Heart valve repair devices and delivery devices therefor

Abstract

Deuces are configured to be positioned within a native or simulated heart valve to impede regurgitation through the heart valve. The devices can include one or more of an expandable or compressible body and anchors. The expandable body can include an inner space having a first state that allows fluid passage and a second state that restricts fluid passage through the heart valve. The body can be adjustable in size, shape, or both, and resiliency to move with the leaflets of the heart valve to thereby open and close.

Description

HEART VALVE REPAIR DEVICES AND DELIVERY DEVICES THEREFORCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Patent Application No. 63 / 661,130, filed on June 18, 2024, the entire disclosure which is incorporated by reference for all purposes.BACKGROUND

[0002] The native heart valves (e.p., the aortic, pulmonary, tricuspid, and mitral valves) se e critical functions in assuring the forw ard flow of an adequate supply of blood through the cardiovascular system. These heart valves may be damaged, and thus rendered less effective, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such damage to the valves may result in serious cardiovascular compromise or death. Damaged valves can be surgically repaired or replaced during open heart surgery. However, open heart surgeries are highly invasive, and complications may occur. Transvascular techniques can be used to introduce and implant devices to treat a heart in a manner that is much less invasive than open heart surgery. As one example, a transvascular technique useable for accessing the native mitral and aortic valves is the transseptal technique. The trans-septal technique comprises advancing a catheter into the right atrium (e.p., inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium). The septum is then punctured, and the catheter passed into the left atrium. A similar transvascular technique can be used to implant a device within the tricuspid valve that begins similarly to the trans-septal technique but stops short of puncturing the septum and instead turns the delivery catheter toward the tricuspid valve in the right atrium.

[0003] A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered 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 generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral valve annulus may form a “D”- shaped, oval, or otherw ise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet may be larger than the posterior leaflet, forming a generally “C”-shaped boundary between the abutting sides of the leaflets when they are closed together.

[0004] When operating properly, the anterior leaflet and the posterior leaflet function 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”), the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as “ventricular systole” or “systole”), the increased blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way 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 leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.

[0005] Valvular regurgitation involves the valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation may have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral valve annulus resulting from dilation of the left ventricle, more than one of these, etc. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (e.g., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle and thus the valve does not close, and regurgitation is present. Tricuspid regurgitation maybe similar, but on the right side of the heart.SUMMARY

[0006] This summaiy is meant to provide some examples and is not intended to limit the scope of the disclosed subject matter in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the feature. Also, the features, components, steps, concepts, etc. described in examples in this summary7and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

[0007] Devices for repairing and / or treating a native valve of a patient are disclosed. The devices can be valve repair devices, implantable devices, valve treatment devices, implants,etc. While the devices may be described and / or depicted as implantable devices in some examples herein, similar configurations can be used on other devices, e.g., valve repair devices, treatment devices, etc., that are not necessarily implanted and may be removed after treatment.

[0008] In some implementations, there is provided a device e.g., a treatment device, a repair device, an implantable device, an implant, etc.) that is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal.

[0009] In some implementations, an implantable device or implant includes an anchor portion. In some implementations, the anchor portion includes one or more anchors. In some implementations, each anchor includes one or more paddles that are each moveable between an open position and a closed position.

[0010] In some implementations a heart valve repair device includes a plurality of anchors and a collapsible body connected to the anchors. The body has an inner space. The inner space has an open state allowing fluid passage therethrough. The inner space has a collapsed state that restricts fluid passage.

[0011] In some implementations the body comprises a first state width and a second state width and wherei n the second state width is greater than the first state width.

[0012] In some implementations the anchors are configured to fix the repair device to leaflet tissue of a heart valve.

[0013] In some implementations the body is configured to collapse during systolic movement of a leaflet.

[0014] In some implementations the body is configured to open during diastolic movement of a leaflet.

[0015] In some implementations the body comprises a plurality of frame members and a plurality of hinged portions.

[0016] In some implementations the body comprises at least one hinged portion between at least two frame members.

[0017] In some implementations one or more cover layers are disposed on an interior and an exterior of the body.

[0018] In some implementations one or more covers have a radial thickness extending into the inner space.

[0019] In some implementations one or more covers disposed on an interior of the body are configured to close the inner space during systolic movement of a heart valve.

[0020] In some implementations one or more covers are disposed on an interior of the body that are configured to open the inner space during diastolic movement of a heart valve.

[0021] In some implementations a valve repair device includes a plurality of anchors and a body. The plurality of anchors are for fixing the device to the heart valve. The body is connected to the anchors. The body includes a plurality of frame member portions including first and second frame member portions and at least one flex portion. The at least one flex portion is between the first and second frame member portions. The body has an inner space. The inner space has a first state that is an open state allowing fluid passage. The inner space has a second state that is a collapsed state restricting fluid passage.

[0022] In some implementations the body comprises a first state width and a second state width and wherein the second state width is greater than the first state width.

[0023] In some implementations the body is configured to collapse during systolic movement of the heart valve.

[0024] In some implementations the body is configured to open during diastolic movement of the heart valve.

[0025] In some implementations the body comprises a resiliency to the first state that is the open state.

[0026] In some implementations the body comprises a resiliency that can be overcome by a systolic movement of the heart valve to place the body in the second state that is the collapsed state.

[0027] In some implementations the body comprises a cylindrical shape.

[0028] In some implementations, the body comprises a frustum shape in the first state that is open to fluid.

[0029] In some implementations comprising one or more cover layers having a first cover material on an exterior of the body and a second cover material on an interior of the body.

[0030] In some implementations the anchors each comprise an inner arm and an outer arm.

[0031] In some implementations a system for heart valve repair includes any of the valve repair devices disclosed herein and a delivery system. The delivery system includes one or more catheters and a control handle.

[0032] In some implementations a simulated method of repairing of a heart valve a repair device is attached to one or more leaflets of a simulated heart valve. A central space ofthe repair device is opened under diastolic movement of the simulated heart valve. The central space of the repair device is closed under systolic movement of the simulated heart valve.

[0033] In some implementations closing the central space of the repair device under systolic movement of the simulated heart valve comprises expanding a width of a body of the repair device.

[0034] In some implementations closing the central space of the repair device under systolic movement of the simulated heart valve comprises collapsing a body of the repair device.

[0035] In some implementations opening the central space of the repair device under diastolic movement of the simulated heart valve comprises expanding a body of the repair device to create the open central space.

[0036] In some implementations closing the central space of the repair device under systolic movement of the simulated heart valve comprises the leaflets of the simulated heart valve pushing on a body of the repair device.

[0037] In some implementations closing the central space of the repair device under systolic movement of the simulated heart valve comprises allowing a body of the repair device to expand to create the open central space.

[0038] In some implementations opening the central space of the repair device under diastolic movement of the simulated heart valve comprises expanding a body of the repair device to create the open central space.

[0039] In some implementations closing the central space of the repair device under systolic movement of the simulated heart valve comprises bending portions of a body of the repair device.

[0040] In some implementations opening the central space of the repair device under diastolic movement of the simulated heart valve comprises expanding portions of a frame of a body of the repair device to create the open central space.

[0041] In some implementations closing the central space of the repair device under systolic movement of the simulated heart valve comprises the leaflets of the simulated heart valve bending portions of a frame of a body of the repair device.

[0042] In some implementations closing the central space of the repair device under systolic movement of the simulated heart valve comprises the leaflets of the simulated heart valve deforming portions of a body of the repair device.

[0043] In some implementations closing of the central space of the repair device under systolic movement of the simulated heart valve comprises moving portions of a cover material on a body of the repair device closer together.

[0044] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0045] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0046] A further understanding of the nature and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.BRIEF DESCRIPTION OF THE DRAWINGS

[0047] To further clarify various aspects of examples in the present disclosure, a more particular description of certain examples and implementations will be made by reference to various aspects of the appended drawings. These drawings depict only example implementations of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, w hile the figures can be drawn to scale for some examples, the figures are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0048] FIG. 1 illustrates a cutaway view of the human heart in a diastolic phase;

[0049] FIG. 2 illustrates a cutaway view of the human heart in a systolic phase;

[0050] FIG. 3 illustrates a cutaway view of the human heart in a systolic phase showing valve regurgitation;

[0051] FIG. 4 is the cutaway view of FIG. 3 annotated to illustrate a natural shape of mitral valve leaflets in the systolic phase;

[0052] FIG. 5 illustrates a healthy mitral valve w ith the leaflets closed as viewed from an atrial side of the mitral valve;

[0053] FIG. 6 illustrates a dysfunctional mitral valve with a visible gap between the leaflets as viewed from an atrial side of the mitral valve;

[0054] FIG. 7 illustrates a tricuspid valve viewed from an atrial side of the tricuspid valve;

[0055] FIGS. 8-14 show an example device or implant, in various stages of deployment;

[0056] FIG. 15 shows an example device that is similar to the device illustrated by FIGS. 8-14, but where the paddles are independently controllable;

[0057] FIGS. 16-21 show the example device of FIGS. 8-14 being delivered and deployed within a native valve;

[0058] FIG. 22 shows a perspective view of an example device in a closed position;

[0059] FIG. 23 shows a perspective view of an example device in a closed position;

[0060] FIG. 24 illustrates an example device with paddles in an open position;

[0061] FIG. 25A illustrates an example device w ith paddles in a closed position;

[0062] FIG. 25B illustrates a top view of an example device;

[0063] FIG. 26 illustrates a perspective view of an example device having paddles of adjustable widths;

[0064] FIG. 27 is a cross-section of the example device of FIG. 26 in which the device is bisected;

[0065] FIG. 28 is another cross-section of the example device of FIG. 26 in which the device is bisected along a plane perpendicular to the plane illustrated in FIG. 28;

[0066] FIG. 29 is a schematic illustration of an example catheter assembly coupled to an example device in which an actuation element is coupled to a paddle actuation control and to a driver head of the device;

[0067] FIG. 30 is an illustration of the assembly of FIG. 29 with the example device rotated 90 degrees to show- the paddle width adjustment element coupled to an inner end of the connector of the device and coupled to a paddle width control;

[0068] FIGS. 31-34 schematically illustrate an example implementation of a heart valve repair device having a coaptation portion;

[0069] FIGS. 35-36 schematically illustrate the delivery and deployment of the heart valve repair device within a native mitral valve;

[0070] FIGS. 37A-37C schematically illustrate top, side and sectional views of another implementation of a repair device fixed to native leaflets that is similar to that of FIGS. 31- 32 in the open (or diastolic) state.

[0071] FIGS. 38A-38B schematically illustrate top and sectional views of the repair device shown in FIGS. 37A-37C when in the closed (or systolic) state.

[0072] FIGS. 39A-39C illustrate open, closed, and perspective views of another implementation of a repair device similar to that shown in FIGS. 37A-37C and FIGS. 38A- 38B.

[0073] FIGS. 40A-40B illustrate top views of a repair device for a tricuspid valve in the open and closed states.

[0074] FIGS. 41A-41B show perspective views of another implementation of a heart valve repair device with a discrete frame.

[0075] FIGS. 42A-42C illustrate an example of a delivery system deploying a valve repair device.

[0076] FIGS. 43A-43C an example of a deliver}' system deploying a valve repair device.

[0077] FIGS. 44A-44B schematically illustrate implantation of a prosthetic valve being implanted in a valve repair device.DETAILED DESCRIPTION

[0078] The following description refers to the accompanying rawings, which illustrate example implementations of the present disclosure. Other implementations having different structures and operation do not depart from the scope of the present disclosure.

[0079] Some implementations of the present disclosure are directed to systems, devices, methods, etc. for repairing a defective heart valve. For example, some implementations of devices, treatment device, repair devices, valve treatment devices, valve repair devices, implantable devices, implants, and systems (including systems for delivery thereof) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible. Further, the techniques, methods, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject {e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulatedheart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary’ person (e.g., if they are just demonstrating in the air on an imaginary’ heart), etc.

[0080] As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection can be direct as between the components or can be indirect such as through the use of one or more intermediary components. Also as described herein, reference to a "member," “component,” or “portion” shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms “substantially” and “about” are defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably^ within 1% of, and most preferably within 0.1% of). The terms “clasp” and “clasp arm” are often used herein with respect to specific examples, but the terms “gripping member” and / or “gripper arm” can be used in place of and function in the same or similar w ays, even if not configured in the same way as a typical clasp.

[0081] FIGS. 1 and 2 are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; e.g., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery’ PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 show n in FIGS. 3-6 and leaflets 30, 32, 34 shown in FIG. 7) extending inward across the respective orifices that come together or “coat” in the flow stream to form the one-w ay, fluidoccluding surfaces. The native valve repair and / or treatment systems of the present application are frequently described and / or illustrated with respect to the mitral valve MV. Therefore, anatomical structures of the left atrium LA and left ventricle LV will be explained in greater detail. However, the devices described herein can also be used in repairing other native valves, e.g., the devices can be used in repairing the tricuspid valve TV, the aortic valve AV, and the pulmonary^ valve PV.

[0082] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in FIG. 1, the blood that was previously collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV and into the left ventricle LV by expansion of the left ventricle LV. In the systolic phase, or systole, seen in FIG. 2, the left ventricle LV contracts to force the blood through the aortic valve AV and ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent the bloodfrom regurgitating from the left ventricle LV and back into the left atrium LA and blood is collected in the left atrium from the pulmonary vein. In some implementations, the devices described by the present application are used to repair the function of a defective mitral valve MV. That is, the devices are configured to help close the leaflets of the mitral valve to prevent, inhibit or reduce blood from regurgitating from the left ventricle LV and back into the left atrium LA. Many of the devices described in the present application are designed to easily grasp and secure the native leaflets around a coaptation element or spacer that beneficially acts as a filler in the regurgitant orifice to prevent or inhibit back flow or regurgitation during systole, though this is not necessary.

[0083] Referring now to FIGS. 1-7, the mitral valve MV includes two leaflets, the anterior leaflet 20 and the posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see Fig. 5), which is a variably dense fibrous ring of tissues that encircles the leaflets 20, 22. Referring to FIGS. 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (e.g., the muscles located at the base of the chordae tendineae CT and within the walls of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM sen e to limit the movements of leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from being reverted. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary7muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the leaflets 20, 22 against the high pressure needed to circulate blood throughout the body. Together the papillary7muscles PM and the chordae tendineae CT are known as the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As seen from a Left Ventricular Outflow Tract (LVOT) view shown in FIG. 3, the anatomy of the leaflets 20, 22 is such that the inner sides of the leaflets coapt at the free end portions and the leaflets 20, 22 start receding or spreading apart from each other. The leaflets 20, 22 spread apart in the atrial direction, until each leaflet meets with the mitral annulus.

[0084] Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow’s Disease, fibroelastic deficiency, etc.), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (e.g., myocardial infarction secondary7to coronary7artery7disease) or other heart diseases (e.g., cardiomyopathy, etc.) may distort a native valve’s geometry7, which may cause the native valve to dysfunction. However, the majority of patients undergoing valve surgery7, such as surgery to the mitralvalve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets 20, 22) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation.

[0085] Generally, a native valve may malfunction in different ways: including (1) valve stenosis; and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely and thereby causes an obstruction of blood flow. Typically, valve stenosis results from buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to fully open to permit forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber (e.g., causing blood to leak from the left ventricle to the left atrium).

[0086] There are three main mechanisms by which a native valve becomes regurgitant— or incompetent— which include Carpentier’s type I, type II, and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal e.g., the leaflets do not coapt properly). Included in a type I mechanism malfunction are perforations of the leaflets, as are present in endocarditis. A Carpentier’s type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaptation. A Carpentier’s type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction may be caused by rheumatic disease or dilation of a ventricle.

[0087] Referring to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Referring to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV is displaced into the left atrium LA during systole so that the edges of the leaflets 20, 22 are not in contact with each other. This failure to coapt causes a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back into the left atrium LA from the left ventricle LV during systole, as illustrated by the mitral regurgitation MR flow path shown in FIG. 3. Referring to FIG. 6, the gap 26 may have a width W between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some situations, the gap 26 may have a w idth W greater than 15 mm or even 17.5 mm. As set forth above, there are several different ways that a leaflet (e.g., leaflets 20, 22 of mitral valve MV) may malfunction which may thereby lead to valvular regurgitation.[oo88] In any of the above-mentioned situations, a device or implant is desired that is capable of engaging the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit regurgitation of blood through the mitral valve MV. As can be seen in FIG. 4, an abstract representation of a repair or treatment device 10 (e.p., a valve treatment device, a valve repair device, an implantable device, an implant, etc.) is shown implanted between the leaflets 20, 22 such that regurgitation does not occur during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation element (e.c / ., spacer, coaption element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) of the device 10 has a generally tapered or triangular shape that naturally adapts to the native valve geometry and to its expanding leaflet nature (toward the annulus). In this application, the terms spacer, coaption element, coaptation element, gap filler, plug, etc. are used interchangeably and refer to an element that fills a portion of the space between native valve leaflets and / or that is configured such that the native valve leaflets engage or “coapt” against (e.y., such that the native leaflets coapt against the coaption element, coaptation element, spacer, etc. instead of only against one another).

[0089] Although stenosis or regurgitation may affect any valve, stenosis is predominantly found to affect either the aortic valve AV or the pulmonary valve PV, and regurgitation is predominantly found to affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to very serious conditions if left un-treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (e.p., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) are primarily responsible for circulating the flow of blood throughout the body. Accordingly, because of the substantially higher pressures on the left side heart dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life threatening.

[0090] Malfunctioning native heart valves can either be repaired or replaced. Repair typically involves the preservation and correction of the patient’s native valve. Replacement typically involves replacing the patient’s native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, treatments for a stenotic aortic valve or stenotic pul monary valve can be removal and replacement of the valve with a surgically implanted heart valve, or displacement of the valve w ith a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets and / or surrounding tissue, which, as described above, may prevent the mitral valve MV or tricuspid valve TV from closing properly and allows for regurgitation or back flow ofblood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow’ from the left ventricle LV to the left atrium LA as shown in FIG. 3). The regurgitation or back flow’ of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable. In addition, regurgitation may occur due to the chordae tendineae CT becoming dysfunctional (e.g., the chordae tendineae CT may stretch or rupture), which allows the anterior leaflet 20 and the posterior leaflet 22 to be reverted such that blood is regurgitated into the left atrium LA. The problems occurring due to dysfunctional chordae tendineae CT can be repaired by repairing the chordae tendineae CT or the structure of the mitral valve MV e.g., by securing the leaflets 20, 22 at the affected portion of the mitral valve).

[0091] The devices and procedures disclosed herein often make reference to repairing 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. Such devices can be used betw een the leaflets 20, 22 of the mitral valve MV to prevent or inhibit regurgitation of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts herein can be used between any tw o of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or inhibit regurgitation of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets 30, 32, 34 together to prevent or inhibit regurgitation of blood from the right ventricle to the right atrium. That is, the treatment device, repair devices, implants, etc. provided herein can be centrally located between the three leaflets 30, 32, 34.

[0092] An example device (e.g., valve repair device, valve treatment device, implantable device, implant, etc.) can optionally have a coaptation element (e.g., spacer, coaption element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, a device (e.g., a valve repair device, a valve treatment device, an implantable device, an implant, etc.) can have any combination or sub-combination of the features disclosed herein without a coaptation element. When included, the coaptation element (e.g., spacer, coaption element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) is configured to be positioned within the native heart valve orifice to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting regurgitation described above. The coaptation element can have a structure that is impervious to blood (or that resists blood flow therethrough) and that allows the native leaflets to close around the coaptation element during ventricular systole to block blood from flowing from the left or right ventricle backinto the left or right atrium, respectively. The device can be configured to seal against two or three native valve leaflets; that is, the device can be used in the native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill a space between improperly functioning native leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely.

[0093] The optional coaptation element (e.g., spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) can have various shapes. In some implementations, the coaptation element can have an elongated cylindrical shape having a round cross-sectional shape. In some implementations, the coaptation element can have an oval cross-sectional shape, an ovoid cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation element can have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a side surface that extends between the native leaflets. In some implementations configured for use in the tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, and the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the side surfaces extend between the native tricuspid leaflets.

[0094] In some implementations, the anchor can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between the two native leaflets.

[0095] In some implementations, the anchor can be configured for use in the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between the three native leaflets.

[0096] In some implementations, the anchor can attach to the coaptation element at a location adjacent the ventricular portion of the coaptation element. In some implementations, the anchor can attach to an actuation element (e.g., an actuation shaft, actuation tube, actuation wire, etc.) to which the coaptation element is also attached. In some implementations, the anchor and the coaptation element can be positioned independently with respect to each other by separately moving each of the anchor and the coaptation element along the longitudinal axis of the actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some implementations, the anchor and the coaptation element can be positioned simultaneously by moving the anchor and the coaptation element together along the longitudinal axis of the actuation element (e.g., shaft, actuation wire, etc.). The anchor can be configured to be positioned behind a native leaflet when deployed such that the leaflet is grasped by the anchor.

[0097] The device can be configured to be deployed and / or implanted via a delivery’ system or other means for delivery’. The delivery’ system can comprise one or more of a guide / delivery sheath, a delivery’ catheter, a steerable catheter, an implant catheter, tube, combinations of these, etc. The coaptation element and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially’ expanded state when compressive pressure is released. The device can be configured for the anchor to be expanded radially away from the still compressed coaptation element initially in order to create a gap between the coaptation element and the anchor. A native leaflet can then be positioned in the gap. The coaptation element can be expanded radially, closing the gap between the coaptation element and the anchor and capturing the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. The implantation and / or deployment methods for some implementations can be different and are more fully discussed below with respect to each implementation. Additional information regarding these and other delivery methods that can be used with the concepts herein can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, 2016 / 0331523, International Patent Application Publication Nos. W02020 / 076898, WO2O23 / 278663, W02023 / 004098, W02023 / 091520, W02023 / 107296, W02023 / 086340, W02023 / 003755, and WO2O22 / 231889 each of which is incorporated herein by reference in its entirety for all purposes. These method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc. mutatis mutandis.

[0098] The disclosed devices or implants can be configured such that the anchor is connected to a leaflet, taking advantage of the tension from native chordae tendineae to resist high systolic pressure urging the device toward the left atrium. During diastole, the devices can rely on the compressive and retention forces exerted on the leaflet that is grasped by the anchor.

[0099] Referring now to FIGS. 8-15, a schematically illustrated device 100 (e.g., a prosthetic device, a valve repair device, valve treatment device, implantable device, implant, etc.) is shown in various stages of deploy ment. The device too and other similar devices and / or implants are described in more detail in International Patent Application Publication Nos. WO2O18 / 195215, W02020 / 076898, W02019 / 139904, WO2O23278663, W02023 / 004098, W02023 / 091520, W02023 / 107296, W02023 / 086340, WO2O23 / OO3755, and WO2O22 / 231889, which are incorporated herein by reference in their entirety7for all purposes. The devices herein can include any7other features for another device or implant discussed in the present application or the applications cited above, and thedevices herein can be positioned to engage valve tissue (e.g., leaflets 20, 22, 30, 32, 34) as part of any suitable treatment and / or repair system (e.g., any treatment and / or repair system disclosed in the present application, or the applications cited herein).

[0100] The device too is deployed from a delivery system 102. The delivery system 102 can comprise one or more of a catheter, a sheath, a guide catheter / sheath, a delivery’ catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc. The device too includes a coaptation portion 104 and an anchor portion 106.

[0101] In some implementations, the coaptation portion 104 of the device too includes a coaptation element 110 that is adapted to be deployed and / or implanted between leaflets of a native valve (e.g., a native mitral valve, native tricuspid valve, etc.) and is slidably attached to an actuation element 112 (e.g., actuation wire, shaft, tube, hypotube, line, suture, braid, etc.). The anchor portion 106 includes one or more anchors 108 that are actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element 112 opens and closes the anchor portion 106 of the device too to grasp the native valve leaflets during deployment and / or implantation. The actuation element 112 (as well as other actuation elements disclosed herein) can take a wide variety of different forms (e.g., as a w ire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the coaptation portion 104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the coaptation portion 104.

[0102] The anchor portion 106 and / or anchors of the device too include outer paddles 120 and inner paddles 122 that are, in some implementations, connected between a cap 114 and a coaptation element 110 by portions 124, 126, 128. The portions 124, 126, 128 can be jointed and / or flexible to move between all of the positions described below. The interconnection of the outer paddles 120, the inner paddles 122, the coaptation element 110, and the cap 114 by the portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.

[0103] In some implementations, the delivery’ system 102 includes a steerable catheter, implant catheter, and the actuation element 112 (e.g., actuation wire, shaft, tube, hypotube, line, suture, braid, etc.). These can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation element 112 extends through a delivery catheter and the coaptation element 110 to the distal end (e.g., a cap 114or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the spacing between the coaptation element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some implementations, a collar or other attachment element (e.g., clamp, clip, lock, sutures, friction fit, buckle, snap fit, lasso, etc.) removably attaches the coaptation element 110 to the delivery system 102, either directly or indirectly, so that the actuation element 112 slides through the collar or other attachment element and, in some implementations, through a coaptation element no during actuation to open and close the paddles 120, 122 of the anchor portion 106 and / or anchors 108.

[0104] In some implementations, the anchor portion 106 and / or anchors 108 can include attachment portions or gripping members (e.g., gripping arms, clasp arms, etc.). The illustrated gripping members can comprise clasps 130 that include a base or fixed arm 132, a moveable arm 134, optional friction-enhancing elements, other securing structures 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion 138. The fixed arms 132 are attached to the inner paddles 122. In some implementations, the fixed arms 132 are attached to the inner paddles 122 with the joint portion 138 disposed proximate the coaptation element 110. The joint portion 138 provides a spring force between the fixed and moveable arms 132, 134 of the clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 138 is a flexible piece of material integrally formed with the fixed and moveable arms 132, 134. The fixed arms 132 are attached to the inner paddles 122 and remain stationary’ or substantially stationary’ relative to the inner paddles 122 when the moveable arms 134 are opened to open the clasps 130 and expose the optional barbs or other frictionenhancing elements 136.

[0105] In some implementations, the clasps t3O are opened by applying tension to actuation lines tt6 attached to the moveable arms 134, thereby causing the moveable arms 134 to articulate, flex, or pivot on the joint portions 138. The actuation lines it6 extend through the delivery system 102 (e.g., through a steerable catheter, an implant catheter, etc.). Other actuation mechanisms are also possible.

[0106] The actuation line 116 can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The clasps 130 can be spring loaded so that in the closed position the clasps 130 continue to provide a pinching force on the grasped native leaflet. Optional barbs or other friction-enhancing elements 136 of the clasps 130 can grab, pinch, and / or pierce the native leaflets to further secure the native leaflets.

[0107] During deployment and / or implantation, the paddles 120, 122 can be opened and closed, for example, to grasp the native leaflets (e.g., native mitral valve leaflets, etc.)between the paddles 120, 122 and / or between the paddles 120, 122 and a coaptation element 110 (e.g., a spacer, plug, membrane, etc.).

[0108] The clasps 130 can be used to grasp and / or further secure the native leaflets by engaging the leaflets w ith optional barbs or other friction-enhancing elements 136 and pinching the leaflets between the moveable and fixed arms 134, 132. The optional barbs or other friction-enhancing elements 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.) of the clasps 130 increase friction w ith the leaflets or can partially or completely puncture the leaflets.

[0109] In some implementations, the actuation lines 116 can be actuated separately (or both separately and simultaneously) so that each clasp 130 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp 130 on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The clasps 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allow ing leaflets to be grasped in a variety of positions as the particular situation requires.

[0110] Referring now to FIG. 8, the device too is shown in an elongated or fully open condition for deployment from a delivery catheter of the delivery system 102. The device too is disposed at the end of the catheter of the delivery system 102 in the fully open position. In the elongated condition the cap 114 is spaced apart from the coaptation element 110 such that the paddles 120, 122 are fully extended. In some implementations, an angle formed between the interior of the outer and inner paddles 120, 122 is approximately 180 degrees. The clasps 130 can be kept in a closed condition during deployment through the delivery system. The actuation lines 116 can extend and attach to the moveable arms 134.

[0111] Referring now’ to FIG. 9, the device too is shown in an elongated condition, similar to FIG. 8, but with the clasps 130 in a fully open position, ranging from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or about 180 degrees between fixed and moveable arms 132, 134 of the clasps 130.

[0112] Referring now to FIG. 10, the device too is shown in a shortened or fully closed condition. To move the device too from the elongated condition to the shortened condition, the actuation element 112 is retracted to pull the cap 114 towards the coaptation element 110. The connection portion(s) 126 (e.g., joint(s), flexible connection(s), etc.) between the outer paddle 120 and inner paddle 122 are constrained in movement such that compression forces acting on the outer paddle 120 from the cap 114 being retracted tow ards the coaptation element 110 cause the paddles or gripping elements to move radially outward. Duringmovement from the open position to the closed position, the outer paddles 120 maintain an acute angle w ith the actuation element 112. The outer paddles 120 can optionally be biased toward a closed position. The inner paddles 122 during the same motion move through a considerably larger angle as they are oriented away from the coaptation element 110 in the open condition and collapse along the sides of the coaptation element 110 in the closed condition.

[0113] Referring now to FIGS. 11-13, the device too is shown in a partially open, graspready condition. To transition from the fully closed to the partially open condition, the actuation element (e.g., actuation w ire, shaft, tube, hypotube, line, suture, braid, etc.) is extended to push the cap 114 away from the coaptation element 110, thereby pulling on the outer paddles 120, which in turn pull on the inner paddles 122, causing the anchors or anchor portion 106 to partially unfold. The actuation lines 116 are also retracted to open the clasps 130 so that the leaflets can be grasped. In some implementations, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single actuation element 112. Also, the positions of the clasps 130 are dependent on the positions of the paddles 122, 120. For example, referring to FIG. 10 closing the paddles 122, 120 also closes the clasps. In some implementations, the paddles 120, 122 can be independently controllable. In the example illustrated by FIG. 15, the device too can have two actuation elements 111, 113 and two independent caps 115, 117 (or other attachment portions), such that one independent actuation element (e.g., actuation wdre, shaft, tube, hypotube, line, suture, braid, etc.) and cap (or other attachment portion) are used to control one paddle, and the other independent actuation element and cap (or other attachment portion) are used to control the other paddle.

[0114] Referring now to FIG. 12, one of the actuation lines 116 is extended to allow one of the clasps 130 to close. Referring now to FIG. 13, the other actuation line 116 is extended to allow’ the other clasp 130 to close. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0115] Referring now to FIG. 14, the device too is shown in a fully closed and deployed condition. The delivery system 102 and actuation element 112 are retracted and the paddles 120, 122 and clasps 130 remain in a fully closed position. Once deployed, the device too can be maintained in the fully closed position with a mechanical latch or can be biased to remain closed through the use of spring materials, such as steel, other metals, plastics, composites, etc. or shape-memory alloys such as Nitinol. For example, the connection portions 124, 126, 128, the joint portions 138, and / or the inner and outer paddles 122, and / or an additional biasing component (not shown) can be formed of metals such as steel or shape-memory alloy, such as Nitinol— produced in a wire, sheet, tubing, or laser sintered powder— and arebiased to hold the outer paddles 120 closed around the coaptation element 110 and the clasps 130 pinched around native leaflets. Similarly, the fixed and moveable arms 132, 134 of the clasps 130 are biased to pinch the leaflets. In some implementations, the attachment or connection portions 124, 126, 128, joint portions 138, and / or the inner and outer paddles 122, and / or an additional biasing component (not shown) can be formed of any other suitably elastic material, such as a metal or polymer material, to maintain the device too in the closed condition after deployment and / or implantation.

[0116] FIG. 15 illustrates an example where the paddles 120, 122 are independently controllable. The device 101 illustrated by FIG. 15 is similar to the device illustrated by FIG. 11, except the device too of FIG. 15 includes an actuation element that is configured as two independent actuation elements 111, 113 that are coupled to two independent caps 115, 117. To transition a first inner paddle 122 and a first outer paddle 120 from the fully closed to the partially^ open condition, the actuation element 111 is extended to push the cap 115 away from the coaptation element 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the first anchor 108 to partially unfold. To transition a second inner paddle 122 and a second outer paddle 120 from the fully closed to the partially open condition, the actuation element 113 is extended to push the cap 115 aw ay from the spacer or coaptation element 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the second anchor 108 to partially unfold. The independent paddle control illustrated by FIG. 15 can be implemented on any of the devices disclosed by the present application. For comparison, in the example illustrated by FIG. 11, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by’ a single actuation element 112.

[0117] Referring now to FIGS. 16-21, the device 100 of FIGS. 8-14 is shown being delivered and deployed within the native mitral valve MV of the heart H. Referring to FIG. 16, a delivery sheath / catheter is inserted into the left atrium LA through the septum and the implant / device 100 is deployed from the delivery^ catheter / sheath in the fully open condition as illustrated in FIG. 16. The actuation element 112 is then retracted to move the implant / device into the fully closed condition shown in FIG. 17.

[0118] As can be seen in FIG. 18, the implant / device is moved into position within the mitral valve MV into the ventricle LV and partially opened so that the leaflets 20, 22 can be grasped. For example, a steerable catheter can be advanced and steered or flexed to position the steerable catheter as illustrated by FIG. 18. The device or implant catheter connected to the implant / device can be advanced from inside the steerable catheter to position the implant as illustrated by FIG. 18.

[0119] Referring now to FIG. 19, the device catheter can be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 in the clasps 130. An actuation line 116 is extended to close one of the clasps 130, capturing a leaflet 20. FIG. 20 shows the other actuation line 116 being then extended to close the other clasp 130, capturing the remaining leaflet 22. Lastly, as can be seen in FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuation element 112 and actuation lines 116 are then retracted and the device too is fully closed and deployed in the native mitral valve MV.

[0120] Any of the features disclosed by the present application can be used in a wide variety of different treatment devices and / or repair devices. FIGS. 22-24 illustrate examples of valve treatment and / or repair devices that can be modified to include any of the features disclosed by the present application. Any combination or sub-combination of the features disclosed by the present application can be combined with, substituted for, and / or added to any combination or sub-combination of the features of the devices illustrated by FIGS. 8-24.

[0121] Referring now to FIG. 22, an example of a device 200 (e.g., treatment device, repair device, implantable device, implant, etc.) is shown. The device 200 can be configured as an implantable device or implant or other valve treatment device (e.g., one that does not necessarily remain implanted). The device 200 is one of the many different configurations that the device too that is schematically illustrated in FIGS. 8-14 can take. The device 200 can include any other features for a device or implant discussed in the present application, and the device 200 can be positioned to engage valve tissue 20, 22 as part of any suitable treatment and / or repair system (e.g., any treatment and / or repair system disclosed in the present application, or the applications cited herein). The device / implant 200 can be a prosthetic spacer device, valve repair device, treatment device, or another type of implant that attaches to leaflets of a native valve.

[0122] In some implementations, the device 200 includes a coaptation portion 204, a proximal or attachment portion 209, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaption element, plug, membrane, sheet, gap filler, plug, wedge, balloon, etc.) for deployment and / or implantation between leaflets of a native valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in a variety of ways. In some implementations, each anchor 208 includes outer paddles 220, inner paddles 222, paddle extension members or paddle frames 224, and clasps 230. In some implementations, the attachment portion 209 includes a first or proximal collar 211 (or other attachment element) for engaging with a capture mechanism of a delivery system. A delivery system for the device 200 can be the same as or similar to delivery system 102 described above and can comprise one or more of a catheter, asheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc. The capture mechanism can be configured in a variety of ways and, in some implementations, can comprise one or more of a clamp, clip, pin, suture, line, lasso, noose, snare, buckle, lock, latch, etc.

[0123] In some implementations, the coaptation element 210 and paddles 220, 222 are formed from a flexible material that can be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shape-memory alloy wire— such as Nitinol— to provide shape-setting capability, or any other flexible material suitable for deployment and / or implantation in the human body.

[0124] An actuation element e.g., actuation wire, shaft, tube, hypotube, line, suture, braid, etc.) can extend from a delivery system (not shown) to engage and enable actuation of the device or implant 200. In some implementations, the actuation element extends through the proximal collar 211, and spacer or coaptation element 210 to engage a cap 214 of the distal portion 207. The actuation element can be configured to removably engage the cap 214 with a threaded connection, or the like, so that the actuation element can be disengaged and removed from the device 200 after implantation.

[0125] The coaptation element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddles 222. In some implementations, the coaptation element 210 has a generally elongated and round shape, though other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above and has a tapered shape or crosssection when seen from a front view and a round shape or cross-section when seen from a side view. A blend of these three geometries can result in the three-dimensional shape of the illustrated coaptation element 210 that achieves the benefits described herein. The round shape of the coaptation element 210 can also be seen, when viewed from above, to substantially follow or be close to the shape of the paddle frames 224.

[0126] The size and / or shape of the coaptation element 210 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In some implementations, the anterior- posterior distance at the top of the coaptation element is about 5 mm, and the medial -lateral distance of the coaptation element at its widest is about 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior- posterior distance anterior-posterior distance and medial-lateral distance as starting points for the device will result in a device having different dimensions. Further, using otherdimensions and the shape strategy described above will also result in a device having different dimensions.

[0127] In some implementations, the outer paddles 220 are jointably attached to the cap 214 of the distal portion 207 by connection portions 221 and to the inner paddles 222 by connection portions 223. The inner paddles 222 are jointably attached to the coaptation element by connection portions 225. In this manner, the anchors 208 are configured similar to legs in that the inner paddles 222 are like upper portions of the legs, the outer paddles 220 are like lower portions of the legs, and the connection portions 223 are like knee portions of the legs.

[0128] In some implementations, the inner paddles 222 are stiff, relatively stiff, rigid, have rigid portions and / or are stiffened by a stiffening member or a fixed portion of the clasps 230. The inner paddle 222, the outer paddle 220, and the coaptation element can all be interconnected as described herein.

[0129] In some implementations, the paddle frames 224 are attached to the cap 214 at the distal portion 207 and extend to the connection portions 223 between the inner and outer paddles 222, 220. In some implementations, the paddle frames 224 are formed of a material that is more rigid and stiff than the material forming the paddles 222, 220 so that the paddle frames 224 provide support for the paddles 222, 220.

[0130] The paddle frames 224 can provide additional pinching force between the inner paddles 222 and the coaptation element 210 and assist in wrapping the leaflets around the sides of the coaptation element 210. That is, the paddle frames 224 can be configured with a round three-dimensional shape extending from the cap 214 to the connection portions 223 of the anchors 208. The connections between the paddle frames 224, the outer and inner paddles 220, 222, the cap 214, and the coaptation element 210 can constrain each of these parts to the movements and positions described herein. In particular the connection portion 223 is constrained by its connection between the outer and inner paddles 220, 222 and by its connection to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connection portion 223 (and thus the inner and outer paddles 222, 220) and to the cap 214.

[0131] The wide configuration of the paddle frames 224 provides increased surface area compared to the inner paddles 222 alone. The increased surface area can distribute the clamping force of the paddles 220 and paddle frames 224 against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue.

[0132] Additional features of the device 200, modified versions of the device, delivery systems for the device, and methods for using the device and deliver)' system are disclosed by International Patent Application No. PCT / US2018 / 028189 (International Patent Application Publication No. WO 2018 / 195215) and the other applications incorporated herein. Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by International Patent Application No. PCT / US2018 / 028189 (International Patent Application Publication No. WO 2018 / 195215) and / or the other applications incorporated herein. International Patent Application No. PCT / US2018 / 028189 (International Patent Application Publication No. WO 2018 / 195215) is incorporated herein by reference in its entirety.

[0133] Referring now to FIG. 23, an example of a device 300 (e.g., a valve repair device, a valve treatment device, an implantable device, an implant, etc.) is show n. The device 300 is one of the many different configurations that the device 100 that is schematically illustrated in FIGS. 8-14 can take. The device 300 can include any other features for a device or implant discussed in the present application, and the device 300 can be positioned to engage valve tissue 20, 22 as part of any suitable treatment and / or repair system (e.g., any treatment and / or repair system disclosed in the present application, or the applications cited herein).

[0134] The device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a coaptation portion 304, and the coaptation portion 304 can optionally include a coaptation element 310 (e.g., spacer, plug, membrane, sheet, etc.) for deployment and / or implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, e.g., outer paddles 320, inner paddles 322, paddle extension members or paddle frames 324. The anchors can also include and / or be coupled to clasps 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging wdth a capture mechanism of a deliver}' system.

[0135] The anchors 308 can be attached to the other portions of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, welding, sutures, adhesive, links, latches, integrally formed, a combination of some or all of these, etc.). In some implementations, the anchors 308 are attached to a coaptation element 310 by connection portions 325 and to a cap 314 by connection portions 321.

[0136] The anchors 308 can comprise first portions or outer paddles 320 and second portions or inner paddles 322 separated by connection portions 323. The connectionportions 323 can be attached to paddle frames 324 that are hingeably attached to a cap 314 or other attachment portion. In this manner, the anchors 308 are configured similar to legs in that the inner paddles 322 are like upper portions of the legs, the outer paddles 320 are like lower portions of the legs, and the connection portions 323 are like knee portions of the legs.

[0137] In implementations with a coaptation element 310, the coaptation element 310 and the anchors 308 can be coupled together in various ways. As shown in the illustrated example, the coaptation element 310 and the anchors 308 can be coupled together by integrally forming the coaptation element 310 and the anchors 308 as a single, unitary component. This can be accomplished, for example, by forming the coaptation element 310 and the anchors 308 from a continuous strip 301 of a braided or woven material, such as braided or woven nitinol wire. In the illustrated example, the coaptation element 310, the outer paddle portions 320, the inner paddle portions 322, and the connection portions 321, 323, 325 are formed from a continuous strip 301.

[0138] Like the anchors 208 of the device 200 described above, the anchors 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement can be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device.

[0139] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connection portions 323 of the anchors 308 are adjacent the longitudinal axis of the spacer or coaptation element 310. From the straight configuration, the anchors 308 can be moved to a fully folded configuration (e.g., FIG. 23), e.g., by moving the proximal end and distal end toward each other and / or toward a midpoint or center of the device.

[0140] In some implementations, the clasps comprise a moveable arm coupled to an anchor. In some implementations, the clasps 330 include a base or fixed arm 332, a moveable arm 334, optional barbs / friction-enhancing elements 336, and a joint portion 338. The fixed arms 332 are attached to the inner paddles 322, with the joint portion 338 disposed proximate the coaptation element 310. The joint portion 338 is spring-loaded so that the fixed and moveable arms 332, 334 are biased tow ard each other when the clasp 330 is in a closed condition.

[0141] The fixed arms 332 are attached to the inner paddles 322 through holes or slots with sutures. The fixed arms 332 can be attached to the inner paddles 322 with any suitable means, such as screw s or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms 332 remain substantially stationaiy relative to the inner paddles 322 when the moveable arms 334 are opened to open the clasps 330 and expose the optional barbs 336. The clasps 330 are opened by applying tension to actuation lines attached to the moveable arms 334, thereby causing the moveable arms 334 to articulate, pivot, and / or flex on the joint portions 338.

[0142] In short, the device 300 is similar in configuration and operation to the device 200 described above, except that the coaptation element 310, outer paddles 320, inner paddles 322, and connection portions 321, 323, 325 are formed from the single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, cap 314, and paddle frames 324 by being woven or inserted through openings in the proximal collar 311, cap 314, and paddle frames 324 that are configured to receive the continuous strip of material 301. The continuous strip 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of the strip of material 301 and other portions are formed from multiple overlapping or overlying layers of the strip of material 301.

[0143] For example, FIG. 23 show's a coaptation element 310 and inner paddles 322 formed from multiple overlapping layers of the strip of material 3Ot. The single continuous strip of material 301 can start and end in various locations of the device 300. The ends of the strip of material 301 can be in the same location or different locations of the device 300. For example, in the illustrated example of FIG. 23, the strip of material 301 begins and ends in the location of the inner paddles 322.

[0144] As with the device 200 described above, the size of the coaptation element 310 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In particular, forming many components of the device 300 from the strip of material 301 allows the device 300 to be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance of the device 300 (e.g., the width of the paddle frames 324 w;hich are w ider than the coaptation element 310) at its widest is about 5 mm.

[0145] Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by International Patent Application No. PCT / US2019 / 055320 (International PatentApplication Publication No. WO 2020 / 076898) and / or any other applications incorporated herein. Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by International Patent Application No. PCT / US2019 / 055320 (International Patent Application Publication No. WO 2020 / 076898) and / or any other applications incorporated herein. International Patent Application No. PCT / US2019 / 055320 (International Patent Application Publication No. WO 2020 / 076898) is incorporated herein by reference in its entirety.

[0146] FIG. 24 illustrates an example of one of the many treatment and / or repair systems 400 for treating and / or repairing a native valve of a patient that the concepts of the present application can be applied to. The treatment and / or repair system 400 includes a delivery device 401 and a treatment and / or repair device 402.

[0147] In some implementations, the treatment device or repair device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408 e.g., clasps, clasp arms, grippers, gripping arms, latches, etc.). In one example, the paddles 406 can be integrally formed with the base assembly. For example, the paddles 406 can be formed as extensions of links of the base assembly. In the illustrated example, the base assembly 404 of the device 402 has a shaft 403, a coupler 405 configured to move along the shaft, and a lock 407 configured to lock the coupler in a stationary position on the shaft. The coupler 405 is mechanically connected to the paddles 406, such that movement of the coupler 405 along the shaft 403 causes the paddles to move between an open position and a closed position. In this way, the coupler 405 serves as a means for mechanically coupling the paddles 406 to the shaft 403 and, when moving along the shaft 403, for causing the paddles 406 to move between their open and closed positions.

[0148] In some implementations, the gripping members 408 are pivotally connected to the base assembly 404 (e.c / ., the gripping members 408 can be pivotally connected to the shaft 403, or any other suitable member of the base assembly), such that the gripping members can be moved to adjust the width of the opening 414 between the paddles 406 and the gripping members 408. The gripping member 408 can include an optional barbed portion 409 for attaching the gripping members to valve tissue when the device 402 is attached to the valve tissue. When the paddles 406 are in the closed position, the paddles engage the gripping members 408, such that, when valve tissue is attached to the barbed portion 409 of the gripping members, the paddles secure the device 402 to the valve tissue. In some implementations, the gripping members 408 are configured to engage the paddles 406 such that the barbed portion 409 engages the valve tissue member and the paddles 406 to secure the device 402 to the valve tissue member. For example, in certain situations, it canbe advantageous to have the paddles 406 maintain an open position and have the gripping members 408 move outward toward the paddles 406 to engage valve tissue and the paddles 406.

[0149] While the example shown in FIG. 24 illustrates a pair of paddles 406 and a pair of gripping members 408, it should be understood that the device 402 can include any suitable number of paddles and gripping members.

[0150] In some implementations, the system 400 includes a placement shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the device 402. In some implementations, after the device 402 is secured to valve tissue, the placement shaft 413 can be removed from the shaft 403 to remove the device 402 from the remainder of the treatment and / or repair system 400, such that the device 402 can remain attached to the valve tissue, and the delivery' device 401 can be removed from a patient’s body.

[0151] The treatment and / or repair system 400 can also include a paddle control mechanism 410, a gripper control mechanism 411, and a lock control mechanism 412. The paddle control mechanism 410 is mechanically attached to the coupler 405 to move the coupler along the shaft, which causes the paddles 406 to move between the open and closed positions. The paddle control mechanism 410 can take any suitable form, and can comprise, for example, a shaft, wire, tube, hypotube, rod, suture, line, etc. For example, the paddle control mechanism can comprise a hollow shaft, a catheter tube or a sleeve that fits over the placement shaft 413 and the shaft 403 and is connected to the coupler 405.

[0152] The gripper control mechanism 411 is configured to move the gripping members 408 such that the width of the opening 414 between the gripping members and the paddles 406 can be altered. The gripper control mechanism 411 can take any suitable form, such as, for example, a line, a suture or w ire, a rod, a catheter, a tube, a hypotube, etc.

[0153] The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 locks the coupler 405 in a stationary position with respect to the shaft 403 and can take a w ide variety of different forms and the type of lock control mechanism 412 can be dictated by the type of lock used. In examples in which the lock 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage the pivotable plate to move the plate between the tilted and substantially non-tilted positions. The lock control mechanism 412 can be, for example, a rod, a suture, a wire, or any other member that is capable of moving a pivotable plate of the lock 407 between a tilted and substantially non-tilted position.

[0154] The device 402 is movable from an open position to a closed position. The base assembly 404 includes links that are moved by the coupler 405. The coupler 405 is movablyattached to the shaft 403. In order to move the device from the open position to the closed position, the coupler 405 is moved along the shaft 403, which moves the links.

[0155] The gripper control mechanism 411 moves the gripping members 408 to provide a w ider or a narrower gap at the opening 414 between the gripping members and the paddles 406. In the illustrated example, the gripper control mechanism 411 includes a line, such as a suture, a wire, etc. that is connected to an opening in an end of the gripping members 408. When the line(s) is pulled, the gripping members 408 move inward, which causes the opening 414 between the gripping members and the paddles 406 to become wider.

[0156] In order to move the device 402 from the open position to the closed position, the lock 407 is moved to an unlocked condition by the lock control mechanism 412. Once the lock 407 is in the unlocked condition, the coupler 405 can be moved along the shaft 403 by the paddle control mechanism 410.

[0157] After the paddles 406 are moved to the closed position, the lock 407 is moved to the locked condition by the lock control mechanism 412 to maintain the device 402 in the closed position. After the device 402 is maintained in the locked condition by the lock 407, the device 402 is removed from the delivery device 401 by disconnecting the shaft 403 from the placement shaft 413. In addition, the device 402 is disengaged from the paddle control mechanism 410, the gripper control mechanism 411, and the lock control mechanism 412.

[0158] Additional features of the device 402, modified versions of the device, delivery’ systems for the dev ice, and methods for using the device and delivery system are disclosed by International Patent Application No. PCT / US2019 / 012707 (International Patent Application Publication No. WO 2019139904) and / or any other applications incorporated herein. Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by International Patent Application No. PCT / US2019 / 012707 (International Patent Application Publication No. WO 2019139904) and / or any other applications incorporated herein.International Patent Application No. PCT / US2019 / 012707 (International Patent Application Publication No. WO 2019139904) is incorporated herein by reference in its entirety.

[0159] Clasps or leaflet gripping devices disclosed herein can take a wide variety of different forms. Examples of clasps are disclosed by International Patent Application No. PCT / US2018 / 028171 (International Patent Application Publication No. WO 2018195201). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by International Patent Application No. PCT / US2018 / 028171 (International Patent Application Publication No. WO 2018195201). International Patent Application No.PCT / US2018 / 028171 (International Patent Application Publication No. WO 2018195201) is incorporated herein by reference in its entirety.

[0160] Referring to FIGS. 25A-25B, an example implementation of a treatment and / or repair device 402 has a coaptation element 3800. The device 402 can have the same configuration as the device illustrated by FIG. 24 with the addition of the coaptation element. The coaptation element 3800 can take a wide variety of different forms. The coaptation element 3800 can be compressible and / or expandable. For example, the coaptation element can be compressed to fit inside one or more catheters of a delivery system, can expand when moved out of the one or more catheters, and / or can be compressed by the paddles 406 to adjust the size of the coaptation element. In the example illustrated by FIGS. 25A and 25B, the size of the coaptation element 3800 can be reduced by squeezing the coaptation element with the paddles 406 and can be increased by moving the paddles 406 away from one another. The coaptation element 3800 can extend past outer edges 4001 of the gripping members or clasps 408 as illustrated for providing additional surface area for closing the gap of a mitral valve.

[0161] The coaptation element 3800 can be coupled to the device 402 in a variety of different ways. For example, the coaptation element 3800 can be fixed to the shaft 403, can be slidably disposed around the shaft, can be connected to the coupler 405, can be connected to the lock 407, and / or can be connected to a central portion of the clasps or gripping members 408. In some implementations, the coupler 405 can take the form of the coaptation element 3800. That is, a single element can be used as the coupler 405 that causes the paddles 406 to move between the open and closed positions and the coaptation element 3800 that closes the gap between the leaflets 20, 22 when the device 402 is attached to the leaflets.

[0162] The coaptation element 3800 can be disposed around one or more of the shafts or other control elements of the system 400. For example, the coaptation element 3800 can be disposed around the shaft 403, the shaft 413, the paddle control mechanism 410, and / or the lock control mechanism 412.

[0163] The device 402 can include any other features for a device, treatment device, repair device, implant, etc. discussed in the present application, and the device 402 can be positioned to engage valve tissue as part of any suitable treatment and / or repair system (e.y., any treatment and / or repair system disclosed in the present application, or the applications cited herein). Additional features of the device 402, modified versions of the device, deliver}' systems for the device, and methods for using the device and deliver}' system are disclosed by International Patent Application No. PCT / US2019 / 012707 (International Patent Application Publication No. WO 2019139904). Any combination or sub-combination of the featuresdisclosed by the present application can be combined w ith any combination or subcombination of the features disclosed by International Patent Application No. PCT / US2019 / 012707 (International Patent Application Publication No. WO 2019139904).

[0164] FIGS. 26-30 illustrate an example of one of the many systems for treating and / or repairing a native valve of a patient that the concepts of the present application can be applied to. Referring to FIGS. 29 and 30, the system includes a catheter assembly 1611 (e.g., a device catheter assembly, an implant catheter assembly, treatment catheter assembly, etc.) and a treatment and / or repair device 8200. Referring to FIGS. 26-28, the device 8200 includes a proximal or attachment portion 8205, paddle frames 8224, and a distal portion 8207. The attachment portion 8205, the distal portion 8207, and the paddle frames 8224 can be configured in a variety of ways.

[0165] In the example illustrated in FIG. 26, the paddle frames 8224 can be symmetric along longitudinal axis YY. However, in some implementations, the paddle frames 8224 are not symmetric about the axis YY. Moreover, referring to FIG. 26, the paddle frames 8224 include outer frame portions 8256 and inner frame portions 8260.

[0166] In some implementations, the connector 8266 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) attaches to the outer frame portions 8256 at outer ends of the connector 8266 and to a coupler 8972 at an inner end 8968 of the connector 8266 (see FIG. 28). Between the connector 8266 and the attachment portion 8205, the outer frame portions 8256 form a curved shape. For example, in the illustrated example, the shape of the outer frame portions 8256 resembles an apple shape in which the outer frame portions 8256 are wider toward the attachment portion 8205 and narrower toward the distal portion 8207. In some implementations, however, the outer frame portions 8256 can be otherwise shaped.

[0167] The inner frame portions 8260 extend from the attachment portion 8205 toward the distal portion 8207. The inner frame portions 8260 then extend inward to form retaining portions 8272 that are attached to the actuation cap 8214. The retaining portions 8272 and the actuation cap 8214 can be configured to attach in any suitable manner.

[0168] In some implementations, the inner frame portions 8260 are rigid frame portions, while the outer frame portions 8256 are flexible frame portions. The proximal end of the outer frame portions 8256 connect to the proximal end of the inner frame portions 8260, as illustrated in FIG. 26.

[0169] The w idth adjustment element 8211 (e.g., width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt, etc.) is configured to move theouter frame portions 8256 from the expanded position to the narrowed position by pulling the inner end 8968 (FIG. 28) and portions of the connector 8266 into the actuation cap 8214. The actuation element 8102 is configured to move the inner frame portions 8260 to open and close the paddles in accordance with some implementations disclosed herein.

[0170] As shown in FIGS. 27 and 28, the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211 such that a user can move the inner end 8968 inside the receiver 8912 (e.g., an internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a cylinder, tracks, etc.) to move the outer frame portions 8256 between a narrowed position and an expanded position. In the illustrated example, the inner end 8968 includes a post 8970 that attaches to the outer frame portions 8256 and a coupler 8972 that extends from the post 8970. The coupler 8972 is configured to attach and detach from both the wi th adjustment element 8211 and the receiver 8912. The coupler 8972 can take a w ide variety of different forms. For example, the coupler 8972 can include one or more of a threaded connection, features that mate w ith threads, detent connections, such as outw ardly biased arms, w alls or other portions. When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver 8912. When the coupler 8972 is detached from the width adjustment element 8211, the coupler is secured to the receiver. The inner end 8968 of the connector can, however, be configured in a variety of w ays. Any configuration that can suitably attach the outer frame portions 8256 to the coupler to allow’ the width adjustment element 8211 to move the outer frame portions 8256 between the narrowed position and the expanded position can be used. The coupler can be configured in a variety of w ays as w ell and can be a separate component or be integral with another portion of the device, e.g., of the connector or inner end of the connector.

[0171] The width adjustment element 8211 allows a user to expand or contract the outer frame portions 8256 of the device 8200. In the example illustrated in FIGS. 27 and 28, the width adjustment element 8211 includes an externally threaded end that is threaded into the coupler 8972. The width adjustment element 8211 moves the coupler in the receiver 8912 to adjust the w idth of the outer frame portions 8256. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages the inner surface of the receiver 8912 to set the width of the outer frame portions 8256.

[0172] In some implementations, the receiver 8912 can be integrally formed with a distal cap 8214. Moving the cap 8214 relative to a body of the attachment portion 8205 opens and closes the paddles. In the illustrated example, the receiver 8912 slides inside the body of the attachment portion. When the coupler 8972 is detached from the width adjustment element 8211, the width of the outer frame portions 8256 is fixed while the actuation element 8102moves the receiver 8912 and cap 8214 relative to a body of the attachment portion 8205. Movement of the cap can open and close the device in the same manner as some of the examples disclosed above.

[0173] In the illustrated example, a driver head 8916 is disposed at a proximal end of the actuation element 8102. The driver head 8916 releasably couples the actuation element 8102 to the receiver 8912. In the illustrated example, the width adjustment element 8211 extends through the actuation element 8102. The actuation element is axially advanced in the direction opposite to direction Y to move the distal cap 8214. Movement of the distal cap 8214 relative to the attachment portion 8205 is effective to open and close the paddles, as indicated by the arrow’s in FIG. 27. That is, movement of the distal cap 8214 in the direction Y closes the device and movement of the distal cap in the direction opposite to direction Y opens the device.

[0174] Also illustrated in FIGS. 27 and 28, the width adjustment element 8211 extends through the actuation element 8102, the driver head 8916, and the receiver 8912 to engage the coupler 8972 attached to the inner end 8968. The movement of the outer frame portions 8256 to the narrowed position can allow the device or implant 8200 to maneuver more easily into position for deployment and / or implantation in the heart by reducing the contact and / or friction between the native structures of the heart— e.g., chordae— and the device 8200. The movement of the outer frame portions 8256 to the expanded position provides the anchor portion of the device 8200 with a larger surface area to engage and capture leaflet(s) of a native heart valve.

[0175] Referring to FIGS. 29 and 30, an example of a catheter assembly 1611 {e.g., a device catheter assembly, an implant catheter assembly, treatment catheter assembly, etc.) in which clasp actuation lines 624 extend through a handle 1616, the actuation element 8102 is coupled to a paddle actuation control 1626, and the width adjustment element 8211 is coupled to a paddle width control 1628. A proximal end portion 1622a of the shaft or catheter of the catheter assembly 1611 can be coupled to the handle 1616, and a distal end portion 1622b of the shaft or catheter can be coupled to the device 8200. The actuation element 8102 can extend distally from the paddle actuation control 1626, through the handle 1616, through the delivery shaft or catheter of the catheter assembly 1611, and through the proximal end of the device 8200, where it couples with the driver head 8916. The actuation element 8102 can be axially movable relative to the outer shaft of the catheter assembly 1611 and the handle 1616 to open and close the device.

[0176] The width adjustment element 8211 can extend distally from the paddle width control 1628, through the paddle actuation control 1626 and through the actuation element 8102 (and, consequently, through the handle 1616, the outer shaft of the implant catheterassembly 1611, and through the device 8200), where it couples with the movable coupler 8972. The width adjustment element 8211 can be axially movable relative to the actuation element 8102, the outer shaft of the implant catheter assembly 1611, and the handle 1616. The clasp actuation lines 624 can extend through and be axially movable relative to the handle 1616 and the outer shaft of the implant catheter assembly 1611. The clasp actuation lines 624 can also be axially movable relative to the actuation element 8102.

[0177] Referring to FIGS. 29 and 30, the width adjustment element 8211 can be releasably coupled to the coupler 8972 of device 8200. Advancing and retracting the width adjustment element 8211 with the paddle width control 1628 w idens and narrows the paddles. Advancing and retracting the actuation element 8102 w ith the paddle actuation control 1626 opens and closes the paddles of the device.

[0178] In the examples of FIGS. 29 and 30, the catheter or shaft of the catheter assembly 1611 is an elongate shaft extending axially between the proximal end portion 1622a, which is coupled to the handle 1616, and the distal end portion 1622b, which is coupled to the device 8200. The outer shaft of the catheter assembly 1611 can also include an intermediate portion 1622c disposed between the proximal and distal end portions 1622a, 1622b.

[0179] As previously mentioned, mitral regurgitation can be reduced by a coaptation element or device that fills the valve’s leak gaps and lets the native leaflets seal against a body. In one implementation, the native leaflets drive the opening and closing of the body and, upon closure, fill gaps between the anterior and posterior of the leaflets, including full or nearly full edge-to-edge coverage of the gaps. The coaptation element or device can conform to the native leaflet anatomy. In some respects, the coaptation element or device acts as a space / gap filler, or leaflet extension, to plug any areas where regurgitation was occurring in the native leaflets. The coaptation element’s body can collapse, compress, or close under leaflet movement closing the heart valve. In this closed state, the coaptation body can fill or substantially fill gap(s) causing regurgitation to thereby restrict or inhibit regurgitant fluid passage through the closed valve. The coaptation body can then expand or open under leaflet movement opening the heart valve, which accordingly allows fluid passage through the valve. Hence, a coaptation element that is driven, moved or changed by the native leaflet movement can provide a leaflet extension and / or reinforcement to reduce regurgitation while still allowing normal valve function.

[0180] FIGS. 31-34 schematically illustrate one implementation of a heart valve device having a coaptation portion 104 that complies to native leaflet anatomy and is driven by leaflet movement. Referring to FIGS. 31 and 32, a mitral valve MV is shown in the open (or diastolic) position and having a coaptation portion 104 therein. Coaptation portion 104 includes a body 3100 that is anchored to native leaflets 20 and 22. In the open or diastolicconfiguration shown in FIGS. 31 and 32, body 3100 is also in an open state and has a central space 3106 that is open to fluid passage therethrough. The native heart valve can also include side or edge openings 3102 and 3104 between the native valve anatomy and the body 3100 which can also allow fluid passage. In this open configuration, the body 3100 includes a width Wi.

[0181] FIGS. 33 and 34 schematically illustrate the mitral valve MV in the closed (or systolic) position. This occurs when native leaflets 20 and 22 move to close the valve. In this closed or systolic position, body 3100 collapses or compresses under the closing force of the native leaflets 20 and 22 to close central space 3106. When central space 3106 is closed, fluid passage through the native heart valve is restricted or blocked. That is, regurgitation through the native heart valve is reduced or eliminated due to the space or gap filling of body 3100. As body 3100 is collapsed or compresses, it conforms to the native leaflet and valve anatomy. In this implementation, the width of body 3100 expands to a width W2 that can extend into side openings 3102 and 3104 of the native heart valve to block or inhibit blood flow through these openings 3102 and 3104. Thus, in comparison, body 3100 has width W2 in the closed state that is greater than the width Wi in the open state (see FIG. 31). This can reduce leakage or regurgitation through the area where the side openings 3102 and 3104 were present during diastole. The amount of extension can be more or less than the amount shown. In essence, any amount of extension provides a degree of reduction of regurgitation through these side openings.

[0182] Thus, the coaptation portion 104 and its body 3100 allow native leaflets 20 and 22 to drive the opening and closing of the body 3100 without requiring the leaflets to conform to the specific shape of the coaptation portion 104 and body 3100. This is because the coaptation portion 104 and body 3100 comply to the native anatomy of the leaflets and collapse (or compress) and expand under native leaflet forces. For damaged or diseased native leaflets, the coaptation portion 104 and body 3100 can provide a leaflet extension and / or reinforcement to assist in the closing of the native valve to reduce regurgitation therethrough.

[0183] FIGS. 35-36 schematically illustrate one implementation of deliveiy and deployment within the native mitral valve MV of a repair device 3500 having the described coaptation portion 104. Referring to FIG. 35, a delivery tube / catheter is inserted into the left atrium LA through the septum and the implant / device 3500 is deployed from the delivery catheter / tube. However, in some implementations the delivery catheter or tube can be inserted into the left atrium, the right atrium (e.g., for tricuspid implantation), the left ventricle, or the right ventricle (e.g., for tricuspid implantation) and can be inserted via a variety of different paths (e.g., transapically). In some implementations, the implant / device3500 is moved into position w ithin the mitral valve MV into the ventricle LV and partially opened so that the leaflets 20, 22 can be grasped. For example, a steerable catheter can be advanced and steered or flexed to position the implant / device 3500. The device or implant catheter can control the anchors 108 to secure the mitral valve leaflets 20, 22 in the anchors 108 thereby fixing the device 3500 to the native leaflets 20 and 22.

[0184] FIGS. 37A-37C schematically illustrate top, side and sectional views of an example of a repair device similar to that of FIGS. 31-32 in the open (or diastolic) state. This implementation includes the coaptation portion 104 having a body 3100. The body can a variety of lengths, widths, and heights. For example, the body 3100 can extend from the mitral annulus to the chordae tendineae or between any two or more points therebetween. Thus, body 3100 can be extended higher than that shown in FIG. 37B,C in the direction of the mitral annulus, or can be shortened to not reach the native valve edges or the region near the chordae tendineae. The body 3100 can include, for example, a frame 3700 having an outer portion 3702 and an inner portion 3704. The frame 3700 can be incorporated into the body 3100 as an integral structural component thereof such as, for example, w alled perimeter of body 3100. In this case, body 3100 can be made of a polymer, metallic or other similar material having structural walls that can compress, bend and / or flex to allow body 3100 to resiliently collapse or compress from the open state show n in FIGS. 31-32 to the closed state shown in FIGS. 33-34. In other implementations, the frame 3700 can be a separate component that is part of or incorporated into a body 3100 assemblage.

[0185] The outer portion 3702 and inner portion 3704 of the frame 3700 can include first and second cover layers or materials, respectively. A first cover material can be used on the outer portion 3702 of the frame and a second cover material can be used on the inner portion 3704 of the frame. The cover materials can be the same or different. In one implementation, the cover materials are made of an anti-thrombotic material or cloth. In one or more implementations, the outer cover material or cloth can provide a scaffold-like arrangement allowing leaflet tissue to heal or grow thereinto to provide further fixation or attachment. The covers can be according to any of the previously described materials and configurations.

[0186] The central space 3106 can be located within body 3100 or perimeter thereof. The body 3100 and / or central space 3106 can be any one of a number of shapes or geometries including, for example, annular, cylindrical, conical, frustum, elliptical, D-shaped, etc. The general shape of the body 3100 can be, for example, such that it conforms to the native leaflet anatomy. Hence, the shapes and geometries disclosed herein are illustrative and others can be used.

[0187] Anchors 108 are provided for fixating, attaching, or connecting the coaptation portion 104 to the native leaflets. The anchors 108 can be according to any of the previously described implementations and examples including, for example, sutures, barbs (e.g. on the body 3100 or on anchors), clips, adhesives, clasps, grips, paddles, etc., and combinations / assemblies of any one or more of the foregoing. The anchors 108 can include covers as previously described thereover that partially and / or fully cover the anchors. Generally, one or more anchors are provided for each leaflet. Hence, anchors 108 can be of any configuration that fixates or attaches the coaptation portion 104 to the native leaflets.

[0188] In the open (or diastolic) state shown in FIGS. 37A-37C, the leaflets 20 and 22 open the heart valve, which allows for fluid (e.g., blood) flow or passage through the open central space 3106. FIG. 37C schematically shows a cross-sectional view taken along section 37C-37C in FIG. 37A and illustrates fluid passage 3706 through the arrangement.

[0189] FIGS. 38A-38B schematically illustrate top and sectional views of the implementation of FIGS. 37A-37C in the closed (or systolic) state. In this state, the leaflets 20 and 22 have moved to the closed position and collapsed or compressed the body 3100. This closes the central space 3106 and restricts or blocks fluid passage or flow through the heart valve. As shown in FIG. 38A, when body 3100 collapses or compresses, its width expands and extends into the side openings 3102 and 3104 to further restrict or block fluid passage or flow therethrough. As previously described, any extension into side openings 3102 and 3104 provides a further reduction in leakage or regurgitation. In some implementations, the collapsing or compressing of the body 3100 brings opposing sections of the inner portion 3704 (or cover) together to close the central space 3106. In other implementations, any inner portion of the body 3100 can be brought together to close central space 3106, whether a cover material is present or not.

[0190] FIGS. 39A-39C illustrate top, side and perspective views of another implementation of a repair device 3900 in the open and closed states. FIG. 39A shows the device 3900 in the open state, which allows fluid passage through the central space 3106. In this implementation, the outer portion 3702 includes a first cover material, which can be in the form of a cloth fabric or equivalent. The inner portion 3704 includes a second cover material in the form of a fine cloth fabric, or equivalent. However, any conformable implantable fabric or coating as previously described that provides sealing or inhibits leakage can be used on either the outer portion 3702 or inner portion 3704 of the body 3100, including the same material on both. As also shown in FIG. 39A, the inner portion 3704 covering extends around the inner perimeter of the body 3100 and can extend to varying degrees into the central space 3106 while still leaving the space open.

[0191] FIG. 39B shows the repair device 3900 in the closed state, which restricts or blocks fluid passage through the central space 3106. In the implementation shown, body 3100 has been compressed or collapsed by the closure force of the native leaflets 20 and 22 to close the central space 3106. As previously described, the central space 3106 is closed by opposing sides of the inner portion 3704 of the body 3100 coming together to close the space. This closure can include the parts of the inner portion 3704 cover (or any other portion of the body 3100) coming together to close the central space 3106. FIG. 39B also shows that the anchors 108 can optionally be located offset from each other by an offset distance 3902. The offset distance 3902 can be any distance sufficient so anchors 108 do not come into contact with each other when the body 3100 closes (e.g., collapses or compresses). In other implementations, the anchors 108 do not need to be offset. In some implementations the anchors are not offset if, for example, they are not likely to come into contact with each other or when anchors 108 and / or body 3100 have sufficient covers that buffer or space apart the anchors from contacting, or the anchors are vertically positioned such that native valve closure does not bring them into contact.

[0192] FIGS. 39A and 39B also illustrate that the body 3100 changes in width (or shape) as it moves from an open state (FIG. 39A) to a closed state (FIG. 39B). In the open (or diastolic) state, the body 3100 has a width Wi as show n in FIG. 39A (see also FIG. 31). In the closed (or systolic) state, w hen the native leaflets 20 and 22 move to close the valve, the body 3100 expands (or changes shape) to a width W2, as shown in FIG. 39B (see also FIG. 33). As previously described, since width W2 is larger than width Wi, the body 3100 can extend into the side openings 3102 and 3104 of the heart valve (see FIGS. 31-34) to reduce leakage or regurgitation in those locations.

[0193] FIG. 39C shows a perspective view- of the repair device with anchors 108 schematically fixated to leaflets 20 and 22. In the implementation shown, the anchors 108 loop or bend around the edge(s) of the leaflet and extend up the inner and outer sides of the leaflet. As previously described, anchors 108 and fixation can be according to a variety of forms, such as, for example, any of the forms disclosed herein.

[0194] FIGS. 40A-40B illustrate top view-s of a repair device 4000 for a tricuspid valve in the open and closed states. The device can be similar to that of FIGS. 39A-39C. One difference is that the device 4000 includes the ability to be fixated to three leaflets. In this regard, three anchors 108 are provided (e.g., one for each leaflet). The operation is similar to that of the implementation shown in FIGS. 39A-39C. That is, in the open (or diastolic) state shown in FIG. 40A, the central space 3106 permits fluid passage through the space. In the closed (or systolic) state shown in FIG. 40B, when the native leaflets (e.g., 3 leaflets) move toclose the heart valve, the body 3100 collapses or compresses to close the central space 3106 to restrict or block fluid passage therethrough.

[0195] The coaptation element 104 can be configured to assume a different shape when the native tricuspid valve is in systole, as compared to a coaptation element for the mitral valve. For example, the coaptation element 104 can be compressed to have a reduced size generally circular shape, a general triangular shape, a generally clover shape and / or a combination of these shapes when implanted in the tricuspid valve. The repair device is applicable to heart valves having two or three leaflets.

[0196] FIGS. 41A-41B show perspective views of another implementation of a heart valve repair device having a discrete frame 3700. In this example, frame 3700 includes a plurality of frame member portions 4100, 4102, 4104, 4106, 4108, 4110, 4112, 4114, 4116, 4118, 4120, 4122, 4124, 4126, 4128, 4130, 4132, 4134 and plurality of bending, flex, or hinge portions 4136, 4138, 4140, 4142, 4144, 4146, 4148, 4150, 4152, 4154, 4156, 4158, 4160, 4162. The collective portions are arranged so that a bending, flexing or hinge portion is present between each frame member portion. The frame member portions can themselves also bend or flex as necessary. This allows the frame 3700 to bend or flex and resiliently return to its native or unbent state (e.g., acting spring-like). This allows the frame 3700 (and body 3100) to collapse or compress, as previously described, from an open state to a closed state. The anchors 108 can be connected to the frame 3700 via any number of ways including suturing, braiding, adhering, welding, etc. In other implementations, anchors 108 can be extensions of one or more frame member portions or separate members of the frame.

[0197] The plurality of frame member portions 4100-4134 and plurality of bending, flex, or hinge portions 4136-4162 can be arranged in zig-zag frame configuration to form a perimeter around central space 3106. While the zig-zag configuration is shown with the frame member portions generally linear and angularly connected to other frame member portions, other configurations can also be used. This includes, for example, a sinuous or “U” shaped configuration whereby the frame member portions and the bending, flex, or hinge portions are curved and in a sinuous connecting arrangement. Further, to generally follow the native leaflet (or valve) anatomy, frame 3700 can have a tapered, conical or frustum shape that is more open or wider at one end 4164 and then progressively narrows toward the other end 4166. The frame 3700 can be made of metal (e.g., nitinol), polymers, or other similar materials. Also, in other implementations, more or less frame member portions and hinge portions can be used such as, for example, a braided frame arrangement. The braiding can vary from coarse to fine depending on the materials, structural strength, and resiliency needed or desired. Further, frame 3700 need not be tapered but can be straight. In such a case, body 3100 incorporating the frame 3700 can be tapered while the frame is not. Furtheryet, frame 3700 can be made from a single piece of material or multiple components assembled or connected together to form a whole. Thus, the exact shape or arrangement of the frame is not critical so long as it provides the described functionality.

[0198] FIGS. 42A-42C illustrate one implementation of a repair device delivery system and configuration 4200. Referring to FIG. 42A, a catheter 4202 or similar lumen type device is provided. The coaptation portion 104 and anchors 108 are arranged inside the catheter passageway. The coaptation portion 104 is collapsed or compressed (or crimped) to its smaller size so that it can fit and be moved within the catheter 4202 passageway (by, for example, a controllable pusher or mover). In this implementation, the anchors 108 are arranged in a transport or delivery' configuration. This configuration has the anchors 108 disposed in a substantially straight or unbent condition to facilitate placement and movement through the catheter 4202. As has been described, anchors 108 can be made of a shape-set material such as, for example, nitinol or other material, that allows anchors 108 to change shape and then return to their original shape-set configuration. Thus, in FIG. 42A, the anchors 108 have been flexed away from their original shape-set configuration (e.g., curved or bent) that shown (e.g., substantially straight). In this implementation, the internal walls of the catheter 4202 maintain the anchors 108 in this delivery' or transport configuration.

[0199] Referring now to FIG. 42B, the repair device has partially moved out of catheter 4202. More particularly, anchors 108 have moved out of the catheter 4202. Because anchors 108 are shape-set, as they emerge from the catheter 4202, they begin to return to their original shape because the walls of the catheter 4202 are no longer present. In the implementation shown, the shape-set of the anchors 108 is one having a curvature or bend(s) that facilitate fixation to the leaflets. Thus, in FIG. 42B, the anchors 108 have advanced out of the catheter 4202 and have returned to their original shape or configuration or partially returned to their original shape or configuration. The catheter can be moved such that the anchors are disposed around the native leaflets 20, 22.

[0200] Referring now to FIG. 42C, the entire repair device has moved out of catheter 4202. More specifically, the coaptation portion 104 has been advanced out of the catheter 4202. In this scenario, the coaptation portion 104 expands from its crimped delivery1state due the previously described resiliency (or shape-set) of the body 3100 (and or its frame 3700) to its open state because its body 3100 is resilient (or shape-set) to be normally open. At this point in the delivery, anchors 108 can be secured to the leaflets 20 and 22 between the expanded body 3100 and the anchors in their original shape or configuration.

[0201] FIGS. 43A-43C illustrate another implementation of repair device deliverysystem and configuration 4300. This configuration is similar to that shown in FIGS. 42A-42C, except that it includes a second catheter 4302 and recesses 4304 and 4306 on the end portion of catheter 4202. Referring now to FIG. 43A, the recesses 4304 and 4306 create a space between the inner catheter 4202 and the outer catheter 4302 allow ing the anchors 108 to be in a curved or bent state (compared to the generally straight configuration of FIG. 42A) during delivery. This configurations requires less of a change in shape of the anchors 108 as they emerge from the delivery catheter(s) and reduces the length of the device as it is delivered through the patient’s vasculature.

[0202] Referring to FIG. 43B, outer catheter 4302 has been retracted (or inner catheter 4202 has been extended) so as to release the anchors 108 from the recesses 4304 and 4306. This allows anchors 108 to return to their original shape-set configuration (as previously described) and to be positioned around leaflets 20 and 22. In FIG. 43C, the entire repair device has moved out of catheter 4202 and the coaptation portion 104 expands from its crimped state to its open state (as previously described). At this point in the delivery, anchors 108 can be secured to the leaflets 20 and 22 betw een the expanded body 3100 and the anchors in their original shape or configuration.

[0203] In any of the previously described deliver}- systems and methods (e.g., FIGS.42A-42C and 43A-43C), anchors 108 can include actuated paddles to assist in the fixation process. The actuated paddles can be according to any of the previously described implementations. This includes two or more simultaneously opened / closed gripping members, independently opened / closed gripping members, tvv or more simultaneously opened paddles, and / or independently actuated paddles (e.g., see FIGS. 8-30 and associated descriptions).

[0204] FIGS. 44A-44B illustrate one implementation of a secondary repair configuration and arrangement 4400. FIG. 44A shows a repair device having coaptation portion 104 and anchors 108 (according to any of the previously described implementations and examples) fixated to native leaflets 20 and 22 of a heart valve. A second valve repair device 4402 is also shown. In FIG. 44A, the second valve repair device 4402 is shown in its compressed or crimped delivery or transport state. Delivery catheters and other components have not been shown for the sake of clarity. The second valve repair device 4402 can be any transcatheter replacement valve device such as, for example, a SAPIEN transcatheter heart valve system manufactured by Edwards Lifesciences Corporation of Irvine, California, U.S.A. FIG. 44B shows that the secondary valve repair device 4402 can be implanted in combination with the first heart valve repair device (e.g., coaptation portion 104 and anchors 108). In this state, the second valve repair device 4402 can be inserted into a heart valve already having a repair device affixed thereto. For example, the second valve repair device 4402 can be affixed to, for example, the inner section of the coaptation portion 104 of the initial repair device. In otherimplementations, the fixation can be to the leaflets 20 and 22 in alternative or in addition to the coaptation portion 104.

[0205] Hence, mitral regurgitation can be reduced by the coaptation devices disclosed herein that fill a native valve’s leak gaps. And, further, native leaflets are allowed to seal against a body of the repair device. The native leaflets drive the opening and closing of the body and upon closure can fill or substantially fill gaps between the anterior and posterior of the leaflets, including full or nearly full edge-to-edge coverage. The coaptation device conforms to the native anatomy of the one or more leaflets. In some respects, the coaptation device acts as a space / gap filler or leaflet extension to plug any areas where regurgitation was occurring in the native leaflets without forcing the native leaflet anatomy to comply with the shape of the repair device.

[0206] In operation, the coaptation body can collapse or close under leaflet movement to close the heart valve. In this closed state, the coaptation body fills any gap(s) causing regurgitation to thereby restrict fluid passage through the closed valve. The coaptation body can then expand or open under leaflet movement to open the heart valve, which allows fluid passage through the valve.

[0207] In any of the previous implementations, the geometry or amount of bending or curvature can be used to regulate the amount of resiliency or spring force provided by the components or portions. Additionally, the width and / or thickness of the material (e.g., nitinol) can also be used to regulate the amount of resiliency or spring force provided.Further yet, shape-setting or non-shape-setting can also be used to regulate the amount of resiliency or spring force provided. Any one or more of these techniques can be used in combination to obtain the desired resiliency and / or spring force.

[0208] Any of the various systems, assemblies, devices, components, apparatuses, etc. in this disclosure can be sterilized {e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0209] While various inventive aspects, concepts and features of the disclosures can be described and illustrated herein as embodied in combination in the examples herein, these various aspects, concepts, and features can be used in many alternative examples, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present application. Still further, w hile various alternative examples as to thevarious aspects, concepts, and features of the disclosures— such as alternative materials, structures, configurations, methods, devices, and components, alternatives as to form, fit, and function, and so on— may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative examples, whether presently known or later developed. Those skilled in the art can readily adopt one or more of the inventive aspects, concepts, or features into additional examples and uses within the scope of the present application even if such examples are not expressly disclosed herein.

[0210] Additionally, even though some features, concepts, or aspects of the disclosures may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary7unless expressly7so stated. Still further, example or representative values and ranges may be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only7if so expressly stated.

[0211] Moreover, while various aspects, features and concepts may7be expressly identified herein as being inventive or forming part of a disclosure, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a specific disclosure, the disclosures instead being set forth in the appended claims. Descriptions of example methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. The words used in the claims have their full ordinary meanings and are not limited in any w ay by the description of the examples in the specification.

Claims

WHAT IS CLAIMED IS:

1. A heart valve repair device comprising: a plurality of anchors; a collapsible body connected to the anchors; the body comprising an inner space having: a first state that is an open state allowing fluid passage therethrough; and a second state that is a collapsed state restricting fluid passage.

2. The heart valve repair device of claim 1 wherein the body comprises a first state w idth and a second state width and wherein the second state width is greater than the first state width.

3. The heart valve repair device of any of claims 1-2 wherein the anchors are configured to fixate the repair device to leaflet tissue of a heart valve.

4. The heart valve repair device of any one of claims 1-2 wherein the body is configured to collapse during systolic movement of a leaflet.

5. The heart valve repair device of any one of claims 1-2 wherein the body is configured to open during diastolic movement of a leaflet.

6. The heart valve repair device of any one of claims 1-5 wherein the body comprises a plurality of frame members and a plurality of hinged portions.

7. The heart valve repair device of any one of claims 1-6 wherein the body comprises at least one hinged portion between at least two frame members.

8. The heart valve repair device of any one of claims 1-7 further including one or more cover layers disposed on an interior and an exterior of the body.

9. The heart valve repair device of any one of claims 1-8 further including one or more covers having a radial thickness extending into the inner space.

10. The heart valve repair device of claim 1 further including one or more covers disposed on an interior of the body that are configured to close the inner space during systolic movement of a heart valve.

11. The heart valve repair device of claim 1 further including one or more covers disposed on an interior of the body that are configured to open the inner space during diastolic movement of a heart valve.

12. A heart valve repair device comprising: a plurality of anchors for fixating the device to the heart valve; a body connected to the anchors; the body comprising:a plurality of frame member portions including first and second frame member portions; at least one flex portion between the first and second frame member portions; a body inner space having: a first state that is an open state allowing fluid passage; and a second state that is a collapsed state restricting fluid passage.

13. The device of claim 12 wherein the body comprises a first state width and a second state width and wherein the second state width is greater than the first state w idth.

14. The device of any one of claims 12-13 wherein the body is configured to collapse during systolic movement of the heart valve.

15. The device of any one of claims 12-14 wherein the body is configured to open during diastolic movement of the heart valve.

16. The device of any one of claims 12-15 wherein the body comprises a resiliency to the first state that is the open state.

17. The device of any one of claims 12-15 wherein the body comprises a resiliency that can be overcome by a systolic movement of the heart valve to place the body in the second state that is the collapsed state.

18. The device of any one of claims 12 and 14-17 wherein the body comprises a cylindrical shape.

19. The device of any one of claims 12 and 14-17 wherein the body comprises a frustum shape in the first state that is open to fluid.

20. The device of any one of claims 12 and 14-17 further comprising one or more cover layers having a first cover material on an exterior of the body and a second cover material on an interior of the body.

21. The device of any one of claims 12-20 wherein the anchors each comprise an inner arm and an outer arm.

22. A system for heart valve repair comprising: a delivery7system comprising one or more catheters and a control handle; a valve repair device coupled to the delivery sy stem, wherein the valve repair device comprises: a plurality’ of anchors for fixating the device to the heart valve; a body’ connected to the anchors, the body comprising: a plurality of frame member portions including first and second frame member portions;at least one flex portion between the first and second frame member portions; a body inner space having: a first state that is an open state allowing fluid passage; and a second state that is a collapsed state restricting fluid passage.

23. The system of claim 22 w herein the body comprises a first state width and a second state width and wherein the second state width is greater than the first state width.

24. The system of any one of claims 22-23 wherein the body is configured to collapse during systolic movement of the heart valve.

25. The system of any one of claims 22-24 w herein the body is configured to open during diastolic movement of the heart valve.

26. The system of any one of claims 22-25 wherein the body comprises a resiliency to the first state that is the open state.

27. The system of any one of claims 22-25 wherein the body comprises a resiliency that can be overcome by a systolic movement of the heart valve to place the body in the second state that is the collapsed state.

28. The system of any one of claims 22 and 24-27 w herein the body comprises a cylindrical shape.

29. The system of any one of claims 22 and 24-27 w herein the body comprises a frustum shape in the first state that is open to fluid.

30. The system of any one of claims 22 and 24-27 further comprising one or more cover layers having a first cover material on an exterior of the body and a second cover material on an interior of the body.

31. A simulated method of repairing of a heart valve comprising: attaching a repair device to one or more leaflets of a simulated heart valve; opening a central space of the repair device under diastolic movement of the simulated heart valve; and closing the central space of the repair device under systolic movement of the simulated heart valve.

32. The simulated method of claim 31 wherein closing the central space of the repair device under systolic movement of the simulated heart valve comprises expanding a width of a body of the repair device.33- The simulated method of any one of claims 31-32 wherein closing the central space of the repair device under systolic movement of the simulated heart valve comprises collapsing a body of the repair device.

34. The simulated method of any one of claims 31-33 wherein opening the central space of the repair device under diastolic movement of the simulated heart valve comprises expanding a body of the repair device to create the open central space.

35. The simulated method of claim 31 wherein closing the central space of the repair device under systolic movement of the simulated heart valve comprises the leaflets of the simulated heart valve pushing on a body of the repair device.

36. The simulated method of claim 31 wherein closing the central space of the repair device under systolic movement of the simulated heart valve comprises allowing a body of the repair device to expand to create the open central space.

37. The simulated method of claim 31 wherein opening the central space of the repair device under diastolic movement of the simulated heart valve comprises expanding a body of the repair device to create the open central space.

38. The simulated method of claim 31 wherein closing the central space of the repair device under systolic movement of the simulated heart valve comprises bending portions of a body of the repair device.

39. The simulated method of claim 31 wherein opening the central space of the repair device under diastolic movement of the simulated heart valve comprises expanding portions of a frame of a body of the repair device to create the open central space.

40. The simulated method of claim 31 wherein closing the central space of the repair device under systolic movement of the simulated heart valve comprises the leaflets of the simulated heart valve bending portions of a frame of a body of the repair device.

41. The simulated method of claim 31 wherein closing the central space of the repair device under systolic movement of the simulated heart valve comprises the leaflets of the simulated heart valve deforming portions of a body of the repair device.

42. The simulated method of claim 31 wherein closing of the central space of the repair device under systolic movement of the simulated heart valve comprises moving portions of a cover material on a body of the repair device closer together.

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