Systems and methods for heart valve repair

Abstract

To provide medical systems and methods for repairing a cardiac valve.SOLUTION: A cardiac valve repair implant includes a central occluder, a frame, and a thin sheet. The central occluder includes a central longitudinal axis. The frame extends proximally from the central occluder, and has the center at and forms a circumference around the central longitudinal axis of the central occluder. The frame self-biases from a collapsed state to an expanded state. A proximal end of the frame projects proximally when the frame is in the collapsed state. The proximal end of the frame projects radially outward away from the central longitudinal axis of the central occluder when the frame is in the expanded state. The thin sheet is supported on a proximal portion of the frame. When the frame is in the expanded state, the thin sheet forms an annular surface defining an inner circular opening having the center at the central longitudinal axis of the central occluder.SELECTED DRAWING: Figure 25

Description

Technical Field

[0001] Cross - Reference to Related Applications This application is a continuation - in - part of Application No. 17 / 227,847, titled "System and Method for Cardiac Valve Repair", filed on April 12, 2021, which is related to U.S. Patent Application No. 63 / 125,035, titled "System and Method for Cardiac Valve Repair", filed on December 14, 2020, and claims the priority thereof under 35 U.S.C.§119(e). The entire content of each of the said applications is incorporated herein by reference in its entirety for all purposes.

[0002] This application also incorporates by reference, for all purposes, U.S. Patent Application No. 17 / 550,660, filed on December 14, 2021, in its entirety as if fully set forth herein.

[0003] Technical Field The present disclosure relates to medical systems and methods for repairing cardiac valves. More specifically, the present disclosure relates to cardiac valve repair implants that are minimally invasive and deliverable and implantable via corresponding minimally invasive delivery tools.

Background Art

[0004] M Background Cardiac valve regurgitation occurs when the cardiac valve does not close completely, so that blood leaks backward through the valve. The cause of regurgitation can be various. Functional regurgitation occurs due to changes in the cardiac shape dimensions near the valve, for example, when the heart enlarges, inducing both geometric deformation around the valve annulus and insufficient leaflet coaptation at valve closure.

[0005] Degenerative regurgitation occurs due to diseases of the valve itself, for example, when the valve leaflets thicken and cannot close completely. In either case, the patient suffers pain because the high - pressure blood in the ventricle flows backward through the valve into the low - pressure venous system.

[0006] While surgical repair and replacement can treat tricuspid and mitral regurgitation with favorable outcomes, the surgery is costly and traumatic. Specifically, surgical procedures require general anesthesia, cardiac arrest using extracorporeal bypass, and valve replacement or repair. Surgical procedures require a painful recovery period of approximately three weeks. Consequently, due to the cost, recovery time, pain, and, in elderly patients, the potentially high risk of death, surgical procedures are often not performed.

[0007] Heart valves can also be repaired by percutaneous systems and methods. For example, percutaneous procedures can permanently clip the valve leaflets together by navigating a nitinol clip between them. Percutaneous clipping procedures result in relatively painless recovery within days, and this procedure has successfully treated hundreds or thousands of mitral regurgitation patients. Unfortunately, percutaneous clipping procedures are costly and difficult to perform, especially by inexperienced surgeons. Furthermore, the feasibility of percutaneous clipping for tricuspid valves has not been proven, and it may be less effective in tricuspid valves. In addition, the mechanisms of valve regurgitation are complex, and repairing one mechanism of the disease (e.g., leaflet gripping) may temporarily alleviate the severity of regurgitation, but it will not improve the natural course of the disease (e.g., deterioration over time).

[0008] Therefore, there is a need for a system for repairing heart valves that is easily delivered, simultaneously targets several disease components, and improves overall outcomes compared to conventional treatments. There is also a need for a method to perform such repairs. [Overview of the project]

[0009] overview Aspects of this disclosure may include cardiac valve repair implants. In one embodiment, the implant includes a central occluder, a frame, and a thin sheet. The central occluder includes a central longitudinal axis. The frame extends proximal to the central occluder, is centered on the central longitudinal axis of the central occluder, and forms a circumference around it. The frame biases itself from a folded state to an expanded state. When the frame is in the folded state, the proximal end of the frame protrudes proximal. When the frame is in the expanded state, the proximal end of the frame protrudes radially outward from the central longitudinal axis of the central occluder. The thin sheet is supported by the proximal portion of the frame. When the frame is in the expanded state, the thin sheet forms an annular surface defining an internal circular opening centered on the central longitudinal axis of the central occluder.

[0010] The frame may include an anchor member on its distal side, and when the frame is in an expanded state, the anchor member protrudes distally from the frame. When the frame is in an expanded state, the anchor member may further protrude radially outward. Alternatively, when the frame is in an expanded state, the anchor member may further protrude radially inward.

[0011] The frame may include spokes extending between the proximal end of the central closure and the proximal portion of the frame supporting the thin sheet. When the frame is folded, the spokes may be substantially straight and parallel to the central longitudinal axis of the central closure, and when the frame is extended, the spokes may curve radially outward with respect to the central longitudinal axis of the central closure.

[0012] The proximal portion of the frame supporting the thin sheet may include arch-shaped petal-like portions extending from the spokes. Each arch-shaped petal-like portion may include an outer arch-shaped member and an inner arch-shaped member located radially inward of the outer arch-shaped member.

[0013] The thin sheet may be supported on the distal side of the frame. Alternatively or additionally, the thin sheet may be supported on the proximal side of the frame.

[0014] The central closure plug may include a cylindrical side and a bullnose extending distally from the cylindrical side. The frame may include a shape-memory material that biases the frame from a folded state to an expanded state. The thin sheet may include a fabric material that allows for tissue intrinsic growth.

[0015] Aspects of this disclosure may also include methods for repairing a target heart valve. In one embodiment, the method includes the steps of: delivering a folded implant adjacent to a target heart valve in an atrium, wherein the implant comprises a central occluder having a central longitudinal axis, a frame extending proximal to the central occluder, and a thin sheet supported in the proximal region of the frame, such that when the implant is folded, the frame and thin sheet are folded inward about the central longitudinal axis; bringing an expanded implant closer to the target heart valve, such that when the implant is expanded, the frame and thin sheet are unfolded to form an annular structure defining an internal circular opening centered on the central longitudinal axis of the central occluder; and positioning the central occluder in the orifice of the target heart valve such that the internal circular opening opens above the orifice of the target heart valve, with the distal end of the annular structure relative to an annular region of cardiac tissue surrounding the target heart valve.

[0016] The implant can be delivered to the target valve via an antegrade percutaneous pathway. The implant can self-bounce from a folded state to an expanded state.

[0017] When the frame is folded, the proximal end of the frame may protrude proximally. When the frame is extended, the proximal end of the frame may protrude radially outward from the central longitudinal axis of the closure plug.

[0018] The frame may include an anchor member on the distal side of the annular structure. The anchor member may project into the annular region of the cardiac tissue surrounding the target heart valve. The implant may be overly expanded to project the anchor member into the annular region. The implant may be pressed distally against the annular region of the cardiac tissue surrounding the target heart valve to project the anchor member into the annular region.

[0019] The frame may include spokes extending between the proximal end of the central closure plug and the proximal portion of the frame supporting the thin sheet. The frame may include a shape memory material that self - biases the implant from a folded state to an expanded state. The thin sheet may include a cloth material that allows for in - tissue growth.

[0020] The central closure plug may be disposed in the orifice of the target heart valve in such a way that the valve leaflets of the target heart valve abut against the cylindrical side surface of the central closure plug.

Brief Description of the Drawings

[0021] [Figure 1A] A diagram of a system for repairing a heart valve, including a minimally invasive delivery tool and an implantable heart valve repair implant supported at the distal end of the delivery tool that is deliverable and implantable via the delivery tool. [Figure 1B] Refer to the description of FIG. 1A. [Figure 1C] Refer to the description of FIG. 1A. [Figure 1D] Refer to the description of FIG. 1A. [Figure 2] A distal side perspective view of an implantable heart valve repair in an expanded state, used when the implant is implanted in the heart valve. [Figure 3] A proximal side perspective view of an implantable heart valve repair implant in an expanded state. [Figure 4] A proximal end perspective view of an implantable heart valve repair implant in an expanded state. [Figure 5] A side view of an implantable heart valve repair implant in an expanded state. [Figure 6]It is a distal plan view of an implantable heart valve repair implant in an expanded state. [Figure 7] It is a side view of an implantable heart valve repair implant in a folded state. [Figure 8] It is an enlarged view of the distal region of the heart repair system of Figure 1A. [Figure 9] It is a side cross-sectional view of the sheath of a delivery tool in which an implantable heart valve repair implant is maintained in a folded state by being confined within the sheath, and the implant is coupled to the distal end of a catheter extending through the sheath. [Figure 10] It is a view of an implantable heart valve repair implant implanted in a target heart valve, seen from the atrial position in the direction of the valve and ventricle below it. [Figure 11A] It is a view of a system for repairing a heart valve, more specifically, a plan view, a side view, and a plan view showing the range of movement of the delivery tool of the system, respectively. [Figure 11B] Refer to the description of Figure 11A. [Figure 11C] Refer to the description of Figure 11A. <e [Figure 12] It is a distal plan view of an implantable heart valve repair implant in an expanded state, including a tension control line. [Figure 13] It is an illustration of an exemplary implantable heart valve repair system in a disassembled state, including the implant and the delivery tool respectively. [Figure 14] It is a side cross-sectional view of the distal portion of the delivery tool of Figure 13. [Figure 15] It is a side cross-sectional view of the distal portion of the delivery tool of Figure 13 coupled to the implant. [Figure 16] It is an illustration of a distal perspective view of an expanded implant coupled to a delivery tool. [Figure 17] It is an illustration of the connection between the delivery tool and the tension control line of the implant, more specifically, the detailed view of the connection between the tension control member of the delivery tool and the control line of the implant using the release line of the delivery tool. [Figure 18]This is a second detailed diagram illustrating the connection between the delivery tool and the implant's tension control line. [Figure 19] This is a plan view of the delivery tool showing the protrusion of the tension control member passing through the release catheter of the delivery tool. [Figure 20] This is a side cross-sectional view of a delivery tool attached to an implant, with the implant in an expanded state. [Figure 21] This is a side cross-sectional view of the delivery tool and the implant when the implant is released from the delivery tool. [Figure 22] This is a side cross-sectional view of the delivery tool and implant after the implant has been released from the delivery tool. [Figure 23] This is a lateral view of the distal portion of the implant. [Figure 24] Figure 23 is a lateral cross-sectional view of the distal portion of the implant. [Figure 25] This is a distal end perspective view of an implant including a closure assembly with an internal sheet. [Figure 26] Figure 25 is a perspective view of the proximal end of the implant. [Figure 27] This is a distal end perspective view of a proximal concave implant. [Figure 28] Figure 27 is a perspective view of the proximal end of the implant. [Figure 29A] This is a simplified elevation view of a proximal concave implant. [Figure 29B] This is a simplified elevation view of a distally concave implant. [Figure 29C] This is a simplified elevation view of an implant, which includes a proximal portion having a concave shape in the proximal direction and a distal portion having a concave shape in the distal direction. [Figure 30] A is a simplified elevation view of a frustoconical implant. B is a simplified elevation view of a planar implant. [Figure 31] This is a distal end perspective view of an implant having a frame that includes an arch-shaped, petal-like portion connected by elongated vertical members. [Figure 32]This is a distal end perspective view of an implant having a frame that includes an arch-shaped, petal-like portion that opens distally. [Figure 33] This is a distal end perspective view of an implant having an arched petal-like portion formed by an arched member extending between vertical members. [Figure 34] This is a distal end perspective view of an implant having an overall shape that includes a proximal portion having a concave shape in the proximal direction and a distal portion having a concave shape in the distal direction, with an arched petal-like portion formed by an arched member extending between vertical members. [Figure 35A] This is a first distal end perspective view of an implant having an overall shape that includes a proximal portion having a concave shape in the proximal direction and a distal portion having a concave shape in the distal direction, with an arched petal-like portion formed by an arched member extending between vertical members. [Figure 35B] Figure 35A is a second distal end perspective view of the implant, including the inner and outer sheets, respectively. [Modes for carrying out the invention]

[0022] Detailed explanation For an overview of the heart valve repair system 10 disclosed herein, see Figures 1A–1D. In particular, Figure 1A is an illustration of the heart valve repair system 10, and Figures 1B–1D are isometric, plan, and side views, respectively, of the valve repair system 10. As can be seen from Figure 1A, the system 10 includes a delivery and deployment tool 15 and an implantable heart valve repair device or implant 20 supported at the distal end 25 of the tool 15. The tool 15 includes a proximal end 30 opposite to the distal end 25. The proximal end 30 includes a control handle 35, which is used by a physician to manipulate the tool 15 when positioning the implant 20 at a target site and deploying the implant 20 within the target site, which is the heart valve to be repaired, as will be described later in this “Detailed Description”. In one embodiment, the tool 15 is used for minimally invasive delivery and deployment of the implant 20 in the heart valve to be repaired.

[0023] The system and its implants are advantageous in that, during the procedure, the implant can be delivered and deployed to the target site via an antegrade percutaneous route (e.g., a transfemoral or transjugular vein route) while the patient is under conscious sedation. The implantation phase is expected to take less than 60 minutes, and the implant and delivery system are expected to cost substantially less than conventional heart valve repair systems. Finally, the regurgitation grade given by the heart valve repair completed with the implant 20 disclosed herein will be 2+ or less. Thus, the heart repair system 10 is a significant improvement over prior art systems because it is non-traumatic, substantially less expensive, takes less time, and all of these provide a significant improvement in reducing regurgitation.

[0024] I. Heart valve repair implants To begin a detailed description of the heart valve repair implant 20, refer to Figures 2–6, which illustrate various aspects of the implant 20 when it is in an expanded state, as it exists when implanted into the heart valve to be repaired. As shown in these figures, the implant includes a distal end 40 and a proximal end 45. The distal end 40 acts as the tip of the implant 20 during implantation, as can be seen in Figures 1A–1D.

[0025] As shown in Figures 2-6, the implant 20 further includes a central closure 50, a frame 55, and a thin sheet 60 (also referred to herein as a thin layer 60) supported on the frame. The frame 55 extends proximal from the proximal end 65 of the central closure 50. When expanded, the frame 55 radiates outward with respect to the central longitudinal axis 70 of the implant 20 (see Figure 5), and the thin sheet 60 forms an annular surface 62 supported on the expanded frame 55. The annular surface 62 has a distal radial inner edge 63 and a proximal radial outer edge 64. The distal radial inner edge 63 defines a central opening 66 in the thin sheet 60 and the implant 20. The proximal radial outer edge 64 forms the proximal radial outer boundary of this embodiment of the implant when expanded. The central longitudinal axis 70 passes through the center point 80 (see Figure 4) of the distal end 75 of the central occluder 50 and the proximal end 65 of the central occluder 50. Considering the foregoing, in at least certain embodiments, the frame 55 is generally designed to seat on the floor of the atrial, induce annular reduction, and cause the formation of a neo-annulus.

[0026] As can be seen in Figures 2-6, the annular surface 62 is not only annular but also conical or relatively conical (e.g., parabolic) so that when the implant 20 is implanted in the target heart valve, as shown in Figure 10, its proximal side facing the atrial chamber acts as a funnel structure leading distally from the atrium to the central opening 66 of the implant 20 and the valve opening distal to the central opening 66. Similarly, as can be seen in Figure 10, the distal side of the annular surface 62 is also conical so that it generally forms mating surface contact with the semiconical region of the atrial wall and the surrounding annular region of the target heart valve.

[0027] When the implant is in a folded state, as shown in Figure 7, a side view of the implant folded to enable its delivery to the target site via tool 15, the frame 55 and thin sheet 60 are folded symmetrically around the central longitudinal axis 70. Thus, a comparison of the implant 20 in the expanded state in Figures 2-6 and the implant 20 in the folded state in Figure 7 demonstrates that the implant can transition from a folded state to an expanded state like an umbrella.

[0028] As can be seen in Figure 9, and as will be described in more detail later in this "Detailed Description," during delivery, the implant 20 is maintained in the folded state shown in Figure 7 by the tool 15 to allow the implant to pass through the patient's vascular system and enter the atrium in preparation for implantation into the target heart valve. With the implant 20 maintained in the folded state, for example by being confined within the tubular sheath 76 of the delivery tool 15, the implant can be delivered to the target site via an antegrade percutaneous route (e.g., a transfemoral or transjugular route) while the patient is conscious and sedated during the procedure, and then deployed.

[0029] As can be seen in Figure 1A, once the implant 20 is correctly positioned in the target heart valve for repair, the physician activates the tool 15 so that the tool no longer holds the implant 20 in a folded state. The frame 55 of the implant 20 is biased to expand on its own to the expanded state shown in Figures 2-6, so the implant expands on its own to the expanded state and fixes itself in the target heart valve, as shown in Figure 10, reducing regurgitation.

[0030] Returning to Figures 2-6, it can be seen that the central occluder 50 may take the form of a bullet or a cone. In this case, the central occluder may have a cylindrical side surface 85 that extends distally from the proximal end 65 of the central occluder and then transitions into a bullnose 90 (extending distally to the most distal end 75 of the central occluder). Such a bullet or cone shape results in a central occluder 50 that is non-traumatic for delivery and implantation purposes. Furthermore, such a shape facilitates the cylindrical side surface 85 of the central occluder substantially sealing the heart valve leaflets, thereby substantially reducing, if not eliminating, central regurgitation passing through the heart valve leaflets.

[0031] Non-limitingly, and depending on the embodiment, the central closure 50 may be formed from polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), acetal, silicone, nylon, polyethylene, polypropylene, polyethylene terephthalate (PET), polyurethane, or other thermoplastic elastomers. In certain embodiments, the material of the central closure 50 may be angio- and / or echo-lucent.

[0032] In certain embodiments, the central closure 50 may be filled with saline, a mixture of saline and a radiopaque contrast agent, or other fluids. In such embodiments, the central closure 50 may be delivered in a first form with a reduced diameter, and then, after delivery, expanded to a second form with an increased diameter by introducing fluid. The amount of saline delivered during implantation can be determined in real time, for example, by monitoring the size of the central closure 50 using radiographic imaging and / or by monitoring the reduction of backflow using ultrasound imaging.

[0033] In certain embodiments, the central closure 50 may be formed from a material having a durometer value of 10A to 100D, 10D to 100D, or 40D to 80D. In one specific embodiment, the material of the central closure 50 has a durometer value of 80D. As shown in Figure 5, the central closure may, in certain embodiments, have a total diameter DO which may be about 5 mm to about 25 mm, about 5 mm to about 15 mm, or about 8 mm to about 12 mm. The central closure 50 may further have a total length LO from its proximal end 65 to its distal end 75 which may be about 5 mm to about 40 mm or about 10 mm to about 20 mm. The bullnose 90 may, in certain embodiments, have a length LB which may be about 2.5 mm to about 12.5 mm, about 2.5 mm to about 7.5 mm, or about 4 mm to about 6 mm. In certain embodiments, and not limited to, the radius of curvature R of the bullnose 90 may be about 2.5 mm to about 12.5 mm, about 2.5 mm to about 7.5 mm, or about 4 mm to about 6 mm. The overall shape of the bullnose 90 may also vary from embodiment to embodiment. For example, the bullnose 90 may have a parabolic, conical, spherical, or other non-traumatic contour. In other exemplary embodiments, the bullnose 90 may have a trihedral, frustoconical, or other non-circular shape. In certain exemplary embodiments, the central closure 50 may have a triangular or trefoil shape that provides a surface for sealing each valve leaflet. In yet another example, the central closure 50 may have a rounded biconcave shape. In yet another embodiment, the central closure 50 may be configured to allow expansion of the distal portion of the frame 55, thereby facilitating re-intervention (e.g., valve implantation). In yet another embodiment, the central closure 50 may include a frame (e.g., an internal support) covered with a flexible material, for example, not limited to, stretched polytetrafluoroethylene (ePTFE), polyester cloth, or a similar material. In such an embodiment, the flexible cover may allow the central closure 50 to be compressed in the case of delivery, but once placed in the original valve, to expand to close the valve and reduce backflow.

[0034] As can be seen from Figure 5, in one embodiment, the central closure 50 may have a total diameter DO of approximately 10 mm, and its total length LO may be approximately 16 mm. In addition, the bullnose 90 may have a total length LB of approximately 5 mm, and the radius of curvature of the bullnose 90 may or may not gradually change from proximal to distal along its length LB. For example, the radius of curvature R may have a maximum value of approximately 2.5 mm to approximately 15 mm when measured from the center of curvature C to the distal end 75 of the central closure 50, but may change to a radius of curvature R of approximately 2.5 mm to approximately 10 mm (however, less than the maximum value) near the distal end 75. However, in one embodiment, the bullnose 90 may have a constant radius of curvature of approximately 5 mm.

[0035] As can be seen from Figures 2-6, the thin sheet 60 is supported on and fixed to the frame 55. For example, in a non-limiting manner, in a particular embodiment, the thin sheet 60 may be fixed to the frame 55 by suturing a skirt portion to the inner and / or outer surface of the frame 55. In another embodiment, the thin sheet 60 may include a cuff or similar folded structure that is folded back over the end of the frame 55. In yet another embodiment, the thin sheet 60 may be fixed to the frame by suturing, welding, adhesive / sealing, stapling or any other suitable method of fixation or combination of methods of fixation. Depending on the embodiment, the thin sheet 60 may be on the distal side, proximal side, or both sides of the frame 55 so that the frame extends through and along the thin sheet. In one embodiment, the frame 55 is covered with the thin sheet 60 on its distal side, where the frame contacts the atrial tissue when the implant 20 is implanted in the target heart valve.

[0036] Depending on the embodiment, the thin sheet 60 may be formed from or include a woven or knitted fabric or cloth that promotes tissue inward growth. The porosity of the fabric of the thin sheet 60 helps to reduce commissure tricuspid regurgitation. Further reduction of commissure tricuspid regurgitation is provided by the angulation of the frame 55, which provides close contact with the commissure in the circumferential direction. For example, when the implant 20 is implanted in the target heart valve, tissue inward growth into the fabric of the thin sheet 60 reinforces the myocardium, helping to prevent further tissue expansion and reducing the risk of future regurgitation.

[0037] The fabric can be produced in various ways, namely by braiding, weaving, single layer, or multilayer. These fabrics can be laminated with polymers to produce a composite structure, namely a two-piece knitted (highly porous) fabric with a polymer coating such as silicone or urethane. Exemplary materials for the woven or knitted fabric include, but are not limited to, polyester, polypropylene, and polyethylene. The thin layer 60 may have a material thickness of about 0.03 mm to about 1 mm, about 0.05 mm to about 0.2 mm, or about 0.07 mm to about 0.12 mm. In one exemplary embodiment, the thickness of the thin layer 60 is about 0.2 mm. In another exemplary embodiment, the thickness of the thin layer 60 is about 0.55 mm. In one embodiment, a further woven layer may be added proximal to the thin sheet 60 to form a smooth surface in the atrium, adjacent to the heart valve where the implant 20 is implanted, to minimize thrombus formation.

[0038] As shown in Figures 5, 6, and 7, the thin sheet 60 has an outer diameter DS. In certain embodiments, the outer diameter DS may be about 40 mm to about 80 mm, about 50 mm to about 70 mm, or about 55 mm to about 65 mm. The thin sheet 60 has a radial width RW. In certain embodiments, the radial width RW may be about 10 mm to about 30 mm, about 13 mm to about 23 mm, or about 17 mm to about 19 mm. The thin sheet 60 has a central opening 66 with an inner diameter DI. In certain embodiments, the inner diameter DI may be about 20 mm to about 60 mm, about 25 mm to about 45 mm, or about 28 mm to about 32 mm. For example, in one embodiment, the thin sheet 60 has an outer diameter DS of about 60 mm, a radial width RW of about 18.2 mm, and a central opening 66 with an inner diameter DI of about 30 mm. With this configuration, once the implant 20 is placed in the target heart valve, the circumferential fabric of the thin sheet 60 covers a portion of the outer valve leaflet commissure, blocking leakage at the edge of the commissure.

[0039] As shown in Figures 2-6, the frame 55 includes spokes 95, arched petal-shaped portions 100, and protruding anchor members 105. The frame 55 may be laser-cut from tubular material or may be made from a variety of superelastic and / or shape memory materials, such as nickel-titanium alloys (e.g., Nitinol), in the form of drawn wire. The features defined in the shape memory material may be defined therein by various cutting methods known in the art, including laser, waterjet, electrical discharge machining (EDM), stamping, etching, and milling.

[0040] In one embodiment, the frame 55 is made of a superelastic shape memory nickel-titanium alloy (e.g., Nitinol). Regardless of the shape memory material used, the shape memory surfaces of the frame 55 allow the frame and consequently the implant 20 to bias themselves from a folded state (see Figure 7) to an extended state (see Figures 2-6) when they are not physically held in a folded state by the delivery tool 15.

[0041] In various embodiments, the frame 55, the central occluder 50, and the remainder of the implant 20 remain implanted as a unit in the target heart valve. In other words, the implant 20 is implanted and remains in place as shown in Figures 2-6.

[0042] There may be situations where it is desirable to remove the central occluder and then implant a replacement valve into the target heart valve. Therefore, in an alternative embodiment, the central occluder 50 and the frame spokes or struts 95 may be removed after implantation, leaving the circumferential annular surface 62 of the implant in place, which is formed by and includes the arched petal-shaped portion 100 of the frame and the thin sheet 60 supported thereon. In such an embodiment, a circumferential suture connection may exist between the spokes 95 and the rest of the frame 55 radially outside the spokes 95. Therefore, if this circumferential suture connection is severed and the central occluder 50 and its spokes 95 are removed through a catheter, leaving the annular portion of the implant, which can then function as an "annuloplasty" frame.

[0043] As shown in Figure 7, when the implant 20 is folded, the spokes 95 extend proximal from the proximal end 65 of the central closure 50 to the arched petal portion 100. In this case, the spokes 95 extend substantially parallel to and along the central longitudinal axis 70 of the implant 20. As can be seen from Figure 7, when the implant is folded, each spoke 95 has a length L from the proximal end 65 of the central closure to the distal boundary of the arched petal portion 100. In certain embodiments, the length L can be approximately 10 mm to approximately 40 mm or approximately 15 mm to approximately 22 mm, with one embodiment having a length L of approximately 19 mm. Thus, as shown in Figure 7, the frame 55 in the folded state has a total length OL which is the sum of the length L (shown in Figure 7) and the radial width RW (shown in Figures 5 and 7), and the candidate dimensions of the radial width RW are as described above with respect to Figure 5.

[0044] As shown in Figures 2-6, when the implant 20 is in an expanded state, the spokes 95 extend proximal from the proximal end 65 of the central occluder and radiate laterally from the central longitudinal axis 70 of the implant 20 to the arched petal-shaped portion 100. At this time, the spokes 95 have a radius of curvature RC of approximately 5 mm to 20 mm, approximately 10 mm to 18 mm, or approximately 15 mm to 16 mm, and one embodiment has a radius of curvature RC of approximately 15 mm, as can be seen in Figure 5.

[0045] Depending on the embodiment, the frame 55 may include about 3 to about 15 spokes 95. In certain embodiments, the number of spokes 95 and the spacing between them may be selected to facilitate the passage of other tools and devices through the frame 55. Embodiments may include spokes 95 of various cross-sectional shapes; however, in at least certain embodiments, the spokes 95 have an annular sector cross-sectional shape as shown in inset AA of Figure 6. In such embodiments, the cross-sectional shape of the spokes 95 may be determined by the strut width SW (defined as the maximum width of the spoke) and the wall thickness WT of the spoke 95, respectively. The spokes 95 may further be determined by the radius of curvature CSR measured with respect to the centerline CL of each spoke. In certain embodiments, the wall thickness WT may be about 0.2 mm to 0.8 mm, about 0.3 mm to about 0.7 mm, or about 0.4 mm to about 0.6 mm. In addition, in certain embodiments, the spokes 95 may conform to a specific spoke aspect ratio, which refers to the ratio of the wall thickness WT to the strut width SW with respect to the spokes 95. For example, non-limitingly, embodiments may have spoke aspects of 4:0.5 to 1:2, 3:1 to 1:1.2, or 2:1 to 1:1. In embodiments, the radius of curvature CSR may be about 2 mm to about 6 mm, about 3 mm to about 5 mm, or about 3.5 mm to about 5 mm. In one particular embodiment, the frame 55 is made of nitinol, and the frame 55 has 12 spokes 95, each spoke 95 having a wall thickness WT of about 0.46 mm, an aspect ratio of about 2:1 (resulting in a strut width SW of about 0.23 mm), and a radius of curvature CSR of about 5 mm. In a particular embodiment, the spokes 95 may be arranged to extend distally from the frame 55 at an angle such that a thin sheet 60 closes a joint gap. In a particular embodiment of this disclosure, each spoke 95 may be dimensionally identical; in other embodiments, one or more spokes 95 may differ in any of the various features described above.

[0046] As shown in Figures 2-6, each arch-shaped petal portion 100 is located between a pair of spokes 95 and forms a section of the circumference of the radially outer half of the expanded frame 55. As can be seen in Figure 5, unlike the spokes 95 which are curved in the expanded state, the arch-shaped petal portions 100 in the expanded state are almost straight in the direction of radiating laterally and have a radial width RW that is approximately the same as the thin sheet 60. Each petal portion 100 has an outer arched member 110 and an inner arched member 115, both of which point radially outward. These arched members 110, 115 intersect at a joint portion 120 extending from each spoke 95 and surround an anchor member 105 that projects distally from the distal side of the joint portion 120.

[0047] Depending on the embodiment, the frame 55 may include a different number of petal-shaped portions 100. For example, in a particular exemplary embodiment, the frame 55 may include 3 to 18 petal-shaped portions 100, 6 to 15 petal-shaped portions 100, or 10 to 14 petal-shaped portions 100. In one embodiment, the frame 55 has 12 petal-shaped portions 100. Similarly, the frame 55 may include a different number of protruding anchor members 105. For example, in a particular exemplary embodiment, the frame 55 may include 6 to 60 protruding anchor members 105, 12 to 36 protruding anchor members 105, or 18 to 30 protruding anchor members 105. In one embodiment, the frame 55 has 24 protruding anchor members 105.

[0048] The frame 55 engages with the atrial tissue via protruding anchor members 105, which may be in the form of small barbs. The protruding anchor members 105 are designed to reliably engage with the atrial tissue without penetrating the tissue or coronary vessels. Depending on the embodiment, the protruding anchor members or barbs 105 may be curved to slide before engaging with the tissue. There may be one or more rows of retaining barbs 105.

[0049] As shown in the enlarged view of the joint 120 in Figure 6, each protruding anchor member 105 is defined in the surrounding joint 120 so that it forms a peninsula shape within the surrounding joint 120 via a slot 125 extending around the protruding anchor member 105. The radially inward end 105A extends uninterrupted to the remainder of the surrounding joint 120 and is on the opposite side from the radially outward free end 105B of the anchor member 105, which forms the tip of the protruding anchor member 105. As can be seen in Figures 2, 3, and 5, the radially outward free end of the anchor member protrudes distally from the remainder of the frame 55.

[0050] Depending on the embodiment, each protruding anchor member 105 may have a length of about 0.5 mm to about 6 mm, about 1 mm to 4 mm, or about 1 mm to about 3 mm. Similar to the spokes 95, the protruding anchor members 105 may have a variety of cross-sectional shapes. In at least certain embodiments, the protruding anchor members 105 have an annular sector cross-sectional shape, similar to that described above with respect to the spokes 95, and as shown in inset AA of Figure 6, which is referenced for the following description. Similar to the spokes 95, the cross-sectional shape of the protruding anchor member 105 may be determined by the strut width SW (defined as the maximum width of the spoke) and the wall thickness WT, respectively. The protruding anchor member 105 may further be determined by the radius of curvature CSR of the cross-section measured with respect to the centerline CL of each anchor member. In certain embodiments, the wall thickness WT may be about 0.2 mm to 0.8 mm, about 0.3 mm to about 0.7 mm, or about 0.4 mm to about 0.6 mm. In addition, in certain embodiments, the protruding anchor member 105 may conform to a specific aspect ratio between the wall thickness WT and the strut width SW. For example, non-limitingly, the protruding anchor member 105 in certain embodiments may have aspect ratios of 4:0.5 to 1:2, 3:1 to 1:1.2, or 2:1 to 1:1. In certain embodiments, the sectional radius of curvature CSR may be about 2 mm to about 6 mm, about 3 mm to about 5 mm, or about 3.5 mm to about 5 mm. Each protruding anchor member 105 has a wall thickness WT of about 0.46 mm, an aspect ratio of about 2:1 (resulting in a strut width SW of about 0.23 mm), a sectional radius of curvature CSR of about 5 mm, and a length of about 1.5 mm. In certain embodiments of this disclosure, each of the protruding anchor members 105 may be dimensionally identical; in other embodiments, one or more of the protruding anchor members 105 may differ in any of the various features described above.

[0051] In one embodiment, as can be seen in Figures 2, 3, and 5, the protruding anchor member or barb 105 is oriented distally and radially outward. As a result, when the frame 55 is pushed toward the ventricle, the anchor member 105 slides along the atrial tissue. Intraventricular pressure pushes the implant 20 toward the atrium, embedding the anchor or barb 105 into the atrial tissue.

[0052] In an alternative embodiment, the anchor or barb 105 is oriented in the opposite direction, projecting distally and radially inward. In this alternative embodiment, the delivery system excessively expands the frame 55 during delivery, and when the frame 55 is released from the delivery system while in contact with the tissue, the anchor or barb 105 engages with the atrial tissue as the frame 55 contracts to its relaxed state.

[0053] II. Delivery Tools and Planting Methods As shown in Figures 1A-1D, the delivery tool 15 includes a proximal end 30, a distal end 25 opposite the proximal end, a control handle 35, a tubular sheath 76, and a catheter 77. The control handle 35 extends distally from the proximal end 30 and is used by the physician to manipulate the tool 15 when positioning the implant 20 at the target site and deploying the implant 20 within the target heart valve requiring repair. The sheath 76 and catheter 77 extend distally from the control handle 35 toward the distal end 25 of the tool 15. The catheter 77 extends longitudinally through the sheath 76, and the distal end 25 of the catheter 77 forms the distal end 25 of the tool 15. The sheath 76 is used to minimize tissue damage as the catheter 77 and implant 20 are advanced toward the implantation site. Thus, the delivery tool 15 is designed to deliver the implant 20 to the implantation site, position it within the target heart valve, and control the opening of the frame 55 of the implant 20 (all in a non-traumatic manner).

[0054] As shown in Figure 8, which is an enlarged view of the distal region of the cardiac repair system 10 in Figure 1A, the suture 130 extends between the distal region of the catheter 77 and the connection point on the frame 55 of the implant 20. The suture 130 further extends from the distal region of the catheter to the handle 35, and in one embodiment, it may extend beyond the handle, as shown in Figure 1A. Depending on the embodiment, the control suture 130 may be replaced with a cable or wire.

[0055] As can be seen in Figures 1A and 18, the opening of the implant frame 55 can be controlled by manipulating the suture 130 via the handle 35 of the tool 15 before the implant 20 is completely released from the delivery tool 15. The operation of the suture may have one or two speeds, which may be in the form of low speed and / or high speed. The low speed may be controlled by a spool mechanism or lead screw mechanism 135 in the handle. The high speed may be controlled by a plunger-type linear actuator 140 in the handle. The suture 130 may be routed within the handle 35 to provide a 2:1 mechanical advantage, thereby facilitating improved control accuracy when deploying the implant 20.

[0056] The catheter 77 may employ steering via selective action of specific sutures (e.g., increasing or decreasing tension) to better control the implant's position during deployment. This steering mechanism can be controlled by the handle 35.

[0057] Figure 9 is a side cross-sectional view of the sheath 76 of a delivery tool 15 having an implantable heart valve repair implant 20 and the distal region of a catheter 77 located within it. As can be seen from Figure 9, during delivery, the implant 20 is kept in a folded state by being confined within the sheath 76 and coupled to the distal end of the catheter 77 extending through the sheath 76. The control suture 130, not shown in Figure 9 for clarity, will extend through the catheter 77 and / or the sheath 76, as can be seen in Figures 1A and 18.

[0058] With the implant 20 held in a folded state by being confined within the sheath 76 of the delivery tool 15, the implant can be delivered to the target site via an antegrade percutaneous route (e.g., transfemoral or transjugular vein route) while the patient is conscious and sedated during the procedure, and then deployed. The distal end 25 of the catheter 77 is coupled to the proximal end 65 of the central closure 50 to hold the implant 20 in a folded state within the sheath 76 until the physician decides to deploy the implant within the target heart valve.

[0059] Once the implant is correctly positioned in the atrium and begins to approach the target heart valve for repair, the physician activates tool 15 to cause the catheter 77 to act as a plunger and / or stopper, thereby allowing the folded implant 20 to be driven distally from the constraint of the sheath 76 and / or the sheath 76 to be withdrawn proximal to the implant 20. Once the folded implant 20 is exposed by its movement out of the distal end 129 of the sheath, the implant 20 biases itself into its expanded state, as shown in Figures 2-6. However, as shown in Figure 8, even though it has emerged from the distal end 129 of the sheath and is in an expanded state, the proximal end 65 of the central closure 50 of the implant 20 remains connected to the distal catheter end 25, and the implant frame 55 is connected to the suture 130, which allows the physician to use the delivery tool 15 to push the implant into the target valve and manipulate the implant within it for implantation.

[0060] The configuration of the implant 20 facilitates delivery and implantation, which is very simple and quick. This facilitates the ease of implant delivery, and generally the user only needs to roughly center the frame and push it into the valve.

[0061] Once the implant 20 reaches the atrium and the target heart valve, the physician simply uses the tool 15 to activate the suture 130, allowing the frame 55 to deflect on its own in a controlled manner and open upward toward the atrial side of the target heart valve. The catheter 77 of the tool 15 is then used to push the implant 20 toward the ventricle, engaging the frame barb 105 into the atrial tissue surrounding the target heart valve. If necessary, the control suture 130 can also be used to fold the frame 55 of the implant 20 to facilitate repositioning of the implant. Once the implant is fully implanted as desired by the physician, the exposed end of the control suture 130 is cut near the point of fixation to the implant frame 55, and the distal catheter end 25 is released from the proximal end 65 of the central closure 50 (e.g., by unscrewing or otherwise detaching). Once the tool 15 is thus detached from the implanted implant, the tool can be removed from the patient.

[0062] Figure 10 shows the implant 20 implanted in the target heart valve, viewed from the atrial position toward the valve and ventricle below. As shown in Figure 10, when implanted in the target heart valve, the implant is configured to fix itself within the target heart valve and reduce regurgitation in the target heart valve. Once implanted, the implant 20 is located on the atrial side of the target heart valve. The frame engages with the atrial tissue via small barbs 105. A thin sheet 60 supported on the frame 55 forms an annular surface 62 supported on the expanded frame 55. This annular surface 62 extends circumferentially across the atrial tissue around the target heart valve. The central closure 50 is suspended from the frame 55 and is located in the center of the valve orifice or opening. When positioned in this manner, the implant offers the following advantages and reduces regurgitation through multiple mechanisms of action.

[0063] Firstly, the metal frame 55 supports a central closure 50 positioned to block central leakage of the target heart valve, thereby reducing central regurgitation passing through the target heart valve. Specifically, the central closure may block some or all of the central regurgitation in the valve.

[0064] Secondly, the thin sheet 60 covering the frame 55 promotes inward growth with the atrial and annular tissues surrounding the target heart valve. Such inward tissue growth allows the thin sheet and its supporting frame 55 to act as an annular formation ring, reinforcing the innate tissues and reducing myocardial stretching that could increase regurgitation.

[0065] Thirdly, the thin sheet 60 covering the frame 55 overlaps with the edge of the valve leaflet commissure, which can reduce the risk of leakage at the commissure.

[0066] Finally, the frame 55 may be excessively expanded before engaging the retention barb 105 into the tissue. Relaxing the frame may reduce the orifice of the target heart valve, improving the juxtaposition of the valve leaflets and thereby reducing or eliminating regurgitation.

[0067] III. Stable Delivery Tools Figures 11A and 11B are a plan view and a side view, respectively, of the alternative valve repair system 1100 according to this disclosure. Similar to the valve repair systems described earlier in this specification, the valve repair system 1100 is generally configured to deliver and deploy an implant 20 to a target site in a heart valve that is generally in need of repair. Embodiments of the valve repair system 1100 may be used with any implant that is detailed herein or otherwise conforms to this disclosure, but are not limited to those described herein.

[0068] As shown in Figures 11A-11B, the valve repair system 1100 includes a delivery tool 1115. The delivery tool 1115 includes a proximal end 1130 opposite to the distal end 1125 of the tool. The delivery tool 1115 further includes a tubular sheath 1176 and a catheter 1177. A control handle 1135 extends distally from the proximal end 1130 and is used by the physician to manipulate the tool 1115 when positioning the implant 20 at the target site and deploying the implant 20 within the target heart valve requiring repair. The sheath 1176 and catheter 1177 extend distally from the control handle 1135 toward the distal end 1125 of the tool 1115. The catheter 1177 extends longitudinally through the sheath 1176, and the distal end 1125 of the catheter 1177 forms the distal end 1125 of the tool 1115. The sheath 1176 is used to minimize tissue damage as the catheter 1177 and implant 20 are advanced to the implantation site. Therefore, the delivery tool 1115 is designed to deliver the implant 20 to the implantation site, position it within the target heart valve, and control the opening of the implant 20 (all in a non-traumatic manner).

[0069] To facilitate the delivery of the implant 20 to the implantation site, the catheter 1177 of the tool 1115 may be steerable. For example, in the specific embodiments shown in Figures 11A and 11B, the control handle 1135 of the tool 1115 includes a bidirectional steering control mechanism 1180 that may be rotatable to steer the distal end 1125 of the tool 1115. As shown in Figure 11C, the steering control mechanism 1180 may rotate between two ranges indicated by dashed contours 1190A and 1190B to steer the distal end 1125 between the corresponding ranges indicated by dashed contours 1192A and 1192B. In the specific example shown, the steering control mechanism 1180 facilitates steering the distal end 1125 within a range of motion of approximately 180°. In other words, the steering control mechanism 1180 can rotate the distal end 1125 between a first position in which the distal end 1125 faces a first lateral direction and a second position in which the distal end faces a second lateral direction opposite to the first lateral direction.

[0070] In a particular embodiment, steering of the distal end 1125 is achieved by coupling a steering control mechanism 1180 to a steering segment 1182 positioned distal to the steering control mechanism 1180 and along the catheter 1177. More specifically, the steering control mechanism 1180 may include transverse members 1184A, 1184B, each of which is coupled to the respective sides of the distal end of the steering segment 1182 by their respective pull wires 1186A, 1186B. Thus, when the steering control mechanism 1180 rotates, the corresponding pull wires are pulled, causing the steering segment 1182 to bend in the same direction. For example, referring to Figure 11C, when the steering control mechanism 1180 is rotated counterclockwise relative to the diagram in Figure 11C, as shown by the dashed outline 1190A, the transverse member 1184A pulls the pull wire 1186A, and as a result, the distal end 1125 curls counterclockwise, as shown by the dashed outline 1192A. Similarly, when the steering control mechanism 1180 is rotated clockwise relative to the diagram in Figure 11C, as shown by the dashed outline 1190B, the transverse member 1184B pulls the pull wire 1186B, and as a result, the distal end 1125 curls clockwise, as shown by the dashed outline 1192B.

[0071] The steering segment 1182 can take various forms; generally, it is a flexible and maneuverable segment of the catheter 1177 or a separate sleeve or sheath coupled to the catheter 1177. In certain embodiments, for example, the steering segment 1182 may be a sleeve or portion of the catheter 1177 formed from a flexible material. In other embodiments, the steering segment 1182 may be segmented or otherwise include slits, notches or similar voids along its length to provide flexibility. In one specific embodiment, the steering segment 1182 may have a helical shape. In yet another embodiment, the steering segment 1182 may be a segment of the catheter 1177 having a reduced wall thickness. The foregoing are merely examples, and other techniques for forming the steering segment 1182 that can be used are also considered.

[0072] In certain embodiments, the pull wires 1186A and 1186B extend within an annular space defined between the sheath 1176 and the catheter 1177. Alternatively, the pull wires 1186A and 1186B may extend through a lumen defined within the wall of the catheter 1177, within the wall of the sheath 1176, or within a third annular body positioned along the distal length of the tool 1115. For example, the catheter 1177 or a further tubular sheath positioned between the catheter 1177 and the sheath 1176 may be formed as a three-lumen extrusion including a central lumen and a pair of smaller lumens (through which the pull wires 1186A and 1186B extend) positioned on either side of the central lumen.

[0073] Although Figure 11C shows a range of motion of 180°, embodiments of the present disclosure may be configured to have other ranges of motion. For example, in certain embodiments, the distal end 1125 may be configured to rotate 360°, for example, from a first position where the distal end 1125 faces a first side of the tool 1115 in the proximal direction to a second position where the distal end 1125 faces a second side of the tool 1115, also in the proximal direction, opposite to the first side. In other embodiments, the distal end 1125 may have a reduced range of motion, such as 135°, 90°, 45°, or 15°, without limitation. In addition, although the range of motion shown in Figure 11C is shown to be substantially equal in both directions, embodiments of the present disclosure may have a range of motion that is unequal in different directions. For example, a tool with a range of motion of 135° may move 90° in the first direction but only 45° in a second direction opposite to the first direction. Furthermore, while the tool 1115 has a neutral position in which the catheter 1177 is substantially straight, the catheter 1177 may, alternatively, be configured to have a bias in a particular direction.

[0074] IV. Implants with tension control lines Figure 12 is a distal plan view of the implant 20 in its expanded state, incorporating the tension control line 200. As described above with respect to Figures 2-6, the implant 20 generally includes a central closure 50, a frame 55, and a thin sheet 60 supported on the frame 55. Further details regarding the components and structure of the implant 20 and frame 55 are provided previously with respect to Figures 2-6.

[0075] As shown in Figure 12, the tension control line 200 may take the form of a wire, suture, cord, or similar elongated body connected to the frame 55 radially inward of the thin sheet 60 relative to the longitudinal axis 70 of the implant 20 (shown in Figure 5). The tension control line 200 may form a loop extending around the frame 55 and may be formed from a single wire, suture, etc. In other embodiments, the tension control line 200 may instead be formed from multiple separate segments of wire, suture, etc., each separate segment connected to the frame 55 and optionally connected to adjacent segments of the control line 200.

[0076] During the procedure, more specifically during the deployment of the implant 20, the tension control line 200 is releasably coupled to a tension control member (e.g., a tension control member 320, also shown in Figures 13-22 and described in more detail below) of a delivery tool (e.g., a delivery tool 300, shown in Figures 13-22 and described in more detail below). The tension control member may be coupled to a handle of the delivery tool or a similar operable component (e.g., the handle 35 of the aforementioned tool 15) to change the tension applied to the tension control line 200 by the tension control member. For example, rotating the handle 35 in a first direction may translate / retract the tension control member proximal, thereby increasing the tension on the tension control line 200, and rotating the handle 35 in the opposite direction may translate / extend the tension control member distally, thereby decreasing the tension on the tension control line 200. In other words, operation of the handle 35 in the first direction generally stops the expansion of the frame 55 of the implant 20 and / or causes the frame 55 of the implant 20 to fold (for example, to allow repositioning of the implant 20), and operation of the handle 35 in the second direction generally stops the folding of the frame 55 and / or causes the frame 55 to expand, either as a result of the action of the handle 35 or as a result of the bias of the frame 55 towards the expanded form.

[0077] Generally, the tension control line 200 is releasably held in place by tension control members at separate positions along its length. However, the tension control line 200 extends across the frame 55 and is coupled to the frame 55 at multiple positions. As a result, even though tension adjustments are applied to the connection points between the tension control members and the tension control line 200, the tension is distributed relatively evenly across the tension control line 200 and the frame 55, thereby providing even expansion and contraction of the frame 55 and improved control during the deployment and positioning of the implant 20.

[0078] In the embodiment shown in Figure 12, the tension control line 200 is coupled (e.g., fastened or glued) to the inner arched member 115 of the frame 55. More generally, the tension control line 200 may be coupled to any suitable portion of the frame 55 such that the tension control line 200 extends substantially around the frame 55. For example, in other embodiments of the present disclosure, the tension control line 200 may instead be fixed to the spokes 95, the outer arched member 110, or any other suitable portion of the petal-shaped portion 100 of the frame 55.

[0079] In certain embodiments, the tension control line 200 may be further coupled to other locations on the frame 55 by additional control segments or connecting structures. For example, Figure 12 shows a tension control line 200 coupled to an inner arched member 115 of the frame 55. The tension control line 200 is further coupled to each of the outer arched members 110 by corresponding links, such as links 202. Similar to the control line 200, the links 202 may be formed of wire, suture or similar material, and may optionally be formed of the same material as the control line 200. During operation, the links 202 help to further distribute tension to the outer arched members 110, thereby further improving the control of the expansion and contraction of the frame during the deployment of the implant 20.

[0080] Figure 12 shows the tension control line 200 coupled to the outer arched member 110, but in other embodiments, depending on how the tension control line 200 is configured, links may be used to couple the tension control line 200 to other elements of the frame 55. For example, in an embodiment where the tension control line 200 is coupled to the outer arched member 110, links may be used to couple the tension control line 200 to the inner arched member 115.

[0081] V. Development of implants with tension control lines As described above, the implants according to this disclosure may include a tension control line for enhanced control during deployment and implantation. Such delivery and implantation may be further facilitated by a corresponding delivery tool configured to adjust and control the tension applied to the tension control line and to selectively release the implant when correctly positioned.

[0082] Figure 13 is an illustration including a delivery tool 300 according to this disclosure in a disassembled state. As illustrated, the delivery tool 300 generally includes a sheath 302, a release catheter 304, and a tension control assembly 306. Also shown is an implant 20 including a tension control line 200. The sheath 302 generally forms the outer surface of the delivery tool 300 and accommodates the other components during insertion into the patient. More specifically, the release catheter 304 is generally located within the sheath 302, and the tension control assembly 306 is further located within the release catheter 304.

[0083] As will be described in more detail below, the tension control line 200 of the implant 20 is releasably connected to the tension control assembly 306 by a release catheter 304 and is maintained in a folded state within the sheath 302 during initial insertion into the patient. During deployment, the release catheter 304 is extended distally from the sheath 302, thereby allowing the implant 20 to expand. Subsequent control of the expansion and folding of the implant 20 is facilitated by a tension control member 320 extending from the tension control assembly 306, which is connected to the control tension control line 200 of the implant 20 by a release line 350 of the release catheter 304. After the implant 20 is placed in the patient's body, the release line 350 is retracted to detach the tension control member 320 from the tension control line 200, thereby releasing the implant 20.

[0084] Figure 14 is a cross-sectional view of the distal portion 301 of the delivery tool 300 in an assembled state, with the release catheter 304 and tension control assembly 306 each in their extended forms, illustrating the various elements of the delivery tool 300. Figure 15 is also a cross-sectional view of the distal portion 301 of the delivery tool 300, further including the implant 20, showing the delivery tool 300 in a retracted state, as is the case when the delivery tool 300 is initially inserted into the patient. For the purpose of illustrating the connection of the implant to the release catheter 304, only the frame 55 and associated components of the implant 20 are partially shown in Figure 15.

[0085] As described above, the tension control assembly 306 generally includes a tension control member 320 that is releasably coupled to the control line 200 of the implant 20. As shown in Figures 14 and 15, the tension control member 320 may be in the form of a cable, control suture, wire, or similar elongated structure extending distally from the distal end of the tension control shaft 324. In at least certain embodiments, the tension control member 320 may be terminated in a loop (e.g., loop 322) or similar structure to facilitate coupling of the tension control member 320 to the tension control line 200 of the implant 20. Figure 19 illustrates a tension control assembly 306 located within a release catheter 304, with the tension control member 320 extending distally from the catheter body 352 of the release catheter 304.

[0086] The release catheter 304 is located within a catheter body 352 and includes a release line 350 extending therein. The catheter body 352 further defines two sets of lateral holes to facilitate the pulling and releasing functions of the delivery tool 300. More specifically, the catheter body 352 defines one set of proximal holes 360 and one set of distal holes 362. The catheter body 352 further defines a distal opening 357. As shown in Figures 14 and 19, the tension control assembly 306 is generally assembled with the release catheter 304 in such a way that the tension control member 320 extends distally through the proximal hole 360.

[0087] The implant 20 is typically coupled to the delivery tool 300 by using a release line 350 to connect the implant 20 to the tension control member 320. Figure 16 is a proximal perspective view of the implant 20 in an extended state coupled to the delivery tool 300 to illustrate such coupling. As shown in detail B of Figure 16, the loop 201 of the tension control line 200 is pulled through the loop 322 of the tension control member 320. The release line 350 then passes through the loop 201 of the tension control line 200 and across the loop 322 of the tension control member 320, thereby securing the loop 201 of the tension control line 200 through the loop 322 of the tension control member 320. To release the coupling between the control line 200 and the tension control member 320, the release line 350 is slid out of loop 201, thereby allowing loop 201 to pass through loop 322 of the tension control member 320, and detaching the tension control member 320 from the control line 200. Detailed illustrations of loop 201 of the tension control line 200 coupled to loop 322 of the tension control member 320 are provided in Figures 17 and 18.

[0088] Referring again to Figure 15, the routing of the release line 350 generally involves routing the release line 350 (shown as a dashed line to make it easier to distinguish from other illustrated elements) through the catheter body 352 and out of it, for example by passing the release line 350 through the distal hole 362 of the catheter body 352. Then, as described above and as shown in Figures 16-18, the release line 350 can be routed proximal to connect the control line 200 to the tension control member 320. Then, the release line 350 is routed proximal and passed through the proximal hole 360 ​​back into the catheter body 352, where the release line 350 can be retained, for example, by friction, until the implant 20 is released.

[0089] As shown in Figure 15, in at least certain embodiments, the closure plug 50 of the implant 20 may include a proximal annular projection 51 that defines a proximal opening ring 53 and a transversely extending hole 57 communicating with the ring 53, respectively. In such embodiments, the annular projection 51 may be positioned within the distal opening 357 (shown in Figure 14) of the release catheter 304 during insertion and delivery to the implantation site, and further, the release line 350 may be routed through the hole 57 into the ring 53 before being passed through the distal hole 362 of the catheter body 352.

[0090] Figures 20-22 illustrate a general process for releasing the implant 20 from the delivery tool 300. Referring first to Figure 20, the delivery tool 300 and the implant 20 are shown with the frame 55 of the implant 20 in an extended state, but still coupled to the delivery tool 300. More specifically, the implant 20 is coupled to the delivery tool 300 by the release line 350 of the release catheter 304, each release line being routed to pass through the catheter body 352, through the annular projection 51 of the implant 20, through one of the distal holes 362 of the catheter body 352, through one of the loops 201 of the tension control line 200 extending through one loop 321 of the tension control member 320, and back into the catheter body 352 through one of the proximal holes 360. As described above, in at least certain embodiments, the end 356 of the release line 350 can be retained within the catheter body 352 by friction.

[0091] In the state shown in Figure 20, activating the tension control shaft 324 of the tension control assembly 306 (for example, by translating and / or rotating the shaft or the handle assembly coupled to the shaft) can change the tension applied to the frame 55 of the implant 20. In doing so, the frame 55 can be extended and / or folded to facilitate the positioning of the implant 20 before releasing the implant 20 from the delivery tool 300.

[0092] Next, referring to Figure 21, the delivery tool 300 and implant 20 are shown in the process of releasing the implant 20 from the delivery tool 300. Generally, the release of the implant 20 from the delivery tool 300 is performed by pulling the release line 350 proximal through the catheter body 352. As shown in the figure, for each release line 350, as indicated by the white arrows, such a pull causes the end 356 of the release line 350 to exit the catheter body 352 through one of the proximal holes 360, through one of the loops 201 of the tension control line 200, releasing the loop 201 from the corresponding control member 320, through one of the distal holes 362 of the catheter body 352 and the annular projection 51 of the implant 20, and to re-enter the catheter body 352 through the distal opening 357 of the catheter body 352. As a result, as shown in Figure 22, pulling the release line 350 detaches the implant from the delivery tool, allowing the delivery tool 300 to be removed while leaving the implant 20 in place. Following the release of the implant 20, the release catheter 304 and the tension control assembly 306 can be retracted proximal to the sheath 302 and / or removed proximal to the surface.

[0093] In particular, the process of releasing the implant 20 from the delivery tool 300 by pulling the release line 350 applies a net force to the implant 20, which causes the frame 55 to expand and / or resist the folding of the frame 55. More specifically, when the release line 350 is pulled to release the implant 20, the release line 350 applies a net distal force to the implant 20, thereby pushing the implant 20 into its current implantation position. Furthermore, since such a distal force is applied to the connection between the control line 200 and the tension control member 320, this force acts to further expand or otherwise provide an additional reaction force against the folding of the frame 55. In contrast, if a net proximal force is applied, the implant 20 may be dislodged or the frame 55 may undergo partial folding, either of which could lead to the implant 20 being displaced or losing its orientation. Therefore, by routing the release line 350 as described above, the correct placement of the implant 20 can be more easily controlled and is more likely to be maintained after the implant 20 is released.

[0094] VI. Multi-part shutoff plug Figures 23 and 24 show the distal portion of an exemplary implant 400 that may be used in embodiments of the present disclosure. More specifically, Figure 23 is a side view of the distal portion of the implant 400, and Figure 24 is a cross-sectional view of the implant 400, each highlighting the closure plug 401 of the implant 400.

[0095] As shown in the figures, the shut-off plug 401 includes a shut-off plug body 402 that defines a cavity 403 in which an insert 404 is placed. The insert 404 is coupled to the shut-off plug body 402. In the specific embodiments shown in Figures 23 and 24, the insert 404 is coupled to the shut-off plug body 402 by a screw connection 406; however, any suitable connection (e.g., adhesive, welding, etc.) may be used instead of the screw connection.

[0096] The closure plug 401 further includes a frame base 408 positioned distal to the insert 404 within a cavity 403 of the closure plug body 402. The frame base 408 is coupled to the frame 455 of the implant 400 (partially shown and may be substantially similar to other frames disclosed herein), the frame 455 of the implant 400 extending from the frame base 408 and proximal to the closure plug body 402. The frame base 408 may be coupled to the closure plug body 402 or may be held in place by the insert 404.

[0097] The insert 404 further includes a proximal annular projection 410. The annular projection 410 includes a side wall 412 through which one or more laterally extending holes 414 may be defined. As described above with respect to Figures 15 and 20-22, during use of the system disclosed herein, the release line of the delivery tool may be routed through this hole 414 to secure the implant 400 to the delivery tool, more specifically to the release catheter of the delivery tool.

[0098] The closure plug 401 further includes a marker 416 disposed within the closure plug body 402. In certain embodiments, the marker 416 may be a radiopaque marker to facilitate fluoroscopic observation of the implant 400 during delivery and implantation. As shown, the marker 416 may be embedded within the closure plug body 402, for example, by molding the closure plug body 402 around the marker 416. In other embodiments, the cavity 403 may be shaped to accommodate the marker 416 in addition to the insert 404 and frame base 408. In yet another embodiment, the marker 416 may be disposed on the outer surface of the closure plug body 402. Although shown as a spherical bead in Figure 24, the marker 416 may have any suitable shape. Similarly, any suitable number of markers may be incorporated into the closure plug body 402. In other embodiments, the closure plug body 402 may be formed from a material containing radiopaque additives. In yet another embodiment, either or both of the frame base 408 and the insert 404 may be formed of a radiopaque material, or may include one or more radiopaque markers.

[0099] VII. Seat base closure assembly with skirt As described above, embodiments of the implant according to this disclosure may include a closed body supported by a frame, with a thin sheet supported by and extending around the proximal portion of the frame. When the implant is deployed in the heart to assist the function of the heart valve, the frame is supported by the annulus or atrial wall so that the closed body is positioned to interact with and seal the valve leaflets. In certain embodiments, the thin sheet may be formed from a material that allows for tissue inward growth so that the implant is more firmly retained in the heart over time. In addition to this structural function, the thin sheet may be configured to at least partially overlap one or more commissures of the valve leaflets to correct or reduce commissure regurgitation.

[0100] In addition to the thin outer sheet described above, embodiments of the present disclosure may optionally or additionally include an inner sheet. For example, an implant of the present disclosure may include a closure assembly comprising a closure body (e.g., a bullnose closure or other closure bodies described above) and a sheet of material (generally referred to herein as the “skirt” or “inner sheet”) extending circumferentially from and around the closure body. In such embodiments, the inner sheet may be coupled to a portion of the implant frame extending from the closure body. In other embodiments, the closure assembly may not have a closure body, and the inner sheet may form a cap-like structure at the distal end of the implant supported by and coupled to the distal portion of the frame. In such an implant, the inner sheet may provide a sealing surface for the valve leaflets, similar to that provided by the closure body. Similar to the outer sheet, the inner sheet may be formed of a material that promotes or enables tissue inward growth to produce a smooth layer of living cells. The layer of living cells may provide a barrier between the inner sheet and the innate valve leaflets to prevent abrasion effects between the inner sheet and the innate valve leaflets. Alternatively, the inner sheet may be formed from a low-friction material (e.g., PTFE or ePTFE) that resists intracellular growth, providing a smooth surface to prevent abrasion between the inner sheet and the innate valve leaflets.

[0101] In certain embodiments, both the outer and inner sheets may have a multilayer structure in which an internal pocket is defined between layers of sheet material. The pocket may include a further fabric layer (e.g., PET, ePTFE, or other fabric layer) that acts as a pad. The pocket may also, or alternatively, include an absorbent material that expands after implantation, such as a hydrogel (e.g., sodium polyacrylate or polyvinyl alcohol). In any of the aforementioned cases, the filler can form a pad. In embodiments in which the inner sheet is formed to include an absorbent / expandable pocket, such a pocket may generally include a pad or otherwise increase the distance between the closure surface / sheet and the frame beneath the implant, thereby preventing and cushioning contact between the valve leaflets and the frame.

[0102] The aforementioned aspects of this disclosure and related concepts will be described in more detail below with reference to the drawings.

[0103] Figures 25 and 26 show an example of implant 2500 including a skirted closure assembly. Specifically, Figure 25 is a distal perspective view of implant 2500, and Figure 26 is a proximal perspective view of implant 2500. Figures 25 and 26 show implant 2500 in an expanded state, such as when implanted in a heart valve to be repaired. As shown in Figure 25, implant 2500 includes a distal end 2540 and a proximal end 2545. The distal end 2540 acts as the tip of implant 2500 during implantation.

[0104] The implant 2500 includes a closure assembly 2502 which includes a central closure 2550 and an inner sheet 2552 extending from the central closure 2550. The implant 2500 further includes a frame 2555 and an outer sheet 2560 supported on the frame 2555. In the embodiments of Figures 25 and 26, the frame 2555 extends proximal to the central closure 2550. When expanded, the frame 2555 radiates laterally outward with respect to the central longitudinal axis 2570 of the implant 2500. In the expanded state, the inner sheet 2552 forms a first annular surface 2561 and the outer sheet 2560 forms a second annular surface 2564, each supported on the frame 2555.

[0105] The first annular surface 2561 has a proximal radial outer edge 2563. Similarly, the second annular surface 2564 has a distal radial inner edge 2565 and a proximal radial outer edge 2566. The proximal radial outer edge 2563 of the first annular surface 2561 and the distal radial inner edge 2565 of the second annular surface 2564 define a central opening 2567 between the inner sheet 2552 and the outer sheet 2560. The proximal radial outer edge 2566 of the outer sheet 2560 may form the proximal radial outer boundary of the implant when in an expanded state; however, as shown in Figures 25 and 26, at least a portion of the frame 2555 may extend beyond the proximal radial outer edge 2566 of the outer sheet 2560. The central longitudinal axis 2570 passes through the most distal end 2575 of the central closure 2550. Considering the foregoing, in at least certain embodiments, the frame 2555 is generally designed to sit on the floor of the atrial, induce annular reduction, and cause neoannular formation.

[0106] In addition to being annular, both the first annular surface 2561 and the second annular surface 2564 may be conical or relatively conical (for example, parabolic).

[0107] When implant 2500 is in the folded state, for example, while delivering implant 2500 to the target site via a corresponding tool (e.g., tool 15 in Figure 1A), the frame 2555, inner sheet 2552, and outer sheet 2560 fold symmetrically around the central longitudinal axis 2570. Thus, similar to implant 20 in Figures 2-6, implant 2500 can transition from the folded state to the expanded state, like an umbrella. For example, as described above herein with respect to implant 20, implant 2500 may be kept in the folded state by tool 15 in preparation for implantation of the implant into the target heart valve, allowing implant 2500 to pass through the patient's vascular system and enter the atrium (similar to the state shown in Figure 7 with respect to implant 20). For example, if the implant 2500 is kept in a folded state by being confined within the tubular sheath 76 of the delivery tool 15, the implant 2500 can be delivered to the target site via an antegrade percutaneous route (e.g., a transfemoral or transjugular route) and deployed while the patient is conscious and sedated during the procedure. Once correctly positioned in the target heart valve for repair, the physician may activate the tool 15 so that the tool 15 no longer holds the implant 2500 in a folded state. Since the frame 2555 of the implant 2500 is biased to expand on its own, the implant 2500 expands to an expanded state, securing itself within the target heart valve and reducing regurgitation.

[0108] The central occluder 2550 can take on various forms and shapes. For example, as described above with respect to the implant 20, the central occluder 2550 may have a bullet-shaped or conical shape. Further details regarding such shapes have been provided previously. Another alternative shape for the central occluder 2550 is spherical, as shown in Figures 25 and 26. In such embodiments, the central occluder 2550 may include a distal sphere 2580 (shown in Figure 25) having a cylindrical side surface 2585 (shown in Figure 26) extending proximal therefrom. In certain embodiments, the distal sphere 2580 may be spherical; alternatively, it may have an oval or rectangular shape. More generally, the distal sphere 2580 may have a shape that facilitates sealing of the distal sphere 2580 to the heart valve leaflets, thereby reducing or eliminating central regurgitation through the heart valve leaflets, selected to be non-traumatic during delivery and implantation purposes.

[0109] In general, the features of the central closure 2550 may be similar to those of the central closure 50 of the implant 20. For example, the central closure 2550 may be formed from, filled with, or fillable (e.g., with saline solution) from a variety of materials, including angio- and / or echo-lucent materials, and may have properties and dimensional characteristics similar to those of the central closure 50 described above.

[0110] Just as the thin sheet 60 of the implant 20 is supported by the frame 55, the inner sheet 2552 and the outer sheet 2560, respectively, are supported on and fixed to the frame 2555. For example, non-limitingly, the inner sheet 2552 and / or the outer sheet 2560 may be fixed to the frame 2555 by suturing their respective sheets to the inner and / or outer surfaces of the frame 2555. In other embodiments, the inner sheet 2552 or the outer sheet 2560 may include a cuff or similar folded structure that folds back over the end of the frame 2555. For example, as shown in Figure 26, the inner sheet 2552 is folded back and sutured to the distal portion 2558 of the frame. More specifically, the distal portion 2558 of the frame includes a circumferential arrangement of arcuate petal-shaped portions (e.g., arcuate petal-shaped portion 2557) extending distally from the central closure 2550. Next, the inner sheet 2552 is wrapped around the distal surface of the distal portion 2558 of the frame, folded over each arch-shaped petal portion 2557, and sutured in place so that the inner sheet 2552 is fixed to the distal portion 2558 of the frame.

[0111] Alternatively, the inner sheet 2552 and the outer sheet 2560, respectively, may be fixed to the frame 2555 by suture, welding, adhesive / tack, stapling, or any other suitable method of fixation or combination of fixation methods. The inner sheet 2552 and / or the outer sheet 2560 may be located distally, proximally, or on either side of the frame 2555 so that the frame extends through and along the inner sheet 2552 and / or the outer sheet 2560. In at least one specific embodiment, the inner sheet 2552 and the outer sheet 2560, respectively, are supported distally to the frame 2555 so that when implanted, the outer sheet 2560 is in contact with the tissue of the atrial bed and the inner sheet 2552 is positioned to interact with and seal the valve leaflets.

[0112] Depending on the specific embodiment, the inner sheet 2552 and / or outer sheet 2560 may be formed from, or include, a woven or knitted fabric or cloth that promotes tissue inward growth. The cloth for the inner sheet 2552 and / or outer sheet 2560 may generally have any of the properties or features described above with respect to the thin sheet 60 of the implant 20. With respect to the outer sheet 2560, the porosity of the cloth may help reduce commissure tricuspid regurgitation. Further reduction of commissure tricuspid regurgitation may be provided by the angulation of the frame 2555, which provides close contact between the outer sheet 2560 and the commissure in the circumferential direction. For example, once the implant 2500 is implanted in the target heart valve, tissue inward growth into the cloth of the outer sheet 2560 helps reinforce the myocardium, preventing further tissue expansion and reducing the risk of future regurgitation. With respect to the inner sheet 2552, the porosity of the fabric may help reduce central backflow by providing an extended surface only to the central closure 2550 to which the valve leaflets can seal. In at least certain embodiments, the inner sheet 2552 may be formed from PTFE, ePTFE, or a similar low-friction material to provide a smooth surface for the intrinsic valve leaflets to contact.

[0113] The frame 2555 may include spokes 2595 from which various arch-petal-shaped portions extend. For example, as described above, the distal portion of the frame 2555 may include distal or inner arch-petal-shaped portions such as arch-petal-shaped portion 2557 that support the inner sheet 2552. The frame 2555 may further include outer arch-petal-shaped portions such as arch-petal-shaped portion 2559 configured to support the outer sheet 2560. The outer arch-petal-shaped portions may be similar to the petal-shaped portions 100 of the implant 20, or may otherwise share their features and variations, as described in more detail above.

[0114] Frame 2555 can be fabricated from a variety of superelastic and / or shape memory materials, such as nickel-titanium alloys (e.g., Nitinol), which may be laser-cut from tubular material or in the form of drawn wire. The features defined within the shape memory material can be defined by various cutting methods known in the art, including laser, waterjet, electrical discharge machining (EDM), stamping, etching, and milling.

[0115] Similar to the central closure plug 50 and frame spokes or struts 95 of the implant 20, the closure assembly 2502 and spokes 2595 may be removed after implantation, leaving in place a second annular surface 2564 formed by the outer sheet 2560. In such embodiments, a circumferential suture connection may exist between the spoke 2595 and the rest of the frame 2555 located radially outside the spoke 2595. Thus, by cutting this circumferential suture connection and removing the closure assembly 2502 and spokes 2595 through a catheter, the annular portion of the implant remains, which then acts as a “valvular annular formation” frame.

[0116] Similar to the spokes 95 of implant 20, spokes 2595 may extend proximal from the central closure 2550 to the outer arched petal portion. In certain embodiments, spokes 2595 may extend substantially parallel to and along the central longitudinal axis 2570 of implant 2500. When implant 2500 is in an expanded state, spokes 2595 extend proximal from the central closure body 2550 and radiate laterally from the central longitudinal axis 2570 to the outer arched petal portion. In general, spokes 2595 may be configured and have the same characteristics as spokes of other frame configurations described herein. For example, the dimensional characteristics and deformations previously provided for the frame 55 (and its elements) of implant 20 may similarly be applicable to the frame 2555 and its components.

[0117] An external arched portion, for example, an arched petal portion 2559, may be similar to the petal portion 100 of the implant 20. An internal arched petal portion, for example, an arched petal portion 2557, may be located between a pair of spokes 2595. When extended, the internal arched petal portion may be straight or curved in a direction that radiates laterally. In certain embodiments, when curved, the radius of curvature of the internal arched petal portion may be the same as or different from the radius of curvature of the spokes 2595. Although illustrated to include only a single arched member, each internal arched petal portion 2557 may instead include multiple arched members, for example, the internal and external arched members of the petal portion 100.

[0118] In various embodiments, the frame 2555 may include a different number of inner arch-petal-like portions. For example, in a particular exemplary embodiment, the frame 2555 may include 6-8, 4-10, or 2-12 inner arch-petal-like portions. In the specific embodiments shown in Figures 25 and 26, for example, the frame 2555 includes 6 inner arch-petal-like portions.

[0119] Similar to frame 55, frame 2555 may engage with atrial tissue via protruding anchor members 2597, which may be in the form of small barbs. The anchor members 2597 are designed to reliably engage with atrial tissue without penetrating the tissue or coronary vessels. Depending on the embodiment, the protruding anchor members or barbs 2597 may be curved to slide before engaging with the tissue, and there may be one or more rows of protruding anchor members 2597. As shown in Figure 25, for example, frame 2555 includes three offset rows of protruding anchor members 2597, with the distal and intermediate rows extending through the outer sheet 2560 and the proximal row protruding from the distal end of frame 2555. Further details and alternative configurations previously provided with respect to the protruding anchor member 105 are similarly applicable to the anchor member 2597, including embodiments in which the orientation is reversed so that 2597 protrudes distally and radially inward.

[0120] Figures 27 and 28 show another implant 2700 according to this disclosure. Specifically, Figure 27 is a distal perspective view of implant 2700, and Figure 28 is a proximal perspective view of implant 2700. Figures 27 and 28 show implant 2700 in an expanded state, such as when implanted in a heart valve to be repaired. As shown in Figures 27 and 28, implant 2700 includes a distal end 2740 (shown in Figure 27) and a proximal end 2745. The distal end 2740 acts as the tip of implant 2700 during implantation.

[0121] The implant 2700 includes a closure assembly 2702 positioned at the distal end 2740. In contrast to the closure assembly 2502 of the implant 2500, the closure assembly 2702 does not include a closure body. Rather, closure in the closure assembly 2702 is provided solely by an inner sheet 2752 that forms a cap-like structure positioned on the distal end 2740. Similar to the implant 2500, the implant 2700 further includes a frame 2755 and an outer sheet 2760, with the inner sheet 2752 and the outer sheet 2760 each supported on the frame 2755. When expanded, the frame 2755 radiates laterally outward with respect to the central longitudinal axis 2770 (shown in Figure 27) of the implant 2500. In the expanded state, the inner sheet 2752 forms a distal surface 2761 and the outer sheet 2760 forms an annular surface 2764, each supported on the frame 2755.

[0122] The distal surface 2761 has a proximal radial lateral edge 2763, and the annular surface 2764 has a distal radial medial edge 2765 and a proximal radial lateral edge 2766. The proximal radial lateral edge 2763 of the distal surface 2761 and the distal radial medial edge 2765 of the annular surface 2764 define a central opening 2767 between the medial sheet 2752 and the lateral sheet 2760. The central longitudinal axis 2770 passes through the most distal end 2775 of the medial sheet 2752. Considering the parabolic shape of the frame 2755, the implant 2700 may be configured to traverse the atrial wall at least partially upward. However, in other embodiments, the frame 2755 may be configured so that the implant 2700 generally sits on the floor of the atrial. In any case, the implant 2700 can generally induce annular reduction and cause neoannular formation.

[0123] Similar to implant 2500, implant 2700 can transition to a folded state during delivery of implant 2700 to the target site. When folded, the frame 2755, inner sheet 2752, and outer sheet 2760 can fold symmetrically around the central longitudinal axis 2570. Therefore, similar to implants 20 and 2500 in Figures 2-6, implant 2700 can transition from a folded state to an expanded state like an umbrella. Also, similar to the frame 55 of implant 20 and the central closure 2550 of implant 2500, the frame 2755 of implant 2700 can be biased to expand on its own so that implant 2700 expands to an expanded state and fixes itself within the target heart valve.

[0124] The inner sheet 2752 and the outer sheet 2760 are supported on the frame 2755 and secured thereto by any suitable means. For example, non-limitingly, the inner sheet 2752 and / or the outer sheet 2760 may be secured to the frame 2755 by sutures, stitching, welding, adhesive / tackling, stapling or any other suitable fastening method or combination of fastening methods. In other embodiments, the inner sheet 2752 or the outer sheet 2760 may include a cuff or similar folded structure that folds back onto a portion of the frame 2755. In a specific embodiment shown in Figure 28, the inner sheet 2752 is joined to the distal frame portion 2758 of the frame 2755 by sutures or other means without such a cuff or folded structure.

[0125] Similar to the sheets described earlier in this specification, the inner sheet 2752 and / or the outer sheet 2760 may be located distal to, proximal to, or on both sides of the frame 2755, such that the frame extends through and along the inner sheet 2752 and / or the outer sheet 2760. In at least one specific embodiment, the inner sheet 2752 and the outer sheet 2760 are each supported distally to the frame 2755 such that, when implanted, the outer sheet 2760 is in contact with the tissue of the atrial floor and / or atrial wall, and the inner sheet 2752 is positioned to interact with and seal the valve leaflets. Similar to the embodiments described herein, the inner sheet 2752 and / or the outer sheet 2760 may be formed from, or include, a woven, knitted, or cloth that promotes tissue endografting in order to provide the various advantages described above.

[0126] Embodiments of the present disclosure are not limited to any size or dimensions and may be modified or customized to meet patient needs and specific applications. Nevertheless, in certain embodiments, the proximal radial outer edge 2763 of the inner sheet 2752 may be about 18 mm to about 28 mm. For example, in one specific embodiment, the proximal radial outer edge 2763 may be 23 mm. Similarly, the distal radial inner edge 2765 may be about 35 mm to about 55 mm. For example, in one specific embodiment, the distal radial inner edge 2765 may be 44 mm. Finally, the proximal radial outer edge 2766 may be about 45 mm to about 65 mm. In one specific example, the proximal radial outer edge 2766 may be 55 mm.

[0127] While implants 20 and 2500 each included their respective frames, which primarily depended on the spoke-based design, frame 2755 illustrates an example of a petal-based frame structure. Referring to Figure 28, frame 2755 includes a distal frame portion 2758 supporting an inner sheet 2752 and a proximal frame portion 2759 supporting an outer sheet 2760. Generally, the distal frame portion 2758 and the proximal frame portion 2759 each include a set of circumferentially distributed arcuate petal-like portions configured to fold and expand as implant 2700 folds and expands during delivery and implantation.

[0128] As shown in detail C of Figure 28, the distal frame portion 2758 may include arcuate petal portions that may have an oval, rhomboid, or other elongated shape (for example, a roughly rhomboid shape with rounded vertices or curved edges). Each such arcuate petal portion may be defined by its respective major and minor axes. For example, as shown in detail C, the arcuate petal portion 2780A may have a substantially longitudinally extending major axis 2781A and a circumferentially extending minor axis 2782A. In certain embodiments, adjacent arcuate petal portions may join at or near their vertices along their minor axes, and these vertices are generally referred to as covertices. For example, as shown in Figure 28, the arcuate petal portions 2780A and 2780B are joined at a joint 2784 located distal to the covertices of the arcuate petal portions 2780A and 2780B.

[0129] The proximal frame portion 2759 may similarly include arcuate petal portions that may have an ovate, rhomboid, or other elongated shape. Each such arcuate petal portion may be defined by its respective long axis and short axis. For example, arcuate petal portion 2785A may have a substantially longitudinally extending long axis 2786A and a circumferentially extending short axis 2787A. In certain embodiments, adjacent arcuate petal portions of the proximal frame portion 2759 may be joined along the short axis at or near the vertex (i.e., the covertex of the arcuate petal portions). For example, arcuate petal portions 2785A and 2785B are joined at a joint 2789 located at the corresponding covertex of arcuate petal portions 2785A and 2785B.

[0130] As further shown in Figure 28, the arch-petal-shaped portions of the distal frame portion 2758 can be joined to the respective arch-petal-shaped portions of the proximal frame portion 2759. For example, the arch-petal-shaped portion 2780A is joined to the arch-petal-shaped portion 2785A by a longitudinal member 2790 extending between the proximal apex 2791 of the arch-petal-shaped portion 2780A and the distal apex 2792 of the arch-petal-shaped portion 2785A.

[0131] Similar to the frames described herein, the frame 2755 may be made from a variety of superelastic and / or shape memory materials, such as nickel-titanium alloys (e.g., nitinol), which may be laser-cut from tubular material or in the form of drawn wire. The features defined in the shape memory material may be defined therein by various cutting methods known in the art, including laser, waterjet, electrical discharge machining (EDM), stamping, etching, and milling.

[0132] Depending on the embodiment, the frame 2755 may include a different number of inner and / or outer arch-petal portions. For example, in a particular exemplary embodiment, the frame 2755 may include 10-14, 8-16, or 6-18 inner and outer arch-petal portions. In the specific embodiments shown in Figures 27 and 28, for example, the frame 2755 includes 12 inner and 12 outer arch-petal portions, with each inner arch-petal portion joined to its respective outer arch-petal portion. In other embodiments, the number of inner arch-petal portions may differ from the number of outer petal portions. For example, the frame 2755 may include twice the number of inner arch-petal portions as the number of outer petal portions. Furthermore, regardless of whether the number of inner arch-petal portions matches the number of outer arch-petal portions, not all of the inner arch-petal portions are joined to the corresponding outer arch-petal portions, and not all of the outer arch-petal portions are joined to the corresponding inner arch-petal portions. Therefore, for example, in one embodiment, the implant may include twice as many inner arch-petal portions as outer arch-petal portions, and every other inner arch-petal portion may be joined to an outer arch-petal portion. In another embodiment, the number of inner and outer arch-petal portions is the same; however, the joining may still occur between every other inner and outer arch-petal portion.

[0133] As shown in Figures 27 and 28, each inner arch-petal portion is uniform (unformed), as is each outer arch-petal portion. In other embodiments, the inner and outer arch-petal portions may differ in any direction. For example, the inner arch-petal portion may alternately include arch-petal portions having a first major axis dimension and arch-petal portions having a second major axis dimension different from the first major axis dimension.

[0134] The following describes other examples of alternative frame structures with respect to Figures 31-33.

[0135] Although not shown in Figures 27 and 28, the frame 2755 may engage with atrial tissue via a protruding anchor member, such as the protruding anchor member 105 of the implant 20 described above or the protruding anchor member 2597 of the implant 2500 described above.

[0136] VIII. Alternative Implant Frame Shapes The overall shape of the implant according to this disclosure when in an expanded state may vary among embodiments to address the diverse needs of the patient. In particular, the shape of the implant may vary to accommodate changes in the patient's anatomical structure and pathology. For example, if the patient may have a weakened valve or a valve exhibiting reduced range, an implant structure in which the closure assembly is positioned deeper in the ventricle may be preferable, such that contact and sealing between the closure assembly and the valve leaflets occurs earlier in the valve leaflet range. In contrast, if commissure regurgitation is present despite substantially normal valve leaflet function, a more planar or flatter implant structure in which the implant seat covers a larger proportion of the tricuspid valve structure may be preferable. These and other considerations will be discussed in further detail below.

[0137] In one aspect, the implants according to this disclosure may have different curvatures when in an expanded state. Examples of different curvatures are provided in Figures 29A–29C. More specifically, Figure 29A is an elevation view of implant 2900A having a proximal concave shape when unfolded / expanded, Figure 29B is an elevation view of implant 2900B having a distal concave shape when unfolded / expanded, and Figure 29C is an elevation view of implant 2900C including a proximal concave portion and a distal concave portion. For clarity and brevity, implants 2900A–2900C are shown in simplified diagrams where the overall shape is emphasized and specific elements of each implant are omitted. Therefore, unless otherwise stated, implants 2900A–2900C generally include and may be equivalent to elements of any other embodiments described herein. For example, Figures 29A to 29C generally omit details regarding the corresponding implant frames; however, it should be understood that such frames may conform to any frame style disclosed herein.

[0138] Referring first to Figure 29A, the implant 2900A includes a distal end 2902A and a proximal end 2904A, with the longitudinal axis 2906A of the implant 2900A extending between the distal end 2902A and the proximal end 2904A. The implant 2900A includes a frame 2908A that supports the closure assembly 2910A at the distal end 2902A. As shown, the closure assembly 2910A includes an inner sheet 2912A; however, in other embodiments, the closure assembly 2910A may include a closure body instead of, or in addition to, the inner sheet 2912A. For example, the closure assembly 2910A may include a spherical or bullnose-shaped closure plug, with the inner sheet 2912A extending around it. The implant 2900A further includes an outer sheet 2914A supported on the frame 2908A at its proximal end 2904A, with an annular opening 2916A defined between the inner sheet 2912A and the outer sheet 2914A.

[0139] Figure 29A shows implant 2900 in an expanded state (e.g., after deployment). As shown, implant 2900A has a proximal concave shape defined by the radius of curvature (RC-A), such that implant 2900A has an overall bowl-shaped form. The implants 2700 in Figures 27 and 28 are examples of proximal concave implants according to this disclosure, which have been described in further detail earlier. In particular, implant 2900A is shown as hemispherical, but alternatively, it may have an oval or similarly rounded but not spherical shape.

[0140] RC-A may vary in embodiments of this disclosure depending on the specific application and patient needs. For example, if the entire diameter of the proximal end 2904A is kept constant, RC-A generally controls the position of the distal end 2902A and the closure assembly 2910A relative to the proximal end 2904A. More specifically, as RC-A increases, the implant 2900A takes on a shallower geometric shape when in its expanded shape, and after deployment, the distal end 2902A moves closer to the annulus. Conversely, as RC-A decreases, the implant 2900A takes on a deeper shape, and the distal end 2902A and the closure assembly 2910A deploy further within the ventricle. As described above, the placement of the closure assembly 2910A relative to the annulus determines when and how the leaflets contact and seal the closure assembly 2910A, and as a result, RC-A may be selected to take into account the various needs and specificities of a particular patient.

[0141] For example, the proximal concave / distal convex shape shown in Figure 29A generally contains a larger, more accessible gap compared to the distal concave / proximal convex design shown in Figure 29B and described in more detail below. As a result, the proximal concave implant according to this disclosure may allow other cardiac devices, such as pacemaker leads, to be inserted through the implant more easily and accurately. The proximal concave implant according to this disclosure can also be easily inverted. Such inversion allows the implant to be narrowed into a funnel shape and pulled back into a retrieval catheter, thus facilitating the removal of the implant at a later date.

[0142] Regardless of its concave shape, implants according to this disclosure having a frame formed of metal or other radiopaque material are visible on fluoroscopy and can further facilitate the placement of pacemaker leads by providing a target for delivering the pacemaker lead. The implant frame can also provide restraint for the pacemaker lead to reduce lead movement during delivery and after implantation. In particular, such restraint of the lead can prevent or reduce the possibility that the pacemaker lead may obstruct or otherwise interfere with the movement of the valve leaflets.

[0143] Referring next to Figure 29B, the implant 2900B includes a distal end 2902B and a proximal end 2904B, with the longitudinal axis 2906B of the implant 2900B extending between the distal end 2902B and the proximal end 2904B. Figure 29B shows the implant 2900B in an expanded state around the longitudinal axis 2906B. The implant 2900B includes a frame 2908B, shown to include an inner sheet 2912B and a closure body 2913B that support the closure assembly 2910B at the distal end 2902B. In other embodiments, the closure assembly 2910B may instead include only one of the inner sheet 2912B and the closure body 2913B. The implant 2900B further includes an outer sheet 2914B supported on the frame 2908B at its proximal end 2904B, with an annular opening 2916B defined between the inner sheet 2912B and the outer sheet 2914B. When in an expanded state (e.g., after deployment), the implant 2900B has a distally concave shape defined by the radius of curvature (RC-B), such that the implant 2900B has an overall funnel-shaped form. Examples of implants having a similar shape include implants 20 and 2500, which were described in more detail earlier.

[0144] Similar to RC-A of implant 2900A, RC-B of implant 2900B may vary in embodiments of this disclosure depending on the specific application and patient needs. In particular, the distally concave design of implant 2900B ensures that the initial contact between the valve leaflet and implant 2900B is with the closure assembly 2910B, as can occur with the distally concave design of implant 2900A, in contrast to contact with a portion of the frame 2908B. More generally, the distally concave shape reduces the overall size of the implant portion within the ventricle, reducing the likelihood that the implant will interfere with or otherwise obstruct the cardiac structure and its respective functions. For example, the distally concave shape reduces contact between the valve leaflet and the implant, thereby reducing the likelihood that the implant will interfere with or otherwise obstruct the range of motion of the valve leaflet. As another example, the distally convex shape may reduce the likelihood that the implant will interfere with or obstruct the coronary sinus or similar vessels of the heart.

[0145] The implant 2900C includes a distal end 2902C and a proximal end 2904C, with the longitudinal axis 2906C of the implant 2900B extending between the distal end 2902C and the proximal end 2904C. Figure 29C shows the implant 2900C in an expanded state around the longitudinal axis 2906C. The implant 2900C includes a frame 2908C, shown to include an inner sheet 2912C that supports the closure assembly 2910C at the distal end 2902C. In other embodiments, the closure assembly 2910C may further, or instead, include a closure body. The implant 2900C also includes an outer sheet 2914C supported on the frame 2908C at the proximal end 2904C, with an annular opening 2916C defined between the inner sheet 2912C and the outer sheet 2914C.

[0146] The implant 2900C includes both a proximal concave portion and a distal concave portion. More specifically, 2900C includes a proximal portion 2920C having a proximal concave shape. The implant 2900C transitions into a distal portion 2922C having a distal concave shape. In the embodiment shown in Figure 29, the distal portion 2922C further transitions into a proximal concave cap portion 2924C, which includes a closure assembly 2910C, more specifically an inner sheet 2912C. In other embodiments, the distal portion 2922C may instead terminate with a closure body, such as the central closure plug 50 of implant 20 or the central closure body 2550 of implant 2500.

[0147] When in an expanded state (e.g., after deployment), the shape of implant 2900C may be defined by at least two radii of curvature. More specifically, the shape of implant 2900C may be defined by a radius of curvature (RC-C) corresponding to the proximal portion 2920C (i.e., the proximal concave portion of implant 2900C) and a radius of curvature (RC-D) corresponding to the distal portion 2922C (i.e., the distal concave portion of implant 2900C). To the extent that embodiments of the present disclosure further include a proximal concave cap portion 2924C, implant 2900C may further be defined by a radius of curvature (RC-E) corresponding to the proximal concave cap portion 2924C. In particular embodiments, RC-E and RC-C may be the same; however, RC-E and RC-C may also differ such that the proximal concave cap portion 2924C may have a somewhat more pronounced curvature than the proximal portion 2920C.

[0148] While implants 2900A, 2900B, and 2900C each have an overall curved shape, implants according to this disclosure may have a non-curved shape when unfolded. Examples of such non-curved implants are provided in Figures 30A and 30B. More specifically, Figure 30A is an elevation view of implant 3000A having a conical shape when unfolded, and Figure 30B is an elevation view of implant 3000B having a flat or planar shape when unfolded. As with Figures 29A and 29B, for the sake of clarity and brevity, implants 3000A and 3000B are shown in simplified diagrams where the overall shape is emphasized and specific elements of each implant are omitted. Therefore, unless otherwise stated, implants 3000A and 3000B may generally include and be equivalent to elements of any other embodiments described herein.

[0149] Referring first to Figure 30A, the implant 3000A includes a distal end 3002A and a proximal end 3004A, with the longitudinal axis 3006A of the implant 3000A extending between the distal end 3002A and the proximal end 3004A. The implant 3000A includes a frame 3008A that supports the closure assembly 3010A at the distal end 3002A. As shown, the closure assembly 3010A includes an inner sheet 3012A and a closure body 3013A. In other embodiments, the closure assembly 3010A may instead include only one of the inner sheet 3012A and the closure body 3013A. The implant 3000A further includes an outer sheet 3014A supported by the proximal portion of the frame 3008A, with an annular opening 3016A defined between the inner sheet 3012A and the outer sheet 3014A.

[0150] Figure 30A shows implant 3000 in its expanded state (e.g., after deployment). As shown, in contrast to the curved funnel shape of implant 2900B, implant 3000A has a funnel shape with straight sides. In other words, when deployed, implant 3000A has a conical or frustoconical shape that expands distally.

[0151] Similar to implants 2900A and 2900B, implant 3000A may be modified to alter the extent to which the closure assembly 3010A enters the ventricle when implant 3000A is deployed within the heart. For example, the general shape of implant 3000B may be determined by an angle θ, which may be defined as the angle between the side of frame 3008A and the longitudinal axis 3006A of implant 3000A when implant 3000A is in an expanded / deployed state. Assuming that other dimensions of implant 3000A (e.g., the maximum diameter of the proximal end 3004A) remain substantially constant, a change in θ alters the overall length of implant 3000A when expanded and, consequently, the depth of the closure assembly 3010A within the ventricle. More specifically, a decrease in θ increases the overall length of implant 3000A and the depth of the closure assembly 3010A within the ventricle when implant 3000A is deployed. Conversely, increasing θ reduces the overall length of implant 3000A when deployed (for example, resulting in a more planar implant 3000A in the expanded state) and reduces the depth of the intraventricular closure assembly 3010A.

[0152] Referring next to Figure 30B, the implant 3000B expands into a flat or planar shape when unfolded. The implant 3000B includes a radially inward portion 3002B and a radially outward portion 3004B with respect to the longitudinal axis 3006B. When folded (for example, during delivery, when the implant 3000B is folded around the longitudinal axis 3006B), the radially inward portion 3002B forms the distal end or tip of the implant 3000B, while the radially outward portion 3004B forms the proximal end of the implant 3000B. As with other implants disclosed herein, the implant 3000B includes a frame 3008B that supports the closure assembly 3010B with the radially inward portion 3002B. As shown, the closure assembly 3010B includes an inner sheet 3012B. In other embodiments, the closure assembly 3010B may further, or instead, include a closure body 3013B, shown by a dashed line in Figure 30B. The implant 3000B further includes an outer sheet 3014B supported by the proximal portion of the frame 3008B, such that an annular opening 3016B is defined between the inner sheet 3012A and the outer sheet 3014B.

[0153] Planar implants, such as implant 3000B, may be particularly advantageous when regurgitation occurs despite substantially normal leaflet movement. When deployed, implant 3000B may be positioned along the floor of the atrial, across the annulus, with the closure assembly 3010B centrally located or nearly centrally located. In embodiments in which the closure assembly 3010B includes a closure body 3013B, the closure body 3013B may, depending on its size and shape, protrude into the annulus or across the annulus into the ventricle. When the valve is in the closed position and implant 3000B is correctly positioned, the leaflets contact and seal the closure assembly 3010B. In this position, a portion of the closure assembly 3010B, such as the inner sheet 3012B, may extend above the leaflets, particularly the commissure between the leaflets. By doing so, the inner sheet 3012B may provide an extended sealing surface to the leaflets, covering at least a portion of any existing commissure gap, thereby reducing regurgitation. In addition to the inner sheet 3012B, further reduction of backflow may be provided by an outer sheet 3014B that similarly seals the leaflets and covers the commissure gap (which may be located near the outer edge of the valve ring).

[0154] IX. Alternative Frame Configurations As described above, the implant according to the present disclosure includes a frame configured to support a distal closure assembly. The frame may further support or otherwise bond to one or more thin sheets or similar structures. In certain embodiments, such sheets may include a proximal or lateral sheet and / or a distal or medial sheet included in the closure assembly (e.g., as a “skirt” extending circumferentially around the closure body of the closure assembly) configured to contact the atrial bed.

[0155] In addition to providing structural integrity, the implant frame according to this disclosure is configured to be expandable around the longitudinal axis of the implant. More specifically, the implant frame according to this disclosure is configured to transition between a folded state and an expanded state. The folded state may correspond to the state of the implant during delivery using a delivery tool, for example, tool 15 (shown in Figure 1A), tool 1115 (shown in Figures 11A-11B), or delivery tool 300 (shown in Figure 13) (each described in detail earlier). In contrast, the expanded state may correspond to the state of the implant after delivery into the patient's heart and deployment. The implant frame according to this disclosure can be biased into an expanded state so that the implant transitions to an expanded state if there is no resistance provided by the delivery tool. For example, referring to Figure 16, a tension control member 320 of the delivery tool may be coupled to a tension control line 200 of the implant so that the user can resist the expansion of the implant by applying tension to the tension control member 320. In certain embodiments, the user may apply sufficient tension to fold the implant (for example, to move the implant from an extended state to a folded state).

[0156] This disclosure has previously described various exemplary frame styles. For example, Figures 2-8 and 12 include a first frame style for a distally concave implant in which radially extending spokes support a circumferentially distributed arcuate petal portion around a central closure. Figures 25 and 26 show a similar frame style, but further including an inner arcuate petal portion configured to support an inner sheet. Figures 27 and 28 introduce the concept of a proximally concave frame formed by joining an inner / distal set of circumferentially distributed arcuate petals to an outer / proximal set of circumferentially distributed arcuate petals. Figures 29A-30B develop these general frame styles by providing further examples of overall frame shapes and configurations.

[0157] To further illustrate the scope of frames considered in this disclosure, Figures 31–33 provide further examples of frame styles that may be used in implants according to this disclosure. In particular, each of Figures 31–33 describes an alternative frame style applicable to a proximal concave implant (similar to implant 2700 in Figures 27 and 28), although the concepts and structures shown in Figures 31–33 may also be applicable to implants having a distal concave, frustoconical, planar or other overall shape. In particular, Figures 31–33 omit certain features of the illustrated implants for clarity. For example, each of Figures 31–33 omits the back side of the illustrated implant (the back side relative to the illustrated perspective view) to more clearly show the structure and configuration of the implant frame.

[0158] Figure 31 shows implant 3100 having a first alternative frame configuration. Implant 3100 includes a distal end 3102 and a proximal end 3104, with the longitudinal axis 3106 of implant 3100 extending between the distal end 3102 and the proximal end 3104. Implant 3100 includes a frame 3108 that supports a closure assembly 3110 at the distal end 3102. As shown, the closure assembly 3110 includes an inner sheet 3112; however, in other embodiments, the closure assembly 3110 may include a closure body instead of, or in addition to, the inner sheet 3112. Implant 3100 further includes an outer sheet 3114 supported by the proximal portion of the frame 3108, with an annular opening 3116 defined between the inner sheet 3112 and the outer sheet 3114.

[0159] Similar to the frame 2755 of implant 2700, the frame 3108 of implant 3100 includes a distal frame portion 3118 containing a first set of circumferentially distributed arch-petal portions, e.g., arch-petal portions 3120A and 3120B, and a distal frame portion 3138 containing a second set of circumferentially distributed arch-petal portions, e.g., arch-petal portions 3140A and 3140B. As described with reference to Figures 27 and 28 above, the arch-petal portions according to this disclosure may have an oval, rhomboid, or other elongated shape (e.g., substantially rhomboid but with rounded vertices or curved edges). More generally, the arch-petal portions according to this disclosure may have any suitable shape that enables folding and expanding of the frame and other functions described herein (e.g., support of fabric sheets such as inner sheet 3112 and outer sheet 3114).

[0160] As shown in Figure 31, adjacent arcuate petal portions of the distal frame portion 3118 can be joined at or near their respective co-vertices. For example, arcuate petal portions 3120A and 3120B are joined at a joint 3126 located at the corresponding co-vertices of arcuate petal portions 3120A and 3120B. Similarly, adjacent arcuate petal portions of the proximal frame portion 3138 can be joined at or near their respective co-vertices. For example, arcuate petal portions 3140A and 3140B are joined at a joint 3146 located at the corresponding co-vertices of arcuate petal portions 3140A and 3140B.

[0161] The arch-shaped petal portions of the distal frame portion 3118 can be joined to the respective arch-shaped petal portions of the proximal frame portion 3138. For example, the arch-shaped petal portion 3120A is joined to the arch-shaped petal portion 3140A by a longitudinal member 3148 extending between the proximal apex 3125 of the arch-shaped petal portion 3120A and the distal apex 3145 of the arch-shaped petal portion 3140A.

[0162] As shown in Figure 31, the longitudinal member 3148 extending between the arch-shaped petal portion 3120A and the arch-shaped petal portion 3140A is substantially longer than the longitudinal member 2790 extending between the arch-shaped petal portion 2780A and the arch-shaped petal portion 2785A of the implant 2700 (shown in Figure 28).

[0163] Figure 31 shows a longitudinal member (e.g., longitudinal member 3148) extending between the proximal vertex of the arched petal portion of the first set and the distal vertex of the arched petal portion of the second set; however, in other embodiments, the longitudinal member may extend between other locations on the frame 3108. For example, in certain embodiments, the longitudinal member may be offset from the arched petal portion so as to extend between the circumferential joints of the arched petal portions. Thus, for example, referring to Figure 31, the longitudinal member may extend between the joint of the arched petal portion of the first set (e.g., joint 3126) and the joint of the arched petal portion of the second set (e.g., joint 3146). In other embodiments, the arched petal portion of the first set may be rotationally offset from the arched petal portion of the second set so that the joint of one set aligns with the vertex of the other set. In such embodiments, the longitudinal member may extend between the joint of one set and the vertex of the other set. Therefore, for example, the longitudinal member may extend between the joint of the first set of arch-petal-shaped portions (e.g., joint 3126) and the distal apex of the second set of arch-petal-shaped portions (e.g., distal apex 3145). Alternatively, the longitudinal member may extend between the proximal apex of the first set of arch-petal-shaped portions (e.g., proximal apex 3125) and the joint of the second set of arch-petal-shaped portions (e.g., joint 3146).

[0164] In embodiments of this disclosure, either an inner sheet or an outer sheet may define one or more internal pockets. For example, in a particular embodiment, the sheet may include two or more layers joined together by suture or other means to form an internal pocket between adjacent layers. In one embodiment, the adjacent layers may include a first layer positioned proximal or on the inner surface of the implant frame and a second layer positioned distal or on the outer surface of the implant frame, with the frame extending between those layers. In other embodiments, the layers forming the internal pocket may be positioned entirely on the proximal / inner surface or distal / outer surface of the frame. The pocket formed in this manner may be filled with a further layer of absorbent material such as cloth, padding, or hydrogel. In such cases, the filling generally forms a pad that can increase the distance between the closure surface / sheet and the frame beneath the implant, thereby preventing and cushioning contact between the valve leaflets and the frame.

[0165] Figure 32 shows implant 3200 having another alternative frame configuration. Implant 3200 includes a distal end 3202 and a proximal end 3204, with the longitudinal axis 3206 of implant 3200 extending between the distal end 3202 and the proximal end 3204. Implant 3200 includes a frame 3208 that supports a closure assembly 3210 at the distal end 3202. As shown, the closure assembly 3210 includes an inner sheet 3212; however, in other embodiments, the closure assembly 3210 may include a closure body instead of, or in addition to, the inner sheet 3212. Implant 3200 further includes an outer sheet 3214 supported by the proximal portion of the frame 3208, with an annular opening 3216 defined between the inner sheet 3212 and the outer sheet 3214.

[0166] The frame 3208 of the implant 3200 includes a distal frame portion 3218 that includes a first set of circumferentially distributed arch-petal-shaped portions, such as arch-petal-shaped portions 3220A and 3220B, and a proximal frame portion 3238 that includes a second set of circumferentially distributed arch-petal-shaped portions, such as arch-petal-shaped portions 3240A and 3240B.

[0167] The arched petal portions of the first or inner set of implant 3200 are shown to be substantially similar to those of implant 3100. On the other hand, the arched petal portions of the second set of implant 3200 have a distally opening shape, in contrast to the oval shape of implant 3100. More specifically, each arched petal portion of the second set of arched petal portions is formed by a pair of longitudinal members and an arched frame portion. For example, arched petal portion 3240A is formed by longitudinal member 3248A, longitudinal member 3248B, and an arched frame portion 3249 extending between longitudinal members 3248A and 3248B. As shown, each longitudinal member extends from the respective joint of the arched petal portions of the first set. For example, longitudinal member 3248A extends from the joint 3226 between arched petal portions 3220A and 3220B. As described above with respect to implant 3100, the arched petal portions of the first and second sets of implant 3200 may be offset in the rotational direction from the arrangement shown in Figure 32, so that the longitudinal member instead extends from the proximal apex (e.g., proximal apex 3125) of the arched petal portion of the first set.

[0168] Figure 33 shows an implant 3300 having yet another alternative frame configuration. The implant 3300 includes a distal end 3302 and a proximal end 3304, with the longitudinal axis 3306 of the implant 3300 extending between the distal end 3302 and the proximal end 3304. The implant 3300 includes a frame 3308 that supports a closure assembly 3310 at the distal end 3302. As shown, the closure assembly 3310 includes an inner sheet 3312; however, in other embodiments, the closure assembly 3310 may include a closure body instead of, or in addition to, the inner sheet 3312. The implant 3300 further includes an outer sheet 3314 supported by the proximal portion of the frame 3308, with an annular opening 3316 defined between the inner sheet 3312 and the outer sheet 3314.

[0169] The frame 3308 of implant 3300 includes a distal frame portion 3318 which includes a set of circumferentially distributed arch-petal-shaped portions, for example, arch-petal-shaped portions 3320A and 3320B. The frame 3308 further includes a proximal frame portion 3338 which includes a second set of circumferentially distributed arch-petal-shaped portions, for example, arch-petal-shaped portions 3340A and 3340B.

[0170] As shown in Figure 33, the first or inner set of the arched petal portions of implant 3300 is shown to be substantially similar to those of implant 3100. However, in contrast to implant 3100, each arched petal portion of the second set of arched petal portions of implant 3300 is formed by arched frame members extending between longitudinal members. For example, arched petal portion 3340A is formed by arched frame members 3341A and 3341B extending between longitudinal members 3348A and 3348B.

[0171] As shown in Figure 33, the longitudinal members 3348A and 3348B extend from the respective joints of the first set of arched petal portions. For example, the longitudinal member 3348A extends from the joint 3326 formed between the arched petal portions 3320A and 3320B. As described above with respect to the implant 3100, the first and second sets of arched petal portions of the implant 3300 may be rotationally offset from the arrangement shown in Figure 33 so that the longitudinal members instead extend from the proximal vertex (e.g., proximal vertex 3325) of the first set of arched petal portions.

[0172] In the illustrated embodiment, the arched frame member 3341A is proximal to the arched frame petal-shaped member 3341B, and both the arched frame member 3341A and the arched frame member 3341B are concave distally. In other embodiments, one or both of the arched frame member 3341A and the arched frame member 3341B may be concave proximally, and in other embodiments, the combination of the arched frame member 3341A and the arched frame member 3341B may be replaced by a single arched frame member or supplemented by any appropriate number of further arched frame members. Furthermore, the number of arched frame members may differ among the arched petal-shaped portions. Thus, for example, a particular arched petal-shaped portion may not contain any arched frame members, may contain one or none, while others may contain two or more.

[0173] As previously described herein, the implants according to this disclosure can transition between an expanded state (e.g., during implantation) and a folded state (e.g., during delivery). The transition from the folded state to the expanded state moves the proximal portion of the implant frame radially outward from the central longitudinal axis of the implant. The transition to the expanded state may also involve longitudinal movement of the proximal portion of the frame. As a result, when the implant expands, it extends radially outward but reduces its length along the longitudinal axis.

[0174] The presence, size, and quantity of the arched petal portion contribute to the overall length of the implant when folded. When the arched petal portion is folded (for example, when the implant is in the folded state), it undergoes circumferential compression and longitudinal elongation, respectively. As a result, even if the first and second implants have the same overall dimensions when in their respective extended states, the first implant, having more and / or larger arched petal portions than the second implant, will typically have a longer folded length than the second implant.

[0175] The relationship between the folded length and the characteristics of the arched petal portion can be used to design implants for specific applications. For example, if a surgeon anticipates that delivery and implantation may be difficult, a first implant with a frame having more and / or longer longitudinal members may be preferred over a second implant with a frame having more and / or larger arched petal portions, because it is shorter and easier to handle when folded (i.e., during delivery). In contrast, if further devices (e.g., pacemaker leads) must be implanted in the patient later, the surgeon may choose the second implant because the size, shape, and placement of the opening defined by the arched petal portion provides more options and flexibility for the delivery and support of the further device.

[0176] As another example, designs with a higher proportion of longitudinal members tend to exert smaller radial forces when transitioning from a folded state to an expanded state and may generally exhibit lower radial stiffness. Therefore, in embodiments where cardiac tissue may be susceptible to damage from larger radial forces, or where the implant may be required to conform to more complex shapes within the heart, an implant frame with a higher proportion of longitudinal members and a lower proportion of arched petal portions (or similar expansion structures) may be selected.

[0177] Figures 31-33 illustrate alternative frame configurations according to this disclosure, which are limited to designs with a proximal concave shape. Nevertheless, the frame configurations can be readily adapted to other implant shapes, including implants having an overall shape that is distally concave, frustoconical, planar, or a combination of different concave shapes. Figures 34-35B illustrate specific alternative frame configurations realized, for example, in implants having a combination of a proximal concave / distally concave distal portion.

[0178] Figure 34 shows implant 3400 having a frame configuration similar to that of implant 3300 in Figure 33. Implant 3400 includes a distal end 3402 and a proximal end 3404, with the longitudinal axis 3406 of implant 3400 extending between the distal end 3402 and the proximal end 3404. Implant 3400 includes a frame 3408 that can support a closure assembly at the distal end 3302. Figure 34 omits the closure assembly to more clearly illustrate the various features and configurations of the frame 3408. As with other embodiments described herein, the closure assembly, when included, may include a closure body and / or an inner sheet. Implant 3400 may also include an outer sheet (not shown in Figure 34) supported by the proximal portion of the frame 3408, with an annular opening defined between the inner sheet / closure assembly and the outer sheet.

[0179] The frame 3408 of implant 3400 includes a distal frame portion 3418 which includes a set of circumferentially distributed arch-shaped petal portions, for example, arch-shaped petal portions 3420A and 3420B. The frame 3408 further includes a proximal frame portion 3438 which includes a second set of circumferentially distributed arch-shaped petal portions, for example, arch-shaped petal portions 3440A and 3440B. Each arch-shaped petal portion of the second set of arch-shaped petal portions of implant 3400 is formed by arch-shaped frame members extending between longitudinal members. For example, arch-shaped petal portion 3440A is formed by arch-shaped frame members 3441A and 3441B extending between longitudinal members 3448A and 3448B. The vertical members 3348A and 3348B extend from the respective proximal ends of the arch-petal portions of the first set, for example, the vertical member 3448A extends from the proximal end 3426 of the arch-petal portion 3420A.

[0180] In contrast to the implant 3300 in Figure 33, which has a proximal concave shape, the implant 3400 in Figure 34 has a varying concave shape, similar to the implant 2900C in Figure 29C. More specifically, the implant 3400 includes a proximal portion 3450 that is proximal concave, a distal portion 3452 that is distal concave, and a cap portion 3454 that is proximal concave.

[0181] The implant 3400 further includes circumferentially distributed anchor members, for example, anchor members 3456 and 3458. Anchor member 3456 is part of a first set of anchor members extending radially outward from the proximal end of each arch-shaped frame member. Specifically, each anchor member of the first set of anchor members extends from the proximal end of the distal frame member of each arch-shaped petal portion. Thus, for example, anchor member 3456 extends from the proximal end of arch-shaped frame member 3441B. On the other hand, anchor member 3458 is part of a second set of anchor members extending radially outward from the joint between the arch-shaped tip member and the longitudinal member. Specifically, each anchor member of the second set of anchor members extends from the respective joint between the proximal frame member of each arch-shaped petal portion and each longitudinal member. Thus, for example, anchor member 3458 extends from the joint between arch-shaped frame member 3441A and longitudinal member 3348A. In other embodiments, anchor members may be located at other positions on the frame, including the proximal end of a proximal arched frame member (e.g., arched frame member 3441A) and joints formed between the distal arched frame member and the longitudinal members.

[0182] Figures 35A and 35B show another implant 3500 having an overall shape with a different concave shape. The implant 3500 includes a distal end 3502 and a proximal end 3504, with the longitudinal axis 3506 of the implant 3500 extending between the distal end 3502 and the proximal end 3504. The implant 3500 includes a frame 3508 that can support a closure assembly 3510 at the distal end 3302. Figure 35A omits the closure assembly to more clearly illustrate the various features and configurations of the frame 3508; Figure 35B includes the closure assembly 3510. As with other embodiments described herein, the closure assembly 3510 includes an inner sheet 3512, but may optionally or additionally include a closure body. The implant 3500 may also include an outer sheet 3514 (also shown in Figure 35B) supported by the proximal portion of the frame 3508, such that an annular opening 3516 is defined between the inner sheet 3512 and the outer sheet 3514.

[0183] The frame 3508 of implant 3500 includes a distal frame portion 3518 which includes a set of circumferentially distributed arch-petal-shaped portions, for example, arch-petal-shaped portions 3520A and 3520B (both labeled in Figure 35A). The frame 3508 further includes an intermediate frame portion 3538 which includes a second set of circumferentially distributed arch-petal-shaped portions, for example, arch-petal-shaped portions 3540A and 3540B (both labeled in Figure 35A), and a proximal frame portion 3558 which includes a third set of circumferentially distributed arch-petal-shaped portions, for example, arch-petal-shaped portions 3560A and 3560B (both labeled in Figure 35A). As is best seen in Figure 35A, the arched petal portions of the first and second sets are aligned to facilitate joining of each arched petal portion of the first set with each arched petal portion of the second set. For example, the proximal end of arched petal portion 3520A is joined to the distal end of arched petal portion 3540A. In contrast, the arched petal portions of the second and third sets are offset in the rotational direction and overlap each other in the longitudinal direction. For example, arched petal portion 3540A is offset in the rotational direction from arched petal portion 3560A and overlaps it in the longitudinal direction. Adjacent arched petal portions of the second and third sets may also share a common frame element. For example, arched petal portion 3540A and arched petal portion 3560A each include frame element 3562.

[0184] Similar to implant 3400 in Figure 34 and implant 2900C in Figure 29C, implant 3500 in Figure 35 has a varying concave shape. More specifically, implant 3500 includes a proximal portion 3550 which is concave in the proximal direction, a distal portion 3552 which is concave in the distal direction, and a cap portion 3554 which is concave in the proximal direction.

[0185] Furthermore, similar to implant 3400, implant 3500 includes circumferentially distributed anchor members, for example, anchor member 3556. Anchor member 3556 is part of the set of anchor members extending radially outward from each joint between adjacent arch-petal portions of the third set of arch-petal portions. Thus, for example, anchor member 3556 extends from joint 3564 between arch-petal portions 3560A and 3560B. In other embodiments, anchor members may be located elsewhere in the frame, either alternatively or additionally, including at joints between adjacent arch-petal portions of the second set of arch-petal portions and at the proximal ends of the arch-petal portions of the third set of arch-petal portions.

[0186] Embodiments of the present disclosure corresponding to implant 3500 are not limited to any size or dimensions and may be modified or customized to meet patient needs and specific applications. Nevertheless, in certain embodiments, the proximal radial outer edge 3563 of the inner sheet 3512 may be about 16 mm to about 30 mm. For example, in one specific embodiment, the proximal radial outer edge 3563 may be 24 mm. Similarly, the distal radial inner edge 3565 of the outer sheet 3514 may be about 35 mm to about 55 mm. For example, in one specific embodiment, the proximal radial inner edge 3563 may be 42 mm. The proximal radial outer edge 3566 of implant 3500 may be about 42 mm to about 68 mm. In one specific example, the proximal radial outer edge 3566 may be 56 mm. In embodiments in which implant 3500 includes an anchor member such as an anchor member 3556, at least a portion of the anchor member may be distributed around a common circumference 3567 of implant 3500. The diameter of the common circumference 3567 may vary, but in at least certain embodiments, the common circumference 3567 may have a diameter of approximately 42 mm to approximately 68 mm. For example, the common circumference 3567 may have a diameter of 54 mm. As a last example, the overall height of the implant 3500 in the expanded state may vary; in at least certain embodiments, the overall height of the implant 3500 may be approximately 26 mm to approximately 48 mm, and in one specific embodiment, it may be 36 mm.

[0187] While only a selection of embodiments of this disclosure are shown or described as including anchor members (e.g., a protruding anchor member 105 of the frame 55), such anchor members may be added to or otherwise included in any implant design described herein. Similarly, while this disclosure describes the control of implant expansion by tension control lines with respect to Figures 12–22, such functions may be adapted to and included in any other implant described herein.

[0188] While this disclosure has been described with reference to various embodiments, it should be understood that these embodiments are illustrative and that the scope of this disclosure is not limited to them. Many variations, alterations, additions, and improvements are possible. More generally, the embodiments described herein are those relating to specific embodiments. Functions may be separated or combined into blocks in different ways in various embodiments of this disclosure, or described in different terms. These and other variations, alterations, additions, and improvements may fall within the scope of this disclosure as defined in the following claims.

[0189] In general, the embodiments described herein, while described with reference to specific embodiments, may be modified without departing from the spirit and scope of this disclosure. Furthermore, note that the term “including” as used herein is intended to be inclusive, i.e., “not limited to including.”

[0190] The configurations and arrangements of systems and methods shown in various exemplary embodiments are for illustrative purposes only. Although only a few embodiments are described in detail in this disclosure, numerous modifications are possible (e.g., changes to the size, dimensions, structure, shape and proportion of various elements, parameter values, mounting structures, material use, color, positioning, etc.). For example, the arrangement of elements may be reversed or otherwise modified, and the nature or number of individual elements or arrangements may be changed. Accordingly, all such modifications are included within the scope of this disclosure. The sequence of any process or method steps may be changed or rearranged according to alternative embodiments. Other substitutions, modifications, exchanges, and omissions may be made in the design, operating conditions, and arrangements of the exemplary embodiments without departing from the scope of this disclosure. [Examples]

[0191] X. Examples Examples of embodiments of this disclosure include the following:

[0192] Scene 1: A heart valve repair implant comprising: a closure assembly including an inner seat; a frame coupled to the closure assembly and configured to transition from a folded state to an expanded state about the central longitudinal axis of the heart valve repair implant, wherein the transition from the folded state to the expanded state causes the proximal end of the frame to expand radially outward from the central longitudinal axis; and an outer seat supported by the proximal portion of the frame, wherein the closure assembly is supported by the distal portion of the frame, and when the frame is in the expanded state, the closure assembly is positioned along the central longitudinal axis, defining an annular opening between the outer seat and the inner seat.

[0193] View 2: A cardiac valve repair implant of View 1, further comprising a closure assembly supported at the distal end of the frame along the central longitudinal axis.

[0194] View 3: A cardiac valve repair implant of View 1, wherein the closure assembly further includes a closure body supported at the distal end of the frame along the central longitudinal axis, with an inner sheet coupled to the closure body.

[0195] Surface 4: A heart valve repair implant of surface 1, where the frame is concave in the proximal direction when in an expanded state.

[0196] Surface 5: A heart valve repair implant of surface 1, where the frame is concave distally when in an expanded state.

[0197] View 6: A heart valve repair implant of View 1, where the frame is planar when in an expanded state.

[0198] Phase 7: The heart valve repair implant from Phase 1, with the frame biased into an expanded state.

[0199] View 8: A heart valve repair implant from View 1, with the medial sheet supported by the distal portion of the frame.

[0200] View 9: A heart valve repair implant of View 1, in which the frame includes a distal arch-petal portion and the medial sheet is supported by the distal arch-petal portion.

[0201] Surface 10: A heart valve repair implant of surface 1, in which the proximal portion of the frame supporting the lateral sheet includes an arched petal-shaped portion.

[0202] Surface 11: A heart valve repair implant of surface 1, wherein the frame includes an anchor member that protrudes distally from the frame when the frame is in an expanded state.

[0203] Surface 12: A heart valve repair implant of surface 1, wherein the frame includes a first set of anchor members and a second set of anchor members, and when the frame is in an extended state, each of the first set of anchor members and the second set of anchor members extends at least partially distally, and the first set of anchor members is positioned at a radius from the central longitudinal axis that is different from that of the second set of anchor members.

[0204] Surface 13: A cardiac valve repair implant of surface 1, wherein at least one of the outer sheet and the inner sheet includes a fabric material that allows for tissue endogeneration.

[0205] Surface 14: A heart valve repair implant comprising: a central occluder; a frame extending from the central occluder and supporting the central occluder at its distal portion, configured to transition from a folded state to an expanded state, wherein when in the folded state, its proximal end protrudes proximally, and when in the expanded state, its proximal end protrudes radially outward from the central longitudinal axis; an outer sheet supported at the proximal portion of the frame; and an inner sheet around the central occluder, wherein when the frame is in the expanded state, the central occluder is aligned along the central axis of the heart valve repair implant, and an annular opening is defined between the outer sheet and the inner sheet, with the annular opening centered on the central longitudinal axis.

[0206] Surface 15: A heart valve repair implant of surface 14, further including an inner frame extending from a central occluder, the inner frame including an inner arched petal portion, and an inner sheet supported by the inner arched petal portion.

[0207] Surface 16: A heart valve repair implant of surface 14, wherein the frame includes an anchor member that protrudes distally from the frame when the frame is in an expanded state.

[0208] Surface 17: A heart valve repair implant of surface 14, wherein the proximal portion of the frame supporting the outer sheet includes a first arch-petal-shaped portion, and the distal portion of the frame supporting the inner sheet includes a second arch-petal-shaped portion.

[0209] Surface 18: A heart valve repair implant of surface 14, wherein the frame is either concave in the proximal direction and concave in the distal direction when in an expanded state.

[0210] Surface 19: A method for repairing a target heart valve, comprising the steps of: delivering a folded implant adjacent to a target heart valve in an atrium, wherein the implant comprises a closure assembly having an inner sheet, a frame coupled to the closure assembly, an outer sheet supported by the proximal portion of the frame, and an inner sheet of the closure assembly supported by the distal portion of the frame, wherein when the implant is folded, the frame and inner sheet are folded inward around the central longitudinal axis of the implant; bringing an expanded implant closer to a target heart valve, wherein when the implant is expanded, the frame, outer sheet and inner sheet are unfolded so that the inner sheet and outer sheet form an annular structure defining an annular opening between the inner sheet and the outer sheet, with the annular opening centered on the central longitudinal axis; and positioning the closure assembly in the orifice of the target heart valve, with the distal end of the annular structure in contact with an annular region of cardiac tissue surrounding the target heart valve, such that the annular opening opens above the orifice of the target heart valve.

[0211] Surface 20: The method of Surface 19, wherein the closure assembly further comprises a closure body supported at the distal end of a frame along a central longitudinal axis, an inner sheet coupled to and extending from the closure body, and the step of positioning the closure assembly in the orifice of a target heart valve includes positioning the closure body to interact with the leaflets of the target heart valve.

[0212] Surface 21: A heart valve repair implant comprising: a closure assembly; a frame coupled to the closure assembly and configured to transition from a folded state to an expanded state about the central longitudinal axis of the heart valve repair implant, wherein the transition from the folded state to the expanded state causes the proximal end of the frame to expand radially outward from the central longitudinal axis; and an outer sheet supported by the proximal portion of the frame, wherein the closure assembly is supported by the distal portion of the frame, and when the frame is in the expanded state, the closure assembly is positioned along the central longitudinal axis, and an annular opening is defined between the outer sheet and the inner sheet.

[0213] Surface 22: A heart valve repair implant of surface 21, further including tension control lines extending around the frame, wherein the transition of the frame between a folded state and an expanded state can be controlled by selectively applying tension to the tension control lines.

[0214] View 23: A heart valve repair implant from view 22, with a tension control line connected to the distal side of the frame.

[0215] Surface 24: A heart valve repair implant of surface 22, in which tension control lines are further connected to the frame by radially extending links.

[0216] Surface 25: A cardiac valve repair implant of surface 21, wherein the closure assembly includes a closure plug, the closure plug comprising a closure plug body defining a cavity and an insert positioned within the cavity.

[0217] View 26: A heart valve repair implant of View 25, with the insert connected to the closure body by a screw connection.

[0218] Scene 27: Heart valve repair implant of scene 25, with the occluder further containing radiopaque markers.

[0219] Surface 28: A heart valve repair implant of surface 21, in which the frame includes an arch-shaped, petal-like portion distributed circumferentially around a central longitudinal axis.

[0220] Surface 29: A heart valve repair implant of surface 28, wherein the arched petal portion includes a first set of arched petal portions and a second set of arched petal portions positioned radially inward of the first set of arched petal portions.

[0221] Surface 30: A heart valve repair implant of surface 28, in which the closure assembly is connected to the arch-petal portion by spokes that extend radially from the closure assembly to the arch-petal portion.

[0222] Surface 31: A heart valve repair implant of surface 21, further comprising an anchor member configured to protrude radially outward when the frame is in an expanded state.

[0223] Surface 32: A heart valve repair implant of surface 31, in which anchor members are distributed circumferentially around the frame.

[0224] Surface 33: A heart valve repair implant of surface 31, in which the outer sheet is positioned distal to the frame and the anchor member extends through the outer sheet.

[0225] Surface 34: A heart valve repair implant of surface 31, wherein the frame includes arched petal-shaped portions distributed circumferentially around a central longitudinal axis, and anchor members extend from the tips of the arched petal-shaped portions and from at least one of the joints between adjacent arched petal-shaped portions.

[0226] Surface 35: A heart valve repair implant of surface 21, in which the frame has a concave shape in the proximal direction when in an expanded state.

[0227] Surface 36: A heart valve repair implant of surface 21, in which the frame has a concave shape distally when in an expanded state.

[0228] Surface 37: A cardiac valve repair implant of surface 21, wherein the frame, when in an expanded state, has a proximal portion that is concave in the proximal direction and a distal portion that is concave in the distal direction.

[0229] Surface 38: A heart valve repair implant of surface 37, wherein the frame, when in an expanded state, further has a proximal concave cap portion located distal to the frame.

[0230] Surface 39: A heart valve repair implant of surface 21, with a frame that has a frustoconical shape when in an expanded state.

[0231] Surface 40: A heart valve repair implant with a surface 21 having a planar shape when the frame is in an expanded state.

[0232] Surface 41: A cardiac valve repair implant of surface 21, wherein the frame includes a distal arch-shaped petal portion, a proximal arch-shaped petal portion, and a longitudinal member extending between the distal arch-shaped petal portion and the proximal arch-shaped petal portion.

[0233] Surface 42: A heart valve repair implant of surface 41, in which each longitudinal member connects the proximal end of the distal arch-shaped petal portion to the distal end of the proximal arch-shaped petal portion.

[0234] Surface 43: A heart valve repair implant of surface 41, in which each longitudinal member connects the joint between adjacent distal arch-shaped petal portions to the distal end of the proximal arch-shaped petal portion.

[0235] Surface 44: A heart valve repair implant of surface 21, wherein the frame includes a distal arch-shaped petal portion, a longitudinal member extending proximal to the distal arch-shaped petal portion, and an arch-shaped frame member extending between adjacent longitudinal members.

[0236] Surface 45: A heart valve repair implant of surface 44, in which each longitudinal member extends from the proximal end of its respective distal arch-shaped petal portion.

[0237] Surface 46: A heart valve repair implant of surface 44, in which each longitudinal member extends from the joint between adjacent distal arch-shaped petal portions.

[0238] Surface 47: A heart valve repair implant of surface 44, wherein the arched frame member includes a first arched frame member and a second arched frame member extending between a pair of longitudinal members, the second arched frame member being positioned distal to the first arched frame member.

[0239] Surface 48: A heart valve repair implant of surface 21, wherein the frame includes a distal arch-shaped petal portion, a proximal arch-shaped frame member, and an intermediate arch-shaped petal portion positioned longitudinally between the distal arch-shaped petal portion and the proximal arch-shaped petal portion.

[0240] Surface 49: A heart valve repair implant of surface 48, wherein the frame further includes longitudinal members extending between each distal arch-petal portion of the arch-petal portion and each intermediate arch-petal portion of the intermediate arch-petal portion.

[0241] Surface 50: A heart valve repair implant of surface 49, in which the longitudinal member connects the proximal end of the distal arch-shaped petal portion to the proximal end of the intermediate arch-shaped petal portion.

[0242] Surface 51: A heart valve repair implant of surface 48, wherein the frame includes frame elements, and the frame elements partially define each proximal arcuate petal portion of the proximal arcuate petal portion and each intermediate arcuate petal portion of the intermediate arcuate petal portion.

[0243] Surface 52: A cardiac valve repair implant of surface 21, wherein the closure assembly further includes an inner sheet extending about a central longitudinal axis, the inner sheet having a proximal radially lateral edge, and the proximal radially lateral edge having a diameter of approximately 16 mm to approximately 30 mm.

[0244] Surface 53: A heart valve repair implant with surface 52, where the proximal radial lateral edge is approximately 24 mm.

[0245] Surface 54: A cardiac valve repair implant of surface 21, in which the lateral sheet has a distal radial medial edge, and the distal radial medial edge has a diameter of approximately 35 mm to approximately 55 mm.

[0246] Surface 55: A heart valve repair implant with surface 54, having a distal radial medial edge with a diameter of approximately 42 mm.

[0247] A cardiac valve repair implant with a curved surface 21, having a proximal radially lateral edge with a diameter of approximately 42 mm to 68 mm (curved surface 56).

[0248] Surface 57: A heart valve repair implant with surface 56, where the proximal radial lateral edge is approximately 56 mm.

[0249] Surface 58: A heart valve repair implant of surface 21, wherein the frame includes anchor members that protrude distally from the frame when the frame is in an expanded state, and the anchor members are distributed circumferentially with respect to the anchor diameter around a central longitudinal axis, with the anchor diameter being approximately 42 mm to approximately 68 mm.

[0250] Surface 59: A heart valve repair implant with surface 58, where the anchor diameter is approximately 54 mm.

[0251] Surface 60: A heart valve repair implant with surface 21, having a length of approximately 26 mm to 48 mm along the central longitudinal axis when in an expanded state.

[0252] Surface 61: A heart valve repair implant comprising: a central occluder including a central longitudinal axis; a frame extending proximal to the central occluder, centered on the central longitudinal axis of the central occluder, forming a circumference thereof, and biasing itself from a folded state to an expanded state, wherein when the frame is in the folded state, the proximal end of the frame protrudes proximal, and when the frame is in the expanded state, the proximal end of the frame protrudes radially outward from the central longitudinal axis of the central occluder; and a thin sheet supported by the proximal portion of the frame, which, when the frame is in the expanded state, forms an annular surface defining an inner circular opening centered on the central longitudinal axis of the central occluder, wherein the frame comprises spokes extending between the proximal end of the central occluder and the proximal portion of the frame supporting the thin sheet, and the proximal portion of the frame supporting the thin sheet comprises arched petal-shaped portions extending from the spokes.

[0253] Surface 62: A heart valve repair implant of surface 61, wherein the frame includes an anchor member on the distal side of the frame, and when the frame is in an expanded state, the anchor member protrudes distally from the frame.

[0254] Surface 63: A heart valve repair implant of surface 62, in which the anchor member protrudes further radially outward when the frame is in an expanded state.

[0255] Surface 64: A heart valve repair implant of surface 63, in which, when the frame is in an expanded state, the anchor member protrudes further radially inward.

[0256] Surface 65: A heart valve repair implant of surface 61, wherein when the frame is folded, the spokes are substantially straight and substantially parallel to the central longitudinal axis of the central occluder, and when the frame is extended, the spokes are curved radially outward with respect to the central longitudinal axis of the central occluder.

[0257] Surface 66: A heart valve repair implant of surface 61, wherein each arch-shaped petal portion includes an outer arch-shaped member and an inner arch-shaped member located radially inward of the outer arch-shaped member.

[0258] Aspect 67: The heart valve repair implant of Aspect 61, where a thin sheet is supported on the distal side of the frame.

[0259] Aspect 68: The heart valve repair implant of Aspect 61, where a thin sheet is supported on the proximal side of the frame.

[0260] Aspect 69: The heart valve repair implant of Aspect 61, where the central closure plug includes a cylindrical side surface and a brim that extends distally from the cylindrical side surface.

[0261] Aspect 70: The heart valve repair implant of Aspect 61, where the frame includes a shape memory material that self - biases the frame from a folded state to an expanded state. [[ID=​​​​​​​

[0264] Scenario 73: The method of Scenario 72 where the implant is delivered to the target valve via a antegrade percutaneous route.

[0265] Scenario 74: The method of Scenario 72 where the implant self-biases from a folded state to an expanded state.

[0266] Scenario 75: When the frame is in the folded state, the proximal end of the frame protrudes in the proximal direction, and when the frame is in the expanded state, the proximal end of the frame protrudes radially outward from the central longitudinal axis of the closure plug, the method of Scenario 72.

[0267] Scenario 76: The method of Scenario 72 where the frame includes an anchor member on the distal side of the annular structure, and the anchor member protrudes into the annular region of the heart tissue surrounding the target heart valve.

[0268] Scenario 77: The method of Scenario 76 further including the step of over-expanding the implant to cause the anchor member to protrude into the annular region.

[0269] Scenario 78: The method of Scenario 76 further including the step of pressing the implant distally against the annular region of the heart tissue surrounding the target heart valve to cause the anchor member to protrude into the annular region.

[0270] Scenario 79: The method of Scenario 76 where the frame includes a shape memory material that self-biases the implant from a folded state to an expanded state

[0271] Scenario 80: The method of Scenario 76 where the thin sheet includes a cloth material that allows for in-growth of tissue.

[0272] Scenario 81: The method of Scenario 76 where the central closure plug is positioned in the orifice of the target heart valve such that the valve leaflets of the target heart valve abut against the cylindrical side surface of the central closure plug.

[0273] Surface 82: A heart valve repair implant comprising: a central occluder including a central longitudinal axis; a frame extending proximal to the central occluder, centered on the central longitudinal axis of the central occluder, forming a circumference around it, and biasing itself from a folded state to an expanded state, wherein when in the folded state, its proximal end protrudes proximal, and when in the expanded state, its proximal end protrudes radially outward from the central longitudinal axis of the central occluder; and a thin sheet supported by the proximal portion of the frame, which, when the frame is in the expanded state, forms an annular surface defining an inner circular opening centered on the central longitudinal axis of the central occluder; a heart valve repair implant comprising the thin sheet.

[0274] Surface 83: A heart valve repair implant of surface 82, wherein the frame includes an anchor member on the distal side of the frame, and when the frame is in an expanded state, the anchor member protrudes distally from the frame.

[0275] Surface 84: A heart valve repair implant of surface 83, in which the anchor member protrudes further radially outward when the frame is in an expanded state.

[0276] Surface 85: A heart valve repair implant with surface 83, in which the anchor member protrudes further radially inward when the frame is in an expanded state.

[0277] Surface 86: A cardiac valve repair implant of surface 82, in which the frame includes spokes extending between the proximal end of the central occluder and the proximal portion of the frame supporting a thin sheet.

[0278] A heart valve repair implant of the form 86, wherein when the frame is folded, the spokes are substantially straight and substantially parallel to the central longitudinal axis of the central closure, and when the frame is unfolded, the spokes are curved radially outward with respect to the central longitudinal axis of the central closure.

[0279] Surface 88: A heart valve repair implant of surface 86, in which the proximal portion of the frame supporting a thin sheet includes an arched, petal-shaped portion extending from the spokes.

[0280] Aspect 89: The heart valve repair implant of Aspect 88, where each arcuate leaflet portion includes an outer arcuate member and an inner arcuate member radially inside the outer arcuate member.

[0281] Aspect 90: The heart valve repair implant of Aspect 82, where a thin sheet is supported on the distal side of the frame.

[0282] Aspect 91: The heart valve repair implant of Aspect 82, where a thin sheet is supported on the proximal side of the frame.

[0283] Aspect 92: The heart valve repair implant of Aspect 82, where the central closure plug includes a cylindrical side surface and a brim extending distally from the cylindrical side surface.

[0284] Aspect 93: The heart valve repair implant of Aspect 82, where the frame includes a shape memory material that self-biases the frame from a folded state to an expanded state.

[0285] Aspect 94: The heart valve repair implant of Aspect 82, where the thin sheet includes a fabric material that enables ingrowth into tissue.

[0286] Section 95: A method for repairing a target heart valve, comprising the steps of: delivering a folded implant adjacent to a target heart valve in an atrium, wherein the implant comprises a central occluder having a central longitudinal axis, a frame extending proximal to the central occluder, and a thin sheet supported in the proximal region of the frame, wherein when the implant is folded, the frame and thin sheet are folded inward around the central longitudinal axis; bringing an expanded implant closer to the target heart valve, wherein when the implant is expanded, the frame and thin sheet are unfolded to form an annular structure defining an internal circular opening centered on the central longitudinal axis of the central occluder; and positioning the central occluder in the orifice of the target heart valve, with the distal end of the annular structure in contact with an annular region of cardiac tissue surrounding the target heart valve, such that the internal circular opening opens above the orifice of the target heart valve.

[0287] Surface 96: The method of surface 95, wherein the implant is delivered to the target valve via an antegrade percutaneous pathway.

[0288] Phase 97: The method of Phase 95, in which the implant biases itself from a folded state to an expanded state.

[0289] Surface 98: The method of Surface 95, wherein when the frame is folded, the proximal end of the frame protrudes proximally, and when the frame is extended, the proximal end of the frame protrudes radially outward from the central longitudinal axis of the closure plug.

[0290] Surface 99: The method of surface 95, wherein the frame includes an anchor member distal to the annular structure, and the anchor member protrudes into an annular region of cardiac tissue surrounding the target cardiac valve.

[0291] Surface 100: The method of surface 99, further comprising the step of excessively expanding the implant to cause the anchor member to protrude into the annular region.

[0292] Surface 101: The method of surface 99, further comprising the step of pressing the implant distally against an annular region of cardiac tissue surrounding a target heart valve, thereby causing the anchor member to protrude into the annular region.

[0293] Surface 102: A method of surface 95 in which the frame includes spokes extending between the proximal end of a central closure plug and the proximal portion of the frame supporting a thin sheet.

[0294] Surface 103: A method of surface 95, wherein the frame includes a shape memory material that biases the implant from a folded state to an extended state.

[0295] Surface 104: A method of surface 95, wherein a thin sheet includes a fabric material that allows tissue growth.

[0296] Surface 105: The method of surface 95, wherein the central occluder is positioned in the orifice of the target heart valve such that the leaflets of the target heart valve abut against the cylindrical side surface of the central occluder.

[0297] Surface 106: A delivery tool for a heart valve repair implant, comprising: an outer sheath; a release catheter insertable to the outer sheath, comprising a release line for selectively coupling a heart valve implant to the distal end of the delivery tool, comprising a tension control assembly insertable to the release catheter, comprising a tension control member selectively coupled to a tension control line of a heart valve implant by the release line, and operable to apply tension to the tension control line using the tension control member; and a tension control assembly comprising a tension control assembly insertable to the release catheter, comprising a tension control member selectively coupled to a tension control line of a heart valve implant by the release line, and operable to apply tension to the tension control line.

[0298] Surface 107: The delivery tool of surface 106, in which the tension member extends through the lateral opening when the release catheter defines a lateral opening and the tension control assembly is inserted into the release catheter.

[0299] Surface 108: A delivery tool of surface 106, where the tension control member terminates in a loop.

[0300] Surface 109: The delivery tool of surface 106, in which, when the release catheter defines a lateral opening and is coupled to the heart valve implant, the release line extends from the distal opening of the release catheter and is returned through the lateral opening.

[0301] Surface 110: A delivery tool for a heart valve repair implant, comprising: an outer sheath defining a central lumen formed to receive an expandable frame of a heart valve repair implant; a catheter insertable into the central lumen of the outer sheath, wherein when inserted into the central lumen with the expandable frame present in the central lumen, the distal catheter end abuts against the closure plug of the heart valve repair implant, so that distal translation of the catheter causes the expandable frame to translate distally from the central lumen; and a handle assembly coupled to the proximal end of the catheter and connectable to the expandable frame by a plurality of sutures, the handle assembly being operable to control the tension on the plurality of sutures when the plurality of sutures are connected to the expandable frame, thereby controlling the expansion of the expandable frame.

[0302] Surface 111: A delivery tool of surface 110, wherein the handle assembly includes a handle that is longitudinally translatable relative to the catheter, and the longitudinal translation of the handle controls the expansion of an expandable frame.

[0303] Surface 112: A delivery tool of surface 110, wherein the handle assembly includes a handle that is rotatable relative to the catheter to control the expansion of the expandable frame.

[0304] Surface 113: A delivery tool of surface 110, comprising a handle assembly that includes a handle that is longitudinally translatable and rotatable relative to the catheter to control the expansion of an expandable frame.

[0305] Phase 114: A delivery tool of phase 113, wherein the translation of the handle changes the expansion of the expandable frame by a first ratio, and the rotation of the handle changes the expansion of the expandable frame by a second ratio lower than the first ratio.

[0306] Surface 115: A delivery tool of surface 110, in which the catheter is steerable by a suture routed from the distal end of the catheter to a handle assembly.

[0307] Surface 116: A delivery tool of surface 110, wherein the handle assembly further includes a steering control mechanism for steering the distal catheter end.

[0308] Surface 117: A delivery tool of surface 116, wherein the steering tool includes a transverse member connected to the distal catheter end by a pull wire, and the rotation of the transverse member generates tension on the pull wire for steering the distal catheter end.

[0309] Surface 118: A delivery tool of surface 116, wherein the steering tool includes a transverse member connected to a first side of the distal catheter end by a first pull wire and to a second side of the distal catheter end by a second pull wire, wherein rotation of the transverse member in a first direction increases the tension on the first pull wire, pulling the distal catheter end toward the first side, and rotation of the transverse member in a second direction increases the tension on the second pull wire, pulling the distal catheter end toward the second side.

Claims

1. Heart valve repair implants, as follows: Closure assembly including inner sheet; A frame extending from the closure assembly and supporting the closure assembly distally, the frame being configured to transition from a folded state to an extended state, wherein when the frame is in the folded state, the proximal end of the frame protrudes proximally, and when the frame is in the extended state, the proximal end of the frame protrudes radially outward from the central longitudinal axis of the heart valve repair implant; and Outer sheet supported in the proximal portion of the frame Includes, When the frame is in an expanded state, the closure assembly is positioned along the central longitudinal axis of the heart valve repair implant, and an annular opening centered on the central longitudinal axis is defined between the outer seat and the inner seat. Heart valve repair implants.

2. The heart valve repair implant according to claim 1, wherein the frame includes a distal frame portion including an internal arch-petal-shaped portion, and a closure assembly is supported by the internal arch-petal-shaped portion.

3. The cardiac valve repair implant according to claim 1, wherein the proximal portion of the frame includes an arch-shaped, petal-like portion distributed circumferentially around a central longitudinal axis.

4. The heart valve repair implant according to claim 3, wherein the proximal portion of the frame includes arched petal-shaped portions distributed circumferentially around a central longitudinal axis, and anchor members that protrude distally from the frame when the frame is in an expanded state and protrude from the joints between adjacent arched petal-shaped portions.

5. The frame includes a distal frame portion that contains an inner arch-shaped petal-like portion, The closing assembly is supported by the inner arch-shaped petal portion, The proximal portion of the frame includes outer, arch-shaped, petal-like portions distributed circumferentially around the central vertical axis. The heart valve repair implant according to claim 1, wherein the inner arch-shaped petal portion is connected to the outer arch-shaped petal portion by spokes extending radially between the inner arch-shaped petal portion and the outer arch-shaped petal portion.

6. The heart valve repair implant according to claim 1, wherein the frame defines at least one of a proximal concave shape and a distal concave shape when in an expanded state.

7. The cardiac valve repair implant according to claim 1, wherein the frame, when in an expanded state, has a proximal portion that is concave in the proximal direction and a distal portion that is concave in the distal direction.

8. The cardiac valve repair implant according to claim 7, further comprising a proximal concave cap portion located distal to the frame when the frame is in an expanded state.

9. The cardiac valve repair implant according to claim 1, wherein the frame includes a distal arch-shaped petal portion, a proximal arch-shaped petal portion, and a longitudinal member extending between the distal arch-shaped petal portion and the proximal arch-shaped petal portion.

10. The cardiac valve repair implant according to claim 9, wherein each longitudinal member connects the proximal end of the distal arch-shaped petal portion to the distal end of the proximal arch-shaped petal portion.

11. The heart valve repair implant according to claim 9, wherein each longitudinal member connects the proximal end of the distal arch-shaped petal portion to the joint between adjacent proximal arch-shaped petal portions.

12. A heart valve repair implant according to claim 1, wherein the frame biases itself into an expanded state.

13. The heart valve repair implant according to claim 1, wherein the frame contains a shape memory material and biases itself into an expanded state.

14. The heart valve repair implant according to claim 1, wherein the inner sheet has a laminated structure.

Images