Sensing heart valve repair device

Abstract

The sensing valve repair system includes a delivery system and a heart valve repair device. The delivery system is configured to deploy the heart valve repair device. The sensing valve repair system has a first sensor associated with one or more of the delivery system and the valve repair device. The first sensor is configured to sense a characteristic of the atrium. The characteristic sensed by the first sensor can be sensed proximal, or at a proximal end, of the valve repair device. The sensing valve repair system has a second sensor associated with one or more of the delivery system and the valve repair device. The second sensor is configured to sense a characteristic of the ventricle. The characteristic sensed by the second sensor can be sensed distal, or at a distal end, of the valve repair device.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 63 / 245,731, entitled "Sensing Heart Valve Repair Devices," filed September 17, 2021, and U.S. Provisional Application No. 63 / 223,904, entitled "Sensing Heart Valve Repair Devices," filed July 20, 2021, each of which is incorporated by reference in its entirety for all purposes. [Background technology]

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring forward flow for adequate blood supply through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc., and thus can become less effective. Such damage to the valves can result in serious cardiovascular problems or even death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and complications can occur. Transvascular techniques can be used to introduce and implant prosthetic devices or implants in a much less invasive manner than open-heart surgery. As an example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, advancing the catheter 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 prosthetic device or implant within the tricuspid valve, starting similarly to the transseptal technique but not puncturing the septum, and instead directing a delivery catheter within the right atrium toward the tricuspid valve.

[0003] A healthy heart has an overall conical shape that tapers toward the apex and base. The heart is a four-chambered structure that includes the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure than other native heart valves. The mitral valve includes an annulus, which is a circular portion of native valve tissue that surrounds the mitral valve opening, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle. The mitral annulus may form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape with major and minor axes. The anterior leaflet is larger than the posterior leaflet, so that when they are closed together, a roughly "C" shaped boundary may be formed between the abutting sides of the leaflets.

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve that allows blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle relaxes (also called "ventricular diastole" or "diastole"), oxygen-rich blood that has collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), the rising blood pressure in the left ventricle forces the two leaflets side-to-side together, thereby closing off the one-way mitral valve and preventing blood from flowing back into the left atrium, but instead expelling blood from the left ventricle through the aortic valve. To prevent the leaflets from prolapsing under pressure and folding back through the mitral annulus into the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0005] Valve regurgitation involves a valve inappropriately 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 during the systolic phase of heart contraction, allowing blood to flow from the left ventricle into the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, papillary muscle insufficiency, stretching of the mitral annulus from dilation of the left ventricle, or a combination of these. Mitral regurgitation in the center of the leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the leaflets' commissures (i.e., where the leaflets meet) 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, so the valve does not close and regurgitation is present. Tricuspid regurgitation is similar but can be on the right side of the heart. Summary of the Invention

[0006] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features contained within an example of this summary are not required by the claims unless the claims explicitly recite those features. Also, features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure can be combined in various manners. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein. [Means for solving the problem]

[0007] Disclosed herein are sensing valve repair devices or implants and sensing valve repair systems that include one or more sensors that are configured to sense a property, such as pressure.

[0008] The sensing valve repair device includes a valve repair component and one or more sensors. The sensing valve repair device is configured to sense a characteristic, such as pressure, at a proximal end of the valve repair component. The sensing valve repair device is configured to sense a characteristic, such as pressure, at a distal end of the valve repair component.

[0009] In some implementations, the sensing valve repair device includes a valve repair component, a first sensor, and a second sensor. The valve repair component has a proximal end and a distal end. The first sensor is connected to the valve repair component and configured to sense a property at the proximal end of the valve repair component. The second sensor is connected to the valve repair component and configured to sense a property at the distal end of the valve repair component.

[0010] In some examples, a pressure gradient across a native valve (e.g., mitral valve, tricuspid valve, etc.) is determined. A valve repair device can be within the native valve such that a first end of the valve repair device is in communication with blood in the atrium and a second end of the valve repair device is in communication with blood in the ventricle. The pressure of the blood in the atrium is sensed with the valve repair device. The pressure of the blood in the ventricle is sensed with the valve repair device.

[0011] In some implementations, an implantable prosthetic device or implant includes at least a first sensor disposed on the device, the first sensor configured to determine a proximal pressure, determine a distal pressure, and calculate a pressure gradient based on the proximal pressure and the distal pressure.

[0012] In some implementations, the sensing valve repair system includes a delivery system and a heart valve repair device delivered by the delivery system. In some implementations, the sensing valve repair system includes a first and a second sensor. In some implementations, the first and the second sensors are associated with and / or part of the delivery system. In some implementations, the first sensor is associated with and / or part of the delivery system and the second sensor is associated with and / or part of the valve repair device. In some implementations, the second sensor is associated with and / or part of the delivery system and the first sensor is associated with and / or part of the valve repair device. The first sensor is configured to sense a property proximal to or at a proximal end of the valve repair device and the second sensor is configured to sense a property distal to or at a distal end of the valve repair device.

[0013] In some implementations, the sensing valve repair system includes a delivery system, a valve repair device, and a first and second sensor. The delivery system includes a steerable catheter and an implant catheter received inside the steerable catheter. The valve repair device is coupled to the implant catheter. The first sensor is associated with one or more of the delivery catheter, the implant catheter, and the valve repair device. The first sensor is configured to sense a characteristic proximal or at a proximal end of the valve repair device. The second sensor is associated with one or more of the delivery system and the valve repair device. The second sensor is configured to sense a characteristic distal or at a distal end of the valve repair device.

[0014] A method of sensing a pressure gradient across a native valve is disclosed. In some implementations, the method includes implanting a valve repair device into the native valve using a delivery system. One or more components of the delivery system and a first end of the valve repair device are in communication with blood in an atrium. At least one of the components of the delivery system and a second end of the valve repair device are in communication with blood in a ventricle. The pressure of the blood in the atrium is sensed with a component of the delivery system in communication with the blood in the atrium and / or the first end of the valve repair device. The pressure of the blood in the ventricle is sensed with a component of the delivery system in communication with the blood in the ventricle and / or the second end of the valve repair device.

[0015] In some implementations, the valve repair device may have a first sensor at a first end of the valve repair device and the valve repair device may have a second sensor at a second end of the valve repair device. The pressure of blood in the atrium and the pressure of blood in the ventricle may be communicated. A gradient between the pressure of blood in the atrium and the pressure of blood in the ventricle may be communicated. The sensed pressure in the atrium may be stored and the sensed pressure in the ventricle may be stored. A flow rate based on the pressure of blood in the atrium and the pressure of blood in the ventricle may be communicated. A heart rate based on the pressure of blood in the atrium and the pressure of blood in the ventricle may be determined.

[0016] The above methods can be performed on a live animal or can be performed on a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, heart, tissue, etc.), etc.

[0017] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like elements bear like reference characters and in which: [Brief description of the drawings]

[0018] To further clarify various aspects of the embodiments of the present disclosure, a more particular description of certain embodiments will be made by reference to various aspects of the accompanying drawings. It will be understood that these drawings depict only typical embodiments of the present disclosure and therefore are not to be considered as limiting the scope of the present disclosure. Moreover, although the drawings may be drawn to scale for some examples, the drawings are not necessarily drawn to scale for all examples. Examples of the present disclosure as well as other features and advantages will be described and explained with additional specificity and detail through the use of the accompanying drawings.

[0019] [Figure 1] FIG. 1 illustrates a cross-sectional view of a human heart in diastole. [Diagram 2] FIG. 2 illustrates a cross-sectional view of a human heart during systole. [Diagram 3] FIG. 3 illustrates a cross-sectional view of a human heart during systole, demonstrating mitral regurgitation. [Figure 4] FIG. 4 is a cross-sectional view of FIG. 3, annotated to illustrate the natural shape of the mitral valve leaflets during systole. [Diagram 5] FIG. 5 illustrates a healthy mitral valve with the leaflets in occlusion when viewed from the atrial side of the mitral valve. [Figure 6] FIG. 6 illustrates an incompetent mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 illustrates the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] FIG. 8 shows an example of an implantable device or implant at various stages of deployment. [Figure 9] FIG. 9 shows an example of an implantable device or implant at various stages of deployment. [Figure 10] FIG. 10 shows an example of an implantable device or implant at various stages of deployment. [Figure 11]FIG. 11 shows an example of an implantable device or implant at various stages of deployment. [Figure 12] FIG. 12 shows an example of an implantable device or implant at various stages of deployment. [Figure 13] FIG. 13 shows an example of an implantable device or implant at various stages of deployment. [Figure 14] FIG. 14 shows an example of an implantable device or implant at various stages of deployment. [Figure 15] FIG. 15 shows an example of an implantable device or implant similar to the device shown in FIGS. 8-14, but with independently controllable paddles. [Figure 16] FIG. 16 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within the native valve. [Figure 17] FIG. 17 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within the native valve. [Figure 18] FIG. 18 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within the native valve. [Figure 19] FIG. 19 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within the native valve. [Figure 20] FIG. 20 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within the native valve. [Figure 21] FIG. 21 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within the native valve. [Figure 22] FIG. 22 illustrates a perspective view of an exemplary implantable device or implant in an occluded position. [Figure 23]FIG. 23 shows a front view of the implantable device or implant of FIG. [Figure 24] FIG. 24 shows a side view of the implantable device or implant of FIG. [Diagram 25] FIG. 25 shows a front view of the implantable device or implant of FIG. 22 with a cover over the paddle and the coaptation element or spacer. [Figure 26] FIG. 26 shows a top perspective view of the implantable device or implant of FIG. 22 in an open position. [Figure 27] FIG. 27 shows a bottom perspective view of the implantable device or implant of FIG. 22 in the open position. [Figure 28] FIG. 28 shows a clasp for use in an implantable device or implant. [Figure 29] FIG. 29 shows a portion of native valve tissue grasped by a clasp. [Diagram 30] FIG. 30 illustrates a side view of an exemplary implantable device or implant in a partially open position with the clasp in a closed position. [Diagram 31] FIG. 31 illustrates a side view of an exemplary implantable device or implant in a partially open position with the clasp in the open position. [Diagram 32] FIG. 32 illustrates a side view of an exemplary implantable device or implant in a semi-open position with the clasp in a closed position. [Diagram 33] FIG. 33 illustrates a side view of an exemplary implantable device or implant in a semi-open position with the clasp in the open position. [Diagram 34] FIG. 34 illustrates a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in a closed position. [Diagram 35]FIG. 35 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in the open position. [Diagram 36] FIG. 36 shows a side view of an exemplary implantable device in a fully open or fully bailed out position with the clasp in a closed position. [Figure 37] FIG. 37 shows a side view of an exemplary implantable device in a fully open or fully bailed out position with the clasp in an open position. [Figure 38] FIG. 38 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 39] FIG. 39 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 40] FIG. 40 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 41] FIG. 41 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 42] FIG. 42 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 43] FIG. 43 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 44] FIG. 44 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 45] FIG. 45 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 46]FIG. 46 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 47] FIG. 47 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 48] FIG. 48 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 49] FIG. 49 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 50] FIG. 50 is a schematic diagram illustrating the path of the native leaflets along each side of a coaptation element or spacer in an exemplary valve repair device or implant. [Figure 51] FIG. 51 is a top schematic view illustrating the path of the native leaflets around a coaptation element or spacer in an exemplary valve repair device or implant. [Figure 52] FIG. 52 illustrates a coaptation element or spacer positioned within the gap of the native valve as viewed from the atrial side of the native valve. [Diagram 53] FIG. 53 illustrates a valve repair device or implant attached to the native valve leaflets with the coaptation elements or spacers positioned within the interstices of the native valve when viewed from the ventricular side of the native valve. [Figure 54] FIG. 54 is a perspective view of a valve repair device or implant attached to the native valve leaflets with coaptation elements or spacers positioned within the interstices of the native valve when viewed from the ventricular side of the native valve. [Figure 55] FIG. 55 shows a perspective view of an exemplary implantable device or implant in an occluded position. [Figure 56] FIG. 56 illustrates a perspective view of an exemplary clasp on an exemplary implantable device or implant in a closed position. [Figure 57]FIG. 57 illustrates the valve repair device with the paddles in the open position. [Figure 58] FIG. 58 illustrates the valve repair device of FIG. 57 with the paddle in an open position and the gripping member actuated to create a wider gap between the gripping member and the paddle. [Figure 59] FIG. 59 illustrates the valve repair device of FIG. 57 in the position shown in FIG. 7 with the valve tissue disposed between the grasping members and the paddles. [Figure 60] FIG. 60 illustrates the valve repair device of FIG. 57 with the gripping members actuated to reduce the gap between the gripping members and the paddles. [Figure 61] 61A-61B illustrate the paddles of the valve repair device of FIG. 57 being actuated from an open position to a closed position. [Figure 62] FIG. 62 illustrates the valve repair device of FIG. 57 in an occluded position with the gripping members engaged against valve tissue. [Figure 63] FIG. 63 illustrates the valve repair device of FIG. 57 after being detached from the delivery device and attached to valve tissue, with the valve repair device in an occluded and locked state. [Figure 64] FIG. 64 shows an example of an implantable device or implant and associated sensor implanted in a native valve. [Figure 65] FIG. 65 shows an example of an implantable device or implant and associated sensor implanted in a native valve. [Figure 66] FIG. 66 shows an example of an implantable device or implant and associated sensor implanted in a native valve. [Figure 67] FIG. 67 shows an example of an implantable device or implant and associated sensor implanted in a native valve. [Figure 68] FIG. 68 shows a perspective view of an exemplary implantable device or implant and associated sensor implanted in a native valve. [Figure 69]FIG. 69 shows a perspective view of an exemplary implantable device or implant and associated sensor. [Figure 70] FIG. 70 shows a perspective view of an exemplary implantable device or implant and associated sensor. [Figure 71] FIG. 71 shows a perspective view of an exemplary implantable device or implant and associated sensor. [Figure 72] FIG. 72 shows a perspective view of an exemplary implantable device or implant and associated sensor. [Figure 73] FIG. 73 shows a perspective view of an exemplary implantable device or implant and associated sensor. [Figure 74] FIG. 74 shows a perspective view of an exemplary implantable device or implant and associated sensor. [Figure 75] FIG. 75 shows a perspective view of an exemplary implantable device or implant and associated sensor. [Figure 76] FIG. 76 shows a perspective view of an exemplary implantable device or implant and associated sensor. [Figure 77] FIG. 77 shows a perspective view of an exemplary implantable device or implant and associated sensor. [Figure 78] FIG. 78 illustrates an exemplary valve repair system and associated sensors. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] In the following description, reference is made to the accompanying drawings which illustrate example implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0021] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, various implementations of implantable devices, valve repair devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components in the disclosed devices and systems can be combined unless mutually exclusive or physically impossible. Furthermore, the techniques and methods herein can be performed on live animals or can be performed on simulations, such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0022] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection can be direct, such as between the components, or can be indirect, such as through the use of one or more intermediate components. Also, as described herein, references to a "member," "component," or "portion" are not 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 including) (preferably within 10%, more preferably within 1%, and most preferably within 0.1%) a given value or condition.

[0023] 1 and 2 are cross-sectional views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. In addition, an aortic valve AV separates the left ventricle LV from the ascending aorta AA, and a pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 in Figs. 3-6 and leaflets 30, 32, 34 in Fig. 7) that extend inwardly across their respective valve openings and that flow together or "coapt" to form a unidirectional fluid-occluding surface. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and the left ventricle LV will now be described in more detail. However, the devices described herein may also be used in the repair of other native valves, for example, the devices may be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0024] The left atrium LA receives oxygen-rich blood from the lungs. During diastole or diastole, as seen in FIG. 1, blood already collected in the left atrium LA (during systole) moves into the left ventricle LV through the mitral valve MV due to the expansion of the left ventricle LV. During systole or contraction, as seen in FIG. 2, the left ventricle LV contracts to pump blood through the aortic valve AV and the ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close, preventing blood from flowing back from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described in this application is used to restore the function of a defective mitral valve MV. That is, the device is configured to assist in the closure of the leaflets of the mitral valve to prevent or block blood from flowing back from the left ventricle LV into the left atrium LA. Although many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation element or spacer that beneficially acts as a filler in the regurgitant opening to prevent or inhibit backflow during systole, this is not required.

[0025] Referring now to Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense, fibrous ring of tissue surrounding the leaflets 20, 22. Referring to Figures 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 (i.e., muscles located at the base of the chordae tendineae CT and in the wall of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from everting. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and in the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, they support and brace the leaflets 20, 22 against the high pressures required to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular tissue, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in FIG. 3, the anatomy of the leaflets 20, 22 is such that the inner surfaces of the leaflets meet at their free ends and the leaflets 20, 22 begin to retract and splay away from each other. The leaflets 20, 22 splay away toward the atrium until each leaflet contacts the mitral annulus.

[0026] Various disease processes can impair the proper function of one or more native valves in the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber 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 right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathies, etc.) can distort the shape of the native valve, which can cause the native valve to malfunction. However, the majority of patients who undergo valve surgery, such as mitral valve MV surgery, suffer from a degenerative disease that causes the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV) to malfunction, resulting in prolapse and regurgitation.

[0027] In general, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when the native valve does not open completely, causing obstruction of blood flow. Typically, valve stenosis is due to the accumulation of calcified material on the leaflets of the valve, thickening the leaflets and impairing the valve's ability to open completely to allow forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely, allowing blood to leak back into the previous chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0028] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier Type I, Type II, and Type III insufficiencies. Carpentier Type I insufficiency involves dilatation of the valve annulus, which causes normally functioning leaflets to move apart and not form a tight seal (i.e., the leaflets do not coapt properly). Type I insufficiencies include leaflet perforation, such as occurs in endocarditis. Carpentier Type II insufficiency involves the deviation of one or more leaflets of the native valve above the plane of coaptation. Carpentier Type III insufficiency involves the restriction of movement of one or more leaflets of the native valve, resulting in abnormal restriction of the leaflets below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or by ventricular dilation (IIIb).

[0029] With reference to FIG. 5, when a healthy mitral valve MV is in the occluded position, the anterior leaflets 20 and posterior leaflets 22 coapt, thereby preventing blood from leaking from the left ventricle LV into the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflets 20 and / or posterior leaflets 22 of the mitral valve MV are displaced into the left atrium LA during systole such that the edges of the leaflets 20, 22 no longer make contact with each other. This failure to coapt results in a gap 26 between the anterior leaflets 20 and posterior leaflets 22, which allows blood to flow regurgitantly from the left ventricle LV into the left atrium LA during systole, as illustrated by the mitral regurgitation MR flow path shown in FIG. 3. With reference to FIG. 6, the gap 26 can have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 can have a width W greater than 15 mm. As discussed above, there are several different ways in which a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) can become incompetent, causing valve regurgitation.

[0030] In any of the above situations, a valve repair device or implant that can engage the anterior leaflets 20 and posterior leaflets 22 to occlude the gap 26 and prevent or inhibit backflow of blood through the mitral valve MV is desirable. As can be seen in Fig. 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the leaflets 20, 22 to prevent backflow during systole (compare Fig. 3 with Fig. 4). In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, etc.) of the device 10 have a generally tapered or triangular shape to naturally conform to the shape of the native valve and its expanded (towards the annulus) nature of the leaflets. In this application, the terms spacer, coaptation element, coaptation element, spacer, and gap filler are used interchangeably and refer to members that fill a portion of the space between the native valve leaflets and / or are configured to engage or "coapt" the native valve leaflets (e.g., to coapt not only to each other but also to the coaptation element, coaptation element, spacer, etc.).

[0031] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve AV or the pulmonary valve PV, and regurgitation has been found to primarily affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the burden on the heart H and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating blood flow throughout the body. Therefore, since pressures are substantially higher in the left side of the heart, malfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening.

[0032] A dysfunctional native heart valve can be either repaired or replaced. Repair typically involves preserving and modifying 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. Since the stenotic damage sustained by the valve leaflets is irreversible, a procedure for a stenotic aortic valve or pulmonary valve can involve removing the valve and replacing it with a surgically implanted heart valve or replacing it with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to deformation of the leaflets and / or surrounding tissue, which, as described above, can prevent the mitral valve MV or tricuspid valve TV from closing properly, allowing blood to flow back or back from the ventricle into the atrium (e.g., a deformed mitral valve MV can allow blood to flow back or back from the left ventricle LV into the left atrium LA, as shown in FIG. 3). Regurgitation or backflow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. In addition, regurgitation can occur due to incompetence of the chordae tendineae CT (e.g., the chordae tendineae CT can stretch or rupture), allowing the anterior leaflet 20 and the posterior leaflet 22 to invert, allowing blood to flow back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be repaired by repairing the chordae tendineae CT or by repairing the structure of the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0033] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it is understood that the devices and concepts provided herein may be used in repairing any native valve, as well as in repairing any component of a native valve. Such devices may be used between the leaflets 20, 22 of the mitral valve MV to prevent or block the backflow 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 provided herein may be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or block the backflow of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein may be used together on all three of the leaflets 30, 32, 34 to prevent or block the backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein may be centrally located between the three leaflets 30, 32, 34.

[0034] An exemplary implantable device (e.g., an implantable prosthetic device, etc.) or implant may optionally have a coaptation element (e.g., a spacer, coaptation element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, an implantable device or implant may have any combination or subcombination of the features disclosed herein without a coaptation element. When included, the coaptation element (e.g., coaptation element, spacer, etc.) is configured to be positioned within the native heart valve opening to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing the backflow discussed above. The coaptation element may have a structure that is impermeable to blood (or resists blood flow therethrough) and may have a structure that allows the native leaflets to close around the coaptation element during ventricular systole, thereby blocking backflow of blood from the left ventricle into the left atrium and from the right ventricle into the right atrium. The device or implant can be configured to seal against two or three native leaflets, i.e., the device can be used in native mitral valves (bicuspid valves) and in native tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill the space between non-properly functioning native leaflets (e.g., mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) that do not completely close.

[0035] The optional coaptation element (e.g., spacer, coaptation element, etc.) can have a variety of shapes. In some implementations, the coaptation element can have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation element can have an elliptical cross-sectional shape, an oval 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 within or adjacent to the atrium, a ventricular or lower portion positioned within or adjacent to the ventricle, and a lateral surface extending between the native leaflets. In some implementations configured for use in a tricuspid valve, the atrial or upper portion is positioned within or adjacent to the right atrium, the ventricular or lower portion is positioned within or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid valve leaflets.

[0036] 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 two native leaflets. In some implementations configured for use in a tricuspid valve, the anchor can be configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between three native leaflets. In some implementations, the anchor can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchor can be attached to an actuating element, such as a shaft or actuation wire, to which the coaptation element is also attached. In some implementations, the anchor and the coaptation element can be independently positioned relative to each other by separately moving each of the anchor and the coaptation element along a longitudinal axis of the actuating element (e.g., actuating shaft, actuating rod, actuating tube, actuating wire, etc.). In some implementations, the anchor and the coaptation element can be simultaneously positioned by moving the anchor and the coaptation element together along a longitudinal axis of the actuating element (e.g., shaft, actuating wire, etc.). The anchors can be configured to be positioned behind the native valve leaflets when implanted such that the leaflets are gripped by the anchors.

[0037] The device or implant can be configured to be implanted via a delivery system or other delivery means. The delivery system can include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The coaptation element and anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when the compressive pressure is released. The device can be configured such that the anchor expands radially away from the initially still compressed coaptation element to form a gap between the coaptation element and the anchor. The native leaflet can then be positioned within the gap. The coaptation element can expand radially to occlude the gap between the coaptation element and the anchor, thereby capturing the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to be self-expanding. The implantation methods for various implementations can be different and are described more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 2016 / 0331523, and PCT Patent Application Publication No. 2020 / 076898, which are incorporated by reference in their entireties for all purposes. These methods can be performed, mutatis mutandis, on live animals or can be performed on simulations, such as cadavers, cadaveric hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0038] The disclosed device or implant can be configured with anchors connected to the leaflets and can utilize tension from the natural chordae tendineae to resist large systolic pressures that urge the device toward the left atrium. During diastole, the device can rely on compressive and retaining forces applied to the leaflets gripped by the anchors.

[0039] 8-15, a schematic illustration of an implantable device or implant 100 (e.g., an artificial spacer device, a valve repair device, etc.) is shown in various stages of deployment. The device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated by reference in their entireties. The device 100 can include any other features of an implantable device or implant described in this application or the applications cited above, and the device 100 can be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above).

[0040] The device or implant 100 is deployed from a delivery system or other delivery means 102. The delivery system 102 may include 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 thereof, etc. The device or implant 100 includes a joint portion 104 and an anchor portion 106.

[0041] In some implementations, the interface portion 104 of the device or implant 100 includes an interface element 110 or interface means (e.g., spacer, plug, filler, foam, sheet, membrane, interface element, etc.) configured to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and slidably attached to an actuation element 112 (e.g., actuation wire, actuation shaft, actuation tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, paddles, gripping members, or the like. Actuation of the actuation means or element 112 opens and closes the anchor portion 106 of the device 100 to grip the native leaflets during implantation. The actuation means or element 112 (as well as other actuation means and elements herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As an example, the actuation element can be threaded such that driving the actuation element in rotation moves the anchor portion 106 relative to the interface portion 104. Alternatively, the actuation element can be unthreaded such that driving the actuation element 112 in a pushing or pulling manner moves the anchor portion 106 relative to the interface portion 104.

[0042] The anchor portion 106 and / or anchor of the device 100, in some implementations, includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the interface means or interface element 110 by portions 124, 126, 128. The portions 124, 126, 128 can be articulated and / or flexible to move between all positions described below. The interconnection of the outer paddle 120, inner paddle 122, interface element 110, and cap 114 by portions 124, 126, 128 can constrain the device to the positions and movements illustrated herein.

[0043] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuation means or element 112 (e.g., an actuation wire, an actuation shaft, etc.), which can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation means or element 112 extends through the delivery catheter and through the attachment means or element 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extension and retraction of the actuation element 112 increases and decreases, respectively, the spacing between the attachment element 110 and the distal end of the device (e.g., a cap 114 or other attachment portion). In some implementations, a collar or other attachment element directly or indirectly removably attaches the interface element 110 to the delivery system 102 such that an actuation means or element 112 slides through the collar or other attachment element, and in some implementations, through the interface element or element 110 upon actuation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0044] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member. The illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, an optional barb, friction enhancing element, or other fastening means 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the joint portion 138 disposed proximate to the joining means or joining element 110. In some implementations, the clasp (e.g., a barbed clasp, etc.) has a flat surface and does not fit within a recess of the inner paddle. Rather, the flat portion of the clasp is disposed against a surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 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 member of material integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary with respect to the inner paddle 122 when the movable arm 134 opens to open the clasp 130 and expose the optional barb, friction enhancing element, or fastening means 136.

[0045] In some implementations, the clasp 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend, or pivot on a joint portion 138. The actuation line 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible.

[0046] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be spring loaded so that in the occluded position, the clasp 130 continues to provide a clamping force against the grasped native leaflet. This clamping force remains constant regardless of the position of the inner paddle 122. Optional barbs, friction enhancing elements, or other fixation means 136 of the clasp 130 can grip, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0047] During implantation, the paddles 120, 122 may open and close to, for example, grip a native leaflet (e.g., a native mitral leaflet, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation means or element 110. The clasps 130 may be used to grip and / or further secure the native leaflet by engaging it with barbs, friction enhancing elements, or fixation means 136 and pinching the leaflet between the movable arm 134 and the fixation arm 132. The barbs, friction enhancing elements, or other fixation means 136 (e.g., barbs, projections, ridges, grooves, textured surfaces, adhesives, etc.) of the optional clasp or barbed clasp 130 may increase friction with the leaflet or partially or fully puncture the leaflet. The actuation lines 116 may be individually actuated such that each clasp 130 may be individually opened and closed. Individual actuation allows for grasping one leaflet at a time, or allows for repositioning of the clasp 130 on a leaflet that is not adequately grasped, without altering the good grip on the other leaflets. The clasp 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), allowing for grasping of the leaflets in a variety of positions as a particular situation requires.

[0048] 8, the device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of a delivery system 102. The device 100 is positioned at the end of the catheter in the delivery system 102 in the fully open position because it takes up the least amount of space and also because the smallest catheter may be used in the fully open position (or the largest device 100 may be used for a given catheter size). In the extended state, the cap 114 is spaced away from the attachment means or element 110 so that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 is maintained in an occluded state during deployment through the delivery system 102 so that the optional barbs, friction enhancing elements, or other fastening means 136 (FIG. 9) do not snag or damage the delivery system 102 or tissue within the patient's heart.

[0049] 9, device 100 is shown in an extended, uncoiled state similar to that of FIG. 8, but with clasp 130 in a fully open position, in the range of about 140 degrees to about 200 degrees, in the range of about 170 degrees to about 190 degrees, or at about 180 degrees between fixed portion 132 and movable portion 134 of clasp 130. Full opening of paddles 120, 122 and clasp 130 has been found to improve ease of disengagement or detachment of device 100 from a patient's anatomical structures, such as chordae tendineae CT, upon implantation.

[0050] Referring now to FIG. 10, the device 100 is shown in a shortened or fully occluded state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement inside the heart. To drive the device 100 from the extended state to the shortened state, the actuation means or element 112 is retracted, pulling the cap 114 towards the attachment means or element 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained in movement such that a compressive force acting from the cap 114 onto the outer paddle 120 retracts the paddle or gripping member towards the attachment means or element 110 and moves radially outward. When driven from the open position to the occluded position, the outer paddle 120 maintains an acute angle with respect to the actuation means or element 112. The outer paddle 120 can optionally be biased towards the occluded position. The inner paddle 122 moves through a significant angle in order to orient away from the open interface means or interface element 110 and to fold along the side of the closed interface means or interface element 110 during the same movement. In some implementations, the inner paddle 122 can be thinner and / or narrower than the outer paddle 120, and the connecting portions 126, 128 (e.g., joints, flexible connections, etc.) connected to the inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility can allow for a larger movement compared to the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the outer paddle 120 can be narrower than the inner paddle 122. The connecting portions 126, 128 connected to the inner paddle 122 can be more flexible, for example, to allow for greater movement compared to the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the inner paddle 122 can be the same width or substantially the same width as the outer paddle.

[0051] 11-13, the device 100 is shown in a partially open state and ready to be grasped. To move from the fully occluded state to the partially open state, the actuation means or element (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation means or element 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122 to partially open the anchor or anchor portion 106. The actuation line 116 is also retracted, thereby opening the clasp 130 so that it can grasp the leaflets. In some implementations, the pair of inner and outer paddles 122, 120 are actuated together, rather than individually, by a single actuation means or single actuation element 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 also closes the clasp. In some implementations, the paddles 120, 122 can be independently controllable. For example, the device 100 can have two actuation elements and two independent caps (or other mounting parts), such that one independent actuation element (e.g., wire, shaft, etc.) and cap (or other mounting part) can be used to control one paddle, and the other independent actuation element and cap (or other mounting part) can be used to control the other paddle.

[0052] 12, one clasp 130 can be closed by extending one actuation line 116. Now, referring to FIG 13, the other clasp 130 can be closed by extending the other actuation line 116. By repeatedly actuating one or both of the actuation lines 116, the clasps 130 can be repeatedly opened and closed.

[0053] 14, the device 100 is shown in a fully closed and deployed state. The delivery system or means 102 and actuation means or elements 112 are retracted, with the paddles 120, 122 and clasp 130 still remaining in the fully closed position. Once deployed, the device 100 may be maintained in the fully closed position by a mechanical latch, or may be biased to remain closed by the use of a spring material such as steel, other metals, plastics, composites, or a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal such as steel or from a shape memory alloy such as Nitinol, which can be manufactured from wire, sheet, tube, or laser sintered powder, and are biased to hold the outer paddle 120 in an occluded state around the coaptation means or element 110 and to clamp the clasp 130 around the native leaflets. Similarly, the fixed arm 132 and the movable arm 134 of the clasp 130 are biased to clamp the leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal or any other suitable elastic material, such as a polymeric material, to maintain the device 100 in an occluded state after implantation.

[0054] Figure 15 illustrates an example where the paddles 120, 122 are independently controllable. The device 101 illustrated by Figure 15 is similar to the device illustrated by Figure 11, except that the device 101 of Figure 15 includes an actuation element configured as two independent actuation elements 111, 113 coupled to two independent caps 115, 117. To move the first inner paddle 122 and the first outer paddle 120 from a fully occluded state to a partially open state, the actuation means or element 111 is extended to push the cap 115 away from the joint means or element 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122 to partially open the first anchor 108. To move the second inner paddle 122 and the second outer paddle 120 from the fully occluded state to the partially open state, the actuation means or element 113 is extended to push the cap 115 away from the mating means or element 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122 to partially open the second anchor 108. The independent paddle control illustrated in Figure 15 can be implemented in any of the devices disclosed in this application. For comparison, in the example illustrated in Figure 11, the pair of inner and outer paddles 122, 120 are driven together by a single actuation means or element 112, rather than individually.

[0055] 16-21, the implantable device 100 of FIGS. 8-14 is shown delivered and implanted within the native mitral valve MV of the heart H. With reference to FIG. 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open condition as shown in FIG. 16. The actuating means or element 112 is then retracted to drive the implant / device into a fully occluded condition as shown in FIG. 17.

[0056] As can be seen in Figure 18, the implant / device is moved into a position within the mitral valve MV and into the ventricle LV and is in a partially open state to grasp the leaflets 20, 22. For example, the steerable catheter can be advanced and steered or bent to position the steerable catheter as shown in Figure 18. An implant catheter connected to the implant / device can be advanced from within the steerable catheter to position the implant as shown in Figure 18.

[0057] 19, the implant catheter is retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasps 130. The actuating line 116 is extended to occlude one of the clasps 130 and capture the leaflet 20. FIG. 20 illustrates that the other actuating line 116 is then extended to occlude the other clasp 130 and capture the remaining leaflet 22. Furthermore, as can be seen in FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuating means or element 112, and actuating line 116 are then retracted to fully occlude and deploy the device or implant 100 within the native mitral valve MV.

[0058] 22-27, an example of an implantable device or implant or implants 200 is shown. The implantable device 200 is one of many different configurations that the device 100 shown generally in FIGS. 8-14 may take. The device 200 may include any other features of an implantable device or implant described herein, and the device 200 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein). The device / implant 200 may be an artificial spacer device, a valve repair device, or another type of implant that attaches to the leaflets of a native valve.

[0059] In some implementations, the implantable device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 205, 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, coaptation element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in various manners. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism 213 (FIGS. 43-49) of the delivery system 202 (FIGS. 38-42 and 49). Delivery system 202 may be the same as or similar to delivery system 102 described elsewhere, and may include 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 thereof, and the like.

[0060] In some implementations, the joint elements 210 and paddles 220, 222 can be formed from a metal fabric such as a mesh, woven fabric, braided, or any other suitable formed, or laser cut or otherwise cut flexible material. The material can be a fabric, a shape memory alloy wire such as Nitinol to provide shape setting capabilities, or any other flexible material suitable for implantation within the body.

[0061] An actuation element 212 (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from the delivery system 202 to engage the implantable device or implant 200 to enable actuation of the implantable device or implant 200. In some implementations, the actuation element 212 extends through the capture mechanism 213, the proximal collar 211, and the interface element 210 to engage the cap 214 of the distal portion 207. The actuation element 212 can be configured to releasably engage the cap 214 via a threaded or similar connection such that the actuation element 212 can be disengaged and removed from the device 200 after implantation.

[0062] The coaptation element 210 extends from a proximal collar 211 (or other attachment element) to an inner paddle 222. In some implementations, the coaptation element 210 has a generally elongated, circular shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above (e.g., FIG. 51), a tapered shape or cross-section when viewed from the front (e.g., FIG. 23), and a circular shape or cross-section when viewed from the side (e.g., FIG. 24). A mixture of these three geometries can result in a three-dimensional shape for the illustrated coaptation element 210 that achieves the advantages described herein. It can be seen that the circular shape of the coaptation element 210 also substantially conforms to or approximates the shape of the paddle frame 224 when viewed from above.

[0063] The size and / or shape of the coaptation element 210 can be selected to minimize the number of implants (preferably one) that a patient will need while at the same time maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation element is about 5 mm, and the medial-lateral distance at the widest point of the coaptation element material is about 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and on the overall shape strategy described above. It will be readily apparent that using other anterior-posterior and medial-lateral distances as a starting point for the device will result in devices with different dimensions. Additionally, using other size and shape strategies described above will also result in devices with different dimensions.

[0064] In some implementations, the outer paddle 220 is articulably attached to the cap 214 of the distal portion 207 by connecting portion 221 and to the inner paddle 222 by connecting portion 223. The inner paddle 222 is articulably attached to the joint element by connecting portion 225. In this manner, the anchor 208 is configured similar to a leg in that the inner paddle 222 is like an upper portion of a leg, the outer paddle 220 is like a lower portion of a leg, and the connecting portion 223 is like a knee portion of a leg.

[0065] In some implementations, the inner paddle 222 is rigid, relatively rigid, stiff, has a stiff portion, and / or is stiffened by a stiffening member or fixed portion 232 of the clasp 230. The stiffening of the inner paddle allows the device to be driven into a variety of different positions as shown and described herein. The inner paddle 222, outer paddle 220, and coaptations can all be interconnected as described herein, thereby constraining the device 200 to the movements and positions as shown and described herein.

[0066] In some implementations, the paddle frame 224 is attached to the cap 214 at the distal portion 207 and extends to a connection portion 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a stiffer and more rigid material compared to the material forming the paddles 222, 220 such that the paddle frame 224 provides support for the paddles 222, 220.

[0067] The paddle frame 224 provides additional clamping force between the inner paddle 222 and the coaptation element 210, as can be seen in FIG. 51, and helps wrap the leaflets around the sides of the coaptation element 210 for a better seal between the coaptation element 210 and the leaflets. That is, the paddle frame 224 can be configured with a rounded three-dimensional shape that extends from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer and inner paddles 220 and 222, the cap 214, and the coaptation element 210 can constrain each of these members to the movements and positions described herein. In particular, the connecting portion 223 is constrained by its connections between the outer and inner paddles 220 and 222, and by its connections to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus the inner paddle 222 and the outer paddle 220 ) and by its attachment to the cap 214 .

[0068] Configuring the paddle frame 224 in this manner provides an increased surface area compared to the outer paddle 220 alone, which may, for example, allow easier grasping and fixation of the native leaflets. The increased surface area may also distribute the clamping force of the paddles 220 and paddle frame 224 on the native leaflets over a larger surface area of ​​the native leaflets to further protect the native leaflet tissue. Referring again to FIG. 51, the increased surface area of ​​the paddle frame 224 may also allow the native leaflets to be clamped against the implantable device or implant 200 such that the native leaflets coapt generally around the periphery of the coaptation member or element 210. This may, for example, improve sealing of the native leaflets 20, 22, thereby preventing or further reducing mitral regurgitation.

[0069] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, the clasp 230 includes a base or fixed arm 232, a movable arm 234, an optional barb 236, and a joint portion 238. The fixed arm 232 is attached to the inner paddle 222 with the joint portion 238 disposed adjacent to the joining element 210. The joint portion 238 is spring loaded such that the fixed arm 232 and the movable arm 234 are biased toward each other when the clasp 230 is in the closed state. In some implementations, the clasp 230 includes friction enhancing elements or fastening means, such as optional barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0070] In some implementations, the fixed arm 232 is attached to the inner paddle 222 through a hole or slot 231 using a suture (not shown). The fixed arm 232 can be attached to the inner paddle 222 using any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, a clamp, a latch, or the like. The fixed arm 232 remains substantially stationary relative to the inner paddle 222 when the movable arm 234 is opened, thereby opening the clasp 230 and exposing the optional barb or other friction enhancing element 236. The clasp 230 is opened by applying tension to an actuation line 216 (e.g., as shown in FIGS. 43-48 ) attached to a hole 235 in the movable arm 234, thereby causing the movable arm 234 to articulate, pivot, and / or bend on a joint portion 238.

[0071] 29, there is shown a close-up view of one of the leaflets 20, 22 being grasped by a clasp, such as clasp 230. The leaflets 20, 22 are grasped between a movable arm 234 and a fixed arm 232 of the clasp 230. The tissue of the leaflets 20, 22 is not pierced by the optional barbs or frictional enhancing elements 236, although in some implementations the optional barbs 236 may partially or completely pierce the leaflets 20, 22. The angle and height of the optional barbs or frictional enhancing elements 236 relative to the movable arms 234 helps secure the leaflets 20, 22 within the clasp 230. In particular, the force of pulling the implant away from the native leaflets 20, 22 will encourage the optional barbs or frictional enhancing elements 236 to further engage the tissue, thereby ensuring a better hold. Retention of the leaflets 20, 22 within the clasp 230 is further improved by the position of the fixed arms 232 located near the optional barbs / frictional enhancement elements 236 when the clasp 230 is closed. In this configuration, the tissue is molded into an S-shaped, distorted path by the fixed arms 232, the movable arms 234, and the optional barbs / frictional enhancement elements 236. Thus, the force pulling the leaflets 20, 22 away from the clasp 230 will encourage the tissue to further engage the optional barbs / frictional enhancement elements 236 before the leaflets 20, 22 can prolapse. For example, tension on the leaflets during diastole can encourage the optional barbs 236 to pull towards the end portions of the leaflets 20, 22. Thus, the S-shaped path can take advantage of the tension on the leaflets during diastole to more tightly engage the leaflets 20, 22 against the optional barbs / frictional enhancement elements 236.

[0072] 25, the prosthetic device or implant 200 may also include a cover 240. In some implementations, the cover 240 may be disposed on the joint elements 210, on the outer paddle 220 and the inner paddle 222, and / or on the paddle frame 224. The cover 240 may be configured to prevent or reduce blood flow through the prosthetic device or implant 200 and / or to promote natural tissue engraftment. In some implementations, the cover 240 may be a cloth or fabric, such as PET, velour, or other suitable fabric. In some implementations, instead of or in addition to a cloth, the cover 240 may include a coating (e.g., a polymer) applied to the implantable prosthetic device or implant 200.

[0073] During implantation, the paddles 220, 222 of the anchor 208 can be opened and closed to grip the native leaflets 20, 22 between the paddles 220, 222 and the coaptation element 210. The anchor 208 is actuated between a closed position (FIGS. 22-25) and various open positions (FIGS. 26-37) by extending and retracting the actuation element 212. The extension and retraction of the actuation element 212 increases and decreases the spacing between the coaptation element 210 and the cap 214, respectively. The proximal collar 211 (or other attachment element) and coaptation element 210 slide along the actuation element 212 during actuation, thereby changing the spacing between the coaptation element 210 and the cap 214 to actuate the paddles 220, 220 between different positions, thereby gripping the mitral leaflets 20, 22 during implantation.

[0074] To open and close the device 200, the pair of inner and outer paddles 222, 220 are actuated together, rather than individually, by a single actuation element 212. Additionally, the position of the clasp 230 depends on the position of the paddles 222, 220. For example, the clasp 230 is configured such that closure of the anchor 208 simultaneously closes the clasp 230. In some implementations, the device 200 can be configured with the paddles 220, 222 independently controllable in the same manner (e.g., the device 100 depicted in FIG. 15).

[0075] In some implementations, the clasps 230 further secure the native leaflets 20, 22 by engaging the leaflets 20, 22 against optional barbs and / or other friction enhancing elements 236 and further by sandwiching the leaflets 20, 22 between the movable arm 234 and the fixed arm 232. In some implementations, the clasps 230 are barbed clasps that include barbs that can increase friction with and / or partially or fully pierce the leaflets 20, 22. The actuation lines 216 (FIGS. 43-48) can be individually actuated such that each clasp 230 can be individually opened and closed. Individual actuation allows for gripping one leaflet 20, 22 at a time, or allows for repositioning the clasp 230 on a leaflet 20, 22 that was not adequately gripped without changing its good grip on the other leaflets 20, 22. The clasps 230 can be fully opened and closed when the inner paddle 222 is not occluded, thereby allowing the leaflets 20, 22 to be grasped in a variety of positions as a particular situation requires.

[0076] 22-25, the device 200 is shown in an occluded position. When occluded, the inner paddle 222 is positioned between the outer paddle 220 and the coaptation element 210. The clasp 230 is positioned between the inner paddle 222 and the coaptation element 210. Upon successful capture of the native leaflets 20, 22, the device 200 is moved to and held in a closed position such that the leaflets 20, 22 are secured within the device 200 by the clasp 230 and pressed against the coaptation element 210 by the paddles 220, 222. The outer paddle 220 may have a wider curved shape that fits around the curved shape of the coaptation element 210 to more firmly grip the leaflets 20, 22 when the device 200 is closed (e.g., as seen in FIG. 51). The curved shape and rounded edges of the outer paddle 220 also prevent or inhibit tearing of the leaflet tissue.

[0077] 30-37, the implantable device or implant 200 described above is shown in various positions and configurations ranging from partially open to fully open. The paddles 220, 222 of the device 200 transition between each of the positions shown in FIGS. 30-37 from the closed position shown in FIGS. 22-25 of the actuating element 212 to a fully retracted position to a fully extended position.

[0078] 30-31, the device 200 is shown in a partially open position. The device 200 is moved to the partially open position by extending the actuation element 212. The extension of the actuation element 212 pulls down the bottom of the outer paddle 220 and the paddle frame 224, which pulls down the inner paddle 222, to which it is connected. Because the proximal collar (or other attachment element) and the interface element 210 are held in place by the capture mechanism 213, the inner paddle 222 is caused to articulate, pivot, and / or bend toward the opening. The inner paddle 222, the outer paddle 220, and the paddle frame all bend to the positions shown in FIGS. 30-31. Releasing the paddles 222, 220 and frame 224 creates a gap between the coaptation element 210 and the inner paddle 222 that can receive and grip the native leaflets 20, 22. This movement also exposes the clasp 230, which can be actuated between a closed position (FIG. 30) and an open position (FIG. 31) to create a second gap for gripping the native leaflets 20, 22. The extent of the gap between the fixed arm 232 and the movable arm 234 of the clasp 230 is limited to the extent that the inner paddle 222 extends away from the coaptation element 210.

[0079] 32-33, the device 200 is shown in a laterally extended or laterally open position. The device 200 is driven into the laterally extended or laterally open position by continuing the extension of the actuating element 212 as described above, thereby increasing the distance between the joint element 210 and the cap 214 of the distal portion 207. Continued extension of the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby spreading the inner paddle 222 further away from the joint element 210. In the laterally extended or laterally open position, the inner paddle 222 extends more horizontally and forms an angle of approximately 90 degrees with respect to the joint element 210 as compared to other positions of the device 200. Similarly, the paddle frame 224 is in their maximum spread position when the device 200 is in the laterally extended or laterally open position. The increased gap formed between the joint element 210 and the inner paddle 222 in the laterally extended or laterally open position allows the clasp 230 to open further (FIG. 33) before engaging the joint element 210, thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0080] 34-35, the exemplary device 200 is shown in a three-quarters extended position. The device 200 is driven to the three-quarters extended position by continuing the extension of the actuating element 212 as described above, thereby increasing the distance between the interface element 210 and the cap 214 of the distal portion 207. Continued extension of the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the interface element 210. In the three-quarters extended position, the inner paddle 222 is open to an angle of more than 90 degrees, approximately 135 degrees, relative to the interface element 210. The paddle frame 224 spreads less compared to the laterally extended or laterally open positions, and begins to move inwardly toward the actuating element 212 as the actuating element 212 is further extended. The outer paddle 220 also bends backwards toward the actuating element 212. Similar to the laterally extended or laterally open position, the increased gap formed between the joint element 210 and the inner paddle 222 in the laterally extended or laterally open position allows the clasp 230 to open even further (FIG. 35), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0081] 36-37, the exemplary device 200 is shown in a fully extended position. The device 200 is driven to the fully extended position by continuing to extend the actuating element 212 as described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207 to the maximum distance allowable by the device 200. Continued extension of the actuating element 212 pulls the outer paddle 220 and paddle frame 224 down, thereby spreading the inner paddle 222 further away from the coaptation element 210. The outer paddle 220 and paddle frame 224 are driven to a position where they are closer to the actuating element. In the fully extended position, the inner paddle 222 is open to an angle of approximately 180 degrees relative to the coaptation element 210. In the fully extended position, the inner and outer paddles 222, 220 are linearly extended to form an angle of approximately 180 degrees between the paddles 222, 220. The fully extended position of the device 200 provides the maximum size of the gap between the coaptation element 210 and the inner paddle 222, and in some implementations allows the clasp 230 to also be fully opened to approximately 180 degrees between the fixed arm 232 and the movable arm 234 of the clasp 230 (FIG. 37). The position of the device 200 is in its longest and narrowest configuration. Thus, the fully extended position of the device 200 may be a desired position for salvaging the device 200 from an attempted implantation, or may be a desired position for placement of the device within a delivery catheter, or the like.

[0082] Configuring the prosthetic device or implant 200 such that the anchors 208 can extend to a straight or nearly straight configuration (e.g., about 120-180 degrees relative to the coaptation element 210) can provide several advantages. For example, this configuration can reduce the radial corrugated profile of the prosthetic device or implant 200. It can also make it easier to grasp the native leaflets 20, 22 by providing a larger opening between the coaptation element 210 and the inner paddle 222 for grasping the native leaflets 20, 22. Additionally, the relatively narrow and straight configuration can prevent or reduce the possibility of the prosthetic device or implant 200 becoming entangled in the native anatomy (e.g., the chordae tendineae CT shown in FIGS. 3 and 4) when positioning and / or retrieving the prosthetic device or implant 200 within the delivery system 202.

[0083] 38-49, an exemplary implantable device 200 is shown being delivered and implanted into the native mitral valve MV of the heart H. As described above, the device 200 shown in FIGS. 38-49 includes an optional cover 240 (e.g., FIG. 25) over the coaptation element 210, the clasp 230, and the inner and / or outer paddles 222 and 220. The device 200 is deployed from a delivery system 202 (which may include, for example, a steerable catheter and / or an implant catheter extendable from a guide sheath) and is held by a capture mechanism 213 (see, for example, FIGS. 43 and 48) and actuated by extending and retracting an actuating element 212. Fingers of the capture mechanism 213 releasably attach the collar 211 to the delivery system 202. In some implementations, the capture mechanism 213 is held in a closed state around the collar 211 by the actuating element 212 so that after the device 200 is successfully implanted, removal of the actuating element 212 allows the fingers of the capture mechanism 213 to open and release the collar 211, thereby detaching the capture mechanism 213 from the device 200.

[0084] 38, a delivery system 202 (e.g., its delivery catheter / sheath) is inserted through the septum into the left atrium LA and the device / implant 200 is deployed from the delivery system 202 in a fully open state for the reasons discussed above with respect to device 100 (e.g., an implant catheter holding the device / implant can be expanded to deploy the device / implant from the steerable catheter). The device 200 is then driven through a partially occluded state (FIG. 39) to a fully occluded state as shown in FIGS. 40-41 by retracting the actuating element 212. The delivery system or catheter then steers the device / implant 200 towards the mitral valve MV as shown in FIG. 41. 42, when the device 200 is aligned with the mitral valve MV, the actuating element 212 extends to open the paddles 220, 222 to a partially open position and the actuating line 216 (FIGS. 43-48) is retracted to open the clasp 230 ready to grasp the leaflets. The partially open device 200 is then inserted (e.g., by advancing an implant catheter from a steerable catheter) through the native valve until the leaflets 20, 22 are properly positioned between the inner paddle 222 and the coaptation element 210 and within the open clasp 230, as shown in FIGS. 43-44.

[0085] FIG. 45 shows the device 200 with both clasps 230 in an occluded state, but with the optional barb 236 of one clasp 230 not engaged against one of the leaflets 22. As can be seen from FIGS. 45-47, the misaligned clasp 230 is again opened and occluded in order to properly grasp the escaped leaflet 22. When both leaflets 20, 22 are properly grasped, retracting the actuating element 212 drives the device 200 to a fully occluded position, as shown in FIG. 48. With the device 200 fully occluded and embedded within the native valve, the actuating element 212 can be disengaged and withdrawn from the cap 214, thereby releasing the capture mechanism 213 from the proximal collar 211 (or other attachment element), allowing the capture mechanism 213 to be withdrawn into the delivery system 202 (e.g., into a catheter / sheath) as shown in FIG. 49. After deployment, the device 200 can be maintained in a fully occluded position by mechanical means such as a latch, or can be biased to remain in an occluded state through the use of a spring material such as steel and / or through the use of a shape memory alloy such as Nitinol. For example, the paddles 220, 222 can be formed from steel or from Nitinol shape memory alloy, which can be fabricated from wire, sheet, tube, or laser sintered powder, and biased to hold the outer paddle 220 in an occluded state around the inner paddle 222, coaptation elements 210, and / or clasps 230, which clamp the native leaflets 20, 22 therearound.

[0086] 50-54, after device 200 is implanted in a native valve, coaptation element 210 functions as a gap filler in a valve regurgitation opening, such as gap 26 in mitral valve MV illustrated in FIG. 6 or in another native valve. In some implementations, when device 200 is deployed between two opposing leaflets 20, 22, leaflets 20, 22 no longer coapt against each other in the region of coaptation element 210, but instead coapt against coaptation element 210. This reduces the distance that leaflets 20, 22 need to approach to occlude mitral valve MV during systole, thereby facilitating repair of functional valve disease that may cause mitral regurgitation. The reduction in leaflet approach distance can result in several other benefits as well. For example, the reduced approach distance required of leaflets 20, 22 reduces or minimizes the stress experienced by the native valve. The shorter approximation distance for the leaflets 20, 22 also requires less approximation force, which may result in less tension experienced by the leaflets 20, 22 and less annular diameter reduction. Lesser or no annular diameter reduction may result in less reduction in valve opening area compared to devices without a coaptation element or spacer. In this manner, the coaptation element 210 may reduce transvalvular gradients.

[0087] In order to adequately fill the gaps 26 between the leaflets 20, 22, the device 200 and its components can have a wide variety of different shapes and sizes. For example, the outer paddle 220 and paddle frame 224 can be configured to fit against the shape or geometry of the coaptation element 210, as shown in FIGS. 50-54. As a result, the outer paddle 220 and paddle frame 224 can engage both the coaptation element 210 and the native leaflets 20, 22. In some implementations, when the leaflets 20, 22 are coapted against the coaptation element 210, the leaflets 20, 22 completely surround or "hugge" the coaptation element 210 in their entirety, thus preventing or inhibiting small leaks at the outer and inner surfaces 201, 203 of the coaptation element 210. The interaction of the leaflets 20, 22 with the device 200 is made clear in Figure 51, which shows a schematic atrial or surgeon's eye view showing a paddle frame 224 (which would not actually be visible from a true atrial view, e.g., in Figure 52) conforming to the geometry of the coaptation element 210. The opposing leaflets 20, 22 (whose ends would also not be visible from a true atrial view, e.g., in Figure 52) are driven closer together by the paddle frame 224 to completely surround or "embrace" the coaptation element 210.

[0088] This coaptation of the leaflets 20, 22 against the lateral and medial surfaces 201, 203 of the coaptation element 210 (shown from the atrial side in FIG. 52 and from the ventricular side in FIG. 53) would seem to contradict the statement above that the presence of the coaptation element 210 minimizes the distance the leaflets need to come together. However, the distance the leaflets 20, 22 need to come together is still minimized if the coaptation element 210 is positioned exactly at the regurgitation gap 26 and, further, if the regurgitation gap 26 is smaller than the width (medial minus lateral) of the coaptation element 210.

[0089] FIG. 50 illustrates the geometry of the coaptation element 210 and paddle frame 224 from the perspective of the LVOT. As can be seen from this figure, the coaptation element 210 has a tapered shape with smaller dimensions in the area close to where the inner surfaces of the leaflets 20, 22 are desired to coapt and larger dimensions as the coaptation element 210 extends toward the atrium. Thus, the challenges of the illustrated native valve geometry are addressed by the tapered coaptation element shape. Still referring to FIG. 50, the tapered coaptation element geometry, in combination with the illustrated expanded paddle frame 224 shape (towards the annulus), can help achieve coaptation at the bottom of the leaflets, reduce stress, and minimize transvalvular gradients.

[0090] 54, the shapes of the coaptation element 210 and the paddle frame 224 can be defined based on the inner commissure view of the native valve and the device 200. Two factors for these shapes are the coaptation of the leaflets to the coaptation element 210 and the reduction of stress on the leaflets due to coaptation. With reference to FIG. 54 and FIG. 24, the coaptation element 210 can have a circular or round shape and the paddle frame 224 can have a full radius that spans almost the entirety of the paddle frame 224 to both coapt the leaflets 20, 22 to the coaptation element 210 and to reduce the stress that the coaptation element 210 and / or paddle frame 224 apply to the leaflets 20, 22. The round shape of the coaptation element 210 and / or the fully round shape of the paddle frame 224 shown distributes the stress on the leaflets 20, 22 over a large curved engagement area. For example, in FIG. 54, the force exerted by the paddle frame on the leaflets 20, 22 is spread along the entire rounded length of the paddle frame 224 as the leaflets 20 attempt to open during diastole.

[0091] 55, an example of an implantable prosthetic device or implant 300 is shown. The implantable device 300 is one of many different configurations that the device 100 may assume, as generally illustrated in Figures 8-14. The device 300 may include any other features of an implantable device or implant described herein, and the device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0092] The implantable 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, which optionally includes a coaptation element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the native valve leaflets 20, 22. 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, such as an outer paddle 320, an inner paddle 322, a paddle extension or paddle frame 324, etc. The anchors can also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging a capture mechanism (e.g., a capture mechanism such as capture mechanism 213 shown in Figures 43-49) of a delivery system (e.g., a delivery system such as the systems shown in Figures 38-42 and 49).

[0093] The anchors 308 can be attached to other portions of the device and / or to each other in a variety of different manners (e.g., directly, indirectly, by welding, by stitching, by adhesive, by linking, by latching, by integral formation, by any or all combinations thereof, etc.) In some implementations, the anchors 308 are attached to the interface member or element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0094] The anchor 308 can include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. The connecting portion 323 can be attached to a paddle frame 324 that is hingedly attached to the cap 314 or to another attachment portion. In this manner, the anchor 308 is configured similar to a leg in that the inner paddle 322 is like an upper portion of a leg, the outer paddle 320 is like a lower portion of a leg, and the connecting portion 323 is like a knee portion of the leg.

[0095] In implementations using the interface member or element 310, the interface member or element 310 and the anchor 308 may be coupled together in a variety of ways. For example, as shown in the illustrated implementation, the interface element 310 and the anchor 308 may be coupled together by integrally forming the interface element 310 and the anchor 308 as a single, unitary component. This may be accomplished, for example, by forming the interface element 310 and the anchor 308 from a continuous strip 301 of braided or woven material, such as braided or woven Nitinol wire. In the illustrated example, the interface element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous strip of fabric 301.

[0096] Similar to the anchor 208 in the implantable device or implant 200 described above, the anchor 308 can be configured to transition 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.), thereby moving the anchor 308 relative to a midpoint of the device. This movement can occur along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and proximal end (e.g., collar 311 or other attachment element, etc.) of the device. For example, the anchor 308 can be positioned in a fully extended or straight configuration (e.g., similar to the configuration of the device 200 shown in FIG. 36) by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device.

[0097] 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 connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the joint element 310 (e.g., similar to the configuration of the device 200 shown in FIG. 36). From the straight configuration, the anchor 308 can be moved to a fully collapsed configuration (e.g., FIG. 55), for example, by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device. First, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and / or midpoint or center of the device, the anchor 308 bends at the connecting portions 321, 323, 325, and the connecting portion 323 moves radially outward relative to the longitudinal axis of the device 300 and axially toward the midpoint and / or proximal end of the device (e.g., similar to the configuration of the device 200 shown in FIG. 34). As cap 314 continues to move toward the midpoint and / or toward the proximal end of the device, connecting portion 323 moves radially inward relative to the longitudinal axis of device 300 and axially toward the proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 30).

[0098] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, the clasp 330 (shown in detail in FIG. 56 ) includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and a joint portion 338. The fixed arm 332 is attached to the inner paddle 322 with the joint portion 338 disposed adjacent to the mating element 310. The joint portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is in the closed state.

[0099] The fixed arm 332 is attached to the inner paddle 322 through a hole or slot 331 using a suture (not shown). The fixed arm 332 can be attached to the inner paddle 322 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened to open the clasp 330 and expose the optional barb 336. The clasp 330 is opened by applying tension to an actuation line (e.g., actuation line 216 shown in FIGS. 43-48 ) attached to a hole 335 in the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or bend on a joint portion 338.

[0100] In summary, the implantable device or implant 300 is similar in construction and operation to the implantable device or implant 200 described above, except that the joint element 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed from a single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, the cap 314, and the paddle frame 324 by weaving or inserting through openings in the proximal collar 311, the cap 314, and the paddle frame 324 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 overlapping layers of the strip of material 301.

[0101] For example, Figure 55 shows a joining element 310 and inner paddle 322 formed from multiple overlapping layers of a strip of material 301. The single continuous strip of material 301 can begin and end at various locations on the apparatus 300. The ends of the strip of material 301 can be located at the same or different locations on the apparatus 300. For example, in the example illustrated in Figure 55, the strip of material 301 begins and ends at the location of the inner paddle 322.

[0102] As with the implantable device or implant 200 described above, the size of the coaptation element 310 can be selected to minimize the number of implants (preferably one) required per patient while maintaining a low transvalvular gradient. In particular, forming many components of the device 300 from a strip of material 301 allows the device 300 to be smaller in size 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 at the widest point of the device 300 (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is about 5 mm.

[0103] The concepts disclosed herein can be used with a wide variety of different valve repair devices. Figures 57-63 illustrate another example of one of many valve repair systems for repairing a patient's native valve, a valve repair system 400, to which the concepts of the present application may be applied. Valve repair system 400 includes a delivery device 401 and a valve repair device 402.

[0104] The valve repair device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408. In some implementations, the paddles 406 can be integrally formed with the base assembly. For example, the paddles 406 can be formed as an extension of a link in the base assembly. In the illustrated example, the base assembly 404 of the valve repair device 402 includes 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 drives the paddles between an open position and a closed position. In this manner, the coupler 405 serves as a means for mechanically coupling the paddles 406 to the shaft 403 and drives the paddles 406 between their open and closed positions when driven along the shaft 403.

[0105] In some implementations, the gripping member 408 is pivotally connected to the base assembly 404 such that the width of the opening 414 between the paddle 406 and the gripping member 408 may be adjusted by actuating the gripping member (e.g., the gripping member 408 may be pivotally connected to the shaft 403 or to any other suitable member in the base assembly). The gripping member 408 may include a barb portion 409 for attaching the gripping member to the valve tissue when the valve repair device 402 is attached to the valve tissue. The gripping member 408 forms a means for gripping the valve tissue (particularly the tissue of the valve leaflets) using an anchoring means or portion such as the optional barb portion 409. When the paddle 406 is in the closed position, it engages the gripping member 408, such that when the valve tissue is attached to the optional barbed portion 409 of the gripping member, the paddle acts as a retention or fixation means to hold the valve tissue with the gripping member and to fix the valve repair device 402 to the valve tissue. In some implementations, the gripping member 408 is configured to engage the paddle 406 such that the optional barbed portion 409 engages the valve tissue member and the paddle 406 to fix the valve repair device 402 to the valve tissue member. For example, in certain circumstances it may be advantageous for the paddle 406 to remain in the open position and for the gripping member 408 to move outwardly toward the paddle 406 to engage the valve tissue with the paddle 406.

[0106] Although the example shown in Figures 57-63 illustrates a pair of paddles 406 and a pair of gripping members 408, it will be understood that the valve repair device 402 may include any suitable number of paddles and gripping members.

[0107] In some implementations, the valve repair system 400 includes a deployment shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the valve repair device 402. After the valve repair device 402 is secured to the valve tissue, the deployment shaft 413 can be removed from the shaft 403, thereby removing the valve repair device 402 from the rest of the valve repair system 400, such that the valve repair device 402 can remain attached to the valve tissue and the delivery device 401 can be removed from the patient's body.

[0108] Valve repair system 400 can also include a paddle control mechanism 410, a gripping member control mechanism 411, and a lock control mechanism 412. Paddle control mechanism 410 is mechanically attached to coupler 405 to drive paddles 406 between open and closed positions by driving the coupler along the shaft. Paddle control mechanism 410 can take any suitable form, such as, for example, a shaft or rod. For example, paddle control mechanism can include a hollow shaft, a catheter tube, or a sleeve that fits over deployment shaft 413 and over shaft 403 and connected to coupler 405.

[0109] The gripping member control mechanism 411 is configured to actuate the gripping member 408 to vary the width of the opening 414 between the gripping member and the paddle 406. The gripping member control mechanism 411 may take any suitable form, such as, for example, a line, a suture or wire, a rod, a catheter, etc.

[0110] The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 serves as a locking means for locking the coupler 405 in a stationary position relative to the shaft 403 and can take a variety of different forms, and the type of lock control mechanism 412 can be dictated by the type of lock used. That is, the lock 407 includes a pivotable plate with a hole, and the shaft 403 of the valve restoration device 402 is disposed within the hole of the pivotable plate. In this example, when the pivotable plate is in a tilted position, the pivotable plate engages the shaft 403 to maintain its position on the shaft 403, but when the pivotable plate is in a substantially non-tilted position, the pivotable plate can move along the shaft (thereby allowing the coupler 405 to move along the shaft 403). In other words, the coupler 405 is prevented from moving in direction Y (as shown in FIG. 61A ) along the shaft 403 when the pivotable plate of the lock 407 is in the tilted position (or locked position), and the coupler is allowed to move in direction Y along the shaft 403 when the pivotable plate is in the substantially non-tilted position (or unlocked position). In an example where the lock 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage the pivotable plate to drive the plate between the tilted position and the substantially non-tilted position. The lock control mechanism 412 can be, for example, a rod, a suture, a wire, or any other member capable of driving the pivotable plate of the lock 407 between the tilted position and the substantially non-tilted position. In some implementations, the pivotable plate of the lock 407 is biased to a tilted position (or locked position), and the plate is driven from the tilted position to a substantially non-tilted position (or unlocked position) using the lock control mechanism 412. In some implementations, the pivotable plate of the lock 407 is biased to a substantially non-tilted position (or unlocked position), and the plate is driven from the substantially non-tilted position to the tilted position (or locked position) using the lock control mechanism 412.

[0111] 61A-61B illustrate the valve repair device 402 being actuated from an open position (shown in FIG. 61A) to a closed position (shown in FIG. 61B). The base assembly 404 includes a first link 1021 extending from point A to point B, a second link 1022 extending from point A to point C, a third link 1023 extending from point B to point D, a fourth link 1024 extending from point C to point E, and a fifth link 1025 extending from point D to point E. The coupler 405 is movably attached to the shaft 403, which is fixed relative to the fifth link 1025. The first link 1021 and the second link 1022 are pivotally attached to the coupler 405 at point A, such that movement of the coupler 405 along the shaft 403 drives the position of point A, which in turn drives the first link 1021 and the second link 1022. The first link 1021 and the third link 1023 are pivotally attached to one another at point B, and the second link 1022 and the fourth link 1024 are pivotally attached to one another at point C. One paddle 406a is attached to the first link 1021 such that movement of the first link 1021 drives the paddle 406a, and the other paddle 406b is attached to the second link 1022 such that movement of the second link 1022 drives the paddle 406b. In some implementations, the paddles 406a, 406b may be connected to the links 1023, 1024 or may be extensions of the links 1023, 1024.

[0112] To drive the valve repair device from an open position (shown in FIG. 61A ) to a closed position (shown in FIG. 61B ), the coupler 405 is driven along the shaft 403 in direction Y, which drives the pivot point A for the first link 1021 and the second link 1022 to a new position. Driving the coupler 405 (and pivot point A) in direction Y drives the portion of the first link 1021 located near point A in direction H, and drives the portion of the first link 1021 located near point B in direction J. The paddle 406a is attached to the first link 1021 such that driving the coupler 405 in direction Y drives the paddle 406a in direction Z. In addition, the third link 1023 is pivotally attached to the first link 1021 at point B, such that driving the coupler 405 in direction Y drives the third link 1023 in direction K. Similarly, driving the coupler 405 (and pivot point A) in direction Y drives the portion of the second link 1022 located near point A in direction L and drives the portion of the second link 1022 located near point C in direction M. The paddle 406b is attached to the second link 1022 such that driving the coupler 405 in direction Y drives the paddle 406b in direction V. In addition, the fourth link 1024 is pivotally attached to the second link 1022 at point C such that driving the coupler 405 in direction Y drives the fourth link 1024 in direction N. FIG. 61B illustrates the final position of the valve repair device 402 after driving the coupler 405 as shown in FIG. 61A.

[0113] 58, the valve repair device 402 is shown in an open position (similar to the position shown in FIG. 61A) with the gripping member control mechanism 411 actuating the gripping members 408 to provide a wider gap at the opening 414 between the gripping members and the paddle 406. In the illustrated example, the gripping member control mechanism 411 includes a line, such as a suture, wire, etc., that is attached through an opening in the end of the gripping member 408. Both ends of the line extend through a delivery opening 516 of the delivery device 401. When the line is pulled through the delivery opening 516 in direction Y, the gripping members 408 are actuated inward in direction X to cause a wider opening 414 between the gripping members and the paddle 406.

[0114] 59, the valve repair device 402 is shown with the valve tissue 20, 22 positioned into the opening 414 between the gripping member 408 and the paddle 406. With reference to FIG. 60, after the valve tissue 20, 22 is positioned between the gripping member 408 and the paddle 406, the gripping member control mechanism 411 is used to narrow the opening 414 between the gripping member and the paddle. That is, in the illustrated example, the line of the gripping member control mechanism 411 is released or pushed out of the delivery member opening 516 in direction H, allowing the gripping member 408 to move in direction D, thereby narrowing the opening 414. Although the gripping member control mechanism 411 is shown as actuating the gripping member 408 to widen the opening 414 between the gripping member and the paddle 406 (FIG. 59), it will be understood that actuation of the gripping member may not be necessary to position the valve tissue within the opening 414. However, in certain circumstances, the opening 414 between the paddle 406 and the gripping member 408 may be made wider to receive the valve tissue.

[0115] 62, the valve repair device 402 is in an occluded position and secured relative to the valve tissue 20, 22. The valve repair device 402 is secured relative to the valve tissue 20 by the paddles 406a, 406b and the gripping members 408a, 408b. In particular, the valve tissue 20, 22 is attached to the valve repair device 402 by optional barbed portions 409 of the gripping members 408a, 408b, and the paddles 406a, 406b engage the gripping members 408, securing the valve repair device 402 relative to the valve tissue 20, 22.

[0116] To drive the valve repair device 402 from the open position to the closed position, the lock 407 is driven to an unlocked state by the lock control mechanism 412 (as shown in FIG. 62). After the lock 407 is in the unlocked state, the coupler 405 can be driven along the shaft 403 by the paddle control mechanism 410. In the illustrated example, the paddle control mechanism 410 drives the coupler 405 along the shaft in direction Y to drive one paddle 406a in direction X and the other paddle 406b in direction Z. Driving the paddle 406a in direction X and driving the paddle 406b in direction Z engages the paddles with the gripping members 408a, 408b and secures the valve repair device 402 to the valve tissue 20, 22.

[0117] 63, after the valve repair device 402 is fixed to the valve tissue 20, 22 by driving the paddle 406 to the occluded position (as shown in FIG. 62), the lock 407 is driven to a locked state by the lock control mechanism 412 (FIG. 62) to maintain the valve repair device 402 in the occluded position. After the valve repair device 402 is maintained in the locked state by the lock 407, the valve repair device 402 is removed from the delivery device 401 by decoupling the shaft 403 from the deployment shaft 413 (FIG. 62). In addition, the valve repair device 402 is removed from the paddle control mechanism 410 (FIG. 62), from the gripping member control mechanism 411 (FIG. 62), and from the lock control mechanism 412. Removing the valve repair device 402 from the delivery device 401 allows the valve repair device to remain fixed to the valve tissue 20, 22 while the delivery device 401 is being removed from the patient.

[0118] 64, an exemplary valve repair device 570 is shown. The valve repair device 570 may include any combination of features of an implantable prosthetic device or implant, as described herein. As shown in this example, the valve repair device 570 is deployed between the atrium A and the ventricle V, such as the mitral or tricuspid valve of the heart. The valve repair device 570 engages tissue, such as the native valve leaflets 20 and 22, to restore native valve function (e.g., control unidirectional blood flow from the atrium A to the ventricle V), as described herein. The valve repair device 570 may be secured in place by, for example, paddles, clasps, barbs, anchors, etc., in any of the methods described herein.

[0119] In some implementations, the valve repair device 570 includes one or more sensors, such as sensor 572 and / or sensor 574. In some implementations, the sensors 572 and / or 574 are pressure sensors operable to measure pressure (e.g., blood pressure) proximate to the sensor. For example, in one example, the sensor 572 is configured to measure a proximal pressure (i.e., pressure in the atrium) and the sensor 574 is configured to measure a distal pressure (i.e., pressure in the ventricle). The measured proximal (atrial) and distal (ventricular) pressures can be used to calculate a pressure gradient that provides insight into the function of the valve repair device and the state of the device within the patient. While the sensors are primarily pressure related, in some examples, the one or more sensors may be configured to measure, collect, interpret, and / or transmit pressure related and non-related data, such as, for example, heart rate, physical activity, blood flow, pressure gradients, etc. Additionally, the ability to observe and collect the above-mentioned data in real time or near real time allows a physician or other medical professional to quickly determine the operational effectiveness of the valve repair device.

[0120] Some sensors described herein may be configured to measure, collect, interpret, and / or transmit multiple types of data within a single sensor device. Of course, different sensors are contemplated, such as, for example, pressure plate sensors, capacitive sensors, inductive sensors, etc. The sensors 572, 574 may be the same type of sensor or different types of sensors. It is further understood that in some implementations, the sensors 572 and 574 may be embodied in a single sensor configuration. Other configurations are contemplated, including those having multiple sensors. With respect to the location of the sensors 572 and 574, although illustrated in various locations described herein, it is understood that the sensors 572 and 574 may be located anywhere on or near the valve repair device in some implementations.

[0121] The sensors 572 and 574 may optionally include a transmitter for wirelessly transmitting data measured by the sensors 572 and 574 in real-time or near real-time. As shown in FIG. 65, an exemplary valve repair device 580 is shown with sensors 572 and 574 and a transmitter 582. The transmitter 582 may take a wide variety of different forms. The transmitter 582 may be an antenna. Such an antenna may take a wide variety of different forms. In the illustrated example, the antenna extends between the sensors 572, 574. In some implementations, the transmitter 582 is a radio frequency (RF) transmitter. In some implementations, the transmitter 582 is a Wi-Fi transmitter. In some implementations, the transmitter 582 is a Bluetooth transmitter.

[0122] Once data is measured, collected, and / or interpreted by the sensors 572 and 574, it may be wirelessly transmitted to a compatible receiver device outside the body. It is understood that the receiver device may be embodied in a variety of devices, including, but not limited to, a mobile phone, a laptop / desktop computer, a tablet computer, a smart watch, and the like. It is further understood that the compatible receiver device may comprise a processor and memory operable to perform calculations, display data, and the like, based on the data received from the sensors 572 and 574. In some implementations, the transmitter 582 is configured to transmit and receive data from the sensors 572 and 574. For example, in some implementations, the receiver device is operable to configure and / or calibrate the sensors 572 and 574 via wireless communication with the transmitter 582. Of course, the transmitter 582 as described above may be integrated within the sensors 572 and 574, the valve repair device 580, or both.

[0123] In some implementations, the sensors 572 and 574 may include a processor and memory. A processor and memory configuration may be associated with the sensors and utilized to perform various calculations related to measurements at the sensors 572 and 574. In certain configurations, the sensors 572 and 574 may further be associated with a memory configured to store measured data, which may then be used by the processor and / or additional memory to process calculations related to the data. Of course, the above-mentioned processor and memory may be integrated within the sensors 572 and 574, the valve repair device (e.g., valve repair device 570 and / or 580), or both.

[0124] In some implementations, the sensors 572 and 574 are battery powered. In some implementations, the sensors 572 and 574 are configured to receive power wirelessly, for example, via a short-range wireless RF power signal. In some implementations, the sensors 572 and 574 are operable when in communication range with the short-range wireless RF power signal. In some implementations, the exemplary receiver device can transmit such a power signal to the sensors 572 and 574 to activate the sensors and facilitate transmission of data from the sensors to the receiver device.

[0125] FIG. 66 illustrates an exemplary valve repair device 590 having a spacer 592. The valve repair device 590 can take a wide variety of different forms. For example, the valve repair device 590 can be the valve repair device 100 shown in FIGS. 8-21 and described herein. The illustrated valve repair device 590 includes a clasp 594 and a paddle 596. The spacer 592, clasp 594, and paddle 596 are used to position and secure the valve repair device 590 within a native valve (e.g., mitral valve, tricuspid valve, etc.) to improve, repair, and / or replace native valve function. However, in some embodiments, the valve repair device 590 can be used with other valves, such as the tricuspid valve, the aortic valve, or the pulmonary valve.

[0126] 66, valve repair device 590 also includes sensors 572 and 574. Spacer 592, clasp 594, and / or paddle 596 may be modified from those of device 100 to facilitate the inclusion of sensors 572 and 574. As shown, sensor 572 may be configured to determine a characteristic or attribute within atrium A, such as pressure within atrium A, and sensor 574 may be configured to determine a characteristic or attribute within the ventricle, such as pressure within ventricle V.

[0127] FIG. 67 illustrates an exemplary valve repair device 600. The valve repair device 600 can take a wide variety of different forms. For example, the valve repair device 600 can be the valve repair device 100 shown in FIGS. 8-21 and described herein. The valve repair device 600 can include a coaptation element or spacer 602, a clasp 604, and a paddle 606. As described herein, the coaptation element / spacer 602, clasp 604, and paddle 606 can be used to position and secure the valve repair device 600 within a native valve (e.g., mitral valve, tricuspid valve, etc.) to improve, repair, and / or replace native valve function. Also illustrated in FIG. 67 are sensors 572 and 574 and a transmitter 582. The coaptation element / spacer 602, clasp 604, and / or paddle 606 can be modified from that of the device 100 to facilitate the inclusion of the sensors 572 and 574 and / or transmitter 582. As shown, sensor 572 may be configured to determine the proximal pressure in atrium A, and sensor 574 may be configured to determine the distal pressure in ventricle V. The proximal and distal pressures may then be transmitted via transmitter 582 to a receiving device (not shown).

[0128] FIG. 68 illustrates an exemplary valve repair device 610 attached to the native valve leaflets 20 and 22. The valve repair device 610 can take a wide variety of different forms. For example, the valve repair device 610 can be the valve repair device 402 shown in FIGS. 57-63 and described herein. The valve repair device 610 includes a clasp 616 and a paddle 612 that is used to secure the valve repair device 600 to the native valve to restore native valve function. The valve repair device 610 includes a coupling 613 that moves the paddle 612. The coupling 613 can be manipulated through movement of a coupler 611 up and down a shaft 615. Once the desired position of the paddle 612 is achieved, the coupler can be locked in place by a lock 618. Also illustrated in FIG. 68 are sensors 572 and 574. Paddle 612, clasp 616, coupling 613, coupler and / or lock 618 may be modified from that of device 402 to facilitate the inclusion of sensors 572 and 574. As shown, sensor 572 may be configured to determine proximal pressure in atrium A and sensor 574 may be configured to determine distal pressure in ventricle V.

[0129] 69 illustrates that the atrial sensor 572 of the device 610 may be disposed in a wide variety of different locations, including but not limited to locations 6916, 6917, and / or 6923. Location 6916 illustrates that the atrial sensor 572 of the device 610 may be positioned on one or more clasps, such as at the end of one or more clasps 616, or along the length of one or more clasps. Location 6917 illustrates that the atrial sensor 572 of the device 610 may be positioned on the shaft 615, such as at the end of the shaft or along the length of the shaft. Location 6923 illustrates that the atrial sensor 572 of the device 610 may be positioned at the link 623 exposed to atrial pressure, or in more locations.

[0130] 70 illustrates that the ventricular sensor 574 of the device 610 may be disposed in a variety of different locations, including but not limited to location 623 and / or location 632. Location 632 illustrates that the ventricular sensor 574 of the device 610 may be positioned on one or more portions of the links of the linkage 613 that are exposed to ventricular pressure. Location 632 illustrates that the ventricular sensor 574 of the device 610 may be positioned on one or more portions of the paddle 612.

[0131] 71 and 72 show an exemplary valve repair device 640. The valve repair device 640 can take a wide variety of different forms. For example, the valve repair device 640 can be the valve repair device 200 shown in FIGS. 22-53 and described herein. The valve repair device 640 further includes an outer paddle 652, an inner paddle 653, a paddle frame 654, a spacer 655, a movable clasp arm 656, and a fixed clasp arm 657. The paddles and clasps are used to position and secure the valve repair device 640 within the native valve to restore native valve function. The valve repair device 640 can further include a collar 658 and a cap 659. Also shown in FIG. 72 are sensors 572 and 574. Outer paddle 652, inner paddle 653, paddle frame 654, spacer 655, movable clasp arm 656, fixed clasp arm 657, collar 658, and / or cap 659 may be modified from that of device 402 to facilitate the inclusion of sensors 572 and 574 and / or transmitter 582. As shown, sensor 572 may be configured to determine proximal pressure in atrium A and sensor 574 may be configured to determine distal pressure in ventricle V.

[0132] 73 illustrates that the atrial sensor 572 of the device 640 may be disposed in a wide variety of different locations, including, but not limited to, locations 7358, 7355a, 7355b, 7356, and / or 7357. Location 7358 illustrates that the atrial sensor 572 of the device 640 may be positioned on the collar 658. Locations 7355a, 7355b illustrate that the sensor may be positioned on the spacer 655. Location 7355a illustrates that the sensor may be positioned on the proximal end of the spacer 655. Location 7355b illustrates that the sensor may be positioned on a middle portion along the length of the coaptation element / spacer 655. Locations 7356, 7357 illustrate that the sensor may be positioned on the movable clasp arm 656. Location 7356 illustrates that the sensor may be positioned on the end of the movable clasp arm 656. Position 7357 indicates that a sensor may be positioned along the length of the movable clasp arm 656 .

[0133] 74 illustrates that the ventricular sensor 574 of the device 640 may be disposed in a wide variety of different locations, including but not limited to locations 7452a, 7452b, 7453, and 7459. Locations 7452a, 7452b illustrate that the ventricular sensor 574 of the device 640 may be positioned on one or more portions of the outer paddle 652 that are exposed to ventricular pressure. Location 7452a illustrates that the ventricular sensor 574 of the device 640 may be positioned on one or more proximal portions of the outer paddle 652. Location 7452b illustrates that the ventricular sensor 574 of the device 640 may be positioned on one or more distal portions of the outer paddle 652. Location 7453 illustrates that the ventricular sensor 574 of the device 640 may be positioned on one or more portions of the inner paddle 653 and / or on one or more portions of the fixation clasp arm 657. Position 7459 indicates that the ventricular sensor 574 of the device 640 may be positioned on the cap 659 .

[0134] FIG. 75 illustrates an exemplary valve repair device 680. The valve repair device 640 can take a wide variety of different forms. For example, the valve repair device 640 can be the valve repair device 300 shown in FIG. 55 and described herein. The valve repair device 680 includes an outer paddle 652, an inner paddle 653, a paddle frame 654, a spacer 655 (including an upper portion 655a and a middle portion 655b), a movable clasp arm 656 (see FIGS. 76 and 77), and a fixed clasp arm 657 (see FIGS. 76 and 77). The spacer, paddles, and clasps are used to position and secure the valve repair device 680 within the native valve to restore native valve function. The valve repair device 680 can also include a collar 658 (FIG. 77) and / or a cap 659 (FIG. 76). Also illustrated in FIG. 75 are sensors 572 and 574. Outer paddle 652, inner paddle 653, paddle frame 654, spacer 655, movable clasp arm 656, fixed clasp arm 657, collar 658, and / or cap 659 may be modified from that of device 300 to facilitate the inclusion of sensors 572 and 574 and / or transmitter 582. As shown, sensor 572 may be configured to determine proximal pressure in atrium A and sensor 574 may be configured to determine distal pressure in ventricle V.

[0135] 76 illustrates that the atrial sensor 572 of device 680 may be disposed in a wide variety of different locations, including but not limited to locations 7658, 7655, and / or 7456. Location 7658 illustrates that the atrial sensor 572 of device 640 may be positioned on collar 658 (see FIG. 77). Location 7655 illustrates that the sensor may be positioned on spacer 655. Location 7656 illustrates that the sensor may be positioned on movable clasp arm 656.

[0136] 77 illustrates that the ventricular sensor 574 of the device 680 may be disposed in a wide variety of different locations, including but not limited to locations 7752a, 7752b, 7753, and 7759. Locations 7752a, 7752b illustrate that the ventricular sensor 574 of the device 640 may be positioned on one or more portions of the outer paddle 652 that are exposed to ventricular pressure. Location 7752a illustrates that the ventricular sensor 574 of the device 640 may be positioned on one or more proximal portions of the outer paddle 652. Location 7752b illustrates that the ventricular sensor 574 of the device 640 may be positioned on one or more distal portions of the outer paddle 652. Location 7753 illustrates that the ventricular sensor 574 of the device 640 may be positioned on one or more portions of the inner paddle 653 and / or on one or more portions of the fixation clasp arm 657. Position 7759 indicates that the ventricular sensor 574 of the device 640 may be positioned on the cap 659 .

[0137] 78 shows an exemplary delivery system 702 for deploying a valve repair device into a human heart H. In the illustrated implementation, as opposed to a valve repair device (e.g., valve repair device 570) that includes one or more sensors, e.g., sensor 572 and / or sensor 574, the one or more sensors are positioned on one or more components of the delivery system 702. However, in some implementations, sensor 572 or sensor 574 may be included on the valve repair device in any of the ways disclosed herein, and other sensors may be included on one or more components of the delivery system. The valve repair device may be any of the valve repair devices disclosed herein, e.g., valve repair device 100.

[0138] FIG. 78 illustrates a valve repair device 100 positioned at the mitral valve MV between the left atrium LA and the left ventricle LV and engaging valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The delivery system 702 can be configured to position the valve repair device at the mitral valve MV between the left atrium LA and the left ventricle LV in a variety of different ways. For example, the valve repair device can be delivered through the atrium as shown, transapically, transseptally, etc. In FIG. 78, delivery through the atrium is selected simply to provide the simplest illustration of the system. Additionally, the valve repair device 10 can be configured to be implanted on other native heart valves, such as the tricuspid valve.

[0139] The device or implant 100 is configured to be implanted between the leaflets 20, 22 of a native valve (e.g., native mitral valve MV, native tricuspid valve, etc.) and includes a coaptation element 110 (e.g., spacer, plug, filler, foam, sheet, membrane, coaptation element, etc.) slidably attached to an actuation element 112 (e.g., actuation wire, actuation shaft, actuation tube, etc.). The anchor portion 106 of the device 100 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, a paddle, a gripping member, or the like. Actuation of the actuation element 112 opens and closes the anchor portion 106 of the device 100 to grip the native leaflets 20, 22 during implantation.

[0140] In some implementations, the delivery system 702 includes a steerable catheter 704, an implant catheter 706, and an actuating element 112, which can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuating element 112 extends through the implant catheter 706 and the joint element 110 to a distal end 714 of the anchor portion 106.

[0141] In some implementations, the sensors 572, 574 are pressure sensors operable to measure pressure proximate to the sensors. For example, in one embodiment, the first sensor 572 is configured to measure a proximal pressure (i.e., pressure in the left atrium) and the second sensor 574 is configured to measure a distal pressure (i.e., pressure in the left ventricle). The first sensor 572 and the second sensor 574 may be located at any suitable location on the delivery system 702 to measure the proximal and distal pressures. The measured proximal (atrial) and distal (ventricular) pressures may be used to calculate pressure gradients that provide insight into the function of the valve repair device and the status of the device within the patient. While the sensors are primarily pressure related, in some embodiments, one or more sensors may be configured to measure, collect, interpret, and / or transmit pressure related and non-related data, such as, for example, heart rate, physical activity, blood flow, pressure gradients, and the like. Additionally, the ability to observe and collect the above-mentioned data in real time or near real time allows a physician or other medical professional to quickly determine the operational effectiveness of the valve repair device.

[0142] In some implementations, the first sensor 572 and the second sensor 574 include fluid-filled lumens, each of which forms a continuous fluid pathway, allowing simultaneous real-time assessment of atrial and ventricular pressures, and thus transvalvular gradient assessment. The first sensor 572 and the second sensor 574 may be provided at any suitable location on the delivery system 702 to measure proximal and distal pressures. In some implementations, the first sensor 572 may be a first lumen formed in the steerable catheter 704 and extending from a distal portion 716 of the steerable catheter 704 to a first outlet pressure port 718, which may be connected to a pressure transducer (not shown) or other pressure sensing device. The fluid (e.g., saline) in the first lumen forms a continuous fluid pathway that may relay a pressure signal along the first lumen from the distal portion 716 of the steerable catheter to a pressure transducer, such that real-time pressure may be monitored. The distal portion 716 of the steerable catheter 704 is positioned within the left atrium LA during deployment of the device or implant 100 so that the first sensor 572 is able to measure the atrial pressure.

[0143] Similarly, the second sensor 574 may be a second lumen formed in one or more of the implant catheter 706 and the actuation means or element 112. For example, the actuation means or element 112 may be an actuation tube including a second lumen or a portion of a second lumen. The tubular actuation element 112 extends from the distal end 714 of the device or implant 100 through the implant catheter 706. The tubular actuation element may be in fluid communication with a second outlet pressure port 720 that may be connected to a pressure transducer (not shown) or other pressure sensing device. The fluid (e.g., saline) in the second lumen forms a continuous fluid pathway that may relay a pressure signal along the second lumen from the distal end 714 of the device or implant 100 to the pressure transducer so that real-time pressure may be monitored. Because the distal end 714 of the device or implant 100 is positioned within the left ventricle LV, the second sensor 574 may measure ventricular pressure that may be relayed along the implant catheter 706 and monitored simultaneously in real time as well as atrial pressure. Combined assessment of atrial and ventricular pressures allows the evaluation of transvalvular gradients before and after the implant procedure, allowing assessment of procedural success.

[0144] In some implementations, both the first lumen and the second lumen may be formed within the implant catheter 706. For example, the second sensor 574 may comprise the actuating element 112 and a lumen within the implant catheter disposed about the actuating element. An optional seal may be provided between the actuating element 112 and the implant catheter 706 to prevent, substantially prevent, or inhibit fluid within the atrium from entering the lumen within the implant catheter disposed about the actuating element 112, but allow the actuating element to slide relative to the implant catheter 706. The lumen within the implant catheter is disposed about the actuating element 112, which extends from a distal end 714 of the device or implant 100 and communicates with a second outlet pressure port 720 to measure ventricular pressure. Instead of being formed in the steerable catheter 704, the first sensor 572' may be formed in the implant catheter 706 and be a first lumen extending from a distal portion 722 of the implant catheter 706 to an exit pressure port 718' that may be connected to a pressure transducer (not shown) or other pressure sensing device. The distal portion 722 of the implant catheter 706 remains in the left atrium during deployment of the device or implant 100 such that the fluid (e.g., saline) in the first lumen forms a continuous fluid pathway that can relay a pressure signal along the first lumen from the distal portion 722 of the implant catheter 706 to the pressure transducer so that real-time pressure can be monitored. Because the distal portion 722 of the implant catheter 706 is positioned in the left atrium LA, the first sensor 572' may measure atrial pressure.

[0145] Any of the various systems, devices, apparatus, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use with patients, and the methods herein can include sterilization (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of the associated systems, devices, apparatus, etc.

[0146] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in various examples, these various aspects, concepts, and features may be used in many alternative implementations, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Still further, although various alternative implementations of the various aspects, concepts, and features of the present disclosure may be described herein, for example, alternative materials, alternative structures, alternative configurations, alternative methods, alternative devices, alternative components, alternatives in form, alternatives in fit, alternatives in function, and the like, such descriptions are not intended to be a complete or exhaustive list of available alternative implementations, whether currently known or later developed. Those skilled in the art may readily employ one or more of the inventive aspects, concepts, or features into additional implementations and applications within the scope of the present application, even if these are additional implementations not expressly disclosed herein.

[0147] Additionally, although some features, concepts, or aspects of the disclosure may be described herein as being preferred configurations or methods, such description is not intended to imply that such features are essential or indispensable unless expressly stated.Furthermore, while exemplary or representative values, and even exemplary or representative ranges, may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be critical values ​​or ranges only if expressly stated as such.

[0148] Moreover, although various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the disclosure, such identification is not intended to be exclusive; 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 particular disclosure, the disclosure being instead defined in the appended claims. Descriptions of exemplary methods or processes are not limited to the inclusion of every step as being essential in all cases, nor is the order in which steps are presented construed as essential or essential unless expressly stated. Terms used in the claims have their full ordinary meaning and are not limited in any way by the description of implementations herein.

Claims

**Claim 1** A sensing valve repair device comprising: A pair of inner paddles; A pair of outer paddles connected to the pair of inner paddles; A pair of clasps, each clasp having a fixed arm attached to one of the pair of inner paddles, a movable arm, and a hinge portion connecting the movable arm to the fixed arm; A pair of sensors; And wherein each sensor of the pair of sensors is attached to one or more of one of the fixed arms of the pair of clasps and one of the pair of inner paddles. A sensing valve repair device according to claim 1, wherein the sensor is configured to sense one or more of pressure, capacitance, and inductance. **Claim 2** The sensing valve repair device according to claim 1, wherein the sensor is configured to sense one or more of pressure, capacitance, and inductance. **Claim 3** The sensing valve repair device according to claim 1, wherein at least a portion of each sensor is disposed in a space between the movable arm and the fixed arm of one of the pair of clasps. **Claim 4** The sensing valve repair device according to claim 1, wherein at least a portion of each sensor is closer to the hinge portion than the free end of the movable arm of one of the pair of clasps. **Claim 5** The sensing valve repair device according to claim 1, further comprising a joining element attached to the pair of inner paddles. **Claim 6** The sensing valve repair device according to claim 1, further comprising a transmitter configured to transmit sensed data from at least one of the pair of sensors to a receiver. **Claim 7** The sensing valve repair device according to claim 5, further comprising a ventricular pressure sensor disposed at a distal end of the device and an atrial pressure sensor disposed at a proximal end of the device. **Claim 8** The sensing valve repair device according to claim 1, wherein the sensing valve repair device is configured to be implanted within a mitral valve. **Claim 9** A sensing valve repair system comprising: A delivery catheter; A sensing valve repair device coupled to the delivery catheter; And wherein the sensing valve repair device comprises: A pair of inner paddles; A pair of outer paddles connected to the pair of inner paddles; A pair of clasps, each clasp having a fixed arm attached to one of the pair of inner paddles, a movable arm, and a hinge portion connecting the movable arm to the fixed arm; A pair of sensors; And wherein each sensor of the pair of sensors is attached to one or more of one of the fixed arms of the pair of clasps and one of the pair of inner paddles. Each sensor of the pair of sensors is attached to one or more of one of the fixed arms of the pair of clasps and one of the pair of inner paddles, a sensing valve repair system.

10. The sensor is configured to sense one or more of pressure, capacitance, and inductance, the sensing valve repair system according to claim 9.

11. At least a portion of each sensor is disposed in a space between the movable arm and the fixed arm of one of the pair of clasps, the sensing valve repair system according to claim 9.

12. At least a portion of each sensor is closer to the hinge portion than the free end of the movable arm of one of the pair of clasps, the sensing valve repair system according to claim 9.

13. The sensing valve repair system according to claim 9, further comprising a joining element attached to the pair of inner paddles.

14. The sensing valve repair system according to claim 9, further comprising a transmitter configured to transmit sensed data from at least one of the pair of sensors to a receiver.

15. The sensing valve repair system according to claim 14, further comprising a ventricular pressure sensor disposed at a distal end of the device and an atrial pressure sensor disposed at a proximal end of the device.

16. The sensing valve repair device is configured to be implanted within a mitral valve, the sensing valve repair system according to claim 9.

17. A sensing valve repair system, A steerable catheter, An implant catheter received within the steerable catheter, A valve repair device coupled to the implant catheter, A first sensor associated with one of the steerable catheter and the implant catheter, the first sensor being configured to sense characteristics of a proximal or proximal end of the valve repair device, the first sensor, A second sensor associated with the implant catheter, the second sensor being configured to sense characteristics of a distal or distal end of the valve repair device, the second sensor, Comprising a sensing valve repair system.

18. The characteristics sensed by both the first sensor and the second sensor are pressure, the sensing valve repair system according to claim 17.

19. The first sensor includes a first lumen of the implant catheter and is a pressure sensor in fluid communication with a first pressure sensing device. The first lumen extends from a distal portion of the implant catheter to the first pressure sensing device. The second sensor includes a second lumen of the implant catheter and is a pressure sensor in fluid communication with a second pressure sensing device. The sensing valve repair system according to claim 17.

20. The sensing valve repair system according to claim 17, further comprising a transmitter configured to transmit data sensed from at least one of the first and second sensors to a receiver.

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