native valve repair devices and procedures

专利摘要:
The present invention relates to a valve repair device for repairing a patient's native valve that includes a pair of paddles, a pair of retaining members, and a spacer element. The blades are movable between an open position and a closed position. Paddles and retaining members are configured to attach to the patient's native valve. 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.
公开号:BR112020010855A2
申请号:R112020010855-3
申请日:2019-01-08
公开日:2020-11-10
发明作者:Asher L. Metchik；Gregory Scott Tyler Ii；Matthew T. Winston；Sergio Delgado；Lauren R. Freschauf；Eric R. Dixon；Alexander J. Siegel
申请人:Edwards Lifesciences Corporation；
IPC主号:

专利说明:

[001] [001] This order claims the benefit of US Provisional Order Serial Number 62 / 615.213, filed on January 9, 2018, entitled "Native Valve Repair Devices and Procedures", which is hereby incorporated by reference in its entirety. FIELD OF THE INVENTION
[002] [002] The present invention generally relates to prosthetic devices and relative methods to help seal native heart valves and prevent or reduce regurgitation therefrom, as well as relative devices and methods to implant such prosthetic devices. BACKGROUND OF THE INVENTION
[003] [003] Native heart valves (ie, aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in ensuring the direct flow of an adequate blood supply through the cardiovascular system. These heart valves can be damaged, and thus made less effective, by congenital malformations, inflammatory processes, infectious conditions or diseases. Such damage to the valves can result in serious cardiovascular impairment or death. For many years, the definitive treatment for such damaged valves has been surgical repair or replacement of the valve during open heart surgery. However, open heart surgery is highly invasive and is prone to many complications. Therefore, elderly and frail patients with defective heart valves were often not treated. More recently, transvascular techniques have been developed to introduce and implant prosthetic devices in a way that is much less invasive than open heart surgery. A specific transvascular technique that is 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, moving up the inferior vena cava and into the right atrium. The septum is then punctured and the catheter is passed into the left atrium.
[004] [004] A healthy heart has a generally tapered shape that tapers to a lower vertex. The heart has four chambers and comprises the left atrium, right atrium, left ventricle and right ventricle. The left and right sides of the heart are separated by a wall usually referred to as the septum. The human heart's native mitral valve connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes a portion of the annular space, which is an annular portion of the native valve tissue that surrounds the mitral valve orifice, and a pair of cusps, or follicles, that extend downward from the annular space into the left ventricle . The annular space of the mitral valve can form a "D" section shape, oval or otherwise out of round shape that has major and minor geometric axes. The anterior follicle may be larger than the posterior follicle, forming a boundary generally shaped like a "C" between the free topping edges of the follicles when they are closed together.
[005] [005] When operated properly, the anterior follicle and the posterior follicle work together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as "ventricular diastole" or "diastole"), oxygenated blood that is collected within 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 referred to as "ventricular systole" or "systole"), the increased blood pressure within the left ventricle forces the two follicles together, thereby closing the unidrectional mitral valve. so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two follicles from proliferating under pressure and bending back through the mitral annular space towards the left atrium, a plurality of fibrous cords called chordae tendineae support the follicles in papillary muscles within the left ventricle.
[006] [006] Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium of the left ventricle during the systolic phase of cardiac contraction. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has different causes, such as follicle prolapse, dysfunctional papillary muscles and / or stretching of the annular space of the mitral valve resulting from left ventricular dilation. Mitral regurgitation in a central portion of the follicles can be referred to as central jet mitral regurgitation and the mitral regurgitation closest to a commissure (that is, location where the follicles meet) of the follicles can be referred to as eccentric jet mitral regurgitation. For central jet regurgitation, the edges of the follicles are not in the middle. Therefore, the valve does not close and regurgitation is present.
[007] [007] Some previous techniques for treating mitral regurgitation in patients include surgically stitching the edges of the native mitral valve follicles directly together. A catheter-supplied clip has been used to try to secure the edges of the follicles together as the surgical sewing method. However, this clip has disadvantages, as it can only be used to attach the middle edges of the follicles, where they overlap by 2 mm or more. Alternatively, it was attempted to use multiple clips over the mitral valve commissures, where there may be more overlap. This results in a longer operating time and the patient's follicles are joined at the sides, restricting blood flow. Both surgical and clip treatments are thought to create tension on the patient's follicles.
[008] [008] Despite these prior techniques, there is a continuing need for improved devices and methods to treat mitral valve regurgitation. SUMMARY
[009] [009] An exemplary valve repair device for repairing a patient's native valve includes a pair of paddles, a pair of retaining members, and a spacer element. The blades are movable between an open position and a closed position. Paddles and retaining members are configured to attach to the patient's native valve. 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.
[0010] [0010] A further understanding of the nature and advantages of the present invention is presented in the following description and claims, specifically when considered in conjunction with the accompanying drawings in which equal parts bear equal reference numbers. BRIEF DESCRIPTION OF THE DRAWINGS
[0011] [0011] In order to further clarify various aspects of modalities in this description, a more specific description of certain modalities will be made with reference to various aspects of the attached drawings. It is appreciated that these drawings have only typical modalities of the present description and, therefore, should not be considered limiting the scope of the description. Furthermore, although figures can be drawn to scale for some modalities, figures are not necessarily drawn to scale for all modalities. The modalities of this description will be described and explained with specificity and additional details using the accompanying drawings.
[0012] [0012] Figure 1 illustrates a sectional view of the human heart in a diastolic phase;
[0013] [0013] Figure 2 illustrates a sectional view of the human heart in a systolic phase;
[0014] [0014] Figure 3 illustrates a healthy mitral valve with closed follicles as seen from an atrial side of the mitral valve;
[0015] [0015] Figure 4 illustrates a dysfunctional mitral valve with a visible space between the follicles as seen from an atrial side of the mitral valve;
[0016] [0016] Figure 4A illustrates a tricuspid valve seen from an atrial side of the tricuspid valve;
[0017] [0017] Figure 5 illustrates a sectional view of the human heart in a diastolic phase, in which the chordae tendineae are shown attaching the follicles of the mitral and tricuspid valves to the ventricle walls;
[0018] [0018] Figure 6 illustrates a valve repair device with paddles in an open position;
[0019] [0019] Figure 7 illustrates the valve repair device of Figure 6, in which the blades are in the open position and retaining members are moved to create a wider space between the retaining members and the blades;
[0020] [0020] Figure 8 illustrates the valve repair device of Figure
[0021] [0021] Figure 9 illustrates the valve repair device of Figure 6, in which the retaining members are moved to decrease the space between the retaining members and the blades;
[0022] [0022] Figures 10A-10B illustrate the movement of the paddles of the valve repair device of Figure 6 from the open position to a closed position;
[0023] [0023] Figure 11 illustrates the valve repair device of Figure 6 in a closed position, in which the retaining members are coupling the valve tissue;
[0024] [0024] Figure 12 illustrates the valve repair device of Figure 6 after being disconnected from an application device and attached to the valve tissue, in which the valve repair device is in a closed and locked condition;
[0025] [0025] Figure 13A illustrates an exemplary embodiment of a valve repair device attached to the anterior follicle and posterior follicle of a patient's mitral valve, shown with the left atrium of the patient's heart with the valve repair device and tissue follicle on the ventricular side shown in hidden lines;
[0026] [0026] Figure 13B is an enlarged version of Figure 13A;
[0027] [0027] Figure 14A is another exemplary embodiment of a valve repair device attached to the anterior follicle and the posterior follicle of a patient's mitral valve with the valve repair device and follicle tissue on the ventricular side shown in hidden lines;
[0028] [0028] Figure 14B is another exemplary embodiment of a valve repair device attached to the anterior follicle and the posterior follicle of a patient's mitral valve, in which the valve repair device includes blades that flex to put less tension on the tissue. mitral valve with the valve repair device and follicle tissue on the ventricular side shown in hidden lines;
[0029] [0029] Figures 15A-15B illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes blades that flex along its length to put less strain on the valve tissue when the repair device valve is trapped in the valve fabric;
[0030] [0030] Figures 16A-16F illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible paddles comprising an exemplary wire loop embodiment;
[0031] [0031] Figures 16G-16H illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible paddles that comprise another exemplary embodiment of a wire loop;
[0032] [0032] Figures 16I-16J illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible paddles that comprise another exemplary embodiment of a wire loop;
[0033] [0033] Figures 17A-17F illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible paddles having a horseshoe shape;
[0034] [0034] Figures 18A-18D illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible paddles having a horseshoe shape;
[0035] [0035] Figures 18E and 18F illustrate a compressible paddle that is similar to the compressible paddle shown in Figures 18C and 18D, except that the paddle legs do not cross when the paddle is loaded into a catheter;
[0036] [0036] Figures 19A-19D illustrate another exemplary embodiment of a valve repair device, in which the valve repair device includes compressible mesh blades;
[0037] [0037] Figures 20A-20B illustrate an exemplary embodiment of a blade for a valve repair device, in which the blade is compressible;
[0038] [0038] Figures 21A-21B illustrate another exemplary embodiment of a valve repair device, in which the blades of the valve repair device are extensible;
[0039] [0039] Figure 22 illustrates another exemplary embodiment of a valve repair set where a retention control mechanism is configured to independently control each retaining member of a valve repair device;
[0040] [0040] Figures 22A-22D illustrate another exemplary embodiment of a valve repair set where an exemplary embodiment of a retention control mechanism is configured to control four retaining members of an exemplary embodiment of a valve repair device independently of each other. ;
[0041] [0041] Figure 23 illustrates another exemplary embodiment of a valve repair set where a retention control mechanism is configured to control each retaining member of a valve repair device independently;
[0042] [0042] Figure 24 illustrates an exemplary embodiment of a connection between a placement axis and a paddle control mechanism axis of the valve repair device of Figure 23, in which the check control mechanism is attached to the repair device. valve on the connection between the laying axis and the blade control mechanism axis;
[0043] [0043] Figures 24A-24B illustrate an exemplary embodiment of a connection between a placement axis and a paddle control mechanism axis of the valve repair device of Figure 23, in which the check control mechanism is attached to the device valve repair in the connection between the placing axis and the axis of the valve repair device;
[0044] [0044] Figure 25 illustrates another exemplary embodiment of a valve repair kit in which a retention control mechanism is configured to control each retaining member of a valve repair device independently of one another;
[0045] [0045] Figure 25A illustrates another exemplary embodiment of a retention control mechanism that is configured to control each retaining member of a valve repair device independently of each other;
[0046] [0046] Figure 26 illustrates another exemplary embodiment of a valve repair kit in which a retention control mechanism is configured to control each retaining member of a valve repair device independently of one another;
[0047] [0047] Figures 27A-27C illustrate another exemplary embodiment of a valve repair device where each blade of the valve repair device can be independently moved from an open position to a closed position;
[0048] [0048] Figures 28A-28F illustrate another exemplary embodiment of a valve repair device where each paddle of the valve repair device can be independently moved from an open position to a closed position;
[0049] [0049] Figures 29A-29B illustrate another exemplary embodiment of a valve repair device where each paddle of the valve repair device can be independently moved from an open position to a closed position independent of each other;
[0050] [0050] Figure 30 illustrates a mitral valve that has a wide space between the posterior follicle and the anterior follicle;
[0051] [0051] Figures 31A-31B illustrate another exemplary embodiment of a valve repair device, in which the blades of the valve repair device expand to create a wide space for receiving the valve tissue;
[0052] [0052] Figures 32A-32C illustrate another exemplary embodiment of a valve repair device, in which the valve repair device is configured so that the blades of the valve repair device expand by pivoting and opening to create a wide space for receiving the valve tissue;
[0053] [0053] Figures 33A-33C illustrate another exemplary embodiment of a valve repair device, in which the valve repair device is configured so that the blades of the valve repair device expand by opening and pivoting to create a wide space for receiving the valve tissue;
[0054] [0054] Figures 34A-34B illustrate another exemplary embodiment of a valve repair device, in which a "W" shaped mechanism expands the blades of the valve repair device to create a wide space;
[0055] [0055] Figures 34C-34D illustrate another exemplary embodiment of a valve repair device, in which a "W" shaped mechanism expands the blades of the valve repair device to create a wide space;
[0056] [0056] Figures 35A-35B illustrate another exemplary embodiment of a valve repair device, in which a "W" shaped mechanism expands the blades of the valve repair device to create a wide space for receiving the valve tissue;
[0057] [0057] Figures 36A-36B illustrate another exemplary embodiment of a valve repair device, in which a "W" shaped mechanism expands the blades of the valve repair device to create a wide space;
[0058] [0058] Figure 36C illustrates an exemplary embodiment of a paddle control mechanism for the valve repair device of Figures 36A-36B;
[0059] [0059] Figures 36D-36E illustrate another exemplary embodiment of a valve repair device, in which a "W" shaped mechanism expands the blades of the valve repair device to create a wide space;
[0060] [0060] Figures 37A-37D illustrate another exemplary embodiment of a valve repair device with mesh paddles and an internal cam to open the mesh paddles to create a wide space for spaced valve fabrics;
[0061] [0061] Figures 37E-37F illustrate another exemplary embodiment of a valve repair device with mesh paddles and an internal cam to open the mesh paddles to create a wide space for spaced valve fabrics;
[0062] [0062] Figure 38 illustrates an exemplary embodiment of a valve repair device that includes an exemplary embodiment of a spacer element, in which the valve repair device is attached to a mitral valve;
[0063] [0063] Figure 39 illustrates another exemplary embodiment of a valve repair device that includes an exemplary embodiment of a spacer element, and in which the valve repair device is attached to a mitral valve;
[0064] [0064] Figures 40A-40B illustrate another exemplary embodiment of a valve repair device that includes an exemplary embodiment of a spacer element, in which the spacer element is attached to an axis of the valve repair device;
[0065] [0065] Figures 41A-41D illustrate another exemplary embodiment of a valve repair device that includes an exemplary embodiment of a spacer element with a first portion attached to a first retaining member of the valve repair device and a second portion attached to a second retaining member of the valve repair device;
[0066] [0066] Figures 42A-42C illustrate the valve repair device of Figures 40A-40B with the spacer element having various shapes;
[0067] [0067] Figures 43A-43C illustrate the valve repair device of Figures 41A-41B with the spacer element having various shapes;
[0068] [0068] Figures 44A-44B illustrate another exemplary embodiment of a valve repair device with wider opening blades and an expansion spacer;
[0069] [0069] Figures 45A-45C illustrate another exemplary embodiment of a valve repair device with an increased rescue angle for removing the valve repair device;
[0070] [0070] Figures 46A-46D illustrate another exemplary embodiment of a valve repair device with an increased rescue angle for removing the valve repair device;
[0071] [0071] Figures 47A-47B illustrate another exemplary embodiment of a valve repair device with a fixing member for connecting the paddles to the fasteners when the valve repair device is in a closed position;
[0072] [0072] Figure 48 illustrates another exemplary embodiment of a valve repair device that has a spring member that is configured to tension the blades of the valve repair device to a closed position;
[0073] [0073] Figure 49 illustrates another exemplary embodiment of a valve repair device that has a threaded mechanism for moving the valve repair device between the open position and the closed position;
[0074] [0074] Figure 50 illustrates another exemplary embodiment of a valve repair device that has retaining members attached to the blades;
[0075] [0075] Figure 51 illustrates another exemplary embodiment of a valve repair device that has retaining members with a single row of splinters;
[0076] [0076] Figures 51A-51E illustrate another exemplary embodiment of a valve repair system that has a valve repair set with a valve repair device that has retaining members configured to place a tensioning force on the valve tissue. when the valve repair device is attached to the valve tissue;
[0077] [0077] Figures 51F-51H illustrate another exemplary embodiment of a valve repair assembly that has retaining members configured to place a tensioning force on the valve tissue when the valve repair device is attached to the valve tissue;
[0078] [0078] Figure 52 illustrates another exemplary embodiment of a valve repair device that has retaining members that are extensible in length;
[0079] [0079] Figures 53A-53B illustrate another exemplary embodiment of a valve repair device that has retaining members that are flexible; and
[0080] [0080] Figure 54 illustrates another exemplary embodiment of a valve repair device, in which the retaining members are attached to a separate spring member. DETAILED DESCRIPTION
[0081] [0081] The following description refers to the accompanying drawings, which illustrate specific embodiments of the invention. Other embodiments that have different structures and operation do not deviate from the scope of the present invention.
[0082] [0082] The exemplary modalities of the present description are directed to devices and methods for repairing a defective heart valve. It should be noted that various modalities of native valve repair devices and systems for delivery are described herein, and any combination of these options can be made unless specifically excluded. In other words, the individual components of the described devices and systems can be combined, unless they are mutually exclusive or otherwise physically impossible.
[0083] [0083] Figures 1 and 2 are seen in section of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; that is, the atrioventricular valves. In addition, the AV aortic valve separates the left ventricle LV from the ascending aorta AA, and the pulmonary PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible follicles (for example, follicles 302, 304 shown in Figures 3 and 4) that extend inward through the respective holes come together or "strain" in the flow to form the unidirectional fluid occlusion surfaces. The native valve repair systems of the present application are described primarily with respect to the MV mitral valve. Therefore, the anatomical structures of the left atrium LA and the left ventricle LV will be explained in more detail. It should be understood that the devices described herein can also be used to repair other native valves, for example, the devices can be used to repair the TV tricuspid valve, AV aortic valve and PV pulmonary valve.
[0084] [0084] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen 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
[0085] [0085] Referring to Figures 1-5, the mitral valve MV includes two follicles, the anterior follicle 302 and the posterior follicle 304. The mitral valve MV also includes an annular space 306, which is a ring of varying dense fibrous tissues surrounds follicles 302,
[0086] [0086] Various disease processes can impair the proper function of one or more native H heart valves. These disease processes include degenerative processes (eg, Barlow's disease, fibroelastic deficiency), inflammatory processes (eg, Rheumatic Heart Disease ) and infectious processes (for example, endocarditis). In addition, damage to the LV left ventricle or RV right ventricle from previous heart attacks (ie, myocardial infarction secondary to coronary artery disease) or other heart diseases (eg, cardiomyopathy) can distort a valve's native geometry, the which can cause the native valve to malfunction. However, the vast majority of patients undergoing valve surgery, such as MV mitral valve surgery, suffer from degenerative disease that causes a malfunction in a follicle (eg, follicles 302, 304) of a native valve (eg , the mitral valve MV), which results in prolapse and regurgitation.
[0087] [0087] Generally, the native valve can malfunction in two different modes. A possible malfunction is valve stenosis, which occurs when a native valve does not open completely and thereby causes an obstruction of blood flow. Typically, valve stenosis results from the accumulation of calcified material over the follicles of a valve, which causes the follicles to thicken and impair the valve's ability to fully open to allow direct blood flow.
[0088] [0088] Another possible malfunction is valve regurgitation, which occurs when the valve follicles do not close completely, thereby causing blood to leak back into the anterior chamber (for example, causing blood leak from the left ventricle into the left atrium). There are three mechanisms by which a native valve becomes regurgitant or incompetent, which include type I, type II and type III Carpentier malfunctions. A Carpentier type I malfunction involves dilating the annular space so that normal-functioning follicles are deflected from each other and fail to form a tight seal (ie, do not strain properly). Included in a type I mechanism malfunction are follicle perforations, as in endocarditis. A malfunction of a Carpentier type II involves the prolapse of one or more follicles of a native valve above a coercion plane. A Carpentier type III malfunction involves restricting the movement of one or more follicles of a native valve so that the follicles are abnormally restricted below the plane of the annular space. Follicle restriction can be caused by rheumatic disease (Ma) or dilation of a ventricle (IIIb).
[0089] [0089] Referring to Figure 3, when a healthy MV mitral valve is in a closed position, the anterior follicle 302 and posterior follicle 304 constrict, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Referring to Figure 4, regurgitation occurs when the anterior follicle 302 and / or posterior follicle 304 of the mitral valve MV is displaced into the left atrium LA during systole. This failure to coerce causes a space 408 between the anterior follicle 302 and the posterior follicle 304, which allows blood to flow back into the left atrium LA of the left ventricle LV during systole. As shown above, there are several different ways that a follicle (for example follicles 302, 304 of the mitral valve MV) can malfunction, which can thereby lead to regurgitation.
[0090] [0090] Although stenosis or regurgitation can affect any valve, stenosis is predominantly found to affect either the AV aortic valve or the pulmonary PV valve, and the predominantly found regurgitation affects either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the H heart and can lead to very serious conditions if left untreated; such as endocarditis, congestive heart failure, permanent cardiac damage, cardiac arrest, and finally death. As the left side of the heart (ie, the left atrium LA, the left ventricle LV, the mitral valve MV and the aortic valve AV) is primarily responsible for the circulation of blood flow throughout the body, the malfunction of the mitral valve MV or AV aortic valve is specifically problematic and often life-threatening. Consequently, due to substantially higher pressures on the left side of the heart, dysfunction of the mitral valve MV or AV aortic valve is much more problematic.
[0091] [0091] Malfunctioning native heart valves can either be repaired or replaced. Repair typically involves preserving and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical replacement. Typically, the AV aortic valve and the PV pulmonary valve are more prone to stenosis. Since the stenotic damage suffered by the follicles is irreversible, the most conventional treatments for a stenotic aortic valve or pulmonary stenotic valve are removal and replacement of the valve with a surgically implanted heart valve, or displacement of the valve with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to follicle deformation, which, as described above, prevents the mitral valve or tricuspid valve from closing properly and allows regurgitation or reflux of blood from the ventricle into the atrium (for example). For example, a deformed MV mitral valve can allow regurgitation or reflux from the left ventricle (LV to the left atrium LA). Regurgitation or reflux of blood from the ventricle to the atrium results in valve failure. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. In addition, regurgitation can occur due to the chordae tendineae 501 becoming dysfunctional (for example, the chordae tendineae can stretch or rupture), which allows the anterior follicle 302 and posterior follicle 304 to be inverted so that the blood is regurgitated to inside the left atrium LA. Problems that occur due to dysfunctional chordae tendineae 501 can be repaired by repairing the chordae tendineae or the structure of the mitral valve (for example, by trapping follicles 302, 304 in the affected portion of the mitral valve).
[0092] [0092] The devices and procedures described here can reference to repair the structure of a mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Referring to Figure 4A, any of the devices and concepts provided herein can be used to repair the TV tricuspid valve. For example, any of the devices and concepts provided herein can be used between any two of the anterior follicle 4011, septal follicle 4012, and posterior follicle 4013 to prevent regurgitation of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used in all three of the follicles 4011, 4012, 4013 together to prevent blood regurgitation from the right ventricle to the right atrium. That is, the valve repair devices provided herein can be centrally located between the three follicles 4011, 4012, 4013.
[0093] [0093] Figures 6-13B illustrate a valve repair system
[0094] [0094] The valve repair device 602 includes a base set 604, a pair of blades 606, and a pair of retaining members 608. In an exemplary embodiment, the blades 606 can be integrally formed with the base set. For example, paddles 606 can be formed as extensions of base set connections. In the illustrated example, the base assembly 604 of the valve repair device 602 has an axis 603, a coupler 605 configured to move along the axis, and a lock 607 configured to lock the coupler in a stationary position on the axis. The coupler 605 is mechanically connected to the blades 606, so that the movement of the coupler 605 along the axis 603 causes the blades to move between an open position and a closed position. In this mode, the coupler 605 serves as a means for mechanically coupling the blades 606 to the axis 603 and, when moving along the axis 603, to cause the blades 606 to move between their open and closed positions. In certain embodiments, the retaining members 608 are hingedly connected to the base assembly 604 (for example, the retaining members 608 may be hingedly connected to the axis 603, or any other suitable member of the base assembly), so that the members retainer can be moved to adjust the width of opening 614 between the blades 606 and the retainer members 608. The retainer member 608 can include a barbed portion 609 to secure the retainer members to the valve tissue when the valve 602 is trapped in the valve fabric. Retaining member 608 forms a means for retaining the valve tissue (specifically the tissue of the valve follicles) with an adhesion means or portion such as the barbed portion 609. When the blades 606 are in the closed position, the blades couple retaining members 608, so that when the valve tissue is attached to the barbed portion 609 of the retaining members, the paddles act as a means of retaining or securing to secure the valve tissue to the retaining members and to secure the device repair valve 602 on the valve fabric. In some embodiments, the retaining members 608 are configured to couple the blades 606 so that the barbed portion 609 engages the valve fabric member and the blades 608 to secure the valve repair device 602 to the valve fabric member. For example, in certain situations, it may be advantageous to have the blades 606 maintain an open position and have the retaining members 608 move outwardly towards the blades 606 to couple a valve fabric member and the blades 606.
[0095] [0095] Although the embodiment shown in Figures 6-13B illustrates a pair of blades 606 and a pair of retaining members 608, it should be understood that the valve repair device 602 can include any suitable number of blades and retaining members. In certain embodiments, valve repair system 600 includes a delivery shaft 613 which is removably secured to shaft 603 of base assembly 604 of valve repair device 602. After valve repair device 602 is attached to the fabric of the valve, the delivery shaft 613 is removed from shaft 603 to remove valve repair device 602 from the rest of valve repair system 600, so that valve repair device 602 can remain trapped in the valve tissue, and the delivery device 601 can be removed from a patient's body.
[0096] [0096] Valve repair system 600 may also include a paddle control mechanism 610, a retention control mechanism 611, and a lock control mechanism 612. Paddle control mechanism 610 is mechanically attached to the coupler 605 to move the coupler along the axis, which causes the blades 606 to move between the open and closed positions. The paddle control mechanism 610 can take any suitable shape, such as, for example, a shaft or rod. For example, the paddle control mechanism may comprise a hollow shaft, a catheter tube or a sleeve that mounts over the placement shaft 613 and the shaft 603 and is connected to the coupler 605. The retaining control mechanism 611 is configured to move the retaining members 608 so that the width of the opening 614 between the retaining members and the blades 606 can be changed. The retention control mechanism 611 can take any suitable shape, such as, for example, a thread, a suture or thread, a nail, a catheter, etc.
[0097] [0097] The lock control mechanism 612 is configured to lock and unlock the lock. Lock 607 serves as a locking means for locking coupler 605 in a stationary position with respect to shaft 603 and can take a wide variety of different shapes and the type of lock control mechanism 612 can be dictated by the type of lock used .
[0098] [0098] Figures 10A-10B illustrate valve repair device 602 moving from an open position (as shown in Figure 10A) to a closed position (as shown in Figure 10B). Base set 604 includes a first connection 1021 that extends from point A to point B, a second connection 1022 that extends from point A to point C, a third connection 1023 that extends from point B to point D, a fourth connection 1024 extending from point C to point E, and a fifth connection 1025 extending from point D to point E. Coupler 605 is movably attached to axis 603, and axis 603 is fixed to fifth connection 1025. The first connection 1021 and the second connection 1022 are hinged to the coupler 605 at point A, so that the movement of the coupler 605 along axis 603 moves the location of point A and, consequently, moves the first connection 1021 and the second connection 1022 The first connection 1021 and the third connection 1023 are hinged to each other at point B, and the second connection 1022 and the fourth connection 1024 are hinged to each other at point C. A paddle 606a is attached to the first connection 1021 of so that the movement of the first c connection 1021 causes paddle 606a to move, and the other paddle 606b is attached to the second connection 1022 so that the movement of the second connection 1022 causes paddle 606b to move. Alternatively, paddles 606a, 606b can be connected to connections 1023, 1024 or be extensions of connections 1023, 1024.
[0099] [0099] In order to move the valve repair device from the open position (as shown in Figure 10A) to the closed position (as shown in Figure 10B), coupler 605 is moved along axis 603 in the Y direction, which moves pivot point A to the first connection 1021 and the second connection 1022 to a new position. The movement of coupler 605 (and hinge point A) in the Y direction causes a portion of the first connection 1021 near point A to move in the H direction, and the portion of the first connection 1021 near point B to move in the direction J. A paddle 606a is attached to the first connection 1021 so that the movement of the coupler 605 in the Y direction causes the paddle 606a to move in the Z direction. In addition, the third connection 1023 is hinged to the first connection 1021 at point B so that the movement of the coupler 605 in the Y direction causes the third connection 1023 to move in the K direction. Similarly, the movement of the coupler 605 (and pivot point A) in the Y direction causes a portion of the second connection 1022 close to point A move in the L direction, and the portion of the second connection 1022 near point C moves in the direction M. The paddle 606b is attached to the second connection 1022 so that the movement of the coupler 605 in the Y direction causes the paddle 606b to move in the direction V. In addition, the fourth 1024 connection is attached to at the second connection 1022 at point C so that the movement of the coupler 605 in the Y direction causes the fourth connection 1024 to move in the N direction. Figure 10B illustrates the final position of the valve repair device 602 after the coupler 605 is moved as shown in Figure 10A.
[00100] [00100] Referring to Figure 7, valve repair device 602 is shown in the open position (similar to the position shown in Figure 10A), and the retention control mechanism 611 is shown by moving the retaining members 608 to provide space wider at the opening 614 between the retaining members and the paddles 606. In the illustrated embodiment, the retention control mechanism 611 includes an align, such as a suture, a thread, etc. which is threaded through an opening at one end of the retaining members 608.
[00101] [00101] Referring to Figure 8, valve repair device 602 is shown so that valve fabric 820 is disposed within opening 614 between retaining members 608 and blades 606. Referring to Figure 9, after fabric valve 820 being arranged between the retaining members 608 and the blades 606, the retaining control mechanism 611 is used to decrease the width of the opening 614 between the retaining members and the blades. That is, in the illustrated embodiment, the line of the retention control mechanism 611 is released from or pushed out of the opening 716 of the application member in the H direction, which allows the retaining members 608 to move in the D direction to decrease the opening width 614. Although the retention control mechanism 611 is shown by moving the retaining members 608 to increase the width of the opening 614 between the retaining members and the blades 606 (Figure 8), it should be understood that the retaining members may not need to be moved in order to position the valve tissue within the opening
[00102] [00102] Referring to Figure 11, valve repair device 602 is in the closed position and attached to valve tissue 820. Valve repair device 602 is attached to valve tissue 820 by paddles 606a, 606b and the limbs of retention 608a, 608b. Specifically, valve tissue 820 is attached to the valve repair device
[00103] [00103] Referring to Figure 12, after paddles 606 are moved to the closed position to secure valve repair device 602 to valve tissue 820 (as shown in Figure 11), lock 607 is moved to the condition locked by locking control mechanism 611 (Figure 11) to hold valve repair device 602 in the closed position. After valve repair device 602 is maintained in the condition locked by latch 607, valve repair device 602 is removed from application device 601 by disconnecting shaft 603 from placement shaft 613 (Figure 11). In addition, valve repair device 602 is decoupled from paddle control mechanism 610 (Figure 11), retention control mechanism 611 (Figure 11), and lock control mechanism 612. Removing the locking device valve repair 602 of application device 601 allows the valve repair device to remain trapped in valve tissue 820 while application device 601 is removed from a patient.
[00104] [00104] Referring to Figures 13A-13B, a patient's mitral valve 1300 is shown with a valve repair device 602 attached to anterior follicle 1301 and posterior follicle 1302 of the mitral valve. Figures 13A-13B are seen from the atrial side of the mitral valve 1300 with portions of the valve repair device 602 and mitral valve follicle tissue captured on the ventricular side of the mitral valve presented in hidden lines. During the diastolic phase (as shown in Figure 1), the blood it collects into the left atrium of the heart enters the 1300 mitral valve by expanding the left ventricle of the heart. Anterior follicle 1301 and posterior follicle 1302 open open to allow blood to travel from the left atrium to the left ventricle. In the systolic phase (as shown in Figure 2), the left ventricle contracts to force blood through the aortic valve and the ascending aorta and into the body. During systole, the MV mitral valve follicles close to prevent blood from regurgitating back into the LA left atrium. As described above, blood regurgitation from the left ventricle to the left atrium through the mitral valve occurs when the anterior follicle 1301 and posterior follicle 1302 do not close entirely so that a space exists between the anterior follicle and the posterior follicle. In order to repair a mitral valve 1300 to prevent blood regurgitation through the mitral valve, valve repair device 602 is connected to anterior follicle 1301 and posterior follicle 1302 to close the gap.
[00105] [00105] Referring to Figure 13A, mitral valve 1300 is shown with the left atrium of a patient's heart (for example, from the view indicated by line A-A in Figure 5). In the illustrated embodiment, the mitral valve 1300 is shown in an open position (that is, the position that the mitral valve takes during the diastolic phase). The valve repair device 602 is attached to the anterior follicle 1301 and the posterior follicle 1302 of the mitral valve 1300 to the left ventricle of the patient's heart, and is shown in dashed lines in Figures 13A-13B to indicate the location of the valve repair device. valve with respect to the mitral valve. As shown in Figures 13A-13B, valve repair device 602 couples anterior follicle 1301 and posterior follicle 1302 and causes the anterior follicle and posterior follicle to mate with each other (i.e., the valve repair device closes a portion of the space between the anterior follicle and the posterior follicle). Valve repair device 602 can be placed in a location where a space exists between anterior follicle 1301 and posterior follicle 1302 when mitral valve 1301 is in a closed position (i.e., the position of the mitral valve during the phase systolic), so the valve repair device will prevent space from occurring. The illustrated embodiment shows a mitral valve 1300 and valve repair device 602 during the diastolic phase. That is, during the diastolic phase, valve repair device 602 will cause a portion of the mitral valve to remain closed, but portions of the mitral valve not coupled by the valve repair device will open so that spaces 1303 are created to allow blood flows from the left atrium to the left ventricle.
[00106] [00106] Referring to Figure 13B, valve repair device 602 is attached to both the anterior follicle 1301 and the posterior follicle 1302. Specifically, a portion 1301a of anterior follicle 1301 is trapped between a paddle 606a and a retaining member 608a of the valve repair device 602, and a portion 1302b of posterior follicle 1302 is trapped between another paddle 606b and another holding member 608b of the valve repair device. The valve repair device 602 is attached and locked to the mitral valve 1300, for example, as shown in Figures 6-12.
[00107] [00107] Figures 14A-14B illustrate exemplary modalities of a valve repair device 602 attached to the anterior follicle 1301 and posterior follicle 1302 of a mitral valve 1300. The mitral valve 1300 is shown from the left atrium of a patient's heart (for example, example, from the view indicated by line AA in Figure 5). Still referring to Figures 14A-14B, the valve repair device 602 includes a first paddle 606a, a second paddle 606b, a first holding member 608a, and a second holding member 608b. A portion 1301a of anterior follicle 1301 is attached between the first paddle 606a and the first retaining member 608a of valve repair device 602, and a portion 1302b of the posterior follicle 1302 is attached between the second paddle 606b and the second retaining member 608b of the valve repair device. The first and second blades 606a, 606b include a main portion 1404 and side portions 1405. Referring to Figure 14A, valve repair device 602 is configured such that portions 1301a, 1302b of mitral valve 1300 conform to or generally conform to the shape of the blades 606a, 606b. That is, the valve follicle portions 1301a, 1302b are pressed into the paddles by the retaining members 608a, 608b, so that the valve follicle portions 1301a, 1301b are arranged along a main portion 1404 and side portions 1405 of paddles 606a, 606b. In the embodiment of the valve repair device 602 shown in Figure 14A, the blades 606a, 606b can be made of a rigid material, for example, steel, molded plastic, etc.
[00108] [00108] In the exemplary embodiment illustrated by Figure 14B, the blades 606a, 606b of the valve repair device 602 are configured to flex. Due to this flexion, when the valve repair device is attached to the mitral valve 1300, the mitral valve tissue portions 1301a, 1302b move the side portions 1405 of the blades as indicated by arrows 1450, which reduces the stress placed on the mitral valve by the valve repair device as compared to the embodiment illustrated in Figure 14A. That is, flexing results in a more gradual contouring of the mitral valve tissue by the paddles, while still securely attaching the valve repair device 602 to the mitral valve tissue. In the embodiment of the valve repair device 602 shown in Figure 14B, the blades 606a, 606b can be made from a wide variety of flexible materials or rigid material that are cut or otherwise processed to provide flexibility.
[00109] [00109] Figures 15A-15B illustrate another exemplary embodiment of a valve repair device 602. Referring to Figure 15A, valve repair device 602 is in the open position and is to couple valve tissue 820 (for example, follicles and a mitral valve). Referring to Figure 15B, the valve repair device 602 is in the closed position and secured in the valve fabric 820. The valve repair device 602 can take any suitable shape, such as, for example, any shape described in the present application. The valve repair device 602 can be moved between the open and closed position, and be attached to the valve fabric 820, by a valve repair system, such as, for example, any valve repair system described in the present application. . In the illustrated embodiment, valve repair device 602 includes paddles 606 and retaining members 608. Retaining members 608 include a barbed portion 609 for securing the retaining members to the valve fabric.
[00110] [00110] Referring to Figures 16A-16F, another exemplary embodiment of a valve repair device 602 includes paddles 606 having a wire loop 1601. The wire loop 1601 can be made of, for example, any suitable metallic material, laser cut loops from a nitinol plate, a nitinol tube, or any other suitable material. In some embodiments, the wire loop 1601 may have variable dimensions across the entire length of the wire loop 1601 to optimize the blade clamping force and the force of the blade crimp on a valve fabric when the blade engages the fabric of the blade. valve. For example, certain sections of the wire loop 1601 may be thinner than other sections of the wire loop 1601. In certain embodiments, the wire loop 1601 of the blades 606 is compressible, which allows the blades 606 to be arranged in one delivery device 601 (for example, a catheter) that has a small diameter (as shown in Figure 16E) for applying valve repair device 602 to a patient's native valve, and also allows paddles 606 to expand (as shown in Figures 16A-16D) when exiting the delivery device 601 so that the paddles 606 have a greater surface area to couple the patient's native valve. The valve repair device 602 can take any suitable shape, such as, for example, any shape described in the present application. The valve repair device 602 can be moved between the open and closed position, and be attached to a native valve, by a valve repair system, such as, for example, any valve repair system described in the present application.
[00111] [00111] Figures 16A-16B illustrate the valve repair device 602 in the open position, and Figures 16C-16D illustrate the valve repair device in the closed position. Referring to
[00112] [00112] Referring to Figure 16E, the blades 606 are in a compressed condition when the blades are arranged within an application device 601. When the blades 606 are in the compressed condition, the blades have a width H. The width H can be , for example between approximately 4 mm and approximately 7 mm, such as, between approximately 5 mm and approximately 6 mm. In alternative embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed blades 606 is substantially equal to a width D of the application opening 716 of the application device 601. The ratio between the width W of the blades in the expanded condition and the width H of the blades in the compressed condition can be, for example, approximately 4 to 1 or less, such as approximately 3 to 1 or less, such as approximately 2 to 1 or less, such as approximately 1.5 to 1, such as approximately 1.25 to 1, such as approximately 1 to 1. In alternative embodiments, the ratio between width W and width H can be more than 4 to 1. Referring to Figure 16F, a blade 606 is moved from the expanded condition to the compressed condition by compressing the blade in the direction Y and extending a blade length in the X direction.
[00113] [00113] Figures 16G-16H illustrate another exemplary embodiment of a valve repair device 602 in the open position, in which the valve repair device includes paddles 606 that have a wire loop
[00114] [00114] The modalities of valve repair devices 602 shown in Figures 16G-16H and 16I-16J can include any of the features described above with reference to Figures 16A-16F. For example, the modalities of valve repair devices 602 shown in Figures 16G-16H and 16I-16J can include a width W, in which the width W can be, for example, between approximately 4 mm and approximately 21 mm, such as , between approximately 5 mm and approximately 20 mm, such as between approximately 7.5 mm and approximately 17.5 mm, such as between approximately 10 mm and approximately 15 mm. In certain embodiments, the width W may be, for example, 5 mm or more, such as approximately 7.5 mm or more, such as approximately 10 mm or more, such as approximately 15 mm or more, such as approximately 20 mm or more. In other embodiments, the width W may be less than 5 mm. The arrangements for the paddles 606 shown in Figures 16G-16H and 16I-16J can also include a material arranged on the wire loop 1601 to create a contact area for the paddles to mate with the valve fabric. The material can be any suitable material such as, for example, a woven material, an EDM material, or any other suitable material that is capable of promoting tissue growth and protecting coatings of the application device 601 (Figure 6) during screening . In certain embodiments, material 1605 may be a blood-impervious fabric, such as a PET fabric or biocompatible covering material such as a fabric that is treated with a coating that is impervious to blood, polyester, or a processed biological material, such as pericardium. The modalities for the blades 606 shown in Figures 16G-16H and 16I-16J can also be compressed when arranged within an application device 601 (for example, exactly as shown in Figure 16E with respect to the modality of the blades 606 shown in Figures 16A -16B). The ratio between the width W of the blades 606 in the expanded condition and the width of the blades in the compressed condition can be, for example, approximately 4 to 1 or less, such as approximately 3 to 1 or less, such as approximately 2 to 1 or less , such as approximately 1.5 to 1, such as approximately 1.25 to 1, such as approximately 1 to 1. In alternative embodiments, the ratio between width W and width H can be more than 4 to 1.
[00115] [00115] Referring to Figures 17A-17F, another exemplary embodiment of a valve repair device 602 includes blades 606 having a horseshoe shape 1701. In certain embodiments, the horseshoe shape 1701 of blades 606 is compressible, which allows that the paddles 606 are arranged within an application device 601 (for example, a catheter) that has a small diameter (as shown in Figure 17F) for applying the valve repair device 602 to a patient's native valve, and it also allows the paddles 606 to expand (as shown in Figures 17A-17D) when exiting the delivery device 601 so that the paddles 606 have a greater surface area to couple the patient's native valve. The valve repair device 602 can take any suitable shape, such as,
[00116] [00116] Figures 17A-17C illustrate the valve repair device 602 in the open position. Referring to Figures 17A-17B, when valve repair device 602 is in the expanded and open position, paddles 606 extend outwardly to create a wide opening 614 between paddles 606 and retaining members 608 of valve repair device 602 In the illustrated embodiment, the horseshoe shape 1701 of the paddles 606 includes side members 1707 that extend from a base 1706 of the paddle 606, and a central member 1709 that extends from the base 1706 and connects to a base assembly 604 of the repair device. valve 602, in which side members 1707 form a horseshoe shape as shown in Figure 17C, for example. In certain embodiments, the paddles 606 include a material 1705 disposed in the form of a horseshoe 1701 to create a contact area for the paddles to engage the valve fabric. Material 1705 can be any suitable material such as, for example, a woven material, an EDM material, or any other material that is capable of promoting tissue growth and protecting coatings of the application device 601 (Figure 6) during scanning . In certain embodiments, material 1605 may be a blood-impervious fabric, such as a PET fabric or biocompatible covering material such as a fabric that is treated with a coating that is impervious to blood, polyester, or a processed biological material, such as pericardium.
[00117] [00117] In various embodiments, paddles 606 are configured to flex to put less stress on the valve tissue when valve repair device 602 is attached to the valve tissue. When the blades 606 are in the expanded condition, the blades have a width W. The width W can be, for example, between approximately 4 mm and approximately 21 mm, such as, between approximately 5 mm and approximately 20 mm, as between approximately 7.5 mm and approximately 17.5 mm, such as between approximately 10 mm and approximately 15 mm. In certain embodiments, the width W may be, for example, 5 mm or more, such as approximately 7.5 mm or more, such as approximately 10 mm or more, such as approximately 15 mm or more, such as approximately 20 mm or more. In other embodiments, the width W may be less than 5 mm. Referring to Figure 17D, in certain embodiments, the thickness T of the blade is, for example, between approximately 0.3 mm and approximately 0.46 mm, such as between approximately 0.32 mm and approximately 0.44 mm, as between approximately 0.34 mm and approximately 0.42 mm, such as between approximately 0.36 mm and approximately 0.40 mm, such as approximately 0.38 mm. In alternative embodiments, the thickness T of the blade can be less than 0.3 mm or more than 0.46 mm.
[00118] [00118] Referring to Figure 17E, the blades 606 are in a compressed condition when the blades are arranged within an application device 601. When the blades 606 are in the compressed condition, the blades have a width H. The width H can be , for example between approximately 4 mm and approximately 7 mm, such as, between approximately 5 mm and approximately 6 mm. In alternative embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed blades 606 is equal to a width D of the application opening 716 of the application device 601. The ratio between the width W of the blades in the expanded condition and the width H of the blades in the compressed condition can be , for example, approximately 4 to 1 or less, such as approximately 3 to 1 or less, such as approximately 2 to 1 or less, such as approximately 1.5 to 1, such as approximately 1.25 to 1, such as approximately 1 to 1. In alternative embodiments, the ratio between width W and width H can be more than 4 to 1. Referring to Figure 17F, a blade 606 is moved from the expanded condition to the compressed condition by compressing the blade in the Y direction and extending a blade length in the X direction. In the illustrated embodiment, the length of the side members 1707 of the blade 606 is extended when the blade is in the compressed condition, but the length of the center member 1709 remains the same length.
[00119] [00119] Referring to Figures 18A-18D, another exemplary embodiment of a valve repair device 602 includes blades 606 that have another horseshoe shape 1801. In certain embodiments, the horseshoe shape 1801 of blades 606 is compressible, which allows that paddles 606 are arranged within an application device 601 (e.g., a catheter) that has a small diameter (as shown in Figures 18C) for applying valve repair device 602 to a patient's native valve, and it also allows the paddles 606 to expand (as shown in Figures 18A-18B) when exiting the delivery device 601 so that the paddles 606 have a greater surface area to couple the patient's native valve. The valve repair device 602 can take any suitable shape, such as, for example, any shape described in the present application. The valve repair device 602 can be moved between the open and closed position, and be attached to a native valve, by a valve repair system, such as, for example, any valve repair system described in the present application.
[00120] [00120] Figures 18A-18B illustrate the valve repair device 602 in the open position. When the valve repair device 602 is in the open position, the paddles 606 extend outward to create a wide opening 614 between the paddles 606 and retaining members 608 of the valve repair device 602. In the illustrated embodiment, the horseshoe shape 1801 of paddles 606 includes side members 1807 extending from base 1806 of paddle 606, and base 1806 is secured to base assembly 604 of valve repair device 602. In certain embodiments, paddles 606 include material 1805 disposed on the horseshoe shape 1801 to create a contact area for the paddles to couple the valve fabric. Material 1805 can be any suitable material such as, for example, a woven material, an EDM material, or any other material that is capable of promoting tissue growth and protecting coatings of the application device 601 (Figure 6) during scanning . In certain embodiments, material 1605 may be a blood-impervious fabric, such as a PET fabric or biocompatible covering material such as a fabric that is treated with a coating that is impervious to blood, polyester, or a processed biological material, such as pericardium.
[00121] [00121] In various embodiments, paddles 606 are configured to flex to put less stress on the valve tissue when valve repair device 602 is attached to the valve tissue. When the blades 606 are in the expanded condition, the blades have a width W. The width W can be, for example, between approximately 4 mm and approximately 21 mm, such as, between approximately 5 mm and approximately 20 mm, as between approximately 7.5 mm and approximately 17.5 mm, such as between approximately 10 mm and approximately 15 mm. In certain embodiments, the width W may be, for example, 5 mm or more, such as approximately 7.5 mm or more, such as approximately
[00122] [00122] Referring to Figure 18C, the blades 606 are in a compressed condition when the blades are arranged within an application device 601. When the blades 606 are in the compressed condition, the blades have a width H. The width H can be , for example between approximately 4 mm and approximately 7 mm, such as, between approximately 5 mm and approximately 6 mm. In alternative embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed blades 606 is equal to a width D of the application opening 716 of the application device 601. The ratio between the width W of the blades in the expanded condition and the width H of the blades in the compressed condition can be , for example, approximately 4 to 1 or less, such as approximately 3 to 1 or less, such as approximately 2 to 1 or less, such as approximately 1.5 to 1, such as approximately 1.25 to 1, such as approximately 1 to 1. In alternative embodiments, the ratio between width W and width H can be more than 4 to 1. Referring to Figure 18D, a blade 606 is moved from the expanded condition to the compressed condition by compressing the blade in the Y direction and extending a blade length in the X direction. In the illustrated embodiment, the length of the side members 1807 of the blade 606 is extended when the blade is in the compressed condition. Referring to Figure 18C, in certain embodiments, when the blades 606 are disposed within the delivery device 601 and in the compressed condition, the side members 1807 of the blades intersect with each other.
[00123] [00123] Referring to Figures 19A-19D, another exemplary embodiment of a valve repair device 602 includes blades 606 having a 1901 mesh structure. In certain embodiments, the mesh structure
[00124] [00124] Figures 19A-19B illustrate the valve repair device 602 in the open position. When the valve repair device 602 is in the expanded and open position, the blades 606 extend outward to create a wide opening 614 between the blades 606 and retaining members 608 of the valve repair device 602. In certain embodiments, the blades 606 include a material disposed on the 1901 mesh structure, such as, for example, a woven material, an EDM material, or any other material that is capable of promoting tissue growth and protecting coatings of the application device 601 (Figure 6 ) while crawling. In certain embodiments, material 1605 may be a blood-impervious fabric, such as a PET fabric or biocompatible covering material such as a fabric that is treated with a coating that is impervious to blood, polyester, or a processed biological material, such as pericardium.
[00125] [00125] In various embodiments, paddles 606 are configured to flex to put less stress on the valve tissue when valve repair device 602 is attached to the valve tissue. When the blades 606 are in the expanded condition, the blades have a width W. The width W can be, for example, between approximately 4 mm and approximately 21 mm, such as, between approximately 5 mm and approximately 20 mm, as between approximately 7.5 mm and approximately 17.5 mm, such as between approximately 10 mm and approximately 15 mm. In certain embodiments, the width W may be, for example, 5 mm or more, such as approximately 7.5 mm or more, such as approximately 10 mm or more, such as approximately 15 mm or more, such as approximately 20 mm or more. In other embodiments, the width W may be less than 5 mm.
[00126] [00126] Referring to Figure 19C, the blades 606 are in a compressed condition when the blades are arranged within an application device 601. When the blades 606 are in the compressed condition, the blades have a width H. The width H can be , for example between approximately 4 mm and approximately 7 mm, such as, between approximately 5 mm and approximately 6 mm. In alternative embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed blades 606 is equal to a width D of the application opening 716 of the application device 601. The ratio between the width W of the blades in the expanded condition and the width H of the blades in the compressed condition can be , for example, approximately 4 to 1 or less, such as approximately 3 to 1 or less, such as approximately 2 to 1 or less, such as approximately 1.5 to 1, such as approximately 1.25 to 1, such as approximately 1 to 1. In alternative embodiments, the ratio between width W and width H can be more than 4 to 1. Referring to Figure 19D, a blade 606 is moved from the expanded condition to the compressed condition by compressing the blade in the Y direction and extending a blade length in the X direction.
[00127] [00127] Referring to Figures 20A-20B, another exemplary embodiment of a valve repair device includes paddles 606 that are compressible, which allows paddles 606 to be disposed within an application device 601 (for example, a catheter) which has a small diameter (as shown in Figure 20A) for applying the valve repair device to a patient's native valve, and also allows the 606 paddles to expand (as shown in Figure 20B) when exiting the 601 application device so that paddles 606 have a greater surface area to couple the patient's native valve. Paddles 606 can be included in a valve repair device 602 that takes any suitable shape, such as, for example, any shape described in the present application. The valve repair device (and paddles 606) can be attached to a native valve by a valve repair system, such as, for example, any valve repair system described in the present application.
[00128] [00128] Figure 20A illustrates the blade 606 in a compressed condition within an application device 601. The blade includes an opening 2001 that allows a portion of the blade to expand when being positioned from the application device 601. In the compressed condition, the blade 606, for example, can have a width H between approximately 4 mm and approximately 7 mm, such as, between approximately 5 mm and approximately 6 mm. In alternative embodiments, the width H can be less than 4 mm or more than 7 mm. In certain embodiments, the width H of the compressed blades 606 is equal to a width D of the application opening 716 of the application device 601. Figure 20B illustrates the blade 606 in an expanded condition. In the expanded condition, the blade 606, for example, can have a width W between approximately 4 mm and approximately 21 mm, such as between approximately 5 mm and approximately 20 mm, such as between approximately 7.5 mm and approximately 17.5 mm, such as between approximately 10 mm and approximately 15 mm. In certain embodiments, the width W may be, for example, 5 mm or more, such as approximately 7.5 mm or more, such as approximately 10 mm or more, such as approximately 15 mm or more, such as approximately 20 mm or more. In other embodiments, the width W may be less than 5 mm. The ratio between the width W of the blades in the expanded condition and the width H of the blades in the compressed condition can be, for example, approximately 4 to 1 or less, such as approximately 3 to 1 or less, such as approximately 2 to 1 or less , such as approximately 1.5 to 1, such as approximately 1.25 to 1, such as approximately 1 to 1. In alternative embodiments, the ratio between width W and width H may be more than 4 to 1. Referring to In Figure 20B, a paddle 606 is moved from the expanded condition to the compressed condition by compressing the paddle in the Y direction. In various embodiments, paddles 606 are configured to flex to put less stress on the valve tissue when the valve repair device 602 is trapped in the valve fabric. In certain embodiments, paddles 606 include material disposed on paddle 606, such as, for example, any material that is capable of promoting tissue growth and protecting coatings of application device 601 (Figure 6) during screening. In certain embodiments, the material may be a blood-impervious fabric, such as a PET fabric or biocompatible covering material such as a fabric that is treated with a coating that is impervious to blood, polyester, or a processed biological material, such as as pericardium.
[00129] [00129] Figures 21A-21B illustrate another exemplary embodiment of a valve repair system 600, in which the valve repair system 600 includes a valve repair device 602 that has extendable blades. The valve repair system 600 can take any suitable shape, such as, for example, any shape described in the present application. In the illustrated embodiment, valve repair device 602 includes blades 606 that are telescopic so that a length L of the blades can be changed. That is, the blades 606 include a main portion 2110 and an extensible portion 2112. The extensible portion 2112 is capable of being housed within the main portion 2110 to create blades that have a shorter length L (as shown in Figure 21A), and the extensible portion 2112 is capable of being extended outside the main portion to create blades that have a longer length L (as shown in Figure 21B). The ratio between the shortest length L (as shown in Figure 21A) and the longest length L (as shown in Figure 21B) 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.
[00130] [00130] In embodiment, the main portion 2110 is a hollow conduit that has an opening, and the extensible portion 2112 is a rod or conduit configured to be housed within the opening of the hollow member. In certain embodiments, the extendable portion 2112 is spring loaded, so that the extendable portion 2112 is tensioned in the direction of the extended position, and an engaging member is arranged in a locked position to hold the extendable portion 2112 housed within the main portion. 2110 in the unextended position. Movement of the engagement member from the locked position to an unlocked position causes the spring loaded portion 2112 to move out of the main portion 2110 and into the extended position. In addition, the extendable portion 2112 can be moved back into the main portion 2110 and the engagement member can be moved from the unlocked position to the locked position to move the blades from the extended position to the recessed position. The hitch member can be moved between the locked and unlocked position by any suitable means, such as, for example, a rod that engages the hitch member to move the hitch member between the locked and unlocked positions. In an alternative embodiment, a suture or thread extends through the main portion 2110 and engages the extensible portion 2112 to hold the extensible portion 2112 in the non-extended position, and removal of the suture or thread allows the spring-loaded extensible portion to move out of the main portion 2110 and to the extended position.
[00131] [00131] Referring to Figure 21A, valve repair device 602 is shown with paddles 606 in an unextended position, and the valve repair device is positioned to couple valve tissue 820. Referring to Figure 21B, after the valve repair device 602 being placed in position to couple the valve fabric 820, the extensible portions 2112 of the pads 606 are extended so that the pads have a greater surface area to couple the valve fabric. After paddles 606 are extended to a desired length L, valve repair device 602 is closed to secure the valve repair device to valve tissue 820, and the valve repair device is removed from the valve repair system. 600. In certain embodiments, valve repair device 602 is configured so that the extendable portions 2112 of the blades can be extended or retracted after the valve repair device is attached to valve tissue 820, so that the tension over valve tissue can be increased or decreased depending on the patient and the procedural circumstances. For example, in modalities in which valve tissue 820 is a patient's mitral valve, a valve with excess follicle material or chordal damage may need more tension to sufficiently seal the mitral valve, or a valve with short, non-coagulating follicles may need less tension to sufficiently 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 mode, such as, for example, any method described in the present application.
[00132] [00132] Referring to Figures 22-26, in certain embodiments, the retention control mechanism 611 is configured to control each of the retention members 608 independently of each other. Independent control for each of the retaining members 608 is advantageous because the openings 614 between the paddles 606 and the retaining members can be adjusted independently as the valve repair device 602 is being attached to the valve tissue (for example, a mitral valve of a patient). In addition, independent retention control will also be advantageous in situations where a retaining member 608 and a paddle 606 sufficiently secure valve repair device 602 to a first portion of valve tissue, but the other retaining member and the another paddle fails to connect the valve repair device to a second portion of valve tissue. In this situation, the retention control mechanism 611 can be used to control only the retention member 608 that is not connected to the valve tissue to create an opening 614 to receive the second portion of the valve tissue, and, after the second portion of the valve fabric to be arranged within the opening, the non-attached retaining member and the non-attached paddle can be closed to secure the valve repair device 602 to the second portion of the valve fabric.
[00133] [00133] Still referring to Figures 22-26, an exemplary embodiment of a valve repair system 600 includes an application device 601 and a valve repair device 602, in which the application device is configured to apply the valve device valve repair on a patient's native valve, and in which the valve repair device is configured to attach follicles to a native valve to repair the patient's native valve. Application device 601 can take any suitable shape that is capable of applying valve repair device 602 to a patient's native valve, such as, for example, any shape described in the present application. Valve repair device 602 is similar to the valve repair device described above and includes a base assembly 604, a pair of paddles 606, and a pair of retaining members 608. Base assembly 604 of the valve repair device valve 602 has an axis 603, a coupler 605 configured to move along the axis, and a lock 607 configured to lock the coupler in a stationary position on the axis. The valve repair device 602 can take any suitable shape, such as, for example, any shape described in the present application. Valve repair system 600 may also include a paddle control mechanism 610, a retention control mechanism 611, and a lock control mechanism 612. Paddle control mechanism 610 is mechanically attached to coupler 605 to move the coupler along axis 603, which causes the blades 606 to move between the open and closed positions. The paddle control mechanism 610 can take any suitable shape, such as, for example, any shape described in the present application. The lock control mechanism 612 is configured to move coupler 605 between locked and unlocked conditions. The lock control mechanism 612 can take any suitable shape, such as, for example, any shape described in the present application.
[00134] [00134] Referring to Figure 22, an exemplary embodiment of a retention control mechanism 611 includes a first retention control member 2202 and a second retention control member 2204. The first retention control member 2202 is configured to move the holding member 608a in the X direction, and the second holding control member 2204 is configured to move the holding member 608b in the Z direction. Moving the holding member 608a in the X direction will adjust the width W of the opening 614a between the retention member 608a and paddle 606a, and movement of the retention member 608b in the Z direction will adjust the width H of the gap between the retention member 608b and paddle 606b. The retention control members 2202, 2204 can take any suitable shape that is capable of independently moving the retention members 608a, 608b. In the illustrated embodiment, the retention control members 2202, 2204 are threads, such as sutures, threads, etc. which are removable fasteners to each of the retaining members 608a, 608b, respectively, with both ends of the line extending through the application opening 716 of the application device 601. The retaining control members 2202, 2204 can be independently pulled into into and released from the catheter to independently control the position of the retaining members 608a, 608b.
[00135] [00135] Referring to Figures 22A-22D, another exemplary embodiment of the valve repair system 600 is shown with another embodiment of a retention control mechanism 611 used to control the retaining members 608a-d from another exemplary embodiment of a device valve repair device 602. For illustrative purposes, the paddles 606 of the valve repair device 602 are not shown in Figures 22A-22D, but it should be noted that the valve repair device 602 also includes paddles 606 that interact with the members retainer 608a-d for attaching valve repair device 602 to the valve tissue, and paddles 606 can take any suitable shape, such as, for example, any shape described in the present application. Figure 22A illustrates valve repair system 600 with each of the four retaining members 608a-d in a first position, and Figure 22C illustrates valve repair system 600 with the one of the retaining members 608a moved to a second position. Figure 22B is a top view (as indicated by lines 22B-22B shown in Figure 22A) of valve repair system 600 with each of the retaining members 608a-d being arranged in a first position. Figure 22D is a cross-sectional view (as indicated by lines C-C shown in Figure 22C) of valve repair system 600 with retaining member 608a disposed in the second position. Each of the four retaining members can be independently moved in the same manner as illustrated by the retaining member 608a.
[00136] [00136] Valve repair device 602 includes a first retaining member 608a, a second retaining member 608b, a third retaining member 608c, and a fourth retaining member 608d. Each retaining member 608a-d includes a barbed portion 609a-d for attaching retaining members 608a-d to the valve tissue. The retention control mechanism 611 includes a first retention control member 2202a configured to control the first retention member 608a, a second retention control member 2202b configured to control the second retention member 608b, a third control control member retention 2202c configured to control third retention member 608c, and a fourth retention control member 2202d configured to control fourth retention member 608d. Specifically, the first holding control member 2202a is configured to move holding member 608a in the X direction, and the second holding control member 2202b is configured to move the second holding member 608b in the X direction. third holding control member 2202c is configured to move holding member 608c in the Z direction, and the fourth holding control member 2202d is configured to move the fourth holding member 608d in the Z direction. The movement of holding members 608a -b in the X direction will adjust the opening width between the retaining members 608a-b and the corresponding blade 606, and the movement of the retaining members 608c-d in the Z direction will adjust the width of the opening between the retaining members 608c-d and the corresponding blade . The retention control mechanism 611 is configured to move each of the retention members 608a-d independently of each other. Retention control members 2202a-d can assume any suitable shape that is capable of independently moving retention members 608a-d. In the illustrated embodiment, the retention control members 2202a-d are threads, such as sutures, threads, etc. which are removably secured to each of the retaining members 608a-d, respectively, with both ends of the line extending through the application opening 716 of the application device 601. The retaining control members 2202a-d can be independently pulled and released from the catheter to independently control the positions of the 608a-d retaining members.
[00137] [00137] Referring to Figures 22A and 22B, each of the retaining members 608a-d is shown in an extended position. Referring to Figures 22C and 22D, the first holding member 608a is shown after the first holding control member 2202a of the holding control mechanism has been pulled into the catheter causes the first holding member 608a to move inwardly into the direction of the axis 603 in the X direction, and the other retaining members 608b-d remained in the position shown in Figures 22A and 22B. In other words, the illustrated embodiment shown in Figures 22A-22D shows a first retaining member 608a being independently controlled in relation to the other retaining members 608b-d. Although the illustrated embodiment shows the first retention member 608a being independently controlled, it should be understood that each of the retention members 608a-d can be independently controlled by the corresponding retention control member 2202a-d of the retention control mechanism 611. In addition, although the illustrated embodiment of Figures 22A-22D illustrates a valve repair assembly 600 having four retaining members 608a-four retaining control members 2202a-d, it should be understood that any suitable number of retaining members and retention control members can be used, and any number of retention members can be independently controlled by the retention control mechanism. In addition, each of the retaining members 608a-608d can have any of the configurations described in this order and each of the control mechanisms 2202a-2202d can have any of the shapes described in this order.
[00138] [00138] Referring to Figure 23, another exemplary embodiment of a 611 retention control mechanism includes a single line 2302, such as the suture or thread, which is removably attached to retention members 608a, 608b and removable fixed between an axis of placement 613 and a shaft 603 of the valve repair device. The connection 615 between the placing axis 613 and an axis 603 of the valve repair device can be in a wide variety of different positions. In the illustrated example, connection 615 is aligned or substantially aligned with the ends of the retaining members 608a, 608b. However, in other embodiments, connection 615 may be further apart, such as in a position closer to which coupler 605 can reach (see, for example, the coupler rescue positions illustrated by Figures 45C and 46D). Single line 2302 is connected between axis 613 and axis 603, so that single line 2302 can independently control retaining members 608a, 608b. That is, the movement of a first portion 2303 of line 2302 in the Y direction will adjust the width W between the retaining member 608a and the blade 606a, but will not adjust the width H between the retaining member 608b and the blade 606b. Similarly, the movement of a second portion 2305 of line 2302 in the M direction will adjust the width H between the retaining member 608b and the blade 606b, but will not adjust the width W between the retaining member 608a and the blade 606a. After the valve repair device 602 is in the closed position and secured in the valve fabric, the placing axis 613 is detached from the axis 603 of the valve repair device 602. Detaching the axis 603 from the axis 613 causes the line be released. Line 2302 can then be drawn back into the catheter to release retaining members 608a, 608b by pulling one end of line 2302 into the catheter. Pulling one end of the line into the catheter pulls the other end of the line through the retaining members 608a, 608b and then into the catheter. Any of the lines described here can be indented in this mode.
[00139] [00139] Referring to Figure 24, in certain embodiments, the placement axis 613 and the axis 603 of the device 602 can be hollow mounted on a coupling axis 2400 that hold the axes 613, 603 together. The axis 603 of the device 602 can include a protruding portion 2406 and a recessed receiving portion 2408. The positioning axis 613 may include a protruding portion 2407 and a recessed receiving portion 2409. When the axes 613, 603 are coupled, the portion protruding 2406 of the axis 603 is arranged within the receiving portion 2409 of the axis 613, and the protruding portion 2407 of the axis 613 is arranged within the receiving portion 2408 of the axis 603. The axes 613, 603 can be connected in a wide variety of different modes. For example, axis 613 may include a hole or channel 2411 that is aligned with a hole or channel 2413 of axis 603 when protruding portions 2406, 2407 are arranged within receiving portions 2408, 2409, respectively. When the openings 2411, 2413 are aligned and the retaining axis 2400 is placed inside the openings 2411, 2413 in the X direction, the axes 613, 603 are held together. When the placement axis is removed from the openings 2411, 2413 in the Z direction, the protruding portions 2406, 2407 can be removed from the receiving portions 2408, 2409, so that the device 602 is detached from the placement axis 613.
[00140] [00140] Still referring to Figure 24, when axes 613, 603 are attached to each other, an opening 2415 is created at interface 2417 between axes 613, 603. Opening 2415 is configured to hold the line 2302 between axes 613, 603 to allow independent control of the retaining members 608a, 608b. That is, opening 2415 is configured so that line 2302 does not move relative to opening 2416 when axes 613, 603 are attached. When detaching axes 613, 603, line 2302 is released from opening 2415 and can be removed from valve repair device 602. Line 2302 can then be drawn back into the catheter to release the retaining members as described above.
[00141] [00141] Referring to Figures 23 and 24A-24B, in an alternative embodiment, line 2302 of the retention control mechanism 611 is secured between the placing axis 613 and the axis 603 by a threaded connection to independently control the retaining members 608a, 608b. Referring to Figure 24A, the placement shaft 613 includes a male threaded member 2419, and the shaft 603 includes a female threaded member 2421 configured to receive male threaded member 2419 from the placement shaft 613. However, the male and female threads can be reversed. Placement shaft 613 is attached to shaft 603 by inserting male threaded member 2419 into female threaded member 2421 of the shaft
[00142] [00142] Referring to Figure 25, another exemplary embodiment of a 611 retention control mechanism includes a first retention control member 2502 and a second retention control member 2504. The first retention control member 2502 is configured to move the holding member 608a bidirectionally in the X direction, and the second holding control member 2504 is configured to move the holding member 608b bidirectionally in the Z direction. The movement of the holding member 608a in the X direction will adjust the width W of the opening 614a between the holding member 608a and the blade 606a, and the movement of the holding member 608b in the Z direction will adjust the width H of the opening between the holding member 608b and the blade 606b. In the illustrated embodiment, the retaining control members 2202, 2204 include a push / pull connection 2503, 2505, such as, for example, a catheter, a flexible rod, or a rigid wire and a coupler 2506, 2507. Each connection push / pull screw 2503, 2505 extends from the application device 601 and is removably secured to the corresponding retaining member 608a, 608b by a coupler 2506, 2507. Connection 2503 is configured to be pushed and pulled in the Y direction. 2503 in the Y direction causes the retaining member 608a to move in the X direction. Similarly, connection 2505 is configured to be pushed and pulled in the M direction, and the movement of catheter 2505 in the M direction causes a catheter 2505 to move the retaining member 608b in the H direction.
[00143] [00143] In another embodiment of a 611 retention control mechanism is shown in Figure 25A. In this embodiment, the retention control members 2202, 2204 include a suture 2511, 2513 and a flexible thread 2503, 2505. In this embodiment, the first flexible thread 2503 includes a loop 2517 for receiving the first suture 2511 and for attaching a member of retention 608a (Figure 25), and the second flexible thread 2505 includes a loop 2519 to receive the second suture 2513 and to couple the retention member 608b (Figure 25). Sutures 2517, 2519 are removable attached to each of the retaining members 608a, 608b, respectively, with both ends of the line extending through the delivery device 601 as described above. Each of the threads 2503, 2505 extends from the application device 601 and the loops 2517, 2519 of the respective threads 2503, 2505 are able to move along the corresponding sutures 2511, 2513, so that the loops 2517, 2519 can couple the member corresponding retaining members 608a, 608b for moving the retaining members (for example, moving the retaining members as described with reference to Figure 25). Yarns 2503, 2505 can be made of, for example, steel, NiTi, or another wire or a plastic material. In certain embodiments, wires 2503, 2505 can have a diameter between approximately 0.1 mm and 0.35 mm, as well as between approximately
[00144] [00144] Referring to Figure 26, another exemplary embodiment of a retention control mechanism 611 includes a first catheter 2603, a second catheter 2605, and a single line 2604, such as a thread or suture. The first catheter 2603 and the line 2604 are configured to move the retaining member 608a in the X direction, and the second catheter 2605 and the line 2604 configured to move the retaining member 608b in the Z direction. The movement of the retaining member 608a in the direction X will adjust the width W of the opening 614a between the holding member 608a and the blade 606a, and the movement of the holding member 608b in the Z direction will adjust the width H of the opening between the holding member 608b and the blade 606b. Line 2604 extends from delivery device 601 through catheters 2603, 2605 and is threaded through openings in both retaining members 608a, 608b. Each catheter 2603, 2605 is configured to couple and move the corresponding retaining member 608a, 608b. Specifically, catheter 2603 is configured to be pushed in the Y direction while line 2604 is unwound from catheter 2603 or the tension in the line is reduced. Catheter 2603 is configured to be pulled in the Y direction while line 2604 is pulled into catheter 2603 or the tension in the line is increased. The movement of the catheter 2603 in the Y direction causes the catheter 2603 to move the retaining member 608a in the X direction. Similarly, the catheter 2605 is configured to be pushed in the M direction while line 2604 is unrolled from the catheter 2605 or the tension in the line is reduced. Catheter 2605 is configured to be pulled in the M direction while line 2604 is pulled into catheter 2605 or the tension in the line is increased. The movement of the catheter 2505 in the M direction causes the catheter 2505 to move the retaining member 608b in the H direction. In an alternative embodiment, the retention control mechanism 611 described above with reference to Figure 26 may include a first flexible wire with a loop (for example, flexible wire 2503 with loop 2517 shown in Figure 25A) and a second flexible wire with a loop (for example, flexible wire 2505 with loop 2519 shown in Figure 25A), and the single line 2604 extends through loop 2517, 2519 of each of the wires 2503.
[00145] [00145] Referring to 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 so that each of the paddles 606 can be controlled independent of each other. Independent control for each of the paddles 606 is advantageous because the openings 614 between the paddles and the retaining members 608 can be adjusted independently as the valve repair device 602 is being attached to the valve tissue (for example, the mitral valve of a patient). In addition, independent paddle control will also be advantageous in situations where a retaining member 608 and a paddle 606 sufficiently secure valve repair device 602 to a first portion of valve tissue, but the other retaining member and the another paddle fails to connect the valve repair device to a second portion of valve tissue. In this situation, the paddle control mechanism 610 can be used to control only paddle 606 that is not connected to the valve tissue to create an opening 614 to receive the second portion of the valve tissue, and, after the second portion of the tissue valve is arranged within the opening, the non-attached retaining member and the non-attached paddle can be closed to secure the valve repair device 602 to the second portion of the valve fabric.
[00146] [00146] Referring to Figures 27A-27C, the base assembly 604 of the valve repair device 602 includes a first shaft 603a, a second shaft 603b, a first coupler 605a, and a second coupler 605b. In addition, the paddle control mechanism 610 includes a first paddle control mechanism 2702 and a second paddle control mechanism 2704. The first paddle control mechanism 2702 is configured to move the first coupler 605a along axis 603a , and the second paddle control mechanism 2704 is configured to move the second coupler 605b along axis 603b. The movement of the first coupler 605a along the axis 603a causes the blade 606a to move between an open position and a closed position, and the movement of the second coupler 605b along the axis 603b causes the blade 606b to move between an open position. and a closed position. In an alternative embodiment, the base assembly 604 can include a single shaft, a first coupler 605a attached to the single axis, and a second coupler 605b attached to the single axis. In this alternative embodiment, the paddle control mechanism 610 may include a first paddle control mechanism 2702 configured to move the first coupler 605a along the single axis 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 coupler 605b along the single axis to cause paddle 606b to move between an open position and a closed position.
[00147] [00147] Figures 27A-27C illustrate the paddles of the valve repair device moving between an open position and a closed position. The base assembly 604 of valve repair device 602 includes a first connection 2721 that extends from point A to point B, a second connection 2722 that extends from point B to point C, a third connection 2723 that extends from point C for point D, a fourth connection 2724 that extends from point D to point E, and a fifth connection 2725 that extends from point E to point F. Coupler 605a is movable on axis 603a, coupler 605b is attached movable on axis 603b, and axes 603a, 603b are fixed on the third connection 2723. The first connection 2721 is hinged to coupler 605a at point A, so that the movement of coupler 605a along axis 603a moves the location of the point A and consequently moves the first connection 2721. Similarly, the fifth connection 2725 is hinged to the coupler 605b at point F, so that the movement of coupler 605b along axis 603b moves the location of point F and, consequently moves the fifth connection 272 5. The first connection 2721 and the second connection 2722 are attached to each other at point B, and the fifth connection 2725 and the fourth connection 2724 are attached to each other at point E. A paddle 606a is attached to the first connection 2721 so that the movement of the first connection 2721 causes the blade 606a to move, and the other blade 606b is attached to the fifth connection 2725 so that the movement of the fifth connection 2725 causes the blade 606b to move.
[00148] [00148] Referring to Figure 27A, the blades 606a, 606b are in the open position. Referring to Figures 27A and 27B, the paddle 606b is moved from the open position (as shown in Figure 27A) to the closed position (as shown in Figure 27B) when the second paddle control mechanism 2704 moves the second coupler 605b along the axis 603b in the Y direction, which causes a portion of the fifth connection 2725 near the F point to move in the H direction, and a portion of the fifth connection 2725 near the E point to move in the J direction. Paddle 606b is attached to the fifth connection 2725 so that the movement of the second coupler 605b in the Y direction causes the blade 606b to move in the Z direction. In addition, the fourth connection 2724 is hinged to the fifth connection 2725 at point E so that the movement of the second coupler 605b in the Y direction it causes the fourth connection 2724 to move in the K direction. Referring to Figure 27B, the paddle 606b moves in the Q direction when moving from the open to the closed position. In an alternative embodiment in which the connection hinged at point E between the fourth connection 2724 and the fifth connection 2725 is significantly lower than the connection hinged at point F between the fifth connection 2725 and the second coupler 605b, the movement of the paddle 606b from the open to the closed position it will act as shown in the mode shown in Figure 27A except that fourth connection 2724 will initially move in the direction substantially opposite to the K direction as the paddle 606b is being closed. In any of the aforementioned embodiments, the second paddle control mechanism 2704 can take any shape suitable for moving the second coupler 605b along axis 603b, such as, for example, any form of paddle control mechanism described herein. order.
[00149] [00149] Referring to Figures 27A and 27C, the paddle 606a is moved from the open position (as shown in Figure 27A) to the closed position (as shown in Figure 27C) when the first paddle control mechanism 2702 moves the first coupler 605a along axis 603a in the N direction, which causes a portion of the first connection 2721 near point A to move in the L direction, and a portion of the first connection 2721 near point B to move in the direction I. Paddle 606a is secured at the first connection 2721 so that the movement of the first coupler 605a in the N direction causes the paddle 606a to move in the V direction. In addition, the second connection 2722 is hinged to the first connection 2721 at point B so that the movement of the first coupler 605a in the N direction causes the second connection 2722 to move in the R direction. Referring to Figure 27C, the paddle 606a moves in the T direction when moving from the open to the closed position. In an alternative embodiment in which the connection hinged at point B between the first connection 2721 and the second connection 2722 is significantly lower than the connection hinged at point A between the first connection 2721 and the first coupler 605a, the movement of the blade 606a from the open position to the closed position it will act as shown in the mode shown in Figure 27A except that the second connection 2722 will initially move in the direction substantially opposite the direction R as the paddle 606b is being closed. In any of the aforementioned embodiments, the first paddle control mechanism 2702 can take any shape suitable for moving the first coupler 605a along axis 603a, such as, for example, any form of a paddle control mechanism described herein. order.
[00150] [00150] Referring to Figures 28A-28C, in certain embodiments, the paddle control mechanism 610 includes a rack and pinion mechanism 2802 that is configured to selectively engage and disengage paddles 606a, 606b from shaft 603. The rack mechanism and pinion 2802 includes a first member 2804 attached to shaft 603 and a toothed member 2806a, 2806b attached to each of the blades 606a, 606b and connected hinged to a base member 2801 at connection points A, B. The first member 2804 is configured so that the blades 606a, 606b can be moved between the open and closed positions independently of each other. In the illustrated embodiment, the first member 2804 has a ribbed portion 2805 and an open portion 2807. When the toothed member (s) 2806a, 2806b are aligned with the ribbed portion 2805 of the first member 2804, the ) toothed member (s) 2806a, 2806b are configured to couple ribbed portion 2805 so that movement of the axis in the Y direction relative to the base member 2801 causes the toothed member 2806a to hinge around the connection point A in direction M to move blade 606a between an open position and a closed position in direction H, and causes toothed member 2806b to pivot around connection point B in direction N to move blade 606b between an open position and a closed position in the Z direction. When the open portion 2807 of the first member 2804 is aligned with any of the toothed members 2806a or 2806b, the toothed member that is aligned with the open portion 2807 is not coupled by the ribbed portion 2805 of the blade 606a or 606b . As a result, the movement of the axis 603 in the Y direction does not affect the position of the blade 606a or 606b.
[00151] [00151] Figures 28A-28B illustrate the corkscrew mechanism 2802 in a first position. In the first position, the toothed members 2806a, 2806b for both blades 606a, 606b are aligned with the ribbed portion 2805 of the first member 2804. Referring to Figure 28A, when the axis 603 is moved in the Y direction, the toothed members 2806a, 2806b both engage the ribbed portion 2805 of the first member, which causes both blades 606a, 606b to be moved between the open and closed positions. Figures 28C-28D illustrate the corkscrew mechanism 2802 in a second position. In the second position, the toothed member 2806a is aligned with the open portion 2807 of the first member 2804, and the toothed member 2806b is aligned with the ribbed portion 2806 of the first member
[00152] [00152] Referring to Figures 29A-29B, the paddle control mechanism 610 is configured to move a coupler 605 along an axis 603 to move the paddles 606a, 606b between the open and closed positions (similar to the mode shown in the Figures 6-12), and a locking mechanism 207 is configured to lock the coupler 605 on the shaft 603 to keep the paddles 606a, 606b in a desired position. In certain embodiments, as shown in Figures 29A-29B, each of the blades 606a, 606b includes a pin 2902a, 2902b and a slot 2904a, 2904b. Pin 2902a is configured to move into slot 2904a, and pin 2902b is configured to move into slot 2904b. Pins 2902a, 2902b are also configured to be locked into slots 2904a, 2904b. When a pin 2902a, 2902b is unlocked within a slot 2904a, 2904b, the corresponding paddle 606a, 606b remains in a current position when paddle control mechanism 610 moves coupler 605 along axis 603. When a pin 2902a, 2902b is locked into a slot 2904a, 2904b, the corresponding paddle 606a, 606b moves between an open and closed position when paddle control mechanism 610 moves coupler 605 along axis 603.
[00153] [00153] Figure 29A illustrates valve repair device 602 with paddles 606a, 606b in an open position. Figure 29B illustrates valve repair device 602 with pin 2902a unlocked within slot 2904a, and pin 2902b locked within slot 2904b. Referring to Figure 29B, lock 607 is in an unlocked condition so that coupler 605 can be moved along axis 603. The movement of coupler 605 along axis 603 in the Y direction causes paddle 606b to pivot around the locked pin 2902b so that the blade 606b moves in the Z direction to a closed position. In addition, movement of the coupler 605 in the Y direction does not cause the paddle 606a to move because pin 2902a is in an unlocked condition within slot 2904a. Instead, movement of the coupler 605 in the Y direction causes pin 2902a to move into slot 2904a. Alternatively, pin 2902a could be locked into slot 2904a and pin 2902b could be unlocked into slot 2904b, so that movement of coupler 605 in the Y direction would cause paddle 606a to move to a closed position, and paddle 606b remained in the open position (by pin 2902b moving into slot 2904b). In addition, pin 2902a could be locked into slot 2904a and pin 2902b could be locked into slot 2904b, so that moving coupler 605 in the Y direction would cause both blades 606a, 606b to move to the closed position . Pins 2902a, 2902b can be locked into slot 2904a, 2904b by any suitable means, such as, for example, any means described herein with reference to lock 607.
[00154] [00154] Referring to Figure 30, in certain situations, the mitral valve
[00155] [00155] Figures 31A-37D provide various modalities of valve repair devices 602 that are configured to close a wide space 3002 (Figure 30) between the anterior follicle 3003 and the posterior follicle 3004 of a mitral valve 3001. Referring to the Figures 31A-31B, an exemplary embodiment of a valve repair device 602 includes paddles 606 and retaining members 608. In addition, valve repair device 602 can include any other characteristics for a valve repair device discussed in the present application , and valve repair device 602 may be positioned to couple valve tissue 820 as part of any suitable valve repair system (for example, any valve repair system described in the present application). Referring to Figure 31A, the blades 606 of the valve repair device 602 are pivoted out in the X direction to create an opening 614 between the blades 606 and the retaining members 608 that has a width W. The width W can be, for example, for example, between approximately 5 mm and approximately 15 mm, such as between 7.5 mm and approximately 12.5 mm, such as approximately 10 mm. In alternative embodiments, the width W can be less than 5 mm or greater than 15 mm. Referring to Figure 31B, the blades 606 of the valve repair device 602 are moved outward in the Z direction so that the opening 614 has a width H. The width H can be, for example, between approximately 10 mm and approximately 25 mm , such as between approximately 10 mm and approximately 20 mm, such as between approximately 12.5 mm and approximately 17.5 mm, such as approximately 15 mm. In alternative embodiments, the width H can be less than 10 mm or more than 25 mm. In certain embodiments, the ratio between width H and width W may be approximately 5 to 1 or less, such as approximately 4 to 1 or less, such as approximately 3 to 1 or less, such as approximately 2 to 1 or less, such as as approximately 1.5 to 1 or less, such as approximately 1.25 to 1 or less, such as approximately 1 to 1. Valve repair device 602 can be configured so that the blades 606 are pivoted out in the direction X and then moved outward in the Z direction to create opening 614 which has a width H between the blades 606 and the retaining members 608. Alternatively, valve repair device 602 can be configured so that the blades are moved to out in the Z direction and then pivoted out in the X direction to create a width H between the blades 606 and the retaining members 608. In addition, the valve repair device 602 can be configured so that the blades 606 are hinged to out in the X direction and moved out in the Z direction simultaneously to create the width H between the blades 606 and the retaining members 608.
[00156] [00156] Figures 32A-32C illustrate a valve repair device 602 in which the blades 606 are pivoted out in the X direction, and subsequently moved out in the Z direction to create a wider opening 614. Figure 32A illustrates valve repair device 602 in a closed position, so that paddles 606 are coupling retaining members 608. Referring to Figure 32B, paddles 606 are pivoted out in the X direction to create an opening 614 that has a width W to receive the valve tissue. Referring to Figure 32C, after the blades 606 are pivoted out in the X direction, the blades 606 are moved outward in the Z direction so that the opening 614 has a width H. After the valve tissue is received into the openings 614 between the paddles 606 and retaining members 608, the valve repair device is moved back to the closed position (as shown in Figure 32A) to secure the valve repair device 602 to the valve tissue. Valve repair device 602 can include any other features for a valve repair device discussed in the present application, and valve repair device 602 can be positioned to couple valve tissue 820 as part of any valve repair system. suitable valve (for example, any valve repair system described in this application).
[00157] [00157] Figures 33A-33C illustrate a valve repair device 602 in which the blades 606 are moved outward in the Z direction, and subsequently pivoted outward in the X direction to create a wider opening 614. Figure 33A illustrates valve repair device 602 in a closed position, so that the blades 606 are engaging the retaining members 608. Referring to Figure 33B, the blades 606 are moved outward in the Z direction to create an opening 614 that has a width W to receive the valve tissue. Referring to Figure 33C, after the blades 606 are moved outward in the Z direction, the blades 606 are pivoted outward in the X direction so that the opening 614 has a width H. After the valve tissue is received into the openings 614 between the paddles 606 and the retaining members 608, the valve repair device is moved back to the closed position (as shown in Figure 33A) to secure the valve repair device 602 to the valve fabric. Valve repair device 602 can include any other features for a valve repair device discussed in the present application, and valve repair device 602 can be positioned to couple valve tissue 820 as part of any valve repair system. suitable valve (for example, any valve repair system described in this application).
[00158] [00158] Although Figures 32A-32C illustrate a valve repair device 602 in which the blades 606 are hinged and then opened, and Figures 33A-33C illustrate a valve repair device 602 in which the blades 606 are opened and then articulated, in alternative embodiments, a valve repair device 602 can include blades 606 that can be opened and articulated simultaneously. In addition, in certain embodiments, the 606 blades can be opened and articulated independently of one another. That is, in the modes for the valve repair device 602 shown in Figures 32A-32C and 33A-33C, as well as the mode in which the opening and articulation of each blade 606 are completed simultaneously, the pads 606 can be controlled independently each other.
[00159] [00159] Referring to Figures 34A-34B, another exemplary embodiment of a valve repair device 602 configured to close a wide space 3002 (Figure 30) between the anterior follicle 3003 and the posterior follicle 3004 includes a W-shaped mechanism. Specifically, valve repair device 602 includes a coupler 605 configured to move along an axis 603 and paddles 606 hinged on coupler 605. Paddles 606 include an internal connection 3402 and an external connection 3404. The internal connection 3402 of each paddle 606 is hinged hinged to coupler 605, and the outer connection 3404 of each paddle 606 is hinged to the corresponding inner connection 3402. Referring to Figure 34A, valve repair device 602 is shown in a closed position. Referring to Figure 34B, the movement of the coupler 605 in the Y direction causes the internal connections 3402 of the blades 606 to extend in an outward direction X. In the illustrated example, the internal connections 3402 couple a cam member 3403, which forces the internal connections 3402 to open in X direction. Although the illustrated embodiment shows a valve repair device 602 that has generally linear connections 3402, 3404 that create a W-shaped mechanism, it should be understood that connections 3402, 3404 can take any suitable shape that allows the device to repair valve 602 works as shown in Figures 34A-34B. In embodiments in which connections 3402, 3404 assume non-linear shapes (for example, a curved shape), the valve repair device may not have a W-shaped mechanism, however, the valve repair device may include connections similar so that the valve repair device will function as shown in Figures 34A-34B.
[00160] [00160] The external connections 3404 can be moved to the most open position illustrated in the Z direction in a variety of different ways. For example, external connections can be moved using any of the closing control arrangements described here. For example, movement of external connections 3404 can be controlled using any of the closure control arrangements shown in Figures 22-26 and / or any of the paddle control arrangements described here. In one embodiment, referring to Figures 34C-34D, a 3411 connection is attached to the hinged connection between the internal connection 3402 and the coupler 605 and the hinged connection between the internal connection 3402 and the external connection 3404, so that the movement of the coupler 605 in the Y direction causes a first end 3413 of the 3411 connection to rotate in the
[00161] [00161] For illustrative purposes, the modality shown in Figures 34C-34D shows a connection 3411 for one of the blades 606, however, it must be understood that another connection 3411 interacts with the other blade in the same way described above to make the outer connection 3404 of the other blade moves to an open position in the Z direction. In an alternative embodiment, a four bar linkage can be used to move the blades 606 to an open position. In another alternative embodiment, a suture can be attached removably to the outer connections 3404 of the pads 606, and the suture can be controlled to move the outer connections 3404 of the pads 606 to an open position in the Z direction.
[00162] [00162] In certain embodiments, the valve repair device 602 includes a tensioning member 3410 (e.g., a spring) that secures the internal connections 3402 of the blades 606 to each other. The tensioning member 3410 keeps the internal connections 3402 in a closed position (as shown in Figures 34A and 34C), until the internal connections 3402 couple the cam member 3403 (as shown in Figures 34B and 34D). Valve repair device 602 can include any other features for a valve repair device discussed in the present application, and valve repair device 602 can be positioned to couple valve tissue 820 as part of any valve repair system. suitable valve (for example, any valve repair system described in this application).
[00163] [00163] Referring to Figures 35A-35B, another exemplary embodiment of a valve repair device 602 configured to close a wide space 3002 (Figure 30) between the anterior follicle 3003 and the posterior follicle 3004 includes a W-shaped mechanism. Specifically, valve repair device 602 includes a coupler 605 configured to be moved along an axis 603 and paddles 606 hinged to the shaft and coupler 605. The bottom ends 3501 of each paddle 606 of valve repair device 602 are connected hinged to the shaft at point A. Each of the blades 606 includes an intermediate member 3502 that hinges the blades in coupler 605 at hinge point B. Referring to Figure 35A, valve repair device 602 is shown in a position closed. Referring to Figure 35B, the movement of the coupler 605 in the Y direction causes the intermediate members 3502 of the blades 606 to articulate so that a lower end 3503 of the intermediate members 3502 extends in an outward direction X, which causes the blades 606 move to an open position in the Z direction. The valve repair device 602 can include any other features for a valve repair device discussed in the present application, and the valve repair device 602 can be positioned to couple the fabric of the valve. valve 820 as part of any suitable valve repair system (for example, any valve repair system described in the present application).
[00164] [00164] Referring to Figures 36A-36B, another exemplary embodiment of a valve repair device 602 configured to close a wide space 3002 (Figure 30) between the anterior follicle 3003 and the posterior follicle 3004 includes a W-shaped mechanism. Specifically, valve repair device 602 includes paddles 606 that have a hinge 3602 that hinges pads 606 hinged to an axis 603 of valve repair device 602. Hinge 3602 includes an internal connection 3603 and an external connection 3605. A internal connection
[00165] [00165] Still referring to Figures 36A and 36B, although the paddle control mechanism is shown attached to the hinge connection point A, it should be understood that the paddle control mechanism 610 can be attached to one or more of any of the connections valve repair device 602. For example, paddle control mechanism 610 may be coupled to paddle 606, port 3605, and / or port
[00166] [00166] Referring to Figures 36C, the paddle control mechanism 610 of the embodiment illustrated by Figures 36A and 36B may include a 3620 spool and a 3622 thread (for example, a suture, a thread, etc.), and the thread is stuck in and wrapped around the spool. In this mode, creating a force on the line 3622 in the Z direction causes the spool 3620 to rotate and the line 3622 to be unwound from the spool. In this embodiment, rotation of the spool 3620 causes the paddle control mechanism 610 to move in the Y direction and the valve repair device 602 to move to the open position (as shown in Figure 36B).
[00167] [00167] Referring to Figures 36D-36E, another exemplary embodiment of a valve repair device 602 configured to close a wide gap 3002 (Figure 30) between the anterior follicle 3003 and the posterior follicle 3004 includes a semi-rigid W-shaped mechanism . Specifically, valve repair device 602 has a hinge 3602 that flexibly attaches paddles 606 to an axis 603 of valve repair device 602. Hinge 3602 includes a rigid internal connection 3603 and a rigid external connection 3605. The rigid connection inner 3603 is flexibly secured to shaft 603 by a flexible member or portion 3613 and flexibly secured to the external rigid connection 3605 by a flexible member or portion 3611, and the outer rigid connection 3506 is flexibly secured to blade 606 by a flexible member or portion 3615 Paddles 606 are also flexiblely attached to a 3608 connection of valve repair device 602 by a flexible member or portion 3617. Rigid connections 3603, 3605 can be made of, for example, steel or nitinol. The flexible members 3611, 3613, 3615, 3617 can be made of, for example, nitinol. A paddle control mechanism 610 is configured to move the hinge connection at point A between the internal connection 3603 and the external connection 3605 of the hinge 3602 in the Y direction, which causes the blades 606 to move between an open position (as shown in Figure 36D) and a closed position (as shown in Figure 36C). However, the 610 paddle control mechanism may be attached to one or more of any of the valve repair device connections. For example, paddle control mechanism 610 can be coupled to paddle 606, connection 3605, and / or connection 3603. Paddle control mechanism 610 can take any suitable shape, such as,
[00168] [00168] Referring to Figures 37A-37D, another exemplary embodiment of a valve repair device 602 configured to close a wide gap 3002 (Figure 30) between the anterior follicle 3003 and the posterior follicle 3004 includes wire mesh paddles 606 and an internal cam 3702 configured to push the mesh paddles 606 apart. The internal cam 3702 is pivotally secured to axis 603 so that the cam can be moved between a first position (as shown in Figures 37A-37B) and a second position (as shown in Figures 37C-37D). Figure 37B is a top view illustrating the internal cam 3702 in the first position, shown along lines B-B in Figure 37A. Figure 37D is a top view showing internal cam 3702 in the second position, shown along lines D-D in Figure 37C.
[00169] [00169] Referring to Figures 37A and 37B, when the internal cam 3702 is in the first position, the internal cam does not engage the paddles 606, and the valve repair device is kept in a closed position. Referring to Figures 37C and 37D, when the internal cam 3702 is in the second position, the internal cam couples the blades 606 to move the blades in an outward direction X to an open position. The valve repair device 602 is moved from the open position to the closed position by moving the internal cam 3702 from the second position to the first position.
[00170] [00170] In some embodiments, referring to Figures 37E-37F, the paddles 606 of the valve repairing device may include a flexible member or portion 3711 that tension the paddles to the closed or open position. The flexible member or portion 3711 can be configured to flex when being coupled by the cam 3702 to allow the blades 606 to move to the open position. The flexible member or portion 3711 is also configured to extend the reach of the blades 606 when the blades are in the open position. Any other suitable mechanisms can be used to tension the blades in the closed position and / or to extend the reach of the blades 606 when the blades are in the open position, such as, for example, a spring loaded mechanism. Valve repair device 602 can include any other features for a valve repair device discussed in the present application, and valve repair device 602 can be positioned to couple valve tissue 820 as part of any valve repair system. suitable valve (for example, any valve repair system described in this application). The 606 mesh paddles can be made of any suitable material that can be expanded by the internal cam 3702, such as, for example, nitinol, stainless steel, or any braided or EDM material.
[00171] [00171] Referring to Figures 38-39, in certain situations, a patient's mitral valve 3001 may have a wide gap 3002 between the anterior follicle 3003 and the posterior follicle 3004 when the mitral valve is in a closed position (ie, during the systolic phase). For example, slot 3002 can 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 space 3002 may have a width W greater than 15 mm. In any of the aforementioned situations, a valve repair device is desired to fill a volume sufficient to allow space 3002 to be closed or filled without placing a large amount of tension on follicles 3003, 3004. For example, the valve repair may include a 3800 spacer element
[00172] [00172] Referring to Figure 39, in certain embodiments, spacer element 3800 is attached to valve repair device 602, so that when paddles 606 and retaining members 608 secure valve repair device 602 to the valve mitral valve 3001, the spacer element 3800 is disposed within the space 3002 between the anterior follicle 3003 and the posterior follicle 3004. The spacer element 3800 can be made of any suitable material such as, for example, braided mesh, fabric, biocompatible material, foam , pericardial tissue, any material described here, etc.
[00173] [00173] Referring to Figures 40A-40B, an exemplary embodiment of a valve repair device 602 has a spacer element 3800 attached to shaft 603 of the valve repair device. The spacer element 3800 may extend beyond the outer edges 4001 of the retaining members 3800 as illustrated to provide an additional surface area to close the space 3002 (Figures 38-39) of a mitral valve 301. In an alternative embodiment, the coupling member 605 can take the form of the spacer element 3800. That is, a single element can be used as the coupling member 605 that causes the blades 606 to move between the open and closed positions and the spacer element 3800 that closes the space between the follicles 3003, 3004 when valve repair device 602 is trapped in the follicles. Valve repair device 602 can include any other features for a valve repair device discussed in the present application, and valve repair device 602 can be positioned to couple valve tissue 820 as part of any valve repair system. suitable valve (for example, any valve repair system described in this application).
[00174] [00174] Referring to Figures 42A-42C, the spacer element 3800 shown in Figures 40A-40B can take a variety of different shapes. Referring to Figure 42A, an exemplary embodiment of a spacer element 3800 includes a main body 4210a that extends between the retaining members 608 and beyond the edges 4201 of the retaining members, and extended portions 4212a that extend from the main body 4210a. The extended portions 4212a allow portions of the space 3002 (Figures 38-39) of the mitral valve between the anterior follicle 3003 and posterior follicle 3004 and adjacent to the valve repair device 602 to be filled when the valve repair device is in a position closed. That is, when valve repair device 602 is attached to a mitral valve to prevent blood regurgitation through the mitral valve, portions of the mitral valve near the valve repair device may include openings in the mitral valve tissue that extends around the valve repair device. The extended portions 4212a are configured to fill or plug the openings adjacent to the valve repair device 602. In the illustrated embodiment, the length L of the extended portions 4212a is greater than the width W of the extended portions.
[00175] [00175] Referring to Figure 42B, another exemplary embodiment of a spacer element 3800 includes a main body 4210b that extends between the retaining members 608 and the extended portions 4212b that extend from the main body 4210b. In the illustrated embodiment, the extended portions 4212b have a semicircular shape. The extended portions 4212b are configured to fill the openings adjacent to the valve repair device 602 due to the mitral valve tissue that extends around the valve repair device.
[00176] [00176] Referring to Figure 42C, another exemplary embodiment of a spacer element 3800 includes a main base assembly 4210c that extends between retaining members 608, first extension portions 4212c that extend from main body 4210c, and second extension portions 4214c extending from the first 4212c extension portions. In the illustrated embodiment, the first extended portions 4212c have a semicircular shape, and the second extended portions 4214c have a length L that is greater than its width W. The extended portions 4212b are configured to fill the openings adjacent to the repair device. valve 602 due to mitral valve tissue that extends around the valve repair device.
[00177] [00177] Referring to Figures 41A-41D, another exemplary embodiment of a valve repair device 602 has a spacer element 3800 attached to the retaining members 608a, 608b of the valve repair device. Spacer element 3800 includes a first portion 4102 attached to a retaining member 608a and a second portion 4104 attached to the other retaining member 608b. Referring to Figure 41C, valve repair device 602 is shown in the closed position. When valve repair device 602 is in the closed position, the first portion 4102 of spacer element 3800 and the second portion 4104 of spacer element 3800 mate with each other and surround shaft 603 (as shown in Figure 41B). Referring to Figure 41D, the valve repair device 602 is shown in the open position, the first portion 4102 of the spacer element 3800 moves with the retaining member 608a, and the second portion 4104 of the spacer element 3800 moves with the retaining member 608b . A spacer element 3800 having multiple portions 4102, 4104 allows the retaining members 608a, 608b to be moved to adjust the width of the opening between the blades 606 and the retaining members, which is advantageous in securing the valve repair device 602 in valve tissue 820. Referring to Figure 41B, spacer element 3800 extends beyond the outer edges 4001 of retaining members 3800 to provide additional surface area to fill space 3002 (Figures 38-39) of a mitral valve 301 Valve repair device 602 can include any other features for a valve repair device discussed in the present application, and valve repair device 602 can be positioned to couple valve fabric 820 as part of any repair system. valve valve (for example, any valve repair system described in this application).
[00178] [00178] Referring to Figures 43A-43C, the spacer element 3800 shown in Figures 41A-41D can take a variety of different shapes. Referring to Figure 43A, an exemplary embodiment of a spacer element 3800 in the closed position includes a main body 4310a that extends between the retaining members 608 and beyond the edges 4201 of the retaining members, and extended portions 4312a that extend from the main body 4310a. The extended portions 4312a allow portions of the space 3002 (Figures 38-39) of the mitral valve between the anterior follicle 3003 and posterior follicle 3004 and adjacent to valve repair device 602 to be filled when the valve repair device is in a position closed. That is, when a valve repair device 602 is attached to a mitral valve to prevent blood regurgitation through the mitral valve, the portions of the mitral valve near the valve repair device may include openings in the mitral valve tissue that extends around the valve repair device. The extended portions 4312a are configured to fill the openings adjacent to the valve repair device 602. In the illustrated embodiment, the length L of the extended portions 4312a is greater than the width W of the extended portions.
[00179] [00179] Referring to Figure 43B, another exemplary embodiment of a spacer element 3800 in the closed position includes a main body 4310b that extends between the retaining members 608 and extended portions 4312b that extend from the main body 4310b. In the illustrated embodiment, the extended portions 4312b are semicircular in shape. The extended portions 4312b are configured to fill the openings adjacent to the valve repair device 602 due to the mitral valve tissue that extends around the valve repair device.
[00180] [00180] Referring to Figure 43C, another exemplary embodiment of a spacer element 3800 includes a main base assembly 4310c that extends between retaining members 608, first extension portions 4312c that extend from main body 4310c, and second extension portions 4314c extending from the first 4312c extension portions. In the illustrated embodiment, the first extended portions 4312c have a semicircular shape, and the second extended portions 4314c have a length L that is greater than their width W. The extended portions 4312b are configured to fill the openings adjacent to the valve repair device. 602 due to the mitral valve tissue that extends around the valve repair device.
[00181] [00181] Referring to Figures 44A-44B, in certain embodiments, an expansion spacer element 3800 is integral with the valve repair device 602. The expansion spacer element 3800 is configured to expand as paddles 606 close (as shown in Figure 44B). Referring to Figure 44A, valve repair device 602 is in an open position so that valve tissue can be received within opening 614 between expansion spacer element 3800 and blades 606. Referring to Figure 44B, the device valve repair kit 602 is in the closed position, in which the paddles 606 and the expansion spacer element 3800 are coupled to secure the valve repair device to the valve fabric. When the spacer elements 3800 and the paddles 606 are coupled, the spacer element 3800 expands to provide a larger surface area to close a space 3002 (Figure 38) between the anterior follicle 3003 and posterior follicle 3004 of a mitral valve 3001. In the modality illustrated, valve repair device 602 takes the form of valve repair device 602 in Figures 35A-35B. However, any valve repair device 602 described in the present application can include an expansion spacer element
[00182] [00182] Referring to Figures 45A-46D, in certain situations, the valve repair device 602 needs to 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 rearranged (to a rescue position) so that the valve repair device will be easier to remove from the patient without disturbing any valve tissue from the heart of the patient. patient. Referring to Figures 45A-45C, base assembly 604 of an exemplary embodiment of a valve repair device 602 includes a first connection 4521 extending from point A to point B, a second connection 4522 extending from point A to point C, a third connection 4523 that extends from point B to point D, a fourth connection 4524 that extends from point C to point E, and a fifth connection 4525 that extends from point D to point E. A coupler
[00183] [00183] In order to move valve repair device 602 from the closed position (as shown in Figure 45A) to the rescue position (as shown in Figure 45C), coupler 605 is moved along axis 603 in the Y direction , which moves pivot point A to the first 4521 connection and the second 4522 connection to a new position. Referring to Figure 45A, valve repair device 602 is shown in a closed position with an angle α between the blade 606 and the shaft 603. The angle α can be, for example, between approximately 0 degrees and approximately 45 degrees, such such as between approximately 5 degrees and approximately 40 degrees, such as between approximately 15 degrees and approximately 30 degrees, such as between approximately 20 degrees and approximately 25 degrees. Referring to Figure 45B, valve repair device 602 is moved to the open position by moving coupler 605 along axis 603 in the Y direction. Moving coupler 605 in the Y direction causes the first connection 4521 to articulate around the point A so that the first connection 4521 and the second connection 4522 move outward in the Z direction, which causes the blades 606a, 606b to move downward and outward in the H direction. Referring to Figure 45C, the repair device valve 602 is moved to the rescue position by continuing to move coupler 605 along axis 603 in the Y direction. Continued movement of coupler 605 in the Y direction causes the first port 4521 and the second port 4522 to move inwardly into the direction M, which causes the blades 606a, 606b to move downward and inward in the N direction. Still referring to Figure 45C, in the rescue position, valve repair device 602 has an angle β between the blades 606 and the 603 axis. The angle β can be, for example, greater than or equal to 120 degrees, such as greater than or equal to 130 degrees, such as greater than or equal to 140 degrees, such as greater than or equal to 150 degrees, such as greater than or equal to 160 degrees.
[00184] [00184] Referring to Figures 46A-46D, the base assembly 604 of another exemplary embodiment of a valve repair device 602 includes a first connection 4621 extending from point A to point B, a second connection 4622 extending from point A to point C, a third connection 4623 that extends from point B to point D, a fourth connection 4624 that extends from point C to point E, a fifth connection 4625 that extends from point D to point F, and a sixth connection 4626 extending from point E to point F. A coupler 605 is movably attached to an axis 603, and the axis 603 is attached to the fifth connection 4625 and the sixth connection 4626 to point F. The first connection 4621 and the second connection 4622 are hinged to the coupler 605 at point A, so that the movement of coupler 605 along axis 603 moves the location of point A and, consequently, moves the first connection 4621 and the second connection 4622. The fifth connection 4625 and the sixth connection 4626 are attached to the axis at point F, so the movement of the axis moves the location of point F and, consequently, moves the fifth connection 4625 and the sixth connection 4626. A locking element 4631 is configured to selectively lock the fifth connection 4625 and the sixth connection 4626 on the axis at point F, so that the fifth connection 4625 and the sixth connection 4626 cannot articulate with respect to axis 603 when the locking element 4631 is in the locked position. However, when the locking element 4631 is in the unlocked position, the fifth connection 4625 and the sixth connection 4626 can pivot around axis 603 when the axis moves the location of point F (as described above). The first connection 4621 and the third connection 4623 are attached to each other at point B, and the second connection 4622 and the fourth connection 4624 are attached to each other at point C. A paddle 606a is attached to the first connection 4621 so that the movement of the first connection 4621 causes the blade 606a to move, and the other blade 606b is attached to the second connection 4622 so that the movement of the second connection 4622 causes the blade 606b to move.
[00185] [00185] In order to move the valve repair device 602 from the closed position (as shown in Figure 46A) to a rescue position (as shown in Figure 46C), the locking element 4631 is held in a locked position, and coupler 605 is moved along axis 603 in the Y direction, which moves pivot point A to first connection 4621 and second connection 4622 to a new position. In order to move the valve repair device 602 from the relief position to the collapsed recovery position (as shown in Figure 46D), the locking element 4631 is moved to an unlocked position, and the shaft 603 is moved in the D direction. , which moves the pivot point F to the fifth connection 4625 and the sixth connection 4626 to a new position, which causes the fifth connection 4625 and the sixth connection 4626 to articulate around the axis 603.
[00186] [00186] Referring to Figure 46A, the valve repair device
[00187] [00187] Referring to Figure 46C, valve repair device 602 is moved to the rescue position by continuing to move coupler 605 along axis 603 in the Y direction. Continued movement of coupler 605 in the Y direction causes the first connection 4621 and second connection 4622 move inward in the M direction, which causes the blades 606a, 606b to move downward and inward in the N direction. Still referring to Figure 45C, in the rescue position, the repair device of valve 602 has an angle β between the blades 606 and the shaft 603. The angle β can be, for example, greater than or equal to 120 degrees, such as greater than or equal to 130 degrees, such as greater than or equal to 140 degrees, such as greater than or equal to 150 degrees, such as greater than or equal to 160 degrees. Locking element 4631 is held in the locked position when valve repair device 602 is moved from the open position (as shown in Figure 46B) to the rescue position (as shown in Figure 46C).
[00188] [00188] Referring to Figure 46D, the valve repair device 602 is moved from the rescue position to the collapsed position by moving the locking element 4631 to an unlocked position and moving the shaft 603 in the D direction, which causes the fifth connection 4625 and sixth connection 4626 pivot around connection point F and move upward in a direction J, which causes the third connection 4623 and the fourth connection 4624 to move inward and downward in direction Q, the which causes the blades 606a, 606b to move downwards and inwards in the Q direction. Still referring to Figure 46D, in the collapsed rescue position, the valve repair device 602 has an angle µ between the blades 606 and the shaft 603 The angle µ can be, for example, greater than or equal to 120 degrees, such as greater than or equal to 130 degrees, such as greater than or equal to 140 degrees, such as greater than or equal to 150 degrees, such as greater than or equal to 160 degrees, such as greater than or equal to 170 degrees.
[00189] [00189] It is advantageous to have a valve repair device that includes features that ensure that the valve repair device remains in a closed position after the valve repair device is attached to a patient's native valve. In other words, it is advantageous to have a valve repair device that includes features to prevent the valve repair device from becoming detached from a patient's native valve after placing the valve repair device inside the patient, which could cause problems (for example, blood regurgitation through the mitral valve). Examples of additional features to prevent a valve repair device from becoming detached from the native valve are shown in Figures 47A-49.
[00190] [00190] Referring to Figures 47A-47B, an exemplary embodiment of a valve repair device 602 includes an engaging member
[00191] [00191] Referring to Figure 47A, valve repair device 602 is in an open position with valve tissue 820 disposed within opening 614 between paddles 606 and retaining members 608. Referring to Figure 47B, the valve repair 602 is moved to the closed position so that valve tissue 820 is trapped between paddles 606 and retaining members 608 of the valve repair device. The valve repair device 602 can be moved to the closed position by any suitable method, such as, for example, any method described in the present application. When the valve repair device 602 is moved to the closed position, the engaging member 4701 punctures the valve fabric 820 and the holding member 608 to secure the paddle to the holding member. Coupling member 4701 can take any suitable shape that is capable of securing paddles 606 to retaining members 608, such as, for example, metals, plastics, etc.
[00192] [00192] Referring to Figure 48, another exemplary embodiment of a valve repair system 600 includes an application device 601 and a valve repair device 602, in which the application device is configured to apply the valve repair device on a patient's native valve, and in which the valve repair device is configured to attach to the follicles of a native valve to repair the patient's native valve. Application device 601 can take any suitable shape that is capable of applying valve repair device 602 to a patient's native valve, such as, for example, any shape described in the present application. The valve repair device 602 includes a base assembly 604, a pair of paddles 606, and a pair of retaining members 608. The base assembly 604 of the valve repair device 602 has a shaft 603 and a coupler 605 configured to move along the axis. The coupler 605 is mechanically connected to the blades so that the movement of the coupler along the axis 603 causes the blades to move between an open position and a closed position. In the closed position, paddles 606 and retaining members 608 couple the valve fabric and each other to secure the valve repair device 602 to the valve fabric. Valve repair device 602 also includes a tensioning member 4807 (e.g., a spring) configured to tension coupler 605 onto the shaft so that valve repair device 602 is in a closed position.
[00193] [00193] In certain embodiments, valve repair system 600 includes a placement shaft 613 that is removably secured to shaft 603 of base assembly 604 of valve repair device 602. After valve repair device 602 is attached in the valve fabric, the placement shaft 613 is removed from shaft 603 to remove valve repair device 602 from valve repair system 600, so that valve repair device 602 can remain trapped in the valve fabric, and the delivery device 601 can be removed from a patient's body. After the valve repair device 602 is attached to the valve tissue, and the valve repair system 600 is removed from the patient's body, tension member 4807 holds the valve repair device in a closed position to prevent detachment valve repair device of the valve tissue. Valve repair device 602 can include any other features for a valve repair device discussed in the present application, and valve repair device 602 can be positioned to couple valve tissue 820 as part of any valve repair system. suitable valve (for example, any valve repair system described in this application).
[00194] [00194] Referring to Figure 49, another exemplary embodiment of a valve repair system 600 includes an application device 601 and a valve repair device 602, in which the application device is configured to apply the valve repair device to a patient's native valve, and in which the valve repair device is configured to secure the follicles of a native valve to repair the patient's native valve. Application device 601 can take any suitable shape that is capable of applying valve repair device 602 to a patient's native valve, such as, for example, any shape described in the present application. The valve repair device 602 includes a base assembly 604, a pair of paddles 606, and a pair of retaining members 608. The base assembly 604 of the valve repair device 602 has a shaft 603 and a coupler 605 configured to move along the axis. In the illustrated embodiment, shaft 603 includes a threaded portion 4902, and coupler 605 is configured to move along threaded portion 4902 of the shaft. That is, turning shaft 603 causes coupler 605 to move up and down shaft 603. Coupler 605 is mechanically connected to the blades so that the movement of the coupler along shaft 603 causes the blades to move between an open position and a closed position. In the closed position, paddles 606 and retaining members 608 engage the valve fabric and each other to secure valve repair device 602 to the valve fabric.
[00195] [00195] In certain embodiments, valve repair system 600 includes a locating shaft 613 which is removably attached to shaft 603 of base assembly 604 of valve repair device 602. After valve repair device 602 is attached in the valve fabric, the placement shaft 613 is removed from shaft 603 to remove valve repair device 602 from valve repair system 600, so that valve repair device 602 can remain trapped in the valve fabric, and the delivery device 601 can be removed from a patient's body. After the valve repair device 602 is attached to the valve tissue, and the valve repair system 600 is removed from the patient's body, the valve repair device is prevented from detaching from the valve tissue, because the coupler can only be moved by rotating shaft 603. Valve repair device 602 can include any other features for a valve repair device discussed in the present application, and valve repair device 602 can be positioned to couple valve fabric 820 as part of any suitable valve repair system (for example, any valve repair system described in this application).
[00196] [00196] Referring to Figures 50-54, the modalities of valve repair systems 600 include an application device 601 and a valve repair device 602, in which the application device is configured to apply the valve repair device on a patient's native valve, and in which the valve repair device is configured to attach follicles to a native valve to repair the patient's native valve. Application device 601 can take any suitable shape that is capable of applying valve repair device 602 to a patient's native valve, such as, for example, any shape described in the present application. The valve repair device 602 is similar to the valve repair devices described above and includes a base assembly 604, a pair of paddles 606, and a pair of retaining members
[00197] [00197] Referring to Figure 50, in some embodiments, the retaining members 608 are attached to the blades 606. In the example illustrated by Figure 50, the retaining members 608 include a fixing portion 5010, a hinge or flexing portion 5012, and a retaining or barbed portion 5014. The retaining portion 5010 can take any shape that allows the retaining member to be attached to the blade 606. The hinge or flexing portion 5012 can take a variety of different shapes. For example, the hinge or flexing portion may be configured to tension the retaining or barbed portion 5014 towards the fixing portion 5010. In an exemplary embodiment, the hinge or flexing portion 5012 tensions the retaining or barbed portion 5014 to a fully closed position where the holding or barbed portion engages the holding portion 5010 and / or the blade 606. When the valve fabric is positioned between the blade 606 and the holding portion 5014, the hinge or flexing portion tensions the retaining portion 5014 for securing the valve fabric between the retaining or barbed portion 5014 and the shovel. The retaining member 608 shown in Figure 50 moves with the paddle 606. The hinge or flexing portion 5012 allows the retaining portion 5014 to move in the direction indicated by the arrows 5020 and may allow the retaining portion to be pulled in the direction indicated by the arrows 5022.
[00198] [00198] In certain embodiments, it is advantageous that the barbed portion 609 is arranged towards an end closer to the retaining members 608 because this will provide for easier release of the retaining members 608 from the valve tissue. Referring to Figure 51, in one embodiment, the retaining members 608 comprise a single row of barbs 5102 configured to couple the valve fabric and the blades 606 to secure the valve repair device to the valve fabric. The single row of barbs 5102 makes it easy for the retaining portion 5014 to release from the valve tissue. In an alternative embodiment, retaining members 608 may comprise two or more rows of barbs 5102 arranged at one end closest to retaining members 608. In additional embodiments, barbs 5102 may be arranged at one end closest to the retaining members 608 in any other suitable configuration that provides for easier release of the retaining members 608 of a valve tissue.
[00199] [00199] In some embodiments, as shown in Figures 51A-51E, retaining member 608 is configured to place a tensioning force on the valve tissue when the valve repair device (for example, any valve repair device 602 described in the present application) is attached to the valve fabric. The retaining member 608 is connected by sliding on the blade 606, so that the retaining member 608 can be moved along the blade in the X direction. For example, a retaining control mechanism 611 can be used to move the retaining member 608 along the paddle 606 in the X direction, and the retention control mechanism 611 can also be used to move the retaining member 608 between the closed position (as shown in Figure 51A) and the open position (as shown in Figure 51B ). The retention control mechanism 611 can take any form described in the present application. In certain embodiments, valve repair device 602 includes an optional tensioning member 5122 (for example, a spring) configured to hold retaining member 608 in a desired position along paddle 606 (for example, the position shown in Figures 51A and 51E). In the illustrated embodiment, the retaining member 608 includes a single row of barbs 609 at one end closest to the retaining members (for example as shown in the valve repair device 602 embodiment shown in Figure 51), however, it must be understood that the features described herein referring to Figures 51A-51E can be used with any of the valve repair device modalities described in the present application.
[00200] [00200] Referring to Figure 51A, the retaining member 608 is shown in a first position on the paddle 606 and in a closed position. Referring to Figure 51B, the retaining member 608 is shown after it has been moved in the Z direction to an open position by the retaining control mechanism 611. Referring to Figure 51C, the retaining member 608 is shown after it has been moved to the long shovel 606 in direction D for a second position. In certain embodiments, the retaining member 608 is moved along the blade in direction D by the retaining control mechanism 611 or a separate mechanism. In embodiments that include tensioning member 5122, sufficient force must be applied to the retaining member 608 to move the retaining member in the D direction, which will further cause the tensioning member to expand and create a tensioning force on retaining member 608 in direction B. Although the illustrated embodiment shows retaining member 608 being moved to an open position (as shown in Figure 51B) before retaining member 608 is moved along paddle 606 in direction D to second position (as shown in Figure 51C), it should be understood that holding member 608 can be moved in the D direction to the second position before holding member 608 is moved in the Z direction to an open position or the movements can be simultaneous. Referring to Figure 51D, the retaining member 608 is moved to a closed position in the Y direction by the retaining control mechanism 611 to secure the barbed portion 609 of the retaining member 608 to the valve fabric (not shown). In the position shown in Figure 51D, tensioning member 5122 is being held in an extended position (for example, as a result of the force applied to retaining member 608 by the retaining control mechanism (or other mechanism) to hold the second position), which means that the tensioning member 5122 is placing a tensioning force on the retention member 608 in direction B. Referring to Figure 51E, after the barbed portion 609 of the retention member 608 is attached to the fabric valve, the force that holds the retaining member 608 in the second position is released, which causes the tensioning force applied by the tensioning member 5122 to move the retaining member 608 along the blade 606 in the M direction. movement of the retaining member 608 in the M direction causes the barbed portion 609 to create a tensioning force on the valve tissue in the T direction. This tensioning force on the valve tissue allows the valve repair device 602 maintain a secure connection to the valve fabric.
[00201] [00201] In another embodiment, as shown in Figures 51F-51G, the retaining member 608 includes a barbed portion 609 and a weakened or flexed portion 5103. The barbed portion 609 is arranged on a first side 5111 of the weakened portion or flexion 5103. In the illustrated embodiment, the barbed portion 609 includes a single row of splinters, but it should be understood that any suitable splice configuration can be used, such as, for example, any configuration described in the present application. The weakened or flexed 5103 can be, for example, a cutout in the retaining member, a different material compared to the rest of the retaining member 608, or can take any other suitable shape that allows the weakened or flexed portion 5103 is weaker and / or more flexible than a remainder of retaining member 608. However, in other embodiments, the weaker and more flexible portion 5103 is omitted and connection 5107 and line 5105 described below are still capable of flexing the portion barbed wire as illustrated in Figures 51F-51H.
[00202] [00202] Referring to Figures 51F-51H, the retention control mechanism 611 includes a 5105 thread (for example, a suture) and a 5107 push / pull connection configured to receive the thread
[00203] [00203] Referring to Figure 51F, the retaining member 608 is shown in an open position with a valve tissue member 820 disposed within an opening 614 between the retaining member 608 and a paddle (not shown). The retaining member can be moved to the open position by pulling on line 5105. Referring to Figure 51G, connection 5107 and line 5105 of the retention control mechanism 611 are used to move the retaining member 608 in the X direction to the closed position and flex the portion 609 in the Y direction. The first end 5125 of line 5105 is pulled in a Y direction, so that the first side 5111 of the retaining member 608 articulates or flexes around the weakened portion 5103. This flexing does causing the barbed portion 609 to move in the U and Y direction to a flexed position. Still referring to Figure 51G, connection 5107 and line 5105 are moved so that the barbed portion 609 pierces the valve tissue 820 while the barbed portion is in the flexed position.
[00204] [00204] Referring to Figure 51H, line 5105 is released, which causes the first end 5111 of the retaining member 608 to pivot around the weakened or flexible portion 5103. This causes the barbed portion 609 to move through the fabric valve 820 in a D direction, which causes the barbed portion 609 of the valve repair device to create a tensioning force on the valve fabric 820 in direction D. After the retaining member 608 is attached to the valve fabric 820 (as shown in Figure 51H), connection 5107 and line 5105 are removed from retaining member 608.
[00205] [00205] Referring to Figure 52, in various embodiments, the retaining members 608 include a stretchable portion 5202 to allow movement in the 5204 direction. Movement in the 5204 direction allows clean decoupling of the valve tissue. In some modalities,
[00206] [00206] Referring to Figures 53A-53B, in certain embodiments, the retaining members 608 are made of a flexible material. Referring to Figure 53A, valve repair device 602 is shown in a closed position and secured to valve tissue 820. Referring to Figure 53B, retaining members 608 are shown being moved by the retaining control mechanism 611 to remove retaining members 608 of valve tissue 820. Specifically, movement of the retaining control mechanism 611 in the Y direction causes the retaining members 608 to recoil from the valve tissue in the Z direction. The flexible material of the retaining members 608 allows the retention of the retaining members 608 when removing the retaining members from the valve tissue 820. The indentation of the retaining members 608 is advantageous because this helps the retaining members to exit the valve tissue 820 without damaging the valve tissue. In certain embodiments, the flexible retaining members 608 allow the barbed portion 609 of the retaining members 608 to be removed from the valve tissue in a direction substantially opposite to the direction in which the barbs entered the valve tissue.
[00207] [00207] Referring to Figure 54, in certain embodiments, the retaining members 608 are connected to each other by a separate tensioning member 5410 (e.g., a spring) that is configured to hold the retaining members in a desired position, so that when the blades 606 are in an open position, a width W exists between the blades and the retaining members. The width W can be adjusted by coupling the retaining members 608 with the retaining control mechanism 611. That is, the movement of the retaining control mechanism 611 within the application device in the Z direction will cause the tensioning member 5410 to flex and the paddles move in an inward direction X. Decoupling the retaining members by the retaining control mechanism 611 will cause the tensioning member 5410 to move to the desired position (as shown in Figure 54). The retention control mechanism 611 can take any form suitable for controlling the retention members 608, such as, for example, any shape described in the present application. In addition, when the blades 606 are moved to the closed position, the blades will couple the retaining members 608, which will cause the tensioning member to flex and the retaining members to move in an inward direction X. The blades 608 can be moved from the open to the closed position in any suitable mode, such as, for example, any method described in the present application. Although the various devices described in this application refer to coupling and repairing the mitral valve, it should be understood that these devices can be used to repair any other native valves (for example, the tricuspid valve, the pulmonary valve, the aortic valve) or any other portion of the heart. In addition, it should be understood that various features of the various embodiments for the devices described herein can be used in combination with each other.
[00208] [00208] Although the above is a complete description of the preferred embodiments of the invention, several alternatives, modifications, and equivalents can be used. Furthermore, it will be obvious that certain other modifications may be practiced within the scope of the appended claims.

权利要求:
Claims (117)
[1]
1. Valve repair system to repair a patient's native valve during an unopened heart procedure, characterized by the fact that the valve repair system comprises: an application device that has at least one lumen; a valve repair device configured to be applied through the lumen of the delivery device, and configured to attach to a patient's native valve, the valve repair device comprising: a pair of paddles that are movable between an open position and a closed position; wherein each paddle includes a main portion and first and second side portions that are integrally formed with the main portion and extend from the main portion and are configured to bypass the shape of the native valve; wherein the pair of paddles is configured so that the first and second side portions flex away from the main portion when being attached to the patient's native valve; and a pair of retaining members that are configured to attach to a patient's native valve.
[2]
2. Valve repair system according to claim 1, characterized by the fact that it comprises a base assembly comprising: an axle; and a coupler fixed movable on the axis so that the coupler can be moved along the axis; where the pair of paddles is hinged to the coupler; where the movement of the coupler in a first direction along the axis causes the pair of blades to move to the closed position,
and the movement of the coupler in a second direction causes the pair of blades to move to the open position.
[3]
3. Valve repair system according to claim 1, characterized by the fact that each blade of the pair of blades comprises one or more flanges, and in which one or more flanges are configured to flex to put less stress on the valve native to the patient.
[4]
4. Valve repair system according to claim 1, characterized by the fact that the pair of paddles is configured to be in a compressed state when disposed within the lumen of the catheter, and in which the pair of paddles is configured to expand when being positioned from the catheter.
[5]
5. Valve repair device (602) to repair a patient's native valve, characterized by the fact that the valve repair device comprises: a pair of paddles (606) that are movable between an open position and a closed position ; wherein each paddle includes a main portion and first and second side portions that are integrally formed with the main portion and extend from the main portion and are configured to bypass the shape of the native valve; wherein the pair of paddles is configured so that the first and second side portions flex away from the main portion when being attached to the patient's native valve; and a pair of retaining members (608) that are configured to attach to a native valve.
[6]
Valve repair device according to claim 5, characterized in that it comprises a base assembly comprising: an axle; and a coupler fixed movable on the axis so that the coupler can be moved along the axis; where the pair of paddles is hinged to the coupler; wherein the movement of the coupler in a first direction along the axis causes the pair of blades to move to the closed position, and movement of the coupler in a second direction causes the pair of blades to move to the open position.
[7]
Valve repair device according to claim 5, characterized in that each blade of the pair of blades comprises one or more flanges, and in which one or more flanges are configured to flex to put less stress on the valve native to the patient.
[8]
8. Valve repair device according to claim 5, characterized in that the pair of paddles is configured to be in a compressed state when disposed within the lumen of the catheter, and in which the pair of paddles is configured to expand when being positioned from the catheter.
[9]
9. Valve repair system to repair a patient's native valve during an unopened heart procedure, characterized by the fact that the valve repair system comprises: an application device that has at least one lumen; a valve repair device configured to be applied through the lumen of the delivery device, and configured to attach to a patient's native valve, the valve repair device comprising: a first paddle and a second paddle, wherein the first paddle and second blades are movable between an open position and a closed position; and a pair of retaining members, wherein the paddles and retaining members are configured to attach 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 one another; a base comprising: a first axis; a second axis; a first movable coupler along the first axis; and a second movable coupler along the second axis; wherein the first blade is hinged to the first coupler, and the second blade is hinged to the second coupler; wherein the movement of the first coupler in a first direction along the first axis causes the first blade to move to a closed position, and movement of the first coupler along the first axis in a second direction causes the first blade to move to a closed position. the open position; wherein the movement of the second coupler in a first direction along the second axis causes the second blade to move to a closed position, and movement of the second coupler along the second axis in a second direction causes the second blade to move to a closed position. the open position.
[10]
Valve repair system according to claim 9, characterized in that the valve repair device still comprises a first lock and a second lock, in which the first and second locks are movable between a locked condition and a unlocked condition, where the first lock is configured to lock the first coupler in a stationary position on the first axis when the first lock is in the locked condition, and where the second lock is configured to lock the second coupler in a stationary position on the second axis when the second lock is in the locked condition.
[11]
11. Valve repair system according to claim 9, characterized in that the first and second blades of the valve repair device are configured to flex when being attached to the patient's native valve.
[12]
Valve repair system according to claim 9, characterized by the fact that it still comprises a retention control mechanism configured to move the retaining members.
[13]
13. Valve repair system according to claim 9, characterized in that the valve repair device still comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[14]
Valve repair system according to claim 10, characterized by the fact that the valve repair device is configured to move to a rescue position for removal of the valve repair device from the patient's body, wherein, when the valve repair device is in the rescue position, an angle between each blade and an axis of the base assembly is greater than or equal to 120 degrees.
[15]
Valve repair system according to claim 9, characterized in that each retaining member of the pair of retaining members is directly attached to a corresponding paddle of the first and second paddles.
[16]
Valve repair system according to claim 9, characterized in that each retaining member of the pair of retaining members is extensible in length to prevent tearing of the patient's native valve when the retaining members are removed from the native valve.
[17]
17. Valve repair system according to claim 9, characterized in that the pair of retaining members comprises a flexible material so that the retaining members can recede from the native valve fabric when the retaining members are detached of native valve tissue.
[18]
18. Valve repair system according to claim 9, characterized in that the retaining members are connected to each other by a tensioning member that is configured to hold the retaining members in a desired position.
[19]
19. Valve repair system to repair a patient's native valve during an unopened heart procedure, characterized by the fact that the valve repair system comprises: an application device that has at least one lumen; a valve repair device configured to be applied through the lumen of the delivery device, and configured to attach to a patient's native valve, the valve repair device comprising: a first paddle and a second paddle, wherein the first paddle and second blades are movable between an open position and a closed position; and a pair of retaining members, wherein the paddles and retaining members are configured to attach 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 one another; and a base assembly comprising: a first shaft having a first threaded portion, and a second shaft having a second threaded portion; and a first coupler fixed movable on the first axis so that the first coupler can be moved along the first threaded portion of the axis; a second coupler fixed movable on the second axis so that the second coupler can be moved along the second threaded portion of the axis; wherein the first paddle is hinged to the first coupler; wherein the second paddle is hinged to the second coupler; wherein the movement of the first coupler in a first direction along the first axis causes the first blade to move to the closed position, and the movement of the first coupler in a second direction along the first axis causes the first blade to move to the open position; wherein the movement of the second coupler in a first direction along the second axis causes the second blade to move to the closed position, and the movement of the second coupler in a second direction along the second axis causes the second blade to move to the open position.
[20]
20. Valve repair device for repairing a patient's native valve, characterized by the fact that the valve repair device comprises: a base assembly that has: an axle; and a cam 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, wherein the pair of paddles is configured to move between an open position and a closed position; and a pair of retaining members secured to the base assembly, wherein the retaining members are configured to secure to the patient's native valve; where the movement of the cam from the first position to the second position causes the pair of paddles to move from the closed position to the open position, and where the movement of the cam from the second position to the first position causes the pair of paddles to move. move from open to closed position; where the cam is fixed on the axis, and where the cam is moved between the first position and the second position by rotating the axis.
[21]
21. Valve repair device according to claim 20, characterized in that it further comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[22]
22. Valve repair device according to claim 20, characterized in that the blades are made of a mesh material.
[23]
23. Valve repair device for repairing a patient's native valve, characterized by the fact that it comprises: a base assembly that has: an axle; and a cam 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, wherein the pair of paddles is configured to move between an open position and a closed position; and a pair of retaining members secured to the base assembly, wherein the retaining members are configured to secure to the patient's native valve; in which the movement of the cam from the first position to the second position causes the pair of paddles to move from the closed position to the open position, and in which the movement of the cam from the second position to the first position causes the pair of blades to move. shovels move from open to closed position; wherein the cam is pivotally secured to the axis, and the cam is moved between the first position and the second position by rotating the cam around the axis.
[24]
24. Valve repair device according to claim 23, characterized in that it further comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[25]
25. Valve repair device according to claim 23, characterized in that the blades are made of a mesh material.
[26]
26. Valve repair device for repairing a patient's native valve, characterized by the fact that it comprises: a base assembly comprising a plurality of articulation connections and an axis, in which the articulation connections are moved by the axis; a pair of blades attached to the base assembly, where the movement of the hinge connections moves the blades between an open position and a closed position; a pair of retaining members attached to the base assembly,
wherein the paddles and retaining members are configured to attach to the patient's valve follicles; at least one spacer element that surrounds the axis and is arranged between the pair of retaining members; wherein the spacer element is made of at least one material selected from the group of materials consisting of braided mesh, fabric, biocompatible material, foam, and pericardial fabric; wherein the spacer element fills a space between the retaining members when the blades are in the closed position.
[27]
27. Valve repair device according to claim 26, characterized in that the base assembly of the valve repair device further comprises: a coupler fixed movable on the shaft so that the coupler can be moved along the shaft ; where the pair of paddles is hinged to the coupler; wherein the movement of the coupler in a first direction along the axis causes the pair of blades to move to the closed position, and movement of the coupler in a second direction causes the pair of blades to move to the open position.
[28]
28. Valve repair device according to claim 26, characterized in that the spacer element includes a first spacer member attached to a first retaining member of the pair of retaining members and a second spacer member attached to a second member of the retaining member pair.
[29]
29. Valve repair device according to claim 26, characterized in that the spacer element extends beyond one or more lateral edges of the retaining members.
[30]
Valve repair device according to claim 26, characterized in that the spacer element comprises a main portion that extends between the retaining members and extended portions that extend beyond the lateral edges of the retaining members.
[31]
31. Valve repair device according to claim 30, characterized in that the extended portions have a semicircular shape.
[32]
32. Valve repair device according to claim 26, characterized in that the spacer element is configured to fill at least a portion of a space between the patient's mitral valve follicles.
[33]
33. Valve repair system to repair a patient's native valve during an unopened heart procedure, characterized by the fact that the valve repair system comprises: an application device that has at least one lumen; a valve repair device configured to be applied through the lumen of the delivery device, and configured to attach to a patient's native valve, the valve repair device comprising: a base assembly comprising a plurality of hinge connections and an axis, where the articulation connections are moved by the axis; a pair of blades attached to the base assembly, where the movement of the hinge connections moves the blades between an open position and a closed position; a pair of retaining members attached to the base assembly, where the paddles and retaining members are configured to attach to the patient's valve follicles; at least one spacer element surrounding the axis and be arranged between the pair of retaining members; wherein the spacer element is made of at least one material selected from the group of materials consisting of braided mesh, fabric, biocompatible material, foam, and pericardial fabric; wherein the spacer element fills a space between the retaining members when the blades are in the closed position.
[34]
34. Valve repair system according to claim 33, characterized in that the base assembly of the valve repair device still comprises: a coupler fixed movable on the shaft so that the coupler can be moved along the shaft ; where the pair of paddles is hinged to the coupler; wherein the movement of the coupler in a first direction along the axis causes the pair of blades to move to the closed position, and movement of the coupler in a second direction causes the pair of blades to move to the open position.
[35]
35. Valve repair system according to claim 34, characterized in that the spacer element includes a first spacer member attached to a first retaining member of the pair of retaining members and a second spacer member attached to the second retaining member retention of the pair of retaining members.
[36]
36. Valve repair system according to claim 33, characterized in that the spacer element extends beyond one or more lateral edges of the retaining members.
[37]
37. Valve repair system according to claim 33, characterized in that the spacer element comprises a main portion that extends between the retaining members and extended portions that extend beyond the lateral edges of the retaining members.
[38]
38. Valve repair system according to claim 37, characterized in that the extended portions are semicircular in shape.
[39]
39. Valve repair device according to claim 33, characterized in that the spacer element is configured to fill at least a portion of a space between the patient's mitral valve follicles.
[40]
40. Valve repair device for repairing a patient's native valve, characterized by the fact that the valve repair device comprises: a base assembly comprising a shaft and a coupler coupled to the shaft so that the coupler can be moved along the axis; a pair of paddles attached to the base assembly, where the paddles are movable between an open position, a closed position and a rescue position; and a pair of retaining members secured to the base assembly, where the paddles and retaining members are configured to secure to the patient's native valve; wherein the movement of the coupler along the axis causes the pair of blades to move between the open position, the closed position, and the rescue position; where, when the blades are in the rescue position, a rescue angle between each blade of the pair of blades and the shaft is greater than or equal to 120 degrees.
[41]
41. Valve repair device according to claim 40, characterized by the fact that the rescue angle is greater than or equal to 130 degrees.
[42]
42. Valve repair device according to claim 40, characterized in that the rescue angle is greater than or equal to 160 degrees.
[43]
43. Valve repair device according to claim 40, characterized by the fact that the blades are movable between the open position, the closed position, the rescue position, and a collapsed position, and in which, when the blades are in the collapsed position, a collapsed angle between each paddle of the pair of paddles and the shaft is greater than or equal to 140 degrees.
[44]
44. Valve repair device according to claim 43, characterized in that the collapsed angle is greater than or equal to 170 degrees.
[45]
45. Valve repair device according to claim 43, characterized in that the movement of the shaft causes the blades to move to the collapsed position.
[46]
46. Valve repair device according to claim 43, characterized in that it further comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[47]
47. Valve repair system to repair a patient's native valve during an unopened heart procedure, characterized by the fact that the valve repair system comprises: an application device that has at least one lumen; a valve repair device configured to be applied through the lumen of the delivery device, and configured to attach to a patient's native valve, the valve repair device comprising: a base assembly comprising a shaft and a coupled coupler on the axis so that the coupler can be moved along the axis; a pair of paddles attached to the base assembly, where the paddles are movable between an open position, a closed position and a rescue position; and a pair of retaining members secured to the base assembly, where the paddles and retaining members are configured to secure to the patient's native valve; wherein the movement of the coupler along the axis causes the pair of blades to move between the open position, the closed position, and the rescue position; where, when the blades are in the rescue position, a rescue angle between each blade of the pair of blades and the shaft is greater than or equal to 120 degrees.
[48]
48. Valve repair system according to claim 47, characterized by the fact that the rescue angle is greater than or equal to 160 degrees.
[49]
49. Valve repair system according to claim 47, characterized by the fact that the blades are movable between the open position, the closed position, the rescue position, and a collapsed position, and in which, when the blades are in the collapsed position, a collapsed angle between each paddle of the pair of paddles and the shaft is greater than or equal to 140 degrees.
[50]
50. Valve repair system according to claim 49, characterized in that the collapsed angle is greater than or equal to 170 degrees.
[51]
51. Valve repair system according to claim 47, characterized in that the movement of the shaft causes the blades to move to the collapsed position.
[52]
52. Valve repair system according to claim 47, characterized in that it further comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[53]
53. Valve repair device for repairing a patient's native valve, characterized by the fact that the valve repair device comprises: a pair of blades each comprising a hitch member, with the blades being movable between one open position and a closed position; a pair of retaining members, where the paddles and retaining members are configured to attach to the patient's native valve; wherein, when the blades are in the closed position, the engaging member of each of the blades secures each of the blades to a corresponding holding member of the holding member pair.
[54]
54. Valve repair device according to claim 53, characterized in that it still comprises a base assembly comprising: an axle; and a coupler fixed movable on the axis so that the coupler can be moved along the axis; where the pair of paddles is hinged to the coupler; wherein the movement of the coupler in a first direction along the axis causes the pair of blades to move to the closed position, and movement of the coupler in a second direction causes the pair of blades to move to the open position.
[55]
55. Valve repair system according to claim 54, characterized by the fact that it still comprises a movable lock between a locked condition and an unlocked condition, in which the lock is configured to lock the coupler in a stationary position on the shaft when the lock is in the locked condition.
[56]
56. Valve repair device according to claim 54, characterized in that it further comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[57]
57. Valve repair device according to claim 54, characterized in that the retaining members are connected to each other by a tensioning member that is configured to hold the retaining members in a desired position.
[58]
58. Valve repair device for repairing a patient's native valve, characterized by the fact that the valve repair device comprises: a pair of blades, in which the blades are movable between an open position and a closed position; a pair of retaining members, where each retaining member of the retaining member pair is directly attached to a corresponding paddle of the pair of paddles, and where the paddles and retaining members are configured to attach 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.
[59]
59. Valve repair device according to claim 58, characterized in that it also comprises a base assembly comprising: an axle; and a coupler fixed movable on the axis so that the coupler can be moved along the axis;
where the pair of paddles is hinged to the coupler; wherein the movement of the coupler in a first direction along the axis causes the pair of blades to move to the closed position, and movement of the coupler in a second direction causes the pair of blades to move to the open position.
[60]
60. Valve repair system according to claim 59, characterized in that the retaining members comprise a barbed portion for attaching the retaining members to a patient's native valve.
[61]
61. Valve repair device according to claim 60, characterized in that the retaining portions comprise a barbed portion for attaching the retaining members to a patient's native valve, and in which the barbed portion of each of the Retention members have only the single row of splinters.
[62]
62. Valve repair device according to claim 58, characterized in that the retaining members each comprise only a single row of splinters.
[63]
63. Valve repair device according to claim 62, characterized in that it further comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[64]
64. Valve repair device according to claim 58, characterized in that each retaining member of the pair of retaining members is extensible in length to prevent tearing of the patient's native valve when the retaining members are removed from the native valve.
[65]
65. Valve repair device according to claim 64, characterized in that it further comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[66]
66. Valve repair device according to claim 65, characterized in that the retaining members comprise a barbed portion for attaching the retaining members to a patient's native valve, and in which the barbed portion of each of the Retention members have only a single row of splinters.
[67]
67. Valve repair device according to claim 65, characterized in that the pair of retaining members comprises a flexible material so that the retaining members can recede from the native valve fabric when the retaining members are detached of native valve tissue.
[68]
68. Valve repair device for repairing a patient's native valve, characterized by the fact that the valve repair device comprises: a pair of blades, in which the blades are movable between an open position and a closed position; a pair of retaining members, where each retaining member of the retaining member pair is directly attached to a corresponding paddle of the pair of paddles, and where the paddles and retaining members are configured to attach to the patient's native valve ; wherein the retaining members each comprise only a single row of splinters.
[69]
69. Valve repair device according to claim 68, characterized in that it still comprises a base assembly comprising: an axle; and a coupler fixed movable on the axis so that the coupler can be moved along the axis; where the pair of paddles is hinged to the coupler; wherein the movement of the coupler in a first direction along the axis causes the pair of blades to move to the closed position, and movement of the coupler in a second direction causes the pair of blades to move to the open position.
[70]
70. Valve repair device according to claim 68, characterized in that each retaining member of the pair of retaining members is extensible in length to prevent tearing of the patient's native valve when the retaining members are removed from the native valve.
[71]
71. Valve repair device according to claim 70, characterized in that the pair of retaining members comprises a flexible material so that the retaining members can recede from the native valve fabric when the retaining members are detached of native valve tissue.
[72]
72. Valve repair device for repairing a patient's native valve, characterized by the fact that the valve repair device comprises: a pair of blades, in which the blades are movable between an open position and a closed position; a pair of retaining members, where each retaining member of the retaining member pair is directly attached to a corresponding paddle of the pair of paddles, and where the paddles and retaining members are configured to attach to the patient's native valve ; wherein each retaining member of the retaining member pair is extensible in length to prevent tearing of the patient's native valve when the retaining members are removed from the native valve.
[73]
73. Valve repair device according to claim 72, characterized by the fact that it still comprises a base assembly comprising: an axle; and a coupler fixed movable on the axis so that the coupler can be moved along the axis; where the pair of paddles is hinged to the coupler; wherein the movement of the coupler in a first direction along the axis causes the pair of blades to move to the closed position, and movement of the coupler in a second direction causes the pair of blades to move to the open position.
[74]
74. Valve repair system according to claim 72, characterized in that the retaining members comprise a barbed portion for attaching the retaining members to a patient's native valve.
[75]
75. Valve repair device according to claim 72, characterized in that the retaining members each comprise only a single row of splinters.
[76]
76. Valve repair device according to claim 72, characterized in that it further comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[77]
77. Valve repair device according to claim 72, characterized in that the pair of retaining members comprises a flexible material so that the retaining members can recede from the native valve fabric when the retaining members are detached of native valve tissue.
[78]
78. Valve repair device for repairing a patient's native valve, characterized by the fact that the valve repair device comprises:
a pair of paddles, where the paddles are movable between an open position and a closed position; a pair of retaining members each having a retaining portion and a retaining portion, wherein the retaining portion of each retaining member of the retaining member pair is directly attached to a corresponding paddle of the pair of paddles, and that the paddles and retaining portions of the retaining members are configured to attach to the patient's native valve.
[79]
79. Valve repair device according to claim 78, characterized in that it still comprises a base assembly comprising: an axle; and a coupler fixed movable on the axis so that the coupler can be moved along the axis; where the pair of paddles is hinged to the coupler; wherein the movement of the coupler in a first direction along the axis causes the pair of blades to move to the closed position, and movement of the coupler in a second direction causes the pair of blades to move to the open position.
[80]
80. Valve repair device according to claim 79, characterized in that the retaining portions each have only a single row of splinters.
[81]
81. Valve repair device according to claim 79, characterized in that it further comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[82]
82. Valve repair device according to claim 70, characterized in that each retaining member of the pair of retaining members is extensible in length to prevent tearing of the patient's native valve when the retaining members are removed from the native valve.
[83]
83. Valve repair device according to claim 82, characterized in that it further comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[84]
84. Valve repair device according to claim 82, characterized in that the pair of retaining members comprises a flexible material so that the retaining members can recede from the native valve fabric when the retaining members are detached of native valve tissue.
[85]
85. Valve repair system to repair a patient's native valve during an unopened heart procedure, characterized by the fact that the valve repair system comprises: an application device that has at least one lumen; a valve repair device configured to be applied through the lumen of the delivery device, and configured to attach to a patient's native valve, the valve repair device comprising: only a pair of paddles that are movable between an open position and a closed position; and at least four retaining members each having a barbed portion, wherein the blades and at least four retaining members are configured to attach to the patient's native valve; where the four retaining members are arranged between the pair of paddles, where the four retaining members are arranged between the pair of paddles of a retention control mechanism configured to independently move each of the at least four retaining members, so that each holding member can be moved by the holding control mechanism without moving the remaining three holding members.
[86]
86. Valve repair system according to claim 85, characterized in that the at least four retaining members comprise a first retaining member, a second retaining member, a third retaining member, and a fourth retaining member. retention, where the first and second retaining members are configured to interact with a first paddle of the pair of paddles to attach to the patient's native valve, and where the third retaining member and the fourth retaining member are configured to interact with a second paddle of the pair of paddles to attach to a patient's native valve.
[87]
87. Valve repair system according to claim 86, characterized in that the retention control mechanism comprises a first retention control configured to move the first retaining member, a second retention control configured to move the second holding member, a third holding control configured to move the third holding member, and a fourth holding control configured to move the fourth holding member.
[88]
88. Valve repair system according to claim 87, characterized in that the first retaining control member comprises a first wire that is removably attached to the first retaining member, wherein the second retaining control member comprises a second removable attached wire on the second retaining member, wherein the third retaining control member comprises a third removable attached wire on the third retaining member, and the fourth retaining control member comprises a fourth removable attached wire in the fourth retaining member.
[89]
89. Valve repair system according to claim 85, characterized by the fact that it still comprises a base assembly comprising: an axle; and a coupler fixed movable on the axis so that the coupler can be moved along the axis; where the pair of paddles is hinged to the coupler; wherein the movement of the coupler in a first direction along the axis causes the pair of blades to move to the closed position, and movement of the coupler in a second direction causes the pair of blades to move to the open position.
[90]
90. Valve repair system according to claim 89, characterized in that it still comprises a placement shaft that is removably attached to the shaft of the valve repair device base assembly.
[91]
91. Valve repair system according to claim 89, characterized in that the valve repair device still comprises a movable lock between a locked condition and an unlocked condition, in which the lock is configured to lock the coupler in a stationary position on the shaft when the lock is in the locked condition.
[92]
92. Valve repair system according to claim 85, characterized in that each of the at least four retaining members comprises a barbed portion for attaching the at least four retaining members to a patient's native valve.
[93]
93. Valve repair system according to claim 85, characterized in that it still comprises a paddle control mechanism configured to move the paddles between the open position and the closed position.
[94]
94. Valve repair system according to claim 85, characterized in that the valve repair device still comprises a spacer element configured to close a space in the patient's native valve when the valve repair device is attached to the native valve.
[95]
95. Valve repair system according to claim 85, characterized in that the blades comprise an engaging member for securing the blades to at least one corresponding holding member of the at least four holding members when the blades are in the closed position.
[96]
96. Valve repair system according to claim 85, characterized in that the valve repair device still comprises a tensioning member to hold the blades in a closed position when the valve repair device is removed from the system valve repair.
[97]
97. Valve repair system according to claim 85, characterized in that each of the at least four retaining members comprises a barbed portion for attaching the at least four retaining members to a patient's native valve, and in that the barbed portion of each of the at least four retaining members has only a single row of splinters.
[98]
98. Valve repair system according to claim 85, characterized in that each of the at least four retaining members is extensible in length to prevent tearing of the patient's native valve when the first and second retaining members are removed from the native valve.
[99]
99. Valve repair device according to claim 85, characterized in that the retention control mechanism comprises a plurality of catheters.
[100]
100. Valve repair device according to claim 85, characterized in that the retention control mechanism comprises a plurality of wires, in which each of the plurality of wires comprises a loop configured to couple at least one of the hairs least four retaining members.
[101]
101. Valve repair system according to claim 85, characterized in that each of the at least four retaining members comprises a flexible material so that each of the at least four retaining members can recede from the valve tissue native when at least four retaining members are detached from the native valve tissue.
[102]
102. Valve repair system according to claim 85, characterized in that each of the at least four retaining members has a barbed portion.
[103]
103. Valve repair system according to claim 85, characterized in that each retaining member can be moved by the retaining control mechanism without moving the remaining three retaining members, so that each retaining member can be moved by the retention control mechanism without moving the remaining three retaining members.
[104]
104. Valve repair system to repair a patient's native valve during an unopened heart procedure, characterized by the fact that the valve repair system comprises: an application device that has at least one lumen; a valve repair device configured to be applied through the lumen of the delivery device, and configured to attach to a patient's native valve, the valve repair device comprising: only a pair of paddles that are movable between an open position and a closed position; and at least four retaining members each having a barbed portion each, wherein the blades and at least four retaining members are configured to attach to the patient's native valve; where the four retaining members are disposed between the pair of paddles, where the four retaining members are disposed between the pair of paddles, a retention control mechanism configured to independently move each of the at least four retaining members, so that each holding member can be moved by the holding control mechanism without moving the remaining three holding members, so that each holding member can be moved by the holding control mechanism without moving the remaining three holding members.
[105]
105. Valve repair device for repairing a patient's native valve, characterized by the fact that the valve repair device comprises: a pair of paddles that are movable between an open position and a closed position; a pair of retaining members each having a barbed portion for attaching the retaining member to the patient's native valve; wherein each retaining member of the retaining member pair is slidably secured to a corresponding paddle of the pair of paddles; wherein each retaining member is moved in a first direction along the blade before the barbed portion of the retaining member pierces the patient's native valve; and wherein each retaining member is moved in a direction along the blade substantially opposite the first direction after the barbed portion pierces the patient's native valve so that the retaining members create a tensioning force on the patient's native valve.
[106]
106. Valve repair system to repair a patient's native valve, characterized by the fact that the valve system comprises: an application device; a valve repair device comprising: a paddle that is movable between an open position and a closed position; a retaining member that has a weakened portion and a barbed portion; wherein the barbed portion is configured to secure the retaining member to the valve tissue of the patient's native valve; and a retention control mechanism configured to move the retention member between an open position and a closed position, the retention control mechanism comprising a removable, attached suture to the retention member at a first connection point and an impulse member configured to couple the retaining member to a second connection point; wherein the weakened portion is between the first and second connection points; wherein the driving member is configured to push on the retaining member and the suture is configured to pull on the retaining member to flex the weakened portion and articulate the barbed portion; wherein the driving member comprises at least one of a catheter, a hypotube, and a wire that has a loop.
[107]
107. Valve repair system according to claim 106, characterized in that the thickness of the weakened portion is less than that of other portions of the retaining members.
[108]
108. Valve repair system according to claim 106, characterized in that the barbed portion comprises a single row of barbs.
[109]
109. Valve repair system to repair a patient's native valve, characterized by the fact that the valve repair system comprises: an application device; a valve repair device comprising: a paddle that is movable between an open position and a closed position; a retaining member that has a weakened portion and a barbed portion; wherein the barbed portion is configured to attach the retaining member to the valve tissue of the patient's native valve; and a retention control mechanism configured to move the retention member between an open position and a closed position, the retention control mechanism comprising a removable attached suture to the retention member at a first connection point and a configured impulse member. to couple the retaining member to a second connection point; wherein the weakened portion is between the first and second connection points;
wherein the pushing member is configured to push on the retaining member and the suture is configured to pull on the retaining member to flex the weakened portion and articulate the barbed portion; where the suture extends from the delivery device, the suture connects to the retaining member at the first connection point, the suture connects to the retaining member at the second connection point, and where the driving member is arranged on the suture between the application device and the second connection point.
[110]
110. Valve repair system according to claim 109, characterized in that the thickness of the weakened portion is less than that of other portions of the retaining members.
[111]
111. Valve repair system according to claim 109, characterized in that the barbed portion comprises a single row of barbs.
[112]
112. Valve repair system according to claim 109, characterized in that the thrust member of the retention control mechanism comprises a hypotube.
[113]
113. Valve repair system according to claim 109, characterized in that the thrust member of the retention control mechanism comprises a catheter.
[114]
114. Valve repair system according to claim 109, characterized in that the thrust member of the retention control mechanism comprises a wire having a loop.
[115]
115. Valve repair system to repair a patient's native valve during an unopened heart procedure, characterized by the fact that the valve repair system comprises:
an application device that has at least one lumen; a valve repair device configured to be applied through the lumen of the delivery device, and configured to attach to a patient's native valve, the valve repair device comprising: a pair of paddles that are movable between an open position and a closed position; and a first retaining member and a second retaining member, wherein the paddles and retaining members are configured to attach to the patient's native valve; and a retention control mechanism comprising: a first removable attached retention control member on the first retention member, the first retention control member comprising a first suture and a first thread having a first loop at a far end of the first thread, where the first suture extends from the delivery device and through the first loop of the first thread and is removably attached to the first retaining member, and where the first loop of the first thread is configured to couple the first retaining member to move the first retaining member between one or more positions; and a second detachable retention control member on the second retention member, the second retention control member comprising a second suture and a second thread having a second loop at an end furthest from the second thread, wherein the second suture extends from the application device and through the second loop of the second wire and is removably secured to the second retaining member, and the second loop of the second wire is configured to engage the second retaining member to move the second retaining member between a or more positions.
[116]
116. Valve repair system according to claim 115, characterized in that the first wire and the second wire are flexible NiTi wires.
[117]
117. Valve repair system according to claim 115, characterized in that the first wire and the second wire each have a diameter between approximately 0.15 mm and approximately 0.3 mm.

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US10973639B2|2018-01-09|2021-04-13|Edwards Lifesciences Corporation|Native valve repair devices and procedures|

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US11207181B2|2018-04-18|2021-12-28|Edwards Lifesciences Corporation|Heart valve sealing devices and delivery devices therefor|

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US10945844B2|2018-10-10|2021-03-16|Edwards Lifesciences Corporation|Heart valve sealing devices and delivery devices therefor|

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AU2020279128A1|2019-05-20|2021-11-25|Edwards Lifesciences Corporation|Heart valve sealing devices, delivery devices therefor, and retrieval devices|

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WO2021202130A1|2020-03-31|2021-10-07|Edwards Lifesciences Corporation|High flexibility implant catheter with low compression|

法律状态:
2021-12-07| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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US201862615213P| true| 2018-01-09|2018-01-09|

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US62/615,213|2018-01-09|

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PCT/US2019/012707|WO2019139904A1|2018-01-09|2019-01-08|Native valve repair devices and procedures|

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