Prosthetic valve systems, components, and methods

Abstract

Devices, systems, and methods for prosthetic valves are described. Prosthetic valve embodiments may be directed to sealing flow at an implantation site, which may include a native valve. Embodiments may be configured to conform to the shape of the native valve, which may be a non-circular shape. Embodiments may include a frame having portions joined together by one or more revolute joints. Embodiments may include a crescent-shaped frame. Embodiments may include a frame structure having an integral portion. Embodiments may include a portion of a prosthetic valve having a micropattern applied to the prosthetic valve. One or more microbeads may be utilized in embodiments. Prosthetic valve structures utilizing support rings may be provided.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 148,058, filed February 10, 2021, the entire contents of which are incorporated herein by reference.

[0002] Certain embodiments disclosed herein relate generally to implants, including prosthetic valves for implantation. [Background technology]

[0003] Human heart valves, including aortic, pulmonary, mitral, and tricuspid valves, essentially function as one-way valves that operate in sync with the pumping heart. The valves allow blood to flow downstream, but block blood from flowing upstream. Affected heart valves exhibit disorders such as valve stenosis or regurgitation, which inhibit the valve's ability to control blood flow. Such disorders can reduce the heart's blood pumping efficiency and lead to debilitating and life-threatening conditions. For example, valve malfunctions can lead to conditions such as cardiac hypertrophy and ventricular dilation. Therefore, there have been extensive efforts to develop methods and devices for repairing or replacing defective heart valves.

[0004] Prostheses exist to correct the problems associated with defective heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace defective native heart valves. More recently, considerable effort has been expended on the development of replacement heart valves, particularly tissue-based replacement heart valves, that can be delivered with less trauma to the patient than open-heart surgery. Replacement valves are designed to be delivered through minimally invasive procedures, even percutaneous procedures. Such replacement valves often include a tissue-based valve body that is connected to an expandable frame and then delivered to the annulus of the native valve.

[0005] These replacement valves are typically "one-way valves," allowing blood to flow in only one direction. However, problems arise when blood leaks around the outside of the prosthesis. For example, in the context of replacement heart valves, paravalvular leaks (PVL) have proven to be particularly problematic. An additional challenge relates to the ability of such prostheses to be secured against intraluminal tissue, such as tissue within any body cavity or cavity, in an atraumatic manner. Summary of the Invention

[0006] Embodiments of the prosthetic valve may be directed to improvements in sealing flow at an implantation site, which may include a native valve. Embodiments may be configured to conform to the shape of the native valve, which may be a non-circular shape. Such a native valve may include a native valve annulus having an oval shape and / or a shape that includes one or more recesses.

[0007] Embodiments may further include improvements in the structure of the prosthetic valve, including the configuration of the components of the prosthetic valve, which may include the leaflets of the prosthetic valve.

[0008]

[0005] Embodiments disclosed herein may include a prosthetic valve configured to be deployed into a native valve. The prosthetic valve may include one or more prosthetic leaflets. The prosthetic valve may include a frame coupled to the one or more prosthetic leaflets and including a first portion and a second portion, and at least one revolute joint coupling the first portion to the second portion and allowing the first portion to rotate relative to the second portion.

[0009] Implementations of the embodiments may include one or more of the following: The at least one revolute joint may include one or more of a suture joint, a t-bracket, a ball and socket joint, an overmolding, or a hinge. The suture joint may include a scissor tie knot. The frame may include an outer frame spaced apart from an inner frame, the inner frame configured to support one or more prosthetic valve leaflets, the outer frame configured to conform to a shape of a native valve annulus. The outer frame may surround the inner frame. The outer frame may have a bulbous shape. The inner frame may have a circular shape. The skirt may be coupled to the outer frame and configured to seal a portion of the annulus. The proximal portion of the outer frame may be coupled to a proximal portion of the inner frame, the outer frame being spaced apart from the inner frame by a gap. The first portion may include at least one strut cell, and the second portion may include at least one strut cell. The first portion may include a row of frames, and the second portion includes an adjacent row of frames. The frame may surround a central axis of the prosthetic valve, and the first portion may be configured to rotate relative to the second portion in a plane extending transversely to the central axis. The first portion may be configured to rotate relative to the second portion to change a shape of an outer surface of the frame. The one or more distal anchors may be configured to extend around one or more leaflets of the native valve to secure the prosthetic valve to the native valve. The prosthetic valve may be configured to be deployed into a mitral valve or a tricuspid valve.

[0010] Embodiments disclosed herein may include a method of deploying a prosthetic valve to a native valve, the prosthetic valve including one or more prosthetic leaflets, a frame coupled to the one or more prosthetic leaflets and including a first portion and a second portion, and at least one revolute joint coupling the first portion to the second portion and allowing the first portion to rotate relative to the second portion.

[0011] Implementations of the embodiments may include one or more of the following: The method may include allowing the first portion to rotate relative to the second portion in response to a shape of the native valve annulus. The method may include allowing the frame to conform to a shape of the native valve annulus. The method may include deploying the prosthetic valve into a mitral valve or a tricuspid valve.

[0012] The embodiments disclosed herein may include a prosthetic valve configured to be deployed into a native valve. The prosthetic valve may include one or more prosthetic valve leaflets. The prosthetic valve may include an outer frame having a crescent shape with two ends circumferentially spaced apart from one another. The prosthetic valve may include an inner frame supporting the one or more prosthetic valve leaflets and surrounded by at least a portion of the outer frame and coupled to each of the two ends of the outer frame.

[0013] Implementations of the embodiments may include one or more of the following: A portion of the inner frame positioned between the two ends of the outer frame may form an outermost frame surface of the prosthetic valve. A skirt may be coupled to the outer frame and a portion of the inner frame positioned between the two ends of the outer frame. The skirt may form an outer surface of the prosthetic valve. A center of the inner frame may be offset from a center of the outer frame. The outer frame and the inner frame together may form a "D" shape of the prosthetic valve. The outer frame may have a diameter and the inner frame may have a diameter smaller than the diameter of the outer frame. A proximal portion of the outer frame may be coupled to a proximal portion of the inner frame. A connector may join the two ends of the outer frame to the inner frame. At least one of the connectors may comprise a revolute joint. The outer frame may have a circular or ovoid shape. The inner frame may have a circular shape. The outer frame may be configured to move to conform to the shape of the annulus of the native valve. The one or more distal anchors may be configured to extend around one or more leaflets of the native valve to secure the prosthetic valve to the native valve. The prosthetic valve may be configured to be deployed in a mitral or tricuspid valve.

[0014] Embodiments disclosed herein may include a method that may include deploying a prosthetic valve into a native valve. The prosthetic valve may include one or more prosthetic leaflets, an outer frame having a crescent shape with two ends circumferentially spaced apart from one another, and an inner frame supporting the one or more prosthetic leaflets, surrounded by at least a portion of the outer frame and coupled to each of the two ends of the outer frame.

[0015] Implementations of the embodiments may include one or more of the following: The method may include deploying a prosthetic valve into the mitral or tricuspid valve.

[0016]

[0013] The embodiments disclosed herein may include a prosthetic valve configured to be deployed into a native valve. The prosthetic valve may include one or more prosthetic leaflets. The prosthetic valve may include an inner frame supporting the one or more prosthetic leaflets. The prosthetic valve may include a sealing body configured to contact a portion of the annulus of the native valve, the sealing body including an outer frame having a skirt and a plurality of elongated struts, each of the plurality of elongated struts having a proximal portion integral with the inner frame and a distal portion spaced apart from the inner frame.

[0017] Implementations of the embodiments may include one or more of the following: Each of the plurality of elongated struts may be integrally formed with the inner frame. Each of the plurality of elongated struts may be biased away from the inner frame. The inner frame and the plurality of elongated struts may be formed from a single piece of material. A distal portion of each of the plurality of elongated struts may be cut away from the inner frame. The inner frame may include a plurality of struts joined at joints, a proximal portion of each of the plurality of elongated struts being integral with one of the joints. One of the joints may include one or more of a suture joint, a t-bracket, a ball and socket joint, an overmolding, or a hinge. One of the joints includes a rotational joint configured to rotate a first portion of the inner frame relative to a second portion of the inner frame. A space may be positioned between the plurality of struts. The plurality of struts may form a strut cell. Each of the plurality of elongated struts may extend radially outward from the inner frame. The inner frame may include a distal anchor configured to extend around one or more leaflets of the native valve to secure the prosthetic valve to the native valve. The sealing body may further include a compressible material positioned between the skirt and the outer frame. The compressible material may include foam. The prosthetic valve may be configured to be deployed into a mitral valve or a tricuspid valve.

[0018] Embodiments disclosed herein may include a method that may include deploying a prosthetic valve into a native valve. The prosthetic valve may include one or more prosthetic leaflets, an inner frame supporting the one or more prosthetic leaflets, and a sealing body configured to contact a portion of the native valve annulus, the sealing body including an outer frame having a skirt and a plurality of elongated struts, each of the plurality of elongated struts having a proximal portion integral with the inner frame and a distal portion spaced apart from the inner frame.

[0019] Implementations of the embodiments may include one or more of the following: The method may include deploying a prosthetic valve into the mitral or tricuspid valve.

[0020]

[0006] Embodiments disclosed herein may include a method of forming at least a portion of a prosthetic valve configured to be deployed into a native valve. The method may include biasing a distal portion of each of a plurality of elongated struts of a sealing body away from an inner frame for supporting a plurality of prosthetic valve leaflets, a proximal portion of each of the plurality of elongated struts being integrally formed with the inner frame. The method may include placing a skirt over the plurality of elongated struts when the plurality of elongated struts are biased away from the inner frame.

[0021] Implementations of the embodiments may include one or more of the following: The method may include forming the inner frame and the plurality of elongated struts from a single piece of material. The single piece of material may have a cylindrical shape. Forming the inner frame and the plurality of elongated struts from a single piece of material may include cutting the inner frame and the plurality of elongated struts from the single piece of material. The method may include pulling a distal portion of each of the plurality of elongated struts away from adjacent struts of the inner frame. The method may include pulling a distal portion of each of the plurality of elongated struts and forming a gap between adjacent struts of the inner frame. The method may include closing the gap with a connector. The method may include coupling one or more prosthetic valve leaflets to the inner frame.

[0022] Embodiments disclosed herein may include an apparatus that includes a prosthetic valve configured to be deployed to a native valve of the body, the prosthetic valve including one or more prosthetic valve leaflets, and a micropattern applied to at least a portion of the prosthetic valve.

[0023] Implementations of the embodiments may include one or more of the following: The micropattern may be applied to at least one of the one or more prosthetic valve leaflets. At least one of the one or more prosthetic valve leaflets may include a first portion and a second portion, the first portion having a first configuration of the micropattern and the second portion having a second configuration of the micropattern different from the first configuration. The micropattern may be configured to reduce formation of thrombus on at least one of the one or more prosthetic valve leaflets. The micropattern may be configured to improve biocompatibility of at least one of the one or more prosthetic valve leaflets with a patient's body. The micropattern may be configured to modify fluid flow through the prosthetic valve. The one or more prosthetic valve leaflets may include a plurality of prosthetic valve leaflets, the micropattern configured to improve coaptation between the plurality of prosthetic valve leaflets. The prosthetic valve may include a frame configured to support at least one of the one or more prosthetic valve leaflets within the native valve, the micropattern configured to improve coupling of the at least one of the one or more prosthetic valve leaflets to the frame. The micropattern may be laser milled on at least one of the one or more prosthetic valve leaflets. At least a portion of the prosthetic valve may include a woven fabric, and the micro-pattern is applied to the woven fabric. The prosthetic valve may include a sealing skirt, and the micro-pattern is applied to the sealing skirt. The micro-pattern may include one or more of a checkered pattern or a sharklet pattern. The micro-pattern may be on a micrometer length scale. The prosthetic valve may include one or more distal anchors configured to extend around one or more leaflets of the native valve to secure the prosthetic valve to the native valve. The prosthetic valve may be configured to be deployed into a mitral valve or a tricuspid valve.

[0024] Embodiments disclosed herein may include a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic leaflets and a micropattern applied to at least a portion of the prosthetic valve.

[0025] Implementations of the embodiments may include one or more of the following: The method may include deploying a prosthetic valve into the mitral or tricuspid valve.

[0026] Embodiments disclosed herein may include a method that may include altering a surface roughness of at least a portion of a prosthetic valve, the prosthetic valve including one or more prosthetic valve leaflets and configured to be deployed into a native valve.

[0027] Implementations of the embodiments may include one or more of the following: Coupling at least one of the one or more prosthetic valve leaflets to the frame configured to support the one or more prosthetic valve leaflets within the native valve. Varying the surface roughness may include applying a micropattern to at least one of the one or more prosthetic valve leaflets. Applying the micropattern may include laser milling the micropattern to at least one of the one or more prosthetic valve leaflets. Varying the surface roughness may include smoothing a surface of at least one of the one or more prosthetic valve leaflets. At least a portion of the prosthetic valve may include a textile and varying the surface roughness may include applying a micropattern to the textile. The prosthetic valve may include a sealing skirt and varying the surface roughness may include applying a micropattern to the sealing skirt. At least a portion of the prosthetic valve may include a textile and varying the surface roughness may include smoothing a surface of the textile.

[0028] The embodiments disclosed herein may include a device that may include a prosthetic valve configured to be deployed to a native valve of the body, the prosthetic valve including one or more prosthetic valve leaflets, and including one or more microbeads for releasing a substance into the body.

[0029] Implementations of the embodiments may include one or more of the following: The prosthetic valve may include a sealing body configured to contact a portion of the annulus of the native valve, and the one or more microbeads are positioned on the sealing body. The prosthetic valve may include a fabric, and the one or more microbeads are coupled to the fabric. The prosthetic valve may include a frame and a skirt portion coupled to the frame, and the one or more microbeads are coupled to the skirt portion. The skirt portion may include a sealing skirt portion. The prosthetic valve may include one or more anchors, and the one or more microbeads are positioned on the one or more anchors. The one or more anchors may include one or more distal anchors configured to hook around leaflets of the native valve. The one or more microbeads may be positioned on one or more leaflets of the prosthetic valve. The prosthetic valve may be configured to be deployed in an aortic valve of the body. The prosthetic valve may be configured to be deployed in a mitral or tricuspid valve of the body. The substance may include a drug. The drug may include an anti-thrombotic drug. The drug may be configured to reduce formation of a blood clot on at least one of the leaflets of the one or more prosthetic valves. The one or more microbeads may be for releasing a substance into a bloodstream in the body. The one or more microbeads may be configured to diffuse for releasing a substance into the body.

[0030] Embodiments disclosed herein may include a method that may include deploying a prosthetic valve into a native valve of a body, the prosthetic valve including one or more prosthetic valve leaflets and including one or more microbeads for releasing a substance into the body.

[0031] Implementations of the embodiments may include one or more of the following: The method may include deploying a prosthetic valve into the mitral or tricuspid valve.

[0032]

[0005] Embodiments disclosed herein may include a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include a support ring configured to extend around an annulus of the native valve. The prosthetic valve may include one or more prosthetic leaflets coupled to the support ring. The prosthetic valve may include one or more anchors configured to secure the support ring to the native valve.

[0033] Implementations of the embodiments may include one or more of the following: The support ring may be flexible. The support ring may be configured to expand from a non-deployed configuration to a deployed configuration. The support ring may include a first end portion and a second end portion configured to slide relative to the first end portion to allow the support ring to move. The second end portion may be configured to slide relative to the first end portion to change a size of a diameter of the support ring. A spring may be configured to bias the first end portion against the second end portion. The second end portion may be configured to automatically slide relative to the first end portion in response to a change in diameter of the annulus. Each of the one or more prosthetic valve leaflets may include a first end portion coupled to the support ring and a second end portion extending distally from the first end portion. The first end portion may be coupled to a sheath configured to extend over at least a portion of the support ring. The second end portion may be configured to extend from the first end portion in a direction toward the ventricle. The one or more prosthetic valve leaflets may include at least two prosthetic valve leaflets circumferentially spaced apart from one another. Each of the leaflets of the one or more prosthetic valves may be configured to contact and overlap at least a portion of a leaflet of the native valve. Each of the one or more anchors may be configured to penetrate tissue. Each of the one or more anchors may include a screw. The prosthetic valve may be configured to be deployed in a mitral valve or a tricuspid valve.

[0034] Embodiments disclosed herein may include a method that may include deploying a prosthetic valve to a native valve. The prosthetic valve may include a support ring configured to extend around an annulus of the native valve, one or more prosthetic leaflets coupled to the support ring, and one or more anchors configured to secure the support ring to the native valve.

[0035] Implementations of the embodiments may include one or more of the following: The method may include deploying a prosthetic valve into the mitral or tricuspid valve.

[0036] Any of the features of the embodiments disclosed herein are applicable to all other aspects and embodiments identified herein. Furthermore, any feature of an embodiment of the various embodiments may be independently combinable, partially or fully, with other embodiments described herein, for example, one, two, or more embodiments may be combinable in whole or in part. Furthermore, any feature of an embodiment may be optional with respect to other aspects or embodiments. Any embodiment of the method may be performed by a system or device of another embodiment, and any embodiment of the system or device may be configured to perform the method of another embodiment. [Brief description of the drawings]

[0037] The features and advantages of the systems, apparatus, and methods disclosed herein will become better understood and appreciated with reference to the specification, claims, and accompanying drawings.

[0038] [Figure 1] FIG. 1 shows a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 shows a side perspective view of the prosthetic valve shown in FIG. [Diagram 3] FIG. 3 shows a bottom perspective view of the prosthetic valve shown in FIG. [Figure 4] FIG. 4 shows a side view of the inner frame of the prosthetic valve shown in FIG. [Diagram 5] FIG. 5 shows a cross-sectional schematic diagram of the artificial valve shown in FIG. [Figure 6] FIG. 6 shows the pattern of a portion of the outer frame of the prosthetic valve. [Figure 7] FIG. 7 shows a close up view of the revolute joint of the outer frame shown in FIG. [Figure 8] FIG. 8 shows a schematic top view of the outer and inner frames shown in FIG. [Figure 9] FIG. 9 shows a schematic diagram of a delivery device passing through a portion of a patient's body according to an embodiment of the present disclosure. [Figure 10]FIG. 10 shows a schematic side view of the prosthetic implant in position to be deployed into the native valve. [Figure 11] FIG. 11 shows a schematic side view of a prosthetic implant being deployed in a native valve. [Figure 12] FIG. 12 shows a schematic diagram of a prosthetic implant deployed within a native mitral valve. [Figure 13] FIG. 13 shows a schematic top view of the outer frame shown in FIG. 8 displaced from the position shown in FIG. [Figure 14] FIG. 14 shows the pattern of a portion of the outer frame of the prosthetic valve. [Figure 15] FIG. 15 shows a schematic top view of the outer and inner frames shown in FIG. [Figure 16A] 16A and 16B show a t-bracket. [Figure 16B] Same as above. [Figure 17A] 17A and 17B show the hinge. [Figure 17B] Same as above. [Figure 18A] 18A and 18B show a ball and socket joint. [Figure 18B] Same as above. [Figure 19] FIG. 19 shows the overmold. [Figure 20] FIG. 20 shows a top schematic view of an outer frame coupled to an inner frame. [Figure 21] FIG. 21 shows a schematic top view of the outer frame shown in FIG. [Figure 22] FIG. 22 shows a schematic top view of the inner frame shown in FIG. [Figure 23] FIG. 23 shows a side view of the outer frame shown in FIG. 21 being joined to the inner frame shown in FIG. [Figure 24] FIG. 24 shows a pattern for a valve frame according to an embodiment of the present disclosure. [Diagram 25] FIG. 25 shows a side cross-sectional view of the elongated struts deflected away from the inner frame relative to the pattern shown in FIG. [Figure 26] FIG. 26 shows the valve frame pattern shown in FIG. 24 with the elongated struts biased away from the inner frame. [Figure 27] FIG. 27 shows a schematic top view of the valve frame shown in FIG. [Figure 28] FIG. 28 shows a schematic top view of the valve frame shown in FIG. 27 with the skirt positioned on the elongated posts. [Figure 29] FIG. 29 shows a cross-sectional view of a portion of the seal body. [Diagram 30] FIG. 30 illustrates a valve frame pattern according to an embodiment of the present disclosure. [Diagram 31] FIG. 31 illustrates an embodiment of the leaflets of a prosthetic valve. [Figure 32A] FIG. 32A shows a side view of a micropattern for application to the leaflets of a prosthetic valve or another portion of a prosthetic valve. [Figure 32B] FIG. 32B shows a perspective view of the micropattern of FIG. 32A applied to the leaflets of a prosthetic valve. [Figure 33A] FIG. 33A shows a side view of a micropattern for application to the leaflets of a prosthetic valve or another portion of a prosthetic valve. [Figure 33B] FIG. 33B shows a perspective view of the micropattern of FIG. 33A applied to the leaflets of a prosthetic valve. [Diagram 34] FIG. 34 shows a diagram of a micropattern for application to the leaflets of a prosthetic valve or another portion of a prosthetic valve. [Diagram 35] FIG. 35 shows a diagram of a micropattern for application to the leaflets of a prosthetic valve or another portion of a prosthetic valve. [Diagram 36] FIG. 36 shows a diagram of a micropattern for application to the leaflets of a prosthetic valve or another portion of a prosthetic valve. [Figure 37] FIG. 37 shows a diagram of a micropattern for application to the leaflets of a prosthetic valve or another portion of a prosthetic valve. [Figure 38] FIG. 38 shows a side cross-sectional view of a portion of a sealing skirt including one or more microbeads. [Figure 39]FIG. 39 shows an assembly diagram of the prosthetic valve anchor. [Diagram 40] FIG. 40 shows a cross-sectional view of the anchor shown in FIG. [Diagram 41] FIG. 41 shows a perspective view of a prosthetic valve configured to be deployed in an aortic valve. [Diagram 42] FIG. 42 shows a top view of the prosthetic valve shown in FIG. 41 with the prosthetic leaflets in a closed position. [Diagram 43] FIG. 43 illustrates a top view of the prosthetic valve shown in FIG. 41 with the prosthetic leaflets in an open position. [Diagram 44] FIG. 44 shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. [Diagram 45] FIG. 45 shows a perspective view of the prosthetic valve. [Figure 46] FIG. 46 shows a side cross-sectional view of a portion of the prosthetic valve taken along line 46-46 shown in FIG. [Figure 47] FIG. 47 shows a diagram of the leaflets of a flattened prosthetic valve. [Figure 48] FIG. 48 shows a diagram of three leaflets of a flattened prosthetic valve. [Figure 49] FIG. 49 shows a diagram of a flattened single prosthetic valve leaflet. [Figure 50] FIG. 50 shows a detailed view of an end portion of the support ring. [Figure 51] FIG. 51 shows a top view of the support ring. [Figure 52] FIG. 52 shows a top view of the support ring shown in FIG. 51 having various diameters. [Figure 53] FIG. 53 shows a side schematic view of a delivery device approaching an implantation site. [Figure 54] FIG. 54 shows a side schematic view of a prosthetic implant being deployed in a native valve.

[0039] [Figure 55] FIG. 55 shows a schematic side view of a prosthetic implant deployed in a native valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] 1 shows a perspective view of a prosthetic valve 10 in the form of a replacement heart valve. The prosthetic valve 10 may be configured to be deployed within a portion of a patient's body. The prosthetic valve 10 may be deployed, for example, in the annulus of a native valve, which may include a native mitral valve or a native tricuspid valve. In embodiments, other implantation locations may be utilized, such as within the aortic valve or pulmonary valve, or in other valves or locations within the patient's body, as desired.

[0041] The prosthetic valve 10 may include a proximal end 12 and a distal end 14 (marked in FIG. 3 ), as well as a length therebetween. The prosthetic valve 10 may further include one or more prosthetic leaflets 16, or a plurality of prosthetic leaflets 16, configured to enclose a flow channel for controlling flow through the valve 10. The prosthetic leaflets 16 may be configured to move between open and closed states to mimic and replace the behavior of the leaflets of a native valve.

[0042] FIG. 2 shows a side view of the prosthetic valve 10, and FIG.

[0043] In an embodiment, the leaflets 16 of the prosthetic valve may be coupled to a frame. The frame may include a valve frame or inner frame 18 as shown in FIG. 4, or an outer frame 20 as shown in FIG. 6, which may be part of the sealing body 11 and may be spaced apart from the inner frame 18. FIG. 4 shows a side view of the inner frame 18 separated from other components of the prosthetic valve 10. With reference to FIG. 4, the inner frame 18 may include a proximal portion including a proximal end 19 and a distal portion including a distal end 21. The inner frame 18 may have a curved configuration including a curved body that curves radially outward between the proximal end 19 and the distal end 21, or may have another configuration in an embodiment as desired. The inner frame 18 may have a circular shape in an embodiment, for example, as depicted in a top view in FIG. 8.

[0044] The inner frame 18 may include a number of struts 23 spaced apart from one another by spaces 15. With such a configuration, the inner frame 18 is movable between a deployed or expanded configuration, a non-deployed configuration, a non-expanded configuration, or a straightened configuration. For example, the inner frame 18 may expand radially outward to move to the deployed or expanded configuration, where the length of the inner frame 18 decreases with an increase in the diameter of the inner frame 18. Other configurations of the inner frame 18 may be utilized as desired.

[0045] The prosthetic valve 10 may include one or more anchors 17, which may be coupled to the prosthetic valve leaflets 16 and each may be configured to anchor to a portion of the patient's heart. The anchors 17 may be specifically configured to anchor to the leaflets of a native valve of the patient's heart. The anchors 17 may extend around the leaflets of the native valve to anchor to the leaflets of the native valve. The anchors 17 may comprise distal anchors positioned at the distal end 14 of the valve 10, or in embodiments may be positioned at another location, as desired.

[0046] Each anchor 17 may be configured as a protruding arm configured to extend distally and then curve proximally relative to the tip of the respective anchor of anchor 17. Such a configuration may allow anchor 17 to extend around the native leaflet and around the distal end of the leaflet, hooking the native leaflet and positioned radially outward from the outward facing surface of the native valve leaflet. Thus, anchor 17 may resist forces applied in an atrial or proximal direction against valve 10 and secure valve 10 within the annulus of the native valve. Other configurations of anchor 17 may be utilized in embodiments as desired.

[0047] Anchor 17 is shown in FIGS. 1-5 in a deployed or expanded configuration with a tip of anchor 17 extending proximally. In embodiments, anchor 17 may be configured to be in an undeployed, unexpanded, or straightened configuration with a tip of anchor 17 extending distally. Such a configuration is shown, for example, in FIG. 10. Anchor 17 may be configured to move from an undeployed configuration to a radially outward deployed configuration upon deployment with the tip everted proximally. Such movement may enable anchor 17 to evert the leaflets of the native valve during deployment to secure to the leaflets of the native valve. Such a configuration is shown, for example, in FIG. 11. Other deployment methods for anchor 17 may be utilized in embodiments, as desired.

[0048] 5 shows a cross-sectional view of the prosthetic valve 10. A proximal portion of the inner frame 18 may be coupled to a proximal portion of a plurality of prosthetic valve leaflets 16. The inner frame 18 may support the prosthetic valve leaflets 16. The prosthetic valve leaflets 16 may be coupled to the inner frame 18 and may extend radially inward from the inner frame 18. The prosthetic valve leaflets 16 may be coupled to the valve frame 18 via a mid-body 28 that may support the prosthetic valve leaflets 16, and the leaflets 16 may be coupled to the inner frame 18 via sutures or another method, as desired.

[0049] The leaflets 16 of the prosthetic valve may surround a flow channel 25, marked in FIG. 5, and may move between an open and a closed state to control flow through the flow channel 25. As shown in FIG. 5, the proximal end of the prosthetic valve 10 may comprise the inflow end of the valve 10 and the distal end of the prosthetic valve 10 may comprise the outflow end, although other configurations may be utilized as desired. The leaflets 16 of the prosthetic valve may be positioned about a central axis 61 of the prosthetic valve 10. The inner frame 18 and the outer frame 20 may each surround the central axis 61 of the prosthetic valve 10.

[0050] The anchors 17 may each extend radially outward from the flow channel 25 and from the leaflets 16 of the prosthetic valve of the valve 10. Figure 5 shows, for example, that the anchors 17 may be coupled to a distal portion of the inner frame 18. The anchors 17 may each include a proximal portion 27 and a distal portion 29, where the proximal portion 27 is coupled to the inner frame 18 and the distal portion 29 includes a tip of the respective anchor 17. The anchors 17 may extend vertically from the proximal portion 27 to the tip of the distal portion 29 when the valve 10 is deployed.

[0051] In embodiments, the prosthetic valve 10 may include a proximal anchor 45 that may be utilized to secure the prosthetic valve within the native valve. Such an anchor 45 is shown in Figures 1-5 and may be coupled to a proximal portion of the inner valve frame 18, or may be in another location, as desired.

[0052] 1, the prosthetic valve 10 may include a sealing body 11. The sealing body 11 may be positioned radially outward from the leaflets 16 of the prosthetic valve and may include an outer surface of the valve 10. The sealing body 11 may define an outer diameter of the valve 10 and may include an outer periphery of the valve 10. The sealing body 11 may include a proximal portion having a proximal end 31 and may include a distal portion having a distal end 33 (marked in FIGS. 3 and 5).

[0053] 5, the seal body 11 may include a frame 20 (also marked in FIG. 6) and a seal skirt 24 (also marked in FIGS. 1-3), or in embodiments may include only a frame or only a seal skirt, as desired. The frame 20 may comprise an outer frame positioned radially outward from the inner frame 18. The seal skirt 24 may be coupled to the outer frame 20 and may comprise an outer portion of the seal body 11, as shown in FIG.

[0054] The outer frame 20 includes at least a portion of the seal body 11 configured to apply a seal to a portion of the heart. The outer frame 20 may have a proximal portion 35 that couples to the proximal end 19 of the inner frame 18. The proximal portion 35 may extend radially outward from the proximal end 19 of the inner frame 18 and from the leaflets 16 of the prosthetic valve. A distal portion 37 of the outer frame 20 may be spaced apart from the leaflets 16 of the prosthetic valve and the inner frame 18 with a gap 39. The gap 39 may be positioned between the outer frame 20 of the seal body 11 and a distal portion of the inner frame 18. Thus, the inner frame 18 may comprise an inner frame, and the frame 20 of the seal body 11 may comprise an outer frame positioned radially outward from the inner frame 18 and surrounding the inner frame 18 and the leaflets 16 of the prosthetic valve.

[0055] 5, the outer frame 20 may have a length that extends a short distance distal to the distal end of the inner frame 18. As such, the outer frame 20 may be shorter than the inner frame 18. The outer frame 20 may further have a curved configuration that curves outward from the inner frame 18, with the largest diameter of the outer frame 20 being at a distal portion of the outer frame 20.

[0056] The outer frame 20 of the seal body 11 may include a number of struts 49 (as marked in FIG. 6) that form the frame 20, with spaces 51 between the struts. Such a configuration utilized in the frame 20 allows the frame 20 to be moved between a deployed or expanded configuration, a non-deployed configuration, a non-expanded configuration, or a straightened configuration, as shown in FIG. 1, with the outer frame 20 and seal body 11 having a curved bulbous shape. Similar to the valve frame 18, the length of the outer frame 20 of the seal body 11 may decrease during deployment as the diameter of the outer frame 20 of the seal body 11 increases. The diameter of the outer frame 20 of the seal body 11 may expand radially outward from the inner valve frame 18 simultaneously, or at a different expansion time or rate than the inner valve frame 18 in embodiments.

[0057] The seal body 11 may include a seal skirt 24 (as shown in FIG. 1 ) that may extend around the inner valve frame 18 and the prosthetic valve leaflets 16. The skirt 24 may be coupled to the seal body frame 20 or may be free from the frame 20 in embodiments.

[0058] The sealing skirt 24 may have a proximal portion 41 (marked in FIG. 5) that may be coupled to a proximal portion of the frame 20 of the sealing body 11, and may be coupled to a proximal portion of the inner frame 18. The skirt 24 may have a distal portion 43 (marked in FIG. 5) that may be coupled to a distal end of the frame 20, and may be coupled to one or more of the inner valve frame 18 or anchors 17 in embodiments. As shown in FIG. 5, the anchors 17 may be configured to extend radially outward from the inner valve frame 18, with gaps 39 between them, to the tips of the respective anchors 17.

[0059] The sealing skirt 24 may be made of a material that will withstand the flow of fluid therethrough, such as a cloth material, a woven material, or other material such as a polymer, or other material that will withstand the flow of fluid therethrough. The material may include a woven material. A variety of materials may be utilized for the skirt 24, as desired.

[0060] The sealing body 11 may be configured to abut a portion of the patient's heart to reduce fluid flow. The skirt portion 24 may be configured to seal against a portion of the annulus of the native valve. For example, the sealing body 11 may abut a surface of a leaflet of the patient's native valve to reduce fluid flow between the sealing body 11 and the native leaflet. The sealing body 11 may be configured to abut other portions of the patient's heart to reduce fluid flow, as desired.

[0061] Figure 6 shows a diagram of the construction of the outer frame 20. While the construction is shown as a flat pattern, the pattern shown in Figure 6 would be wrapped around the inner frame 18 to form a bulbous shape in an embodiment. Additionally, only a portion of the outer frame 20 is shown, the pattern and use of revolute joints 53 may be repeated as much as desired.

[0062] The proximal portion 35 of the outer frame 20 may include posts 47 configured to couple to corresponding posts 38 of the inner frame 18, as marked in Fig. 4. Both posts may include, for example, through holes that allow the outer frame 20 to be coupled to the inner frame 18. Thus, the outer frame 20 may be coupled to the proximal end 19 of the inner frame 18 to maintain an outward biasing force by the outer frame 20. The distal end of the outer frame 20 may remain uncoupled to the inner frame 18.

[0063] The posts 49 of the outer frame 20 may form one or more post cells that enclose spaces 51 between the posts 49. For example, posts 52a-d form a post cell that encloses an interior space 51a. The cells may be positioned adjacent to one another as shown in FIG.

[0064] The cells may form rows of the outer frame 20 extending from a proximal portion 35 of the outer frame 20 to a distal portion 37 of the outer frame 20. The rows may include rows of adjacent strut cells, for example, as shown in FIG.

[0065] Adjacent strut cells or struts 49 may include, for example, adjacent portions of the outer frame 20. The portions may each include at least one strut cell in an embodiment.

[0066] In an embodiment, portions of the outer frame 20 may be coupled together with one or more revolute joints 53, as shown in FIG. 6. The revolute joints 53 couple the portions together and allow the portions to rotate relative to one another. FIG. 6 illustrates the revolute joints 53, for example, as seams that couple adjacent portions of the outer frame 20 together. The revolute joints 53 may be coupled to strut cells formed by struts 54a-d and couple adjacent strut cells together, such as strut cells formed by adjacent struts 52a-d. For example, the strut cell formed by struts 52a-d may comprise a first portion of the outer frame 20, and the strut cell formed by struts 54a-d may comprise a second portion of the outer frame 20, for example. The strut cell formed by struts 52a-d and the strut cell formed by struts 54a-d each comprise adjacent columns of the outer frame 20. In an embodiment, other portions of the outer frame 20 may be coupled together with one or more revolute joints 53.

[0067] 7 shows a close-up view of one of the rotational joints 53 connecting adjacent struts 52c, 52d, 54a, and 54b to one another. Struts 52c, 52d may be non-integral with struts 54a, 54b and may be connected together via sutures forming suture joints between adjacent struts. Adjacent strut cells formed by struts 52a-d and by struts 54a-d may thus be connected to one another and configured to rotate relative to one another. The sutures may be made of a stiff or elastic material in embodiments.

[0068] The suture joints may include knots, which may be knots of various configurations. The knots may include a scissor tie knot, shown in FIG. 7. For example, a scissor tie knot may include a horizontal wrap 55 of suture material and one or more vertical wraps 57 that wrap over the horizontal wrap and between adjacent struts 52c, 52d and 54a, 54b. The horizontal wrap 55 may allow adjacent portions to rotate, and the vertical wraps 57 may allow for balanced compression. Thus, a scissor tie knot may allow the struts to rotate relative to one another, further reducing the possibility of slippage between adjacent struts. The number of wraps may vary depending on the degree of rotation desired and the controlled compression required. Other configurations of scissor tie knots, or other knots, may be utilized in embodiments, as desired.

[0069] The rotational joints 53 may couple portions of the outer frame 20 together at various circumferentially spaced portions of the outer frame 20. For example, FIG. 8 shows a top schematic view of the outer frame 20 extending around the inner frame 18 and spaced from the inner frame 18 by a gap 39, as shown in FIG. 5. Other features of the prosthetic valve 10 are excluded from the view of FIG. 8. The rotational joints 53 are represented as nodes positioned between adjacent portions 59 of the outer frame 20 and allowing the adjacent portions 59 to rotate relative to one another. The portions 59 may include, for example, strut cells or struts as shown in FIG. 6, or another portion of the outer frame 20. In an embodiment, the sealing skirt 24 may be coupled to the outer frame 20, as shown, for example, in FIG. 1, to seal with a portion of the native heart annulus.

[0070] The revolute joints 53 may be evenly spaced from one another, or various spacings may be provided, as desired. Twelve revolute joints 53 are shown in FIG. 8, although in embodiments, a greater or lesser number may be utilized, as desired. The revolute joints 53 may be configured to rotate the portion 59 in a plane extending transversely to a central axis 61 of the prosthetic valve 10 that the inner frame 18 and the outer frame 20 surround. As such, the portion 59 may rotate radially inward or outward relative to the central axis 61 and relative to the inner frame 18. However, in embodiments, the revolute joints 53 may be configured to permit rotation toward or away from a proximal or distal portion of the outer frame 20.

[0071] The rotation joint 53 may rotate the portion 59 of the outer frame 20 to improve the conformity of the outer frame 20 to the shape of the native valve annulus. The outer frame 20 may be configured to conform to the shape of the native valve annulus. The native valve annulus may not have a perfect circular shape, but may have other shapes, such as other circular shapes, and oval shapes, such as oval or elliptical shapes, which may include recesses. Calcification points may further change the shape of the native valve annulus. The rotation joint 53 may improve the ability of the portion 59 to rotate to conform to the natural shape, rather than presenting a rigid circular shape to the native annulus.

[0072] Figure 9, for example, illustrates an exemplary method of deploying the prosthetic valve 10. With reference to Figure 9, a delivery device 60 can be passed percutaneously into the patient's body in a minimally invasive manner. In other embodiments, more invasive means may be utilized, as desired.

[0073] The delivery device 60 may be utilized for transcatheter delivery of the valve. The delivery device 60 may be passed transvenously through a femoral artery 62 or another portion of the patient's vasculature. For example, a transjugular access or other access method may be utilized, as desired. The delivery device 60 may be passed to the patient's heart 64.

[0074] The delivery device 60 may be used to deliver the valve to the tricuspid valve, and thus may be positioned within the right atrium 66 of the patient's heart for delivery to the tricuspid valve. In embodiments where delivery is to the mitral valve, the delivery device 60 may be passed transseptally into the left atrium 68, allowing delivery to the mitral valve. The delivery device 60 may be advanced toward the left ventricle 70 of the patient's heart for delivery to the mitral valve.

[0075] The prosthetic valve 10 may then be deployed with the capsule of the delivery device 60 retracted relative to the prosthetic valve 10. Figure 10 shows the prosthetic valve 10 positioned in position, for example, within the capsule 54 of the delivery device 60, for deployment to the native valve within the native valve annulus 56. The anchors 17 may be in position to extend around the distal tips of the leaflets 58 to secure the prosthetic valve 10 within the native valve annulus 56.

[0076] FIG. 11 shows capsule 54 housed relative to prosthetic valve 10 to allow anchors 17 to extend radially outward from capsule 54 and around the distal tips of the leaflets of the native heart valve.

[0077] FIG. 12 shows the valve frame 18 deployed in the annulus of the native valve, with other portions of the prosthetic valve 10 removed from the view for clarity.

[0078] A native valve annulus 56, such as a native mitral valve annulus, may not have a perfect circular shape. The shape may include an oval shape or other shape that may include a recess. Figure 13, for example, shows a top schematic view of a prosthetic valve 10 deployed on a native valve annulus 56 that does not have a perfect circular shape. A portion 74 of the native valve annulus 56 may have an oval shape and a portion 76 may include a recess.

[0079] Thus, portions 59 of outer frame 20 can be rotated relative to one another upon deployment in response to the shape of the native valve annulus. Frame 20 can be made to conform to the shape of the native valve annulus.

[0080] The rotation joint 53 may allow the portions 59 of the outer frame 20 to rotate relative to each other to match (fully or partially) the shape of the native valve annulus 56. The portions 59 may rotate relative to each other to change the shape of the outer surface of the frame 20 and the prosthetic valve 10. Each portion 59 may be deflected radially inward or outward relative to the inner frame 18. Various portions of the outer frame 20 may rotate inward or outward, one portion may rotate inward and another portion may rotate outward. The inner frame 18 may retain its shape during the rotation of the portions 59 of the outer frame 20. For example, the inner frame 18 may retain a circular shape. The rotation of the portions 59 of the outer frame 20 may further allow the sealing skirt 24 (marked in FIG. 1 ) to have various shapes that match (fully or partially) the shape of the native valve annulus 56. Thus, the sealing of the prosthetic valve 10 to the native valve annulus 56 may be improved.

[0081] Rotation may continue during the cardiac cycle, thus allowing outer frame 20 to more accurately conform to the annular anatomy throughout the cardiac cycle.

[0082] A proximal portion of the outer frame 20 may remain coupled to the proximal end of the valve frame 18 to maintain an outward biasing force by the outer frame 20 against the annulus of the native valve.

[0083] Various other configurations of outer frame 20 and revolute joints may be utilized. Figure 14, for example, illustrates an embodiment in which each joint point of the struts 78 includes a revolute joint 53. Thus, increased rotation and flexibility of the outer frame 80 may result. Figure 15, for example, illustrates a top schematic view showing an increased number of revolute joints 53 connecting portions 82 of the outer frame 80 together.

[0084] 16A and 16B show an embodiment of a rotational joint that includes a t-bracket 84. The t-bracket 84 joins adjacent portions 86 of the outer frame and allows the portions 86 to rotate relative to one another. A central support 88 of the t-bracket 84 may reduce the possibility of misalignment between the portions 86.

[0085] A rotational joint, such as a t-bracket, may support the frame 20 during procedural loading of the delivery system into the delivery device, during deployment, and, if necessary, during recapture. The t-bracket may reduce the degree of freedom to prevent inward rotation of the rotational joint. Such unidirectional rotation may ensure that the outer frame 20 behaves as desired, generating radially outward forces for sealing the annulus, localized flexibility, and reduced inter-strut slippage during loading into and deployment from the delivery system. Any of the embodiments of the rotational joint disclosed herein may include unidirectional rotation, or a single degree of freedom, as desired.

[0086] 17A and 17B show an embodiment of a revolute joint that includes a hinge 90. The hinge 90 may join adjacent portions 92 of an outer frame and allow the portions 92 to rotate relative to one another. The hinge 90 may be formed to only allow movement in a single plane.

[0087] 18A and 18B show an embodiment of a rotational joint that includes a ball and socket joint 94. The ball and socket joint 94 connects adjacent portions 96 of an outer frame and allows the portions 96 to rotate relative to one another. Multiple degrees of freedom may be provided with the ball and socket joint 94, including rotation radially inward and outward, and deflection toward or away from the prosthetic valve prosthesis proximal or distal ends.

[0088] 19 illustrates an embodiment of a revolute joint that includes an overmold 98. The overmold 98 may include a tube of material (such as shrink tubing or other material) that may be positioned to wrap around and bond adjacent portions 100, 102 of the outer frame to allow the portions 100, 102 to rotate relative to one another. The overmold 98 may include a plastic and / or silicone material or another form of material. The portions 100, 102 may include the struts of the outer frame as shown in FIG.

[0089] A combination of types of revolute joints may be utilized in an embodiment, or a single type of revolute joint may be utilized, as desired. Thus, in embodiments, the revolute joint may include one or more of a suture joint, a t-bracket, a ball and socket joint, an overmolded, or a hinge, or other form of revolute joint. Any of the revolute joint embodiments disclosed herein may include a single direction of rotation, or a single degree of freedom, as desired. In embodiments, other flex points may be utilized to increase the degrees of freedom, as desired.

[0090] The embodiments of Figures 1-19 may beneficially allow for improved conformance of the prosthetic valve embodiment to the native valve, among other advantages. As a result, the likelihood of paravalvular leakage (PVL) may be reduced. Various modifications of the embodiments may be provided, including substitutions or additions of features across the various embodiments disclosed herein. The embodiments of Figures 1-19 may be utilized alone or in combination with features of other embodiments disclosed herein.

[0091] 20 shows a top schematic view of an embodiment of a prosthetic valve 104 including an outer frame 106 having a crescent shape with two ends 108, 109 circumferentially spaced apart from one another. The prosthetic valve 104 may include an inner frame 110 that supports one or more prosthetic valve leaflets and is surrounded by at least a portion of the outer frame 106 and coupled to each of the two ends 108, 109 of the outer frame 106.

[0092] The inner frame 110 may have a circular shape, as shown in FIG. 20 (and in FIG. 22, the inner frame 110 is shown separate from the outer frame 106). The inner frame 110 may surround a center 112 of the inner frame 110, which may be positioned within a flow channel of the inner frame 110. The inner frame 110 may be configured similarly to the inner frame 18 shown and discussed with respect to FIGS. 1-5 and may be coupled to the leaflets of the prosthetic valve, for example, including distal anchors (as shown in FIG. 1) for securing the prosthetic valve 104 to the native valve. For example, the distal anchors may be configured to extend around one or more leaflets of the native valve to secure the prosthetic valve to the native valve. Features of the prosthetic valve 104 are omitted from the illustration for clarity in FIG. 20.

[0093] The outer frame 106 may have a diameter larger than that of the inner frame 110, and may have a crescent shape, such as a "C" shape or other form of crescent shape, and may form the outer frame periphery of the prosthetic valve 104. The outer frame 106 may include a portion of a sealing body that extends around a portion of the inner frame 110, similar to the outer frame 20 shown in FIGS. 1-5. However, the outer frame 106 may extend around a portion of the inner frame 110. Ends 108, 109 of the outer frame 106 may be coupled to the inner frame 110, such that a portion 114 of the inner frame 110 between the two ends 108, 109 is exposed by the outer frame 106, and thus the portion 114 forms the outermost frame surface of the prosthetic valve 104 in that location. The sealing skirt 116 may be coupled to and extend around portions 114 of the outer frame 106 and inner frame 110 between ends 108, 109 to form an outer surface of the prosthetic valve 104 similar to the sealing skirt 24 shown in Figures 1-5.

[0094] 20, the center 118 of the outer frame 106 may be offset from the center 112 of the inner frame 110. The frames 106, 110 may be non-concentric with respect to one another.

[0095] FIG. 21 shows a top schematic view of the outer frame 106 separated from the inner frame 110. The space 120 between the ends 108, 109 of the outer frame 106 is shown. The outer frame 106 may have a circular shape, which may include a portion of a circle as shown in FIG. 21, or other shapes, such as an oval. The shape of the outer frame 106 may be configured such that when the outer frame 106 is joined to the inner frame 110, a "D" shape may be formed by the outer frame 106 and the inner frame 110 together due to the various radii of the outer frame 106 and the inner frame 110. FIG. 22, for example, shows the inner frame 110 separate from the outer frame 106.

[0096] A "D" shape, or other shape that does not include a circle, formed by the combination of the outer frame 106 and the inner frame 110 may improve positioning of the prosthetic valve 104 within the annulus of the native valve. For example, the native valve annulus itself may have a "D" shape, and the resulting outer shape of the prosthetic valve 104 may have a similar "D" shape that may conform to the shape of the native valve annulus. The "D" shape may better conform to the "D" shape of the native valve annulus than a circular shape of the prosthetic valve 104. Additionally, upon deployment of the prosthetic valve 104 into the native valve, the outer frame 106 may have an outer surface that may be configured to move in response to the shape of the annulus to conform to the shape of the native valve annulus.

[0097] In a configuration resulting in a "D" shape, the flattened portion (corresponding to portion 114 of inner frame 110) may be positioned at each flattened portion of the native valve annulus having a "D" shape. Such a portion may include an anterior portion of the native valve annulus. The curved portion of the "D" shape may be positioned at a posterior portion of the native valve annulus. Other configurations may be utilized based on the configuration of the native valve annulus.

[0098] The ends 108, 109 of the outer frame 106 may be coupled to the inner frame 110 in a variety of ways, for example, via connectors between the outer frame 106 and the inner frame 110. In embodiments, the connectors may include other forms of connectors disclosed herein, including the use of revolute joints. For example, FIG. 23 illustrates a side view of a portion of a prosthetic valve showing the ends 108, 109 of the outer frame 106 coupled to the inner frame 110 via connectors 122. The connectors 122 may include sutures, and may include knots, such as a scissor tie knot in embodiments. Other forms of connectors may be utilized in embodiments.

[0099] In embodiments, the proximal portions of the outer frame 106 and inner frame 110 may be coupled to one another in a manner similar to the proximal portions of the outer frame 20 and inner frame 18 discussed with respect to Figures 1-6.

[0100] The percentage of the inner frame 110 that is not covered by the outer frame 106 may vary in embodiments. For example, in embodiments, at least 10% of the circumference of the inner frame may not be covered by the outer frame 106, as well as at least 20%, or at least 30%, or at least 40%, or another percentage as desired. In embodiments, less than 10% of the circumference of the inner frame may not be covered by the outer frame 106, as well as less than 20%, or less than 30%, or less than 40%, or another percentage as desired. The percentage may be set based on the desired shape of the prosthetic valve to be created.

[0101] In embodiments, both the outer frame 106 and the inner frame 110 may be independently varied in size to modify the shape of the resulting prosthetic valve. For example, the shape and size of the resulting "D" shape may be varied as desired. If the native valve has a larger rounded posterior portion, a larger outer frame 106 may be utilized. If the native valve has a larger flattened anterior portion, a larger inner frame 110 may be utilized. Other shapes may be utilized based on the shape of the annulus.

[0102] In embodiments, other configurations of the outer frame and inner frame may be utilized in combination. For example, in embodiments, the outer frame may completely surround the inner frame 110 and thus include a sealing body having an "O" shape or another form of circular or ovoid shape rather than the "C" shape shown in FIG. 21. However, the inner frame 110 may be connected to a portion of the inner surface of the outer frame in an offset manner, for example, as shown in FIG. 20. Thus, the inner frame 110 may have a smaller diameter than such an outer frame and may be positioned offset within the outer frame. The center 112 of the inner frame 110 may be offset from the center of the outer frame. In such a configuration, the outer surface of the outer frame may include the outermost frame surface of such a valve and may be covered with a sealing skirt for forming a seal with the annulus of the native valve.

[0103] The embodiments of Figures 20-23 may beneficially allow for improved conformance of the prosthetic valve embodiments to the native valve, among other advantages. As a result, the likelihood of paravalvular leakage and outflow tract obstruction may be reduced. Various modifications of the embodiments may be provided, including substitutions or additions of features across the various embodiments disclosed herein. The embodiments of Figures 20-23 may be utilized alone or in combination with features of other embodiments disclosed herein.

[0104] 24 illustrates a pattern of frame 124 that may be utilized in a prosthetic valve. The frame 124 may include a plurality of struts 126 that are joined with spaces 128 between the struts 126. The struts 126 may be joined at joints 130 that exist between the struts 126.

[0105] The pattern of posts 126, spaces 128, and joints 130 may result from the formation of frame 124. Frame 124 may be formed from a single piece of material and cut from such material to form the configuration of posts 126, spaces 128, and joints 130. The single piece of material may have a cylindrical shape in an embodiment, resulting in a cylindrical frame 124 after cutting (although frame 124 is shown as a flat pattern in FIG. 24 ).

[0106] The elongated struts 134 may be made to extend distally from joints 132. During the formation process, joints 132 may exist between the struts 126 and the elongated struts 134 may extend distally from such joints 132. Thus, the proximal portions 133 of the elongated struts 134 may be integrally formed with the joints 132. The elongated struts 134 may extend longitudinally in a distal direction to the distal ends 136 of the elongated struts 134. Cuts 138 may exist between the distal portions 131 of the elongated struts 134 and adjacent struts 126 such that the distal portions 131 of the elongated struts 134 are cut at these points. Thus, the distal portions 131 may not be integral with the adjacent struts 126 and may be deflected away from the adjacent struts 126 at the cuts 138. Thus, proximal portions 133 of elongate struts 134 may be integral with joints 132 , and distal portions 131 of elongate struts 134 may be cut away and non-integral with the remainder of frame 124 .

[0107] With the distal portion 131 of the elongated strut 134 deflectable from the remainder of the frame 124, in the forming step the distal portion 131 may be deflected away from the remainder of the frame 124. FIG. 25, for example, shows that the distal end 131 of the elongated strut 134 is deflected outwardly from the remainder of the frame 124 to form an outer extension portion 142 and a vertical extension portion 144 that terminate at the distal end 136 of the elongated strut 134. The proximal portion 133 of the elongated strut remains integral with the joint 132.

[0108] With the elongate struts 134 in such a configuration, the elongate struts 134 may form an outer frame 146 that extends around the remainder of the frame 124, which may include an inner frame 148. The inner frame 148 may thus be coupled to one or more, or multiple, leaflets of a prosthetic valve and may support such leaflets in a manner similar to the inner frame 18 discussed with respect to Figures 1-5.

[0109] The method of forming at least a portion of the prosthetic valve may include deflecting a distal portion 131 of each of a plurality of elongated struts 134 of the seal body away from an inner frame 148 for supporting one or more prosthetic valve leaflets or a plurality of prosthetic valve leaflets. A proximal portion 133 of each of the plurality of elongated struts 134 may be integrally formed with the inner frame 148. The inner frame 148 and the plurality of elongated struts 134 may be formed from a single piece of material.

[0110] FIG. 26 illustrates the inner frame 148 with the elongated struts 134 removed from view. With the distal portion 131 of the elongated struts 134 removed from the inner frame 148, a gap may exist. Such a gap may be formed between adjacent struts of the inner frame 148. Such a gap may be closed with a connector 150, such as a suture connector as disclosed herein, which may be configured as a knot, such as a scissor knot. In embodiments, other forms of connectors may be utilized at the joints disclosed herein, including one or more of a suture joint, a t-bracket, a ball and socket joint, an overmolding, or a hinge, or other forms of connector. A rotational joint as disclosed herein may be utilized to rotate a first portion of the inner frame 148 relative to a second portion of the inner frame 148 in the manner discussed with respect to the embodiment of FIGS. 1-19. In embodiments, the inner frame 148 may be biased to fill any remaining gaps after the distal portions 131 of the elongate struts 134 are deflected from the inner frame 148 .

[0111] The distal anchor 140 may be shaped to curve proximally, as shown in Fig. 25. The distal anchor 140 may extend from a distal end of the inner frame 148 and may be configured to extend around one or more leaflets of the native valve to secure the prosthetic valve to the native valve.

[0112] The inner frame 148 and the outer frame 146 may be formed, for example, in a round bulbous shape as shown in FIG. 1. The elongated struts 134 may extend radially outward from the inner frame 148, as depicted in the top schematic view of FIG. 27. The elongated struts 134 may be positioned evenly from one another or at various intervals as desired. In embodiments, various numbers of elongated struts 134 may be utilized. FIG. 28 illustrates that a sealing skirt 151 may be provided positioned over the multiple elongated struts 134 when the elongated struts 134 are deflected from the inner frame 148. The sealing skirt 151 may form a sealing body that surrounds at least a portion of the inner frame 148 and is configured to seal against a portion of the annulus of the native valve. The sealing body may contact a portion of the annulus of the native valve.

[0113] The seal body may include an outer frame 146 having a skirt portion 151 and a plurality of elongated struts 134. Each of the plurality of elongated struts 134 may have a proximal portion 133 that is integral with the inner frame 148 and a distal portion 131 that is spaced apart from the inner frame 148. One or more prosthetic valve leaflets may be coupled to the inner frame 148.

[0114] The resulting prosthetic valve may have an appearance similar to the prosthetic valve 10 shown in FIG 1, and further the prosthetic valve configuration may include elongated struts 134 integral with an inner frame 148. An outer frame 146 may surround the inner frame 148 and may be utilized to seal with the annulus of the native valve. The resulting prosthetic valve may be deployed in a manner similar to the prosthetic valve 10 shown in FIG 1.

[0115] Referring to Figure 29, a cross-sectional view of a portion of the sealing body is shown. In an embodiment, compressible material 152a,b may be positioned between the outer frame 146 and the sealing skirt 151. The compressible material 152a,b may include one or more layers of compressible material or other forms of compressible material as desired. Figure 29 illustrates the use of layers of compressible material, with the sealing skirt 151 forming the outermost surface of the prosthetic valve and the outer frame 146 (including the elongated struts 134) positioned inside the compressible material 152a,b.

[0116] In embodiments, the compressible material 152a,b may include foam or another form of compressible material 152a,b, which may function to compress to improve sealing against the native valve annulus when a force is applied by the native valve annulus against the sealing skirt 151.

[0117] FIG. 30 shows an alternative configuration of the frame shown in FIG. 24 in which the elongated struts 154 are equally spaced and staggered in predetermined positions with distal anchors 156 .

[0118] The embodiments of Figures 24-30 may beneficially provide for improved construction of prosthetic valves in which the inner and outer frames are formed from a single frame pattern. Such a configuration may reduce the complexity of manufacturing a prosthetic valve having an inner frame mechanically joined to an outer frame. Various modifications of the embodiments may be provided, including substitutions or additions of features across the various embodiments disclosed herein. The embodiments of Figures 24-30 may be utilized alone or in combination with features of other embodiments disclosed herein.

[0119] In embodiments herein, the surface roughness of at least a portion of the prosthetic valve may be varied. The prosthetic valve may be configured similarly to the embodiments of the prosthetic valve disclosed herein, may include one or more prosthetic leaflets, and may be configured to be deployed into a native valve. Other configurations of the prosthetic valve may be utilized as desired. The surface roughness of one or more of the prosthetic leaflets 160 may be varied, or the surface roughness of other portions of the prosthetic valve, such as the fabric, anchors, sealing body, or sealing skirt, among other portions, may be varied. For example, the sealing body 11 shown in FIG. 1, including the sealing skirt 24, may have a varied surface roughness. One or more of the anchors 17 may have a varied surface roughness, as desired, including the fabric applied to one or more of the anchors 17. Other portions may have a varied surface roughness.

[0120] In embodiments herein, one or more micropatterns may be applied to a portion of the prosthetic valve to modify the surface roughness. The one or more micropatterns may be applied to the leaflets 160 of the prosthetic valve or another portion of the prosthetic valve, such as the fabric, the anchor, the sealing body, or the sealing skirt, among other portions.

[0121] The micropattern may be applied to the leaflets 160 of the prosthetic valve or to another portion of the prosthetic valve in a variety of ways, including laser milling and other methods of forming a micropattern. The micropattern may be applied to a surface of the leaflets 160 of the prosthetic valve or to a surface of another portion of the prosthetic valve.

[0122] The micropattern may be applied to generate a pattern on the leaflets 160 of the prosthetic valve or other portions of the prosthetic valve, or in embodiments, a similar method may be utilized to smooth the surface of the leaflets 160 of the prosthetic valve or the surface of another portion of the prosthetic valve (e.g., the fabric, anchors, sealing body, or sealing skirt).

[0123] For example, laser milling may be applied to smooth one or more surfaces (such as an inward facing surface and an outward facing surface) of the leaflets 160 of the prosthetic valve. The inward facing surface may be the surface that faces the flow channel of the prosthetic valve, and the outward facing surface may be the surface that faces away from the flow channel of the prosthetic valve. In embodiments herein, either or both surfaces may be smoothed. Smoothing, which may be via laser milling or another method, may be applied to one or more surfaces of a portion of the prosthetic valve, such as the sealing body, the sealing skirt, or the fabric, among other portions.

[0124] In embodiments, applying the micropattern may include applying a pattern to the leaflets of the prosthetic valve, or other portions of the prosthetic valve, with the pattern having a height. The micropattern may be on a micrometer length scale, according to an embodiment, or another scale, as desired. The micropattern may be applied to modify the surface roughness of at least a portion of the prosthetic valve.

[0125] 31 illustrates an embodiment of a prosthetic valve leaflet 160 that may be utilized on a prosthetic valve and may include one or more micropatterns applied to the prosthetic valve leaflet 160. For example, the prosthetic valve leaflet 160 may include multiple portions 162, 164, 166, each of which may include different or identical configurations of micropatterns applied to that portion of the prosthetic valve leaflet 160. In embodiments, the micropatterns may be applied to vary the surface roughness of the prosthetic valve leaflet 160.

[0126] FIG. 32A illustrates a micropattern 168 according to an embodiment herein, for example, having multiple peaks separated by troughs. The micropattern 168 may be applied to the leaflets of the prosthetic valve or another portion of the prosthetic valve (e.g., the fabric, anchors, sealing body, or sealing skirt). The peaks may have heights on the micrometer scale. FIG. 32B illustrates that the peaks may form channels on the surface of the leaflets 160 of the prosthetic valve or another surface of a portion of the prosthetic valve.

[0127] FIG. 33A illustrates a micropattern 170 according to an embodiment herein in which the peaks include plateau portions. The micropattern 170 may be applied to the leaflets of the prosthetic valve or another portion of the prosthetic valve (e.g., the fabric, anchors, sealing body, or sealing skirt). The plateau portions may be separated by troughs. FIG. 33B illustrates that the peaks may form channels on the surface of the leaflets 160 of the prosthetic valve or another surface of a portion of the prosthetic valve. The peaks may have heights on the micrometer scale.

[0128] A variety of patterns may be formed on the leaflets 160 of the prosthetic valve or on another portion of the prosthetic valve. FIG. 34 shows a non-uniform pattern 172 with a scattered appearance. FIG. 35 shows a sharklet pattern 174 that is uniform and may have the appearance of multiple chevrons. FIG. 36 shows a uniform checkered pattern 176. FIG. 37 shows another form of sharklet pattern 178 with the appearance of multiple chevrons. Other patterns may include hexagonal patterns for sealing and providing wet adhesion. A variety of patterns may be applied as desired.

[0129] The different configuration patterns may be applied to different portions of the prosthetic valve leaflets 160 or to other portions of the prosthetic valve, as desired. For example, the micropattern may include one or more of a checkered pattern or a sharklet pattern. The portions may be on the inward facing surface of the prosthetic valve leaflets, or on the outward facing surface, or on another surface, such as a surface that couples to the valve frame. A portion of the prosthetic valve leaflets may have a first configuration of the micropattern applied thereto, and another portion of the prosthetic valve leaflets may have a second configuration applied thereto that is different from the first configuration.

[0130] 31, an exemplary portion of a leaflet 160 of a prosthetic valve may include a portion 162 that contacts another similar portion of another leaflet during coaptation of the leaflet. The portion may include a portion 164 through which fluid (e.g., blood) flows during opening of the leaflet. The portion may include a portion 166 that may be coupled to a valve frame. Various other portions may include micropatterns.

[0131] The configuration of the applied micropattern may be selected to provide a desired performance of a portion of the leaflet 160 of the prosthetic valve. For example, the portion 162 that contacts another portion of the leaflet during coaptation may include a pattern that increases or reduces friction with another portion of the leaflet. The portion 164 through which fluid flows may include a pattern that improves fluid flow. The portion 166 that couples to the valve frame may include a pattern that improves friction and improves grip to the valve frame. The micropattern may be applied to provide results including, but not limited to, reducing the formation of thrombus on the leaflets of the prosthetic valve, improving the biocompatibility of the leaflets of the prosthetic valve with the patient's body, modifying the flow of fluid through the prosthetic valve, improving coaptation between multiple prosthetic leaflets, and improving coupling of the leaflets of the prosthetic valve to the frame. Various other results may be produced by applying the micropattern to one or more portions of the leaflets of the prosthetic valve. Such results may be utilized on the leaflets of the prosthetic valve or may be utilized on another portion of the prosthetic valve such as a sealing body, an anchor, a sealing skirt, or a fabric. For example, a surface of the sealing body, anchor, sealing skirt, or fabric, such as an exterior surface or other surface, may include a micropattern, which may include, among other results, reducing the formation of thrombus on a portion of the prosthetic valve, improving biocompatibility of a portion of the prosthetic valve with the patient's body, and altering fluid flow through the prosthetic valve.

[0132] At least one of the leaflets of one or more prosthetic valves can be coupled to a frame disclosed herein. The frame can be configured to support a plurality of prosthetic valve leaflets. At least one of the prosthetic valve leaflets can have a micropattern applied thereto. The resulting prosthetic valve can include, for example, any of the prosthetic valves disclosed herein or another form of prosthetic valve. The prosthetic valve can be deployed into a native valve.

[0133] In embodiments, the micropatterns disclosed herein may be applied to other portions of the prosthetic valve. A prosthetic valve configured to be deployed in a natural valve of the body may be provided, the prosthetic valve including one or more prosthetic valve leaflets, and including a micropattern applied to at least a portion of the prosthetic valve. For example, one or more portions of the sealing body, anchors, sealing skirt, or textile disclosed herein, among other portions of the prosthetic valve, may have a micropattern applied thereto. At least a portion of the prosthetic valve may comprise a textile disclosed herein, and the micropattern may be applied to the textile. The textile may be the textile of the sealing body or the sealing skirt, among other forms of textile. The textile may include one or more anchors (such as distal anchors or other forms of anchors) or textile on the prosthetic valve. The outer surface of such a portion may include a micropattern, among other surfaces. The outer surface 179 of the sealing body, textile, and sealing skirt, which may include a micropattern, are marked, for example, in FIG. 1. The textile of the anchor, which may include a micropattern, is shown, for example, in FIG. 39 and FIG. 40.

[0134] The micropattern that may be applied to the portion of the prosthetic valve may include any micropattern configuration, as desired. For example, a pattern may be utilized to improve friction and therefore sealing between the outer surface of the sealing skirt and the surface of the annulus. As a result, improved fixation between the native valve annulus and the sealing skirt may occur. Such a pattern may include a sharklet pattern 178, as shown in FIG. 37. For example, the sharklet pattern may create hard points that may improve adhesion between the sealing skirt and the annulus of the native valve. One or more checkerboard or sharklet patterns may be utilized. Other forms of patterns may be utilized, as desired.

[0135] The micropatterned embodiments may provide a variety of benefits. Various modifications of the embodiments may be provided, including substitutions or additions of features across the various embodiments disclosed herein. The micropatterned embodiments may be utilized alone or in combination with features of other embodiments disclosed herein.

[0136] 38-44 show embodiments in which one or more microbeads may be utilized. The microbeads may be used in prosthetic valves configured to be deployed in the body's native valves. In embodiments, the one or more microbeads may be for releasing a substance into the body.

[0137] The microbeads may each be configured to release a substance into the body by diffusion of the microbeads. For example, the microbeads may be made of or coated with a substance and configured to release the substance by gradual or slow diffusion into the body. Thus, the microbeads may gradually decrease in size as release of the substance occurs. Other methods of release by the microbeads may be utilized, as desired.

[0138] The substances that can be released by the microbeads can include various forms of substances, including, but not limited to, drugs. Drugs can include chemicals that can be released into the body in liquid form, although other forms of release can be utilized as desired. The substances that can be released by the microbeads can be configured to produce a therapeutic effect on the patient's body, although other forms of substances can be released by the microbeads as desired.

[0139] The medication may, in embodiments, include an antithrombotic drug. The antithrombotic drug may include a vitamin K antagonist, an anticoagulant (including a novel oral anticoagulant (NOAC) or a non-VKA oral anticoagulant (NOAC) or a direct acting oral anticoagulant (DOAC)), among other forms of antithrombotic drugs. In embodiments, other forms of medication may be utilized, as desired.

[0140] The agent may be released to reduce the formation of thrombus on the prosthetic leaflets or otherwise on the prosthetic valve. The agent may, for example, reduce the accumulation of thrombus on the prosthetic leaflets or otherwise on the prosthetic valve. Thus, the agent may be released in embodiments to reduce thickening of the prosthetic leaflets or to reduce thickening of other portions of the prosthetic valve.

[0141] A drug may be released near a surface for the reduction of thrombus (e.g., in the leaflets of the prosthetic valve or another portion of the prosthetic valve). Thus, one or more microbeads may be positioned near such a surface and release a drug or other substance near the surface. In embodiments, one or more microbeads may release a substance locally within the patient's body near the surface for the reduction of thrombus. One or more microbeads may diffuse into the bloodstream local to the prosthetic valve to reduce the accumulation of thrombus.

[0142] In embodiments, one or more microbeads may be positioned on a fabric or skirt of the prosthetic valve. The fabric or skirt may include a portion of the sealing body configured to contact a portion of the annulus of the native valve. For example, FIG. 38 shows a cross-sectional detail of a portion of a sealing skirt 180 that may be positioned on an outer frame 182. The sealing skirt 180 may be configured similarly to the sealing skirt 24 shown in FIG. 5, and the outer frame 182 may be configured similarly to the outer frame 20 shown in FIG. 5. The sealing skirt 180 may include a fabric or other form of material. Other portions of the prosthetic valve may include the sealing skirt 180 or fabric, or may include one or more microbeads. The microbeads may be positioned on a portion of the sealing body or other portions of the prosthetic valve that may lack a fabric or skirt. The microbeads may be positioned, for example, on the frame or other portions of the prosthetic valve. The prosthetic valve may be configured similarly to other prosthetic valves disclosed herein and may include one or more prosthetic valve leaflets or other features of the prosthetic valve disclosed herein. Other forms of prosthetic valves may be utilized, as desired.

[0143] 38, one or more microbeads may be embedded in the sealing skirt 180. For example, microbead 184a may be fully embedded in the sealing skirt 180 and within the fabric of the sealing skirt 180. As such, when fluid (e.g., blood) contacts the microbead 184a, the microbead 184a may diffuse and release substances into the patient's body that may be in close proximity to the native and prosthetic heart valve components. The microbead 184a may release substances locally to the prosthetic heart valve components to reduce the formation of blood clots on such areas.

[0144] In embodiments, the microbeads 184b may be partially embedded in the sealing skirt 180 and the fabric of the sealing skirt 180, or may be positioned on the exterior surface of the sealing skirt 180 and the fabric of the sealing skirt 180. Such microbeads 184b may be partially or completely exposed on the exterior of the sealing skirt 180. The exterior surface may include, for example, the exterior surface 179 marked in FIG.

[0145] In embodiments, the varying depths of the microbeads 184a, 184b from the exterior surface of the sealing skirt 180 may create a graded release of the substance into the patient's body. For example, the microbeads 184b at the exterior surface of the sealing skirt 180 may release or diffuse the substance more quickly than the microbeads 184a that are fully embedded in the sealing skirt 180. Thus, graded rates of release of the substance from the microbeads 184a, 184b may occur based on the size, number, and / or location of the microbeads from the exterior surface of the sealing skirt 180. The release rate may be controlled based on controlling the size, number, and / or location of the microbeads from the exterior surface of the sealing skirt 180 in embodiments.

[0146] The microbeads may be positioned at other locations relative to the prosthetic valve. The locations may include the fabric or another portion of the prosthetic valve. FIG. 39 shows an assembly view of a fabric or other material that may be positioned on the anchors of the prosthetic valve, for example. The prosthetic valve may include one or more anchors, and one or more microbeads may be positioned on the one or more anchors. The anchor may include a distal anchor in an embodiment. The distal anchor 186 may include an anchor arm 188 that may be covered by a sleeve 190, which may be covered by an end cover 192, for example.

[0147] 40 shows a side cross-sectional view of distal anchor 186, showing that sleeve 190 extends over anchor arms 188 and end cover 192 extends over sleeve 190. The resulting configuration of distal anchor 186 may have a similar appearance to anchor 17 shown in FIG 1. Distal anchor 186 may be configured to hook around the leaflets of the native valve or may have another configuration, as desired.

[0148] The sleeve 190 and end cover 192 may include a fabric that may include one or more microbeads 194, 196. The microbeads 194, 196 may be configured similarly to the microbeads 184a, b and may be positioned on the respective sleeve 190 and end cover 192. The microbeads 194, 196 may be configured to release a substance in a manner similar to the microbeads 184a, b, which may be configured to reduce the formation of blood clots or may produce another result, as desired.

[0149] The components discussed with respect to Figures 38-40 may include components of a prosthetic valve configured to be deployed in a mitral or tricuspid valve of the body. However, the use of microbeads is not limited to such prosthetic valves and may be utilized in other forms of prosthetic valves. Figures 41-43 show diagrams of a prosthetic valve 200 configured to be deployed in a corporal aortic valve, for example. The prosthetic valve 200 may include a frame 201, for example, supporting one or more prosthetic valve leaflets 203a-c and including an outer surface 205 and an inner surface 207 (marked in Figure 42). The prosthetic valve leaflets 203a-c may be positioned within a flow channel 214 (marked in Figure 43) of the prosthetic valve 200. The prosthetic valve 200 may include a skirt portion 202, which may be made of a woven fabric. The skirt portion 202 may include an outer surface of the prosthetic valve 200 and may be configured to contact a portion of the patient's body (e.g., the leaflets of a native valve and / or the annulus of a native aortic valve). In an embodiment, the inner surface of the prosthetic valve 200 may include a skirt portion 204 (marked in FIG. 44).

[0150] Figure 44 shows a cross-sectional schematic view of a prosthetic valve 200. The skirt portion 202 may include one or more microbeads 206, which may be embedded in the skirt portion 202 in a manner similar to the microbeads 184a, b discussed with respect to Figure 38. The inner skirt portion 204 may include one or more microbeads 208, which may be embedded in the skirt portion 204 in a manner similar to the microbeads 184a, b discussed with respect to Figure 38.

[0151] In an embodiment, microbeads 212 may be positioned on the prosthetic valve leaflets 203a-c. The prosthetic valve leaflets 203a-c may include microbeads 212, which may be configured similarly to the microbeads 184a,b. The microbeads 206, 208, 212 may each be configured to release a substance that may be configured to provide a therapeutic effect to the patient's body. For example, a drug may be released that may reduce the formation of blood clots or produce another result, as desired. The reduction in blood clots may be on the prosthetic valve leaflets 203a-c or on another portion of the prosthetic valve 200. The microbeads 212 on the prosthetic valve leaflets 203a-c may be configured to reduce the formation of blood clots on the prosthetic valve leaflets 203a-c. The microbeads 206, 208 may be configured to reduce the formation of blood clots on the prosthetic valve leaflets 203a-c or on another portion of the prosthetic valve 200 (e.g., the internal flow channel 214 of the prosthetic valve 200).

[0152] In embodiments, the microbeads may be positioned on a portion of the prosthetic valve that may not include a skirt or fabric. For example, a portion of the frame or another portion of the valve body may have one or more microbeads attached to it. The microbeads may be configured to release a substance in a manner similar to other microbeads disclosed herein.

[0153] Various modifications of the embodiments may be provided, including substitutions or additions of features across the various embodiments disclosed herein. One or more microbeads may be utilized alone or in combination with features of other embodiments disclosed herein.

[0154] 45-55 illustrate embodiments of prosthetic valves that may be utilized herein. With reference to FIG. 45, prosthetic valve 220 may include a support ring 222 and one or more prosthetic leaflets 224a,b, and in embodiments, may include one or more anchors 226.

[0155] The support ring 222 can be configured to extend around the annulus of the native valve. The support ring 222 can have an annular shape and can include a first end portion 228 and a second end portion 230 that can be joined together to form a closed loop for the support ring 222. In embodiments, the support ring 222 can comprise an open ring with a gap between the ends 228, 230, or can have another configuration, as desired.

[0156] FIG. 46 shows a cross-sectional view of the support ring 222 along line 46-46 of FIG. 45. The support ring 222 may include a ring body 232, which may include an inner ring body, and a sheath 234 extending over the ring body 232. The support ring 222 and the ring body 232 may have a circular cross-sectional shape, or may have another shape (e.g., rectangular, triangular, or other cross-sectional shape) as desired. The support ring 222 may be flexible and configured to form a desired shape upon deployment. For example, the support ring 222 may be configured to conform to the shape of the valve annulus upon deployment. The shape may include an oval shape or a "D" shape, among other possible shapes. The support ring 222 upon deployment may thus have a circular shape, or may have an elongated shape, such as an oval shape or other shape.

[0157] The support ring 222 may be configured to be expanded from an undeployed configuration to a deployed configuration. For example, due to the flexibility of the support ring 222, the support ring 222 and prosthetic valve 220 may be compressed to an undeployed, unexpanded, or straightened configuration and then expanded to a deployed or expanded configuration. The support ring 222 may be folded, for example, to be disposed in an undeployed, unexpanded, or straightened configuration and then expanded to form a ring shape, for example, as shown in FIG.

[0158] The ring body 232, in embodiments, may include a body made from a metal, polymer, or alloy material that may be configured to bend. The ring body 232 may include a shape memory material, such as, for example, Nitinol or another form of shape memory material. The ring body 232 may be made from a material such that upon deployment, the ring body 232 may automatically expand into a deployed configuration, such as a ring shape that may conform to the shape of the valve annulus. Other materials may be utilized in embodiments.

[0159] The sheath 234 may extend over the ring body 232 and may include a coupler to one or more prosthetic leaflets 224a, 224b. The one or more prosthetic leaflets 224a, 224b may be coupled to the support ring 222 via the sheath 234. The sheath 234 may extend over at least a portion of the support ring 222 and may extend completely or partially over the ring body 232. The sheath 234 may be integrally coupled to one or more prosthetic leaflets 224a, 224b to couple the leaflets 224a, 224b to the ring body 232. The sheath 234 may extend along the length or circumference of the ring body 232, and may extend the entire length or circumference, or only a portion of the length or circumference. In embodiments, other forms of couplers may be utilized to couple one or more prosthetic valve leaflets 224a, 224b to the ring body 232 and, accordingly, the support ring 222.

[0160] 45, one or more prosthetic valve leaflets 224a,b may each include a respective first end portion 236a,b and a second end portion 238a,b extending distally from a first end portion 236a,b. The first end portion 236a,b may be coupled to the support ring 222, and the second end portion 238a,b may extend distally from the first end portion 236a,b. The first end portion 236a,b may be coupled to the ring body 232, in embodiments via a sheath 234, and the second end portion 238a,b may comprise a free end of the leaflet 224a configured to move inward and outward to mimic the behavior of the leaflets of a native valve. The second end portion 238a,b may not be coupled to other portions of the prosthetic valve 220, and other structures of the prosthetic valve 220 may not surround or constrain the second end portion 238a,b. As such, the second end portions 238 a,b may be configured to contact the leaflets of the native valve and may move with the leaflets of the native valve upon deployment. The first end portions 236 a,b may comprise supported ends of the leaflets of the prosthetic valve, and the second end portions 238 a,b may comprise unsupported ends of the leaflets of the prosthetic valve.

[0161] The leaflets of the prosthetic valve may extend distally from the support ring 222 to form a cylindrical curtain structure, as shown in FIG 45. The first end portions 236a,b may have a cylindrical shape that may match the shape of the support ring 222. The cylindrical curtain structure may extend distally from the support ring 222. The second end portions 238a,b may be configured to move toward and away from each other during opening and closing of the prosthetic leaflets of the prosthetic valve 220.

[0162] 47 shows a view of the leaflets 224a,b of a flattened prosthetic valve. The leaflets 224a,b may extend from a respective first end portion 236a,b to a respective second end portion 238a,b and may have a rectangular shape when flattened or another shape as desired. A central portion 240a,b of each prosthetic leaflet 224a,b may be positioned between the respective first end portion 236a,b and the respective second end portion 238a,b and may be coapted during opening and closing of the prosthetic leaflets 224a,b. The prosthetic leaflets 224a,b may include a gap 242 positioned circumferentially between adjacent edges 244a and 246a and may include a gap between adjacent edges 244b, 246b. In embodiments, one or more of the gaps may be omitted.

[0163] In embodiments, a greater or lesser number of prosthetic leaflets may be utilized. In embodiments, at least two prosthetic leaflets may be utilized. The prosthetic leaflets may be circumferentially spaced apart from one another. FIG. 48 illustrates, for example, a flattened configuration in which three prosthetic leaflets 248a, b, c may be utilized. Such a configuration may be utilized, for example, in an embodiment in which the prosthetic valve is deployed in a tricuspid valve. FIG. 49 illustrates a flattened configuration in which a single prosthetic leaflet 250 may be utilized. The prosthetic leaflets 250 may have ends that may meet or overlap, or in embodiments, may comprise a single body extending from the support ring 222.

[0164] In an embodiment, the first end portion 228 and the second end portion 230 of the support ring 222 may be configured to move relative to one another. For example, referring to FIG. 50, the first end portion 228 may be configured to insert into the second end portion 230, which may slide relative to the first end portion 228. The second end portion 230 may slide relative to the first end portion 228, moving the support ring 222. The movement of the second end portion 230 relative to the first end portion 228 may be either into and towards the first end portion 228 or out and away from the first end portion 228. With such movement, the size and shape of the support ring 222 may be changeable. For example, referring to FIG. 51, when deployed, the support ring 222 may have a diameter 252. The second end portion 230 may slide relative to the first end portion 228 to change the size of the diameter 252 of the support ring 222. As the first end portion 228 moves into and toward the second end portion 230, the diameter 252 may decrease to a diameter 252′ shown in FIG. 52. Thus, by moving the first end portion 228 relative to the second end portion 230, the size of the support ring 222 may be altered.

[0165] 50, in an embodiment, a spring 254 may be provided to bias the first end portion 228 against the second end portion 230. The spring 254 may be biased to draw the first end portion 228 into and toward the second end portion 230. As such, the spring 254 may be configured to reduce the size of the support ring 222, which may be configured to reduce the size of the annulus to which the support ring 222 is coupled. In an embodiment, the spring 254 may be biased to move the first end portion 228 away from the second end portion 230. As such, in an embodiment, the spring 254 may promote expansion of the support ring 222 upon deployment, which may be overcome by the size of the annulus decreasing due to the cardiac cycle or by another reduction in the size of the annulus.

[0166] In an embodiment, the support ring 222 may be configured to change size to accommodate movement of the annulus during the cardiac cycle. In an embodiment, the second end portion 230 may be configured to automatically slide relative to the first end portion 228 in response to changes in the diameter of the annulus. The support ring 222 may be configured to change size to allow the support ring 222 to reduce in size along with the annulus. For example, the size of the annulus may decrease as a result of a therapeutic benefit provided by the prosthetic valve 220 or as a result of a reduction in the size of the annulus produced by other effects. The annulus may decrease in size, for example, as stress on the native valve is reduced and / or stress causing dilation in the ventricle or atrium is reduced. The support ring 222 may decrease in size along with the annulus. In an embodiment, the support ring 222 may increase in size if further dilation of the annulus occurs as a result of disease or other causes of dilation of the annulus.

[0167] 45, in embodiments, one or more anchors 226 may be provided. The anchors 226 may be configured to secure the support ring 222 to the native valve. The anchors may have a variety of configurations and may include penetrating bodies such as screws, hooks, barbs, clamps, or fasteners, among other forms of anchors. The anchors 226 may each be configured to penetrate tissue. The anchors 226 may be coupled to the support ring 222, for example, through a sheath 234 and coupled to the ring body 232. Other configurations of anchors may be utilized in embodiments, as desired.

[0168] 53-55 show an exemplary deployment sequence of the prosthetic valve 220. FIG. 53 shows the prosthetic valve 220 in an undeployed configuration, which may be positioned, for example, within a delivery system 260. The delivery system 260 may include an implant retention area, for example, in the form of a capsule 262 that retains the prosthetic valve 220. The prosthetic valve 220, and in particular the support ring 222, may be in a compressed configuration, which may include an elongated configuration in which the support ring 222 has a reduced thickness and increased length from the deployed configuration, as shown, for example, in FIG. 51. The support ring 222 may be elongated and may be folded in the undeployed configuration. The support ring 222 may have an elongated shape with sides of the support ring 222 drawn together in a compressed state.

[0169] 54 shows the prosthetic valve 220 deployed from the capsule 262. The support ring 222 may deploy and expand outwardly upon release from the capsule 262. Such expansion may occur automatically in embodiments or the support ring 222 may be expanded via an expansion device or another expansion method. The support ring 222 may expand to conform to the shape of the valve annulus as desired.

[0170] The second end portions 238a,b of the prosthetic valve leaflets 224a,b can be configured to extend from the first end portions 236a,b in a direction toward the ventricle.

[0171] The leaflets 224 a, b of the prosthetic valve may contact and overlap at least a portion of the leaflets of the native valve. Thus, the leaflets 224 a, b of the prosthetic valve may be configured to move with the opening and closing movement of the leaflets of the native valve. In embodiments, the leaflets 224 a, b of the prosthetic valve may open and close independently of the leaflets of the native valve.

[0172] The anchor 226 is shown in Figure 54 not yet inserted into tissue of the patient's body. The deployment device 264 of the delivery system 260 can engage the anchor 226 and may be utilized to drive the anchor 226 into tissue to secure the anchor 226 in place.

[0173] FIG. 55, for example, shows anchors 226 inserted in place to secure the support ring 222 to the native valve.

[0174] Various other methods of deployment of the prosthetic valve 220 may be utilized, as desired.

[0175] The prosthetic valve 220 may comprise a valve having a single support (e.g., support ring 222) for the leaflets of the prosthetic valve, and in embodiments may be frameless. The lack of a frame may reduce the complexity of the prosthetic valve 220 and reduce the overall material that may be deployed within the patient's body upon delivery of the prosthetic valve 220. Thus, the prosthetic valve 220 in embodiments may include a frameless prosthetic valve 220. In embodiments, the prosthetic valve 220 may be limited to the components disclosed herein and may be devoid of additional components. In embodiments, additional components may be utilized, as desired.

[0176] Various modifications of the embodiments may be provided, including substitutions or additions of features across the various embodiments disclosed herein. The embodiments of Figures 45-55 may be utilized alone or in combination with features of other embodiments disclosed herein.

[0177] The prosthetic valve embodiments, as disclosed herein, may be utilized in the mitral valve, or in other deployment locations, such as the native tricuspid valve, aortic or pulmonary valve deployment, or other implantation sites may be utilized.

[0178] Various modifications of the embodiments disclosed herein may be provided. Features of the embodiments may be modified, substituted, excluded, or combined across embodiments as desired. Combinations of features across embodiments may be provided as desired. Combinations of features may be provided across embodiments to the exclusion of other features of such embodiments, if desired.

[0179] Various embodiments of the sealing skirt disclosed herein may have a variety of configurations, including a cloth skirt, a foam skirt, or a braided skirt, as desired. Various materials may be utilized, as desired.

[0180] The implants disclosed herein may include, among others, prosthetic heart valves, or other forms of implants such as stents or filters, or diagnostic devices. The implants may be expandable implants configured to move from a compressed or undeployed state to an expanded or deployed state. The implants may be compressible implants having a reduced outer profile and configured to be compressed inwardly to move the implant to the compressed or undeployed state.

[0181] Various forms of delivery devices may be utilized in the embodiments disclosed herein. The delivery devices disclosed herein may be utilized for the replacement and repair of aortic, mitral, tricuspid, and pulmonary valves as well. The delivery devices may include, among others, delivery devices for the delivery of stents or filters, or other forms of implants, such as diagnostic devices.

[0182] The implants and systems disclosed herein may be used for transcatheter mitral or tricuspid valve implantation, as well as aortic valve implantation (TAVI) or replacement of other native heart valves (e.g., pulmonary valves). The delivery devices and systems disclosed herein may be utilized for transarterial access, including transfemoral access, to a patient's heart. The delivery devices and systems may be utilized for transcatheter percutaneous procedures, including transarterial procedures, which may be transfemoral or transjugular. Transradicular procedures may also be utilized, among others. Other procedures may be utilized, as desired.

[0183] Additionally, the methods herein are not limited to those specifically described, but may include methods utilizing the systems and devices disclosed herein. Method steps may be modified, removed, or added using the systems, devices, and methods disclosed herein. The embodiments disclosed herein may, in embodiments, include systems for implantation within the human body.

[0184] In summary, although aspects of the present specification are highlighted by reference to specific embodiments, it will be understood that those skilled in the art will readily recognize that these disclosed embodiments are merely illustrative of the principles of the subject matter disclosed herein. Thus, the disclosed subject matter is in no way limited to the specific methodology, protocols, and / or reagents, etc. described herein. Thus, various modifications or variations of the subject matter disclosed herein, or alternative configurations, can be made in accordance with the teachings herein without departing from the spirit of the present specification. Finally, the terms used herein are intended to describe only specific embodiments, and are not intended to limit the scope of the systems, devices, and methods disclosed herein, which are defined solely by the claims. Thus, the systems, devices, and methods are not limited to exactly as shown and described.

[0185] Certain embodiments of the systems, devices, and methods are described herein, including the best mode known to the inventors for carrying them out. Of course, variations of these described embodiments will become apparent to those of ordinary skill in the art upon reading the above description. The inventors expect those of ordinary skill in the art to adopt such variations as appropriate, and the inventors intend for the systems, devices, and methods to be practiced in ways other than as specifically described herein. Accordingly, the systems, devices, and methods include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described embodiments in all possible variations thereof is encompassed by the systems, devices, and methods, unless otherwise indicated herein or clearly contradicted by context.

[0186] Groupings of alternative embodiments, elements, or steps of systems, devices, and methods are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification will be deemed to contain the group as modified and thus fulfill the recitation of all Markush groups used in the appended claims.

[0187] Unless otherwise indicated, all numbers expressing features, items, quantities, parameters, characteristics, terms, etc. used in the specification and claims are to be understood in all instances as being modified by the term "about." As used herein, the term "about" means that the feature, item, quantity, parameter, characteristic, or term so modified encompasses approximations that may vary and is still capable of performing the desired operation or process discussed herein.

[0188] The terms "a," "an," "the," and similar references used in the context of describing systems, devices, and methods (particularly in the context of the claims below) shall be construed as covering both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. All methods described herein may be performed in any suitable order, unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended merely to further clarify the systems, devices, and methods, and does not otherwise limit the scope of the claimed systems, devices, and methods. No language in this specification should be construed as indicating any non-claimed element essential to the practice of the systems, devices, and methods.

[0189] All patents, patent publications, and other publications referenced and identified herein are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing the compositions and methodologies described therein that may be used in connection with, for example, the systems, apparatus, and methods. These publications are provided solely for their disclosure prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by reason of prior invention or for any other reason. All statements as to dates or representations regarding the contents of these documents are based on the information available to the applicants and do not constitute an admission as to the accuracy of the dates or contents of these documents.

Claims

1. A system for replacing the function of a defective natural heart valve, said system comprising:

1. A prosthetic heart valve comprising: an inner frame having a proximal portion and a distal portion, the inner frame surrounding a flow channel, the proximal portion comprising an inflow portion of the prosthetic heart valve and the distal portion including an outflow portion of the prosthetic heart valve; an outer frame surrounding the inner frame, the outer frame having a proximal portion connected to the proximal portion of the inner frame, the outer frame including a longitudinal hinge for allowing a first region of the outer frame to rotate relative to a second region of the outer frame, thereby enabling the outer frame to conform to a shape of the annulus of the defective native heart valve; a plurality of prosthetic leaflets disposed within the flow channel of the inner frame; An artificial heart valve comprising: a delivery catheter for delivering the prosthetic heart valve to the defective native heart valve; A system comprising:

2. The system described in claim 1, wherein the longitudinal hinge is capable of rotating the first region radially inward and radially outward relative to the second region.

3. The system described in claim 1, wherein the longitudinal hinge enables the first region to rotate relative to the second region in only one direction.

4. The system described in claim 1, wherein the first region comprises a row extending in a first axial direction of the outer frame, and the second region comprises a row extending in a second axial direction of the outer frame adjacent to the row extending in the first axial direction.

5. The system described in claim 4, wherein the row extending in the first axial direction includes a first support cell of the outer frame, the row extending in the second axial direction includes a second support cell of the outer frame, and the longitudinal hinge connects a first support of the first support cell to a second support of the second support cell that is not integral with the first support.

6. The system of claim 1, wherein a gap is provided between a distal portion of the outer frame and the inner frame.

7. The system of claim 1, wherein the artificial heart valve includes one or more distal anchors configured to hook onto one or more natural cusps of the defective native heart valve to secure the artificial heart valve to the defective native heart valve.

8. The system of claim 1, further comprising a micropattern applied to at least a portion of the artificial heart valve.

9. The system described in claim 1, wherein the artificial heart valve is an artificial mitral valve or an artificial tricuspid valve.

10. A prosthetic heart valve for replacing the function of a defective natural heart valve, said prosthetic heart valve comprising: an inner frame having a proximal portion and a distal portion, the inner frame surrounding a flow channel, a central axis of the prosthetic heart valve extending through the flow channel, the proximal portion comprising an inflow portion of the prosthetic heart valve, and the distal portion comprising an outflow portion of the prosthetic heart valve; an outer frame having a proximal portion and a distal portion and surrounding the inner frame, the proximal portion of the outer frame being coupled to the proximal portion of the inner frame, the outer frame including a first portion and a second portion and at least one rotational joint coupling the first portion to the second portion to rotate the first portion relative to the second portion in a plane extending transversely to the central axis, thereby allowing the outer frame to conform to a shape of the annulus of the defective native heart valve; a plurality of prosthetic leaflets disposed within the flow channel and supported by the inner frame; 1. An artificial heart valve comprising:

11. The prosthetic heart valve of claim 10, wherein the at least one rotary joint comprises one or more of a suture joint, a T-bracket, a ball and socket joint, an overmold, or a hinge.

12. The prosthetic heart valve of claim 11, wherein the suture joints include scissor tie knots.

13. The artificial heart valve of claim 10, wherein the at least one rotary joint is capable of rotating the first portion radially inward and radially outward relative to the second portion.

14. The prosthetic heart valve of claim 10, wherein the at least one revolute joint allows the first portion to rotate relative to the second portion in only one direction.

15. The prosthetic heart valve of claim 10, wherein the first portion comprises a first axially extending row of the outer frame including a first strut cell, the second portion comprises a second axially extending row of the outer frame including a second strut cell adjacent the first strut cell, and the at least one rotary joint connects a first strut of the first strut cell to a second strut of the second strut cell that is not integral with the first strut.

16. The artificial heart valve of claim 10, comprising one or more distal anchors configured to hook onto one or more natural cusps of the defective native heart valve to secure the artificial heart valve to the defective native heart valve.

17. A prosthetic heart valve for replacing the function of a defective natural heart valve, said prosthetic heart valve comprising: a tubular metal frame surrounding the flow channel; a plurality of prosthetic valve leaflets disposed within the flow channel; Equipped with The prosthetic heart valve includes a wall of the frame having a plurality of longitudinal hinges such that at least a first region of the frame is rotatable relative to a second region of the frame.

18. The artificial heart valve of claim 17, wherein the frame is made from a shape memory material.

19. The prosthetic heart valve of claim 17, wherein the frame is made of stainless steel.

20. The prosthetic heart valve of claim 17, wherein the frame is sized to be suitable for replacement of a native mitral or tricuspid valve.

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