Systems and methods for repairing leaking cardiac valves

Abstract

Methods and systems are provided for repairing a defective cardiac valve having at least three native leaflets and three native commissures. An example system includes a coaptation device having an adaptive support structure comprising a central hub, a first radial support member extending from the central hub into a region of the first native commissure, a second radial support member extending from the central hub into a region of the second native commissure, and a third radial support member extending from the central hub into a region of the third commissure. The system also includes a coaptation member suspended by the adaptive support structure. The coaptation member is configured to occupy a portion of the central opening in the defective cardiac valve and coapt against one or more of the native leaflets of the cardiac valve during systole such that the blood backflow through the defective cardiac valve is reduced.

Description

SYSTEMS AND METHODS FOR REPAIRING LEAKING CARDIAC VALVESCross Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial Number 63 / 522496;filed June 22, 2023, the entire disclosure of which is incorporated herein by reference.Technical Field

[0002] This application generally relates to an apparatus and methods for repairing a leaking cardiac valve such as a tricuspid valve or a tricuspid aortic valve.Background

[0003] The human heart contains four valves that regulate the flow of blood through the heart and into the pulmonary and arterial system: the tricuspid valve, the pulmonary valve, the mitral valve, and the aortic valve. These valves may become defective, thereby impairing the function of the heart. Dilation of the heart chambers may cause these valves to leak. This is referred to as functional regurgitation. In functional regurgitation, the native valve leaflets do not fully coapt leaving a central gap for blood to flow back through the valve. The back flow forces the heart to pump harder in order to maintain the same cardiac output. Chronic regurgitation may result in overload of the heart and ultimately heart failure.

[0004] Systems and methods have been developed to treat valvular regurgitation. They include valve replacement and valve repair devices and procedures. One approach to valve repair is the placement of a device into the leaking valve that enhances the coaptation of the native leaflets. Concepts for enhancing leaflet coaptation are disclosed in US Patent Nos. 8,758,432, 9,011,523, 9,474,605, 9,363,223, and 10,888,424. Once challenge in reducing these concepts to practice is the need to center the coaptation device into the annulus of the defective valve and maintain its position throughout the implant period. Another challenge is the need to fit the coaptation device to the unique geometry of the leaking valve, which may comprise a defective valve with three or more native leaflets such as a tricuspid valve feature having an asymmetric geometry that can greatly vary from patient to patient.The shape of the heart chambers and the shape of the leaking valve may change over the implant period due to disease progression or positive remodeling. In case of disease progression, the heart chambersPage 1SUBSTITUTE SHEET (RULE 26)and the valve annulus may continue to dilate and the central opening in the leaking valve may increase. Conversely in case of positive remodeling, the heart chambers and the valve annulus may contract and the central opening in the leaking valve may decrease. Furthermore, these geometrical changes may be asymmetric. There is a need for systems and methods for enhancing the coaptation in leaking cardiac valves that can adapt to the geometrical variations and geometrical changes in the cardiac anatomy.Summary

[0005] The present disclosure provides systems and methods for the treatment of regurgitation in cardiac valves. The devices and methods disclosed herein are specifically suitable for the treatment of valves containing three or more leaflets. The devices disclosed herein can be implanted into the heart using open surgical, minimal-invasive surgical, and trans-vascular methods of delivery and placement.

[0006] For consistency, when describing the systems and methods, the direction of the blood flow during systole is referred to as "downstream" and the opposite direction is referred to as "upstream". When describing systems for the repair of a tricuspid valve, the right ventricle of the heart is located downstream of the tricuspid valve annulus and the right atrium of the heart is located upstream of the tricuspid valve annulus. When describing systems for the repair of a tricuspid aortic valve, the aorta is located downstream of the aortic valve annulus and the left ventricle of the heart is located upstream of the aortic valve annulus.

[0007] The present disclosure provides a coaptation device that includes an adaptive support structure that is configured to be placed into the annulus of the defective cardiac valve. The adaptive support structure comprises a central hub and three radial support members extending radially outward from the central hub into the regions of the native commissures. One or more radial support members may be configured to pivot around the central hub. A coaptation member is suspended by the adaptive support structure in the flow path. The coaptation member is configured to occupy a portion of the central opening in the defective cardiac valve and coapt against one or more of the native leaflets of the cardiac valve during systole such that the backflow through the defective cardiac valve is reduced. The coaptation member may comprise one or more prosthetic leaflets. The coaptation member may be an inflated balloon or any other means of improving the coaptation of the defective cardiac valve.

[0008] In accordance with one aspect of the disclosure, the coaptation device may be configured to expand from a first contracted delivery state to a second expanded deployed state. The adaptivePage 2SUBSTITUTE SHEET (RULE 26)support structure may be configured to position the three radial support members in an angular relationship that is close to the angular relationship between the three native commissures of the defective cardiac valve such that the radial support members expand into the regions of the native commissures when the coaptation device is deployed into the annulus of the defective cardiac valve. The angular relationships between the radial support members may be established by locking the radial support members into the desired angular positions prior to compressing the coaptation device into the contracted delivery state, when compressing the coaptation device into the contracted delivery state, by actively pivoting the radial support members prior to placement of the coaptation device into the annulus of the defective cardiac valve, or by partially placing the expanded leaflet assembly into the annulus of the defective cardiac valve and allowing the native leaflets to deflect the radial support members into a preferred angular orientation.

[0009] In some embodiments, a radial support member may have a first end that contains a pivot mechanism that engages with the central hub, a second end that contains a positioning strut that engages with the region of the native commissures, and a prosthetic leaflet commissure positioned between the first end and the second end that suspends the prosthetic leaflet. In a preferred embodiment, the positioning strut can flex radially inward to adjust to the diameter of the annulus of the defective cardiac valve and center the coaptation device in the valve annulus, while the prosthetic leaflet commissure maintains its radial position to preserve the configuration of a suspended prosthetic leaflet.

[0010] The coaptation device may further include one or more anchors to maintain the axial position of the deployed coaptation device in the defective cardiac valve. In some embodiments, the anchors may engage with the cardiac tissue downstream of the defective cardiac valve. For the treatment of a defective tricuspid valve, the one or more anchors may engage with the right ventricular wall downstream of the defective tricuspid valve or the apex of the right ventricle. For the treatment of a defective tricuspid aortic valve, the one or more anchors may engage with the aortic wall at the level of the sinotubular junction.

[0011] In accordance with another aspect of the present disclosure, exemplary methods are provided for delivering a coaptation device trans-vascularly and trans-apically into the defective cardiac valve. The methods may include compressing a coaptation device into a delivery sheath, positioning the delivery sheath upstream of the defective cardiac valve, at least partially deploying the coaptationPage 3SUBSTITUTE SHEET (RULE 26)device upstream of the valve annulus, orienting the radial support members toward the native commissures of the defective cardiac valve, positioning the coaptation device in the annulus of the defective cardiac valve such that the radial support members engage with the annulus of the defective cardiac valve in the regions of the commissures and a coaptation member coapts with at least one leaflet of the defective cardiac valve, and fixating the coaptation device in the defective cardiac valve by engaging an anchor with the downstream cardiac tissue.Brief Description of Drawings

[0012] FIGS 1A-B illustrate the anatomy of the tricuspid valve and the disease progression of functional regurgitation.

[0013] FIGS 2A-B illustrate a first exemplary embodiment of an adaptive support structure of a coaptation device.

[0014] FIG 3 illustrates a first exemplary embodiment of the coaptation device.

[0015] FIGS 4A-C illustrate exemplary embodiments of a prosthetic leaflet of the coaptation device.

[0016] FIG 5 illustrates an exemplary embodiment of the adaptive support structure placed in the annulus of a defective tricuspid valve.

[0017] FIGS 6A-B illustrate an exemplary embodiment of the coaptation device placed into the annulus of a defective tricuspid valve in systole and diastole.

[0018] FIGS 7A-B illustrate an exemplary embodiment of the coaptation device in a compressed delivery state.

[0019] FIGS 8A-E illustrate an exemplary trans-apical implant procedure to repair a defective tricuspid valve with a coaptation device.

[0020] FIGS 9A-B illustrate an exemplary embodiment of an active alignment system for rotating the radial support members of a coaptation device.Page 4SUBSTITUTE SHEET (RULE 26)

[0021] FIGS 10A-B illustrate an alternative embodiment of the coaptation device having arched commissures.

[0022] FIG 11 illustrates an exemplary embodiment of a loading tool to compress a coaptation device into a contracted delivery state.

[0023] FIG 12 illustrates the exemplary embodiment of a coaptation device having arched commissures deployed into a defective tricuspid valve.

[0024] FIG 13 illustrates an exemplary embodiment of an adaptive support structure laser-cut from a metal tube.

[0025] FIGS 14A-B illustrate an exemplary embodiment of an anchoring mechanism to fixate a coaptation device into a defective cardiac valve.

[0026] FIGS 15A-B illustrate an exemplary embodiment of a locking member to prevent a radial support member from pivoting around the central hub of a coaptation device.

[0027] FIGS 16A-B illustrate a method for determining the desired angular orientation of the radial support members for the treatment of a tri-leaf let defective cardiac valve.

[0028] FIG 17 illustrates an exemplary tray containing an array of locking members.

[0029] FIGS 18A-E illustrate an exemplary trans-vascular implant procedure to repair a defective tricuspid valve with a coaptation device.

[0030] FIGS 19A-B illustrate another alternative embodiment of the coaptation device having a trileaflet valve.

[0031] FIGS 20A-B illustrate the alternative embodiment of the coaptation device having a tri-leaf I et valve during systole and diastole.

[0032] FIG 21 illustrates an exemplary embodiment of the coaptation device particularly suited for the treatment of a defective tricuspid aortic valve.

[0033] FIG 22 illustrates the exemplary embodiment of the coaptation device particularly suited for the treatment of a defective tricuspid aortic valve deployed into an aorta.Page 5SUBSTITUTE SHEET (RULE 26)

[0034] FIG 23 illustrates an exemplary embodiment of the coaptation device having a prosthetic leaflet connected to the adaptive support structure by tethers.

[0035] FIG 24 illustrates an exemplary embodiment of the coaptation device having an inflatable balloon configured to coapt with the leaflets of a defective cardiac valve.Detailed Description

[0036] FIG 1A shows a schematic of the tricuspid valve (from PT Tornis, JF Rodriguez-Palomares, MJ Antunes, Secondary Tricuspid Valve Regurgitation: A Forgotten Entity, Heart, 2015, 101:1840-1848). The tricuspid valve is asymmetric and comprises of a septal leaflet, an anterior leaflet, and a posterior leaflet. The three leaflets may be of different sizes and the size relationship between the leaflets may vary from patient to patient. The distances and angles between the native commissures may also vary from patient to patient. In some cases, the tricuspid valve may have more than three leaflets. Disease progression may cause a dilation of the tricuspid annulus along the outer wall of the right ventricle and right atrium as illustrated in FIG IB. The dilation may be associated with a shape change of the annulus and changes in the distances and angular relationships between the commissures.

[0037] FIGS 2A, 2B, and 3 illustrate an exemplary embodiment of a coaptation device that is configured to address the unique geometrical aspects of a defective tricuspid valve. FIG 2A illustrate adaptive support structure (200) of the coaptation device comprising a central hub (201) and radial support members (202a-c) connected to central hub (201). Radial support members (202a-c) are configured to pivot around central hub (201). Central hub (201) consists of hollow tube (203) with axially extending slots (204a-b). As illustrated in FIG 2B, radial support member (206) comprises axially-oriented struts (207a-b) that engage with axial slots (204a-b) in central hub (201), positioning strut (208), and commissural strut (209) positioned between the inner end and outer end of radial support member (206). Prosthetic leaflet (300) is suspended by commissural struts (301a-c) as illustrated in FIG 3.Prosthetic leaflet (300) may be connected to commissural struts (301a-c) by sutures, clips, adhesives, or any other means that create a permanent connection. Optionally, points along the free margin of flexible leaflet (300) may be connected to central hub (302) by tethers (303) to assist in preventing flexible leaflet (300) from prolapsing upstream in systole. The upstream end of central hub (302) has an atraumatic tip and is configured to prevent prosthetic leaflet (300) from collapsing downstream during diastole. Positioning struts (304a-c) are configured to flex inward toward central hub (302) withoutPage 6SUBSTITUTE SHEET (RULE 26)changing the radial position of commissural struts (301a-c). This allows adaptive support structure (305) to conform to the annular diameter of a tricuspid valve without altering the suspension of prosthetic leaflet (300). It is understood that the design of the pivot connection is not restricted to the exemplary embodiment illustrated in FIGS 2A-B. The pivot connection may have an oar-pin hinge configuration. The pivot connection may be formed by a flexible element that connects the radial support member to the central hub. The pivot connection may be constructed from pliable material that can be plastically deformed into the desired angular position. The radial support members may be made from a shapememory alloy or shape-memory polymer.

[0038] FIGS 4A-C show exemplary embodiments of the prosthetic leaflet. FIG 4A illustrates prosthetic leaflet (400) made from a single sheet of material having three ends (401a-c) for fixation to the commissural struts. FIG 4B illustrates prosthetic leaflet (402) made from pieces of material (403a-c), which are connected along edges (404a-b), edges (404c-d), and edges (404e-f) respectively to form a three-dimensional structure. Pieces of material (403a-c) may be connected by sutures, adhesives, or other suitable bonding methods. FIG 4C illustrates prosthetic leaflet (405) with ends (406a-c) for fixation to the commissural struts and attachment points (407a-c) along the free margin for fixation to tethers or directly to the central hub. It is understood that the geometry and construction of the flexible leaflet is not limited to the embodiments illustrated in FIGS 4A-C. The shape of the prosthetic leaflet may not be symmetric to better coapt with an asymmetric tricuspid valve. The free margin between two adjacent commissures of the prosthetic leaflet may take on any shape to provide a coaptation surface to an opposing native leaflet. The flexible leaflet may be made from animal tissue, human tissue, or synthetic material including but not limited to ePTFE and polyurethane. The flexible leaflet may be made from a scaffold suitable for growing tissue. In a preferred embodiment, the flexible leaflet is made from pericardial tissue harvested from an animal and cross-linked. Prosthetic leaflet may be connected to the commissural struts by sutures, adhesives, or other suitable bonding methods.

[0039] FIG 5 illustrates a top view of adaptive support structure (500) deployed into defective tricuspid valve (501). Radial support members (502a-c) are radially oriented toward the regions of respective native commissures (503a-c). The pivot features of adaptive support structure (500) allow radial support members (502a-c) to accommodate a wide range of angles between native commissures (503a-c). Oversizing adaptive support structure (500) with respect to the size of the valve annulus biases positioning struts (504a-c) against the valve annulus in the regions of native commissures (503a-c) and positions central hub (505) into the center of defective cardiac valve (501). FIGS 6A-B illustratePage 7SUBSTITUTE SHEET (RULE 26)coaptation device (600) placed into defective cardiac valve (601) having three leaflets and three commissures. Radial support members (602a-c) engage with the annulus of defective cardiac valve (601) in the regions of the native commissures. FIG 6A shows a top view of coaptation device (600) placed in defective cardiac valve (601) in systole. Prosthetic leaflet (603) coapts against native leaflets (604a-c) and prevents backflow through defective cardiac valve (601). FIG 6B shows defective cardiac valve (601) and coaptation device (600) in diastole. Native leaflets (604a-c) are in the open position. Prosthetic leaflet (603) collapses onto the distal end of the central hub of the adaptive support frame allowing blood to flow through the openings between the native leaflets (604a-c) and prosthetic leaflet (603).

[0040] It is understood that the coaptation device may have more than three radial support members for the treatment of a cardiac valves with more than three leaflets. It is further understood that not all three radial support members may be configured to pivot around the central hub. One or more radial support members may be rigidly connected to the central hub. For example, for the treatment of a defective tricuspid valve a first radial support member may be rigidly connected to the central hub and may be used to index the coaptation device to a first native commissure. A second radial support member and a third radial support member may be flexibly connected to the central hub and may pivot to align with a respective second and third native commissure. In some cases, it may be sufficient to have only one pivoting or no pivoting radial support member.

[0041] In a symmetric coaptation device, the angles between the three pivot connections are 120 degrees. To adapt to a defective tricuspid valve, the angles between the three radial support members may be different from 120 degrees. For example, the respective angles between the three radial support members may be 140, 100, and 100 degrees. The individual angles between two radial support members may be in the range from 90 and 180 degrees. The range of pivot angles that the radial support members can achieve may be restricted to less than + / - 45 degrees, preferably to less than + / - 30 degrees. The adaptive support structure may be configured such that the maximum achievable angle between two adjacent radial support members is restricted to less than 180 degrees preferably less than 160 degrees to stabilize the coaptation device in the center of the defective cardiac valve. In a preferred embodiment of the coaptation device, one radial support member is rigidly connected to the central hub and the pivot angles of the second and third radial support member are restricted such that the achievable angle between two adjacent radial support members is between 90 degrees and 160 degrees.Page 8SUBSTITUTE SHEET (RULE 26)

[0042] A defective tricuspid valve may have an annular diameter ranging from less than 30mm to more than 50mm. The radial distension of a radial support member from the central hub may be at least one- half of the annular diameter. The radial distance of a commissural strut from the central hub may be less than one-half of the annular diameter. The radial distance of a commissural strut from the central hub may be in the range from 6mm to 15mm, preferably between 8mm and 12mm. It is understood that the above dimensions are preferred dimensions for the treatment of a defective tricuspid valve. For the treatment of a defective tricuspid aortic valve, the dimensions of the radial support members may be smaller to conform to the annulus of a diseased tricuspid aortic valve, which is typically of a diameter of 20mm to 30mm.

[0043] FIGS 7A-B illustrate the embodiment of the coaptation device shown in FIG 3in a collapsed state for insertion into a delivery sheath for placement in a defective cardiac valve. Radial support members (701a-c) of coaptation device (700) are compressed radially inward to minimize the overall profile of coaptation device (700) in the collapsed state. Prosthetic leaflet (702) collapses onto the central hub of compressed adaptive support structure (703). FIG 7B illustrates an exemplary embodiment of a delivery sheath of the delivery system. Tubular delivery sheath (704) comprises of axially oriented channels (705a-c) in which the outer ends of radial support members (701a-c) are placed. Channels (705a-c) maintain a predefined angular orientation of collapsed radial support members (701a-c). In FIG 7B, channels (705a-c) are arranged 120 degrees from each other. It is understood that the angles between the channels may be different from 120 degrees. The angles between the channels may approximate the anticipated angles between the native commissures of the defective cardiac valve to be treated.

[0044] FIGS 8A-E illustrate a first method of deploying the exemplary embodiment of the coaptation device shown in FIGS 3A-B into a defective tricuspid valve. FIG 8A shows a side view of the right heart including inferior vena cava (800), superior vena cava (801), right atrium (802), right ventricle (803), and tricuspid valve (804). Access to right ventricle (803) is gained surgically in the region of apex (805) as shown in FIG 8B. Delivery sheath (806) containing coaptation device (807) in the compressed state is advanced through the surgical access past tricuspid valve (804) into right atrium (802). Coaptation device (807) is expanded by retracting delivery sheath (806) as illustrated in FIG 8C. Coaptation device (807) may be rotated to orient positioning struts (808a-c) to respective native commissures (809a-c). A complete alignment of positioning struts (808a-c) with native commissures (809a-c) may not be achieved due to the variability in the location of native commissures (809a-c). To achieve a complete alignment, coaptation device (807) may be partially retracted into tricuspid valve (804) until the nativePage 9SUBSTITUTE SHEET (RULE 26)leaflets of tricuspid valve (804) contact the positioning struts (808a-c) in systole as shown in FIG 8D. The forces exerted by native leaflets onto the positioning struts (808a-c) steer positioning struts (808a-c) into the regions of the native commissures. Once alignment is achieved, coaptation device (807) is lowered into tricuspid valve (804) as shown in FIG 8E. Positioning struts (808a-c) engage with the walls of right ventricle (803). Post (810) is connected to the downstream end of coaptation device (807). Delivery sheath (806) is removed from the heart, and the downstream end of post (810) is secured to the outer wall of right ventricle (803) at apex (805). Post (810) anchors coaptation device (807) in right ventricle (803) and prevents migration of coaptation device (807) into right atrium (802) in systole. A button, pledget, or fabric cloth (811) may be used to reinforce the anchoring of post (810). Post (810) is configured to provide sufficient column strength to prevent migration of coaptation device (807) into right ventricle (803) in diastole. Post (810) may be a Nitinol wire, a metal rod, a polymer rod, or a braid- reinforced polymer extrusion.

[0045] FIGS 9A-B illustrate an exemplary embodiment of an active alignment mechanism to align the radial support members with the native commissures. FIG 9A shows an axial cut through the central hub of the exemplary embodiment of the adaptive support structure illustrated in FIGS 2A-B. First radial support member (901a) is rigidly connected to central hub (900). Second radial support member (901b) and third radial support member (901c) are flexibly connected to central hub (900). FIG 2B shows a side view of an inner end of flexibly connected radial support member (902). The end of support member (902) is keyed to engage with torque wire (903). When positioning the coaptation device into a tricuspid valve, first radial support member (901a) is aligned with a first native commissure by rotating the entire coaptation device. Second radial support member (901b) is aligned with a second native commissure by rotating a first torque wire that is engaged with the keyed end of second radial support member (901b). Third radial support member (901c) is aligned with a third native commissure by rotating a second torque wire that is engaged with the keyed end of third radial support member (901c). Once the coaptation device is placed in the tricuspid valve, the torque wires are retracted and removed from the heart through the delivery sheath.

[0046] FIGS 10A-B illustrate an alternative embodiment of the coaptation device. The adaptive support structure (1000) consists of central hubs (lOOla-b) containing three axial lumens (1002a-c) for housing the inner ends of radial support members (1003a-c). Central hubs (lOOla-b) are connected by rod (1004). The upstream ends of commissural struts (1005a-c) extend inward to form a dome-shaped support for prosthetic leaflet (1006). To secure radial support member (1008) into the cardiac wallPage 10SUBSTITUTE SHEET (RULE 26)downstream of a defective cardiac valve, barbs (1007) may extend radially outward from positioning strut (1009) as shown in FIG 10B. FIG 11 illustrates exemplary loading tool (1100) for transitioning the coaptation device shown in FIGS 10A-B into a contracted state for insertion into a delivery sheath. Loading tool (1100) consists of a funnel (1101) for contracting the adaptive support structure. Inlet surface (1102) of funnel (1101) has first marker (1107a) to indicate the position of a first radial support member that is used to rotationally align the coaptation device with a first commissure of the defective cardiac valve. Second marker (1107b) and third marker (1107c) indicate angular positions of 120 degrees away from first marker (1107c). Groove (1103) extends along funnel (1101) at the location of first marker (1107a). Series of grooves (1104, 1005) extend along funnel (1101) in the regions of second and third marker (1107b-c). Prior to loading the coaptation device into the delivery sheath, the angular relationship between the native commissures of the targeted defective cardiac valve may be determined by suitable imaging modalities such as echocardiography, MRI, or radiographic imaging. First positioning strut (1106a) is placed into groove (1103). Second positioning strut (1106b) and third positioning strut (1106c) are placed into respective grooves (1104, 1105) such that positioning struts (1106a-c) are configured into a similar angular relationship as the commissures of the targeted defective cardiac valve. The loading tool (1100) effectively pre-aligns the three radial support members with the native commissures facilitating the placement of the coaptation device into the defective cardiac valve. FIG 12 shows the exemplary embodiment of coaptation device (1200) illustrated in FIGS 10A-B deployed into defective cardiac valve (1201) with positioning struts (1202a-c) positioned in the regions of native commissures (1203a-c). In this configuration, the motion of the native leaflets (1204a-c) is not impaired. Prosthetic leaflet (1205) is centered in defective cardiac valve (1201) and coapts with the free margins of native leaflets (1204a-c). The size of prosthetic leaflet (1205) is preferably larger that the size of the central opening of defective cardiac valve (1201) in systole to minimize the backflow of blood through defective cardiac valve (1201).

[0047] FIG 13 illustrates another alternative embodiment of the coaptation device. Adaptive support structure (1300) is laser-cut from a single Nitinol tube. Central hubs (1301a-b) are positioned on the upstream and downstream ends of adaptive support structure (1300). Flexible axial struts (1302a-f) form the pivot connections to radial support members (1303a-c). Commissures (1304a-c) made from a separate material are mounted onto commissural struts (1305a-c). The advantage of this configuration is that prosthetic leaflet (1306) can be connected to commissures (1304a-c) prior to connecting commissures (1304a-c) to commissural struts (1305a-c). Furthermore, the prosthetic leaflet assemblyPage 11SUBSTITUTE SHEET (RULE 26)comprising of commissures (1304a-c) and leaflet (1306) may be stored separately from adaptive support structure (1300) and connected to adaptive support structure (1300) prior to loading the coaptation device into a delivery sheath. FIGS 14A-B illustrate an exemplary anchoring mechanism that may be integrated into the embodiment of the coaptation device shown in FIG 13. Spring-loaded anchor (1404) is mounted onto downstream strut (1401) of radial support member (1402). In a first configuration, spring (1400) is compressed and secured in the compressed configuration by release wire (1403). Release wire (1403) is routed to the proximal end of the delivery system. Pulling on release wire (1403) releases spring (1400) and drives anchor (1404) into the cardiac tissue downstream of the native commissure. An advantage of placing the anchor downstream of the native commissures of a tricuspid valve into the wall of the right ventricle is that the motion of the native leaflets and the sub-valvular chordae are not compromised by the anchoring mechanism. Alternatively, the disclosed anchors and barbs may engage with the annular tissue of the defective cardiac valve. It is understood that other means of anchoring may be deployed to fixate the coaptation device in a defective cardiac valve. Clips may secure the adaptive support structure to the leaflets of the defective cardiac valve. The adaptive support structure may be connected to a stent anchored in a blood vessel upstream or downstream of the defective cardiac valve or to an expandable cage deployed in one of the chambers of the heart.

[0048] FIGS 15A-B illustrate an embodiment of an alignment member (1500) that may be used to facilitate the deployment of the coaptation device into a defective cardiac valve. Alignment member (1500) is configured to be connected to central hub (1501) of adaptive support structure (1502). Alignment member (1500) contains axial slots (1503a-c) that engage with radial support members (1504a-c) and lock radial support members (1504a-c) in an angular configuration that matches the angular configuration of the native commissures in the defective cardiac valve to be treated. FIGS 16A-B illustrate a method of determining the angular configuration of the native commissures of a targeted defective cardiac valve. FIG 16A shows an axial view of defective tricuspid cardiac valve (1600) comprising leaflets (1601a-c) and native commissures (1602a-c). An image of the axial view may be obtained by suitable imaging modalities such as echocardiography, MRI, or radiographic imaging. As shown in FIG 16B, circle (1603) is drawn into the axial view of defective cardiac valve (1600). Circle (1603) passes through the locations of commissures (1602a-c). Radial lines (1604a-c) are drawn from center (1605) of circle (1603) to commissures (1602a-c). A first commissure (1602a) is identified as the index commissure. Angles (1606a-b) between index commissure (1602a) and second and third commissures (1602b-c) are measured and recorded. The recorded angles may then be used to select aPage 12SUBSTITUTE SHEET (RULE 26)suitable configuration of the alignment member as further illustrated in FIG 17. FIG 17 shows an exemplary embodiment of tray (1700) for providing an array of holes (1701) for housing a series of alignment members (1702) for the treatment of a defective tricuspid valve. In the exemplary embodiment the index commissure is the posteroseptal commissure between the septal leaflet and the posterior leaflet of a defective tricuspid valve (see FIG 1A). Each alignment member (1702) provides one angular configuration of slots (1503a-c). The angles from the index radial support member to the adjacent posterior-anterior radial and septal-anterior radial support member are indicated by the number labeling on tray (1703a-b). In the exemplary embodiment of tray (1700), angular configurations of alignment member (1702) are provided from 85 degrees to 120 degrees in increments of 5 degrees. It is understood that any array of configurations of alignment member (1702) suitable for the treatment of a defective cardiac valve may be provided. The current disclosure provides a method of aligning the radial support members of a coaptation device with the native commissures of a defective tricuspid cardiac valve comprising the steps of determining the angular configuration of the native commissures, orienting the radial support members in a similar angular configuration as the native commissures, locking the radial support members into the desired angular configuration, and delivering the coaptation device to the defective tricuspid cardiac valve with the radial support members in the locked configuration. It is understood that the radial support members may be locked into position using other means then the exemplary locking member illustrated in FIG 15A-B. The radial support member may be locked into position by a locking screw, an adhesive, a crimp, a clip, a friction fit, an interference fit, or any other means that prevents the radial support members from pivoting.

[0049] FIGS 18A-E illustrate an exemplary method of deploying the embodiment of coaptation device in FIGS 13-15 into a defective tricuspid valve. The radial support members of the coaptation device are oriented and locked into the desired configuration using the method described previously. The configured coaptation device is compressed into the delivery state and loaded into the delivery sheath of the delivery system. FIGS 18A-E show a side view of the right heart including inferior vena cava (1800), superior vena cava (1801), right atrium (1802), right ventricle (1803), and tricuspid valve (1804). Referring to FIG 18A, delivery sheath (1805) is advanced from a venous access vessel to right atrium (1802). Delivery sheath (1805) may have steerable features to orient the tip of delivery sheath toward tricuspid valve (1804). Coaptation device (1806) is expanded in right atrium (1802) and rotated to align radial support members with the respective native commissures as shown in FIG 18B. Then, coaptation device (1806) is advanced into the annulus of tricuspid valve (1804) until prosthetic leaflet (1807) coaptsPage 13SUBSTITUTE SHEET (RULE 26)with the native leaflets of tricuspid valve (1804) such that the backflow of blood through tricuspid valve (1804) is minimized as shown in FIG 18C. Once the desired implant position of coaptation device (1806) is achieved, anchors (1808a-b) are deployed into the wall of right ventricle (1803) by pulling on release wires (1809a-b) as shown in FIG 18D. FIG 18E shows coaptation device (1806) disconnected from the delivery system and the delivery system removed from the heart. It is understood that a coaptation device may be delivered to the tricuspid valve from a venous access vessel upstream of the inferior vena cava or from a venous access vessel upstream of the superior vena cava. For the treatment of a tricuspid aortic valve, a coaptation device may be delivered from a venous access vessel across the septum between the right and left atrium, past the mitral valve to the aortic valve. Alternatively, the coaptation device may be delivered from an arterial access vessel to the aortic valve.

[0050] FIGS 19A-B illustrate an alternative embodiment of the coaptation device. Coaptation device (1900) comprises adaptive support structure (1901) and prosthetic leaflet (1902). Referring to FIG 19A, adaptive support structure (1901) comprises central hub (1902) and radial support members (1903a-c). The positioning struts disclosed in previous embodiments of the adaptive support structure are integrated into commissural struts (1904a-c). Commissural struts (1904a-c) are connected to flexible arch-shaped leaflet support members (1905a-c). Prosthetic leaflets (1906a-c) are connected to commissural struts (1904a-c) and leaflet support members (1905a-c) forming a tri-leaf let valve as shown in FIG 19B. Prosthetic tri-leaflet valve is configured to be positioned into the annulus of a defective cardiac valve such that the native leaflets coapt against the outer surface of prosthetic leaflets (1906a- c). FIGS 20 A-B provide axial views onto the alternative embodiment of the coaptation device shown in FIGS 19A-B. In diastole, prosthetic tri-leaflet valve (2000) forms a central opening (2001) as shown in FIG 20A. In systole, prosthetic leaflets (2002a-c) coapt in the center and prevent backflow through the center of prosthetic tri-leaflet valve (2000) as shown in FIG 20B. The native leaflets (not shown) coapt against the outer surfaces of prosthetic leaflets (2002a-c) to prevent backflow between the native valve and prosthetic tri-leaflet valve (2000).

[0051] FIGS 21-22 illustrate another embodiment of the coaptation device particularly suited for the treatment of a defective tricuspid aortic valve. Referring to FIG 21, coaptation device (2100) comprises central hub (2101), radial support members (2102a-c) that are configured to engage with the regions of the native commissures, and prosthetic leaflet (2103). Commissure members (2104a-c) are connected to positioning struts (2105a-c) and configured to suspend prosthetic leaflet (2103). Positioning struts (2105a-c) contain a series of barbs (2106a-c). Referring to FIG 22, barbs (2200a-c) engage with thePage 14SUBSTITUTE SHEET (RULE 26)aortic wall (2205) at the level of sinotubular junction (2201) and anchor coaptation device (2202) in defective aortic valve (2203). The central position of coaptation device (2202) prevents obstruction of flow into coronary artery (2204).

[0052] FIG 23 illustrates another alternative embodiment of the coaptation device. Coaptation device (2300) comprises adaptive support structure (2301) and flexible leaflet (2302). Adaptive support structure (2301) comprises central hub (2303) and radial support members (2304a-c). Commissural struts shown in some of the previous exemplary embodiments of the coaptation device are eliminated. The free margins of flexible leaflet (2302) are connected to central hub (2303) by a series of tethers (2305a-d). Tethers (2305a-d) are configured to prevent prolapse of flexible leaflet (2302) in systole. Upstream end of central hub (2303) is connected to prosthetic leaflet (2302) to center prosthetic leaflet (2302) in adaptive support structure (2301) and prevent prosthetic leaflet (2302) from collapsing downstream in diastole.

[0053] FIG 24 illustrates a further alternative embodiment of the coaptation device. Coaptation device (2400) comprises adaptive support structure (2401) and inflatable coaptation member (2402). Filled inflatable coaptation member (2402) coapts with the native leaflets of a defective cardiac valve to reduce the backflow. Inflatable coaptation member (2402) may have a first collapsed configuration for delivery to the defective cardiac valve and a second filled configuration after deployment into the defective cardiac valve. Inflatable coaptation member (2402) may be filled with a gas or a liquid. Inflatable coaptation member (2402) may be filled with a liquid polymer that solidifies after injection into inflatable coaptation member (2402). The wall of inflatable coaptation member (2402) may be semi-permeable to allow for diffusion of water molecules into inflatable coaptation member (2402) while inhibiting the diffusion of high molecular-weight molecules out of inflatable coaptation member (2402). The wall of inflatable coaptation member (2402) may be made from a polymer such as nylon, polyurethane, RTFE, or ePTFE. Inflatable member (2402) may contain a substance that creates an osmotic pressure across the wall of inflatable coaptation member (2402). The substance may be a high- molecular weight water-soluble polymer or a non-soluble polymer with hydrophilic properties. The osmotic pressure drives water molecules from the surrounding blood into inflatable coaptation member (2402). The osmotic pressure may be used to fill inflatable coaptation member (2402) and maintain inflatable coaptation member (2402) in the inflated configuration. The osmotic filling process may take minutes, hours, or days. Alternatively, the lumen of the balloon may be connected to plug (2403). Plug (2403) may be punctured by a needle which is in fluid communication with a fluid reservoir such as aPage 15SUBSTITUTE SHEET (RULE 26)syringe. When deploying coaptation device (2400) into a diseased cardiac valve, inflatable coaptation member (2402) may be inflated by transferring the fluid from the fluid reservoir into inflatable coaptation member (2402). The needle is removed from plug (2403) after inflatable coaptation member (2402) is filled to the desired volume. Plug (2403) permanently seals off inflatable coaptation member (4202).

[0054] While the above is a complete description of the preferred embodiments of the disclosure, various alternatives, modifications, and equivalents may be used. The various features of the embodiments disclosed herein may be combined or substituted with one another. Therefore, the above description should not be taken as limiting in scope of the disclosure, which is defined by the appended claims.

[0055] Unless otherwise indicated, all numbers expressing quantities or dimensions used in the specification and claims are to be understood as being modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present disclosure. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the disclosure are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0056] The terms "a," "an," "the" and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein is intended merely to better illuminate the invention and does not pose a limitation onPage 16SUBSTITUTE SHEET (RULE 26)the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0057] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0058] Certain embodiments of this disclosure are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.

[0059] In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present disclosure. Other modifications that may be employed are within the scope of the disclosure. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present disclosure is not limited to that precisely as shown and described.Page 17SUBSTITUTE SHEET (RULE 26)

Claims

WHAT IS CLAIMED:

1. A coaptation device for repairing a defective cardiac valve having at least three native commissures and at least three native leaflets, the coaptation device comprising: an adaptive support structure comprising: a central hub, a first radial support member extending from the central hub into a region of the first native commissure, a second radial support member extending from the central hub into a region of the second native commissure, and a third radial support member extending from the central hub into a region of the third commissure; and a coaptation member suspended by the adaptive support structure.

2. The coaptation device of claim 1, wherein at least the first radial support member is configured to pivot around the central hub.

3. The coaptation device of claim 1, wherein the coaptation member comprises one or more prosthetic leaflets.

4. The coaptation device of claim 3, wherein each radial support member comprises a positioning strut in contact with the respective region of a native commissure and a commissural strut suspending the one or more prosthetic leaflets.

5. The coaptation device of claim 3, wherein the one or more prosthetic leaflets coapt with a native leaflet.

6. The coaptation device of claim 1, wherein the coaptation device contains at least one anchor engaging with downstream cardiac wall tissue.

7. The coaptation device of claim 1, wherein the defective cardiac valve is a tricuspid valve, and the coaptation device is anchored into a right ventricular wall.Page 18SUBSTITUTE SHEET (RULE 26)8. The coaptation device of claim 1, wherein the adaptive support structure is configured to transition from a contracted delivery state to an expanded deployed state.

9. A method of repairing a defective cardiac valve having at least three native commissures and at least three native leaflets, the method comprising: providing a coaptation device comprising a central hub, three radial support members extending outward from the central hub, and a coaptation member; and implanting the coaptation device into a heart having the defective cardiac valve such that the radial support members extend into the regions of the native commissures of the defective cardiac valve and the coaptation member reduces a backflow of blood through the defective cardiac valve.

10. A method of claim 9, wherein the coaptation device is anchored into downstream cardiac wall tissue.

11. A method of claim 9, wherein the coaptation device is advanced to the heart in a collapsed delivery state and transitions in the heart to an expanded deployed state.

12. A coaptation device for repairing a defective cardiac valve having at least three native commissures and at least three native leaflets, the coaptation device comprising a central hub, three radial support members extending outward from the central hub, and a coaptation member, wherein the angular orientation of the three radial support members can be configured such that it matches an angular orientation of the three native commissures of the defective cardiac valve.

13. The coaptation device of claim 12, wherein the coaptation device is configured to transition from a contracted delivery state to an expanded deployed state.

14. The coaptation device of claim 13, wherein the matching angular configuration of the radial support members is obtained prior to transitioning the coaptation into the expanded deployed state.

15. The coaptation device of claim 13, wherein the matching angular configuration of the radial support members is obtained after transitioning the coaptation device into the expanded deployed state.Page 19SUBSTITUTE SHEET (RULE 26)

Images