Artificial 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 Feb. 10, 2021, the entire content of which is incorporated herein by reference.

[0002] Certain embodiments disclosed herein generally relate to implants, including artificial valves for transplantation.

Background Art

[0003] The human heart valves include the aortic valve, pulmonary valve, mitral valve, and tricuspid valve, and essentially function as one - way valves that operate in synchronization with the heart that pumps blood. By this valve, blood flows downstream, but the upstream flow of blood is blocked. Diseased heart valves exhibit disorders such as stenosis or regurgitation of the valve that inhibit the valve's blood flow control ability. Such disorders can reduce the heart's blood pumping efficiency and lead to debilitating and life - threatening conditions. For example, if there is valve insufficiency, it can lead to conditions such as heart hypertrophy and ventricular dilation. Therefore, extensive efforts have been made to develop methods and devices for repairing or replacing diseased heart valves.

[0004] Artificial organs exist to correct problems associated with diseased heart valves. For example, mechanical and tissue - based artificial heart valves can be used to replace diseased natural heart valves. More recently, considerable effort has been spent 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, and even percutaneous procedures. Such replacement valves often include a tissue - based valve body connected to an expandable frame and then delivered to the valve annulus of the natural valve.

[0005] These replacement valves are typically "one-way valves," allowing blood to flow in only one direction. However, problems arise if blood leaks around the outside of the prosthesis. Paravalvular leakage (PVL), for example, in relation to replacement heart valves, has demonstrated to be particularly problematic. An additional challenge concerns the ability of such prostheses to be fixed to intraluminal tissues, such as tissues within any body cavity or cavity, in a non-traumatic manner. [Overview of the project]

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

[0007] The embodiments may further include improvements to the structure of the prosthetic valve, including the configuration of components of the prosthetic valve, which may include the leaflets of the prosthetic valve.

[0008] Embodiments disclosed herein may include artificial valves configured to unfold into natural valves. An artificial valve may include one or more artificial valve leaflets. An artificial valve may include a frame coupled to one or more artificial valve leaflets, comprising a first part and a second part, and at least one rotational joint that connects the first part to the second part and makes the first part rotatable relative to the second part.

[0009] Implementation examples of the embodiment may include one or more of the following: At least one rotational joint may include one or more of a suture joint, a t-bracket, a ball and socket joint, an overmolde, or a hinge. A suture joint may include a scissor knot. The frame may comprise an outer frame spaced apart from an inner frame, the inner frame configured to support the leaflets of one or more artificial valves, and the outer frame configured to conform to the shape of the annulus of a natural valve. The outer frame may enclose the inner frame. The outer frame may have a bulbous shape. The inner frame may have a circular shape. A skirt portion 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 the proximal portion of the inner frame, and the outer frame is spaced apart from the inner frame by a gap. The first portion may include at least one support cell, and the second portion may include at least one support cell. The first portion may include a row of frames, and the second portion may include adjacent rows of frames. The frame may enclose the central axis of the prosthetic valve, and the first portion is configured to rotate relative to the second portion in a plane extending laterally with respect to the central axis. The first portion may be configured to rotate relative to the second portion in order to change the shape of the outer surface of the frame. One or more distal anchors may be configured to extend around one or more leaflets of the natural valve in order to secure the prosthetic valve to the natural valve. The prosthetic valve may be configured to deploy in a mitral valve or a tricuspid valve.

[0010] Embodiments disclosed herein may include a method for deploying an artificial valve into a natural valve, wherein the artificial valve includes one or more leaflets of the artificial valve, a frame coupled to the leaflets of the one or more artificial valves and comprising a first part and a second part, and at least one rotational joint that connects the first part to the second part and makes the first part rotatable relative to the second part.

[0011] Implementation examples of the embodiments may include one or more of the following: The method may include making a first part rotatable relative to a second part in response to the shape of the annulus of a natural valve. The method may include making a frame adaptable to the shape of the annulus of a natural valve. The method may include deploying the artificial valve onto a mitral valve or a tricuspid valve.

[0012] Embodiments disclosed herein may include prosthetic valves configured to unfold into natural valves. 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 spaced circumferentially apart from each other. The prosthetic valve may include an inner frame supporting one or more prosthetic valve leaflets, surrounded by at least a portion of the outer frame, and coupled to each of the two ends of the outer frame.

[0013] Implementation examples of the embodiment 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 the outermost frame surface of the artificial valve. A skirt portion may be coupled to the outer frame and the portion of the inner frame positioned between the two ends of the outer frame. The skirt portion may form the outer surface of the artificial valve. The center of the inner frame may be offset from the center of the outer frame. Together, the outer frame and the inner frame may form a "D" shape of the artificial valve. The outer frame may have a diameter, and the inner frame may have a diameter smaller than the diameter of the outer frame. The proximal portion of the outer frame may be coupled to the proximal portion of the inner frame. Connectors may join the two ends of the outer frame to the inner frame. At least one of the connectors may have a pivot joint. The outer frame may have a circular or oval 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 natural valve. One or more distal anchors may be configured to extend around one or more leaflets of the natural valve to secure the artificial valve to the natural valve. The artificial valve may be configured to deploy in the mitral valve or tricuspid valve.

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

[0015] Implementation examples of the embodiment may include one or more of the following: The method may include deploying the artificial valve to the mitral valve or tricuspid valve.

[0016] Embodiments disclosed herein may include an artificial valve configured to unfold into a natural valve. The artificial valve may include one or more artificial valve leaflets. The artificial valve may include an inner frame supporting one or more artificial valve leaflets. The artificial valve may include a sealing body configured to contact a portion of the annulus of a natural valve, the sealing body including an outer frame having a skirt portion and a plurality of elongated struts, each of which has a proximal portion integral with the inner frame and a distal portion spaced apart from the inner frame.

[0017] Implementation examples of the embodiment may include one or more of the following: Each of the multiple elongated struts may be formed integrally with the inner frame. Each of the multiple elongated struts may be deflected away from the inner frame. The inner frame and the multiple elongated struts may be formed from a single piece of material. The distal portion of each of the multiple elongated struts may be cut away from the inner frame. The inner frame may include multiple struts joined at joints, and the proximal portion of each of the multiple elongated struts may be 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 overmolde, 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. Space may be positioned between the multiple struts. The multiple struts may form a strut cell. Each of the multiple elongated struts may extend radially outward from the inner frame. The inner frame may include distal anchors configured to extend around one or more leaflets of the natural valve in order to secure the prosthetic valve to the natural valve. The sealing body may further include a compressible material positioned between the skirt portion and the outer frame. The compressible material may include foam. The prosthetic valve may be configured to deploy into a mitral valve or a tricuspid valve.

[0018] Embodiments disclosed herein may include a method for deploying an artificial valve onto a natural valve. The artificial valve may include one or more artificial valve leaflets, an inner frame supporting one or more artificial valve leaflets, and a sealing body configured to contact a portion of the annulus of a natural valve, wherein the sealing body includes an outer frame having a skirt portion and a plurality of elongated struts, each of which has a proximal portion integral with the inner frame and a distal portion spaced apart from the inner frame.

[0019] Implementation examples of the embodiment may include one or more of the following: The method may include deploying the artificial valve to the mitral valve or tricuspid valve.

[0020] Embodiments disclosed herein may include a method for forming at least a portion of an artificial valve configured to unfold into a natural valve. The method may include deflecting the distal portion of each of a plurality of elongated struts of a sealing body away from an inner frame for supporting the leaflets of a plurality of artificial valves, with the proximal portion of each of the plurality of elongated struts being formed integrally with the inner frame. If the plurality of elongated struts are deflected away from the inner frame, the method may include placing a skirt portion on the plurality of elongated struts.

[0021] Implementation examples of the embodiment may include one or more of the following: The method may include forming an inner frame and a plurality of elongated supports from a single piece of material. The single piece of material may have a cylindrical shape. Forming an inner frame and a plurality of elongated supports from a single piece of material may include cutting the inner frame and a plurality of elongated supports from a single piece of material. The method may include pulling the distal portion of each of the plurality of elongated supports away from adjacent supports of the inner frame. The method may include pulling the distal portion of each of the plurality of elongated supports and creating a gap between adjacent supports of the inner frame. The method may include closing the gap with a connector. The method may include connecting the leaflets of one or more artificial valves to the inner frame.

[0022] Embodiments disclosed herein may include a device configured to deploy to a natural valve of the body, wherein the artificial valve includes one or more valve leaflets and includes a micropattern applied to at least a portion of the artificial valve.

[0023] Implementation examples of the embodiment may include one or more of the following: The micropattern may be applied to at least one of the leaflets of one or more prosthetic valves. At least one of the leaflets of one or more prosthetic valves may include a first part and a second part, the first part having a first configuration of the micropattern and the second part having a second configuration of the micropattern different from the first configuration. The micropattern may be configured to reduce thrombus formation on at least one of the leaflets of one or more prosthetic valves. The micropattern may be configured to improve biocompatibility between at least one of the leaflets of one or more prosthetic valves and the patient's body. The micropattern may be configured to alter the fluid flow through the prosthetic valve. The leaflets of one or more prosthetic valves may include a plurality of prosthetic valve leaflets, and the micropattern may be configured to improve the coupling between the plurality of prosthetic valve leaflets. The prosthetic valve may include a frame configured to support at least one of the leaflets of one or more prosthetic valves within the natural valve, and the micropattern may be configured to improve the coupling of one or more prosthetic valve leaflets to at least one frame. The micropattern may be laser-ground on at least one of the leaflets of one or more prosthetic valves. At least a portion of the prosthetic valve may include a fabric, and the micropattern may be applied to the fabric. The prosthetic valve may include a sealing skirt portion, and the micropattern may be applied to the sealing skirt portion. The micropattern may include one or more of a check pattern or a sharklet pattern. The micropattern may be on a micrometer scale. The prosthetic valve may include one or more distal anchors configured to extend around one or more leaflets of the natural valve in order to secure the prosthetic valve to the natural valve. The prosthetic valve may be configured to deploy to a mitral valve or a tricuspid valve.

[0024] Embodiments disclosed herein may include a method, which may include deploying an artificial valve onto a natural valve. The artificial valve may include the leaflets of one or more artificial valves and a micropattern applied to at least a portion of the artificial valve.

[0025] Implementation examples of embodiments may include one or more of the following. The method may include deploying an artificial valve to the mitral valve or the tricuspid valve.

[0026] Embodiments disclosed herein may include a method. The method may include varying the surface roughness of at least a portion of an artificial valve, where the artificial valve includes one or more valve tips of the artificial valve and is configured to be deployed to a natural valve.

[0027] Implementation examples of embodiments may include one or more of the following. Coupling at least one of the valve tips of one or more artificial valves to a frame is configured to support the valve tips of one or more artificial valves within a natural valve. Varying the surface roughness may include applying a micropattern to at least one of the valve tips of one or more artificial valves. Applying the micropattern may include laser milling the micropattern onto at least one of the valve tips of one or more artificial valves. Varying the surface roughness may include smoothing the surface of at least one of the valve tips of one or more artificial valves. At least a portion of the artificial valve may include a fabric, and varying the surface roughness may include applying a micropattern to the fabric. The artificial valve may include a sealing skirt portion, and varying the surface roughness may include applying a micropattern to the sealing skirt portion. At least a portion of the artificial valve may include a fabric, and varying the surface roughness may include smoothing the surface of the fabric.

[0028] Embodiments disclosed herein may include a device. The device may include an artificial valve configured to be deployed to a natural valve of a body, where the artificial valve includes one or more valve tips of the artificial valve and includes one or more microbeads for releasing a substance to the body.

[0029] Implementation examples of embodiments may include one or more of the following. The artificial valve may include a sealing body configured to contact a portion of the valve annulus of the native valve, and one or more microbeads may be positioned on the sealing body. The artificial valve may include a fabric, and one or more microbeads may be coupled to the fabric. The artificial valve may include a frame and a skirt portion coupled to the frame, and one or more microbeads may be coupled to the skirt portion. The skirt portion may include a sealing skirt portion. The artificial valve may include one or more anchors, and one or more microbeads may be positioned on the one or more anchors. The one or more anchors may include one or more distal anchors configured to hook around the valve leaflets of the native valve. One or more microbeads may be positioned on the valve leaflets of one or more artificial valves. The artificial valve may be configured to be deployed in the aortic valve of the body. The artificial valve may be configured to be deployed in the mitral valve or tricuspid valve of the body. The substance may include a drug. The drug may include an antithrombotic agent. The drug may be configured to reduce the formation of thrombi on at least one of the valve leaflets of one or more artificial valves. One or more microbeads may be for releasing a substance into the bloodstream within the body. One or more microbeads may be configured to diffuse to release a substance into the body.

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

[0031] Implementation examples of embodiments may include one or more of the following. The method may include deploying the artificial valve in the mitral valve or tricuspid valve.

[0032] Embodiments disclosed herein may include an artificial valve configured to be deployed in a native valve. The artificial valve may include a support ring configured to extend around the valve annulus of the native valve. The artificial valve may include one or more valve leaflets of the one or more artificial valves coupled to the support ring. The artificial valve may include one or more anchors configured to fix the support ring to the native valve.

[0033] Implementation examples of the embodiment 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-expanded configuration to an expanded configuration. The support ring may include a first end portion and a second end portion configured to slide relative to the first end portion in order to make the support ring movable. The second end portion may be configured to slide relative to the first end portion in order to change the size of the diameter of the support ring. A spring may be configured to bias the first end portion relative to the second end portion. The second end portion may be configured to slide automatically relative to the first end portion in response to a change in the diameter of the annulus. Each of the leaflets of one or more prosthetic valves may include a first end portion coupled to a 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 one portion of the support ring. The second end portion may be configured to extend in the direction toward the ventricle from the first end portion. The leaflets of one or more prosthetic valves may include at least two prosthetic valve leaflets arranged circumferentially apart from one another. Each of the leaflets of one or more artificial valves may be configured to contact and overlap at least a portion of the leaflets of a natural valve. Each of the one or more anchors may be configured to penetrate tissue. Each of the one or more anchors may be threaded. The artificial valve may be configured to deploy into a mitral valve or a tricuspid valve.

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

[0035] Implementation examples of the embodiment may include one or more of the following: The method may include deploying the artificial valve to the mitral valve or tricuspid valve.

[0036] Any feature of the embodiments disclosed herein is applicable to all other embodiments and forms identified herein. Furthermore, any feature of any embodiment among the various embodiments may be independently combined in part or in whole with other embodiments described herein, for example, one, two, or three or more embodiments may be combined in whole or in part. Furthermore, any feature of any embodiment may be optional to other embodiments or forms. Any embodiment of a method may be carried out by a system or apparatus of another embodiment, and any embodiment of a system or apparatus may be configured to carry out a method of another embodiment. [Brief explanation of the drawing]

[0037] The features and advantages of the systems, apparatus, and methods disclosed herein will become more apparent as they are better understood by referring to this specification, the claims, and the accompanying drawings.

[0038] [Figure 1] Figure 1 shows an upper perspective view of an artificial valve according to an embodiment of the present disclosure. [Figure 2] Figure 2 shows a lateral perspective view of the artificial valve shown in Figure 1. [Figure 3] Figure 3 shows a lower perspective view of the artificial valve shown in Figure 1. [Figure 4] Figure 4 shows a side view of the inner frame of the artificial valve shown in Figure 1. [Figure 5] Figure 5 shows a schematic cross-sectional view of the artificial valve shown in Figure 1. [Figure 6] Figure 6 shows the pattern of a portion of the outer frame of the artificial valve. [Figure 7] Figure 7 shows a close-up view of the rotational joint of the outer frame shown in Figure 6. [Figure 8] Figure 8 shows schematic top views of the outer and inner frames shown in Figure 6. [Figure 9] Figure 9 shows a schematic diagram of a delivery device that passes through a portion of a patient's body according to an embodiment of this disclosure. [Figure 10]Figure 10 shows a schematic side view of an artificial implant positioned to be deployed into the natural valve. [Figure 11] Figure 11 shows a schematic side view of an artificial implant deployed in a natural valve. [Figure 12] Figure 12 shows a schematic diagram of an artificial implant deployed within the natural mitral valve. [Figure 13] Figure 13 shows a schematic top view of the outer frame shown in Figure 8, after it has been moved from its position shown in Figure 8. [Figure 14] Figure 14 shows the pattern of a portion of the outer frame of the artificial valve. [Figure 15] Figure 15 shows schematic top views of the outer and inner frames shown in Figure 14. [Figure 16A] Figures 16A and 16B show the t-bracket. [Figure 16B] Same as above. [Figure 17A] Figures 17A and 17B show the hinge. [Figure 17B] Same as above. [Figure 18A] Figures 18A and 18B show ball and socket joints. [Figure 18B] Same as above. [Figure 19] Figure 19 shows the overmolding. [Figure 20] Figure 20 shows a schematic top view of the outer frame connected to the inner frame. [Figure 21] Figure 21 shows a schematic top view of the outer frame shown in Figure 20. [Figure 22] Figure 22 shows a schematic top view of the inner frame shown in Figure 20. [Figure 23] Figure 23 shows a side view of the connection between the outer frame shown in Figure 21 and the inner frame shown in Figure 22. [Figure 24] Figure 24 shows a valve frame pattern according to an embodiment of the present disclosure. [Figure 25] Figure 25 shows a side cross-sectional view of an elongated support column deflected away from the inner frame, in relation to the pattern shown in Figure 24. [Figure 26] Figure 26 shows the valve frame pattern shown in Figure 24, with the elongated support columns deflected away from the inner frame. [Figure 27] Figure 27 shows a schematic top view of the valve frame shown in Figure 26. [Figure 28] Figure 28 shows a schematic top view of the valve frame shown in Figure 27, in which the skirt portion is positioned on a slender support column. [Figure 29] Figure 29 shows a cross-sectional view of a portion of the sealing body. [Figure 30] Figure 30 shows a valve frame pattern according to an embodiment of the present disclosure. [Figure 31] Figure 31 shows an embodiment of the valve leaflets of an artificial valve. [Figure 32A] Figure 32A shows a side view of a micropattern for application to the leaflets of an artificial valve or another part of an artificial valve. [Figure 32B] Figure 32B shows a perspective view of the micropattern from Figure 32A applied to the leaflets of an artificial valve. [Figure 33A] Figure 33A shows a side view of a micropattern for application to the leaflets of an artificial valve or another part of an artificial valve. [Figure 33B] Figure 33B shows a perspective view of the micropattern from Figure 33A applied to the leaflets of an artificial valve. [Figure 34] Figure 34 shows a diagram of a micropattern for application to the leaflets of an artificial valve or another part of an artificial valve. [Figure 35] Figure 35 shows a diagram of a micropattern for application to the leaflets of an artificial valve or another part of an artificial valve. [Figure 36] Figure 36 shows a diagram of a micropattern for application to the leaflet of an artificial valve or another part of an artificial valve. [Figure 37] Figure 37 shows a diagram of a micropattern for application to the leaflets of an artificial valve or another part of an artificial valve. [Figure 38] Figure 38 shows a side cross-sectional view of a portion of the sealing skirt containing one or more microbeads. [Figure 39]Figure 39 shows an assembly diagram of the artificial valve anchor. [Figure 40] Figure 40 shows a cross-sectional view of the anchor shown in Figure 39. [Figure 41] Figure 41 shows a perspective view of an artificial valve configured to be deployed in the aortic valve. [Figure 42] Figure 42 shows a top view of the artificial valve shown in Figure 41, with the artificial valve leaflets closed. [Figure 43] Figure 43 shows a top view of the artificial valve shown in Figure 41, with the artificial valve leaflets in the open position. [Figure 44] Figure 44 shows a schematic side cross-sectional view of the artificial valve shown in Figure 41. [Figure 45] Figure 45 shows a perspective view of the artificial valve. [Figure 46] Figure 46 shows a lateral cross-sectional view of a portion of the artificial valve along the line 46-46 shown in Figure 45. [Figure 47] Figure 47 shows diagrams of the leaflets of several flattened artificial valves. [Figure 48] Figure 48 shows diagrams of the leaflets of three flattened artificial valves. [Figure 49] Figure 49 shows a diagram of the leaflets of a flattened, single artificial valve. [Figure 50] Figure 50 shows a detailed view of the end portion of the support ring. [Figure 51] Figure 51 shows a top view of the support ring. [Figure 52] Figure 52 shows a top view of the support rings shown in Figure 51, which have various diameters. [Figure 53] Figure 53 shows a schematic side view of the delivery device approaching the transplant site. [Figure 54] Figure 54 shows a schematic side view of an artificial implant deployed in a natural valve.

[0039] [Figure 55] Figure 55 shows a schematic side view of an artificial implant deployed in a natural valve. [Modes for carrying out the invention]

[0040] Figure 1 shows a perspective view of an artificial valve 10 in the form of a replacement heart valve. The artificial valve 10 may be configured to be deployed within a portion of the patient's body. The artificial valve 10 may include a natural mitral valve or a natural tricuspid valve, for example, it may be deployed in the annulus of a natural valve. In embodiments, other implantation sites 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 artificial valve 10 may include a proximal end 12 and a distal end 14 (marked in Figure 3), as well as the length between them. The artificial valve 10 may further include one or more artificial valve leaflets 16, or a plurality of artificial valve leaflets 16, configured to surround a flow channel for controlling the flow through the valve 10. The artificial valve leaflets 16 may be configured to move between open and closed positions to mimic and replace the operation of the leaflets of a natural valve.

[0042] Figure 2 shows a side view of the artificial valve 10, and Figure 3 shows a lower perspective view of the artificial valve 10.

[0043] In embodiments, the valve leaflets 16 of the artificial valve may be coupled to a frame. The frame may include a valve frame or inner frame 18 as shown in Figure 4, or an outer frame 20 as shown in Figure 6, which may be part of the sealing body 11 and may be spaced apart from the inner frame 18. Figure 4 shows a side view of the inner frame 18 separated from the other components of the artificial valve 10. Referring to Figure 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 a different configuration in embodiments as desired. The inner frame 18 may have a circular shape in embodiments, for example, as shown in the top view of Figure 8.

[0044] The inner frame 18 may include a plurality of support columns 23 spaced apart from each other by the space 15. Such a configuration allows the inner frame 18 to move between an unfolded or extended configuration and between a non-folded, non-extended, or linear configuration. For example, the inner frame 18 may extend radially outward to move into an unfolded or extended configuration, and the length of the inner frame 18 decreases by increasing its diameter. Other configurations of the inner frame 18 may be utilized as desired.

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

[0046] Each anchor 17 may be configured as a projecting arm that extends distally and then curves proximally relative to the tip of each anchor 17. Such a configuration allows the anchor 17 to extend around the natural valve leaflets and the distal ends of the leaflets, hooking onto the natural leaflets and positioning radially outward from the outward-facing surface of the natural valve leaflets. Thus, the anchor 17 can resist forces applied to the valve 10 in an atrial or proximal direction, and can fix the valve 10 within the annulus of the natural valve. Other configurations of the anchor 17 may be utilized in the embodiment as desired.

[0047] The anchor 17 is in an unfolded or extended configuration in which the tip of the anchor 17 extends proximal, as shown in Figures 1-5. In embodiments, the anchor 17 may be configured in a non-unfolded, non-extended, or linear configuration in which the tip of the anchor 17 extends distally. Such a configuration is shown, for example, in Figure 10. The anchor 17 may be configured to move from a non-unfolded configuration to a radially outward unfolded configuration when unfolded, with the tip inverted proximal. Such movement may allow the anchor 17 to invert the leaflets of a natural valve in order to fix it to the leaflets of the natural valve during unfolding. Such a configuration is shown, for example, in Figure 11. Other unfolding methods for the anchor 17 may be utilized in embodiments as desired.

[0048] Figure 5 shows a cross-sectional view of the prosthetic valve 10. The proximal portion of the inner frame 18 can be coupled to the proximal portions of the leaflets 16 of a plurality of prosthetic valves. The inner frame 18 can support the leaflets 16 of the prosthetic valves. The leaflets 16 of the prosthetic valves can be coupled to the inner frame 18 and may extend radially inward from the inner frame 18. The leaflets 16 of the prosthetic valves can be coupled to the valve frame 18 via an intermediate body 28 that can support the leaflets 16 of the prosthetic valves, and the leaflets 16 can be coupled to the inner frame 18 via sutures or by other means, as desired.

[0049] The valve leaflets 16 of the prosthetic valve may surround a flow channel 25 marked in Figure 5 and may move between open and closed states to control the flow through the flow channel 25. As shown in Figure 5, the proximal end of the prosthetic valve 10 may be the inlet end of the valve 10, and the distal end of the prosthetic valve 10 may be the outlet end, but other configurations may be used as desired. The valve leaflets 16 of the prosthetic valve may be positioned around the 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] Each anchor 17 may extend radially outward from the flow channel 25 and radially outward from the valve leaflet 16 of the prosthetic valve of the valve 10. Figure 5 shows, for example, that an anchor 17 may be coupled to the distal portion of the inner frame 18. Each anchor 17 may include a proximal portion 27 and a distal portion 29, the proximal portion 27 being coupled to the inner frame 18 and the distal portion 29 including the tip of each anchor 17. When the valve 10 is deployed, the anchor 17 may extend vertically from the proximal portion 27 to the tip of the distal portion 29.

[0051] In embodiments, the artificial valve 10 may include a proximal anchor 45 that can be used to secure the artificial valve within the natural valve. Such an anchor 45 is shown in Figures 1-5 and may be coupled to the proximal portion of the internal valve frame 18, or may be located in another position as desired.

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

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

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

[0055] As shown in Figure 5, the outer frame 20 may have a length that extends distally to a shorter distance than the distal end of the inner frame 18. Therefore, 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, and the maximum diameter of the outer frame 20 is in the distal portion of the outer frame 20.

[0056] The outer frame 20 of the sealing body 11 may include a plurality of support columns 49 (as marked in Figure 6) that form the frame 20, with spaces 51 between the columns. Such a configuration utilized in the frame 20 allows the frame 20 to move between an unfolded, unextended, or linear configuration, as shown in Figure 1, to an unfolded or extended configuration, and the outer frame 20 and the sealing body 11 have a curved bulbous shape. Similar to the valve frame 18, the length of the outer frame 20 of the sealing body 11 may decrease during unfolding as the diameter of the outer frame 20 of the sealing body 11 increases. The diameter of the outer frame 20 of the sealing body 11 may expand radially outward from the inner valve frame 18 simultaneously, or at a different expansion time or speed than the inner valve frame 18 in the embodiment.

[0057] The sealing body 11 may include a sealing skirt portion 24 (as shown in Figure 1) that may extend around the inner valve frame 18 and the valve leaflets 16 of the artificial valve. The skirt portion 24 may be coupled to the frame 20 of the sealing body, or, in embodiments, may be detached from the frame 20.

[0058] The sealing skirt portion 24 may have a proximal portion 41 (marked in Figure 5) which is coupled to the proximal portion of the frame 20 of the sealing body 11, and may be coupled to the proximal portion of the inner frame 18. The skirt portion 24 may have a distal portion 43 (marked in Figure 5) which can be coupled to the distal end of the frame 20, and in embodiments may be coupled to one or more of the inner valve frame 18 or anchors 17. As shown in Figure 5, the anchors 17 may be configured to extend radially outward from the inner valve frame 18, across a gap 39, to the tip of each anchor 17.

[0059] The sealing skirt portion 24 may be made of a material that can withstand the flow of fluid through it, such as cloth material, woven material, or other material such as polymer, or other material that can withstand the flow of fluid through it. The material may include woven fabric. Various materials can be used for the skirt portion 24 as desired.

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

[0061] Figure 6 shows a diagram of the structure of the outer frame 20. The structure is shown as a flat pattern, but the pattern shown in Figure 6 will be wrapped around the inner frame 18 to form a bulbous shape in the embodiment. Furthermore, only a portion of the outer frame 20 is shown, and the pattern and use of the rotary joint 53 will be repeated to the desired amount.

[0062] The proximal portion 35 of the outer frame 20 may include a support 47 configured to connect to a corresponding support 38 of the inner frame 18, as marked in Figure 4. Both supports may include through holes, for example, that allow the outer frame 20 to connect to the inner frame 18. Thus, the outer frame 20 may be connected to the proximal end 19 of the inner frame 18 in order to maintain an outward biasing force by the outer frame 20. The distal end of the outer frame 20 may remain unconnected to the inner frame 18.

[0063] The columns 49 of the outer frame 20 may form one or more column cells surrounding the space 51 between the columns 49. For example, columns 52a to 52d may form a column cell surrounding the internal space 51a. The cells may be positioned adjacent to each other, as shown in Figure 6.

[0064] The cells may form a row of the outer frame 20 extending from the proximal portion 35 to the distal portion 37 of the outer frame 20. This row may include, for example, a row of adjacent support cells, as shown in Figure 6.

[0065] Adjacent support cells or support columns 49 may include, for example, adjacent portions of the outer frame 20. Each of these portions may, in an embodiment, include at least one support cell.

[0066] In the embodiment, portions of the outer frame 20 may be connected to one or more rotary joints 53, as shown in Figure 6. The rotary joints 53 connect the portions to each other and allow the portions to rotate relative to each other. Figure 6 shows, for example, a rotary joint 53 as a suture connecting adjacent portions of the outer frame 20 to each other. The rotary joints 53 may be connected to column cells formed by columns 54a to d, and may connect adjacent column cells together, such as column cells formed by adjacent columns 52a to d. For example, a column cell formed by columns 52a to d may include a first portion of the outer frame 20, and a column cell formed by columns 54a to d may include, for example, a second portion of the outer frame 20. Each of the column cells formed by columns 52a to d and the column cells formed by columns 54a to d includes an adjacent row of the outer frame 20. In the embodiment, other portions of the outer frame 20 may be connected to one or more rotary joints 53.

[0067] Figure 7 shows a close-up view of a rotational joint 53 connecting adjacent struts 52c, 52d, 54a, and 54b to each other. Struts 52c and 52d may be non-integrated with struts 54a and 54b, and may be joined together via a suture that forms a suture joint between adjacent struts. Adjacent strut cells formed by struts 52a-d and struts 54a-d may therefore be configured to be joined to each other and to rotate relative to each other. In embodiments, the suture may be made of a rigid or elastic material.

[0068] The suture joint may include knots of various forms. These knots may include a scissor knot, as shown in Figure 7. For example, a scissor knot may include a horizontal wrap 55 of the suture material and one or more vertical wraps 57 over the horizontal wrap, wrapping between adjacent supports 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, the scissor knot may allow the supports to rotate relative to each other and further reduce the possibility of slippage between adjacent supports. The number of wraps may vary depending on the desired degree of rotation and the required controlled compression. Other forms of scissor knots, or other types of knots, may be used in the embodiment as desired.

[0069] The rotary joints 53 are portions of the outer frame 20 spaced apart in various circumferential directions, and can connect portions of the outer frame 20 to one another. For example, Figure 8 shows a schematic top view of the outer frame 20 extending around the inner frame 18 and spaced apart from the inner frame 18 by a gap 39, as shown in Figure 5. Other mechanisms of the artificial valve 10 are excluded from the view in Figure 8. The rotary joints 53 are positioned between adjacent portions 59 of the outer frame 20 and are represented as nodes that allow adjacent portions 59 to rotate relative to one another. The portions 59 may include, for example, a strut cell or strut shown in Figure 6, or another portion of the outer frame 20. In embodiments, the sealing skirt portion 24 may be connected to the outer frame 20, for example, as shown in Figure 1, and seal with a portion of the annulus of a natural heart.

[0070] The rotary joints 53 may be arranged at equal intervals from one another, or various intervals may be provided as desired. Twelve rotary joints 53 are shown in Figure 8, but in embodiments, a larger or smaller number may be used as desired. The rotary joints 53 may be configured to rotate a portion 59 in a plane that extends laterally with respect to the central axis 61 of the artificial valve 10, enclosed by the inner frame 18 and the outer frame 20. Thus, the portion 59 may rotate radially inward or outward with respect to the central axis 61 and the inner frame 18. However, in embodiments, the rotary joints 53 may be configured to rotate toward or away from the proximal or distal portion of the outer frame 20.

[0071] The rotary joint 53 can rotate a portion 59 of the outer frame 20, improving the conformity of the outer frame 20 to the shape of the natural valve annulus. The outer frame 20 may be configured to conform to the shape of the natural valve annulus. The natural valve annulus may not have to be a perfect circle, for example, but may have other shapes such as other circular shapes, and oval shapes such as egg-shaped or elliptical shapes, which may include recesses. Calcification points may further alter the shape of the natural valve annulus. The rotary joint 53 may improve the rotational capability of the portion 59 to conform to the natural shape rather than presenting a rigid circular shape to the natural valve annulus.

[0072] Figure 9 shows, for example, an exemplary method for deploying the artificial valve 10. Referring to Figure 9, the 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 used as desired.

[0073] The delivery device 60 may be used for transcatheter delivery of the valve. The delivery device 60 may pass transvenously through the femoral artery 62 or another part of the patient's vascular system. For example, transjugular access or other methods of access may be used as desired. The delivery device 60 may pass through to the patient's heart 64.

[0074] The delivery device 60 may be used to deliver a valve to the tricuspid valve, and therefore 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 pass transseptally into the left atrium 68 to deliver to the mitral valve. The delivery device 60 may advance toward the left ventricle 70 of the patient's heart for delivery to the mitral valve.

[0075] Subsequently, the artificial valve 10 can be deployed with the capsule of the delivery device 60 housed within the artificial valve 10. Figure 10 shows, for example, the artificial valve 10 positioned in place within the capsule 54 of the delivery device 60 to deploy the artificial valve 10 into the natural valve within the annulus 56 of the natural valve. The anchor 17 may be positioned to extend around the distal tip of the valve leaflet 58 in order to secure the artificial valve 10 within the annulus 56 of the natural valve.

[0076] Figure 11 shows the capsule 54 housed within the prosthetic valve 10, allowing the anchor 17 to extend radially outward from the capsule 54 and around the distal tip of the leaflet of the natural heart valve.

[0077] Figure 12 shows the valve frame 18 unfolded on the annulus of the natural valve, with the rest of the artificial valve 10 excluded from the figure for clarity.

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

[0079] Therefore, the portions 59 of the outer frame 20 can be rotated relative to each other in response to the shape of the valve ring of the natural valve when deployed. The frame 20 can be made to conform to the shape of the valve ring of the natural valve.

[0080] The rotating joint 53 allows portions 59 of the outer frame 20 to rotate relative to each other in order to (fully or partially) conform to the shape of the annulus 56 of the natural valve. The portions 59 can rotate relative to each other to change the shape of the outer surfaces of the frame 20 and the artificial valve 10. Each portion 59 can be deflected radially inward or outward with respect to the inner frame 18. Various portions of the outer frame 20 can rotate inward or outward, with one portion rotating inward and another rotating outward. The inner frame 18 can maintain its shape during the rotation of portions 59 of the outer frame 20. For example, the inner frame 18 may maintain a circular shape. The rotation of portions 59 of the outer frame 20 can further allow the sealing skirt portion 24 (marked in Figure 1) to have various shapes that (fully or partially) conform to the shape of the annulus 56 of the natural valve. Thus, the sealing of the artificial valve 10 to the annulus 56 of the natural valve can be improved.

[0081] The rotation can continue throughout the cardiac cycle, and therefore the outer frame 20 can more accurately adhere to the anatomical shape of the valve annulus throughout the cardiac cycle.

[0082] The proximal portion of the outer frame 20 may remain connected to the proximal end of the valve frame 18 in order to maintain the outward biasing force exerted by the outer frame 20 on the valve ring of the natural valve.

[0083] Various other configurations of the outer frame 20 and the rotary joints may be utilized. Figure 14 shows, for example, an embodiment in which each joint of the support column 78 includes a rotary joint 53. This can result in increased rotation and flexibility of the outer frame 80. Figure 15 shows, for example, a top schematic view showing an increase in the number of rotary joints 53 that connect parts 82 of the outer frame 80 to each other.

[0084] Figures 16A and 16B show an embodiment of a rotary joint including a t-bracket 84. The t-bracket 84 connects adjacent portions 86 of the outer frame, making the portions 86 rotatable relative to each other. The central support 88 of the t-bracket 84 can reduce the possibility of misalignment between the portions 86.

[0085] A rotary 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 rotary joint. Such unidirectional rotation may ensure that the outer frame 20 behaves as desired, generating radially outward force for sealing the valve ring, local flexibility, and reduced stratification between the struts during loading into and deployment from the delivery system. Any embodiment of the rotary joint disclosed herein may include unidirectional rotation or a single degree of freedom, as desired.

[0086] Figures 17A and 17B show an embodiment of a rotary joint including a hinge 90. The hinge 90 connects adjacent portions 92 of an outer frame, allowing the portions 92 to rotate relative to each other. The hinge 90 may be formed to allow movement only in a single plane.

[0087] Figures 18A and 18B show embodiments of a rotational joint including a ball-and-socket joint 94. The ball-and-socket joint 94 connects adjacent portions 96 of an outer frame and can rotate the portions 96 relative to each other. Multiple degrees of freedom may be provided for the ball-and-socket joint 94, including radially inward and outward rotation, and deflection toward or away from the proximal or distal end of the prosthetic valve.

[0088] Figure 19 shows an embodiment of a rotary joint including an overmolded 98. The overmolded 98 may include a tubular material (such as shrink tubing or other material) that wraps around and joins adjacent portions 100, 102 of the outer frame and can be positioned so that portions 100, 102 are rotatable relative to each other. The overmolded 98 may include plastic and / or silicone material or other forms of material. Portions 100, 102 may include struts of the outer frame, as shown in Figure 19.

[0089] Combinations of types of rotary joints may be used in embodiments, or a single type of rotary joint may be used as desired. Thus, in embodiments, a rotary joint may include one or more of suture joints, t-brackets, ball and socket joints, overmoldes, or hinges, or other forms of rotary joints. Any embodiment of a rotary joint disclosed herein may include rotation in one direction or a single degree of freedom as desired. In embodiments, other bending points may be used to increase the degrees of freedom as desired.

[0090] The embodiments shown in Figures 1–19, among other advantages, can beneficially enable improved adaptation of the prosthetic valve embodiment to a natural valve. As a result, the possibility of perimetrial leakage (PVL) can be reduced. Various modifications of the embodiments can be provided, including the substitution or addition of mechanisms across the various embodiments disclosed herein. The embodiments shown in Figures 1–19 can be used alone or in combination with mechanisms of other embodiments disclosed herein.

[0091] Figure 20 shows a schematic top view of an embodiment of a prosthetic valve 104, which includes a crescent-shaped outer frame 106 with two ends 108, 109 spaced circumferentially apart from each other. 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 Figure 20 (and in Figure 22, the inner frame 110 is shown separately from the outer frame 106). The inner frame 110 may surround the center 112 of the inner frame 110, which can be positioned within the flow channel of the inner frame 110. The inner frame 110 may be configured similarly to the inner frame 18 illustrated and discussed with respect to Figures 1-5, and may be coupled to the leaflets of the prosthetic valve, and may include, for example, a distal anchor (as shown in Figure 1) for fixing the prosthetic valve 104 to the natural valve. For example, the distal anchor may be configured to extend around one or more leaflets of the natural valve in order to fix the prosthetic valve to the natural valve. The mechanism of the prosthetic valve 104 is excluded from the figure for clarity in Figure 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 forms of crescent shape, and may form the outer circumference of the outer frame of the artificial 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 Figures 1-5. However, the outer frame 106 may extend around a portion of the inner frame 110. The ends 108, 109 of the outer frame 106 may be coupled to the inner frame 110, so that the portion 114 of the inner frame 110 between the two ends 108, 109 is exposed by the outer frame 106, and therefore the portion 114 forms the outermost frame surface of the artificial valve 104 at that location. The sealing skirt portion 116 may be coupled to and extend around portions 114 of the outer frame 106 and inner frame 110 between ends 108 and 109 to form the outer surface of the artificial valve 104, similar to the sealing skirt portion 24 shown in Figures 1-5.

[0094] As shown in Figure 20, the center 118 of the outer frame 106 may be offset from the center 112 of the inner frame 110. Frames 106 and 110 may be non-concentric with each other.

[0095] Figure 21 shows a schematic top view of the outer frame 106 separated from the inner frame 110. It shows the space 120 between the ends 108 and 109 of the outer frame 106. The outer frame 106 may have a circular shape that may include a portion of the circle shown in Figure 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 can be formed together by the outer frame 106 and the inner frame 110 due to the various radii of the outer frame 106 and the inner frame 110. Figure 22 shows, for example, an inner frame 110 separate from the outer frame 106.

[0096] A "D" shape, or any other non-circular shape formed by the combination of the outer frame 106 and the inner frame 110, can improve the positioning of the artificial valve 104 within the annulus of the natural valve. For example, the annulus of the natural valve itself may have a "D" shape, and the resulting outer shape of the artificial valve 104 may have a similar "D" shape that can conform to the shape of the annulus of the natural valve. The "D" shape may conform better to the "D" shape of the annulus of the natural valve than to the circular shape of the artificial valve 104. Furthermore, when the artificial valve 104 is deployed into the natural valve, the outer frame 106 may have an outer surface that can be configured to move in response to the shape of the annulus portion in order to conform to the shape of the annulus of the natural valve.

[0097] In a configuration resulting in a "D" shape, the flattened portion (corresponding to portion 114 of the inner frame 110) can be positioned at each flattened portion of the valve ring of the natural valve having a "D" shape. Such portions may include the front part of the valve ring of the natural valve. The curved portion of the "D" shape can be positioned at the rear part of the valve ring of the natural valve. Other configurations may be used based on the configuration of the valve ring of the natural valve.

[0098] The ends 108, 109 of the outer frame 106 can be coupled to the inner frame 110 in various ways, for example, via a connector between the outer frame 106 and the inner frame 110. In embodiments, the connector may include other forms of connectors disclosed herein, including the use of a rotary joint. For example, Figure 23 shows a side view of a portion of the artificial valve showing the ends 108, 109 of the outer frame 106 coupled to the inner frame 110 via a connector 122. The connector 122 may include a suture and may include a knot, such as a scissor knot in embodiments. Other forms of connectors may be used in embodiments.

[0099] In this embodiment, the proximal portions of the outer frame 106 and the inner frame 110 can be joined to each other in a manner similar to that of the proximal portions of the outer frame 20 and the inner frame 18 discussed with reference 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, the outer periphery of the inner frame may be uncovered by the outer frame 106 by at least 10%, and at least 20%, or at least 30%, or at least 40%, or as desired, by another percentage. In embodiments, the outer periphery of the inner frame may be uncovered by the outer frame 106 by less than 10%, and less than 20%, or less than 30%, or less than 40%, or as desired, by another percentage. The percentage may be set based on the desired shape of the artificial valve to be fabricated.

[0101] In the embodiment, both the outer frame 106 and the inner frame 110 can be independently sized to modify the resulting shape of the artificial valve. For example, the resulting "D" shape and size can be varied as desired. A larger outer frame 106 can be used if the rounded rear portion of the natural valve is large. A larger inner frame 110 can be used if the flattened front portion of the natural valve is large. Other shapes can be used based on the shape of the valve annulus.

[0102] In embodiments, other configurations of the outer and inner frames may be used in combination. For example, in embodiments, the outer frame may completely enclose the inner frame 110 and thus include a sealing body having an "O" shape or another form of circular or oval shape, rather than the "C" shape shown in Figure 21. However, the inner frame 110 may be connected to a portion of the inner surface of the outer frame in an offset manner, as shown, for example, in Figure 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 portion for forming a seal with the valve ring of a natural valve.

[0103] The embodiments shown in Figures 20–23, among other advantages, can beneficially enable improved compatibility of the prosthetic valve embodiments with natural valves. As a result, the possibility of paravalve leakage and outflow tract obstruction can be reduced. Various modifications of the embodiments can be provided, including the substitution or addition of mechanisms across the various embodiments disclosed herein. The embodiments shown in Figures 20–23 can be used alone or in combination with mechanisms of other embodiments disclosed herein.

[0104] Figure 24 shows a pattern of a frame 124 that may be used in an artificial valve. The frame 124 may include a plurality of struts 126 joined together with spaces 128 between them. The struts 126 may be joined at joints 130 that exist between the struts 126.

[0105] The patterns of the support columns 126, spaces 128, and joints 130 may arise from the formation of the frame 124. The frame 124 may be formed from a single piece of material, or cut from such material, to form the configuration of the support columns 126, spaces 128, and joints 130. The single piece of material may have a cylindrical shape in embodiments, resulting in a cylindrical frame 124 after cutting (although the frame 124 is shown as a flat pattern in Figure 24).

[0106] The elongated strut 134 may be fabricated to extend distally from the joint 132. During the forming process, the joint 132 may be located between the struts 126, and the elongated strut 134 may extend distally from such joint 132. Thus, the proximal portion 133 of the elongated strut 134 may be formed integrally with the joint 132. The elongated strut 134 may extend longitudinally distally to the distal end 136 of the elongated strut 134. A cut portion 138 may be located between the distal portion 131 of the elongated strut 134 and the adjacent strut 126, resulting in the distal portion 131 of the elongated strut 134 being cut at these points. Thus, the distal portion 131 may not be integral with the adjacent strut 126 and may be deflected away from the adjacent strut 126 at the cut portion 138. Therefore, the proximal portion 133 of the elongated support 134 may be integral with the joint 132, while the distal portion 131 of the elongated support 134 may be cut off and not integral with the rest of the frame 124.

[0107] In the forming step, the distal portion 131 of the elongated support 134 can be deflected away from the rest of the frame 124. Figure 25 shows, for example, that the distal end 131 of the elongated support 134 is deflected outward from the rest of the frame 124 to form an outwardly extending portion 142 and a vertically extending portion 144 that terminate at the distal end 136 of the elongated support 134. The proximal portion 133 of the elongated support remains integral with the joint 132.

[0108] With the elongated support 134 in this configuration, the elongated support 134 may form an outer frame 146 extending around the remaining portion of the frame 124, which may include an inner frame 148. The inner frame 148 may therefore be coupled to the leaflets of one or more artificial valves and may support such leaflets in a manner similar to the inner frame 18 considered with respect to Figures 1-5.

[0109] A method for forming at least a portion of an artificial valve may include deflecting each distal portion 131 of a plurality of elongated struts 134 of a sealing body away from an inner frame 148 for supporting the leaflets of one or more artificial valves. Each proximal portion 133 of the plurality of elongated struts 134 may be formed integrally 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] Figure 26 shows the inner frame 148 with the elongated struts 134 removed from view. The distal portion 131 of the elongated struts 134 is removed from the inner frame 148, and 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 disclosed herein, which may be configured as a knot, such as a scissor knot. In embodiments, other forms of connectors may be used at joints disclosed herein, including one or more of suture joints, t-brackets, ball and socket joints, overmoldes, or hinges, or other forms of connectors. The rotary joints disclosed herein may be used to rotate a first part of the inner frame 148 relative to a second part of the inner frame 148, in the manner considered with respect to the embodiments of Figures 1-19. In this embodiment, the inner frame 148 can be biased to fill the remaining gap after the distal portion 131 of the elongated support 134 has been deflected away from the inner frame 148.

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

[0112] The inner frame 148 and the outer frame 146 may be formed, for example, in a round bulb shape as shown in Figure 1. The elongated struts 134 may extend radially outward from the inner frame 148, as shown in the schematic top view of Figure 27. The elongated struts 134 may be positioned at various intervals, evenly spaced or as desired. In embodiments, various numbers of elongated struts 134 may be utilized. Figure 28 shows that when the elongated struts 134 are deflected from the inner frame 148, a sealing skirt portion 151 may be provided, positioned on a plurality of elongated struts 134. The sealing skirt portion 151 may form a sealing body surrounding at least a portion of the inner frame 148 and is configured to seal a portion of the valve ring of the natural valve. The sealing body may contact a portion of the valve ring of the natural valve.

[0113] The sealing body may include an outer frame 146 having a skirt portion 151 and a plurality of elongated supports 134. Each of the plurality of elongated supports 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. The leaflets of one or more artificial valves may be coupled to the inner frame 148.

[0114] The resulting artificial valve may have an appearance similar to the artificial valve 10 shown in Figure 1, and the structure of the artificial valve may include an elongated support 134 integrated with an inner frame 148. An outer frame 146 may surround the inner frame 148 and may be used to seal with the annulus of the natural valve. The resulting artificial valve can be deployed in a manner similar to the artificial valve 10 shown in Figure 1.

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

[0116] In the embodiment, the compressible materials 152a,b may include foam or other forms of compressible materials 152a,b. The compressible materials 152a,b may function to compress in order to improve the seal to the valve ring of the natural valve when force is applied to the sealing skirt portion 151 by the valve ring of the natural valve.

[0117] Figure 30 shows an alternative configuration of the frame shown in Figure 24, in which slender support columns 154 are alternately arranged at predetermined positions, equally spaced from the distal anchors 156.

[0118] The embodiments shown in Figures 24–30 may be beneficial to the improved construction of artificial valves in which the inner and outer frames are formed from a single frame pattern. Such configurations can reduce the complexity of manufacturing artificial valves having an inner frame mechanically bonded to an outer frame. Various modifications of the embodiments may be provided, including the substitution or addition of mechanisms across the various embodiments disclosed herein. The embodiments shown in Figures 24–30 may be used alone or in combination with mechanisms of other embodiments disclosed herein.

[0119] In embodiments of this specification, the surface roughness of at least a portion of the prosthetic valve may be modified. The prosthetic valve may be configured similarly to embodiments of the prosthetic valve disclosed herein, and may include one or more prosthetic valve leaflets, and may be configured to unfold into a natural valve. Other components of the prosthetic valve may be utilized as desired. The surface roughness of one or more prosthetic valve leaflets 160 may be modified, or the surface roughness of other parts of the prosthetic valve, in particular, such as the fabric, anchors, sealing body, or sealing skirt portion, may be modified. For example, the sealing body 11 shown in Figure 1, including the sealing skirt portion 24, may have a modified surface roughness. One or more anchors 17, including the fabric applied to one or more anchors 17, may have a modified surface roughness as desired. Other parts may have a modified surface roughness.

[0120] In embodiments of this specification, one or more micropatterns may be applied to a portion of the prosthetic valve to modify the surface roughness. One or more micropatterns may be applied to the leaflet 160 of the prosthetic valve or to other portions of the prosthetic valve, in particular to the fabric, anchor, sealing body, or sealing skirt portion.

[0121] Micropatterns can be applied to the leaflets 160 of the prosthetic valve or to other parts of the prosthetic valve in various ways, including laser grinding and other methods for forming the micropatterns. Micropatterns can be applied to the surface of the leaflets 160 of the prosthetic valve or to the surface of other parts of the prosthetic valve.

[0122] The micropattern may be applied to generate a pattern on the leaflet 160 of the prosthetic valve or other parts of the prosthetic valve, or similar methods may be used in embodiments to smooth the surface of the leaflet 160 of the prosthetic valve or the surface of another part of the prosthetic valve (e.g., fabric, anchor, sealing body, or sealing skirt portion).

[0123] For example, laser grinding may be applied to smooth one or more surfaces (such as an inward-facing surface and an outward-facing surface) of the valve leaflets 160 of the prosthetic valve. The inward-facing surface may be the surface facing the flow channel of the prosthetic valve, and the outward-facing surface may be the surface facing 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 grinding or another method, may be applied to one or more surfaces of parts of the prosthetic valve, in particular, such as the sealing body, sealing skirt, or fabric.

[0124] In embodiments, applying a micropattern may involve applying the pattern to the leaflets of an artificial valve, or to other parts of the artificial valve, such that the pattern has height. The micropattern may be on a micrometer scale, or on another scale as desired, depending on the embodiment. The micropattern may be applied to alter the surface roughness of at least a portion of the artificial valve.

[0125] Figure 31 shows an embodiment of a prosthetic valve leaflet 160 that may be used in 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 a plurality of parts 162, 164, 166, each of which may include different or identical micropatterns applied to that portion of the prosthetic valve leaflet 160. In the embodiment, the micropatterns may be applied in such a way that they can alter the surface roughness of the prosthetic valve leaflet 160.

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

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

[0128] Various patterns can be formed on the leaflets 160 of the prosthetic valve or on other parts of the prosthetic valve. Figure 34 shows a heterogeneous pattern 172 with a scattered appearance. Figure 35 shows a sharklet pattern 174 that is uniform and may have a multiple chevron appearance. Figure 36 shows a uniform check pattern 176. Figure 37 shows another form of sharklet pattern 178 with a multiple chevron appearance. Other patterns may include hexagonal patterns for sealing and providing wet adhesion. Various patterns can be applied as desired.

[0129] Different configurations of patterns can be applied to different portions of the prosthetic valve leaflet 160 or to other portions of the prosthetic valve, as desired. For example, the micropattern may include one or more of a check pattern or a sharklet pattern. The portion may be on an inward-facing surface or an outward-facing surface of the prosthetic valve leaflet, or on another surface such as a surface coupled to the valve frame. One portion of the prosthetic valve leaflet may have a first configuration of the micropattern applied to it, and another portion of the prosthetic valve leaflet may have a second configuration applied to it that is different from the first configuration.

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

[0131] The configuration of the applied micropattern may be selected to provide desired performance for a portion of the prosthetic valve leaflet 160. For example, a portion 162 that contacts another portion of the leaflet during joining may include a pattern that increases or decreases friction with the other portion of the leaflet. A portion 164 through which fluid flows may include a pattern that improves fluid flow. A portion 166 that connects to the valve frame may include a pattern that improves friction and grip to the valve frame. Micropatterns may be applied to provide results including, but are not limited to, reducing thrombus formation on the prosthetic valve leaflets, improving biocompatibility between the prosthetic valve leaflets and the patient's body, altering fluid flow through the prosthetic valve, improving joining between multiple prosthetic valve leaflets, and improving the joining of the prosthetic valve leaflets to the frame. A variety of other results may be produced by applying micropatterns to one or more portions of the prosthetic valve leaflets. Such results may be utilized on the prosthetic valve leaflets or on other portions of the prosthetic valve, such as the sealing body, anchor, sealing skirt, or fabric. For example, the sealing body, anchor, sealing skirt portion, or surface of the fabric, such as the outer surface or other surface, may include a micropattern that may, among other results, reduce the formation of thrombi on a portion of the prosthetic valve, improve the biocompatibility between a portion of the prosthetic valve and the patient's body, and alter the flow of fluid through the prosthetic valve.

[0132] At least one of the leaflets of one or more prosthetic valves may be coupled to a frame disclosed herein. The frame may be configured to support multiple prosthetic valve leaflets. At least one of the prosthetic valve leaflets may have a micropattern applied to the leaflet of the prosthetic valve. The resulting prosthetic valve may include, for example, the prosthetic valves disclosed herein or other forms of prosthetic valves. The prosthetic valve may be deployed in a natural valve.

[0133] In embodiments, the micropatterns disclosed herein may be applied to other parts of the artificial valve. An artificial valve may be provided configured to unfold into a natural valve of the body, and the artificial valve may include one or more valve leaflets and include a micropattern applied to at least one part of the artificial valve. For example, one or more parts of the sealing body, anchor, sealing skirt, or fabric disclosed herein may have a micropattern applied to it, in particular among other parts of the artificial valve. At least one part of the artificial valve may comprise a fabric disclosed herein, and the micropattern may be applied to the fabric. The fabric may be the fabric of the sealing body or sealing skirt, in particular among other forms of fabric. The fabric may include one or more anchors (such as distal anchors or other forms of anchors) or fabric on the artificial valve. The outer surfaces of such parts may include a micropattern, in particular among other surfaces. The outer surfaces 179 of the sealing body, fabric, and sealing skirt that may include a micropattern are marked, for example, in Figure 1. An anchor fabric that may include a micropattern is shown, for example, in Figures 39 and 40.

[0134] The micropatterns that can be applied to a portion of the artificial valve may include any configuration of micropatterns as desired. For example, the pattern may be used to improve friction and thus improve the seal between the outer surface of the sealing skirt portion and the surface of the valve ring. As a result, improved fixation between the natural valve ring and the sealing skirt portion may occur. Such a pattern may include a sharklet pattern 178, as shown in Figure 37. For example, a sharklet pattern may generate hard points that can improve adhesion between the sealing skirt portion and the valve ring of the natural valve. One or more check patterns or sharklet patterns may be used. Other forms of patterns may be used as desired.

[0135] The micro-pattern embodiments may offer various benefits. Various modifications of the embodiments may be provided, including the replacement or addition of mechanisms across the various embodiments disclosed herein. The micro-pattern embodiments may be used alone or in combination with mechanisms of other embodiments disclosed herein.

[0136] Figures 38–44 illustrate embodiments in which one or more microbeads may be used. Microbeads may be used in artificial valves configured to deploy into the body's natural valves. In embodiments, one or more microbeads may be used to release substances into the body.

[0137] Each microbead may be configured to release a substance into the body through diffusion. For example, microbeads may be made from a substance or coated with a substance and configured to release the substance by gradually or slowly diffusing it into the body. Thus, the size of the microbeads may gradually decrease as the release of the substance occurs. Other methods of release by microbeads may be utilized as desired.

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

[0139] The drug may, in embodiments, include an antithrombotic agent. The antithrombotic agent may, in particular, include vitamin K antagonists, anticoagulants (including novel oral anticoagulants (NOACs) or non-VKA oral anticoagulants (NOACs) or direct-acting oral anticoagulants (DOACs)), among other forms of antithrombotic agents. In embodiments, other forms of the drug may be used as desired.

[0140] The drug may be released to reduce the formation of thrombi on the prosthetic valve leaflets or otherwise on the prosthetic valve. The drug may, for example, reduce the accumulation of thrombi on the prosthetic valve leaflets or otherwise on the prosthetic valve. Therefore, the drug may be released in embodiments to reduce the thickening of the prosthetic valve leaflets or other parts of the prosthetic valve.

[0141] The drug may be released near the surface to reduce thrombi (e.g., on the leaflets of a prosthetic valve or another part of the prosthetic valve). Therefore, one or more microbeads may be positioned near such a surface and may release the drug or other substance near the surface. In the embodiment, one or more microbeads may release substances locally within the patient's body near the surface to reduce thrombi. One or more microbeads may diffuse into the local blood flow to the prosthetic valve to reduce thrombus accumulation.

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

[0143] Referring to Figure 38, one or more microbeads may be embedded in the sealing skirt portion 180. For example, microbead 184a may be completely embedded in the sealing skirt portion 180 and within the fabric of the sealing skirt portion 180. Therefore, when a fluid (e.g., blood) comes into contact with microbead 184a, the microbead 184a may diffuse and release material into the patient's body, which may be close to components of the natural and artificial heart valves. Microbead 184a may release material locally onto components of the artificial heart valve to reduce the formation of thrombi on such areas.

[0144] In embodiments, the microbeads 184b may be partially embedded in the sealing skirt portion 180 and the fabric of the sealing skirt portion 180, or they may be positioned on the outer surface of the sealing skirt portion 180 and on the fabric of the sealing skirt portion. Such microbeads 184b may be partially or completely exposed to the outside of the sealing skirt portion 180. The outer surface may include, for example, the outer surface 179 marked in Figure 1.

[0145] In the embodiment, varying depths of the microbeads 184a, 184b from the outer surface of the sealing skirt portion 180 can generate a gradual release of the substance into the patient's body. For example, microbeads 184b on the outer surface of the sealing skirt portion 180 may release or diffuse the substance more rapidly than microbeads 184a that are fully embedded in the sealing skirt portion 180. Therefore, the gradual rate of substance release from the microbeads 184a, 184b may occur based on the size, number, and / or position of the microbeads from the outer surface of the sealing skirt portion 180. The release rate can be controlled based on the control of the size, number, and / or position of the microbeads from the outer surface of the sealing skirt portion 180 in the embodiment.

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

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

[0148] The sleeve 190 and end cover 192 may include a fabric which may contain 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 similar manner to the microbeads 184a, b, the substance may be configured to reduce thrombus formation, or produce other results as desired.

[0149] The components considered in relation to Figures 38-40 may include components of a prosthetic valve configured to deploy to the 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 deploy to, for example, the aortic valve of the body. The prosthetic valve 200 may include a frame 201 that supports, for example, one or more prosthetic valve leaflets 203a-c and includes 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 from a fabric. The skirt portion 202 may include the outer surface of the prosthetic valve 200 and may be configured to contact a part of the patient's body (e.g., the leaflets of a natural valve and / or the annulus of a natural aortic valve). In this embodiment, the inner surface of the artificial valve 200 may include a skirt portion 204 (marked in Figure 44).

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

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

[0152] In embodiments, microbeads may be positioned on a portion of an artificial valve, which 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 thereto. The microbeads may be configured to release material in a manner similar to other microbeads disclosed herein.

[0153] Various modifications of the embodiments may be provided, including the substitution or addition of mechanisms across the various embodiments disclosed herein. One or more microbeads may be used alone or in combination with mechanisms of other embodiments disclosed herein.

[0154] Figures 45-55 show embodiments of artificial valves that may be used herein. Referring to Figure 45, the artificial valve 220 may include a support ring 222 and one or more artificial valve leaflets 224a, b, and in embodiments may include one or more anchors 226.

[0155] The support ring 222 may be configured to extend around the valve ring of the natural valve. The support ring 222 may have an annular shape and may 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 may have an open ring with a gap between the ends 228, 230, or may have another configuration as desired.

[0156] Figure 46 shows a cross-sectional view of the support ring 222 along line 46-46 of Figure 45. The support ring 222 may include a ring body 232, which may have 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 other shapes (e.g., rectangular, triangular, or other cross-sectional shapes) as desired. The support ring 222 may be flexible and may be configured to form a desired shape when unfolded. For example, the support ring 222 may be configured to conform to the shape of the valve ring when unfolded. The shape may include an oval or "D" shape, among other possible shapes. The support ring 222 when unfolded may therefore have a circular shape, or an elongated shape such as an oval or other shape.

[0157] The support ring 222 may be configured to expand from a non-expanded configuration to an expanded configuration. For example, due to the flexibility of the support ring 222, the support ring 222 and the artificial valve 220 may be compressed into an unexpanded, unexpanded, or linear configuration and then expanded into an expanded or expanded configuration. The support ring 222 may be folded to be positioned in an unexpanded, unexpanded, or linear configuration and then expanded to form a ring shape, for example, as shown in Figure 45.

[0158] In embodiments, the ring body 232 may include a body made of a metal, polymer, or alloy material that can be configured to be flexible. The ring body 232 may include a shape memory material, such as nitinol or another form of shape memory material. The ring body 232 may be made of a material that, when unfolded, can automatically expand into an unfolded configuration, such as a ring shape that can conform to the shape of the valve ring. Other materials may be used in embodiments.

[0159] The sheath 234 may extend over the ring body 232 and may be equipped with connectors for the leaflets 224a, 224b of one or more artificial valves. The leaflets 224a, 224b of one or more artificial valves 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 all or partially over the ring body 232. The sheath 234 may be integrally coupled to the leaflets 224a, 224b of one or more artificial valves in order 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, along the entire length or circumference, or along only a portion of the length or circumference. In the embodiment, other forms of coupling devices may be used to couple the leaflets 224a, 224b of one or more artificial valves to the ring body 232 and, accordingly, to the support ring 222.

[0160] Referring to Figure 45, the leaflets 224a,b of one or more artificial valves may each include a first end portion 236a,b and a second end portion 238a,b, respectively, extending distally from the first end portions 236a,b. The first end portions 236a,b may be coupled to a support ring 222, and the second end portions 238a,b may extend distally from the first end portions 236a,b. The first end portions 236a,b may, in embodiments, be coupled to a ring body 232 via a sheath 234, and the second end portions 238a,b may comprise the free ends of the leaflets 224a configured to move inward and outward to mimic the movement of the leaflets of a natural valve. The second end portions 238a,b may not be coupled to any other part of the artificial valve 220, and other structures of the artificial valve 220 may not surround or restrain the second end portions 238a,b. Therefore, the second end portions 238a,b may be configured to contact the leaflets of a natural valve and may move together with the leaflets of the natural valve when deployed. The first end portions 236a,b may comprise the supported ends of the leaflets of the artificial valve, and the second end portions 238a,b may comprise the unsupported ends of the leaflets of the artificial valve.

[0161] The leaflets of the artificial valve may extend distally from the support ring 222 to form a cylindrical curtain structure, as shown in Figure 45. The first end portions 236a,b may have a cylindrical shape that can 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 when the artificial leaflets of the artificial valve 220 are open and closed.

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

[0163] In embodiments, more or fewer prosthetic valve leaflets may be used. In embodiments, at least two prosthetic valve leaflets may be used. The prosthetic valve leaflets may be spaced circumferentially apart from one another. Figure 48 shows a flattened configuration in which, for example, three prosthetic valve leaflets 248a, b, and c may be used. Such a configuration may be used, for example, in embodiments in which the prosthetic valve is developed into a tricuspid valve. Figure 49 shows a flattened configuration in which a single prosthetic valve leaflet 250 may be used. The prosthetic valve leaflet 250 may have intersecting or overlapping ends, or, in embodiments, may comprise a single body extending from a support ring 222.

[0164] In embodiments, the first end portion 228 and the second end portion 230 of the support ring 222 may be configured to move relative to each other. For example, referring to Figure 50, the first end portion 228 may be configured to be inserted into the second end portion 230, and the second end portion 230 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 inward from and toward the first end portion 228, or outward from and away from the first end portion 228. This movement may change the size and shape of the support ring 222. For example, referring to Figure 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 the diameter 252' shown in Figure 52. Thus, the size of the support ring 222 may be changeable by the movement of the first end portion 228 relative to the second end portion 230.

[0165] Referring to Figure 50, in an embodiment, the spring 254 may be provided to bias the first end portion 228 toward the second end portion 230. The spring 254 may be biased to pull the first end portion 228 into and toward the second end portion 230. Thus, the spring 254 may be configured to reduce the size of the support ring 222 and 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. Thus, in an embodiment, the spring 254 may facilitate the expansion of the support ring 222 during deployment, which may be overcome by a decreasing annulus size due to the cardiac cycle or by another reduction in the annulus size.

[0166] In embodiments, the support ring 222 may be configured to change size to adapt to the movement of the annulus during the cardiac cycle. In embodiments, the second end portion 230 may be configured to automatically slide against 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 so that the support ring 222 can decrease in size along with the annulus. For example, the size of the annulus may decrease as a result of the 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 as, for example, the stress on the natural valve is reduced and / or the stress that causes expansion in the ventricle or atrium is reduced. The support ring 222 may decrease in size along with the annulus. In embodiments, the support ring 222 may increase in size if further expansion of the annulus occurs as a result of disease or other causes of annular expansion.

[0167] Referring to Figure 45, in the embodiment, one or more anchors 226 may be provided. The anchors 226 may be configured to secure the support ring 222 to the natural valve. The anchors may have various forms, and among other forms of anchors, they may include penetrating bodies such as screws, hooks, spikes, clamps, or fasteners. Each of the anchors 226 may be configured to penetrate the tissue. The anchors 226 may be coupled to the support ring 222, for example, by passing through a sheath 234 to the ring body 232. Other configurations of the anchors may be utilized in the embodiment as desired.

[0168] Figures 53-55 show exemplary deployment sequences of the artificial valve 220. Figure 53 shows the artificial valve 220 in an undeployed configuration, which can be positioned, for example, within a delivery system 260. The delivery system 260 may include, for example, an implant retention area in the form of a capsule 262 that holds the artificial valve 220. The artificial valve 220, in particular the support ring 222, may be in a compressed configuration, for example, as shown in Figure 51, in which the support ring 222 may have an elongated configuration in which the thickness is reduced and the length is increased from the deployed configuration. The support ring 222 may be elongated and may be folded in the undeployed configuration. The support ring 222 may have an elongated shape in which the sides of the support ring 222 are pulled together in a compressed state.

[0169] Figure 54 shows the artificial valve 220 deployed from the capsule 262. The support ring 222 may deploy and expand outward once released from the capsule 262. Such expansion may occur automatically in the embodiment, 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 ring as desired.

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

[0171] The leaflets 224a and 224b of the artificial valve may contact and overlap at least a portion of the leaflets of the natural valve. Therefore, the leaflets 224a and 224b of the artificial valve may be configured to move in conjunction with the opening and closing movements of the leaflets of the natural valve. In some embodiments, the leaflets 224a and 224b of the artificial valve may open and close independently of the leaflets of the natural valve.

[0172] The anchor 226, shown in Figure 54, has not yet been inserted into the patient's body tissue. The deployment device 264 of the delivery system 260 can engage with the anchor 226 and may be used to drive the anchor 226 into the tissue in order to fix the anchor 226 in place.

[0173] Figure 55 shows, for example, an anchor 226 inserted into a fixed position to secure the support ring 222 to the natural valve.

[0174] Various other methods of deploying the artificial valve 220 may be used as desired.

[0175] The prosthetic valve 220 may comprise a valve having a single support (e.g., a support ring 222) for the valve leaflets of the prosthetic valve, and in embodiments, it may be frameless. The absence of a frame may reduce the complexity of the prosthetic valve 220 and reduce the overall amount of material that can be deployed in the patient's body when the prosthetic valve 220 is delivered. 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 without additional components. In embodiments, additional components may be utilized as desired.

[0176] Various modifications of the embodiments may be provided, including the substitution or addition of mechanisms across the various embodiments disclosed herein. The embodiments shown in Figures 45–55 may be used alone or in combination with mechanisms of other embodiments disclosed herein.

[0177] Embodiments of the artificial valve may be used in the mitral valve, as disclosed herein, or in other deployment sites such as the natural tricuspid valve, or in other deployment sites as well. Deployment to the aortic valve or pulmonary valve, or other implantation sites may be used.

[0178] Various modifications of the embodiments disclosed herein may be provided. Mechanisms of embodiments may be modified, replaced, excluded, or combined across embodiments as desired. Combinations of mechanisms across embodiments may be provided as desired. Combinations of mechanisms may be provided across embodiments such as excluding other mechanisms of such embodiments, if desired.

[0179] Various embodiments of the sealing skirt portion disclosed herein may have a variety of forms, including a fabric skirt portion, a foamed skirt portion, or, as desired, a braided skirt portion. Various materials may be used as desired.

[0180] The implants disclosed herein may include, among other things, artificial heart valves, or stents or filters, or other forms of implants such as diagnostic devices. The implant may be an expandable implant configured to move from a compressed or undeployed state to an expanded or undeployed state. The implant may be a compressible implant having a reduced outer shape and configured to compress inward in order to move the implant to a compressed or undeployed state.

[0181] Various forms of delivery devices may be used in the embodiments disclosed herein. These delivery devices may also be used for the replacement and repair of aortic, mitral, tricuspid, and pulmonary valves. The delivery devices may, in particular, include those 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 for aortic valve implantation (TAVI) or replacement of other natural heart valves (e.g., pulmonary valve). The delivery devices and systems disclosed herein may be used for transarterial access, including transfemoral access to the patient's heart. The delivery devices and systems may be used for transcatheter percutaneous procedures, including transarterial procedures, which may be transfemoral or transjugular. Transradicular procedures may also be used, among other things. Other procedures may be used as desired.

[0183] Furthermore, the methods described herein are not limited to those specifically described herein and may include methods utilizing the systems and apparatus disclosed herein. Steps of the methods may be modified, excluded, or added using the systems, apparatus, and methods disclosed herein. Embodiments disclosed herein may, in embodiments, include systems for implantation in the human body.

[0184] In summary, while aspects of this specification are emphasized 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. Therefore, the disclosed subject matter is by no means limited to the specific methodologies, protocols, and / or reagents described herein. Accordingly, various modifications or alterations, or alternative configurations, of the subject matter of this disclosure can be made in accordance with the teachings herein without departing from the spirit of this specification. Finally, the terms used herein are not intended to limit the scope of the systems, apparatus, and methods disclosed herein solely for the purpose of describing specific embodiments, which are defined only by the claims. Therefore, the systems, apparatus, and methods are not limited to those precisely illustrated and described herein.

[0185] Specific embodiments of the systems, apparatus, and methods are described herein, including the best modes known to the inventors for performing them. Naturally, variations of these described embodiments will be obvious to those skilled in the art upon reading the foregoing description. The inventors expect that those skilled in the art will appropriately adopt such variations, and the inventors intend that the systems, apparatus, and methods may be carried out in ways other than those specifically described herein. Accordingly, the systems, apparatus, and methods include all modifications and equivalents of the subject matter enumerated in the claims appended herein, as permitted by applicable law. Furthermore, unless otherwise suggested herein or unless clearly contradicted by context, any combination of the above embodiments in all possible variations thereof is encompassed by the systems, apparatus, and methods.

[0186] The grouping of alternative embodiments, elements, or steps of a system, apparatus, and method should not be construed as limitation. Members of each group may be referred to and claimed individually or in any combination with members of other groups disclosed herein. It is anticipated that one or more members of a group may be included in or removed from a group for convenience and / or patentability reasons. In the event of any such inclusion or omission, this specification shall be deemed to include the modified groups and thus satisfy the description of all Markush groups used in the appended claims.

[0187] Unless otherwise indicated, all figures used herein to represent mechanisms, items, quantities, parameters, characteristics, terms, etc., should be understood in all cases to be modified by the term “about.” As used herein, “about” means that the thus modified mechanism, item, quantity, parameter, characteristic, or term encompasses a variable approximation and is capable of performing the desired operation or process discussed herein.

[0188] The terms “a,” “an,” “the,” and similar reference terms used in the context of describing systems, apparatuses, and methods (particularly in the context of the following claims) shall be interpreted as encompassing both singular and plural forms unless otherwise suggested herein or unless the context clearly contradicts them. All methods described herein may be performed in any appropriate order unless otherwise suggested herein or unless the context clearly contradicts them. Any and all examples or exemplary language provided herein (e.g., “such as”) is intended merely to clarify the systems, apparatuses, and methods and not to limit the scope of any other claimed systems, apparatuses, and methods. Nothing in this specification should be interpreted as indicating any unclaimed elements essential to the practice of any system, apparatus, or method.

[0189] All patents, patent publications, and other publications referenced and identified herein are incorporated herein by whole, individually and expressly, by reference for the purpose of describing and disclosing compositions and methodologies described herein, which may be used, for example, in connection with systems, apparatus, and methods. These publications were made available prior to the filing date of this application, solely for the purpose of their disclosure. Nothing in this regard should be construed as an acknowledgment that the inventor does not have prior rights to such disclosure on the grounds of prior invention or for any other reason. All statements relating to dates or representations concerning the contents of these documents are based on information available to the applicant and do not constitute an acknowledgment of the accuracy of the dates or contents of these documents.

Claims

1. A system for replacing the function of a defective natural heart valve, wherein the system is It is an artificial heart valve, An inner frame having a proximal portion and a distal portion, wherein the inner frame surrounds a flow channel, the proximal portion includes an inlet for the artificial heart valve, and the distal portion includes an outlet for the artificial heart valve, An outer frame surrounding the inner frame, wherein the outer frame has a proximal portion connected to the proximal portion of the inner frame, and the outer frame includes 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 the shape of the annulus of the defective natural heart valve, A plurality of artificial valve leaflets are arranged within the flow channel of the inner frame, An artificial heart valve equipped with, A delivery catheter for delivering the artificial heart valve to the defective natural heart valve, A system equipped with these features.

2. The system according to 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 according to claim 1, wherein the longitudinal hinge allows the first region to be rotated in only one direction relative to the second region.

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

5. The system according to claim 4, wherein the first axially extending row includes a first support cell of the outer frame, the second axially extending row includes a second support cell of the outer frame, and the longitudinal hinge connects the first support of the first support cell to the second support of the second support cell, which is not integrated with the first support.

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

7. The system according to claim 1, wherein the artificial heart valve includes one or more distal anchors configured to hook onto one or more natural valve leaflets of the defective natural heart valve in order to fix the artificial heart valve to the defective natural heart valve.

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

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

10. An artificial heart valve for replacing the function of a defective natural heart valve, wherein the artificial heart valve is An inner frame having a proximal portion and a distal portion, wherein the inner frame surrounds a flow channel, the central axis of the artificial heart valve extends through the flow channel, the proximal portion comprises an inlet portion of the artificial heart valve, and the distal portion comprises an outlet portion of the artificial heart valve, An outer frame having a proximal portion and a distal portion, surrounding the inner frame, wherein the proximal portion of the outer frame is coupled to the proximal portion of the inner frame, and the outer frame includes a first portion and a second portion, and at least one rotational joint connecting the first portion to the second portion such that the first portion rotates relative to the second portion in a plane extending laterally with respect to the central axis, thereby enabling the outer frame to conform to the shape of the annulus of the defective natural heart valve, A plurality of artificial valve leaflets are arranged within the flow channel and supported by the inner frame, An artificial heart valve equipped with [a specific feature / feature].

11. The artificial heart valve according to claim 10, wherein the at least one rotational joint includes one or more of a suture joint, a t-bracket, a ball and socket joint, an overmolde, or a hinge.

12. The artificial heart valve according to claim 11, wherein the suture joint includes a scissor knot.

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

14. The at least one rotational joint allows the first portion to rotate in only one direction relative to the second portion. The artificial heart valve according to claim 10.

15. The artificial heart valve according to claim 10, wherein the first portion comprises a first axially extending row of the outer frame including a first support cell, and the second portion comprises a second axially extending row of the outer frame including a second support cell adjacent to the first support cell, and the at least one rotary joint connects the first support of the first support cell to the second support of the second support cell which is not integrated with the first support.

16. The artificial heart valve according to claim 10, wherein the artificial heart valve includes one or more distal anchors configured to hook onto one or more natural valve leaflets of the defective natural heart valve in order to fix the artificial heart valve to the defective natural heart valve.

17. An artificial heart valve for replacing the function of a defective natural heart valve, wherein the artificial heart valve is A tubular metal frame surrounding the flow channel, A plurality of artificial valve leaflets arranged within the flow channel, Equipped with, Multiple longitudinal hinges are provided on the wall of the frame, and at least a first region of the frame is rotatable relative to a second region of the frame. An artificial heart valve, wherein the frame includes a longitudinal hinge for allowing the first region of the frame to rotate relative to the second region of the frame, thereby enabling the frame to conform to the shape of the annulus of the defective natural heart valve.

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

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

20. The artificial heart valve according to claim 17, wherein the frame is sized to be suitable for replacing a natural mitral valve or tricuspid valve.

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