodiment of a valve repair device which includes an exemplary embodiment of a spacer element, wherein the valve repair device is attached to a mitral valve; Fig. Figure 39 shows another exemplary embodiment of a valve repair device, which includes an exemplary embodiment of a spacer element and in which the valve repair device is attached to a mitral valve; Fig. Figures 40A-40B show a further exemplary embodiment of a flap repair device, which includes an exemplary embodiment of a spacer element, wherein the spacer element is attached to a shaft of the flap repair device; Fig. Figures 41A-41D show a further exemplary embodiment of a flap repair device comprising an exemplary embodiment of a spacer element, wherein a first section is attached to a first gripping element of the flap repair device and a second section is attached to a second gripping element of the flap repair device; Fig. 42A-42C show the flap repair device of the Fig. 40A-40B, wherein the spacer element has different shapes; Fig. 43A-43C show the flap repair device of the Fig. 41A-41B, wherein the spacer element has different shapes; Fig. Figures 44A-44B show another exemplary embodiment of a flap repair device with paddles that spread further and an expanding spacer element; Fig. Figures 45A-45C show another exemplary embodiment of a flap repair device with an enlarged removal angle for removing the flap repair device; Fig. Figures 46A-46D show another exemplary embodiment of a flap repair device with an enlarged removal angle for removing the flap repair device; Fig. Figures 47A-47B show another exemplary embodiment of a flap repair device with an attachment element for connecting the paddles to the grippers when the flap repair device is in a closed position; Fig. Figure 48 shows another exemplary embodiment of a flap repair device, which includes a spring element configured to bias the paddles of the flap repair device into a closed position; Fig. Figure 49 shows another exemplary embodiment of a flap repair device with a threaded mechanism for moving the flap repair device between the open and closed positions; Fig. Figure 50 shows another exemplary embodiment of a flap repair device, which has gripping elements attached to the paddles; Fig. Figure 51 shows another exemplary embodiment of a flap repair device having gripping elements with a single row of spikes; Fig. Figures 51A-51E show a further exemplary embodiment of a flap repair system comprising a flap assembly with a flap repair device having gripping elements configured to exert a clamping force on the flap fabric when the flap repair device is attached to the flap fabric; Fig. 51F-51H show another exemplary embodiment of a flap repair arrangement comprising gripping elements configured to exert a clamping force on the flap fabric when the flap repair device is attached to the flap fabric; Fig. Figure 52 shows another exemplary embodiment of a flap repair device with gripping elements that are extendable in length; Fig. Figures 53A-53B show a further exemplary embodiment of a flap repair device with bendable gripping elements; and Fig. Figure 54 shows another exemplary embodiment of a flap repair device in which the gripping elements are attached to a separate spring element. DETAILED DESCRIPTION

[0011] The following description refers to the accompanying drawings, which show certain embodiments of the invention. Other embodiments, which differ in structure and function, do not deviate from the scope of the present invention.

[0012] Exemplary embodiments of the present disclosure relate to devices for repairing a defective heart valve. It should be noted that various embodiments of devices and systems for repairing a native valve are disclosed here, and any combination of these possibilities can be manufactured unless expressly excluded. In other words, the individual components of the disclosed devices and systems can be combined, provided they are not mutually exclusive or otherwise physically impossible.

[0013] The Fig. 1 and Fig. Figure 2 shows cross-sectional views of the human heart H during the diastolic and systolic phases, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and the mitral valve MV, i.e., the atrioventricular valves. Additionally, 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 (for example, those shown in the Fig. 3 and Fig. (Leaflets 302 and 304, as shown in Figure 4), extend inwards over the respective openings and "coapt" in the fluid flow to form the fluid-impermeable backflow surfaces. The native valve repair systems in this application are primarily described with respect to the mitral valve (MV). Therefore, the anatomical structures of the left atrium (LA) and left ventricle (LV) are explained in more detail. It should be clear that the devices described here can also be used for the repair of other native valves, for example, the tricuspid valve (TV), the aortic valve (AV), and the pulmonary valve (PV).

[0014] The left atrium (LA) receives oxygen-rich blood from the lungs. During the diastolic phase, or diastole, which occurs in Fig. As shown in Figure 1, the blood that was previously collected in the left atrium (LA) during the systolic phase moves through the mitral valve (MV) and into the left ventricle (LV) through expansion of the left ventricle (LV). During the systolic phase, or systole, which is seen in Fig. As shown in Figure 2, the left ventricle (LV) contracts to push blood through the aortic valve (AV) and the ascending aorta (AA) into the body. During systole, the leaflets of the mitral valve (MV) close to prevent blood from regurgitating from the left ventricle (LV) back into the left atrium (LA), and blood is collected in the left atrium from the pulmonary vein. In an exemplary embodiment, the devices described in the present application are used to repair the function of a defective mitral valve (MV). That is, the devices are configured to assist the closure of the mitral valve leaflets to prevent blood from regurgitating from the left ventricle (LV) back into the left atrium (LA).

[0015] As in the Fig. As shown in Figures 1-5, the mitral valve (MV) comprises two leaflets, the anterior leaflet 302 and the posterior leaflet 304. The mitral valve (MV) also includes an annulus 306, a fibrous ring of tissue of varying density that surrounds leaflets 302 and 304. As shown in Fig. As shown in Figure 5, the mitral valve (MV) is anchored to the wall of the left ventricle (LV) by the chordae tendineae (501). The chordae tendineae (501) are cord-like tendons that connect the papillary muscles (503) (i.e., the muscles located at the base of the chordae tendineae and within the walls 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 it from inverting. 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) themselves. Rather, they support the mitral valve (MV) against the high pressure required for blood circulation throughout the body.Together, the papillary muscles and the chordae tendineae form the so-called subvalvular apparatus, which ensures that the mitral valve (MV) does not prolapse into the left atrium (LA) when the mitral valve closes.

[0016] Various disease processes can impair the proper function of one or more of the heart's native valves. These include degenerative processes (e.g., Barlow's disease, fibroelastic deficiency), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). Furthermore, damage to the left ventricle (LV) or right ventricle (RV) from previous heart attacks (e.g., myocardial infarction as a consequence of coronary artery disease) or other heart conditions (e.g., cardiomyopathy) can distort the geometry of a native valve, potentially leading to its dysfunction. However, the vast majority of patients undergoing valve surgery, such as mitral valve surgery (MV), suffer from a degenerative condition that causes dysfunction of one leaflet (e.g., leaflets 302, 304) of a native valve (e.g., the mitral valve).of the mitral valve (MV), which leads to a prolapse and regurgitation.

[0017] In general, a native valve can fail in two different ways. One possible malfunction is valve stenosis, which occurs when a native valve does not open fully, thus obstructing blood flow. Typically, valve stenosis results from the buildup of calcified material on the leaflets of a valve, causing the leaflets to thicken and impairing the valve's ability to open fully and allow forward blood flow.

[0018] Another possible malfunction is valve regurgitation, which occurs when the valve leaflets do not close completely, allowing blood to flow back into the preceding chamber (for example, blood from the left ventricle into the left atrium). There are three mechanisms by which a native valve becomes regurgitant or ineffective: Carpentier type I, type II, and type III dysfunctions. In Carpentier type I dysfunction, the annulus is so enlarged that the normally functioning leaflets are separated and no longer form a tight seal (i.e., they no longer coapt properly). Type I dysfunction also includes leaflet perforations, as seen in endocarditis. In Carpentier type II dysfunction, one or more leaflets of a native valve prolapse above a coaptation plane.In Carpentier valve type III dysfunction, the movement of one or more leaflets of a native valve is so restricted that the leaflets are abnormally narrowed below the level of the annulus. This restriction of the leaflets can be caused by a rheumatic disease (Ma) or dilatation of a ventricle (IIIb).

[0019] As in Fig. As shown in Figure 3, the anterior leaflet 302 and the posterior leaflet 304 coapte when a healthy mitral valve (MV) is in the closed position, thus preventing blood from flowing from the left ventricle (LV) into the left atrium (LA). As shown in Figure 3, the anterior leaflet 302 and the posterior leaflet 304 coapt when a healthy mitral valve (MV) is in the closed position, thus preventing blood from flowing from the left ventricle (LV) into the left atrium (LA). Fig. As shown in Figure 4, regurgitation occurs when the anterior leaflet 302 and / or the posterior leaflet 304 of the mitral valve (MV) displaces into the left atrium (LA) during systole. This failure of coaptation results in a gap (gap) 408 between the anterior leaflet 302 and the posterior leaflet 304, through which blood can flow back from the left ventricle (LV) into the left atrium (LA) during systole. As explained above, there are several ways in which a leaflet (for example, leaflets 302 and 304 of the mitral valve (MV)) can malfunction, leading to regurgitation.

[0020] Although stenosis or regurgitation can affect any valve, stenosis is most commonly found to affect either the aortic valve (AV) or the pulmonary valve (PV), while regurgitation predominantly affects either the mitral valve (MV) or the tricuspid valve (TV). Both valve stenosis and 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 flow throughout the body, malfunction of the mitral valve (MV) or the aortic valve (AV) is particularly problematic and often life-threatening.Accordingly, a malfunction of the mitral valve (MV) or the aortic valve (AV) is much more problematic due to the significantly higher pressures on the left side of the heart.

[0021] Faulty native heart valves can either be repaired or replaced. Repair usually involves preserving and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. The aortic valve (AV) and the pulmonary valve (PV) are typically more prone to narrowing. Because stenotic damage to the leaflets is irreversible, the most conventional treatments for a stenotic aortic or pulmonary valve are removal and replacement with a surgically implanted heart valve or valve displacement with a transcatheter heart valve.The mitral valve (MV) and the tricuspid valve (TV) are more prone to leaflet deformation, which, as described above, prevents the mitral or tricuspid valve from closing properly and allows regurgitation, or backflow of blood from the ventricle into the atrium (for example, a deformed mitral valve (MV) can allow regurgitation, or backflow, from the left ventricle (LV) into the left atrium (LA)). Regurgitation, or backflow of blood from the ventricle into the atrium, leads to valvular insufficiency. Deformations in the structure or shape of the mitral valve (MV) or the tricuspid valve (TV) are often repairable. Furthermore, regurgitation may occur due to a dysfunction of the chordae tendineae 501 (for example, the chordae tendineae may stretch or tear), which can cause the anterior leaflet 302 and the posterior leaflet 304 to be everted, resulting in blood regurgitating into the left atrium LA.The problems that arise due to dysfunctional chordae tendineae 501 can be resolved by repairing the chordae tendineae or the structure of the mitral valve (for example, by attaching leaflets 302, 304 to the affected section of the mitral valve).

[0022] The devices and procedures disclosed here relate to the repair of the mitral valve structure. However, it is clear that the devices and concepts presented here can be used for the repair of any native valve as well as any component of a native valve. As in Fig. As shown in Figure 4A, any of the devices and concepts presented here can be used to repair the tricuspid valve (TV). For example, any of the devices and concepts presented here can be placed between the anterior leaflet (4011), the septal leaflet (4012), and the posterior leaflet (4013) to prevent the regurgitation of blood from the right ventricle into the right atrium. Furthermore, any of the devices and concepts presented here can be applied to all three leaflets (4011, 4012, 4013) together to prevent the regurgitation of blood from the right ventricle into the right atrium. That is, the valve repair devices provided here can be positioned centrally between the three leaflets (4011, 4012, 4013).

[0023] The Fig. Figures 6-13B show a valve repair system 600 for repairing a patient's native valve. The valve repair system 600 comprises 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 native valve, and wherein the valve repair device is configured to attach to the leaflets of a native valve to repair the patient's native valve. The delivery device 601 can be of any suitable shape capable of delivering the valve repair device 602 to the patient's native valve. In certain embodiments, the valve repair system 600 is configured to deliver the valve repair device 602 to a patient's native valve during a non-open-heart procedure.Suitable delivery devices for the percutaneous delivery of the Valve Repair System 600 in a minimally invasive procedure can be delivery sheaths or delivery catheters that can be inserted through small incisions in the skin of a patient and advanced to the implantation site, for example along an endovascular (e.g. transfemoral) pathway or a transapical pathway.

[0024] The flap repair device 602 comprises a base assembly 604, a pair of paddles 606, and a pair of gripping elements 608. In an exemplary embodiment, the paddles 606 can be formed integrally with the base assembly. For example, the paddles 606 can be formed as extensions of links of the base assembly. In the example shown, the base assembly 604 of the flap repair device 602 has a shaft 603, a coupling 605 movable along the shaft, and a locking mechanism 607 configured to lock the coupling in a stationary position on the shaft. The coupling 605 is mechanically connected to the paddles 606, so that the movement of the coupling 605 along the shaft 603 causes the paddles to move between an open and a closed position.In this way, the coupling 605 serves as a means for mechanically coupling the paddles 606 to the shaft 603 and, when moved along the shaft 603, causes the paddles 606 to move between their open and closed positions. In certain embodiments, the gripping elements 608 are pivotably connected to the base assembly 604 (for example, the gripping elements 608 can be pivotally connected to the shaft 603 or another suitable element of the base assembly), so that the gripping elements can be moved to adjust the width of the opening 614 between the paddles 606 and the gripping elements 608. The gripping element 608 can have a spiked section 609 to secure the gripping elements to the flap fabric when the flap repair device 602 is attached to the flap fabric.The gripping element 608 forms a means for gripping the flap fabric (in particular the fabric of the flap sails) with an adhesive or section such as the spiked section 609. When the paddles 606 are in the closed position, the paddles engage with the gripping elements 608, so that when the flap fabric is attached to the spiked section 609 of the gripping elements, the paddles act as a holding or securing means to hold the flap fabric to the gripping elements and to attach the flap repair device 602 to the flap fabric. In some embodiments, the gripping elements 608 are configured to engage with the paddles 606, so that the spiked section 609 engages with the flap fabric element and the paddles 608 to attach the flap repair device 602 to the flap fabric element.For example, in certain situations it may be advantageous for the paddles 606 to maintain an open position and for the gripping elements 608 to move outwards towards the paddles 606 in order to engage with a flap fabric element and the paddles 606.

[0025] While the in the Fig. In the embodiment shown in Figure 6-13B, which depicts a pair of paddles 606 and a pair of gripping elements 608, the valve repair device 602 can comprise any suitable number of paddles and gripping elements. In certain embodiments, the valve repair system 600 comprises a placement shaft 613 that is detachably attached to the shaft 603 of the base assembly 604 of the valve repair device 602. After the valve repair device 602 is attached to the valve tissue, the placement shaft 613 is removed from the shaft 603 to separate 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.

[0026] The flap repair system 600 can also include a paddle control mechanism 610, a gripper control mechanism 611, and a locking control mechanism 612. The paddle control mechanism 610 is mechanically attached to the coupling 605 to move the coupling along the shaft, thereby moving the paddles 606 between the open and closed positions. The paddle control mechanism 610 can take any suitable shape, such as a shaft or a rod. For example, the paddle control mechanism can include a hollow shaft, a catheter tube, or a sheath that fits over the placement shaft 613 and the shaft 603 and is connected to the coupler 605. The gripper control mechanism 611 is configured to move the grippers 608 so that the width of the opening 614 between the grippers and the paddles 606 can be changed.The gripper control mechanism 611 can assume any suitable shape, such as a rope, suture material or wire, rod, catheter, etc.

[0027] The locking control mechanism 612 is configured to lock and unlock the detent (lock). The detent (lock) 607 serves as a locking means for locking the coupling 605 in a stationary position relative to the shaft 603 and can assume a variety of different forms, and the type of locking control mechanism 612 can be determined by the type of detent used. In one embodiment, the detent 607 assumes the form of detent mechanisms commonly used in caulking guns. The detent 607 comprises a pivoting plate with a hole, wherein the shaft 603 of the flap repair device 602 is arranged in the hole of the pivoting plate.In this embodiment, when the pivoting plate is in the tilted position, the pivoting plate engages with the shaft 603 to maintain a position on the shaft 603, but when the pivoting plate is in a substantially non-tilted position, the pivoting plate can move along the shaft (allowing the coupling 605 to move along the shaft 603). In other words, the coupling 605 is prevented from moving in the Y direction (as in ). Fig. (10A shown) along the shaft 603 when the pivoting plate of the lock 607 is in a tilted (or locked) position, and the coupling can move in the Y direction along the shaft 603 when the pivoting plate is in a substantially non-tilted (or unlocked) position. In embodiments in which the detent 607 comprises a pivoting plate, the locking control mechanism 612 is configured to engage with the pivoting plate to move the plate between the tilted and the substantially non-tilted positions. The locking control mechanisms 612 can be, for example, a rod, a suture material, a wire, or any other element capable of moving a pivoting plate of the detent 607 between a tilted and a substantially non-tilted position.In certain embodiments, the pivoting plate of the lock 607 is biased into the tilted (or locked) position, and the locking control mechanism 612 is used to move the plate from the tilted position to the substantially untilted (or unlocked) position. In other embodiments, the pivoting plate of the lock 607 is biased into the substantially untilted (or unlocked) position, and the locking control mechanism 612 is used to move the plate from the substantially untilted position to the tilted (or locked) position.

[0028] The Fig. Figures 10A-10B show how the flap repair device 602 moves from an open position (as in Fig. 10A) into a closed position (as shown in Fig. (shown in Figure 10B). The basic arrangement 604 comprises 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 coupling 605 is movably attached to the shaft 603, and the shaft 603 is attached to the fifth link 1025. The first link 1021 and the second link 1022 are pivotally attached to the coupling 605 at point A, such that a movement of the coupling 605 along the shaft 603 shifts the position of point A and consequently also moves the first link 1021 and the second link 1022. The first link 1021 and the third link 1023 are pivotally connected to each other at point B, and the second link 1022 and the fourth link 1024 are pivotally connected to each other at point C.One paddle 606a is attached to the first segment 1021 such that the movement of the first segment 1021 causes the movement of paddle 606a, and the other paddle 606b is attached to the second segment 1022 such that the movement of the second segment 1022 causes the movement of paddle 606b. Alternatively, paddles 606a and 606b can also be connected to segments 1023 and 1024, or be extensions of segments 1023 and 1024.

[0029] To remove the flap repair device from the open position (as in Fig. 10A shown) into the closed position (as shown in Fig. To bring the coupling 605 (shown in Figure 10B) into position, the coupling 605 is moved along the shaft 603 in the Y direction, thereby repositioning the pivot point A for the first links 1021 and the second link 1022. The movement of the coupling 605 (and the pivot point A) in the Y direction causes a section of the first link 1021 near point A to move in the H direction and the section of the first link 1021 near point B to move in the J direction. The paddle 606a is attached to the first link 1021 such that a movement of the coupling 605 in the Y direction causes the paddle 606a to move in the Z direction. Furthermore, the third link 1023 is pivotably attached to the first link 1021 at point B such that a movement of the coupling 605 in the Y direction causes the third link 1023 to move in the K direction.Similarly, a movement of the coupling 605 (and the pivot point A) in direction Y causes a section of the second link 1022 near point A to move in direction L, and the section of the second link 1022 near point C to move in direction M. The paddle 606b is attached to the second link 1022 such that a movement of the coupling 605 in direction Y causes the paddle 606b to move in direction V. Furthermore, the fourth link 1024 is pivotally attached to the second link 1022 at point C, such that a movement of the coupling 605 in direction Y causes the fourth link 1024 to move in direction N. Fig. Figure 10B shows the final position of the flap repair device 602 after the clutch 605 has been installed as shown in Fig. 10A was shown moving.

[0030] In Fig. Figure 7 shows the flap repair device 602 in the open position (similar to the one in Fig. Figure 10A shows the gripper control mechanism 611 moving the gripping elements 608 to create a larger gap at the opening 614 between the gripping elements and the paddles 606. In the illustrated embodiment, the gripper control mechanism 611 includes a cord, such as suture material, wire, etc., which is guided through an opening in one end of the gripping elements 608. Both ends of the cord extend through the feed opening 716 of the feed device 601. When the cord is pulled through the feed opening 716 in the Y direction, the gripping elements 608 move inward in the X direction, thereby widening the opening 614 between the gripping elements and the paddles 606.

[0031] As in Fig. As shown in Figure 8, the flap repair device 602 is depicted such that the flap fabric 820 is arranged in the opening 614 between the gripping elements 608 and the paddles 606. As shown in Fig. As shown in Figure 9, the gripper control mechanism 611 is used to reduce the width of the opening 614 between the gripping elements 608 and the paddles after the flap fabric 820 has been arranged between the gripping elements 608 and the paddles 606. That is, in the embodiment shown, the cord of the gripper control mechanism 611 is released or pushed out of the opening 716 of the conveying element in the direction H, allowing the gripping elements 608 to move in the direction D to reduce the width of the opening 614. Meanwhile, the gripper control mechanism 611 is shown moving the gripping elements 608 to increase the width of the opening 614 between the gripping elements and the paddles 606 ( Fig. 8) It is clear that the gripping elements may not need to be moved to position the flap fabric in the opening 614. However, under certain circumstances, the opening 614 between the paddles 606 and the gripping elements 608 must be wider to accommodate the flap fabric.

[0032] In Fig. 11 The flap repair device 602 is in the closed position and is attached to the flap fabric 820. The flap repair device 602 is attached to the flap fabric 820 by the paddles 606a, 606b and the gripping elements 608a, 608b. In particular, the flap fabric 820 is attached to the flap repair device 602 by the spiked section 609 of the gripping elements 608a, 608b, and the paddles 606a, 606b engage with the gripping elements 608 to attach the flap repair device 602 to the flap fabric 820. To move the flap repair device 602 from the open to the closed position, the locking mechanism 607 is moved into an unlocked state by the locking control mechanism 612 (as shown in Fig. (as shown in Figure 11). Once the locking mechanism 607 is in the unlocked state, the coupling 605 can be moved along the shaft 603 by the paddle control mechanisms 610. In the illustrated embodiment, the paddle control mechanism 610 moves the coupling 605 in a Y direction along the shaft, causing one paddle 606a to move in a direct X direction and the other paddle 606b to move in a Z direction. The movement of the paddles 606a and 606b in the X and Z directions causes the paddles to engage with the gripping elements 608a and 608b, securing the flap repair device 602 to the flap fabric 820.

[0033] According to Fig. 12, after the paddles 606 have been moved into the closed position, to attach the flap repair device 602 to the flap fabric 820 (as in Fig. 11 shown), the locking mechanism 607 by the locking control mechanism 611 ( Fig. 11) moved into the locked position to hold the flap repair device 602 in the closed position. After the flap repair device 602 is held in the locked position by the detent 607, the flap repair device 602 is removed from the feed device 601 by separating the shaft 603 from the placement shaft 613 ( Fig. 11). In addition, the flap repair device 602 is connected to the paddle control mechanism 610 ( Fig. 11), the gripper control mechanism 611 ( Fig. 11) and the locking control mechanism 612. Removing the valve repair device 602 from the delivery device 601 allows the valve repair device to remain attached to the valve tissue 820 while the delivery device 601 is removed from the patient.

[0034] In the Fig. Figures 13A-13B show the mitral valve 1300 of a patient with a valve repair device 602 attached to the anterior leaflet 1301 and the posterior leaflet 1302 of the mitral valve. Fig. Figures 13A-13B are views of the atrium side of the mitral valve 1300, with sections of the valve repair device 602 and the absorbed tissue of the mitral valve leaflet on the ventricular side of the mitral valve shown in hidden lines. During the diastolic phase (as in Fig. (as shown in Figure 1) the blood collected in the left atrium of the heart enters the mitral valve 1300 through the expansion of the left ventricle. The anterior leaflet 1301 and the posterior leaflet 1302 open to allow blood to flow from the left atrium into the left ventricle. During the systolic phase (as shown in Figure 1), the blood collected in the left atrium is forced into the left ventricle. Fig. (as shown in Figure 2) the left ventricle contracts to pump blood through the aortic valve and up the aorta into the body. During systole, the leaflets of the mitral valve (MV) close to prevent blood from regurgitating back into the left atrium (LA). As described above, regurgitation of blood from the left ventricle into the left atrium through the mitral valve occurs if the anterior leaflet (1301) and the posterior leaflet (1302) do not close completely, leaving a gap between the anterior and posterior leaflets. To repair a damaged mitral valve (1300) and prevent regurgitation of blood through the mitral valve, the valve repair device (602) connects to the anterior leaflet (1301) and the posterior leaflet (1302) to close the gap.

[0035] In Fig. Figure 13A shows the mitral valve 1300 from the left atrium of a patient's heart (for example, from the view through line AA in Fig. 5 (see view shown). In the embodiment shown, the mitral valve 1300 is shown in an open position (i.e., the position the mitral valve assumes during the diastolic phase). 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 is inserted into the Fig. Figures 13A-13B are shown by dashed lines to indicate the location of the valve repair device in relation to the mitral valve. As shown in the Fig. As shown in Figures 13A-13B, the valve repair device 602 engages with the anterior leaflet 1301 and the posterior leaflet 1302, causing the anterior and posterior leaflets to engage with each other (i.e., the valve repair device closes a portion of the gap between the anterior and posterior leaflets). The valve repair device 602 can be positioned at a location where a gap exists between the anterior and posterior leaflets 1301 when the mitral valve 1301 is in a closed position (i.e., the position of the mitral valve during the systolic phase), so that the valve repair device prevents the gap from forming. The illustrated embodiment shows the mitral valve 1300 and the valve repair device 602 in the diastolic phase.That is, during the diastolic phase, the valve repair device 602 causes a section of the mitral valve to remain closed, but the sections of the mitral valve where the valve repair device does not act open, so that gaps 1303 are created which allow blood flow from the left atrium to the left ventricle.

[0036] As in Fig. As shown in Figure 13B, the flap repair device 602 is attached to both the anterior flap 1301 and the posterior flap 1302. In particular, a section 1301a of the anterior flap 1301 is attached between a paddle 606a and a gripping element 608a of the flap repair device 602, and a section 1302b of the posterior flap 1302 is attached between another paddle 606b and another gripping element 608b of the flap repair device. The flap repair device 602 is attached to the mitral flap 1300 and locked in place, for example as shown in the Fig. Shown 6-12.

[0037] The Fig. Figures 14A-14B show exemplary embodiments of a valve repair device 602 attached to the anterior leaflet 1301 and the posterior leaflet 1302 of a mitral valve 1300. The mitral valve 1300 is shown from the left atrium of the heart of a patient (for example, from the area defined by line AA in Figure 14A-14B). Fig. 5 specified view). With reference to the Fig. 14A-14B, the flap repair device 602 comprises a first paddle 606a, a second paddle 606b, a first gripping element 608a, and a second gripping element 608b. A section 1301a of the anterior sail 1301 is attached between the first paddle 606a and the first gripping element 608a of the flap repair device 602, and a section 1302b of the posterior sail 1302 is attached between the second paddle 606b and the second gripping element 608b of the flap repair device. The first and second paddles 606a, 606b comprise a main section 1404 and side sections 1405. With reference to Fig. In 14A, the flap repair device 602 is configured such that the sections 1301a, 1302b of the mitral flap 1300 match or substantially match the shape of the paddles 606a, 606b. That is, the sections 1301a, 1302b of the flap sail are pressed into the paddles by the gripping elements 608a, 608b, so that the sections 1301a, 1301b of the flap sail are arranged along a main section 1404 and the side sections 1405 of the paddles 606a, 606b. In the Fig. In the embodiment of the flap repair device 602 shown in Figure 14A, the paddles 606a, 606b can be made of a rigid material, for example steel, molded plastic, etc.

[0038] In the exemplary embodiment shown in Fig. As shown in Figure 14B, the paddles 606a, 606b of the flap repair device 602 are configured to bend. When the flap repair device is attached to the mitral valve 1300, this bending causes the sections 1301a, 1302b of the mitral valve flap fabric to move the lateral sections 1405 of the paddles, as indicated by the arrows 1450, thus reducing the load exerted on the mitral valve by the flap repair device compared to that shown in Figure 14B. Fig. The embodiment shown in Figure 14A is reduced. That is, the bending results in a more gradual contouring of the mitral valve tissue by the paddles, while the valve repair device 602 is still securely attached to the mitral valve tissue. In the embodiment shown in Fig. In the embodiment of flap repair device 602 shown in Figure 14B, the paddles 606a, 606b can be made from a variety of different flexible or rigid materials which have been cut or otherwise machined to provide flexibility.

[0039] The Fig. Figures 15A-15B show another exemplary embodiment of a flap repair device 602. As in Fig. As shown in Figure 15A, the valve repair device 602 is in the open position and is about to engage with valve tissue 820 (for example, the leaflets of a mitral valve). As shown in Fig. As shown in Figure 15B, the flap repair device 602 is in the closed position and is attached to the flap fabric 820. The flap repair device 602 can assume any suitable shape, such as any shape described in the present application. The flap repair device 602 can be moved between the open and closed positions and attached to the flap fabric 820 by a flap repair system, such as a flap repair system described in the present application. In the embodiment shown, the flap repair device 602 comprises paddles 606 and gripping elements 608. The gripping elements 608 comprise a spiked section 609 for attaching the gripping elements to the flap fabric 820. As shown in Figure 15B, the flap repair device 602 can be moved between the open and closed positions and attached to the flap fabric 820. Fig. As shown in Figure 15A, the paddles 606 retain their original shape when the flap repair device 602 is in the open position. With reference to Fig. 15B The paddles 606 bend along their length L upon contact with the flap fabric 820. That is, one section of the paddles 606 bends in an inward direction X, and another section of the paddles extends in an outward direction Z. This bending of the paddles 606 allows the paddles to adapt to the shape of the flap fabric, thereby reducing the stress on the flap fabric.

[0040] As in the Fig. Figures 16A-16F illustrate another exemplary embodiment of a flap repair device 602, comprising a paddle 606 with a wire loop 1601. The wire loop 1601 can be made, for example, from any suitable metal material, from laser-cut loops of Nitinol sheet, Nitinol tube, or other suitable material. In some embodiments, the wire loop 1601 can have different dimensions along its entire length to optimize the paddle's crushing force and crimping force on the flap fabric when the paddle engages with the flap fabric. For example, certain sections of the wire loop 1601 can be thinner than other sections.In certain embodiments, the wire loop 1601 of the paddle 606 is compressible, so that the paddle 606 can be arranged in a delivery device 601 (for example, a catheter) which has a small diameter (as in . Fig. 16E) for the delivery device of the valve repair device 602 to a patient's native valve, and also allows the paddles 606 to expand upon exiting the delivery device 601 (as shown in the Fig. (shown in Figures 16A-16D), so that the paddles 606 have a larger surface area to engage with the patient's native valve. The valve repair device 602 can take any suitable shape, such as any shape described in the present application. The valve repair device 602 can be moved between the open and closed positions and attached to a native valve by a valve repair system, such as a valve repair system described in the present application.

[0041] The Fig. Figures 16A-16B show the flap repair device 602 in the open position, and the Fig. Figures 16C-16D show the flap repair device in the closed position. As shown in the Fig. As shown in Figures 16A-16B, the paddles 606 extend outwards when the flap repair device 602 is in the expanded and open position to create a wide opening 614 between the paddles 606 and the gripping elements 608 of the flap repair device 602. Fig. As shown in Figures 16C-16D, the paddles 606 engage with the gripping elements 608 when the flap repair device 602 is in the expanded and closed position, allowing the flap fabric to be secured between the paddles and the gripping elements. The paddles 606 have a curved surface 1603 configured to exert less pressure on the flap fabric when the flap repair device 602 is attached to the flap fabric. When the paddles 606 are in the expanded state, they have a width W. The width W can be, for example, between about 4 mm and about 21 mm, between about 5 mm and about 20 mm, between about 7.5 mm and about 17.5 mm, or between about 10 mm and about 15 mm. In certain embodiments, the width W may be, for example, 5 mm or more, such as 7.5 mm or more, such as 10 mm or more, such as 15 mm or more, such as 20 mm or more.In other embodiments, the width W can be less than 5 mm. In certain embodiments, the paddles 606 comprise a material 1605 arranged over the wire loop 1601 to provide a contact surface for the paddles to engage with the flap fabric. The material 1605 can be any suitable material, such as a woven material, an electrospun material, or any other material capable of promoting fabric ingrowth and lining the feed device 601. Fig. 6) to protect during movement. In certain embodiments, material 1605 may be a blood-impermeable fabric, such as a PET fabric, or a biocompatible covering material, such as a fabric treated with a blood-impermeable coating, polyester, or a processed biological material, such as pericardium.

[0042] As in Fig. As shown in Figure 16E, the paddles 606 are in a compressed state when arranged in a feeder 601. When the paddles 606 are in the compressed state, they have a width H. The width H can be, for example, between about 4 mm and about 7 mm, or between about 5 mm and about 6 mm. In other embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed paddle 606 is essentially the same as the width D of the feed opening 716 of the feeder 601. The ratio between the width W of the paddles in the expanded state and the width H of the paddles in the compressed state can be, for example, about 4 to 1 or less, about 3 to 1 or less, about 2 to 1 or less, about 1.5 to 1, about 1.25 to 1, or about 1 to 1.In other embodiments, the ratio between the width W and the width H can be greater than 4 to 1. With reference to... Fig. 16F a paddle 606 is moved from the expanded state to the compressed state by compressing the paddle in the direction Y and extending a length of the paddle in the direction X.

[0043] The Fig. Figures 16G-16H show a further exemplary embodiment of a flap repair device 602 in the open position, wherein the flap repair device has paddles 606 with a wire loop 1601. In the embodiment shown, the paddles 606 with a wire loop 1601 are shown, which comprises three wings 1611. Another exemplary embodiment of a flap repair device 602, which relates to the Fig. 16I-16J refers to paddle 606 with a wire loop 1601 with two wings 1611. While the in the Fig. In the embodiments shown in Figures 16G-16H and 16I-16J, where the wire loop 1601 of the paddle 606 has three or two wings, respectively, the flap repair device 602 can comprise a paddle 606 with a wire loop 1601 having any number of wings 1611, such as two or more wings, three or more wings, four or more wings, five or more wings, and the like. A paddle 606 having a wire loop 1601 with wings is advantageous because a paddle with wings allows the chordae tendineae to assume their natural positions more easily than a single wire loop without wings. That is, the chordae tendineae can move into the spaces between the multiple loops.

[0044] The embodiments of the in the Fig. The flap repair devices 602 shown in 16G-16H and 16I-16J can be used for any of the above with reference to the Fig. exhibit the characteristics described in sections 16A-16F. For example, the characteristics described in the Fig. In embodiments of the flap repair devices 602 shown in Figures 16G-16H and 16I-16J, 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 certain embodiments, the width W may be, for example, 5 mm or more, such as 7.5 mm or more, such as 10 mm or more, such as 15 mm or more, such as 20 mm or more. In other embodiments, the width W may be less than 5 mm. The dimensions shown in the Fig. In embodiments 16G-16H and 16I-16J for the paddles 606, this may also include a material arranged over the wire loop 1601 to provide a contact surface for the paddles to engage with the flap fabric. The material may be any suitable material, such as a woven material, an electrospun material, or any other suitable material capable of promoting fabric ingrowth and lining the feed device 601 ( Fig. 6) to protect during movement. In certain embodiments, material 1605 may be a blood-impermeable fabric, e.g., a PET fabric, or a biocompatible covering material, e.g., a fabric treated with a blood-impermeable coating, polyester, or a processed biological material, e.g., pericardium. The [unclear] Fig. The embodiments of the paddles 606 shown in Figures 16G-16H and 16I-16J can also be compressed when they are arranged in a feed device 601 (for example, as shown in Figure 16G-16H and 16I-16J). Fig. 16E in relation to the in the Fig. (16A-16B shown embodiment of the paddle 606). The ratio between the width W of the paddle 606 in the expanded state and the width of the paddle in the compressed state may, for example, be 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 other embodiments, the ratio between the width W and the width H may be more than 4 to 1.

[0045] As in the Fig. Figures 17A-17F illustrate another exemplary embodiment of a valve repair device 602 comprising paddles 606 having a horseshoe shape 1701. In certain embodiments, the horseshoe shape 1701 of the paddles 606 is compressible, allowing the paddles 606 to be arranged in a delivery device 601 (for example, a catheter) having a small diameter (as shown in the Fig. 17F) for the delivery of the valve repair device 602 to a patient's native valve, and also allows the paddles 606 to expand upon exiting the delivery device 601 (as shown in the Fig. (shown in Figures 17A-17D), so that the paddles 606 have a larger surface area to engage with the patient's native valve. The valve repair device 602 can assume any suitable shape, such as any shape described in the present application. The valve repair device 602 can be moved between the open and closed positions and attached to a native valve by a valve repair system, such as a valve repair system described in the present application.

[0046] The Fig. Figures 17A-17C show the flap repair device 602 in the open position. As shown in the Fig. As shown in Figures 17A-17B, the paddles 606 extend outwards when the flap repair device 602 is in the expanded and open position to form a wide opening 614 between the paddles 606 and the gripping elements 608 of the flap repair device 602. In the illustrated embodiment, the horseshoe shape 1701 of the paddles 606 comprises side elements 1707 extending from a base 1706 of the paddle 606 and a central element 1709 extending from the base 1706 and connected to a base assembly 604 of the flap repair device 602, the side elements 1707 forming a horseshoe shape, as shown, for example, in Fig. 17C shown. In certain embodiments, the paddles 606 comprise a material 1705 arranged over the horseshoe shape 1701 to provide a contact surface for the paddles to engage with the flap tissue. The material 1705 can be any suitable material, such as a woven material, an electrospun material, or any other material capable of promoting tissue ingrowth and lining the feed device 601 ( Fig. 6) to protect during movement. In certain embodiments, material 1605 may be a blood-impermeable fabric, such as a PET fabric, or a biocompatible covering material, such as a fabric treated with a blood-impermeable coating, polyester, or a processed biological material, such as pericardium.

[0047] In various embodiments, the paddles 606 are configured to flex in order to reduce stress on the flap fabric when the flap repair device 602 is attached to the flap fabric. When the paddles 606 are in the expanded state, they have 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 certain embodiments, the width W can be, for example, 5 mm or more, such as 7.5 mm or more, such as 10 mm or more, such as 15 mm or more, such as 20 mm or more. In other embodiments, the width W can be less than 5 mm. With reference to Fig. 17D In certain 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 other embodiments, the thickness T of the paddle may be less than 0.3 mm or more than 0.46 mm.

[0048] As in Fig. As shown in Figure 17E, the paddles 606 are in a compressed state when arranged in a feed device 601. When the paddles 606 are in the compressed state, they have a width H. The width H can be, for example, between about 4 mm and about 7 mm, or between about 5 mm and about 6 mm. In other embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed paddles 606 corresponds to a width D of the feed opening 716 of the device 601. The ratio between the width W of the paddles in the expanded state and the width H of the paddles in the compressed state can be, for example, about 4 to 1 or less, about 3 to 1 or less, about 2 to 1 or less, about 1.5 to 1, about 1.25 to 1, or about 1 to 1.In other embodiments, the ratio between the width W and the width H can be greater than 4 to 1. With reference to... Fig. In 17F, a paddle 606 is moved from the expanded state to the compressed state by compressing the paddle in the Y direction and stretching a length of the paddle in the X direction. In the illustrated embodiment, the length of the side elements 1707 of the paddle 606 is stretched when the paddle is in the compressed state, but the length of the central element 1709 remains the same.

[0049] As in the Fig. Figures 18A-18D illustrate another exemplary embodiment of a valve repair device 602 comprising paddles 606 having a different horseshoe shape 1801. In certain embodiments, the horseshoe shape 1801 of the paddles 606 is compressible, so that the paddles 606 can be arranged in a delivery device 601 (for example, a catheter) having a small diameter (as in the Fig. 18C) for the delivery of the valve repair device 602 to a patient's native valve, and also allows the paddles 606 to expand (as shown in the Fig. (shown in Figures 18A-18B) when they exit the feed device 601, so that the paddles 606 have a larger surface area to engage with the patient's native valve. The valve repair device 602 can take any suitable shape, such as any shape described in the present application. The valve repair device 602 can be moved between the open and closed positions and attached to a native valve by a valve repair system, such as any valve repair system described in the present application.

[0050] The Fig. Figures 18A-18B show the flap repair device 602 in the open position. When the flap repair device 602 is in the open position, the paddles 606 extend outwards to create a wide opening 614 between the paddles 606 and the gripping elements 608 of the flap repair device 602. In the embodiment shown, the horseshoe shape 1801 of the paddles 606 comprises side parts 1807 extending from a base 1806 of the paddles 606, and the base 1806 is attached to the base assembly 604 of the flap repair device 602. In certain embodiments, the paddles 606 comprise a material 1805 arranged above the horseshoe shape 1801 to provide a contact surface for the paddles to engage with the flap tissue.The material 1805 can be any suitable material, such as a woven material, an electrospun material or any other material capable of promoting the ingrowth of fabric and lining the feed device 601 (. Fig. 6) to protect during movement. In certain embodiments, material 1605 may be a blood-impermeable fabric, such as a PET fabric, or a biocompatible covering material, such as a fabric treated with a blood-impermeable coating, polyester, or a processed biological material, such as pericardium.

[0051] In various embodiments, the paddles 606 are configured to flex in order to reduce stress on the flap fabric when the flap repair device 602 is attached to the flap fabric. When the paddles 606 are in the expanded state, they have 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 certain embodiments, the width W can be, for example, 5 mm or more, such as 7.5 mm or more, such as 10 mm or more, such as 15 mm or more, such as 20 mm or more. In other embodiments, the width W can be less than 5 mm.

[0052] As in Fig. As shown in Figure 18C, the paddles 606 are in a compressed state when arranged in a feed device 601. When the paddles 606 are in the compressed state, they have a width H. The width H can be, for example, between about 4 mm and about 7 mm, or between about 5 mm and about 6 mm. In other embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed paddles 606 corresponds to a width D of the feed opening 716 of the device 601. The ratio between the width W of the paddles in the expanded state and the width H of the paddles in the compressed state can be, for example, about 4 to 1 or less, about 3 to 1 or less, about 2 to 1 or less, about 1.5 to 1, about 1.25 to 1, or about 1 to 1.In other embodiments, the ratio between the width W and the width H can be greater than 4 to 1. As in . Fig. As shown in Figure 18D, a paddle 606 is moved from the expanded state to the compressed state by compressing the paddle in the Y direction and stretching a length of the paddle in the X direction. In the illustrated embodiment, the length of the side elements 1807 of the paddle 606 is stretched when the paddle is in the compressed state. As shown in Fig. As shown in Figure 18C, in certain embodiments the side elements 1807 of the paddles cross each other when the paddles 606 are arranged in the feed device 601 and are in the compressed state.

[0053] As in the Fig. Figures 19A-19D illustrate another exemplary embodiment of a valve repair device 602 comprising paddles 606 having a mesh structure 1901. In certain embodiments, the mesh structure 1901 of the paddles 606 is compressible, which makes it possible to arrange the paddles 606 in a delivery device 601 (for example, a catheter) having a small diameter (as in the Fig. 19C) for the delivery of the valve repair device 602 to a patient's native valve, and also allows the paddles 606 to expand upon exiting the delivery device 601 (as shown in the Fig. (shown in Figures 19A-19B), so that the paddles 606 have a larger surface area to engage with the patient's native valve. The valve repair device 602 can take any suitable shape, such as any shape described in the present application. The valve repair device 602 can be moved between the open and closed positions and attached to a native valve by a valve repair system, such as any valve repair system described in the present application.

[0054] The Fig. Figures 19A-19B show the flap repair device 602 in the open position. When the flap repair device 602 is in the expanded and open position, the paddles 606 extend outwards to create a wide opening 614 between the paddles 606 and the gripping elements 608 of the flap repair device 602. In certain embodiments, the paddles 606 comprise a material arranged over the mesh structure 1901, such as a woven material, an electrospun material, or another material capable of promoting the ingrowth of fabric and the linings of the feed device 601 ( Fig. 6) to protect during movement. In certain embodiments, material 1605 may be a blood-impermeable fabric, such as a PET fabric, or a biocompatible covering material, such as a fabric treated with a blood-impermeable coating, polyester, or a processed biological material, such as pericardium.

[0055] In various embodiments, the paddles 606 are configured to flex in order to reduce stress on the flap fabric when the flap repair device 602 is attached to the flap fabric. When the paddles 606 are in the expanded state, they have 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 certain embodiments, the width W can be, for example, 5 mm or more, such as 7.5 mm or more, such as 10 mm or more, such as 15 mm or more, such as 20 mm or more. In other embodiments, the width W can be less than 5 mm.

[0056] As in Fig. As shown in Figure 19C, the paddles 606 are in a compressed state when arranged in a feed device 601. When the paddles 606 are in the compressed state, they have a width H. The width H can be, for example, between about 4 mm and about 7 mm, or between about 5 mm and about 6 mm. In other embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed paddles 606 corresponds to a width D of the feed opening 716 of the feed device 601. The ratio between the width W of the paddles in the expanded state and the width H of the paddles in the compressed state can be, for example, about 4 to 1 or less, about 3 to 1 or less, about 2 to 1 or less, about 1.5 to 1, about 1.25 to 1, or about 1 to 1.In other embodiments, the ratio between the width W and the width H can be greater than 4 to 1. As in . Fig. As shown in Figure 19D, a paddle 606 is moved from the expanded state to the compressed state by compressing the paddle in the Y direction and stretching a length of the paddle in the X direction.

[0057] As in the Fig. Figures 20A-20B illustrate another exemplary embodiment of a valve repair device comprising paddles 606 which are compressible, thereby enabling the paddles 606 to be arranged in a delivery device 601 (for example, a catheter) which has a small diameter (as shown in Figure 20A-20B). Fig. 20A), for delivering the valve repair device to a patient's native valve, and also allows the paddles 606 to expand upon exiting the delivery device 601 (as shown in Fig. (20B shown), so that the paddles 606 have a larger surface area to engage with the patient's native valve. The paddles 606 can be contained in a valve repair device 602, which can take any suitable shape, such as any shape described in the present application. The valve repair device (and the paddles 606) can be attached to a native valve by a valve repair system, such as any valve repair system described in the present application.

[0058] Fig. Figure 20A shows the paddle 606 in a compressed state within a feed device 601. The paddle has an opening 2001 that allows a section of the paddle to expand when it is ejected from the feed device 601. In the compressed state, the paddle 606 may, for example, have a width H between approximately 4 mm and approximately 7 mm, or between approximately 5 mm and approximately 6 mm. In other embodiments, the width H may be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed paddle 606 is equal to the width D of the feed opening 716 of the feed device 601. Fig. Figure 20B shows the paddle 606 in an expanded state. In the expanded state, the paddle 606 can, for example, have a width W between about 4 mm and about 21 mm, for example between about 5 mm and about 20 mm, for example between about 7.5 mm and about 17.5 mm, for example between about 10 mm and about 15 mm. In certain 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. 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 other embodiments, the ratio between the width W and the width H can be greater than 4 to 1. As in . Fig. As shown in Figure 20B, a paddle 606 is moved from the expanded state to the compressed state by compressing the paddle in the Y direction. In various embodiments, the paddles 606 are configured to flex in order to reduce stress on the flap tissue when the flap repair device 602 is attached to the flap tissue. In certain embodiments, the paddles 606 comprise a material arranged above the paddle 606, such as any material capable of promoting tissue ingrowth and lining the feed device 601 ( Fig. 6) to protect during movement. In certain embodiments, the material may be a blood-impermeable fabric, such as a PET fabric, or a biocompatible covering material, such as a fabric treated with a blood-impermeable coating, polyester, or a processed biological material, such as pericardium.

[0059] The Fig. Figures 21A-21B show a further exemplary embodiment of a flap repair system 600, in which the flap repair system 600 comprises a flap repair device 602 having extendable paddles. The flap repair system 600 can take any suitable shape, such as any shape described in the present application. In the embodiment shown, the flap repair device 602 comprises paddles 606 which are extendable so that the length L of the paddles can be changed. That is, the paddles 606 comprise a main section 2110 and an extendable section 2112. The extendable section 2112 can be accommodated within the main section 2110 to produce paddles with a shorter length L (as in Fig. 21A), and the extendable section 2112 can extend outside the main section to produce paddles of a longer length L (as shown in Fig. 21B). The ratio between the shorter length L (as shown in Fig. 21A) and the longer length L (as shown in Fig. 21B shown) can be, for example, 1.25 to 1 or more, such as 1.5 to 1 or more, such as 2 to 1 or more, such as 2 to 1 or more, such as 4 to 1 or more, such as 5 to 1 or more.

[0060] In one embodiment, the main section 2110 is a hollow channel having an opening, and the extendable section 2112 is a rod or channel configured to fit within the opening of the hollow element. In certain embodiments, the extendable section 2112 is spring-loaded, such that it is biased toward the extended position, and a locking element is arranged in a locked position to hold the extendable section 2112, housed within the main section 2110, in the retracted position. Movement of the locking element from the locked position to an unlocked position causes the spring-loaded extendable section 2112 to move out of the main section 2110 and into the extended position.Furthermore, the extendable section 2112 can be moved back into the main section 2110, and the locking element can be moved from the unlocked position to the locked position to move the paddles from the extended position to the retracted position. The locking element can be moved between the locked and unlocked positions by any suitable means, for example, by a rod engaging with the locking element to move it between the locked and unlocked positions.In an alternative embodiment, a suture material or wire extends through the main section 2110 and engages with the extendable section 2112 to hold the extendable section 2112 in the non-extended position, and the removal of the suture material or wire allows the spring-loaded extendable section to move out of the main section 2110 and into the extended position.

[0061] As in Fig. As shown in Figure 21A, the flap repair device 602 with the paddles 606 is in a retracted position, and the flap repair device is positioned to engage with the flap fabric 820. With reference to Fig. 21B After the valve repair device 602 is positioned to engage with the valve tissue 820, the extendable sections 2112 of the paddles 606 are extended so that the paddles have a larger surface area for engagement with the valve tissue. Once the paddles 606 have extended to a desired length L, the valve repair device 602 is closed to secure it to the valve tissue 820, and the device is removed from the valve repair system 600. In certain embodiments, the valve repair device 602 is configured such that the extendable sections 2112 of the paddles can be extended or retracted after the device is secured to the valve tissue 820, allowing the tension on the valve tissue to be increased or decreased depending on the patient and the procedural circumstances.For example, in embodiments where the valve tissue 820 is a patient's mitral valve, a valve with excessive leaflet material or tendon damage may require more tension to adequately seal the mitral valve, or a valve with short, non-coapting leaflets may require less tension to adequately seal the mitral valve. The valve repair device can be moved from the open position to a closed position and removed from the valve repair system 600 in any suitable manner, such as any manner described in the present application.

[0062] As in the Fig. As shown in Figures 22-26, in certain embodiments the gripper control mechanism 611 is configured to control each of the gripping elements 608 independently. Independent control for each of the gripping elements 608 is advantageous because the openings 614 between the paddles 606 and the gripping elements can be adjusted independently while the valve repair device 602 is being attached to the valve tissue (for example, a patient's mitral valve). Furthermore, independent gripper control is also advantageous in situations where one gripping element 608 and one paddle 606 can adequately secure the valve repair device 602 to a first section of the valve tissue, but the other gripping element and paddle cannot connect the valve repair device to a second section of the valve tissue.In this situation, the gripper control mechanism 611 can be used to control only the gripper element 608, which is not connected to the flap fabric, to create an opening 614 to receive the second section of the flap fabric, and after the second section of the flap fabric is arranged in the opening, the unattached gripper element and the unattached paddle can be closed to attach the flap repair device 602 to the second section of the flap fabric.

[0063] What next in the Fig. Figures 22-26 illustrate an exemplary embodiment of a valve repair system 600 comprising 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 the leaflets of a native valve to repair the patient's native valve. The delivery device 601 can assume any suitable shape capable of delivering the valve repair device 602 to a patient's native valve, such as any shape described in the present application. The valve repair device 602 is similar to the valve repair device described above and comprises a base assembly 604, a pair of paddles 606, and a pair of gripping elements 608.The basic assembly 604 of the flap repair device 602 comprises a shaft 603, a coupling 605 configured to move along the shaft, and a locking device 607 configured to lock the coupling in a stationary position on the shaft. The flap repair device 602 can take any suitable form, such as any form described in the present application. The flap repair system 600 can also include a paddle control mechanism 610, a gripper control mechanism 611, and a locking control mechanism 612. The paddle control mechanism 610 is mechanically connected to the coupling 605 to move the coupling along the shaft 603, thereby moving the paddles 606 between the open and closed positions. The paddle control mechanism 610 can take any suitable form, such as any form described in the present application.The locking control mechanism 612 is configured to move the coupling 605 between the locked and unlocked states. The locking control mechanism 612 can take any suitable form, such as any form described in the present application.

[0064] As in Fig. Figure 22 shows an exemplary embodiment of a gripper control mechanism 611 comprising a first gripper control element 2202 and a second gripper control element 2204. The first gripper control element 2202 is configured to move the gripper element 608a in the X direction, and the second gripper control element 2204 is configured to move the gripper element 608b in the Z direction. Moving the gripper element 608a in the X direction adjusts the width W of the opening 614a between the gripper element 608a and the paddle 606a, and moving the gripper element 608b in the Z direction adjusts the width H of the opening between the gripper element 608b and the paddle 606b. The gripper control elements 2202, 2204 can assume any suitable shape capable of moving the gripper elements 608a, 608b independently of one another. In the embodiment shown, the gripper control elements 2202, 2204 are lines, such as, for example,Suture material, wires, etc., which are detachably attached to each of the gripping elements 608a, 608b, with both ends of the cord extending through the feed opening 716 of the feed device 601. The gripper control elements 2202, 2204 can be independently drawn into and ejected from the catheter to independently control the positions of the gripping elements 608a, 608b.

[0065] As in the Fig. Figures 22A-22D show another exemplary embodiment of the flap repair system 600 with a different embodiment of a gripper control mechanism 611, which serves to control the gripping elements 608a-d of another exemplary embodiment of a flap repair device 602. For clarity, the paddles 606 of the flap repair device 602 are shown in the Fig. 22A-22D not shown, but it should be noted that the flap repair device 602 also comprises paddles 606 which cooperate with the gripping elements 608a-d to attach the flap repair device 602 to the flap fabric, the paddles 606 being able to take any suitable shape, such as any shape described in the present application. Fig. Figure 22A shows the flap repair system 600 with each of the four gripping elements 608a-d in a first position, and Fig. Figure 22C shows the flap repair system 600 with one of the gripping elements 608a in a second position. Fig. 22B is a top view (as seen through the in Fig. 22A shown lines 22B-22B) to the flap repair system 600, wherein each of the gripping elements 608a-d is in a first position. Fig. 22D is a cross-sectional view (as shown in Fig. (Lines CC shown in Figure 22C) of the flap repair system 600, with the gripping element 608a in the second position. Each of the four gripping elements can be moved independently of one another in the same manner as shown by the gripping element 608a.

[0066] The valve repair device 602 comprises a first gripping element 608a, a second gripping element 608b, a third gripping element 608c, and a fourth gripping element 608d. Each of the gripping elements 608a-d includes a spiked section 609a-d for attaching the gripping elements 608a-d to the valve tissue. The gripper control mechanism 611 comprises a first gripper control element 2202a configured to control the first gripping element 608a, a second gripper control element 2202b configured to control the second gripping element 608b, a third gripper control element 2202c configured to control the third gripping element 608c, and a fourth gripper control element 2202d configured to control the fourth gripping element 608d.Specifically, the first gripper control 2202a is configured to move the gripper 608a in the X direction, and the second gripper control 2202b is configured to move the second gripper 608b in the X direction. Furthermore, the third gripper control 2202c is configured to move the gripper 608c in the Z direction, and the fourth gripper control 2202d is configured to move the fourth gripper 608d in the Z direction. Moving the gripper elements 608a-b in the X direction adjusts the width of the opening between the gripper elements 608a-b and the corresponding paddle 606, and moving the gripper elements 608c-d in the Z direction adjusts the width of the opening between the gripper elements 608c-d and the corresponding paddle. The gripper control mechanism 611 is configured so that each of the gripping elements 608a-d can be moved independently of each other.The gripper control elements 2202a-d can assume any suitable shape capable of independently moving the gripping elements 608a-d. In the illustrated embodiment, the gripper control elements 2202a-d are cords, such as suture material, wires, etc., which are detachably attached to each of the gripping elements 608a-d, with both ends of the cord extending through the feed opening 716 of the feed device 601. The gripper control elements 2202a-d can be independently drawn into and released from the catheter to independently control the positions of the gripping elements 608a-d.

[0067] As in the Fig. 22A and Fig. As shown in Figure 22B, each of the gripping elements 608a-d is in an extended position. In the Fig. 22C and Fig. Figure 22D shows the first gripping element 608a after the first gripper control element 2202a of the gripper control mechanism has been drawn into the catheter, causing the first gripping element 608a to move inwards towards the shaft 603 in the X direction, while the other gripping elements 608b-d are in the Fig. 22A and Fig. Remain in the position shown on 22B. In other words, those in the Fig. The embodiment shown in Figures 22A-22D depicts a first gripping element 608a that is controlled independently relative to the other gripping elements 608b-d. Although the illustrated embodiment shows that the first gripping element 608a is controlled independently, each of the gripping elements 608a-d can be controlled independently by the corresponding gripper control element 2202a-d of the gripper control mechanism 611. While the gripping elements shown in the Fig. In the embodiment shown in Figures 22A-22D, a flap repair arrangement 600 is shown, which has four gripping elements 608a-d and four gripper control elements 2202a-d. It can also be assumed that any number of gripping elements and gripper control elements can be used, and that any number of gripping elements can be controlled independently of one another by the gripper control mechanism. Furthermore, each of the gripping elements 608a-608d can have any of the configurations disclosed in this application, and each of the control devices 2202a-2202d can have any of the shapes disclosed in this application.

[0068] As in Fig. As shown in Figure 23, another exemplary embodiment of a gripper control mechanism 611 comprises a single cord 2302, e.g., suture material or wire, which is detachably attached to the gripping elements 608a, 608b and detachably fastened between a placement shaft 613 and a shaft 603 of the flap repair device. The connection 615 between the placement shaft 613 and a shaft 603 of the flap repair device can be located in a variety of different positions. In the example shown, the connection 615 is aligned with or substantially in line with the ends of the gripping elements 608a, 608b. In other embodiments, however, the connection 615 can also be located further distally, for example, in the most proximal position possible that the coupling 605 can reach (see, for example, the illustrations in the Fig. 45°C and Fig. (46D shown release positions of the coupling). The single line 2302 is connected between the shaft 613 and the shaft 603, so that the single line 2302 can independently control the gripping elements 608a, 608b. That is, the movement of a first section 2303 of the line 2302 in direction Y sets the width W between the gripping element 608a and the paddle 606a, but not the width H between the gripping element 608b and the paddle 606b. Similarly, the movement of a second section 2305 of the line 2302 in direction M sets the width H between the gripping element 608b and the paddle 606b, but not the width W between the gripping element 608a and the paddle 606a. Once the flap repair device 602 is in the closed position and attached to the flap fabric, the placement shaft 613 is detached from the shaft 603 of the flap repair device 602.Releasing the shaft 603 from the shaft 613 releases the cord. The cord 2302 can then be retracted into the catheter to release the gripping elements 608a and 608b by pulling one end of the cord 2302 into the catheter. Pulling one end of the cord into the catheter draws the other end of the cord through the gripping elements 608a and 608b and then into the catheter. Each of the cords described here can be retracted in this manner.

[0069] As in Fig. As shown in Figure 24, in certain embodiments the placement shaft 613 and the shaft 603 of the device 602 can be hollow and fit over a coupling shaft 2400 that holds the shafts 613 and 603 together. The shaft 603 of the device 602 can have a projecting section 2406 and a recessed receiving section 2408. The placement shaft 613 can have a projecting section 2407 and a recessed receiving section 2409. When the shafts 613 and 603 are coupled, the forward section 2406 of shaft 603 is located in the receiving section 2409 of shaft 613, and the forward section 2407 of shaft 613 is located in the receiving section 2408 of shaft 603. The shafts 613 and 603 can be connected to each other in various ways.For example, the shaft 613 can have a bore or channel 2411 that aligns with a bore or channel 2413 of the shaft 602 when the protruding sections 2406, 2407 are arranged in the receiving sections 2408 and 2409, respectively. When the openings 2411, 2413 are aligned with each other and the shaft 2400 is placed into the openings 2411, 2413 in the X direction, the shafts 613, 603 are held together. When the placement shaft is removed from the openings 2411, 2413 in the Z direction, the protruding sections 2406, 2407 can be removed from the receiving sections 2408, 2409, thus releasing the device 602 from the placement shaft 613.

[0070] As in Fig. As shown in Figure 24, when the shafts 613 and 603 are attached to one another, an opening 2415 is created at the transition point 2417 between the shafts 613 and 603. The opening 2415 is configured to secure the rope 2302 between the shafts 613 and 603, enabling independent control of the gripping elements 608a and 608b. That is, the opening 2415 is configured such that the rope 2302 does not move relative to the opening 2416 when the shafts 613 and 603 are attached. After the shafts 613 and 603 are detached, the rope 2302 is released from the opening 2415 and can be removed from the flap repair device 602. The 2302 cord can then be retracted into the catheter to release the gripping elements as described above.

[0071] As in the Fig. As shown in Figures 23 and 24A-24B, in an alternative embodiment the cord 2302 of the gripper control mechanism 610 is fastened between the placement shaft 603 and the shaft 603 by a threaded connection in order to control the gripping elements 608a, 608b independently of each other. As shown in Fig. As shown in Figure 24A, the placement shaft 613 includes an external threaded element 2419, and the shaft 603 includes an internal threaded element 2421 configured to receive the external threaded element 2419 of the placement shaft 613. The external and internal threads may be reversed. The placement shaft 613 is attached to the shaft 603 by inserting the external threaded element 2419 into the internal threaded element 2421 of the shaft 603. The cord 2302 of the gripper control mechanism 611 is positioned between the placement shaft 613 and the shaft 603 such that, when the placement shaft 613 is attached to the shaft 603, the cord 2302 is compressed between the placement shaft 613 and the shaft 603 (as indicated by the reference numeral M).The compression M of the line 2302 between the placement shaft 613 and the shaft 603 prevents the line 2302 from moving relative to the engagement point 2423 between the placement shaft 613, the shaft 603, and the line 2302 when the line 2302 controls the gripping elements 608a, 608b. The compression M and the resulting restraint of the line 2302 allow the line 2302 to control the gripping elements 608a, 608b independently.

[0072] As in Fig. As shown in Figure 25, another exemplary embodiment of a gripper control mechanism 611 comprises a first gripper control element 2502 and a second gripper control element 2504. The first gripper control element 2502 is configured to move the gripper element 608a bidirectionally in the X direction, and the second gripper control element 2504 is configured to move the gripper element 608b bidirectionally in the Z direction. By moving the gripper element 608a in the X direction, the width W of the opening 614a between the gripper element 608a and the paddle 606a is adjusted, and by moving the gripper element 608b in the Z direction, the width H of the opening between the gripper element 608b and the paddle 606b is adjusted. In the embodiment shown, the gripper control elements 2202, 2204 comprise a push / pull element 2503, 2505, such as a catheter, a flexible rod or a rigid wire, and a coupling 2506, 2507.Each push / pull link 2503, 2505 extends from the feed device 601 and is detachably attached to the corresponding gripping element 608a, 608b by a coupling 2506, 2507. Link 2503 is configured to be pushed and pulled in the Y direction. Movement of link 2503 in the Y direction causes the gripping element 608a to move in the X direction. Similarly, link 2505 is configured to be pushed and pulled in the M direction, and movement of link 2505 in the M direction causes the gripping element 608b to move in the H direction.

[0073] Another embodiment of a gripper control mechanism 611 is described in Fig. 25A shown. In this embodiment, the gripper control elements 2202, 2204 comprise a suture material 2511, 2513 and a flexible wire 2503, 2505. In this embodiment, the first flexible wire 2503 comprises a loop 2517 for receiving the first suture material 2511 and for engaging with a gripper element 608a ( Fig. 25), and the second flexible wire 2505 includes a loop 2519 for receiving the second suture material 2513 and for engagement with the gripping element 608b ( Fig. 25) The suture materials 2517, 2519 are detachably attached to each of the gripping elements 608a and 608b, respectively, with both ends of the cord extending through the feed device 601 as described above. Each of the wires 2503, 2505 extends from the feed device 601, and the loops 2517, 2519 of the respective wires 2503, 2505 are able to move along the corresponding suture materials 2511, 2513, so that the loops 2517, 2519 can engage with the corresponding gripping element 608a, 608b to move the gripping elements (for example, to move the gripping elements as described above). Fig. (described in 25). The wires 2503, 2505 can be made, for example, of steel, NiTi or other wires, or a plastic material. In certain embodiments, the wires 2503, 2505 can have a diameter between approximately 0.1 mm and 0.35 mm, e.g., between approximately 0.15 mm and 0.3 mm, e.g., between approximately 0.2 mm and 0.25 mm.

[0074] As in Fig. As shown in Figure 26, another exemplary embodiment of a gripper control mechanism 611 comprises a first catheter 2603, a second catheter 2605, and a single cord 2604, for example, a wire or suture material. The first catheter 2603 and the cord 2604 are configured to move the gripper element 608a in the X direction, and the second catheter 2605 and the cord 2604 are configured to move the gripper element 608b in the Z direction. By moving the gripper element 608a in the X direction, the width W of the opening 614a between the gripper element 608a and the paddle 606a is adjusted, and by moving the gripper element 608b in the Z direction, the width H of the opening between the gripper element 608b and the paddle 606b is adjusted. The line 2604 extends from the feed device 601 through the catheters 2603, 2605 and is threaded through openings in both gripping elements 608a, 608b.Each catheter 2603, 2605 is configured to engage with and move the corresponding grasping element 608a, 608b. Specifically, catheter 2603 is configured to be pushed in the Y direction while the line 2604 is pushed out of catheter 2603 or the tension in the line is reduced. Catheter 2603 is configured to be pulled in the Y direction while the line 2604 is pulled into catheter 2603 or the tension in the line is increased. The movement of catheter 2603 in the Y direction causes catheter 2603 to move the grasping element 608a in the X direction. Similarly, catheter 2605 is configured to be pushed in the M direction while the line 2604 is pushed out of catheter 2605 or the tension in the line is reduced.The catheter 2605 is configured to be pulled in direction M while the line 2604 is pulled into the catheter 2605 or the tension in the line is increased. The movement of the catheter 2605 in direction M causes the catheter 2605 to move the gripping element 608b in direction H. In an alternative embodiment, the above with reference to . Fig. 26 described gripper control mechanism 611 a first bendable wire with a loop (e.g. the bendable wire 2503 with the in Fig. 25A loop 2517) and a second bendable wire with a loop (e.g. the bendable wire 2505 with the one shown in Fig. 25A loop 2519) include, and the single wire 2604 extends through loop 2517, 2519 each of the wires 2503.

[0075] As in the Fig. As shown in Figures 27A-29B, in certain embodiments the valve repair device 602 and the paddle control mechanism 610 for a valve repair device 602 are configured such that each of the paddles 606 can be controlled independently of the others. Independent control for each of the paddles 606 is advantageous because the openings 614 between the paddles and the gripping elements 608 can be adjusted independently of one another while the valve repair device 602 is being attached to the valve tissue (for example, a patient's mitral valve). Furthermore, independent paddle control is also advantageous in situations where one gripping element 608 and one paddle 606 can adequately secure the valve repair device 602 to a first section of the valve tissue, but the other gripping element and the other paddle cannot connect the valve repair device to a second section of the valve tissue.In this situation, the paddle control mechanism 610 can be used to control only the paddle 606, which is not connected to the flap fabric, in order to create an opening 614 to receive the second section of the flap fabric, and after the second section of the flap fabric has been placed in the opening, the unattached gripping element and the unattached paddle can be closed to attach the flap repair device 602 to the second section of the flap fabric.

[0076] As in the Fig. As shown in Figures 27A-27C, the basic assembly 604 of the flap repair device 602 comprises a first shaft 603a, a second shaft 603b, a first clutch 605a, and a second clutch 605b. The paddle control mechanism 610 also comprises 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 clutch 605a along the shaft 603a, and the second paddle control mechanism 2704 is configured to move the second clutch 605b along the shaft 603b. The movement of the first clutch 605a along the shaft 603a causes a movement of the paddle 606a between an open position and a closed position, and the movement of the second clutch 605b along the shaft 603b causes a movement of the paddle 606b between an open position and a closed position.In an alternative embodiment, the base arrangement 604 can comprise a single shaft, a first coupling 605a attached to the single shaft, and a second coupling 605b attached to the single shaft. In this alternative embodiment, the paddle control mechanism 610 can comprise a first paddle control mechanism 2702 configured to move the first coupling 605a along the single shaft to cause the paddle 606a to move between an open position and a closed position, and a second paddle control mechanism 2704 configured to move the second coupling 605b along the single shaft to cause the paddle 606b to move between an open position and a closed position.

[0077] The Fig. Figures 27A-27C show how the paddles of the flap repair device move between an open position and a closed position. The basic assembly 604 of the flap repair device 602 comprises 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 coupling 605a is movably attached to the shaft 603a, the coupling 605b is movably attached to the shaft 603b, and the shafts 603a and 603b are attached to the third link 2723. The first link 2721 is pivotably attached to the coupling 605a at point A, so that a movement of the coupling 605a along the shaft 603a moves the position of point A and consequently also the first link 2721.Similarly, the fifth link 2725 is pivotally attached to the coupling 605b at point F, such that a movement of the coupling 605b along the shaft 603b displaces the position of point F and consequently moves the fifth link 2725. The first link 2721 and the second link 2722 are pivotally connected to each other at point B, and the fifth link 2725 and the fourth link 2724 are pivotally connected to each other at point E. One paddle 606a is attached to the first link 2721 such that a movement of the first link 2721 causes a movement of the paddle 606a, and the other paddle 606b is attached to the fifth link 2725 such that a movement of the fifth link 2725 causes a movement of the paddle 606b.

[0078] In Fig. In section 27A, paddles 606a and 606b are in the open position. As in the Fig. 27A and Fig. As shown in 27B, the paddle 606b is used from the open position (as in Fig. 27A) into the closed position (as shown in Fig. (shown in Figure 27B) moves when the second paddle control mechanism 2704 moves the second coupling 605b along the shaft 603b in the direction of Y, causing a section of the fifth link 2725 near point F to move in the direction of H and a section of the fifth link 2725 near point E to move in the direction of J. The paddle 606b is attached to the fifth link 2725 such that a movement of the second coupling 605b in the direction of Y causes the paddle 606b to move in the direction of Z. Furthermore, the fourth link 2724 is pivotally attached to the fifth link 2725 at point E, such that a movement of the second coupling 605b in the direction of Y causes the fourth link 2724 to move in the direction of K. As shown in Figure 27B. Fig. As shown in Figure 27B, the paddle 606b moves in the direction of Q when it transitions from the open position to the closed position. In an alternative embodiment, where the pivotable connection at point E between the fourth member 2724 and the fifth member 2725 is significantly lower than the pivotable connection at point F between the fifth member 2725 and the second coupling 605b, the movement of the paddle 606b from the open position to the closed position occurs as shown in Figure 27B. Fig. 27A, the embodiment shown, except that when the paddle 606b closes, the fourth member 2724 initially moves in the direction substantially opposite to direction K. In each of the above-mentioned embodiments, the second paddle control mechanism 2704 can assume any suitable form to move the second coupling 605b along the shaft 603b, such as any form of paddle control mechanism described in the present application.

[0079] As in the Fig. 27A and Fig. As shown in 27C, paddle 606a is used from the open position (as in Fig. 27A) into the closed position (as shown in Fig. (shown in Figure 27C) moves when the first paddle control mechanism 2702 moves the first coupling 605a along the shaft 603a in the direction N, causing a section of the first link 2721 near point A to move in the direction L and a section of the first link 2721 near point B to move in the direction I. The paddle 606a is attached to the first link 2721 such that a movement of the first coupling 605a in the direction N causes the paddle 606a to move in the direction V. Furthermore, the second link 2722 is pivotally attached to the first link 2721 at point B, such that a movement of the first coupling 605a in the direction N causes the second link 2722 to move in the direction R. As shown in Figure 27C. Fig.As shown in Figure 27C, the paddle 606a moves in the direction of T when it transitions from the open position to the closed position. In an alternative embodiment, where the pivotable connection at point B between the first link 2721 and the second link 2722 is significantly lower than the pivotable connection at point A between the first link 2721 and the first coupling 605a, the movement of the paddle 606a from the open position to the closed position occurs as shown in Figure 27C. Fig. 27A, the embodiment shown, except that when the paddle 606b closes, the second member 2722 initially moves in the direction substantially opposite to direction R. In each of the above-mentioned embodiments, the first paddle control mechanism 2702 can assume any suitable form to move the first coupling 605a along the shaft 603a, such as any form of paddle control mechanism described in the present application.

[0080] As in the Fig. As shown in Figures 28A-28C, the paddle control mechanism 610 in certain embodiments comprises 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 comprises a first element 2804 attached to the shaft 603 and a toothed element 2806a, 2806b attached to each of the paddles 606a, 606b and pivotably connected at connection points A, B to a base element 2801. The first element 2804 is configured to allow the paddles 606a, 606b to be moved independently between the open and closed positions. In the embodiment shown, the first element 2804 has a ribbed section 2805 and an open section 2807.When the toothed element(s) 2806a, 2806b is aligned with the ribbed section 2805 of the first element 2804, the toothed element(s) 2806a, 2806b is configured to engage with the ribbed section 2805, such that a movement of the shaft in the direction Y relative to the base element 2801 causes the toothed element 2806a to pivot about the connection point A in the direction M to move the paddle 606a between an open position and a closed position in the direction H, and causes the toothed element 2806b to pivot about the connection point B in the direction N to move the paddle 606b between an open position and a closed position in the direction Z.When the open section 2807 of the first element 2804 is aligned with one of the toothed elements 2806a or 2806b, the toothed element aligned with the open section 2807 does not engage with the ribbed section 2805 of the paddle 606a or 606b. Consequently, the movement of the shaft 603 in the Y direction does not affect the position of the paddle 606a or 606b.

[0081] The Fig. Figures 28A-28B show the corkscrew mechanism 2802 in a first position. In the first position, the toothed elements 2806a, 2806b for both paddles 606a, 606b are aligned with the ribbed section 2805 of the first element 2804. As shown in Fig. As shown in Figure 28A, the toothed elements 2806a, 2806b engage with the ribbed section 2805 of the first element when the shaft 603 is moved in the Y direction, thereby moving both paddles 606a, 606b between the open and closed positions. Fig. Figures 28C-28D show the corkscrew mechanism 2802 in a second position. In the second position, the toothed element 2806a is aligned with the open section 2807 of the first element 2804, and the toothed element 2806b is aligned with the ribbed section 2806 of the first element 2804. As shown in Fig. As shown in Figure 28C, the toothed element 2806b engages with the ribbed section 2805 of the first element 2804 when the shaft 603 is moved in the Y direction, thereby moving the paddle 606b between the open and closed positions, while the toothed element 2806a does not engage with the first element, leaving the paddle 606a in a fixed position. Fig. Figures 28E-28F show the corkscrew mechanism 2802 in a third position. In the third position, the toothed element 2806b is aligned with the open section 2807 of the first element 2804, and the toothed element 2806a is aligned with the ribbed section 2806 of the first element 2804. As shown in Fig. As shown in Figure 28E, when the shaft 603 is moved in the Y direction, the toothed element 2806a engages with the ribbed section 2805 of the first element 2804, thereby moving the paddle 606a between the open and closed positions, and the toothed element 2806b does not engage with the first element, leaving the paddle 606b in a fixed position. In certain embodiments, the rack and pinion mechanism 2802 is operated by rotating the shaft 603 between the positions shown in the Fig. The positions shown in Figures 28A-28F are moved. In various embodiments, the rack and pinion mechanism 2802 comprises a mechanism configured to hold the paddles 606a, 606b in a desired position when the paddles are aligned with the open section 2807 of the first element 2804, but also configured to allow the paddles to move when they are aligned with the ribbed section 2805 of the first element 2804. The mechanism can take any suitable form, such as a clutch mechanism, a preload element, a friction element, or the like.

[0082] As in the Fig. As shown in Figures 29A-29B, the paddle control mechanism 610 is configured to move a clutch 605 along a shaft 603 to move the paddles 606a, 606b between the open and closed positions (similar to the one shown in the Fig. (6-12 embodiment shown), and a locking control mechanism 207 is configured to lock the coupling 605 onto the shaft 603 to hold the paddles 606a, 606b in a desired position. In certain embodiments, such as in the Fig. As shown in Figures 29A-29B, each paddle 606a, 606b comprises a pin 2902a, 2902b and a slot 2904a, 2904b. The pin 2902a is configured to move within the slot 2904a, and the pin 2902b is configured to move within the slot 2904b. The pins 2902a, 2902b are also configured to lock in the slots 2904a, 2904b. When a pin 2902a, 2902b is unlocked in a slot 2904a, 2904b, the corresponding paddle 606a, 606b remains in its current position when the control device 610 moves the clutch 605 along the shaft 603. When a pin 2902a, 2902b is locked in a slot 2904a, 2904b, the corresponding paddle 606a, 606b moves between an open and a closed position when the paddle control mechanism 610 moves the clutch 605 along the shaft 603.

[0083] Fig. Figure 29A shows the flap repair device 602 with the paddles 606a, 606b in an open position. Fig. Figure 29B shows the flap repair device 602 with the pin 2902a unlocked in slot 2904a and the pin 2902b locked in slot 2904b. The detent 607 is located according to Fig. 29B is in an unlocked state, allowing the coupling 605 to move along the shaft 603. The movement of the coupling 605 along the shaft 603 in the Y direction causes the paddle 606b to rotate around the locked pin 2902b, moving the paddle 606b in the Z direction into a closed position. Furthermore, the movement of the coupling 605 in the Y direction does not cause the paddle 606a to move, as the pin 2902a is in an unlocked state in the slot 2904a. Instead, the movement of the coupling 605 in the Y direction causes the pin 2902a to move within the slot 2904a. Alternatively, pin 2902a could be locked in slot 2904a and pin 2902b could be unlocked in slot 2904b, so that a movement of the coupling 605 in the direction of Y would cause paddle 606a to move into a closed position and paddle 606b to remain in the open position (by moving pin 2902b in slot 2904b).Furthermore, pin 2902a could be locked in slot 2904a and pin 2902b in slot 2904b, so that a movement of the coupling 605 in the Y direction would cause both paddles 606a, 606b to move into the closed position. Pins 2902a, 2902b can be locked in slot 2904a, 2904b by any suitable means, such as any means described here with reference to the locking device 607.

[0084] As in Fig. As shown in Figure 30, a patient's mitral valve 3001 may, in certain situations, exhibit 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 the systolic phase). For example, the gap 3002 may have a width W between approximately 2.5 mm and approximately 17.5 mm, such as between approximately 5 mm and approximately 15 mm, such as between approximately 7.5 mm and approximately 12.5 mm, such as approximately 10 mm. In some situations, the gap 3002 may have a width W greater than 15 mm. In each of the above situations, a valve repair device is desired that is capable of interlocking with the anterior leaflet 3003 and the posterior leaflet 3004 to close the gap 3002 and prevent the regurgitation of blood through the mitral valve 3001.

[0085] The Fig. Figures 31A-37D show various embodiments of flap repair devices 602 configured to provide a wide gap 3002 ( Fig. 30) between the anterior leaflet 3003 and the posterior leaflet 3004 of a mitral valve 3001. As in the Fig. Figures 31A-31B illustrate an exemplary embodiment of a flap repair device 602 comprising paddles 606 and gripping elements 608. Furthermore, the flap repair device 602 may have any other features for a flap repair device discussed in the present application, and the flap repair device 602 may be positioned to engage with the flap fabric 820 as part of any suitable flap repair system (for example, a flap repair system disclosed in the present application). As shown in Fig. As shown in Figure 31A, the paddles 606 of the flap repair device 602 are pivoted outwards in the direction X to create an opening 614 between the paddles 606 and the gripping elements 608, which has a width W. 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 more than 15 mm. As shown in Fig. As shown in Figure 31B, the paddles 606 of the flap repair device 602 are moved outwards 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 other embodiments, the width H can be less than 10 mm or more 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 4 to 1 or less, such as 3 to 1 or less, such as 2 to 1 or less, such as 1.5 to 1 or less, such as 1.25 to 1 or less, such as 1 to 1.The flap repair device 602 can be configured such that the paddles 606 are pivoted outwards in the X direction and then moved outwards in the Z direction to create the opening 614, which has a width H between the paddles 606 and the gripping elements 608. Alternatively, the flap repair device 602 can be configured such that the paddles are moved outwards in the Z direction and then pivoted outwards in the X direction to create the width H between the paddles 606 and the gripping elements 608. Furthermore, the flap repair device 602 can be configured such that the paddles 606 are pivoted outwards in the X direction and simultaneously moved outwards in the Z direction to create the width H between the paddles 606 and the gripping elements 608.

[0086] The Fig. Figures 32A-32C show a flap repair device 602 in which the paddles 606 are pivoted outwards in the X direction and then moved outwards in the Z direction to create a wider opening 614. Fig. Figure 32A shows the flap repair device 602 in a closed position, in which the paddles 606 engage with the gripping elements 608. As in Fig. As shown in Figure 32B, the paddles 606 are pivoted outwards in the X direction to create an opening 614 with a width W for receiving flap fabric. As shown in Fig. As shown in Figure 32C, the paddles 606, after being pivoted outwards in direction X, are moved outwards in direction Z so that the opening 614 has a width H. After the flap fabric has been received in the openings 614 between the paddles 606 and the gripping elements 608, the flap repair device is moved back to the closed position (as shown in Figure 32C). Fig. 32A), to attach the flap repair device 602 to the flap fabric. The flap repair device 602 may have all the other features of a flap repair device discussed in the present application, and the flap repair device 602 may be positioned to engage with the flap fabric 820 as part of any suitable flap repair system (for example, any flap repair system disclosed in the present application).

[0087] The Fig. Figures 33A-33C show a flap repair device 602 in which the paddles 606 are moved outwards in the Z direction and then pivoted outwards in the X direction to create a wider opening 614. Fig. Figure 33A shows the flap repair device 602 in a closed position, in which the paddles 606 engage with the gripping elements 608. As in Fig. As shown in Figure 33B, the paddles 606 are moved outwards in the Z direction to create an opening 614 which has a width W to accommodate flap fabric. As shown in Fig. As shown in Figure 33C, the paddles 606, after being moved outwards in the Z direction, are pivoted outwards in the X direction so that the opening 614 has a width H. After the flap fabric has been received in the openings 614 between the paddles 606 and the gripping elements 608, the flap repair device is moved back into the closed position (as shown in Figure 33C). Fig. 33A), to attach the flap repair device 602 to the flap fabric. The flap repair device 602 can have all the other features of a flap repair device discussed in the present application, and the flap repair device 602 can be positioned to engage with the flap fabric 820 as part of any suitable flap repair system (for example, any flap repair system disclosed in the present application).

[0088] Although the Fig. Figures 32A-32C show a flap repair device 602 in which the paddles 606 are pivoted and then spread apart, and the Fig. Figures 33A-33C show a flap repair device 602 in which the paddles 606 are spread apart and then pivoted. In alternative embodiments, a flap repair device 602 may include paddles 606 that can be spread apart and pivoted simultaneously. Furthermore, in certain embodiments, the paddles 606 may be spread apart and pivoted independently of one another. That is to say, in the embodiments shown in the Fig. In the embodiments of the flap repair device 602 shown in Figures 32A-32C and 33A-33C, and in the embodiment in which the spreading apart and pivoting of each paddle 606 takes place simultaneously, the paddles 606 can be controlled independently of each other.

[0089] As in the Fig. Figures 34A-34B show a further exemplary embodiment of a flap repair device 602 configured to provide a wide gap 3002 ( Fig. 30) between the anterior sail 3003 and the posterior sail 3004, a W-shaped mechanism. More precisely, the flap repair device 602 comprises a coupling 605 configured to move along a shaft 603, and paddles 606 pivotally attached to the coupling 605. The paddles 606 comprise an inner link 3402 and an outer link 3404. The inner link 3402 of each paddle 606 is pivotally attached to the coupling 605, and the outer link 3404 of each paddle 606 is pivotally attached to the corresponding inner link 3402. As in Fig. As shown in Figure 34A, the flap repair device 602 is in a closed position. As in Fig. As shown in Figure 34B, movement of the clutch 605 in the Y direction causes the inner links 3402 of the paddle 606 to extend outwards in the X direction. In the illustrated example, the inner links 3402 engage with a cam element 3403, which forces the inner links 3402 to open in the X direction. Although the illustrated embodiment shows a flap repair device 602 that generally has linear links 3402, 3404 forming a W-shaped mechanism, the links 3402, 3404 can assume any suitable shape that allows the flap repair device 602 to function as shown in the Fig. Figures 34A-34B show how to function. In embodiments where the links 3402, 3404 assume nonlinear shapes (for example, a curved shape), the flap repair device may not have a W-shaped mechanism; however, the flap repair device may have similar connections so that the flap repair device functions as shown in the Fig. 34A-34B shown works.

[0090] The outer links 3404 can be moved into the more open position shown in the Z direction in different ways. For example, the outer links can be moved using one of the clamp control devices described here. For example, the movement of the outer links 3404 can be carried out using one of the devices described in the Fig. The clamp control devices shown in 22-26 and / or one of the paddle control devices described herein can be controlled. In an embodiment as shown in the Fig. In 34C-34D, a link 3411 is attached to the pivotable connection between the inner link 3402 and the coupling 605 and to the pivotable connection between the inner link 3402 and the outer link 3404, such that a movement of the coupling 605 in the Y direction causes a first end 3413 of the link 3411 to rotate in the M direction with the pivotable connection 3475, which in turn causes a second end 3415 of the link 3411 to rotate in the N direction with the pivotable connection 3477. The rotation of the second end 3415 of the link 3411 in the N direction causes the outer link 3404 to move into an open position in the Z direction.

[0091] To illustrate, the following is shown in the Fig. In the embodiment shown in Figures 34C-34D, a link 3411 is provided for one of the paddles 606. However, it can be assumed that another link 3411 interacts with the other paddle in the manner described above to cause the outer link 3404 of the other paddle to move into an open position in the Z direction. In an alternative embodiment, a four-link linkage can be used to move the paddles 606 into an open position. In a further alternative embodiment, a suture material can be detachably attached to the outer links 3404 of the paddles 606, and the suture material can be controlled to move the outer links 3404 of the paddles 606 into an open position in the Z direction.

[0092] In certain embodiments, the flap repair device 602 comprises a preload element 3410 (for example, a spring) that fastens the inner links 3402 of the paddles 606 together. The preload element 3410 holds the inner links 3402 in a closed position (as in the Fig. 34A and Fig. 34C), until the inner links 3402 engage with the cam element 3403 (as shown in the Fig. 34B and Fig. 34D). The flap repair device 602 can have all the other features of a flap repair device discussed in the present application, and the flap repair device 602 can be positioned to engage with the flap tissue 820 as part of any suitable flap repair system (for example, any flap repair system disclosed in the present application).

[0093] As in the Fig. Figures 35A-35B show a further exemplary embodiment of a flap repair device 602 configured to provide a wide gap 3002 ( Fig. 30) between the anterior sail 3003 and the posterior sail 3004, a W-shaped mechanism. More precisely, the flap repair device 602 comprises a coupling 605 configured to move along a shaft 603, and paddles 606 pivotally attached to the shaft and the coupling 605. The lower ends 3501 of each paddle 606 of the flap repair device 602 are pivotally connected to the shaft at point A. Each of the paddles 606 includes an intermediate element 3502 that pivotally attaches the paddles to the coupling 605 at pivot point B. As in Fig. As shown in Figure 35A, the flap repair device 602 is in a closed position. As shown in Fig. As shown in Figure 35B, a movement of the coupling 605 in the direction Y causes the intermediate elements 3502 of the paddles 606 to pivot such that a lower end 3503 of the intermediate elements 3502 extends outwards in a direction X, causing the paddles 606 to move into an open position in the direction Z. The flap repair device 602 can have all the other features of a flap repair device discussed in the present application, and the flap repair device 602 can be positioned to engage with the flap fabric 820 as part of any suitable flap repair system (for example, any flap repair system disclosed in the present application).

[0094] As in the Fig. Figures 36A-36B show a further exemplary embodiment of a flap repair device 602 configured to provide a wide gap 3002 ( Fig. 30) between the anterior sail 3003 and the posterior sail 3004, a W-shaped mechanism. More precisely, the flap repair device 602 has paddles 606 which have a linkage 3602 that pivotally attaches the paddles 606 to a shaft 603 of the flap repair device 602. The linkage 3602 comprises 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 connected to the inner link 3603 and pivotally connected to the paddle 606. The paddles 606 are also attached to a link 3608 of the flap repair device 602. A paddle control mechanism 610 is configured to move the pivoting connection at point A between the inner link 3603 and the outer link 3605 of the linkage 3602 in the direction Y, thereby moving the paddles 606 between an open position (as in Fig. 36B) and a closed position (as shown in Fig. 36A shown) can be moved.

[0095] As in the Fig. 36A and Fig. As further shown in Figure 36B, the paddle control mechanism 610 can be attached to one or more of any links of the flap repair device 602, although the paddle control mechanism is shown attached to the pivotable connection point A. For example, the paddle control mechanism 610 can be coupled to the paddle 606, the link 3605, and / or the link 3603. The paddle control mechanism 610 can take any suitable form, such as a control wire or any other form described in this application. For example, the paddle control device 610 can take the form of one of the [described] shown in the Fig. The gripper control devices shown in Figures 6-8 and 22-26 may be adopted. The flap repair device 602 may have all other features of a flap repair device described in the present application.

[0096] As in Fig. As shown in 36C, the paddle control mechanism 610 can be used in Fig. 36A and Fig. In the embodiment shown in Figure 36B, the assembly comprises a spool 3620 and a cord 3622 (for example, suture material, wire, etc.), the cord being attached to and wound around the spool. In this embodiment, the generation of a force on the cord 3622 in the Z direction causes the spool 3620 to rotate and the cord 3622 to unwind from the spool. In this embodiment, the rotation of the spool 3620 causes the paddle control mechanism 610 to move in the Y direction and the flap repair device 602 to move into the open position (as shown in Figure 36B). Fig. 36B shown).

[0097] As in the Fig. Figures 36D-36E show a further exemplary embodiment of a flap repair device 602 configured to provide a wide gap 3002 ( Fig. 30) between the anterior sail 3003 and the posterior sail 3004, a semi-rigid W-shaped mechanism. More precisely, the flap repair device 602 has a linkage 3602 that flexibly attaches the paddles 606 to a shaft 603 of the flap repair device 602. The linkage 3602 comprises a rigid inner link 3603 and an outer rigid link 3605. The inner rigid link 3603 is flexibly attached to the shaft 603 by a flexible element or section 3613 and flexibly attached to the outer rigid link 3605 by a flexible element or section 3611, and the outer rigid link 3605 is flexibly attached to the paddle 606 by a flexible element or section 3615. The paddles 606 are also flexibly attached to a link 3608 of the flap repair device 602 by means of a flexible element or a flexible section 3617.The rigid links 3603, 3605 can be made of steel or Nitinol, for example. The flexible elements 3611, 3613, 3615, 3617 can be made of Nitinol, for example. A paddle control mechanism 610 is configured to move the pivoting connection at point A between the inner link 3603 and the outer link 3605 of the linkage 3602 in the Y direction, thereby moving the paddles 606 between an open position (as in ). Fig. 36D) and a closed position (as shown in Fig. The paddle control mechanism 610 can be moved (as shown in Figure 36C). However, the paddle control mechanism 610 can also be attached to one or more of the links of the flap repair device. For example, the paddle control mechanism 610 can be coupled to the paddle 606, link 3605, and / or link 3603. The paddle control mechanism 610 can take any suitable form, such as a control wire or any other form described in this application. For example, the control device 610 for the paddle can take the form of one of the [shown in the] Fig. The gripper control devices shown in Figures 6-8 and 22-26 may be adopted. The flap repair device 602 may have all other features of a flap repair device described in the present application.

[0098] As in the Fig. Figures 37A-37D show a further exemplary embodiment of a flap repair device 602 configured to provide a wide gap 3002 ( Fig. 30) between the anterior sail 3003 and the posterior sail 3004, wire mesh paddles 606 (wire meshes) and an inner cam 3702 configured to push the wire mesh paddles 606 apart. The inner cam 3702 is rotatably attached to the shaft 603, so that the cam can be positioned between a first position (as in the Fig. 37A-37B) and a second position (as shown in the Fig. 37C-37D) can be moved. Fig. 37B is a top view showing the inner cam 3702 in the first position along lines BB in Fig. 37A is shown. Fig. 37D is a top view showing the inner cam 3702 in the second position, along the lines DD in Fig. 37C is shown.

[0099] As in the Fig. 37A and Fig. As shown in Figure 37B, the inner cam 3702 does not engage with the paddles 606 in the first position, and the flap repair device is held in a closed position. As shown in the Fig. 37C and Fig. As shown in Figure 370, the inner cam 3702 engages with the paddles 606 in the second position to move the paddles in an outward direction X into an open position. The flap repair device 602 is moved from the open position to the closed position by moving the inner cam 3702 from the second position to the first position.

[0100] In some embodiments, such as in the Fig. In references 37E-37F, the paddles 606 of the flap repair device may have a bendable element or section 3711 that biases the paddles into the closed or open position. The bendable element or section 3711 may be configured to bend when the cam 3702 engages, allowing the paddles 606 to move into the open position. The bendable element or section 3711 is also configured to increase the reach of the paddles 606 when the paddles are in the open position. Any other suitable mechanism may be used to bias the paddles into the closed position and / or to increase the reach of the paddles 606 when the paddles are in the open position, such as a spring-loaded mechanism.The flap repair device 602 can have all the other features of a flap repair device discussed in the present application, and the flap repair device 602 can be positioned to engage with the flap mesh 820 as part of any suitable flap repair system (for example, any flap repair system disclosed in the present application). The mesh paddles 606 can be made of any suitable material that can be expanded by the internal cam 3702, such as nitinol, stainless steel, or any braided or electrospun material.

[0101] As in the Fig. As shown in Figures 38-39, in certain situations, a 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 the systolic phase). For example, the gap 3002 may have a width W between approximately 2.5 mm and approximately 17.5 mm, such as between approximately 5 mm and approximately 15 mm, such as between approximately 7.5 mm and approximately 12.5 mm, such as approximately 10 mm. In some situations, the gap 3002 may have a width W greater than 15 mm. In each of the above situations, a valve repair device is desired that fills a sufficient volume to close or fill the gap 3002 without placing excessive stress on the valves 3003 and 3004. For example, the valve repair device may include a spacer element 3800.

[0102] As in Fig. As shown in Figure 39, in certain embodiments the spacer element 3800 is attached to the flap repair device 602 such that the spacer element 3800 is positioned in the gap 3002 between the anterior flap 3003 and the posterior flap 3004 when the paddles 606 and gripping elements 608 attach the flap repair device 602 to the mitral valve 3001. The spacer element 3800 can be made of any suitable material, such as woven mesh, fabric, biocompatible material, foam, pericardial fabric, any material disclosed herein, and the like.

[0103] As in the Fig. As shown in Figures 40A-40B, an exemplary embodiment of a flap repair device 602 has a spacer element 3800 attached to the shaft 603 of the flap repair device. The spacer element 3800 can, as shown, extend over the outer edges 4001 of the gripping elements 3800 to provide an additional surface for closing the gap 3002 ( Fig. 38-39) to provide a mitral valve 301. In an alternative embodiment, the coupling element 605 can take the form of the spacer element 3800. That is, a single element can be used as the coupling element 605, which causes the paddles 606 to move between the open and closed positions, and as the spacer element 3800, which closes the gap between the sails 3003, 3004 when the valve repair device 602 is attached to the sails. The valve repair device 602 can have all the other features of a valve repair device discussed in the present application, and the valve repair device 602 can be positioned to engage with the valve fabric 820 as part of any suitable valve repair system (for example, any valve repair system disclosed in the present application).

[0104] As in the Fig. 42A-42C shown, this can be in the Fig. The spacer element 3800 shown in 40A-40B can take on a variety of different shapes. As shown in Fig. As shown in Figure 42A, an exemplary embodiment of a spacer element 3800 comprises a main body 4210a extending between the gripping elements 608 and beyond the edges 4201 of the gripping elements, as well as extended sections (or extension sections) 4212a extending from the main body 4210a. The extended sections 4212a allow sections of the gap 3002 ( Fig. 38-39) of the mitral valve between the anterior leaflet 3003 and the posterior leaflet 3004 and adjacent to the valve repair device 602 can be filled when the valve repair device is in a closed position. That is, when a valve repair device 602 is attached to a mitral valve to prevent regurgitation of blood through the mitral valve, the sections of the mitral valve adjacent to the valve repair device can have openings from the mitral valve tissue that extend around the valve repair device. The extended sections 4212a are configured to fill or close the openings adjacent to the valve repair device 602. In the embodiment shown, the length L of the extended sections 4212a is greater than the width W of the extended sections.

[0105] As in the Fig. As shown in Figure 42B, another exemplary embodiment of a spacer element 3800 comprises a main body 4210b extending between the gripping elements 608 and extended sections 4212b extending from the main body 4210b. In the embodiment shown, the extended sections 4212b have a semicircular shape. The extended sections 4212b are configured to fill the openings adjacent to the valve repair device 602, since the mitral valve tissue extends around the valve repair device.

[0106] As in Fig. As shown in Figure 42C, another exemplary embodiment of a spacer element 3800 comprises a main base assembly 4210c extending between the gripping elements 608, first extension sections 4212c extending from the main body 4210c, and second extension sections 4214c extending from the first extension sections 4212c. In the illustrated embodiment, the first extension sections 4212c have a semicircular shape, and the second extension sections 4214c have a length L that is greater than their width W. The extension sections 4212b are configured to fill the openings adjacent to the valve repair device 602, since mitral valve tissue extends around the valve repair device.

[0107] As in the Fig. As shown in Figures 41A-41D, another exemplary embodiment of a flap repair device 602 has a spacer element 3800 attached to the gripping elements 608a, 608b of the flap repair device. The spacer element 3800 comprises a first section 4102, which is attached to one gripping element 608a, and a second section 4104, which is attached to the other gripping element 608b. As shown in Fig. As shown in Figure 41C, the flap repair device 602 is in the closed position. When the flap repair device 602 is in the closed position, the first section 4102 and the second section 4104 of the spacer element 3800 engage with each other and surround the shaft 603 (as shown in Figure 41C). Fig. 41B shown). In Fig. Figure 41D shows the flap repair device 602 in the open position, with the first section 4102 of the spacer element 3800 moving with the gripping element 608a and the second section 4104 of the spacer element 3800 moving with the gripping element 608b. A spacer element 3800 having multiple sections 4102, 4104 makes it possible to move the gripping elements 608a, 608b to adjust the width of the opening between the paddles 606 and the gripping elements, which is advantageous when attaching the flap repair device 602 to the flap fabric 820. As shown in Fig. As shown in Figure 41B, the spacer element 3800 extends beyond the outer edges 4001 of the gripping elements 608a and 608b to provide an additional surface for filling the gap 3002 ( Fig. 38-39) to provide a mitral valve 301. The valve repair device 602 may have all the other features of a valve repair device discussed in the present application, and the valve repair device 602 may be positioned to engage with the valve tissue 820 as part of any suitable valve repair system (for example, any valve repair system disclosed in the present application).

[0108] As in the Fig. 43A-43C shown, this can be in the Fig. The spacer element 3800 shown in 41A-41D can take on a variety of different shapes. As shown in Fig. Figure 43A shows an exemplary embodiment of a spacer element 3800 in the closed position comprising a main body 4310a extending between the gripping elements 608 and beyond the edges 4201 of the gripping elements, as well as extended sections 4312a extending from the main body 4310a. The extended sections 4312a allow parts of the gap 3002 ( Fig. 38-39) of the mitral valve between the anterior leaflet 3003 and the posterior leaflet 3004 and adjacent to the valve repair device 602 can be filled when the valve repair device is in a closed position. That is, when a valve repair device 602 is attached to a mitral valve to prevent regurgitation of blood through the mitral valve, the sections of the mitral valve adjacent to the valve repair device can have openings from the mitral valve tissue that extend around the valve repair device. The extended sections 4312a are configured to fill the openings adjacent to the valve repair device 602. In the embodiment shown, the length L of the extended sections 4312a is greater than the width W of the extended sections.

[0109] As in Fig. As shown in Figure 43B, another exemplary embodiment of a spacer element 3800 in the closed position comprises a main body 4310b extending between the gripping elements 608 and extended sections 4312b extending from the main body 4310b. In the embodiment shown, the extended sections 4312b have a semicircular shape. The extended sections 4312b are configured to fill the openings adjacent to the valve repair device 602, since the mitral valve tissue extends around the valve repair device.

[0110] As in Fig. As shown in Figure 43C, another exemplary embodiment of a spacer element 3800 comprises a main base assembly 4310c extending between the gripping elements 608, first extension sections 4312c extending from the main body 4310c, and second extension sections 4314c extending from the first extension sections 4312c. In the illustrated embodiment, the first extended sections 4312c have a semicircular shape, and the second extended sections 4314c have a length L that is greater than their width W. The extended sections 4312b are configured to fill the openings adjacent to the valve repair device 602, since mitral valve tissue extends around the valve repair device.

[0111] As in the Fig. As shown in Figures 44A-44B, in certain embodiments an expanding spacer element 3800 is integrated into the flap repair device 602. The expanding spacer element 3800 is configured to expand when the paddles 606 close (as shown in Figure 44A-44B). Fig. 44B shown). As in Fig. As shown in Figure 44A, the flap repair device 602 is in an open position, so that the flap fabric can be received in the opening 614 between the expanding spacer element 3800 and the paddles 606. As shown in Fig. As shown in Figure 44B, the flap repair device 602 is in the closed position, in which the paddles 606 and the expanded spacer 3800 engage to secure the flap repair device to the flap fabric. When the spacers 3800 and the paddles 606 engage, the spacer 3800 expands to provide a larger surface area for closing a gap 3002 ( Fig. 38) to provide between the anterior leaflet 3003 and the posterior leaflet 3004 of a mitral valve 3001. In the embodiment shown, the valve repair device 602 takes the form of the valve repair device 602 in the Fig. 35A-35B. However, each flap repair device 602 described in the present application may include an expanding spacer element 3800. The flap repair device 602 may have all the other features of a flap repair device discussed in the present application, and the flap repair device 602 may be positioned to engage with the flap tissue 820 as part of any suitable flap repair system (for example, a flap repair system described in the present application).

[0112] As in the Fig. As shown in Figures 45A-46D, in certain situations the valve repair device 602 must be detached from a native valve and removed from the patient. In these situations, it is advantageous to have a valve repair device that can be narrowed and repositioned (in a release position) so that the valve repair device can be more easily removed from the patient without disturbing the patient's heart valve tissue. As shown in the Fig. As shown in Figures 45A-45C, the basic arrangement 604 of an exemplary embodiment of a flap repair device 602 comprises a first member 4521 extending from point A to point B, a second member 4522 extending from point A to point C, a third member 4523 extending from point B to point D, a fourth member 4524 extending from point C to point E, and a fifth member 4525 extending from point D to point E. A coupling 605 is movably connected to a shaft 603, and the shaft 603 is attached to the fifth member 4525. The first link 4521 and the second link 4522 are pivotably attached to the coupling 605 at point A, so that a movement of the coupling 605 along the shaft 603 shifts the position of point A and consequently also moves the first link 4521 and the second link 4522.The first link 4521 and the third link 4523 are pivotally connected to each other at point B, and the second link 4522 and the fourth link 4524 are pivotally connected to each other at point C. One paddle 606a is attached to the first link 4521 such that the movement of the first link 4521 causes the movement of paddle 606a, and the other paddle 606b is attached to the second link 4522 such that the movement of the second link 4522 causes the movement of paddle 606b.

[0113] To remove the flap repair device 602 from the closed position (as in Fig. 45A) to bring into the release position (as shown in Fig. (as shown in Figure 45C), the coupling 605 is moved along the shaft 603 in the Y direction, thereby bringing the pivot point A for the first link 4521 and the second link 4522 into a new position. As shown in Fig. As shown in Figure 45A, the flap repair device 602 is in a closed position with an angle α between the paddle 606 and the shaft 603. The angle α can be, for example, between approximately α degrees and approximately 45 degrees, between approximately 5 degrees and approximately 40 degrees, between approximately 15 degrees and approximately 30 degrees, or between approximately 20 degrees and approximately 25 degrees. As shown in Fig. As shown in Figure 45B, the flap repair device 602 is moved into the open position by moving the coupling 605 along the shaft 603 in the Y direction. The movement of the coupling 605 in the Y direction causes the first link 4521 to rotate about point A, so that the first link 4521 and the second link 4522 move outwards in the Z direction, causing the paddles 606a, 606b to move downwards and outwards in the H direction. As shown in Fig. As shown in Figure 45C, the flap repair device 602 is moved into the release position by advancing the coupling 605 along the shaft 603 in the Y direction. The continued movement of the coupling 605 in the Y direction causes the first link 4521 and the second link 4522 to move inwards in the M direction, which in turn causes the paddles 606a, 606b to move downwards and inwards in the N direction. As shown in Fig. As can be seen further in Figure 45C, the flap repair device 602, in the release position, has an angle β between the paddles 606 and the shaft 603. The angle β can be, for example, greater than or equal to 120 degrees, greater than or equal to 130 degrees, greater than or equal to 140 degrees, greater than or equal to 150 degrees, or greater than or equal to 160 degrees.

[0114] As in the Fig. As shown in Figures 46A-46D, the basic arrangement 604 of a further exemplary embodiment of a flap repair device 602 comprises a first member 4621 extending from point A to point B, a second member 4622 extending from point A to point C, a third member 4623 extending from point B to point D, a fourth member 4624 extending from point C to point E, a fifth member 4625 extending from point D to point F, and a sixth member 4626 extending from point E to point F. A coupling 605 is movably attached to a shaft 603, and the shaft 603 is attached to the fifth member 4625 and the sixth member 4626 at point F. The first link 4621 and the second link 4622 are pivotally attached to the coupling 605 at point A, so that a movement of the coupling 605 along the shaft 603 shifts the position of point A and consequently 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, such that a movement of the shaft shifts the position of point F and consequently moves the fifth link 4625 and the sixth link 4626. A 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 the fifth link 4625 and the sixth link 4626 cannot pivot relative to the shaft 603 when the locking element 4631 is in the locked position. However, when the locking element 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 connected to each other at point B, and the second link 4622 and the fourth link 4624 are pivotally connected to each other at point C. One paddle 606a is attached to the first link 4621 such that the movement of the first link 4621 causes the movement of paddle 606a, and the other paddle 606b is attached to the second link 4622 such that the movement of the second link 4622 causes the movement of paddle 606b.

[0115] To remove the flap repair device 602 from the closed position (as in Fig. 46A) to bring into a release position (as shown in Fig. (as shown in Figure 46C), the locking element 4631 is held in a locked position, and the coupling 605 is moved along the shaft 603 in the Y direction, thereby bringing the pivot point A for the first link 4621 and the second link 4622 into a new position. To move the flap repair device 602 from the release position to the folded release position (as shown in Figure 46C), the locking element 4631 is held in a locked position, and the coupling 605 is moved along the shaft 603 in the Y direction, thereby bringing the pivot point A for the first link 4621 and the second link 4622 into a new position. Fig. (as shown in Figure 46D), the locking element 4631 is brought into an unlocked position, and the shaft 603 is moved in the direction of D, thereby bringing the pivot point F for the fifth link 4625 and the sixth link 4626 into a new position, causing the fifth link 4625 and the sixth link 4626 to pivot around the shaft 603.

[0116] In Fig. Figure 46A shows the flap repair device 602 in a closed position with an angle α between the paddle 606 and the shaft 603. The angle α can be, for example, between approximately α degrees and approximately 45 degrees, between approximately 5 degrees and approximately 40 degrees, between approximately 15 degrees and approximately 30 degrees, or between approximately 20 degrees and approximately 25 degrees. As shown in Fig. As shown in Figure 46B, the flap repair device 602 is moved into the open position by moving the coupling 605 along the shaft 603 in the Y direction. The movement of the coupling 605 in the Y direction causes the first link 4621 and the second link 4622 to move outwards in the Z direction, which in turn moves the paddles 606a and 606b downwards and outwards in the H direction. The locking element 4631 is held in the locked position when the flap repair device 602 is moved from the closed position (as shown in Figure 46B). Fig. 46A) into the open position (as shown in Fig. 46B) is moved.

[0117] As in Fig. As shown in Figure 46C, the flap repair device 602 is moved into the release position by advancing the coupling 605 along the shaft 603 in the Y direction. The continued movement of the coupling 605 in the Y direction causes the first link 4621 and the second link 4622 to move inwards in the M direction, which in turn causes the paddles 606a and 606b to move downwards and inwards in the N direction. As shown in Fig. As shown in Figure 45C, the flap repair device 602, in the release position, has an angle β between the paddles 606 and the shaft 603. The angle β can be, for example, greater than or equal to 120 degrees, greater than or equal to 130 degrees, greater than or equal to 140 degrees, greater than or equal to 150 degrees, or greater than or equal to 160 degrees. The locking element 4631 is held in the locked position when the flap repair device 602 is released from the open position (as shown in Figure 45C). Fig. 46B) is moved into the release position (as shown in Fig. 46C shown).

[0118] As shown in Figure 460, the flap repair device 602 is moved from the release position to the folded position by moving the locking element 4631 into an unlocked position and moving the shaft 603 in direction D, causing the fifth link 4625 and the sixth link 4626 to pivot about the connection point F and move upwards in direction J, causing the third link 4623 and the fourth link 4624 to move inwards and downwards in direction Q, causing the paddles 606a, 606b to move downwards and inwards in direction Q. As shown in Fig. As shown in Figure 46D, the flap repair device 602, in the folded release position, has an angle µ between the paddles 606 and the shaft 603. The angle µ can be, for example, greater than or equal to 120 degrees, greater than or equal to 130 degrees, greater than or equal to 140 degrees, greater than or equal to 150 degrees, greater than or equal to 160 degrees, or greater than or equal to 170 degrees.

[0119] It is advantageous to have a valve repair device that incorporates features to ensure it remains in a closed position after being attached to a patient's native valve. In other words, it is advantageous to have a valve repair device with features that prevent it from detaching from the patient's native valve after insertion, which could lead to problems (such as regurgitation of blood through the mitral valve). Examples of additional features that prevent a valve repair device from detaching from a native valve are described in the Fig. 47A-49 shown.

[0120] As in the Fig. As shown in Figures 47A-47B, an exemplary embodiment of a flap repair device 602 comprises a locking element 4701 attached to the paddles 606, the locking element 4701 being configured to secure the paddles 606 to the gripping elements 608 when the flap repair device is in the closed position. The flap repair device 602 may have all other features of a flap repair device discussed in the present application, and the flap repair device 602 may be positioned to engage with the flap fabric 820 as part of any suitable flap repair system (for example, any flap repair system disclosed in the present application).In the illustrated embodiment, the flap repair device 602 includes an optional detent 607 configured to hold a coupling 605 in a locked position on the shaft 603. However, should the optional detent 607 fail, the coupling 605 could move on the shaft 603 and bring the flap repair device into an open position. The locking element 4701 is configured to hold the flap repair device 602 in the closed position if the detent 607 fails.

[0121] As in Fig. As shown in Figure 47A, the flap repair device 602 is in an open position, with the flap fabric 820 arranged in the opening 614 between the paddles 606 and the gripping elements 608. As shown in Fig. As shown in Figure 47B, the flap repair device 602 is moved into the closed position, so that the flap fabric 820 is secured between the paddles 606 and the gripping elements 608 of the flap repair device. The flap repair device 602 can be moved into the closed position in any suitable manner, such as any manner described in the present application. When the flap repair device 602 is moved into the closed position, the locking element 4701 pierces the flap fabric 820 and the gripping element 608 to secure the paddle to the gripping element. The locking element 4701 can assume any suitable shape capable of securing the paddles 606 to the gripping elements 608, such as metals, plastics, or the like.

[0122] As in Fig. As shown in Figure 48, another exemplary embodiment of a valve repair system 600 comprises 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 be attached to the leaflets of a native valve to repair the patient's native valve. The delivery device 601 can take any suitable shape capable of delivering the valve repair device 602 to a patient's native valve, such as any shape described in the present application. The valve repair device 602 comprises a base assembly 604, a pair of paddles 606, and a pair of gripping elements 608.The basic assembly 604 of the flap repair device 602 comprises a shaft 603 and a coupling 605 configured to move along the shaft. The coupling 605 is mechanically connected to the paddles, so that the movement of the coupling along the shaft 603 causes the paddles to move between an open and a closed position. In the closed position, the paddles 606 and the gripping elements 608 engage with the flap fabric and with each other to secure the flap repair device 602 to the flap fabric. The flap repair device 602 also includes a preloading element 4807 (for example, a spring) configured to preload the coupling 605 on the shaft so that the flap repair device 602 is in a closed position.

[0123] In certain embodiments, the valve repair system 600 comprises a placement shaft 613, which is detachably attached to the shaft 603 of the base assembly 604 of the valve repair device 602. After the valve repair device 602 is attached 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 has been removed from the patient's body, the tensioning element 4807 holds the valve repair device in a closed position to prevent it from detaching from the valve tissue.The valve repair device 602 can have all the other features of a valve repair device discussed in the present application, and the valve repair device 602 can be positioned to engage with the valve fabric 820 as part of any suitable valve repair system (for example, any valve repair system disclosed in the present application).

[0124] As in Fig. As shown in Figure 49, another exemplary embodiment of a valve repair system 600 comprises 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 be attached to the leaflets of a native valve to repair the patient's native valve. The delivery device 601 can take any suitable shape capable of delivering the valve repair device 602 to a patient's native valve, such as any shape described in the present application. The valve repair device 602 comprises a base assembly 604, a pair of paddles 606, and a pair of gripping elements 608.The base assembly 604 of the flap repair device 602 comprises a shaft 603 and a coupling 605 configured to move along the shaft. In the illustrated embodiment, the shaft 603 includes a threaded section 4902, and the coupling 605 is configured to move along the threaded section 4902 of the shaft. That is, the rotation of the shaft 603 causes the coupling 605 to move up and down on the shaft 603. The coupling 605 is mechanically connected to the paddles, so that the movement of the coupling along the shaft 603 causes the paddles to move between an open position and a closed position. In the closed position, the paddles 606 and the gripping elements 608 engage with the flap fabric and with each other to secure the flap repair device 602 to the flap fabric.

[0125] In certain embodiments, the valve repair system 600 comprises a placement shaft 613, which is detachably attached to the shaft 603 of the base assembly 604 of the valve repair device 602. After the valve repair device 602 has been attached 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 has been attached to the valve tissue and the valve repair system 600 has been removed from the patient's body, the valve repair device is prevented from detaching from the valve tissue, as the coupling can only be moved by rotating the shaft 603.The valve repair device 602 can have all the other features of a valve repair device discussed in the present application, and the valve repair device 602 can be positioned to engage with the valve fabric 820 as part of any suitable valve repair system (for example, any valve repair system disclosed in the present application).

[0126] As in the Fig. Figures 50-54 illustrate embodiments of valve repair systems 600, comprising a delivery device 601 and a valve repair device 602. The delivery device is configured to deliver the valve repair device to a patient's native valve, and the valve repair device is configured to be attached to the leaflets of a native valve to repair the patient's native valve. The delivery device 601 can have any suitable shape capable of delivering the valve repair device 602 to a patient's native valve, such as any shape described in the present application. The valve repair device 602 is similar to the valve repair devices described above and comprises a base assembly 604, a pair of paddles 606, and a pair of gripping elements 608.The basic assembly 604 of the flap repair device 602 comprises a shaft 603 and a coupling 605 configured to move along the shaft. The coupling 605 is mechanically connected to the paddles, so that the movement of the coupling along the shaft 603 causes the paddles to move between an open position and a closed position. In some embodiments, the flap repair device 602 includes a detent 607 configured to lock the coupling 605 in a desired position on the shaft (as shown in the figures). Fig. 50-53B). In alternative embodiments, the flap repair device 602 comprises a preload element 4807 configured to hold the coupling 605 in a desired position on the shaft 603 (as shown in Fig. (54 shown). In the closed position, the paddles 606 and the gripping elements 608 engage with the valve tissue and with each other to attach the valve repair device 602 to the valve tissue. In certain embodiments, the valve repair system 600 comprises a placement shaft 613, which is detachably attached to the shaft 603 of the base assembly 604 of the valve repair device 602. After the valve repair device 602 has been attached 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 can have all the other features of a valve repair device discussed in the present application, and the valve repair device 602 can be positioned to engage with the valve fabric 820 as part of any suitable valve repair system (for example, any valve repair system disclosed in the present application).

[0127] As in Fig. As shown in Figure 50, the gripping elements 608 are attached to the paddles 606 in some embodiments. In the embodiment shown in Fig. In the example shown in Figure 50, the gripping elements 608 comprise a fastening section 5010, a hinged or flexible section 5012, and a spiked section 5014. The fastening section 5010 can assume any shape that allows the gripping element to be attached to the paddle 606. The hinged or flexible section 5012 can assume a variety of different shapes. For example, the hinged section can be configured to bias the spiked section 5014 toward the fastening section 5010. In one exemplary embodiment, the hinged section 5012 biases the spiked section 5014 into a fully closed position in which the spiked section engages with the fastening section 5010 and / or the paddle section 606.When the flap fabric is positioned between the paddle 606 and the gripping section 5014, the gripping section 5014 is pre-tensioned by the hinged section or flexible section such that the flap fabric is clamped between the gripping section or spiked section 5014 and the paddle. This is described in... Fig. The gripping element 608 shown in Figure 50 moves with the paddle 606. The joint section or flexible section 5012 enables the gripping section 5014 to move in the direction indicated by the arrows 5020 and can enable the gripping section to be pulled in the direction indicated by the arrows 5022.

[0128] In certain embodiments, it is advantageous if the spiked section 609 is arranged towards a proximal end of the gripping elements 608, as this makes it easier to detach the gripping elements 608 from the flap tissue. As in Fig. As shown in Figure 51, in one embodiment the gripping elements 608 comprise a single row of spikes 5102 configured to engage with the flap fabric and the paddles 606 to secure the flap repair device to the flap fabric. The single row of spikes 5102 makes it easier for the gripping section 5014 to detach from the flap fabric. In an alternative embodiment, the gripping elements 608 may comprise two or more rows of spikes 5102 arranged at a proximal end of the gripping elements 608. In further embodiments, the spikes 5102 at a proximal end of the gripping elements 608 may be arranged in any other suitable configuration that facilitates easier detachment of the gripping elements 608 from the flap fabric.

[0129] In some embodiments, such as in the Fig. As shown in Figures 51A-51E, the gripping element 608 is configured to exert a clamping force on the flap fabric when the flap repair device (e.g., any flap repair device 602 described in the present application) is attached to the flap fabric. The gripping element 608 is slidably connected to the paddle 606 so that the gripping element 608 can be moved along the paddle in the X direction. For example, a gripper control mechanism 611 can be used to move the gripping element 608 along the paddle 606 in the X direction, and the gripper control mechanism 611 can also be used to move the gripping element 608 between the closed position (as shown in Figures 51A-51E) and the open position (as shown in Figures 51A-51E). Fig. 51A) and the open position (as shown in Fig. 51B) to move. The gripper control mechanism 611 can take any form described in the present application. In certain embodiments, the flap repair device 602 includes an optional preload element 5122 (for example, a spring) configured to hold the gripper element 608 in a desired position along the paddle 606 (for example, as shown in the Fig. 51A and Fig. 51E position shown). In the illustrated embodiment, the gripping element 608 comprises a single row of spikes 609 at a proximal end of the gripping elements (for example, as in the Fig. 51 embodiment of the flap repair device 602), however, it should be assumed that the embodiment shown here in relation to the Fig. The features described in 51A-51E can be used with each of the embodiments of the flap repair device described in the present application.

[0130] In Fig. Figure 51A shows the gripping element 608 in a first position on the paddle 606 and in a closed position. Fig. Figure 51B shows the gripping element 608 after it has been moved into an open position in the direction Z by the gripper control mechanism 611. Fig. Figure 51C shows the gripping element 608 after it has been moved along the paddle 606 in direction D into a second position. In certain embodiments, the gripping element 608 is moved along the paddle in direction D by the gripper control mechanism 611 or a separate mechanism. In embodiments that include the preloading element 5122, a sufficient force must be exerted on the gripping element 608 to move it in direction D, causing the preloading element to expand and generate a clamping force on the gripping element 608 in direction B. While the illustrated embodiment shows that the gripping element 608 is moved into an open position (as in Figure 51C), the gripping element 608 is moved in an open position (as in Figure 51C). Fig. 51B), before the gripping element 608 is moved along the paddle 606 in the direction of D into the second position (as shown in Fig. (as shown in Figure 51C), the gripping element 608 can be moved in direction D to the second position before the gripping element 608 is moved in direction Z to an open position, or the movements can be performed simultaneously. As shown in Fig. As shown in Figure 51D, the gripping element 608 is moved by the gripper control mechanism 611 into a closed position in the Y direction in order to attach the spiked section 609 of the gripping element 608 to the flap fabric (not shown). In the Fig. In the position shown in Figure 51D, the pretensioning element 5122 is held in an extended position (for example, as a result of the force exerted on the gripping element 608 by the gripper control mechanism (or another mechanism) to hold the gripping element in the second position), which means that the pretensioning element 5122 exerts a clamping force on the gripping element 608 in direction B. As shown in Figure 51D, the pretensioning element 5122 is held in an extended position (for example, as a result of the force exerted on the gripping element 608 by the gripper control mechanism (or another mechanism) to hold the gripping element in the second position), which means that the pretensioning element 5122 exerts a clamping force on the gripping element 608 in direction B. Fig. As shown in Figure 51E, after the spiked section 609 of the gripping element 608 is attached to the flap fabric, the force holding the gripping element 608 in the second position is released. This causes the tension applied by the pre-tensioning element 5122 to move the gripping element 608 along the paddle 606 in the direction M. The movement of the gripping element 608 in the direction M causes the spiked section 609 to exert a tension force on the flap fabric in the direction T. This tension force on the flap fabric enables the flap repair device 602 to maintain a secure connection to the flap fabric.

[0131] In another embodiment, as described in the Fig. As shown in Figures 51F-51G, the gripping element 608 comprises a spiked section 609 and a weakened or flexible section 5103. The spiked section 609 is arranged on a first side 5111 of the weakened or flexible section 5103. In the embodiment shown, the spiked section 609 comprises a single row of spikes, but it is understood that any suitable configuration of the spikes may be used, such as any configuration described in the present application. The weakened or flexible section 5103 may, for example, be a recess in the gripping element, be made of a different material than the remainder of the gripping element 608, or assume any other suitable shape that allows the weakened or flexible section 5103 to be weaker and / or more flexible than the remainder of the gripping element 608.In other embodiments, however, the weaker and spiked section 5103 is omitted, and the link 5107 and the line 5105 described below are still able to bend the spiked section, as in the . Fig. 51F-51H shown.

[0132] As in the Fig. As shown in Figures 51F-51H, the gripper control mechanism 611 comprises a cord 5105 (for example, suture material) and a push / pull element 5107 configured to receive the cord 5105. For example, the push / pull element 5107 can be a catheter, a wire with a loop (as in Figure 51F-51H). Fig. (25A shown) or any other link capable of receiving the cord 5105 and pushing / pulling the gripping element 608. A first end 5125 of the cord 5105 extends from a feed device (for example, any feed device 601 described in the present application) and is detachably attached to the gripping element 608 at a first connection point A on a first side 5111 of the weakened or flexible section 5103. The cord 5105 also extends from connection point A and is detachably attached to the gripping element 608 at a second connection point B on a second side 5113 of the weakened or flexible section 5103. Furthermore, the cord 5105 extends from the second connection point B and through the push / pull link 5107.

[0133] In Fig. Figure 51F shows the gripping element 608 in an open position, in which a flap fabric element 820 is arranged in an opening 614 between the gripping element 608 and a paddle (not shown). The gripping element can be moved into the open position by pulling on the line 5105. As shown in Fig. As shown in Figure 51G, the link 5107 and the line 5105 of the gripper control mechanism 611 are used to move the gripping element 608 in the X direction into the closed position and to bend the section 609 in the Y direction. The first end 5125 of the line 5105 is pulled in the Y direction, so that the first side 5111 of the gripping element 608 pivots or bends about the weakened section 5103. This bending causes the spiked section 609 to move into a bent position in the U and Y directions. As shown in Fig. As shown in Figure 51G, the link 5107 and the line 5105 are moved such that the spiked section 609 pierces the flap fabric 820 while the spiked section is in the bent position.

[0134] As in Fig. As shown in Figure 51H, the cord 5105 is released, causing the first end 5111 of the gripping element 608 to pivot around the weakened or flexible section 5103. This causes the spiked section 609 to move through the flap fabric 820 in direction D, thereby generating a tension force on the flap fabric 820 in direction D. After the gripping element 608 is attached to the flap fabric 820 (as shown in Figure 51H), the first end 5111 of the gripping element 608 pivots around the weakened or flexible section 5103. This causes the spiked section 609 of the flap repair device to move through the flap fabric 820 in direction D. Fig. (shown in 51H), the link 5107 and the line 5105 are removed from the gripping element 608.

[0135] As in Fig. As shown in Figure 52, the gripping elements 608 in various embodiments include an extendable section 5202 that allows movement in the direction 5204. Movement in the direction 5204 enables clean release from the valve tissue. In some embodiments, the extendable section 5202 is configured so that it can be moved such that the prongs 5102 exit the valve tissue in a direction substantially opposite to the direction in which the prongs entered the valve tissue. Alternatively, the gripping elements 608 can also be extendable in other ways so that they can release from the valve tissue without tearing it. For example, as mentioned above, the joint sections 5012 can be configured so that the gripping sections 5014 of the gripping elements 608 can be pulled in the direction 5204.

[0136] As in the Fig. As shown in Figures 53A-53B, the gripping elements 608 are made of bendable material in certain embodiments. Fig. Figure 53A shows the flap repair device 602 in a closed position and attached to the flap fabric 820. Fig. Figure 53B shows how the gripping elements 608 are moved by the gripper control mechanism 611 to remove them from the flap fabric 820. More precisely, the movement of the gripper control mechanism 611 in the Y direction causes the gripping elements 608 to detach from the flap fabric in the Z direction. The flexible material of the gripping elements 608 allows them to detach when removed from the flap fabric 820. This detachment is advantageous because it facilitates the removal of the gripping elements from the flap fabric 820 without damaging it. In certain embodiments, the flexible gripping elements 608 allow the spiked section 609 of the gripping elements 608 to be removed from the flap fabric in a direction that is essentially opposite to the direction in which the spikes penetrated the flap fabric.

[0137] As in Fig. As shown in Figure 54, in certain embodiments the gripping elements 608 are connected to each other by a separate preload element 5410 (for example, a spring) which is configured to hold the gripping elements in a desired position such that, when the paddles 606 are in an open position, a width W exists between the paddles and the gripping elements. The width W can be adjusted by engaging the gripping elements 608 with the gripper control mechanism 611. That is, movement of the gripper control mechanism 611 into the feed device in the direction Z causes the preload element 5410 to bend and the paddles to move inwards in a direction X. Release of the gripping elements by the gripper control mechanism 611 causes the preload element 5410 to move into the desired position (as shown in Figure 54). Fig.(54). The gripper control mechanism 611 can assume any suitable shape to control the gripping elements 608, such as any shape described in the present application. Furthermore, the paddles 608 engage with the gripping elements 608 when the paddles 606 are moved into the closed position, causing the preload element to bend and the gripping elements to move in an inward direction X. The paddles 608 can be moved from the open position to the closed position in any suitable manner, such as any manner described in the present application. Although the various devices described in the present application relate to the intervention and repair of the mitral valve, it is understood that these devices can also be used for the repair of other native valves (for example, the tricuspid valve, the pulmonary valve, the aortic valve) or other sections of the heart.Furthermore, it is clear that the various embodiments of the devices described here can also be used in combination with each other.

[0138] Although the foregoing is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Furthermore, it is clear that certain other modifications may be carried out within the scope of the appended claims.

Claims

[1] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a basic arrangement comprising several pivotable links and a shaft, wherein the pivotable links are moved by the shaft; a pair of paddles attached to the base assembly, wherein the movement of the pivoting links moves the paddles between an open position and a closed position; a pair of gripping elements attached to the base assembly, the paddles and gripping elements being configured to be attached to the patient's valve leaflets; at least one spacer element that surrounds the shaft and is arranged between the pair of gripping elements; wherein the spacer element is made of at least one material selected from the group of materials consisting of woven mesh, fabric, biocompatible material, foam and pericardial fabric; the spacer element fills a space between the gripping elements when the paddles are in the closed position. [2] Flap repair device according to claim 1, wherein the spacer element extends beyond one or more side edges of the gripping elements. [3] Valve repair device according to one of claims 1 or 2, wherein the spacer element is configured to fill at least a section of a gap between mitral or tricuspid valve leaflets of the patient. [4] Valve repair device according to one of the preceding claims, wherein the basic arrangement of the valve repair device further comprises: a coupling that is movably attached to the shaft so that the coupling can be moved along the shaft; the pair of paddles is pivotably attached to the coupling; wherein a movement of the coupling in a first direction along the shaft causes the pair of paddles to move into the closed position, and a movement of the coupling in a second direction causes the pair of paddles to move into the open position. [5] Flap repair device according to one of the preceding claims, wherein the paddles are formed integrally with the base assembly; preferably wherein the paddles are formed as extensions of links of the base assembly. [6] Flap repair device according to one of the preceding claims, wherein a gripper control mechanism is configured to control each gripper element independently. [7] Flap repair device according to claim 6, wherein the gripper control mechanism comprises a first gripper control element and a second gripper control element. [8] Flap repair device according to claim 7, wherein the first and second gripper control elements are lines, such as suture material or wires, which are each detachably attached to each of the gripper elements, with both ends of the line extending through a feed opening of a feed device. [9] Valve repair device according to one of the preceding claims, wherein the spacer element has a non-circular cross-section. [10] Valve repair system for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feeding device having at least one lumen; a valve repair device configured to be delivered through the lumen of the delivery device and configured to be attached to a patient's native valve, the valve repair device comprising: a basic arrangement comprising several pivotable links and a shaft, wherein the pivotable links are moved by the shaft; a pair of paddles attached to the base assembly, wherein the movement of the pivoting links moves the paddles between an open position and a closed position; a pair of gripping elements attached to the base assembly, the paddles and gripping elements being configured to be attached to the patient's valve leaflets; at least one spacer element that surrounds the shaft and is arranged between the pair of gripping elements; wherein the spacer element is made of at least one material selected from the group of materials consisting of woven mesh, fabric, biocompatible material, foam and pericardial fabric; the spacer element fills a space between the gripping elements when the paddles are in the closed position. [11] Flap repair system according to claim 10, wherein the spacer element extends beyond one or more side edges of the gripping elements. [12] Flap repair system according to one of claims 10 or 11, wherein the spacer element comprises a main section extending between the gripping elements and extension sections extending beyond the side edges of the gripping elements. [13] Valve repair device (602) for repairing a patient's native valve, the valve repair device comprising: a base arrangement (604) comprising several pivotable links and a shaft (603); a pair of paddles (606) attached to the base arrangement, wherein the movement of the pivoting links moves the paddles between an open position and a closed position; a pair of gripping elements (608) attached to the base assembly, wherein the paddles and the gripping elements are arranged such that openings (614) are provided between them in which at least sections of the patient's native valve leaflets can be received; and at least one spacer element (3800) that surrounds the shaft and is arranged between the pair of gripping elements; wherein the spacer element is configured to fill a sufficient volume to close or fill a gap (3002) in the patient's native valve when the paddles are in the closed position. [14] Valve repair device (602) for repairing a patient's native valve, the valve repair device comprising: a basic arrangement (604) comprising several pivotable links (605) and a shaft (603), wherein the pivotable links are moved by the shaft; a pair of paddles (606) attached to the base arrangement, wherein the movement of the pivoting links (605) moves the paddles (606) between an open position and a closed position; a pair of gripping elements (608) attached to the base assembly (604), wherein the paddles (606) and the gripping elements (608) are each configured to be movable towards each other in order to be attached to the patient's leaflet flaps, and the gripping elements (608a, 608b) each have a distal end section, wherein the gripping elements are connected to each other at their distal end sections by a distal connecting section (608, 5410); at least one spacer element (3800) that surrounds the shaft (603) and is arranged between the pair of gripping elements (608); wherein the spacer element (3800) fills a space between the gripping elements (608) when the paddles (606) are in the closed position; wherein the spacer element (3800), as seen from an atrial side of the native valve in a top view, extends beyond one or more side edges of the gripping elements (608) when the paddles (606) and the gripping elements (608) are attached to the valve leaflets of the patient. [15] Valve repair system (600) for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feed device (601) having at least one lumen; a valve repair device (602) for repairing a patient's native valve, wherein the valve repair device is configured to be fed through the lumen of the delivery device (601) and is configured to be attached to a patient's native valve, the valve repair device (602) comprising: a basic arrangement (604) comprising several pivotable links (605) and a shaft (603), wherein the pivotable links are moved by the shaft; a pair of paddles (606) attached to the base arrangement, wherein the movement of the pivoting links (605) moves the paddles (606) between an open position and a closed position; a pair of gripping elements (608) attached to the base assembly (604), wherein the paddles (606) and the gripping elements (608) are each configured to be movable towards each other in order to be attached to valve leaflets of the patient, and the gripping elements (608a, 608b) each have a distal end section, wherein the gripping elements are connected to each other at their distal end sections by a distal connecting section (608, 5410); at least one spacer element (3800) that surrounds the shaft (603) and is arranged between the pair of gripping elements (608); wherein the spacer element (3800) fills a space between the gripping elements (608) when the paddles (606) are in the closed position; wherein the spacer element (3800), as seen from an atrial side of the native valve in a top view, extends beyond one or more side edges of the gripping elements (608) when the paddles (606) and the gripping elements (608) are attached to the valve leaflets of the patient; wherein each of the paddles (606) comprises a main section (1404) and side sections (1405) and is made of a rigid material; wherein the spacer element (3800) is made of a woven net; and a gripper control mechanism (611) configured to control each of the gripper elements (608) independently, the gripper control mechanism comprising a first gripper control element (2202) and a second gripper control element (2204), wherein the first and second gripper control elements (2202, 2204) are lines, such as suture material or wires, which are each detachably attached to each of the gripper elements (608), with both ends of the line extending through a feed opening (716) of the feed device (601). [16] Valve repair system (600) for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feed device (601) having at least one lumen; a valve repair device (602) configured to be delivered through the lumen of the delivery device (601) and configured to be attached to a patient's native valve, the valve repair device (602) comprising: a pair of paddles (606a, 606b) which can be moved between an open position and a closed position; a first gripping element (608a) and a second gripping element (608b), wherein the paddles (606a, 606b) and the gripping elements (608a, 608b) are configured to be attached to the patient's native valve; and a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve; the flap repair system further includes a gripper control mechanism (611) comprising: a first gripper control element (2202) detachably attached to the first gripper element (608a), wherein the first gripper control element comprises a first tether (2202) detachably attached to the first gripper element (608a), wherein a section of the first tether (2202) extends or may extend through a feed opening (716) of the feeder (601), and wherein the first tether is configured to engage with the first gripper element (608a) in order to move the first gripper element between one or more positions; and a second gripper control element (2204) which is detachably attached to the second gripper element (608b), wherein the second gripper control element comprises a second cord (2204) which is detachably attached to the second gripper element (608b), wherein a section of the second cord extends or may extend through the feed opening (716) of the feed device (601), and wherein the second cord is configured to engage with the second gripper element (608b) in order to move the second gripper element between one or more positions. [17] Valve repair device (602) for repairing a patient's native valve, the valve repair device comprising: a basic arrangement (604) comprising several pivotable links (605) and a shaft (603), wherein the pivotable links are moved by the shaft; a pair of paddles (606) attached to the base arrangement, wherein the movement of the pivoting links (605) moves the paddles (606) between an open position and a closed position; a pair of gripping elements (608) attached to the base assembly (604), wherein the paddles (606) and the gripping elements (608) are each configured to be movable towards each other in order to be attached to valve leaflets of the patient, and the gripping elements (608a, 608b) each have a distal end section, wherein the gripping elements are connected to each other at their distal end sections by a distal connecting section (608); wherein the distal connecting section (608) extends perpendicular to the shaft; at least one spacer element (3800) that surrounds the shaft (603) and is arranged between the pair of gripping elements (608); wherein the spacer element (3800) fills a space between the gripping elements (608) when the paddles (606) are in the closed position. [18] Valve repair device according to claim 17, wherein the base arrangement (604) of the valve repair device further comprises: a coupling (605) which is movably attached to the shaft so that the coupling can be moved along the shaft (603); wherein the pair of paddles (606) is pivotably attached to the coupling (605); wherein a movement of the coupling (605) in a first direction along the shaft (603) causes the pair of paddles (606) to move into the closed position, and a movement of the coupling in a second direction causes the pair of paddles to move into the open position. [19] Flap repair device according to claim 17, wherein the spacer element (3800) comprises a first spacer element (4102) attached to a first gripping element (608a) of the pair of gripping elements, and a second spacer element (4104) attached to a second gripping element (608b) of the pair of gripping elements. [20] Flap repair device according to claim 17, wherein the spacer element (3800) comprises a main section (4210a, 4210b, 4210c) extending between the gripping elements (608) and extension sections (4212a, 4212b, 4212c) extending beyond the side edges of the gripping elements (608). [21] Flap repair device according to claim 20, wherein the extension sections (4212b) have a semicircular shape. [22] Valve repair device according to claim 17, wherein the spacer element is configured (3800) to fill at least one section of a gap between mitral or tricuspid valve leaflets of the patient. [23] Valve repair device according to claim 17, wherein the spacer element (3800) is made of at least one material selected from the group of materials consisting of woven mesh, fabric, biocompatible material, foam and pericardial fabric. [24] Valve repair device according to one of claims 17 to 23, wherein the distal connecting section (608) and the gripping elements (608) are arranged in a U-shape. [25] Valve repair device according to one of claims 17 to 24, wherein the distal connecting section (608) is slidably connected to the shaft (603). [26] Valve repair system (600) for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feed device (601) having at least one lumen; a valve repair device (602) according to any one of claims 17 to 25, which is configured to be fed through the lumen of the delivery device (601) and is configured to be attached to a native valve of a patient. [27] Flap repair system according to claim 26, further comprising a gripper control mechanism (611) for the pair of gripper elements (608), comprising a first gripper control element (2202) and a second gripper control element (2204), wherein the first gripper control element (2202) is configured to move a first gripper element (608a) of the pair of gripper elements (608) in opposite directions towards a first paddle (606a) of the pair of paddles (606) and away from the first paddle in order to set a width (W) of an opening (614a) between the first gripper element (608a) and the first paddle (606a), and the second gripper control element (2204) is configured to move a second gripper element (608b) of the pair of gripper elements (608) in opposite directions (Z) towards a second paddle (606b) of the pair of paddles (606) and away from the second paddle (606b) to set a width (H) of an opening (614b) between the second gripper element (608b) and the second paddle (606b). [28] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a pair of paddles; a pair of gripping elements; and a spacer element; the paddles are movable between an open position and a closed position; the paddles and gripping elements are configured to be attached to the patient's native valve; and wherein the spacer element is configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [29] Valve repair device configured to attach to leaflets of a native valve for repairing a patient's native valve, the valve repair device comprising: a base; a pair of paddles; and a pair of gripping elements. [30] Flap repair device according to claim 29, wherein the paddles are formed integrally with the base assembly. [31] Flap repair device according to claim 30, wherein the paddles are designed as extensions of links of the base arrangement. [32] Flap repair device according to any one of claims 29 to 31, wherein the base arrangement comprises a shaft, a coupling configured to move along the shaft, and a locking mechanism configured to lock the coupling in a stationary position on the shaft. [33] Flap repair device according to one of claims 29 to 32, wherein the gripping elements are pivotably connected to the base arrangement so that the gripping elements can be moved to adjust the width of the opening between the paddles and the gripping elements. [34] Valve repair system for repairing a patient's native valve, comprising: a feeding device; and a flap repair device as defined in any one of claims 29 to 33. the delivery device is configured to deliver the valve repair device to a patient's native valve. [35] System according to claim 34, further comprising a gripper control mechanism comprising a single line, such as suture material or wire, which is detachably attached to the gripper elements and detachably fastened between a placement shaft and a shaft of the flap repair device. [36] System according to claim 35, wherein the individual line is connected between the placement shaft and the shaft of the flap repair device, so that the individual line can control the gripping elements independently of each other. [37] Valve repair system (600) for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system (600) comprising: a valve repair device (602) for attachment to a patient's native valve, the valve repair device (602) comprising: a pair of paddles (606a, 606b) that are movable between an open position and a closed position; and a first gripping element (608a) and a second gripping element (608b), wherein the paddles (606a, 606b) and the gripping elements (608a, 608b) are arranged such that openings (614a, 614b) are provided between the paddles (606a, 606b) and the gripping elements (608a, 608b) in which at least sections of the patient's native valve can be received; a gripper control mechanism (611) configured to move the first and second gripper elements (608a, 608b) independently of each other, wherein the gripper control mechanism (611) comprises a single line (2302), such as suture material or wire, which is detachably attached to the first gripper element and the second gripper element (608a, 608b), wherein the single line (2302) is detachably attached to the flap repair system (600) at a connection point (615) between the first gripper element (608) and the second gripper element (608), and wherein a movement of a first section (2303) of the single line (2302) sets a width of the opening (614a) between the first gripper element (608a) and the first paddle (606a), but does not set a width of the opening (614b) between the second gripper element (608b) and the second paddle (606b), and wherein a movement of a second section (2305) of the single line (2302) sets the width of the opening (614b) between the second gripping element (608b) and the second paddle (606b),however, it does not adjust the width of the opening (614a) between the first gripping element (608a) and the first paddle (606a). [38] Valve repair device (602) for repairing a patient's native valve, the valve repair device comprising: a basic arrangement (604) comprising: a shaft (603) with a threaded section (4902); a coupling (605) with an internal thread that fits with the threaded section (4902) of the shaft (603) so that the coupling (605) can be moved along the shaft (603); a pair of paddles (606) attached to the coupling (605) of the base assembly (604), wherein the paddles (606) are movable between an open position and a closed position; a pair of gripping elements (608) attached to the base assembly (604), wherein the paddles (606) and the gripping elements (608) are arranged such that openings (614) are provided between the paddles (606) and the gripping elements (608), and wherein the paddles (606) and the gripping elements (608) are configured to be attached to the patient's native valve; wherein a rotation of the shaft (603) causes the coupling (605) to move along the shaft (603) and the pair of paddles (606) to move between the open position and the closed position. [39] Valve repair system, comprising: a feeding device; and a valve repair device configured to attach to the leaflets of a native valve in order to repair a patient's native valve; wherein the delivery device is configured to deliver the valve repair device to the patient's native valve; the flap repair device includes: a basic arrangement; a pair of paddles; and a pair of gripping elements; wherein the basic arrangement comprises a shaft and a coupling configured to move along the shaft; and wherein the shaft includes a threaded section and the coupling is configured to move along the threaded section of the shaft; and wherein the coupling is mechanically connected to the paddles, so that a movement of the coupling along the shaft causes the paddles to move between an open position and a closed position. [40] Valve repair system for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feeding device having at least one lumen; a valve repair device configured to be delivered through the lumen of the delivery device and configured to be attached to a patient's native valve, the valve repair device comprising: a pair of paddles that can be moved between an open position and a closed position; wherein each paddle comprises a main section and a first and a second side section which are formed integrally with the main section and extend from the main section and are configured to conform to the shape of the native flap; wherein the pair of paddles is configured such that the first and second side sections bend away from the main section when attached to the patient's native valve; and a pair of gripping elements configured to be attached to the patient's native valve. [41] Valve repair system according to claim 40, further comprising a base arrangement comprising: a shaft; and a coupling that is movably attached to the shaft so that the coupling can be moved along the shaft; the pair of paddles is pivotably attached to the coupling; wherein a movement of the coupling in a first direction along the shaft causes the pair of paddles to move into the closed position, and a movement of the coupling in a second direction causes the pair of paddles to move into the open position. [42] Valve repair system according to claim 40, wherein each paddle of the paddle pair comprises one or more flanges and wherein the one or more flanges are configured to bend in order to place less stress on the patient's native valve. [43] Valve repair system according to claim 40, wherein the pair of paddles is configured to be in a compressed state when it is positioned in the lumen of the catheter, and wherein the pair of paddles is configured to expand when it is deployed from the catheter. [44] Valve repair device (602) for repairing a patient's native valve, the valve repair device comprising: a pair of paddles (606) which can be moved between an open position and a closed position; wherein each paddle comprises a main section and a first and a second side section which are formed integrally with the main section and extend from the main section and are configured to conform to the shape of the native flap; wherein the pair of paddles is configured such that the first and second side sections bend away from the main section in order to bend when attached to the patient's native valve; and a pair of gripping elements (608) configured to be attached to the native flap. [45] Valve repair device according to claim 44, further comprising a base arrangement comprising: a shaft; and a coupling that is movably attached to the shaft so that the coupling can be moved along the shaft; the pair of paddles is pivotably attached to the coupling; wherein a movement of the coupling in a first direction along the shaft causes the pair of paddles to move into the closed position, and a movement of the coupling in a second direction causes the pair of paddles to move into the open position. [46] Valve repair device according to claim 44, wherein each paddle of the paddle pair comprises one or more flanges and wherein the one or more flanges are configured to bend in order to place less stress on the patient's native valve. [47] Valve repair device according to claim 44, wherein the paddle pair is configured to be in a compressed state when it is positioned in the lumen of the catheter, and wherein the paddle pair is configured to expand when it is deployed from the catheter. [48] ​​Valve repair system for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feeding device having at least one lumen; a valve repair device configured to be delivered through the lumen of the delivery device and configured to be attached to a patient's native valve, the valve repair device comprising: a first paddle and a second paddle, wherein the first and the second paddle are movable between an open position and a closed position; and a pair of gripping elements, wherein the paddles and gripping elements are configured to be attached to the patient's native valve; a paddle control mechanism for moving the first and second paddles, wherein the paddle control mechanism is configured to move the first and second paddles independently of each other; a base that includes: a first shaft; a second shaft; a first coupling that is movable along the first shaft; and a second coupling that is movable along the second shaft; wherein the first paddle is pivotably attached to the first coupling and the second paddle is pivotably attached to the second coupling; wherein a movement of the first clutch in a first direction along the first shaft causes the first paddle to move into a closed position, and a movement of the first clutch along the first shaft in a second direction causes the first paddle to move into the open position; wherein a movement of the second coupling in a first direction along the second shaft causes the second paddle to move into a closed position, and a movement of the second coupling along the second shaft in a second direction causes the second paddle to move into the open position. [49] Flap repair system according to claim 48, wherein the flap repair device further comprises a first locking mechanism and a second locking mechanism, wherein the first and the second locking mechanism are movable between a locked state and an unlocked state, wherein the first locking mechanism is configured to lock the first coupling in a stationary position on the first shaft when the first locking mechanism is in the locked state, and wherein the second locking mechanism is configured to lock the second coupling in a stationary position on the second shaft when the second locking mechanism is in the locked state. [50] Valve repair system according to claim 48, wherein the first and second paddles of the valve repair device are configured to bend when attached to the patient's native valve. [51] Flap repair system according to claim 48, further comprising a gripper control mechanism configured to move the gripper elements. [52] Valve repair system according to claim 48, wherein the valve repair device further comprises a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [53] Valve repair system according to claim 49, wherein the valve repair device is configured to move into a release position for removing the valve repair device from the patient's body, wherein, when the valve repair device is in the release position, an angle between each paddle and a shaft of the base arrangement is greater than or equal to 120 degrees. [54] Flap repair system according to claim 48, wherein each gripping element of the pair of gripping elements is directly attached to a corresponding paddle of the first and second paddle. [55] Valve repair system according to claim 48, wherein each gripping element of the pair of gripping elements is extendable in length to prevent tearing of the patient's native valve when the gripping elements are removed from the native valve. [56] Valve repair system according to claim 48, wherein the pair of gripping elements comprises a flexible material so that the gripping elements can detach from the tissue of the native valve when the gripping elements are detached from the tissue of the native valve. [57] Flap repair system according to claim 48, wherein the gripping elements are connected to each other by a preload element configured to hold the gripping elements in a desired position. [58] Valve repair system for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feeding device having at least one lumen; a valve repair device configured to be delivered through the lumen of the delivery device and configured to be attached to a patient's native valve, the valve repair device comprising: a first paddle and a second paddle, wherein the first and the second paddle are movable between an open position and a closed position; and a pair of gripping elements, wherein the paddles and gripping elements are configured to be attached to the patient's native valve; a paddle control mechanism for moving the first and second paddles, wherein the paddle control mechanism is configured to move the first and second paddles independently of each other; and a basic arrangement that includes: a first shaft having a first threaded section, and a second shaft having a second threaded section; and a first coupling which is movably attached to the first shaft, so that the first coupling can be moved along the first threaded section of the shaft; a second coupling which is movably attached to the second shaft, so that the second coupling can be moved along the second threaded section of the shaft; wherein the first paddle is pivotably attached to the first coupling; wherein the second paddle is pivotably attached to the second coupling; wherein a movement of the first clutch in a first direction along the first shaft causes the first paddle to move into the closed position, and a movement of the first clutch in a second direction along the first shaft causes the first paddle to move into the open position; wherein a movement of the second clutch in a first direction along the second shaft causes the second paddle to move into the closed position, and a movement of the second clutch in a second direction along the second shaft causes the second paddle to move into the open position. [59] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a basic arrangement which features: a shaft; and a cam that is attached to the shaft and configured to move between a first position and a second position; a pair of paddles attached to the base assembly, the pair of paddles being configured to move between an open position and a closed position; and a pair of gripping elements attached to the base assembly, the gripping elements being configured to be attached to the patient's native valve; wherein the movement of the cam from the first position to the second position causes the paddle pair to move from the closed position to the open position, and wherein the movement of the cam from the second position to the first position causes the paddle pair to move from the open position to the closed position; wherein the cam is attached to the shaft and wherein the cam is moved between the first position and the second position by rotating the shaft. [60] Valve repair device according to claim 59, further comprising a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [61] Flap repair device according to claim 59, wherein the paddles are made of a net-like material. [62] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a basic arrangement which features: a shaft; and a cam that is attached to the shaft and configured to move between a first position and a second position; a pair of paddles attached to the base assembly, the pair of paddles being configured to move between an open position and a closed position; and a pair of gripping elements attached to the base assembly, the gripping elements being configured to be attached to the patient's native valve; wherein the movement of the cam from the first position to the second position causes the paddle pair to move from the closed position to the open position, and wherein the movement of the cam from the second position to the first position causes the paddle pair to move from the open position to the closed position; wherein the cam is rotatably attached to the shaft and wherein the cam is moved between the first position and the second position by rotating the cam around the shaft. [63] Valve repair device according to claim 62, further comprising a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [64] Flap repair device according to claim 62, wherein the paddles are made of a net-like material. [65] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a basic arrangement comprising several pivotable links and a shaft, wherein the pivotable links are moved by the shaft; a pair of paddles attached to the base assembly, wherein the movement of the pivoting links moves the paddles between an open position and a closed position; a pair of gripping elements attached to the base assembly, wherein the paddles and gripping elements are configured to be attached to the patient's valve leaflets; at least one spacer element that surrounds the shaft and is arranged between the pair of gripping elements; wherein the spacer element is made of at least one material selected from the group of materials consisting of woven mesh, fabric, biocompatible material, foam and pericardial fabric; the spacer element fills a space between the gripping elements when the paddles are in the closed position. [66] Valve repair device according to claim 65, wherein the basic arrangement of the valve repair device further comprises: a coupling that is movably attached to the shaft so that the coupling can be moved along the shaft; the pair of paddles is pivotably attached to the coupling; wherein a movement of the coupling in a first direction along the shaft causes the paddle pair to move into the closed position, and a movement of the coupling in a second direction causes the paddle pair to move into the open position. [67] Flap repair device according to claim 65, wherein the spacer element comprises a first spacer element attached to a first gripping element of the pair of gripping elements and a second spacer element attached to a second gripping element of the pair of gripping elements. [68] Flap repair device according to claim 65, wherein the spacer element extends over one or more side edges of the gripping elements. [69] Flap repair device according to claim 65, wherein the spacer element comprises a main section extending between the gripping elements and extension sections extending over the side edges of the gripping elements. [70] Flap repair device according to claim 69, wherein the extension sections have a semicircular shape. [71] Valve repair device according to claim 65, wherein the spacer element is configured to fill at least one section of a gap between mitral valve leaflets of the patient. [72] Valve repair system for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feeding device having at least one lumen; a valve repair device configured to be delivered through the lumen of the delivery device and configured to be attached to a patient's native valve, the valve repair device comprising: a basic arrangement comprising several pivotable links and a shaft, wherein the pivotable links are moved by the shaft; a pair of paddles attached to the base assembly, wherein the movement of the pivoting links moves the paddles between an open position and a closed position; a pair of gripping elements attached to the base assembly, the paddles and gripping elements being configured to be attached to the patient's valve leaflets; at least one spacer element that surrounds the shaft and is arranged between the pair of gripping elements; wherein the spacer element is made of at least one material selected from the group of materials consisting of woven fabric, cloth, biocompatible material, foam and pericardial fabric; the spacer element fills a space between the gripping elements when the paddles are in the closed position. [73] Flap repair system according to claim 72, wherein the base of the flap comprises a coupling which is movably attached to the shaft so that the coupling can be moved along the shaft; the pair of paddles is pivotably attached to the coupling; wherein a movement of the coupling in a first direction along the shaft causes the paddle pair to move into the closed position, and a movement of the coupling in a second direction causes the paddle pair to move into the open position. [74] Valve repair system according to claim 73, wherein the spacer element comprises a first spacer element attached to a first gripping element of the pair of gripping elements and a second spacer element attached to a second gripping element of the pair of gripping elements. [75] Flap repair system according to claim 72, wherein the spacer element extends over one or more side edges of the gripping elements. [76] Flap repair system according to claim 72, wherein the spacer element comprises a main section extending between the gripping elements and extension sections extending beyond the side edges of the gripping elements. [77] Valve repair system according to claim 76, wherein the extension sections have a semicircular shape. [78] Valve repair device according to claim 72, wherein the spacer element is configured to fill at least one section of a gap between mitral valve leaflets of the patient. [79] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a basic arrangement comprising a shaft and a coupling that is coupled to the shaft so that the coupling can be moved along the shaft; a pair of paddles attached to the base assembly, wherein the paddles are movable between an open position, a closed position and a release position; and a pair of gripping elements attached to the base assembly, wherein the paddles and gripping elements are configured to be attached to the patient's native valve; the movement of the coupling along the shaft causes the paddle pair to move between the open position, the closed position and the release position; where, when the paddles are in the release position, the withdrawal angle between each paddle of the paddle pair and the shaft is greater than or equal to 120 degrees. [80] Flap repair device according to claim 79, wherein the removal angle is greater than or equal to 130 degrees. [81] Flap repair device according to claim 79, wherein the removal angle is greater than or equal to 160 degrees. [82] Flap repair device according to claim 79, wherein the paddles are movable between the open position, the closed position, the release position and a folded position, and wherein, when the paddles are in the folded position, the folding angle between each paddle of the paddle pair and the shaft is greater than or equal to 140 degrees. [83] Flap repair device according to claim 79, wherein the folding angle is greater than or equal to 170 degrees. [84] Flap repair device according to claim 79, wherein the movement of the shaft causes the paddles to move into the folded position. [85] Valve repair device according to claim 79, further comprising a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [86] Valve repair system for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feeding device having at least one lumen; a valve repair device configured to be delivered through the lumen of the delivery device and configured to be attached to a patient's native valve, the valve repair device comprising: a basic arrangement comprising a shaft and a coupling which is coupled to the shaft in such a way that the coupling can be moved along the shaft; a pair of paddles attached to the base assembly, wherein the paddles are movable between an open position, a closed position and a release position; and a pair of gripping elements attached to the base assembly, the paddles and gripping elements being configured to be attached to the patient's native valve. wherein a movement of the coupling along the shaft causes the paddle pair to move between the open position, the closed position and the release position; where, when the paddles are in the release position, the withdrawal angle between each paddle of the paddle pair and the shaft is greater than or equal to 120 degrees. [87] Valve repair system according to claim 86, wherein the removal angle is greater than or equal to 160 degrees. [88] Flap repair system according to claim 86, wherein the paddles are movable between the open position, the closed position, the release position and a folded position, and wherein, when the paddles are in the folded position, the folding angle between each paddle of the paddle pair and the shaft is greater than or equal to 140 degrees. [89] Flap repair system according to claim 88, wherein the folding angle is greater than or equal to 170 degrees. [90] Flap repair system according to claim 86, wherein the movement of the shaft causes the paddles to move into the folded position. [91] Valve repair system according to claim 86, further comprising a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [92] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a pair of paddles, each comprising a locking element, wherein the paddles are movable between an open position and a closed position; a pair of gripping elements, wherein the paddles and gripping elements are configured to be attached to the patient's native valve; wherein, when the paddles are in the closed position, the locking element of each paddle attaches the respective paddles to a corresponding gripping element of the pair of gripping elements. [93] Valve repair device according to claim 92, further comprising a base arrangement comprising: a shaft; and a coupling that is movably attached to the shaft so that the coupling can be moved along the shaft; the pair of paddles is pivotably attached to the coupling; wherein a movement of the coupling in a first direction along the shaft causes the paddle pair to move into the closed position, and a movement of the coupling in a second direction causes the paddle pair to move into the open position. [94] Flap repair system according to claim 93, further comprising a locking mechanism movable between a locked state and an unlocked state, wherein the locking mechanism is configured to lock the coupling in a stationary position on the shaft when the locking mechanism is in the locked state. [95] Valve repair device according to claim 93, further comprising a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [96] Flap repair device according to claim 92, wherein the gripping elements are connected to each other by a preload element configured to hold the gripping elements in a desired position. [97] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a pair of paddles, wherein the paddles are movable between an open position and a closed position; a pair of gripping elements, wherein each gripping element of the pair of gripping elements is directly attached to a corresponding paddle of the pair of paddles, and wherein the paddles and the gripping elements are configured to be attached to the patient's native valve; a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [98] Valve repair device according to claim 97, further comprising a base arrangement comprising: a shaft; and a coupling that is movably attached to the shaft so that the coupling can be moved along the shaft; the pair of paddles is pivotably attached to the coupling; wherein a movement of the coupling in a first direction along the shaft causes the paddle pair to move into the closed position, and a movement of the coupling in a second direction causes the paddle pair to move into the open position. [99] Valve repair system according to claim 98, wherein the gripping elements comprise a spiked section for attaching the gripping elements to the native valve of a patient. [100] Valve repair device according to claim 99, wherein the gripping sections comprise a spiked section for attaching the gripping elements to the native valve of a patient, and wherein the spiked section has only a single row of spikes for each of the gripping elements. [101] Flap repair device according to claim 100, wherein the gripping elements each comprise only a single row of spikes. [102] Valve repair device according to claim 101, further comprising a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [103] Valve repair device according to claim 97, wherein each gripping element of the pair of gripping elements is extendable in length to prevent tearing of the patient's native valve when the gripping elements are removed from the native valve. [104] Valve repair device according to claim 103, further comprising a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [105] Valve repair device according to claim 104, wherein the gripping elements comprise a spiked section for attaching the gripping elements to the native valve of a patient, and wherein the spiked section of each of the gripping elements has only a single row of spikes. [106] Valve repair device according to claim 104, wherein the pair of gripping elements comprises a flexible material so that the gripping elements can detach from the tissue of the native valve when the gripping elements are detached from the tissue of the native valve. [107] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a pair of paddles, wherein the paddles are movable between an open position and a closed position; a pair of gripping elements, wherein each gripping element of the pair of gripping elements is directly attached to a corresponding paddle of the paddle pair, and wherein the paddles and the gripping elements are configured to be attached to the patient's native valve; where the gripping elements each comprise only a single row of spikes. [108] Valve repair device according to claim 107, further comprising a base arrangement comprising: a shaft; and a coupling that is movably attached to the shaft so that the coupling can be moved along the shaft; the pair of paddles is pivotably attached to the coupling; wherein a movement of the coupling in a first direction along the shaft causes the paddle pair to move into the closed position, and a movement of the coupling in a second direction causes the paddle pair to move into the open position. [109] Valve repair device according to claim 107, wherein each gripping element of the pair of gripping elements is extendable in length to prevent tearing of the patient's native valve when the gripping elements are removed from the native valve. [110] Valve repair device according to claim 109, wherein the pair of gripping elements comprises a flexible material so that the gripping elements can detach from the tissue of the native valve when the gripping elements are detached from the tissue of the native valve. [111] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a pair of paddles, wherein the paddles are movable between an open position and a closed position; a pair of gripping elements, wherein each gripping element of the pair of gripping elements is directly attached to a corresponding paddle of the pair of paddles, and wherein the paddles and gripping elements are configured to be attached to the patient's native valve; wherein each gripping element of the pair of gripping elements is extendable in length to prevent tearing of the patient's native valve when the gripping elements are removed from the native valve. [112] Valve repair device according to claim 111, further comprising a base arrangement comprising: a shaft; and a coupling that is movably attached to the shaft so that the coupling can be moved along the shaft; the pair of paddles is pivotably attached to the coupling; wherein a movement of the coupling in a first direction along the shaft causes the paddle pair to move into the closed position, and a movement of the coupling in a second direction causes the paddle pair to move into the open position. [113] Valve repair system according to claim 111, wherein the gripping elements comprise a spiked section for attaching the gripping elements to the native valve of a patient. [114] Flap repair device according to claim 111, wherein the gripping elements each comprise only a single row of spikes. [115] Valve repair device according to claim 111, further comprising a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [116] Valve repair device according to claim 111, wherein the pair of gripping elements comprises a flexible material so that the gripping elements can detach from the tissue of the native valve when the gripping elements are detached from the tissue of the native valve. [117] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a pair of paddles, wherein the paddles are movable between an open position and a closed position; a pair of gripping elements, each having an attachment section and a gripping section, wherein the attachment section of each gripping element of the pair of gripping elements is directly attached to a corresponding paddle of the pair of paddles, and the paddles and gripping sections of the gripping elements are configured to be attached to the patient's native valve. [118] Valve repair device according to claim 116, further comprising a base arrangement comprising: a shaft; and a coupling that is movably attached to the shaft so that the coupling can be moved along the shaft; the pair of paddles is pivotably attached to the coupling; wherein a movement of the coupling in a first direction along the shaft causes the paddle pair to move into the closed position, and a movement of the coupling in a second direction causes the paddle pair to move into the open position. [119] Flap repair device according to claim 118, wherein the gripping sections each have only a single row of spikes. [120] Valve repair device according to claim 118, further comprising a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [121] Valve repair device according to claim 118, wherein each gripping element of the pair of gripping elements is extendable in length to prevent tearing of the patient's native valve when the gripping elements are removed from the native valve. [122] Valve repair device according to claim 121, further comprising a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [123] Valve repair device according to claim 121, wherein the pair of gripping elements comprises a flexible material so that the gripping elements can detach from the tissue of the native valve when the gripping elements are detached from the tissue of the native valve. [124] Valve repair system for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feeding device having at least one lumen; a valve repair device configured to be fed through the lumen of the delivery device and configured to be attached to a patient's native valve, the valve repair device comprising: only a pair of paddles that can be moved between an open and a closed position; and at least four gripping elements, each having a section equipped with spikes, wherein the paddles and the at least four gripping elements are configured to be attached to the patient's native valve; the four gripping elements are arranged between the pair of paddles, the four gripping elements are arranged between the pair of paddles; a gripper control mechanism configured to move each of the at least four gripping elements independently, so that each gripping element can be moved by the gripper control mechanism without moving the other three gripping elements. [125] Valve repair system according to claim 124, wherein the at least four gripping elements comprise a first gripping element, a second gripping element, a third gripping element and a fourth gripping element, wherein the first and the second gripping element are configured to cooperate with a first paddle of the paddle pair in order to be attached to the patient's native valve, and wherein the third gripping element and the fourth gripping element are configured to cooperate with a second paddle of the paddle pair in order to be attached to the patient's native valve. [126] Valve repair system according to claim 125, wherein the gripper control mechanism comprises a first gripper control mechanism configured to move the first gripper element, a second gripper control mechanism configured to move the second gripper element, a third gripper control mechanism configured to move the third gripper element, and a fourth gripper control mechanism configured to move the fourth gripper element. [127] Flap repair system according to claim 126, wherein the first gripper control element comprises a first wire which is detachably attached to the first gripper element, wherein the second gripper control element comprises a second wire which is detachably attached to the second gripper element, wherein the third gripper control element comprises a third wire which is detachably attached to the third gripper element, and wherein the fourth gripper control element comprises a fourth wire which is detachably attached to the fourth gripper element. [128] Valve repair system according to claim 124, further comprising a base arrangement comprising: a shaft; and a coupling that is movably attached to the shaft so that the coupling can be moved along the shaft; the pair of paddles is pivotably attached to the coupling; wherein a movement of the coupling in a first direction along the shaft causes the paddle pair to move into the closed position, and a movement of the coupling in a second direction causes the paddle pair to move into the open position. [129] Valve repair system according to claim 128, further comprising a placement shaft which is detachably attached to the shaft of the base arrangement of the valve repair device. [130] Flap repair system according to claim 128, wherein the flap repair device further comprises a locking mechanism movable between a locked state and an unlocked state, wherein the locking mechanism is configured to lock the coupling in a stationary position on the shaft when the locking mechanism is in the locked state. [131] Valve repair system according to claim 124, wherein each of the at least four gripping elements comprises a spiked section for attaching the at least four gripping elements to the native valve of a patient. [132] Flap repair system according to claim 124, further comprising a paddle control mechanism configured to move the paddles between the open position and the closed position. [133] Valve repair system according to claim 124, wherein the valve repair device further comprises a spacer element configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve. [134] Flap repair system according to claim 124, wherein the paddles comprise a locking element for attaching the paddles to at least one corresponding gripping element of the at least four gripping elements when the paddles are in the closed position. [135] Flap repair system according to claim 124, wherein the flap repair device further comprises a preloading element to hold the paddles in a closed position when the flap repair device is removed from the flap repair system. [136] Valve repair system according to claim 124, wherein each of the at least four gripping elements comprises a spiked section for attaching the at least four gripping elements to the native valve of a patient, and wherein the spiked section has only a single row of spikes for each of the at least four gripping elements. [137] Valve repair system according to claim 124, wherein each of the at least four gripping elements is extendable in length to prevent tearing of the patient's native valve when the first and second gripping elements are removed from the native valve. [138] Valve repair device according to claim 124, wherein the gripper control mechanism comprises multiple catheters. [139] Valve repair device according to claim 124, wherein the gripper control mechanism comprises several wires, each of the several wires comprising a tire configured to engage with at least one of the at least four gripping elements. [140] Valve repair system according to claim 124, wherein each of the at least four gripping elements comprises a flexible material such that each of the at least four gripping elements can detach from the tissue of the native valve when the at least four gripping elements are detached from the tissue of the native valve. [141] Valve repair system according to claim 124, wherein each of the at least four gripping elements has a section provided with spikes. [142] Flap repair system according to claim 124, wherein each gripping element can be moved by the gripper control mechanism without moving the other three gripping elements, so that each gripping element can be moved by the gripper control mechanism without moving any of the other three gripping elements. [143] Valve repair system for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feeding device having at least one lumen; a valve repair device configured to be delivered through the lumen of the delivery device and configured to be attached to a patient's native valve, the valve repair device comprising: only one pair of paddles that can be moved between an open position and a closed position; and at least four gripping elements, each having a section equipped with spikes, wherein the paddles and the at least four gripping elements are configured to be attached to the patient's native valve; the four gripping elements are arranged between the pair of paddles, a gripper control mechanism configured to move each of the at least four gripping elements independently, such that each gripping element can be moved by the gripper control mechanism without moving the other three gripping elements. [144] Valve repair device for repairing a patient's native valve, the valve repair device comprising: a pair of paddles that can be moved between an open position and a closed position; a pair of gripping elements, each having a spiked section for attaching the gripping element to the patient's native valve; wherein each gripping element of the pair of gripping elements is slidably attached to a corresponding paddle of the paddle pair; wherein each grasping element is moved in a first direction along the paddle before the spiked section of the grasping element penetrates the patient's native valve; and wherein each gripping element is moved in a direction along the paddle that is substantially opposite to the first direction after the spiked section penetrates the patient's native valve, so that the gripping elements exert a tension force on the patient's native valve. [145] Valve repair system for repairing a patient's native valve, the valve repair system comprising: a feeding device; a flap repair device, comprising: a paddle that can be moved between an open position and a closed position; a gripping element that has a weakened section and a section equipped with spikes; wherein the spiked section is configured to attach the grasping element to the valve tissue of the patient's native valve; and a gripper control mechanism configured to move the gripper element between an open position and a closed position, the gripper control mechanism comprising a suture material detachably attached to the gripper element at a first connection point and a sliding element configured to engage with the gripper element at a second connection point; the weakened section lies between the first and second connection points; wherein the sliding element is configured to push on the gripping element, and the suture material is configured to pull on the gripping element to bend the weakened section and pivot the spiked section; wherein the sliding element comprises at least one of a catheter, a hypotube and a wire with a loop. [146] Valve repair system according to claim 145, wherein the thickness of the weakened section is less than the thickness of other sections of the gripping elements. [147] Valve repair system according to claim 145, wherein the spiked section comprises a single row of spikes. [148] Valve repair system for repairing a patient's native valve, the valve repair system comprising: a feeding device; a flap repair device, comprising: a paddle that can be moved between an open position and a closed position; a gripping element that has a weakened section and a section equipped with spikes; wherein the spiked section is configured to attach the grasping element to the valve tissue of the patient's native valve; and a gripper control mechanism configured to move the gripper element between an open position and a closed position, wherein the gripper control mechanism comprises a suture material detachably attached to the gripper element at a first connection point and a sliding element configured to engage with the gripper element at a second connection point; the weakened section lies between the first and second connection points; wherein the sliding element is configured to push on the gripping element, and the suture material is configured to pull on the gripping element to bend the weakened section and pivot the spiked section; wherein the suture material extends from the feeding device, the suture material is connected to the gripping element at the first connection point, the suture material is connected to the gripping element at the second connection point, and wherein the sliding element is arranged above the suture material between the feeding device and the second connection point. [149] Valve repair system according to claim 148, wherein the thickness of the weakened section is less than the thickness of other sections of the gripping elements. [150] Valve repair system according to claim 148, wherein the spiked section comprises a single row of spikes. [151] Valve repair system according to claim 148, wherein the sliding element of the gripper control device comprises a hypotube. [152] Valve repair system according to claim 148, wherein the sliding element of the gripper control mechanism comprises a catheter. [153] Flap repair system according to claim 148, wherein the sliding element of the gripper control mechanism comprises a wire with a loop. [154] Valve repair system for repairing a patient's native valve during a procedure on the unopened heart, the valve repair system comprising: a feeding device having at least one lumen; a valve repair device configured to be delivered through the lumen of the delivery device and to be attached to a patient's natural valve, the valve repair device comprising: a pair of paddles that can be moved between an open and a closed position; and a first grasping element and a second grasping element, wherein the paddles and the grasping elements are configured to be attached to the patient's natural valve; and a paddle steering mechanism that includes: a first gripper control element detachably attached to the first gripper element, wherein the first gripper control element comprises a first suture material and a first wire with a first loop at a distal end of the first wire, wherein the first suture material extends from the feeder and through the first loop of the first wire and is detachably attached to the first gripper element, and wherein the first loop of the first wire is configured to engage with the first gripper element to move the first gripper element between one or more positions; and a second gripper control element detachably attached to the second gripper element, wherein the second gripper control element comprises a second suture material and a second wire with a second loop at a distal end of the second wire, wherein the second suture material extends from the feeder and through the second loop of the second wire and is detachably attached to the second gripper element, and wherein the second loop of the second wire is configured to engage with the second gripper element to move the second gripper element between one or more positions. [155] Valve repair system according to claim 154, wherein the first wire and the second wire are flexible NiTi wires. [156] Valve repair system according to claim 154, wherein the first wire and the second wire each have a diameter between about 0.15 mm and about 0.3 mm.

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