Systems and methods for repair leaking heart valve

Abstract

Methods and systems are provided for repairing a defective heart valve having at least three native leaflets and three native conjunctions. An example system includes an involution device having an adaptive support structure; the adaptive support structure includes a central hub, a first radial support member extending from the central hub into the region of the first native engagement, a second radial support member extending from the central hub into the region of the second native engagement, and a third radial support member extending from the central hub into the region of the second native engagement. And a third radial support member extending from the central hub into the region of the third engagement. The system also includes a mating member suspended by the adaptive support structure. The involution member is configured to occupy a portion of a central opening in the defective heart valve and to involution with one or more native leaflets of the heart valve during systole to reduce blood backflow through the defective heart valve.

Description

[0001] Cross Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application 63 / 522,496, filed June 22, 2023, the entire disclosure of which is incorporated herein by reference. TECHNICAL FIELD

[0002] The present application generally relates to a device and method for repairing a leaking heart valve, such as a tricuspid or tricuspid aortic valve. BACKGROUND

[0003] The human heart contains four valves that regulate the flow of blood through the heart into the pulmonary and arterial systems: the tricuspid, pulmonary, mitral, and aortic valves. These valves can develop defects, impairing the function of the heart. Dilatation of the heart chambers can cause these valves to leak. This is known as functional regurgitation. In functional regurgitation, the native valve leaflets do not fully coapt, leaving a central gap that allows blood to flow back through the valve. The regurgitation forces the heart to work harder to pump the same cardiac output. Chronic regurgitation can cause the heart to become overloaded, eventually leading to heart failure.

[0004] Systems and methods have been developed to treat valve regurgitation. These systems and methods include valve replacement and valve repair devices and procedures. One method of valve repair is to place a device in the leaking valve to enhance coaptation of the native valve leaflets. Concepts for enhancing coaptation of valve leaflets are disclosed in U.S. Patent Nos. 8,758,432, 9,011,523, 9,474,605, 9,363,223, and 10,888,424. One challenge in putting these concepts into practice is the need to align the coaptation device to the annulus of the defective valve and maintain the position of the coaptation device throughout implantation. Another challenge is the need to fit the coaptation device to the unique geometry of the leaking valve, which can include defective valves having three or more native valve leaflets, such as tricuspid valve features having asymmetric geometry that can vary from patient to patient. The shape of the heart chamber and the shape of the leaking valve can change during implantation due to disease progression or positive remodeling. If disease progression, the heart chamber and annulus can continue to dilate, and the central opening of the leaking valve can increase. Conversely, in the case of positive remodeling, the heart chamber and annulus can contract, and the central opening of the leaking valve can decrease. Moreover, these geometric changes can be asymmetric. There is a need for systems and methods for enhancing coaptation in leaking heart valves that allow the leaking heart valve to accommodate geometric deformations and geometric changes in the heart anatomy. SUMMARY

[0005] The present disclosure provides systems and methods for treating regurgitation in heart valves. The devices and methods disclosed herein are particularly suitable for treating valves comprising three or more leaflets. The devices disclosed herein can be implanted in the heart using open surgery, minimally invasive surgery, and methods of transluminal delivery and placement.

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

[0007] The present disclosure provides a coaptation device comprising an adaptive support structure configured to be placed in an annulus of a defective heart valve. The adaptive support structure comprises a central hub and three radial support members extending radially outward from the central hub into the region of the native coaptation. One or more of the radial support members are configurable to pivot about the central hub. A coaptation member is suspended by the adaptive support structure in a flow path. The coaptation member is configured to occupy a portion of a central opening in the defective heart valve and coapt with one or more native leaflets of the heart valve during systole, thereby reducing regurgitation through the defective heart valve. The coaptation member can comprise one or more artificial leaflets. The coaptation member can be an inflatable balloon or any other device that improves coaptation of the defective heart valve.

[0008] According to one aspect of the present disclosure, the coaptation device is configurable to inflate from a first, collapsed delivery state to a second, inflated deployed state. The adaptive support structure is configurable to position the three radial support members in an angular relationship approximating an angular relationship between three native coaptations of the defective heart valve, such that when the coaptation device is deployed in the defective heart annulus, the radial support members inflate into the region of the native coaptations. The angular relationship between the radial support members can be established by locking the radial support members in the desired angular position prior to collapsing the coaptation device to the collapsed delivery state, by actively pivoting the radial support members prior to placing the coaptation device in the defective heart annulus, or by placing an inflatable leaflet assembly portion into the annulus of the defective heart valve and allowing the native leaflets to deflect the radial support members to a preferred angular orientation.

[0009] In some embodiments, the radial support member can have a first end comprising a pivot mechanism that articulates with the central hub, a second end comprising a positioning strut that articulates with a region of the native commissure, and an artificial leaflet commissure between the first end and the second end that suspends the artificial leaflet. In a preferred embodiment, the positioning strut can bend radially inward to accommodate the diameter of the annulus of the defective heart valve and to place the articulation device in the center of the annulus while the artificial leaflet commissure maintains its radial position to preserve the configuration of the suspended artificial leaflet.

[0010] The articulation device can also include one or more anchors to maintain the axial position of the deployed articulation device in the defective heart valve. In some embodiments, the anchors can articulate with the downstream heart tissue of the defective heart valve. For treatment of a defective tricuspid valve, the one or more anchors can articulate with the right ventricular wall or right ventricular apex downstream of the defective tricuspid valve. For treatment of a defective tricuspid valve aortic valve, the one or more anchors can articulate with the aortic wall at the level of the sinus tubular junction.

[0011] According to another aspect of the disclosure, an exemplary method for transvascular and transapical delivery of an articulation device into a defective heart valve is provided. The method can include compressing the articulation device into a delivery sheath, positioning the delivery sheath upstream of the defective heart valve, at least partially deploying the articulation device upstream of the annulus, directing the radial support member toward the native commissure of the defective heart valve, positioning the articulation device in the annulus of the defective heart valve such that the radial support member engages the annulus of the defective heart valve at the commissure region, articulating the articulation member with at least one leaflet of the defective heart valve, and securing the articulation device in the defective heart valve by engaging the anchors with downstream heart tissue. BRIEF DESCRIPTION OF DRAWINGS

[0012] Figure 1A -B illustrates the anatomical structure of the tricuspid valve and the development of the disease of functional regurgitation.

[0013] Figure 2A -B illustrates a first exemplary embodiment of an adaptive support structure of an articulation device.

[0014] Figure 3 A first exemplary embodiment of an articulation device is illustrated.

[0015] Figure 4A -C illustrates an exemplary embodiment of an artificial leaflet of an articulation device.

[0016] Figure 5 An exemplary embodiment of an adaptive support structure placed in the annulus of a defective tricuspid valve is illustrated.

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

[0018] Figure 7A -B shows an exemplary embodiment of a coaptation device in a compressed delivery state.

[0019] Figure 8A -E shows an exemplary transepicardial implantation procedure to repair a defective tricuspid valve with a coaptation device.

[0020] Figure 9A -B shows an exemplary embodiment of an active alignment system for rotating radial support members in a coaptation device.

[0021] Figure 10A -B shows an alternative embodiment of a coaptation device with an arched commissure.

[0022] Figure 11 An exemplary embodiment of a loading tool for compressing a coaptation device into a collapsed delivery state is shown.

[0023] Figure 12 An exemplary embodiment of a coaptation device with an arched commissure deployed in a defective tricuspid valve is shown.

[0024] Figure 13 An exemplary embodiment of an adaptive support structure laser cut from a metal tube is shown.

[0025] Figure 14A -B shows an exemplary embodiment of an anchoring mechanism for securing a coaptation device into a defective heart valve.

[0026] Figure 15A -B shows an exemplary embodiment of a locking member that prevents the radial support members from pivoting around the central hub of the coaptation device.

[0027] Figure 16A -B shows a method for determining the desired angular orientation of the radial support members for treating a defective heart valve with a tricuspid leaflet.

[0028] Figure 17 An exemplary tray containing an array of locking members is shown.

[0029] Figure 18A -E shows an exemplary illustration of a transvascular implantation procedure to repair a defective tricuspid valve with a coaptation device.

[0030] Figure 19A -B shows another alternative embodiment of a coaptation device with a tricuspid leaflet valve.

[0031] Figure 20A-B illustrates alternative embodiments of occlusion devices with tricuspid leaflets during systole and diastole.

[0032] Figure 21 An exemplary embodiment of a occlusion device particularly suitable for treating defective tricuspid and aortic valves is shown.

[0033] Figure 22 An exemplary embodiment of a chokehold device that unfolds in the aorta and is particularly suitable for treating defective tricuspid and aortic valves is shown.

[0034] Figure 23 An exemplary embodiment of a mating device having artificial leaflets connected to an adaptive support structure by tethers is shown.

[0035] Figure 24 An exemplary embodiment of a mating device with an expandable ball configured to mate with the leaflets of a defective heart valve is shown. Detailed Implementation

[0036] Figure 1A A schematic diagram of the tricuspid valve is shown (from PT Tornis, JF Rodriguez Palomares, MJAntunes, Secondary Tricuspid Valve Regurgitation: A Forgotten Entity, Heart, 2015101:1840-1848). The tricuspid valve is asymmetrical and consists of a septal leaflet, anterior leaflet, and posterior leaflet. The three leaflets can have different sizes, and the dimensional relationships between the leaflets may vary from patient to patient. The distance and angle between the primary commissures may also vary from patient to patient. In some cases, the tricuspid valve may have more than three leaflets. Figure 1B As shown, disease progression can cause the tricuspid valve annulus to dilate along the outer walls of the right ventricle and right atrium. This dilation may be related to changes in the shape of the annulus and variations in the distance and angular relationship between the commissures.

[0037] Figure 2A , Figure 2B and Figure 3 An exemplary embodiment of a mating device is shown, which is configured to address the unique geometric aspects of a defective tricuspid valve. Figure 2A An adaptive support structure 200 for the mating device is shown. The adaptive support structure includes a central hub 201 and radial support members 202a-c connected to the central hub 201. The radial support members 202a-c are configured to pivot about the central hub 201. The central hub 201 consists of a hollow tube 203 having axially extending grooves 204a-b. Figure 2BAs shown, the radial support member 206 includes axially oriented struts 207a-b that engage with axial grooves 204a-b in the central hub 201, a positioning strut 208, and a connecting strut 209 located between the inner and outer ends of the radial support member. Figure 3 As shown, the artificial leaflet 300 is suspended by syndesmotic struts 301a-c. The artificial leaflet 300 can be attached to the syndesmotic struts 301a-c by sutures, clips, adhesives, or any other means of creating a permanent connection. Optionally, points along the free edge of the flexible leaflet 300 can be connected to the central hub 302 by tethers 303 to help prevent the flexible leaflet from dislodging upstream during systole. The upstream end of the central hub 302 has a non-invasive tip and is configured to prevent the artificial leaflet 300 from collapsing downstream during diastole. Positioning struts 304a-c are configured to bend inward toward the central hub 302 without altering the radial position of the syndesmotic struts 301a-c. This allows the adaptive support structure 305 to conform to the annular diameter of the tricuspid valve without altering the suspension of the artificial leaflet 300. It should be understood that the design of the pivot connection is not limited to... Figure 2A -Exemplary embodiment shown in -B. The pivot connection may have a paddle-pin hinge configuration. The pivot connection may be formed by a flexible element connecting a radial support member to a central hub. The pivot connection may be made of a flexible material that can be plastically deformed to a desired angular position. The radial support member may be made of a shape memory alloy or a shape memory polymer.

[0038] Figure 4A -C illustrates an exemplary embodiment of an artificial leaflet. Figure 4A An artificial leaflet 400 made of a single piece of material with three ends 401a-c is shown for attachment to a synaptic strut. Figure 4B An artificial leaflet 402 is shown, made of multiple materials 403a-c, which are connected along edges 404a-b, 404c-d, and 404e-f to form a three-dimensional structure. The multiple materials 403a-c can be connected by sutures, adhesives, or other suitable bonding methods. Figure 4C An artificial leaflet 405 is shown, having ends 406a-c for attachment to the connecting strut and attachment points 407a-c along the free edge for attachment to a tether or directly to the central hub. It should be understood that the geometry and construction of the flexible leaflet are not limited to... Figure 4A-C shows an embodiment. The shape of the artificial leaflet can not be symmetrical in order to better couple with the asymmetric tricuspid valve. The free edge between two adjacent commissures of the artificial leaflet can take any shape to provide a coaptation surface for the opposing native leaflets. The flexible leaflet can be made of animal tissue, human tissue, or synthetic material, including but not limited to ePTFE and polyurethane. The flexible leaflet can be made of a scaffold suitable for growing tissue. In a preferred embodiment, the flexible leaflet is made of pericardial tissue harvested from an animal and cross-linked. The artificial leaflet can be connected to the commissure posts by suturing, adhesive, or other suitable bonding methods.

[0039] Figure 5 A top view showing the adaptive support structure 500 deployed in a defective tricuspid valve 501. The radial support members 502a-c are oriented radially towards the regions of the respective native commissures 503a-c. The pivot feature of the adaptive support structure 500 allows the radial support members 502a-c to accommodate a wide range of angles between the native commissures 503a-c. The oversized adaptive support structure 500 will position the posts 504a-c to bias on the annulus in the regions of the native commissures 503a-c and position the central hub 505 in the center of the defective heart valve 501 relative to the size of the annulus. Figure 6A -B shows a coaptation device 600 placed in a defective heart valve 601 having three leaflets and three commissures. The radial support members 602a-c coapt with the annulus of the defective heart valve 601 in the regions of the native commissures. Figure 6A A top view of the coaptation device 600 placed in a defective heart valve 601 is shown during systole. The artificial leaflet 603 abuts the native leaflets 604a-c and prevents regurgitation through the defective heart valve 601. Figure 6B The defective heart valve 601 and the coaptation device 600 are shown during diastole. The native leaflets 604a-c are in an open position. The artificial leaflet 603 is folded to the distal end of the central hub of the adaptive support frame, allowing blood to flow through the opening between the native leaflets 604a-c and the artificial leaflet 602.

[0040] It can be appreciated that the coaptation device can have more than three radial support members for treating heart valves having more than three leaflets. It is further appreciated that not all three radial support members can be configured to pivot about the central hub. One or more radial support members can be rigidly connected to the central hub. For example, to treat a defective tricuspid valve, a first radial support member can be rigidly connected to the central hub and can be used to guide the coaptation device to a first native commissure. A second radial support member and a third radial support member can be flexibly connected to the central hub and can pivot to align with a respective second native commissure and third native commissure. In some cases, it can be sufficient to have only one radial support member that pivots or no pivoting radial support members.

[0041] In a symmetrical coaptation device, the angles between the three pivotal connections are 120 degrees. To accommodate a defective tricuspid valve, the angles between the three radial support members can differ from 120 degrees. For example, the respective angles between the three radial support members can be 140 degrees, 100 degrees and 100 degrees. The individual angles between two radial support members can be in the range of 90 degrees to 180 degrees. The range of pivotable angles that can be achieved by the radial support members can be limited to less than + / - 45 degrees, preferably less than + / - 30 degrees. The accommodating support structure can be configured such that the maximum achievable angle between two adjacent radial support members is limited to less than 180 degrees, preferably less than 160 degrees, to stabilize the coaptation device in the center of the defective heart valve. In a preferred embodiment of the coaptation device, one radial support member is rigidly connected to the central hub and the pivotable angles of the second and third radial support members are limited such that the achievable angle between two adjacent radial support members is between 90 degrees and 160 degrees.

[0042] The defective tricuspid annulus diameter can be less than 30 mm to more than 50 mm. The radial expansion of the radial support members from the central hub can be at least half of the annulus diameter. The radial distance of the commissure posts from the central hub can be less than half of the annulus diameter. The radial distance of the commissure posts from the central hub can be in the range of 6 mm to 15 mm, preferably between 8 mm and 12 mm. 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 radial support members can be of smaller dimensions to conform to the annulus of the diseased tricuspid aortic valve, which typically has a diameter of 20 mm to 30 mm.

[0043] Figure 7A - B shows Figure 3 The illustrated embodiment of the coaptation device in a folded state for insertion into a delivery sheath for placement in a defective heart valve. The radial support members 701a-c of the coaptation device 700 are radially compressed inward to minimize the overall profile of the coaptation device 70 in the folded state. The artificial valve leaflets 702 are folded onto the central hub of the compressed accommodating support structure 703. Figure 7B An exemplary embodiment of a delivery sheath of a delivery system is shown. The tubular delivery sheath 704 comprises axially oriented channels 705a-c in which the outer ends of the radial support members 701a-c are placed. The channels 705a-c maintain the predetermined angular orientation of the folded radial support members 701a-c. In Figure 7B The channels 705a-c are arranged at an angle of 120 degrees to each other. It is understood that the angle between the channels can differ from 120 degrees. The angle between the channels can approximate the expected angle between the native commissures of the defective heart valve to be treated.

[0044] Figure 8A -E shows Figure 3 An exemplary embodiment of the mating device shown in AB describes a first method of unfolding in a defective tricuspid valve. Figure 8A The image shows a lateral view of the right heart, including the inferior vena cava (800), superior vena cava (801), right atrium (802), right ventricle (803), and tricuspid valve (804). Figure 8B As shown, the right ventricle 803 is accessed surgically in the region of the apex 805. A delivery sheath 806, containing a compressed occlusion device 807, advances through the surgical pathway, passing through the tricuspid valve 804 and into the right atrium 802. (As shown...) Figure 8C As shown, the mating device 807 expands by retracting the delivery sheath 806. The mating device 807 can rotate to orient the positioning struts 808a-c to the corresponding native couplings 809a-c. Due to the variability of the position of the native couplings 809a-c, perfect alignment of the positioning struts 808a-c with the native couplings may not be possible. To achieve perfect alignment, as... Figure 8D As shown, the closure device 807 can partially retract the tricuspid valve 804 until the native leaflet 804 of the tricuspid valve contacts the positioning struts 808a-c during systole. The force exerted by the native leaflet on the positioning struts 808a-c guides the positioning struts 808a-c into the region of the native closure. Once alignment is achieved, as... Figure 8E As shown, the occlusal device 807 is lowered into the tricuspid valve 804. Positioning struts 808a-c align with the wall of the right ventricle 803. A column 810 is attached to the downstream end of the occlusal device 807. The delivery sheath 806 is removed from the heart, and the downstream end of the column 810 is secured to the outer wall of the right ventricle 803 at the apex 805. The column 810 anchors the occlusal device 807 in the right ventricle 803 and prevents the occlusal device 808 from migrating into the right atrium 802 during systole. Fasteners, gauze, or fabric 811 may be used to reinforce the anchoring of the column 810. The column 810 is configured to provide sufficient column strength to prevent the occlusal device 807 from migrating into the right ventricle 803 during diastole. The column 810 may be a nitinol wire, a metal rod, a polymer rod, or a braided reinforced polymer extrusion.

[0045] Figure 9A -B illustrates an exemplary embodiment of an active alignment mechanism that aligns radial support members with the native coupling. Figure 9A Showing the passage Figure 2A -B shows an exemplary embodiment of the adaptive support structure with an axial cutout in the center hub. A first radial support member 901a is rigidly connected to the center hub 900. A second radial support member 901b and a third radial support member 901c are flexibly connected to the center hub 900. Figure 2BA side view of the inner end of the flexible connecting radial support members 902 is shown. The ends of the support members 902 are keyed to mate with the torque wires 903. When positioning the coaptation device into the tricuspid valve, the first radial support member 901a is aligned with the first native commissure by rotating the entire coaptation device. The second radial support member 901b is aligned with the second native commissure by rotating the first torque wire engaged with the keyed end of the second radial support member 901b. The third radial support member 901c is aligned with the third native commissure by rotating the second torque wire engaged with the keyed end of the 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] Figure 10A -B shows an alternative embodiment of the coaptation device. The adaptive support structure 1000 consists of central hubs 1001a-b containing three axial lumens 1002a-c for housing the inner ends of the radial support members 1003a-c. The central hubs 1001a-b are connected by a stem 1004. The upstream ends of the commissure struts 1005a-c extend inward forming a domed support for the artificial leaflets 1006. To secure the radial support members 1008 into the heart wall downstream of the defective heart valve, barbs 1007 can extend radially outward from positioning struts 1009 as shown. Figure 10B Figure 11 shows a method for securing the radial support members 1008 into the heart wall downstream of the defective heart valve. Figure 10A ​-B illustrates an exemplary loading tool 1100 in which the merging device is converted into a retracted state for insertion into a delivery sheath. The loading tool 1100 comprises a funnel-shaped portion 1101 for a retractable adaptive support structure. The inlet surface 1102 of the funnel-shaped portion 1101 has a first mark 1107a indicating the position of a first radial support member used for rotationally aligning the merging device with the first merging of a defective heart valve. Second marks 1107b and third marks 1107c indicate angular positions 120 degrees away from the first mark 1107c. A groove 1103 extends along the funnel-shaped portion 1101 at the position of the first mark 1107a. A series of grooves 1104, 1005 extend along the funnel-shaped portion 1101 in the regions of the second and third marks 1107b and 1107c. Before loading the occlusion device into the delivery sheath, the angular relationship between the native commissures of the targeted defective heart valve can be determined using appropriate imaging methods (such as echocardiography, MRI, or radiographic imaging). A first positioning strut 1106a is placed in a recess 1103. A second positioning strut 1106b and a third positioning strut 1106c are placed in corresponding recesses 1104 and 1105, such that the positioning struts 1106a-c are configured with an angular relationship similar to that of the commissures of the targeted defective heart valve. The loading tool 1100 effectively pre-aligns the three radial support members with the native commissures, thereby facilitating the placement of the occlusion device into the defective heart valve. Figure 12 Showing Figure 10A An exemplary embodiment of the mating device 1200 shown in -B unfolds within a defective heart valve 1201, with positioning struts 1202a-c located in the region of the native commissures 1203a-c. In this configuration, movement of the native leaflets 1204a-c is not impaired. An artificial leaflet 1205 is located at the center of the defective heart valve 1201 and mates against the free edges of the native leaflets 1204a-c. Preferably, the artificial leaflet 1205 is larger than the size of the central opening of the heart valve defect 1201 during systole to minimize backflow of blood through the defective heart valve.

[0047] Figure 13Another alternative embodiment of a coaptation device is shown. The adaptive support structure 1300 is laser cut from a single Nitinol tube. Central hubs 1301a-b are located at the upstream and downstream ends of the adaptive support structure 1300. Flexible axial struts 1302a-f form a pivotal connection with radial support members 1303a-c. Commissures 1304a-c, made of a separate material, are mounted on commissure struts 1305a-c. The advantage of this configuration is that the prosthetic leaflets 1306 can be attached to the commissures 1304a-c prior to attaching the commissures 1304a-c to the commissure struts 1305a-c. In addition, the prosthetic leaflet assembly, including the commissures 1304a-c and the leaflets 1306, can be stored separately from the adaptive support structure 1300 and attached to the adaptive support structure prior to loading the coaptation device into a delivery sheath. Figure 14A -B shows an alignment member 1500 that can be used to facilitate deployment of a coaptation device in a defective heart valve. The alignment member 1500 is configured to attach to the central hub 1501 of an adaptive support structure 1502. The alignment member 1500 contains axial slots 1503a-c that coapt with and lock the radial support members 1504a-c in an angular configuration that matches the angular configuration of the native commissures in the defective heart valve to be treated. Figure 13 An exemplary anchoring mechanism in an embodiment of a coaptation device is shown. A spring-loaded anchor 1404 is mounted on a downstream strut 1401 of a radial support member 1402. In a first configuration, the spring 1400 is compressed and held in the compressed configuration by a release wire 1403. The release wire 1403 is routed to the proximal end of the delivery system. Pulling on the release wire 1403 releases the spring 1400 and drives the anchor 1404 into the heart tissue downstream of the native commissures. The advantage of placing the anchor into the right ventricular wall downstream of the native commissures of the tricuspid valve is that the motion of the native leaflets and chordae tendineae is not affected by the anchoring mechanism. Alternatively, the disclosed anchor and barb can coapt with the annular tissue of a defective heart valve. It can be appreciated that other anchoring means can be employed to secure the coaptation device in a defective heart valve. A clip can secure the adaptive support structure to the leaflets of a defective heart valve. The adaptive support structure can be attached to a stent anchored in a blood vessel upstream or downstream of the defective heart valve, or to an expandable cage deployed in one of the heart chambers.

[0048] Figure 15A -B shows an embodiment of an alignment member 1500 that can be used to facilitate deployment of a coaptation device in a defective heart valve. The alignment member 1500 is configured to attach to the central hub 1501 of an adaptive support structure 1502. The alignment member 1500 contains axial slots 1503a-c that coapt with and lock the radial support members 1504a-c in an angular configuration that matches the angular configuration of the native commissures in the defective heart valve to be treated. Figure 16A -B shows a method of determining the angular configuration of the native commissures of a targeted defective heart valve. Figure 16AAn axial view of a defective tricuspid valve 1600, including leaflets 1601a-c and the native commissure 1602a-c, is shown. Images of the axial view can be obtained using appropriate imaging methods, such as echocardiography, MRI, or radiographic imaging. Figure 16B As shown, circle 1603 is drawn in an axial view of the defective heart valve 1600. Circle 1603 passes through the locations of compartments 1602a-c. Radial lines 1604a-c are drawn from the center 1605 of circle 1603 to compartments 1602a-c. The first compartment 1602a is identified as the index compartment. Angles 1606a-b between the index compartment 1602a and the second and third compartments 1603b are measured and recorded. Then, as... Figure 17 As further shown, the recorded angle can be used to select a suitable configuration for aligning components. Figure 17 An exemplary embodiment of a tray 1700 for providing a perforation array 1701 is shown, the perforation array being used to receive a series of alignment members 1702 for treating a defective tricuspid valve. In the exemplary embodiment, index commissure is a posterior septal commissure between the septal leaflet and the posterior leaflet of the defective tricuspid valve (see [link to example]). Figure 1A Each alignment member 1702 provides an angularly configured slot 1503a-c. The angle from the indexed radial support member to the adjacent posterior anterior radial support member and the spaced anterior radial support member is indicated by numerical labels 1703a-b on the tray. In an exemplary embodiment of the tray 1700, the angular configuration of the alignment members 1702 is provided from 85 degrees to 120 degrees in 5-degree increments. It should be understood that any configuration array of alignment members 1702 suitable for treating defective heart valves can be provided. This disclosure provides a method for aligning a radial support member of an occlusion device with the native commissure of a defective tricuspid heart valve, comprising the steps of: determining an angular configuration of the native commissure, orienting the radial support member to an angular configuration similar to the native commissure, locking the radial support member into the desired angular configuration, and delivering the occlusion device to the defective tricuspid heart valve with the radial support member in the locked configuration. It should be understood that, except for Figure 15A The radial support member can be locked in place by means other than the exemplary locking member shown in -B. The radial support member can be locked in place by locking screws, adhesives, crimping, clamps, friction fits, interference fits, or any other means that prevents the radial support member from pivoting.

[0049] Figure 18A -E shows Figure 13 The embodiment of the mating device in -15 is an exemplary method of deployment in a defective tricuspid valve. The radial support members of the mating device are oriented and locked into the desired configuration using the methods described above. The configured mating device is compressed into a delivery state and loaded into the delivery sheath of the delivery system.Figure 18A -E shows a side view of the right side of the heart, including the inferior vena cava 1800, superior vena cava 1801, right atrium 1802, right ventricle 1803, and tricuspid valve 1804. (See reference) Figure 18A The delivery sheath 1805 is advanced from the venous access vessel into the right atrium 1802. The delivery sheath 1805 may have a tamperable feature to orient the tip of the delivery sheath toward the tricuspid valve 1804. For example... Figure 18B As shown, the aligning device 1806 expands and rotates within the right atrium 1802 to align the radial support member with the corresponding native alignment. Then, as... Figure 18C As shown, the occlusion device 1806 is advanced into the annulus of the tricuspid valve 1804 until the artificial leaflet 1807 occludes with the native leaflet of the tricuspid valve, thereby minimizing blood backflow through the tricuspid valve 1804. Figure 18D As shown, once the desired implantation position of the mate device 1806 is reached, the anchor 1808a-b is deployed in the wall of the right ventricle 1803 by pulling the release line 1809a-b. Figure 18E The diagram shows the occlusive device 1806 disconnected from the delivery system and the delivery system removed from the heart. It is understood that the occlusive device can be delivered to the tricuspid valve from a venous access vessel upstream of the inferior vena cava or a vessel upstream of the superior vena cava. For tricuspid and aortic valve treatment, the occlusive device can be delivered from a venous access vessel, across the septum between the right and left atria, through the mitral valve, and to the aortic valve. Alternatively, the occlusive device can be delivered to the aortic valve from an arterial access vessel.

[0050] Figure 19A -B illustrates an alternative embodiment of the mating device. The mating device 1900 includes an adaptive support structure 1901 and an artificial leaflet 1902. (See reference...) Figure 19A The adaptive support structure 1901 includes a central hub 1902 and radial support members 1903a-c. The positioning struts disclosed in the foregoing embodiments of the adaptive support structure are integrated into the connecting struts 1904a-c. The connecting struts 1904a-c are connected to the flexible arched leaflet support members 1905a-c. Figure 19B As shown, the artificial leaflet 1906a-c is connected to the commissural strut 1904a-c and the leaflet support member 1905a-c to form a tricuspid valve. The artificial tricuspid valve is configured to be positioned in the annulus of the defective heart valve such that the native leaflet abuts against the outer surface 1906a-c of the artificial leaflet. Figure 20A -B provides Figure 19A -B shows an axial view of an alternative embodiment of the mating device. (See figure.) Figure 20A As shown, during diastole, the artificial trilobite 2000 forms a central opening 2001. (As...) Figure 20BAs shown, during systole, the artificial leaflets 2002a-c overlap centrally to prevent backflow through the center of the artificial tricuspid valve 2000. The native leaflet (not shown) abuts against the outer surface of the artificial leaflets 2002a-c to prevent backflow between the native valve and the artificial tricuspid valve 2000.

[0051] Figures 21-22 Another embodiment of a occlusion device particularly suitable for treating defective tricuspid and aortic valves is shown. (Refer to...) Figure 21 The mating device 2100 includes a central hub 2101, radial support members 2102a-c configured to mate with the native mating region, and an artificial flap 2103. The mating members 2104a-c are connected to positioning struts 2105a-c and configured to suspend the artificial flap 2103. The positioning struts 2105a-c include a series of barbs 2106a-c. (See reference...) Figure 22 The barbs 2200a-c mate with the aortic wall 2205 at the level of the sinus junction 2201, and with the anchoring mate device 2202 in the defective aortic valve 2203. The central position of the mate device 2202 prevents obstruction of blood flow into the coronary artery 2204.

[0052] Figure 23 Another alternative embodiment of the closure device is shown. The closure device 2300 includes an adaptive support structure 2301 and a flexible leaflet 2302. The adaptive support structure 2301 includes a central hub 2303 and radial support members 2304a-c. The closure struts shown in some of the aforementioned exemplary embodiments of the closure device are eliminated. The free edge of the flexible leaflet 2302 is connected to the central hub 2303 by a series of tethers 2305a-d. The tethers 2305a-d are configured to prevent the flexible leaflet 2302 from dislodging during systole. The upstream end of the central hub 2303 is connected to the artificial leaflet 2302 to center the artificial leaflet in the adaptive support structure 2301 and to prevent the artificial leaflet from collapsing downstream during diastole.

[0053] Figure 24Another alternative embodiment of an coaptation device is shown. Coaptation device 2400 includes an adaptive support structure 2401 and an inflatable coaptation member 2402. The inflated inflatable coaptation member 2402 coapts with native leaflets of a defective heart valve to reduce regurgitation. The inflatable coaptation member 2402 can have a first collapsed configuration for delivery to the defective heart valve and a second inflated configuration after deployment in the defective heart valve. The inflatable coaptation member 2402 can be inflated with a gas or a liquid. The inflatable coaptation member 2402 can be inflated with a liquid polymer that solidifies after injection into the inflatable coaptation member 2402. The walls of the inflatable coaptation member 2402 can be semi-permeable to allow water molecules to diffuse into the inflatable coaptation member 2402. The walls of the inflatable coaptation member 2402 can be made of a polymer such as nylon, polyurethane, PTFE, or ePTFE. The inflatable member 2402 can contain a substance that creates an osmotic pressure on the walls of the inflatable coaptation member 2402. The substance can be a water-soluble polymer of high molecular weight or an insoluble polymer with hydrophilic properties. The osmotic pressure drives water molecules from the surrounding blood into the inflatable coaptation member 2402. The osmotic pressure can be used to inflate the inflatable coaptation member 2402 and to keep the inflatable coaptation member 2402 in the inflated configuration. The osmotic inflation process can take minutes, hours, or days. Alternatively, the lumen of the balloon can be connected to a plug 2403. The plug 2403 can be pierced by a needle in fluid communication with a fluid reservoir such as a syringe. The inflatable coaptation member can be inflated by transferring fluid from the fluid reservoir into the inflatable coaptation member 2402 when the coaptation device 2400 is deployed in the diseased heart valve. After the inflatable coaptation member 2402 is inflated to the desired volume, the needle is removed from the plug 2403. The plug 2403 permanently seals the inflatable coaptation member 4202.

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

[0055] Unless otherwise indicated, all numbers expressing quantities or dimensions in the specification and claims are to be understood as being modified in all instances by the term "about." Accordingly, unless otherwise indicated, the numerical parameters are approximations and may vary depending upon the required 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 in the context of describing the application (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 a range 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 application and does not pose a limitation on the scope of the application otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the application.

[0057] The grouping of alternative elements or embodiments of the application disclosed herein should not be interpreted as a limitation of the claimed application. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found in the specification. One or more members of a group can 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 to be construed to include the altered group, nonetheless. The specification is to be understood to include any patentable subcombination of the elements expressly listed herein for a single group. By way of example only, any of the alternative components or embodiments of the application can be included in, or deleted from, a group.

[0058] Certain embodiments of the present disclosure are described herein, including the best mode known to the inventors for carrying out the application. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art once the nature of the application has been disclosed herein. The inventors expect skilled persons to employ such variations as appropriate, and the inventors intend for the application to be practiced with in the general context of these teachings. Accordingly, the disclosure includes all modifications and equivalents of the subject matter recited in the claims presented by the language of the claims themselves, the full scope of which is afforded by the patent laws. Furthermore, any combination of the above-described elements in all possible variations thereof is encompassed by the disclosure unless otherwise indicated herein or otherwise obvious to one of ordinary skill in the art to the contrary.

[0059] Finally, it should be understood that the embodiments of the application disclosed herein are illustrative of the principles of the present disclosure. Other modifications that are obvious within the spirit of the disclosure are intended to be within the scope of the disclosure. Thus, by way of example, and not of limitation, alternative configuration of the application can be used in accordance with the teachings herein. Accordingly, the disclosure is not limited to that precisely as shown and described.

Claims

1. A closure device for repairing a defective heart valve, said defective heart valve having at least three native commissures and at least three native leaflets, said closure device comprising: Adaptive support structures, including: Center hub; A first radial support member extends from the central hub into the region of the first original connection; A second radial support member extends from the central hub into the region of the second primary connection; and A third radial support member extends from the central hub into the region of the third union; and The mating components are suspended by the adaptive support structure.

2. The mating device according to claim 1, wherein, At least the first radial support member is configured to pivot about the central hub.

3. The mating device according to claim 1, wherein, The mating component includes one or more artificial leaflets.

4. The mating device according to claim 3, wherein, Each of the radial support members includes a positioning strut and a merging strut, the positioning strut contacting a corresponding area of ​​the original merging, and the merging strut suspending the one or more artificial leaflets.

5. The mating device according to claim 3, wherein, The one or more artificial leaflets are aligned with the native leaflets.

6. The mating device according to claim 1, wherein, The engagement device includes at least one anchor that engages with downstream heart wall tissue.

7. The mating device according to claim 1, wherein, The defective heart valve is a tricuspid valve, and the occlusion device is anchored in the right ventricular wall.

8. The mating device according to claim 1, wherein, The adaptive support structure is configured to transition from a contraction and delivery state to an expansion and deployment state.

9. A method for repairing a defective heart valve, said defective heart valve having at least three native commissures and at least three native leaflets, the method comprising: A mating device is provided, comprising a central hub, three radial support members extending outward from the central hub, and mating members; as well as The occlusion device is implanted into a heart with the defective heart valve such that the radial support member extends into the region of the original occlusion of the defective heart valve, and the occlusion member reduces blood backflow through the defective heart valve.

10. The method according to claim 9, wherein, The coupling device is anchored to the downstream heart wall tissue.

11. The method according to claim 9, wherein, The pairing device advances to the heart in a folded transport state and transforms into an expanded and unfolded state within the heart.

12. A closure device for repairing a defective heart valve, the defective heart valve having at least three native commissures and at least three native leaflets, the closure device comprising: A central hub, three radial support members extending outward from the central hub, and a mating member; wherein the angular orientation of the three radial support members can be configured to match the angular orientation of the three native commissures of the defective heart valve.

13. The mating device according to claim 12, wherein, The pairing device is configured to transition from a contraction conveying state to an expansion unfolding state.

14. The mating device according to claim 13, wherein, Before converting the mating device into an expanded state, the matching angle configuration of the radial support member is obtained.

15. The mating device according to claim 13, wherein, After the mating device is transformed into an expanded state, the matching angle configuration of the radial support member is obtained.

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