Artificial valve for implantation into a calcified natural valve

Abstract

Apparatus, system, and method for an artificial valve. In embodiments, the implantation site may include a native heart valve or another implantation site. The embodiments may be utilized for improved anchoring to a native heart valve having calcification and for sealing of flow (e.g., paravalvular leakage). The embodiments may reduce the likelihood of occlusion of the left ventricular outflow tract (LVOT) of the heart, whether arising from implantation of an artificial valve or otherwise.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 355,503, filed on June 24, 2022, the entire content of which is incorporated herein by reference.

[0002] The present disclosure relates primarily to artificial heart valves and delivery systems for implanting heart valves.

Background Art

[0003] 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 heartbeat of the heart. The valve allows blood to flow downstream but prevents blood from flowing upstream. Diseased heart valves exhibit disorders such as stenosis or regurgitation of the valve, which inhibit the valve's ability to control blood flow. Such disorders can reduce the heart's blood - pumping efficiency and can be debilitating and life - threatening conditions. For example, valve insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilation. Thus, considerable efforts have been made to develop methods and devices for repairing or replacing malfunctioning heart valves.

[0004] Artificial organs exist to correct problems associated with malfunctioning natural heart valves. For example, mechanical tissue - based artificial heart valves can be used to replace malfunctioning natural heart valves. Recently, significant efforts have been devoted to the development of tissue - based replacement heart valves that can be delivered to patients with less trauma, particularly as compared to open - heart surgery. Replacement valves are designed to be delivered by minimally invasive procedures and, more recently, by non - invasive percutaneous procedures.

[0005] These replacement valves are often intended to allow fluid flow through them while sealing or blocking the fluid flow outside the replacement valve (perivalvular leakage (PVL)). Effective sealing can be particularly difficult if the native heart valve (e.g., the annulus) has a distorted shape or has calcification that can create an irregular surface. Distorted and / or calcified native heart valves can also reduce the likelihood of proper anchoring of the replacement valve within the native heart valve. SUMMARY OF THE INVENTION

[0006] Examples of artificial valves can provide improved anchoring. Examples of artificial valves can also reduce perivalvular leakage by strengthening the seal around the outside of the artificial valve. This type of artificial valve is particularly useful for replacing calcified native heart valves such as a calcified mitral or tricuspid valve. Embodiments can reduce the likelihood of obstruction of the left ventricular outflow tract (LVOT) of the heart, whether resulting from implantation of the artificial valve or otherwise. Various other improvements are disclosed.

[0007] Embodiments disclosed herein can include an artificial valve configured to be deployed against a native valve. The artificial valve can include one or more artificial valve leaflets positioned within a flow channel and a valve body configured to support the one or more artificial valve leaflets. The valve body can include a proximal anchor comprising a first flange configured to extend radially outward from the flow channel and a distal anchor comprising a second flange configured to extend radially outward from the flow channel.

[0008] Examples disclosed herein may include an artificial valve configured to be deployed against a native valve. The artificial valve may include an inner support stent having an inlet end portion and an outlet end portion, the inner support stent being made of a shape memory material. The artificial valve may include a valve portion positioned within the passageway of the inner support stent, the valve portion comprising a plurality of valve leaflets made of pericardium, the valve portion allowing for one-way blood flow through the passageway to replace the function of the native valve. The artificial valve may include an outer conforming structure surrounding the inner support stent. The outer conforming structure may be adapted to conform to calcification on the native valve to enhance sealing and anchor to the native valve.

[0009] Examples disclosed herein may include a method of implanting an artificial valve within a native valve. The artificial valve may comprise one or more artificial valve leaflets configured to be positioned within a flow channel and a valve body configured to support the one or more artificial valve leaflets, the valve body including a proximal anchor including a first flange configured to extend radially outward from the flow channel and a distal anchor including a second flange configured to extend radially outward from the flow channel.

[0010] Examples disclosed herein may include an artificial valve configured to be deployed against a native valve. The artificial valve may comprise one or more artificial valve leaflets configured to be positioned within a flow channel and a valve body configured to support the one or more artificial valve leaflets, the valve body including an atrial anchor forming a ring around the flow channel.

[0011] Examples disclosed herein may include an artificial valve for replacing a native valve. The artificial valve may include a support structure for deployment upstream of the native valve and may include an atrial anchor forming a ring around the flow channel. A plurality of valve leaflets made of pericardium may be coupled to the support structure and may be disposed within the passageway of the support structure to provide one-way blood flow.

[0012] The embodiments disclosed herein may include a method of implanting an artificial valve within a native valve. The artificial valve may comprise one or more artificial valve leaflets configured to be positioned within a flow channel, and a valve body configured to support the one or more artificial valve leaflets, the valve body including an atrial anchor that forms a ring around the flow channel.

[0013] The artificial valve system may comprise one or more artificial valve leaflets configured to be positioned within a flow channel, a valve body that supports the one or more artificial valve leaflets and surrounds the flow channel, and a dock having a first end portion and a second end portion and comprising an extended body configured to form a crescent shape, the first end portion including a first through-body configured to be anchor-ringed to cardiac tissue, the second end portion including a second through-body configured to be anchor-ringed to cardiac tissue, the dock being configured to dock with the valve body.

[0014] The embodiments disclosed herein may include a method comprising deploying a dock proximate to a native valve, the dock having a first end portion and a second end portion and comprising an extended body configured to form a crescent shape, the first end portion including a first through-body configured to be anchor-ringed to cardiac tissue, the second end portion including a second through-body configured to be anchor-ringed to cardiac tissue, and deploying a valve body that supports one or more artificial valve leaflets to the dock.

[0015] In another embodiment, the artificial valve may comprise one or more artificial valve leaflets configured to be positioned within a flow channel, and a valve body configured to support the one or more artificial valve leaflets, the valve body including an outer periphery that includes a first portion forming at least one quarter of the outer periphery and a second portion forming the remaining portion of the outer periphery, the valve body including one or more distal anchors protruding from the second portion and lacking distal anchors protruding from the first portion.

[0016] In another embodiment, the prosthetic valve for implantation within a native valve may comprise a support structure having an outer perimeter that includes a first portion forming at least one quarter of the outer perimeter and a second portion forming the remaining portion of the outer perimeter, the support structure including one or more distal anchors protruding from the second portion for capturing the native valve leaflets and lacking distal anchors protruding from the first portion. The prosthetic valve may include one or more prosthetic valve leaflets positioned within the flow channel of the support structure.

[0017] In another embodiment, the prosthetic valve may comprise one or more prosthetic valve leaflets configured to be positioned within a flow channel and a valve body including a sealing body configured to support the one or more prosthetic valve leaflets and having a first portion and a second portion, the first portion obstructing fluid flow at the height of the valve body, the second portion being at the height of the first portion and being circumferentially offset from the position of the first portion, and the second portion being recessed at the circumferentially offset position to allow fluid to flow.

[0018] In another embodiment, the prosthetic valve may comprise one or more prosthetic valve leaflets configured to be positioned within a flow channel and a valve body including a sealing body configured to support the one or more prosthetic valve leaflets and having a first portion and a second portion, the first portion obstructing fluid flow at the height of the valve body, the second portion being at the height of the first portion and being circumferentially offset from the position of the first portion, and the second portion being recessed at the circumferentially offset position to allow fluid to flow.

[0019] In another embodiment, the prosthetic valve may comprise one or more prosthetic valve leaflets configured to be positioned within a flow channel, a valve body configured to support the one or more prosthetic valve leaflets, and at least one distal anchor coupled to the valve body, the at least one distal anchor including a hinge forming a loop and a straight portion configured to extend radially outward from the loop.

[0020] Other embodiments disclosed herein may include a compression system for the heart. The system may include a first compressor configured to be positioned on a first side of the ventricular septum of the heart proximate to the left ventricular outflow tract, a second compressor configured to be positioned on a second side of the ventricular septum or on the free wall of the right ventricle of the heart, and a tether configured to compress the first compressor and the second compressor together to increase the size of the left ventricular outflow tract.

[0021] Other embodiments disclosed herein may include a compression system for the heart. The compression system may include a first compressor for being positioned on a first side of the ventricular septum of the heart proximate to the left ventricular outflow tract. The compression system may include a second compressor for being positioned on a second side of the ventricular septum or on the free wall of the right ventricle of the heart. The compression system may include a tether for reducing the distance between the first compressor and the second compressor to improve the flow through the left ventricular outflow tract.

[0022] Embodiments disclosed herein may include a system for the heart. The system may include a stent configured to be deployed within the heart proximate to the left ventricular outflow tract of the heart and including a flow channel through which fluid passes through the left ventricular outflow tract.

[0023] Embodiments disclosed herein may include a system for the heart. The system may include a first artificial heart valve configured to be implanted in the aortic valve of the heart and a second artificial heart valve coupled to the first artificial heart valve and configured to be implanted in the mitral valve of the heart.

[0024] In another embodiment, the artificial valve may include one or more artificial valve leaflets configured to be positioned within a flow channel, a valve body configured to support the one or more artificial valve leaflets, and at least one distal arm coupled to the valve body and configured to apply a force to the ventricular septum between the left ventricle and the right ventricle of the heart.

[0025] The features and advantages regarding the systems, devices and methods disclosed in this specification will become apparent as they are more clearly understood with reference to the specification, the claims and the accompanying drawings.

Brief Description of the Drawings

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[0027] FIG. 1 shows a perspective view of an artificial valve 10 in the form of a replacement heart valve. The artificial valve 10 can be configured to be deployed within a portion of a patient's body. The artificial valve 10 can include a native mitral valve or a native tricuspid valve, for example, and can be deployed around the valve annulus of the native valve. In an example, other implantation sites can be utilized, such as within the aortic valve or pulmonary valve, or, optionally, other valves or other locations within the patient's body can be utilized as desired.

[0028] The artificial valve 10 can include a proximal end 12 (or inlet end), a distal end 14 (or outlet end) (marked in FIG. 2), and a length therebetween. The artificial valve 10 can further include a valve portion that includes one or more artificial valve leaflets 16 or a plurality of artificial valve leaflets 16 configured to be positioned within a flow channel to control flow through the valve 10. The leaflets 16 can be made of pericardium or another desired material. The artificial valve leaflets 16 can be configured to mimic the operation of the native valve leaflets and move between an open state and a closed state to replace the native valve leaflets. The valve portion can enable one-way blood flow through a flow channel or passageway to replace the function of the native valve.

[0029] In an embodiment, the artificial valve leaflets 16 can be coupled to a valve body or support structure 15 configured to support the one or more artificial valve leaflets 16. The support structure 15 can include a frame (e.g., a valve frame or an outer support stent having an inner frame 18 and an outer frame 20, particularly in the form of a frame), and an inner support stent having a sealing body 11. The valve frame or inner frame 18 is shown in FIG. 1B and in a cross-sectional view of FIG. 2. The outer frame 20 is shown in FIGS. 1A and 2. The outer frame 20 can be part of the sealing body 11 and can be spaced apart from the inner frame 18. The support structure 15 can be formed from a shape memory material such as nitinol or another form of shape memory material in an embodiment.

[0030] Referring to FIGS. 1A and 2, the prosthetic valve 10 may include one or more anchors 17 that may be coupled to the prosthetic valve leaflet 16. Each anchor 17 may be configured to anchor the prosthetic valve leaflet 16 to a portion of the patient's heart that may include a native valve. In particular, the anchor 17 may be configured to anchor to the native valve leaflet of the patient's heart. The anchor 17 may extend around the native valve leaflet and may be capable of anchoring to the native valve leaflet. The anchor 17 may include a distal anchor positioned at the distal end 14 of the valve 10, or in embodiments, may be positioned at another location as desired.

[0031] Each anchor 17 may be configured to extend distally and then configured as a projecting arm that curves proximally to the tip of each respective anchor 17. With such a configuration, the anchor 17 may be capable of extending around the native valve leaflet and around the distal tip of the valve leaflet and latching onto the distal tip of the native valve leaflet, and may be capable of being disposed radially outside the outer surface of the native valve leaflet. The anchor 17 may be configured, for example, to form a latching configuration as shown in FIGS. 1A-2. Thus, the anchor 17 may resist a force applied to the valve 10 in the atrial direction, i.e., the proximal direction, and may be capable of anchoring the valve 10 within the native valve annulus. Optionally, in embodiments, other configurations for the anchor 17 may be utilized.

[0032] The prosthetic valve leaflet 16 may surround a passageway or flow channel 25, as marked in FIG. 2, and may move between an open state and a closed state and control the flow through the flow channel 25. As shown in FIG. 2, the proximal end of the prosthetic valve 10 may include the inflow end of the valve 10, and the distal end of the prosthetic valve 10 may include the outflow end, although other configurations may be utilized as desired. The prosthetic valve leaflet 16 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.

[0033] Referring again to FIG. 1, the prosthetic valve 10 can include an outer support stent having a sealing body 11. The sealing body 11 can be positioned radially outwardly from the prosthetic valve tip 16 and can be configured to seal a portion of the native valve. The sealing body 11 can include the outer surface of the valve 10. The sealing body 11 can define the outer diameter of the valve 10 and can include the outer periphery of the valve 10. The sealing body 11 may include a proximal portion having a proximal end 31 and may include a distal portion having a distal end 33 (shown in FIG. 2).

[0034] Referring to the cross-sectional view of FIG. 2, the sealing body 11 can include a frame 20 and a sealing skirt 24, or, in an embodiment, can include only the frame, or only the sealing skirt, as desired. The frame 20 can include an outer frame positioned radially outwardly from the inner frame 18. The sealing skirt 24 may be coupled to the outer frame 20 and can include the outer portion of the sealing body 11, as shown in FIG. 1A.

[0035] The sealing skirt 24 can be made of a material resistant to fluid flow therethrough, such as a cloth material, a woven material, or other materials such as a polymer, or other materials resistant to fluid flow therethrough. The material can include a fabric. Various materials can be utilized for the skirt 24, as desired.

[0036] The sealing body 11 can be configured to abut against a portion of the patient's heart so as to reduce fluid flow. The skirt 24 can be configured to seal a portion of the native valve annulus. For example, the sealing body 11 can abut against the surface formed by the patient's native valve tip so as to reduce fluid flow between the sealing body 11 and the native valve tip. The sealing body 11 can be configured to abut against other portions of the patient's heart, as desired, so as to reduce fluid flow.

[0037] In an embodiment, the sealing body 11 can be made flexible to allow movement and conformity to the native valve annulus.

[0038] FIG. 3 shows the advancement of a delivery system 70 for deploying the prosthetic valve 10 relative to an implantation site. The delivery system 70 may include an elongated shaft 72 having a proximal portion and a distal portion, the proximal portion being coupled to a housing in the form of a handle 74. The delivery system 70 may be advanced through a patient's vasculature including the femoral vein as shown in FIG. 3. In embodiments, other introduction techniques may be utilized, including transapical ones and those via surgical techniques such as thoracotomy or cardiotomy.

[0039] In embodiments, the prosthetic valve 10 may be positioned within the implant retention region of the delivery system 70 and may be covered by a capsule or otherwise retained at a pre-deployment time. The prosthetic valve 10 may be deployed as a self-expanding prosthesis. The shape memory material of the support structure may enable the valve 10 to self-expand. However, in embodiments, the prosthetic valve may be, among other deployment forms, a balloon-expandable prosthetic valve (e.g., positioned on a body or balloon that is expandable upon introduction into the patient's body or slid onto a body or balloon that is expandable within the patient's body), or may be mechanically expanded.

[0040] The delivery system 70 may be advanced to pass into the atrium of the heart and may reach the implantation site by passing transseptally into another atrium (e.g., from the right atrium to the left atrium). Such a delivery approach may be utilized, for example, with respect to access to the mitral native valve. In an example, the delivery system 70 may extend to the right atrium for tricuspid valve access, or, as desired, in embodiments, other delivery approaches to other implantation sites may be utilized.

[0041] The prosthetic valve 10 may be held in a compressed configuration within the capsule of the delivery system 70. The anchor 17 may be advanced and deployed radially outward from the capsule.

[0042] Figure 4 shows the prosthetic valve 10 deployed relative to the native valve 80. The sealing body 11 can extend radially outward and contact the inward surface of the native valve leaflet 82. The anchor 17 can be latched onto the native valve leaflet 82 such that the tip of the anchor 17 is positioned radially outward of the native valve leaflet 82.

[0043] In an embodiment, the configuration of the native valve 80 including calcification can prevent the prosthetic valve from properly deploying at the implantation site. For example, calcification can prevent the prosthetic valve from sealing with the native valve. Calcification can prevent the prosthetic valve from anchoring to the native valve. Calcification can result in occlusion of the left ventricular outflow tract (LVOT) 350, for example, based on implantation of a prosthetic valve into a calcified native mitral valve as shown in FIG. 17C. Calcification can have other undesirable effects on the implantation of the prosthetic valve or other treatments of the native valve or heart.

[0044] For example, referring to FIG. 5, calcification 84 can be present under or radially outward of the outward surface of the leaflet 83 of the native heart valve 88. The outward surface can comprise a downstream or downstream surface. Such calcification 84 can prevent the ability of the anchor 17, as shown in FIG. 4, to latch around and anchor to the native valve leaflet 83, for example. Calcification 84 can prevent the anchor 17 from being positioned radially outward of the outer surface of the leaflet 83 in a desired manner.

[0045] Calcification 86 can be positioned radially inward of the leaflet 83. For example, calcification 86 can be positioned on the upstream side or upstream surface of the leaflet 83, or on a surface facing inward, or can project inwardly towards the flow channel between the leaflets 83. In an embodiment, calcification 86 can be positioned on the annulus of the native heart valve 88 or can be positioned within the atrium of the heart. Such calcification 86 can prevent the prosthetic valve from sealing or anchoring to the native valve. An irregularly shaped annulus can be produced, which can prevent the prosthetic valve from deploying to the native heart valve 88 in a desired manner. Calcification can be present in the mitral valve and can include mitral annular calcification (MAC).

[0046] Figures 6A-6C show examples of the anchor 90 that can be utilized in the embodiments of this specification. The anchor 90 can include a hinge 92 that forms a loop, and a straight portion 94 configured to extend radially outward from the loop. The anchor 90 can include a coupling portion 96 configured to couple to a support structure configured to support one or more prosthetic valve leaflets, such as the support structure 15 shown in FIG. 1A or another form of support structure. At least one anchor 90 can be coupled to the support structure 15. The anchor 90 can be utilized with a prosthetic valve having one or more prosthetic valve leaflets configured to be positioned within a flow channel, such as shown in FIG. 2. The anchor 90 can be configured as an arm or can have another configuration in an embodiment.

[0047] The coupling portion 96 can be configured to couple to the frame of the support structure, for example, at a support structure or a distal portion 98 of a frame, such as described in FIG. 2. The coupling portion 96 can extend distally from the distal portion 98 of the support structure to the hinge 92 in an embodiment. The coupling portion 96 can include an arm or can have another configuration in an embodiment.

[0048] As shown in FIG. 6A, the hinge 92 can project radially inwardly and can form a loop having a semi-circular shape. The loop shape of the hinge 92 can allow the straight portion 94 to rotate around the hinge 92 while the straight portion 94 maintains a straight shape. The hinge 92 can be positioned between the straight portion 94 and the coupling portion 96 and configured to couple the hinge 92 to the support structure.

[0049] The hinge 92 can allow the straight portion 94 to extend at various angles with respect to the support structure and with respect to the central axis 61 of the prosthetic valve, such as shown in FIG. 2. As shown in FIG. 6A, the straight portion 94 can extend at an acute angle 100 that can be between 0 degrees and 90 degrees, or can extend at a straight angle 102 or more, such as shown in FIG. 6B. The angle 104 can be a right angle, such as shown in FIG. 6C.

[0050] The straight portion 94 can include a straight portion that can extend from the hinge 92 to the tip 106 of the anchor 90. The straight portion 94 can be positioned between the hinge including the loop and the tip 106. The tip 106 can be angled with respect to the straight portion 94.

[0051] Prior to deployment, the anchor 90 can be held in an extended or straight angle position, as shown in FIG. 6B. The anchor 90 can extend distally with the tip 106 distal to the hinge 92. During deployment, the anchor 90 can be released such that the straight portion 94 rotates proximally around the hinge 92.

[0052] For example, referring to FIG. 6C, the straight portion 94 rotates proximally to reduce the angle 104 between the coupling portion 96 and the straight portion 94. The straight portion 94 can be configured to extend radially outward of the native valve leaflet 83 and can extend over the distal tip 108 of the leaflet 83. The straight portion 94 can contact the calcification 84 positioned radially outward of the leaflet 83. The straight portion 94 can extend along the calcification 84, anchor to the calcification 84, and resist the proximal force applied to the anchor 90 and the support structure. In an embodiment, the tip 106 can engage the calcification 84 and be anchored to the calcification 84.

[0053] The hinge 92 can be biased to rotate the straight portion 94 proximally. For example, the straight portion 94 is shown extending vertically as shown in FIG. 6C, and the straight portion 94 can continue to rotate proximally to a configuration that depends on the calcification 84 and the shape of the native valve, as shown in FIG. 6A. Various angles can occur between the straight portion 94 and the coupling portion 96.

[0054] The features of the embodiments of FIGS. 1A - 6C can be utilized alone or in combination with any other embodiment disclosed herein.

[0055] In an embodiment, other forms of anchors can be utilized.

[0056] Figures 7A-7B show an embodiment of an artificial valve 110 configured to include a proximal anchor (shown in Figure 7B) including a proximal or first flange 114 configured to extend radially outwardly from a passageway or flow channel 116, and a distal anchor (shown in Figure 7B) including a distal or second flange 118.

[0057] Referring to FIGS. 7A and 7B, the support structure 112 may include an inner support stent 111 having an inlet end portion 113 and an outlet end portion 115. The support structure 112 may include an outer conforming structure 117 for conforming to calcification on a calcified native mitral valve to enhance sealing and anchoring to the calcified native mitral valve. The outer conforming structure 117 may surround the inner support stent 111. The inner support stent 111 and / or the outer conforming structure 117 may be in the form of a fabric or may have another configuration and may comprise a mesh. The mesh may enable the support structure 112 to move and conform to the shape of a native valve, including a native valve having calcification. For example, referring to FIG. 7A, the support structure 112 may be in an undeployed or unexpanded configuration and may have a cylindrical configuration. In such a configuration, the flanges 114, 118 may not protrude from the support structure 112 or may not protrude fully, as shown in FIG. 7B. The flanges 114, 118 may be made of mesh in an embodiment. The support structure 112 may be retained in a cylindrical configuration in an undeployed or unexpanded configuration to reduce the profile or outer diameter of the support structure 112 as it passes through an individual's vasculature. The flanges 114, 118 may be retained in a stowed configuration in the cylindrical configuration. The support structure 112 may be covered by components of a delivery device (e.g., a capsule, or other components) or may be exposed as it passes through the vasculature.

[0058] The support structure 112 can be configured to expand to a radially outwardly expanded configuration. The outer conforming structure 117 can form flanges 114, 118. The flanges 114, 118 can be configured to move radially outwardly in the expanded configuration. In an embodiment, the support structure 112 can be biased to expand radially outwardly. For example, the support structure 112 can be made of a shape memory material that expands radially outwardly when completely or partially released from the delivery device 120. The shape memory material can include, in an embodiment, nitinol (NiTi), or another form of shape memory material. In an embodiment, the support structure 112 can be axially compressed to be configured to expand the support structure 112 radially outwardly. The delivery device 120 can be configured to compress, for example, the proximal end 122 and the distal end 124 of the support structure 112 together to expand the support structure 112 radially outwardly.

[0059] FIG. 7B shows a cross-sectional view of the support structure 112 expanded to a radially outwardly deployed or expanded configuration. The first flange 114 can extend radially outwardly and can form a disk. The disk can extend circumferentially around the flow channel 116. The disk may be positioned on the proximal or atrial side of the native heart valve and can resist the distal or ventricular forces applied to the support structure 112.

[0060] The disk of the first flange 114 may include a first end portion 126 and a second end portion 128, and a protruding portion 130 configured to protrude radially outward from the first end portion 126 and the second end portion 128. The protrusion of the protruding portion 130 may define a diameter 132 of the disk. The first end portion 126 and the second end portion 128 may be configured to move toward each other when the support structure 112 extends radially outward from the configuration shown in FIG. 7A to the extended configuration shown in FIG. 7B. The movement between the end portions 126, 128 may be axial along the protruding portion 130 extending radially outward from the end portions 126, 128. Thus, while the diameter 132 of the support structure 112 may increase, the axial length 134 (shown in FIG. 7A) of the support structure 112 may decrease. The protruding portion 130 may comprise a loop of material forming the outer wall 150 of the outer conforming structure 117.

[0061] The second flange 118 may be configured similarly to the first flange 114. The second flange 118 may, for example, extend radially outward and may form a disk. The disk may extend circumferentially around the flow channel 116. The disk may be positioned on the distal or ventricular side of the native heart valve and may resist the proximal or atrial force applied to the support structure 112. The disk may similarly include a first end portion 136 and a second end portion 138, and a protruding portion 140 configured to protrude radially outward from the first end portion 136 and the second end portion 138. The protrusion of the protruding portion 140 may define a diameter 142 of the disk. The first end portion 136 and the second end portion 138 may be configured to move toward each other when the support structure 112 expands radially outward from the configuration shown in FIG. 7A to the extended configuration shown in FIG. 7B. The movement between the end portions 136, 138 may be axial with the protruding portion 140 extending radially outward from the end portions 136, 138.

[0062] The central portion 144 may be positioned between the first flange 114 and the second flange 118 and may include a reduced diameter portion of the support structure 112. The central portion 144 may have a diameter 146 that is, for example, smaller than the diameter 132 of the first flange 114 and the diameter 142 of the second flange 118. The central portion 144 may include a waist of the support structure 112 that may curve inwardly from the protruding portions 130, 140 of each of the first flange 114 and the second flange 118.

[0063] In an embodiment, the central portion 144 may be configured to conform to the shape of a native valve. The central portion 144 may be configured to accommodate calcification or other shapes of the native valve. In an embodiment, the central portion 144 may include a curved portion that may curve radially inwardly from the protruding portions 130, 140 of each of the first flange 114 and the second flange 118. The central portion 144 may have other shapes in embodiments.

[0064] The central portion 144 or one or more of the flanges 114, 118 may be configured to conform to the shape of a native valve and provide a seal with the native valve. In an embodiment, all or a portion of the support structure 112 may include a sealing skirt or, alternatively, may be configured to provide a seal with the native valve.

[0065] In an embodiment, the support structure 112 may include a cavity 148 that may extend between the outer wall 150 of the outer conforming structure 117 and the flow channel 116 of the support structure 112. In an embodiment, the interior of the support structure 112 may be filled or may lack the cavity 148.

[0066] The support structure 112 may be coupled to one or more prosthetic valve leaflets 152 that may be disposed within the flow channel 116. The support structure 112, particularly the inner support stent 111, may be configured to support one or more prosthetic valve leaflets 152. The prosthetic valve leaflets 152 may be coupled to the inner wall 154 of the inner support stent 111 and may extend radially inwardly from the inner wall 154.

[0067] In an embodiment, the support structure 112 and the inner support stent 111 can be configured to include a dock that can engage an insert such as a cusp support that can hold the prosthetic valve cusp 152. In such an embodiment, the support structure 112 can be initially deployed, and the insert can be deployed in a subsequent action that can engage the inner support stent 111.

[0068] The support structure 112 can advantageously be configured to conform to the shape of a native valve including calcification 84. The calcification 84 can be positioned radially outward of the cusp 83 of the native valve, or can be positioned radially inward or atrial of the cusp 83 of the native valve. The first flange 114 or the second flange 118 can be anchored to and configured to conform to the calcification of the native valve, or another portion of the native valve.

[0069] The prosthetic valve 110 can be utilized with a mitral or tricuspid valve of the heart, or another location for placement as needed.

[0070] The features of the embodiments of FIGS. 7A-7B can be utilized alone or in combination with any other embodiment disclosed herein.

[0071] FIGS. 8A-8B show an embodiment of a prosthetic valve 160 including a support structure 162 including a proximal anchor including a proximal or first flange 164 configured to extend radially outward from a flow channel 166, and a distal anchor including a distal or second flange 168 configured to extend radially outward from the flow channel 166. The support structure 162 can be configured to support one or more prosthetic valve cusps 186 that can be positioned within the flow channel 166.

[0072] The support structure 162 can be configured to form the first flange 164 and the second flange 168, and can include an inner support stent including a frame 170 (shown in FIG. 8B) that can extend between the first flange 164 and the second flange 168.

[0073] A portion of the frame 170 with the first flange 164 can be configured to be positioned in an undeployed or compressed configuration where the first end portion 172 is positioned proximal to the second end portion 174. When moving to a deployed or expanded configuration, the first end portion 172 can move radially outward from the second end portion 174 to the positions shown in FIGS. 8A and 8B. The first flange 164 can extend horizontally relative to the central portion of the frame 170. Similarly, a portion of the frame 170 with the second flange 168 can be configured to be positioned in an undeployed or compressed configuration where the first end portion 176 is positioned distal to the second end portion 178. When moving to a deployed or expanded configuration, the first end portion 176 can move radially outward from the second end portion 178 to the positions shown in FIGS. 8A and 8B. The second flange 168 can extend horizontally relative to the central portion of the frame 170. Thus, the first flange 164 and the second flange 168 can be stored with the support structure 162 in a cylindrical configuration and configured to move radially outward in an expanded configuration.

[0074] The first flange 164 may form a disk, and the second flange 168 may form a disk. Each disk can extend circumferentially around the flow channel 166, for example, as shown in FIG. 8A. The disk of the first flange 164 may be positioned on the proximal or atrial side of the native heart valve and can resist the distal or ventricular forces applied to the support structure 162. The disk of the second flange 168 may be positioned on the distal or ventricular side of the native heart valve and can resist the proximal or atrial forces applied to the support structure 162.

[0075] The outer conforming structure can be provided to conform to calcification on the calcified native mitral valve in order to enhance sealing and anchoring to the calcified native mitral valve. For example, the frame 170 may be configured to form a seal with the native valve and may be covered with a material including an outer conforming structure that can form the outer surface 171 of the artificial valve 160. The material may include a sealing skirt in an embodiment or in another form of material. A conformable or compliant body, such as the pad 180, may be positioned between the frame 170 and a material that can be configured to conform to the shape of the native valve. For example, the pad 180 may include a compressible cloth or a compressible foam that can be configured to conform to the shape of the native valve. In an embodiment, the pad 180 may include a shape memory material (e.g., a shape memory foam). The pad 180 may be positioned on one or more of the central portion 182 of the support structure 162 positioned between the flanges 164, 168 or the flanges 164, 168. Thus, the support structure 162 and the flanges 164, 168 can be configured to anchor to and conform to the shape of the native valve, which may include calcification.

[0076] In an embodiment, the second flange 168 may include a plurality of distal anchors, such as paddles or another form of anchor, that can be positioned distally or in the ventricle of the native valve.

[0077] In an embodiment, the support structure 162, particularly the inner support stent, may include a distal portion 184 that can project distally from the second flange 168. The artificial valve tip 186 may be positioned within the distal portion 184 or may be positioned in another way relative to the support structure 162. In an embodiment, the distal portion 184 may include a cylindrical portion that projects distally from the second flange 168 or may have another configuration as desired.

[0078] The artificial valve 160 can be used with the mitral valve or tricuspid valve of the heart or another location for placement as needed.

[0079] The features of the embodiments of FIGS. 8A-8B can be utilized alone or in combination with any other embodiment disclosed herein.

[0080] FIGS. 9A-9B show an embodiment of an artificial valve 190 including a support structure 192 that includes a proximal anchor having a proximal or first flange 194 (shown in FIG. 9B) configured to extend radially outwardly from a flow channel 195, and a distal anchor having a distal or second flange 196 (shown in FIG. 9B) configured to extend radially outwardly from the flow channel 195. The support structure 192 can be configured to support one or more artificial valve leaflets 208 that can be positioned within the flow channel 195.

[0081] In an embodiment, the first flange 194 may comprise an expandable body and the second flange 196 may comprise an expandable body. The support structure 192 may, in an embodiment, comprise a single expandable body (as shown in FIG. 9B) that can join the first flange 194 to the second flange 196, or may comprise a plurality of expandable bodies. The expandable body can, in an embodiment, be positioned on an inner support stent, or frame 206, of the support structure 192. The expandable body can, in an embodiment, comprise an outer conforming structure or bladder configured to be filled with a fluid that is expanded to increase the diameter 198 of the first flange 194 and the diameter 200 of the second flange 196. The expandable body can comprise a chamber. The bladder may include a silicone bladder or, in an embodiment, may have another configuration.

[0082] For example, referring to FIG. 9A, the support structure 192 may be in a compressed or undeployed configuration and can be advanced to a implantation site using a delivery device 202. The expandable body can be in an undeployed configuration. A fluid conduit 204 can, in an embodiment, extend to the expandable body to fill the expandable body.

[0083] Once the support structure 192 is positioned at the desired location, the inflatable body can be filled via the fluid conduit 204. Referring to FIG. 9B, the first flange 194 may expand radially outward to form a disk positioned on the proximal or atrial side of the native valve, and the second flange 196 may expand radially outward to form a disk positioned on the distal or ventricular side of the native valve. Thus, the flanges 194, 196 may each be housed in a cylindrical configuration as shown in FIG. 9A and configured to move radially outward in an expanded configuration. The flanges 194, 196 can be filled with fluid to conform to the shape of the native valve, which may include calcification 84. The flanges 194, 196 can be anchored to the calcification 84. The central portion 205 of the support structure 192 between the first flange 194 and the second flange 196 can likewise be filled with fluid to conform to the shape of the native valve. The support structure 192 can seal with the native valve to reduce fluid flow (e.g., paravalvular leakage) around the support structure 192.

[0084] In embodiments, the filling material that can be utilized can include a fluid such as saline or other forms of fluid. The filling material can be a liquid, foam, epoxy, gas, or other material. The filling material can be a liquid and can effect a hydraulic expansion of the inflatable body. The filling material in the form of a gas can include carbon dioxide or helium among other forms of gas.

[0085] In embodiments, the filling material can include a curable material. The filling material can be configured to cure over time to enhance the sealing of the outer conforming structure. The curable material can be introduced into the inflatable body at a first relatively low viscosity and can be converted to a second relatively high viscosity. The increase in viscosity can be achieved by various UV-initiated polymerization reactions, by various catalyst-initiated polymerization reactions, or by other chemical systems. The end point of the viscosity increase process can be to result in any hardness from a gel to a rigid structure, depending on the desired performance.

[0086] The curable material may include epoxy. Epoxy can be cured by mixing materials that cure when combined. The curing catalyst can be delivered at the time of implantation or after implantation. The curable material may be biocompatible and may be capable of conforming to the shape of a local native valve. In an embodiment, the curable material may be bioabsorbable.

[0087] In an embodiment, the filling material may be radiopaque for visualization during implantation. The radiopaque material can be added during filling, for example, as part of the curing process.

[0088] In an embodiment, the filling material may include a gel or a foam, which may be biocompatible and may be configured to cure over time. The gel or foam may be inserted into the sealing body or may be provided within a capsule that dissolves during implantation to allow for inflation.

[0089] In an embodiment, a gel that can be produced via polymer precipitation from a biocompatible solvent can be utilized. Various siloxanes can also be utilized as expanding gels. Other gel systems that can be utilized may include phase change systems that gel upon heating or cooling from an initial liquid state, i.e., a thixotropic state. The gel may also include a thixotropic material that can be easily injected via a fluid conduit and that remains in a gel state even when the shear rate is zero or low, such that it undergoes sufficient shear thinning.

[0090] In an embodiment, the filling material may contain a foaming agent. The foaming agent can generate pressure inside the expandable body.

[0091] Any of the filling materials disclosed herein may, in an embodiment, be biocompatible and may, optionally, be bioabsorbable. The bioabsorbable sealing body can improve sealing through tissue adhesion to the native valve.

[0092] In an embodiment, the expandable body of the support structure 192 can be positioned on an inner support stent, or frame 206, that can support the valve tip 208 of the prosthetic valve within the flow channel 195.

[0093] The prosthetic valve 190 can be used with the mitral or tricuspid valve of the heart, or another location for placement as needed.

[0094] The features of the embodiments of FIGS. 9A - 9B can be utilized alone or in combination with any other embodiment disclosed herein.

[0095] FIG. 10 shows an embodiment of a prosthetic valve 210 including a support structure 212 that includes a proximal or first flange 214 configured to extend radially outwardly from the flow channel 216 and a distal or second flange 218 configured to extend radially outwardly from the flow channel 216.

[0096] The support structure 212 can include an inner support stent, or frame 220, that can support one or more prosthetic valve tips (not shown) within the flow channel 216. The frame 220 is visible in FIG. 10, and the other components of the prosthetic valve 210 are excluded in FIG. 10 for clarity. The frame 220 may include a proximal ridge 222 that can include the proximal or first flange 214 and a distal ridge 224 that can include the distal or second flange 218. The first flange 214 and the second flange 218 can each be configured to anchor to a native valve that can include calcification 84.

[0097] The first flange 214 may be positioned, for example, proximally or on the atrial side of a native heart valve and may resist distal or ventricular forces applied to the support structure 212. The second flange 218 may be positioned distally or on the ventricular side of a native heart valve and may resist proximal or atrial forces applied to the support structure 212. In an embodiment, the sealing body or outer conforming structure may be applied to the frame 220 to conform to calcification on a calcified native mitral valve to enhance sealing and anchoring to the calcified native mitral valve.

[0098] The artificial valve 210 may be utilized with the mitral valve, tricuspid valve of the heart, or another location for placement as needed.

[0099] The features of the embodiment of FIG. 10 may be utilized alone or in combination with any other embodiment disclosed herein.

[0100] FIG. 11B shows an embodiment of an artificial valve 230 including a support structure 232 including a proximal anchor with a proximal or first flange 234 configured to extend radially outwardly from the flow channel 236 and a distal anchor with a distal or second flange 238 configured to extend radially outwardly from the flow channel 236. The support structure 232 may include a plurality of flanges including additional proximal flange 240 and distal flange 242 and may include additional flanges.

[0101] The support structure 232 may be configured to support one or more artificial valve leaflets (not shown) positioned within the flow channel 236.

[0102] FIG. 11A shows the flat pattern of the frame 233, or the inner support stent, of the support structure 232 shown in FIG. 11B. The flanges 234, 238, 240, 242 may comprise cut-out portions of the flat sheet of the frame. The channel 244 may be formed between the flanges 234, 238, 240, 242 due to the cut-out of material from the frame 233. Each of the flanges 234, 238, 240, 242 may have respective ends 246, 248, 250, 252 configured to project radially outward from the frame 233. The ends 250, 252 of the flanges 240, 242 may be angled towards each other (as shown in FIG. 11B), and the ends 248, 246 of the flanges 238, 234 may be angled towards each other (as shown in FIG. 11B). The flanges 234, 238, 240, 242 may each, in an embodiment, comprise barbs.

[0103] The angles of the flanges 234, 238, 240, 242 can enable the proximal flanges 234, 240 to engage the proximal portion or atrial portion of the native valve, and the distal flanges 238, 242 can enable engagement with the distal portion or ventricular portion of the native valve. The flanges 234, 238, 240, 242 may be configured to engage the leaflets of the native valve and may be configured to engage the calcification of the native valve. In an embodiment, the sealing body or outer conforming structure is applied to the frame 233 to conform to the calcification on the calcified native mitral valve to enhance sealing and anchoring to the calcified native mitral valve.

[0104] The artificial valve 230 can be utilized with the mitral valve, or tricuspid valve, of the heart, or at another location for deployment as needed.

[0105] The features of the embodiments of FIGS. 11A - 11B can be utilized alone or in combination with any other embodiments disclosed herein.

[0106] Figure 12 shows an embodiment of an artificial valve 260 having a support structure 261 that includes an atrial anchor 262 that forms a ring around a flow channel 264. The support structure 261 can include a support stent. The support structure 261 can be for deployment upstream of a native valve. The ring can extend circumferentially around the flow channel 264 and can include a disk that extends radially outward from the flow channel 264. The support structure 261 can be configured to support one or more artificial valve leaflets 263 that can be positioned within the flow channel 264.

[0107] The ring can include an upper surface 266 configured to face in the atrial direction and a lower surface 268 opposite the upper surface 266 and configured to face in the ventricular direction. An adaptor 270 can be positioned on the lower surface 268 and can be configured to conform to the shape of the native valve. The adaptor 270 can include, for example, an inflatable body, or a foam, or other material that can be configured to conform to the shape of the native valve. The inflatable body can be filled with a curable material disclosed herein. The adaptor 270 can be configured to conform to the shape of calcification 86 of the native valve. Thus, the atrial anchor 262 can anchor to the calcification 86.

[0108] In an embodiment, the adaptor 270 can include a sealing body configured to form a seal with the native valve. The seal can prevent fluid flow (e.g., paravalvular leakage) outside of the flow channel 264.

[0109] The ring can be configured to resist distal or ventricular forces applied to the artificial valve 260. Contact between the ring and the native valve or calcification 86 of the native valve can, for example, impede distal movement of the artificial valve 260.

[0110] The artificial valve 260 can be deployed with an atrial anchor 262 angled upward or downward (in a non-deployed configuration). Next, the atrial anchor 262 can extend radially outward and extend horizontally in a deployed configuration.

[0111] In an embodiment, the prosthetic valve 260 can include one or more distal anchors 272 configured to anchor the prosthetic valve 260 to the native valve from the ventricular side of the native valve. The distal anchor 272 can be configured similarly to any of the distal anchor embodiments disclosed herein.

[0112] The prosthetic valve 260 can be utilized with the mitral valve, tricuspid valve of the heart, or another location for deployment as needed.

[0113] The features of the embodiment of FIG. 12 can be utilized alone or in combination with any of the other embodiments disclosed herein.

[0114] FIG. 13 shows an embodiment of a prosthetic valve 280 having a support structure 281 that includes an atrial anchor 282 that forms a ring around a flow channel 284. The support structure 281 can include a support stent. The ring can extend radially outwardly from the flow channel 284. The support structure 281 can be configured to support one or more prosthetic valve leaflets 283 positioned within the flow channel 284.

[0115] The ring can include a gasket configured to conform to the shape of the native valve on the atrial side of the valve. For example, the gasket can be adapted and configured to conform to the shape of the calcification 86 on the atrial side of the valve. Accordingly, the gasket can be anchored to the calcification 86. The gasket can include any form of compliant, or conformable body disclosed herein. A foam or rubber material can be utilized in an embodiment among other forms of materials.

[0116] The gasket can be configured to resist distal or ventricular forces applied to the prosthetic valve 280. The contact between the gasket and the native valve or the calcification 86 of the native valve can, for example, impede the distal or ventricular movement of the prosthetic valve 280.

[0117] In an embodiment, the gasket may include a sealing body configured to form a seal with the native valve. The seal may prevent fluid flow outside of the flow channel 284 (e.g., perivalvular leakage).

[0118] The prosthetic valve 280 may further include one or more distal anchors 286 configured to anchor the prosthetic valve 280 to the native valve from the ventricular side of the native valve. The distal anchors 286 may be configured similarly to any of the embodiments of distal anchors disclosed herein.

[0119] The prosthetic valve 280 may be utilized with the mitral valve, tricuspid valve, or another location of the heart as needed for deployment.

[0120] The features of the embodiment of FIG. 13 may be utilized alone or in combination with any of the other embodiments disclosed herein.

[0121] FIGS. 14A-14B illustrate an embodiment of a prosthetic valve 290 that includes a support structure 291 having an atrial anchor 292 that forms a ring around a passageway or flow channel 294. The ring may have a tubular shape. The support structure 291 may be configured to support one or more prosthetic valve leaflets 296 positioned within the flow channel 294.

[0122] One or more prosthetic valve leaflets 296 may be coupled to the ring. One or more prosthetic valve leaflets 296 may be configured to overlap one or more native valve leaflets 298 of the native valve. One or more prosthetic valve leaflets 296 may overlap upstream of one or more native valve leaflets 298. One or more prosthetic valve leaflets 296 may be configured to provide a junction with each other (e.g., during systole) and may be configured to open (e.g., during diastole).

[0123] Referring to FIG. 14B, the atrial anchor 292 may extend around the atrial side of the native valve and may have a crescent shape with end portions 300, 302 of the atrial anchor 292 that are separated from each other by a gap 303. The end portions 300, 302 may be repositionable to accommodate the size of the native valve. The atrial anchor 292 may be anchored in place due to the radially outward expansion force of the atrial anchor 292, or other forms of anchors may be utilized to fix the atrial anchor 292 in place. Other forms of anchors may include barbs, screws, adhesives, or other anchoring methods. The artificial valve 290 may be utilized with the mitral valve, tricuspid valve, or another location for deployment as needed in the heart.

[0124] The features of the embodiments of FIGS. 14A - 14B may be utilized alone or in combination with any of the other embodiments disclosed herein.

[0125] The configuration of the artificial valve leaflet may vary in the embodiments. For example, FIG. 15 shows the configuration of an artificial valve leaflet 304 that extends around the native valve leaflet 298 and is positioned on the surface of the native valve leaflet 298 that faces the ventricle or distal or downstream. The artificial valve leaflet 304 may lock around the tip 306 of the native valve leaflet 298 or may be wound around the tip 306. The artificial valve leaflet 304 may overlap the ventricle side or distal side or downstream side (and calcification in the embodiments) of the native valve leaflet 298. The artificial valve leaflet 304 may be wound around the native valve leaflet 298 to cover the upstream and downstream sides of the leaflet 298. The artificial valve leaflet 304 may include a distal end portion 305 having barbs 307 or other forms of anchors for anchoring to calcification 309 on the ventricle or distal or downstream side of the native valve leaflet 298. The barbs 307 may engage with the calcification 309 to fix the position of the artificial valve leaflet 304 on the native valve leaflet 298.

[0126] The features of the embodiment of FIG. 15 may be utilized alone or in combination with any of the other embodiments disclosed herein.

[0127] Figures 16A - 16B show an embodiment of an artificial valve 310 including a support structure 318 having an atrial anchor 312 that forms a ring around a flow channel 314. The atrial anchor 312 may comprise a flange configured as a disk that extends radially outward from a proximal end portion 316 of the support structure 318 and extends circumferentially around the flow channel 314. The support structure 318 may be configured to support one or more artificial valve leaflets 311 that may be positioned within the flow channel 314.

[0128] In an embodiment, one or more penetrators 320 may be configured to pass through the ring and anchor the support structure 318 to the native valve. The penetrator 320 may include a screw or may have another form in the embodiment. In an embodiment, the penetrator 320 may have another form such as a barb or an expandable clip or other desired form. The penetrator 320 may be inserted on the proximal side or atrial side of the ring and may be circumferentially positioned around the flow channel 314.

[0129] In an embodiment, one or more penetrators 320 may be configured to be anchored to calcification 84 of the native valve, for example, as shown in Figure 16B.

[0130] The artificial valve 310 may be utilized with the mitral valve, tricuspid valve of the heart, or another location for deployment as needed.

[0131] The features of the embodiment of Figures 16A - 16B may be utilized alone or in combination with any other embodiment disclosed herein.

[0132] Figures 17A - 17D show an embodiment of an artificial valve system 330 (depicted in Figure 17D) configured to be deployed to a native valve. The artificial valve system 330 may include a valve body, or support structure 332 (depicted in Figure 17B), and a dock 334 (depicted in Figure 17A). The dock 334 may be configured to dock with the support structure 332.

[0133] Referring to FIG. 17A, the dock 334 can include a first end portion 336 and a second end portion 338 and can have an elongated body configured to form a crescent shape. The first end portion 336 can include a first through-body 340 configured to anchor to heart tissue. The second end portion 338 can include a second through-body 342 configured to anchor to heart tissue.

[0134] The first through-body 340 and the second through-body 342 can each include a screw or can have another configuration (e.g., barbs, or expandable clips, or another configuration) as desired. The first through-body 340 and the second through-body 342 can each be configured to anchor to tissue, and the dock 334 can form a loop for receiving the support structure 332.

[0135] Referring to FIG. 17B, the support structure 332 can support one or more artificial valve leaflets (not shown) and can surround a flow channel 344. The one or more artificial valve leaflets can be configured to be positioned within the flow channel 344. The support structure 332 can support the artificial valve leaflets. The support structure 332 can include an outer surface 346 that can include a sealing surface configured to form a seal with a natural valve including the leaflets of the natural valve. The outer surface 346 can include a cloth surface in an embodiment or can have another configuration.

[0136] FIG. 17C shows the deployed configuration of the dock 334. The dock 334 can extend over a native valve leaflet 348 (e.g., an anterior leaflet) that can be positioned proximate to the left ventricular outflow tract (LVOT) 350. The dock 334 can extend around the radially outward surface of the leaflet 348. The dock 334 can pull the leaflet 348 away from the LVOT 350, reducing the likelihood that the leaflet 348 will undesirably extend radially outwardly and block or otherwise impede fluid flow to the LVOT 350 and the aortic valve 352. Accordingly, the native valve leaflet 348 can be anchored to the posterior wall 354 to reduce the likelihood that the leaflet 348 will interfere with the LVOT 350. The anchoring of the native valve leaflet 348 can be utilized to address the presence of calcification 349 that can be present in the vicinity of the native valve.

[0137] The first and second penetrants 340, 342 can have sufficient anchor strength against the tissue wall such that the anchor resists a radial force (e.g., a contractile force resisted by native chordae tendineae).

[0138] Referring to FIG. 17D, with the dock 334 in place, the support structure 332 can be deployed onto the dock 334. The support structure 332 can be arranged such that the leaflet 348 is positioned between the outer surface 346 of the support structure 332 and the dock 334.

[0139] The prosthetic valve system 330 can be utilized with the mitral valve, or tricuspid valve, of the heart, or at another location for deployment as needed.

[0140] The features of the embodiments of FIGS. 17A - 17D can be utilized alone or in combination with any other embodiment disclosed herein.

[0141] Figures 18A - 18D illustrate an embodiment of an artificial valve 360 including a valve body or support structure 362 that includes an outer perimeter 364 that includes a first portion 366 that forms at least a quarter of the outer perimeter 364 and a second portion 368 that forms the remaining portion of the outer perimeter 364. The support structure 362 may include one or more distal anchors 370 that project from the second portion 368 and may lack distal anchors that project from the first portion 366. The support structure 362 may be configured to support one or more artificial valve leaflets (not shown) positioned within a flow channel 371.

[0142] In an embodiment, the first portion 366 may include a rear portion of the support structure 362. The first portion 366 may include a rear portion because calcification may be more likely to occur on the rear side of a native valve (e.g., mitral valve). Excluding or lacking a rear - side distal anchor may reduce the likelihood that the distal anchor 370 is inappropriately anchored to such calcification. The second portion 368 or the portion including the distal anchor 370 may include a distal anchor 370 for attachment to the native valve leaflets. The distal anchor 370 may be configured to lock onto the distal tip of the native valve leaflets. The native valve leaflets may, in an embodiment, be free of calcification or may have calcification. In an embodiment, the positions of the first and second portions may vary as desired. The distal anchor 370 may be configured in the same manner as any of the distal anchor embodiments disclosed herein.

[0143] Referring to FIGS. 18A and 18B, the first portion 366 may include a sealing surface 372 configured to form a seal with a native valve that includes calcification of the native valve. The sealing surface 372 may be adapted and configured to conform to the shape of the native valve, such as the shape of the calcification. A compliant and conformable body may be utilized. The sealing surface 372 may be compliant or conformable and may include a sealing cloth or pad cloth that can conform to the shape of the native valve.

[0144] In an embodiment, the first portion 366 can form a lesser or greater percentage of the outer periphery 364. For example, in an embodiment, the first portion 366 can include at least half of the percentage of the outer periphery 364. A greater percentage can be utilized in an embodiment. For example, as shown in FIGS. 18A and 18B, the first portion can include at least two-thirds of the percentage of the outer periphery 364. Various percentages can be utilized in an embodiment.

[0145] Referring to FIGS. 18C and 18D, in an embodiment, the first portion 366 can include one or more barbs 373, or other forms of protrusions protruding from the outer periphery 364. The barbs 373 can be for anchoring with a native valve. The barbs 373 can be spaced apart from each other on the first portion 366 and can protrude radially outward from the support structure 362. The barbs 373 can be configured to penetrate the surface of the native valve (e.g., the inward wall or upstream side of the native valve leaflet) to provide an anchor ring. The barbs 373 can be configured to penetrate calcification in an embodiment (i.e., for replacing a calcified valve). In various embodiments, the barbs can be oriented towards the inflow end of the support structure, towards the outflow end of the support structure, or directly outward. The barbs can also be angled circumferentially such that rotation of the support structure causes the barbs to penetrate tissue and / or calcification.

[0146] In an embodiment, a combination of the barb 373 or other form of protrusion and a sealing surface 372 (e.g., a compliant, or conformable body) can be provided. The barb 373 can protrude from the sealing surface 372, for example, when a radially inward pressure is applied to the sealing surface 372. The barb 373 can protrude from the outer surface of the sealing surface 372 for anchoring. The sealing surface 372 can be compressed inward for sealing, and the barb 373 provides an anchor ring with the native valve. Other combinations can be utilized in an embodiment.

[0147] The artificial valve 360 can be utilized with the mitral valve, or tricuspid valve of the heart, or another location for deployment as needed.

[0148] The features of the embodiments of FIGS. 18A - 18B can be utilized alone or in combination with any other embodiment disclosed herein.

[0149] FIGS. 19A - 19B show an embodiment of an artificial valve 380 including a valve body or support structure 382 that includes a sealing body 384 having a first portion 386 and a second portion 388. The first portion 386 obstructs fluid flow at the height 390 of the support structure 382, and the second portion 388 is at the height 390 of the first portion 386 and is circumferentially offset from the position of the first portion 386. The second portion 388 can be recessed at the circumferentially offset position to allow fluid to flow. The support structure 382 can support one or more artificial valve leaflets (not shown) configured to be positioned within a flow channel 389.

[0150] Thus, referring to FIG. 19A, the recessed second portion 388 of the sealing body 384 can be recessed from the frame 392 of the support structure 382. The recessed second portion 388 can expose an opening 394 of the frame 392 that can be positioned between the struts 396 of the frame 392. The opening 394 can be surrounded by a plurality of struts 396. The sealing body 384 at the second portion 388 does not cover at least one of the plurality of openings 394 to allow fluid to pass therethrough. Thus, fluid can flow through at least one of the openings 394 of the second portion 388 due to the recessed second portion 388.

[0151] The sealing body 384 may comprise a sealing skirt or may have other forms in the embodiments.

[0152] In an embodiment, a portion of the frame 392 can be recessed at the second portion 388 to allow fluid to pass through.

[0153] In an embodiment, the second portion 388 may include a front portion of the support structure 382. The second portion 388 may include a front portion that allows fluid flow therethrough to increase fluid flow in the left ventricular outflow tract (LVOT) 350. For example, referring to FIG. 19B, the second portion 388 may be positioned to allow fluid flow therethrough and into the LVOT 350. The second portion 388 may be at a height distal to the prosthetic valve leaflets of the prosthetic valve 380 to allow fluid flow through the second portion 388 and the operation of the prosthetic valve leaflets.

[0154] The prosthetic valve 380 may be utilized with the mitral valve, or tricuspid valve, of the heart or another location for deployment as needed.

[0155] The features of the embodiments of FIGS. 19A - 19B may be utilized alone or in combination with any other embodiments disclosed herein.

[0156] In an embodiment, a compression system 400 (described in FIG. 20B) may be utilized to compress a portion of the heart. Referring to FIG. 20A, in an individual, a portion of the interventricular septum 402 between the left ventricle 404 and the right ventricle has a thickness 406. The thickness 406 may desirably be decreased to increase the size of the LVOT 350 to reduce the likelihood of occlusion or other blockage of the LVOT 350. For example, a prosthetic heart valve implanted in a calcified mitral valve 408 may increase the likelihood that the LVOT 350 is obstructed. The thickness 406 may be decreased to reduce the protrusion of the interventricular septum 402 into the LVOT 350. Such a decrease in thickness 406 may desirably occur prior to implantation of the prosthetic heart valve into the calcifiable mitral valve 408.

[0157] Figure 20B shows a perspective view of a compression system 400 that can be utilized to compress the ventricular septum 402. The compression system 400 can include a first compression body 410 and a second compression body 412. The first compression body 410 can be configured to be positioned on a first side of the ventricular septum 402 proximate to the LVOT 350. The second compression body 412 can be configured to be positioned on a second side of the ventricular septum 402 or on the free wall of the right ventricle of the heart.

[0158] The first compression body 410 and the second compression body 412 can each include a disk that can be configured to apply a force to a portion of the heart. The first compression body 410 and the second compression body 412 can each be rigid and can be configured to apply a compressive force. In an embodiment, a portion of the first compression body 410 or the second compression body 412 can be adapted and configured to provide a cushion to the portion of the heart being compressed. In an embodiment, one or more of the first compression body 410 or the second compression body 412 can be compressed or straightened to pass through an opening through which the tether 414 passes. Such a configuration can enable one or more of the first compression body 410 or the second compression body 412 to be positioned on opposite sides of the ventricular septum 402. In other embodiments, other configurations can be utilized.

[0159] In an embodiment, the tether 414 can be configured to reduce the distance between the first compression body and the second compression body to improve the flow through the LVOT 350. The tether 414 can compress the first compression body 410 and the second compression body 412 together. In an embodiment, the tether 414 can be configured to compress the bodies 410, 412 together to increase the size of the LVOT 350.

[0160] The tether 414 can include a cord, wire, braid, or another form of tether that can couple the first compression body 410 to the second compression body 412.

[0161] Referring to FIG. 20C, in an embodiment, the first compressor 410 may be deployed on the side of the ventricular septum 402 in the left ventricle 404, and the second compressor 412 may be deployed on the opposite side of the ventricular septum 402 in the right ventricle. The tether 414 may be tensioned to compress the ventricular septum 402 and reduce the thickness 406 of the ventricular septum 402. The thickness 406 may be reduced in the vicinity of the LVOT 350 to reduce the possibility of occlusion of the LVOT 350 during the placement of the artificial heart valve.

[0162] FIG. 20D shows, for example, an artificial valve 416 deployed against the mitral valve. The use of the compression system 400 may reduce the possibility of occlusion of the LVOT 350 during the deployment of the artificial valve 416.

[0163] FIG. 21 shows a variation in which the second compressor 412 may be deployed on the free wall of the right ventricle 418. The tether 420 may extend across the right ventricle 418 and pull the ventricular septum 402 toward the right ventricle 418 to increase the size of the LVOT 350. The tether 420 may apply a force to the ventricular septum 402 to move the ventricular septum 402 into the right ventricle 418.

[0164] Variations of the compression system 400 may be utilized in an embodiment.

[0165] The features of the embodiments of FIGS. 20A - 21 may be utilized alone or in combination with any other embodiment disclosed herein.

[0166] FIG. 22 shows the use of a stent 430 deployed on the heart proximate the LVOT 350. The stent 430 may include a flow channel 432 for fluid to pass through the LVOT 350.

[0167] As shown in FIG. 22, the stent 430 can pass through the tissue of the heart, for example, the tissue of the inner ventricular wall (e.g., ventricular septum 402), and form a tunnel within the inner ventricular wall. The stent 430 can create a tunnel to the aortic valve 434. The first portion 433 of the stent 430 may be configured to form a first opening of the flow channel 432 proximate to the aortic valve 434, and the second portion 435 of the stent 430 can be configured to form a second opening on the opposite side of the first opening and on the surface of the inner ventricular wall. The stent 430 can reduce the likelihood of occlusion of the LVOT 350 during implantation of an artificial valve into the mitral valve 408, or other possible events that can cause occlusion of the LVOT 350.

[0168] The features of the embodiment of FIG. 22 can be utilized alone or in combination with any other embodiment disclosed herein.

[0169] In an embodiment, one or more stents can be alternatively positioned. Referring to FIG. 23, for example, the stent 436 can be positioned proximate to the aortic valve 434 and within the LVOT 350. The stent 430 can include a flow channel 437 for fluid to pass through the LVOT 350. Referring to FIG. 24, in an embodiment, the stent 436 can include an anchor 438 configured to extend from the stent 436 and be anchored to the valve leaflet 440. The anchor 438 can be configured to latch onto the valve leaflet 440. The valve leaflet 440 can include, in an embodiment, the anterior leaflet of the mitral valve. The anchor 438 can be anchored to the valve leaflet 440 if the valve leaflet 440 is free of calcification, or otherwise can be anchored to the valve leaflet 440. The artificial heart valve can be deployed onto the native mitral valve to provide leaflets for opening and closing by the mitral valve.

[0170] The features of the embodiments of FIGS. 23 - 24 can be utilized alone or in combination with any other embodiment disclosed herein.

[0171] FIG. 25A shows an example of a stent 442 that can be positioned within the LVOT 350. The stent 442 may be configured to be deployed within the heart proximate to the LVOT 350 and may include a flow channel 443 for fluid to pass through the LVOT 350. The stent 442 may be coupled to an artificial heart valve 444 that can be implanted into the mitral valve 446. In an embodiment, the stent 442 may be utilized to anchor the artificial heart valve 444. For example, the artificial heart valve 444 may include an atrial anchor 448, and the stent 442 may include an anchor that resists proximal or atrial movement of the artificial heart valve 444.

[0172] In an embodiment, a curved coupler 450 may be used between the stent 442 and the artificial heart valve 444 as shown in FIG. 25A. The curved coupler 450 may be arcuate with respect to the stent 442 within the left ventricle. In an embodiment, referring to FIG. 25B, the coupler 445 may comprise a bladder that can be positioned within the ventricle. The bladder may be configured to be filled with blood, and the movement of the ventricle fills and drains blood from the bladder. The bladder may, in an embodiment, substantially fill the ventricle. The coupler 445 may couple the stent 442 to the artificial heart valve 444 as shown in FIG. 25B. Referring to FIG. 26, in an embodiment, the coupler 452 may couple the stent 442 to an adjacent artificial heart valve 444. As shown in FIG. 26, the stent 442 may be coupled to a bumper 454 that is positioned adjacent to the stent 442 and configured to provide a stent spacing from the wall of the ventricular septum 402.

[0173] In an embodiment, the artificial heart valve 456 may be configured to be implanted into the aortic valve 434 and may be coupled to an artificial heart valve 458 configured to be implanted into the mitral valve. FIG. 27 shows an exemplary configuration. The aortic artificial heart valve 456 may be configured to have one or more artificial valve leaflets coupled to a frame, and the mitral artificial heart valve 458 may include one or more artificial valve leaflets coupled to a frame. Other configurations of the artificial heart valve may be utilized as desired.

[0174] The tether 460 can extend from the aortic heart valve prosthesis 456 to the mitral heart valve prosthesis 458. The tether 460 can be configured to prevent the mitral valve leaflet 440 from undesirably protruding into the LVOT 350. For example, the tether 460 can extend over the mitral valve leaflet 440 and engage the mitral valve leaflet 440. The aortic heart valve prosthesis 456 can further function as an anchor for the mitral heart valve prosthesis 458 to prevent proximal or atrial movement of the heart valve prosthesis 458.

[0175] The features of the embodiments of FIGS. 25A - 27 can be utilized alone or in combination with any other embodiment disclosed herein.

[0176] FIGS. 28A - 28B show an embodiment of an artificial valve 470 including a valve body or support structure 472 and at least one distal arm 474 coupled to the support structure 472 and configured to apply a force to the interventricular septum 402 between the left ventricle 404 and the right ventricle of the heart. The support structure 472 can support one or more artificial valve leaflets 471 configured to be positioned within the flow channel 473.

[0177] The distal arm 474 can project distally and contact the interventricular septum 402 to push the septum 402 away from the LVOT 350 and increase or maintain the size of the LVOT 350. The distal arm 474 can apply a force to the interventricular septum 402 to increase the size of the LVOT 350. The distal arm 474 can extend across the LVOT 350 from the mitral valve.

[0178] As shown in FIG. 28B, the artificial valve 470 can further include one or more distal anchors 476 having a length shorter than that of the distal arm 474 and configured to engage a calcified native valve leaflet.

[0179] In an embodiment, the artificial valve 470 can include a proximal anchor having a flange 478 configured to extend radially outward from the flow channel 473. The flange 478 can project and prevent distal or ventricular movement of the artificial valve 470. The artificial valve 470 can be configured to be deployed in the mitral valve.

[0180] Examples of the artificial valve may be used in the mitral valve, as disclosed herein, or in other deployment positions such as the native tricuspid valve, or, unless otherwise stated, in other deployment positions. Deployment to the aortic valve or pulmonary valve or other implantation sites may be used.

[0181] The features of the embodiments of FIGS. 28A-28B may be used alone or in combination with any other embodiments disclosed herein.

[0182] The features of the embodiments may be used alone or in combination with other features disclosed herein.

[0183] Various modifications of the embodiments disclosed herein may be made. Each feature in the examples may be modified, substituted, excluded, or combined between examples as desired. Combinations of features across embodiments may be made as desired. Combinations of features may be provided across embodiments with other features in those embodiments excluded as necessary.

[0184] The implants disclosed herein may include an artificial heart valve, or, in particular, other forms of implants such as stents or filters, or diagnostic devices. The implant may be an expandable implant configured to transition from a compressed or undeployed state to an expanded or deployed state. The implant may be a compressible implant configured to compress inwardly to have a reduced outer profile and transition to a compressed or undeployed state.

[0185] Delivery devices in various forms can be utilized together with the embodiments disclosed herein. The delivery devices disclosed herein can be utilized in replacement as well as repair of the aortic valve, mitral valve, tricuspid valve, and pulmonary valve. The delivery device can include, in particular, a delivery device for delivering other forms of implants such as stents or filters, or, especially, for delivering diagnostic devices.

[0186] The implants and systems disclosed herein can be used in transcatheter mitral or tricuspid valve implantation, and also in aortic valve implantation (TAVI) or replacement of other native heart valves (e.g., pulmonary valve). The delivery devices and systems disclosed herein can be utilized in transarterial access to a patient's heart, including transfemoral access. The delivery devices and systems can be utilized in transcatheter percutaneous procedures, including transarterial procedures that can be transfemoral or transcervical. In particular, a transapical procedure can also be utilized. Other procedures can be utilized as desired.

[0187] In addition, the methods described herein are not specifically limited to the methods described, and can include methods for utilizing the systems and devices disclosed herein. Each step in the method can be modified, excluded, or added by the systems, devices, and methods disclosed herein. Each embodiment disclosed herein can, in an embodiment, include a system for implantation into a human body.

[0188] For the purposes of this specification, specific aspects, advantages, and novel features regarding each embodiment of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any aspect. Instead, the present disclosure is directed to all novel and non-obvious features and aspects regarding the various disclosed embodiments in various combinations and in various sub-combinations thereof. The methods, apparatuses, and systems are not limited to any specific aspect or feature, nor to combinations thereof, and furthermore, the disclosed embodiments are not required to have any one or more specific advantages or to solve any problems. Features, elements, or combinations regarding one embodiment may be combined with those in other embodiments herein.

[0189] Example 1: An artificial valve configured to be deployed in a native valve, the artificial valve comprising one or more artificial valve leaflets configured to be positioned within a flow channel, and a valve body configured to support the one or more artificial valve leaflets, the valve body comprising a proximal anchor having a first flange configured to extend radially outward from the flow channel, and a distal anchor having a second flange configured to extend radially outward from the flow channel.

[0190] Example 2: The artificial valve according to any embodiment described herein, particularly Example 1, wherein the first flange comprises a first disk and the second flange comprises a second disk.

[0191] Example 3: The valve body is configured to expand radially outwardly to an extended configuration, the first disk includes the first end portion and the second end portion, and a protruding portion configured to protrude radially outwardly from the first end portion and the second end portion, and the first end portion and the second end portion are configured to move towards each other when the valve body expands radially outwardly to the extended configuration, any of the embodiments described herein, particularly the artificial valve described in Example 2.

[0192] Example 4: The protruding portion includes a loop of material, any of the embodiments described herein, particularly the artificial valve described in Example 3.

[0193] Example 5: The first flange includes a mesh, and the second flange includes a mesh, any of the embodiments described herein, particularly the artificial valve described in Examples 1 to 4.

[0194] Example 6: The first flange and the second flange each include an inflatable body, any of the embodiments described herein, particularly the artificial valve described in Examples 1 to 5.

[0195] Example 7: The first flange and the second flange each include a compressible cloth or a compressible foam, any of the embodiments described herein, particularly the artificial valve described in Examples 1 to 6.

[0196] Example 8: The valve body includes a frame, and the first flange and the second flange each include a raised portion of the frame, any of the embodiments described herein, particularly the artificial valve described in Examples 1 to 7.

[0197] Example 9: The valve body includes a frame, and the first flange and the second flange each include a cut-out portion of the frame having an end portion configured to protrude radially outwardly from the frame and angled towards each other, any of the embodiments described herein, particularly the artificial valve described in Examples 1 to 8.

[0198] Example 10: An artificial valve according to any example described herein, particularly the artificial valves described in Examples 1 to 9, wherein the first flange and the second flange each comprise barbs.

[0199] Example 11: An artificial valve according to any example described herein, particularly the artificial valves described in Examples 1 to 10, wherein the valve body is configured to have a cylindrical configuration and an expanded configuration, and the first flange and the second flange are each configured to be stored in the cylindrical configuration and move radially outward in the expanded configuration.

[0200] Example 12: An artificial valve according to any example described herein, particularly the artificial valves described in Examples 1 to 11, wherein the valve body is configured to dock with an insert that holds the one or more artificial valve leaflets.

[0201] Example 13: An artificial valve according to any example described herein, particularly the artificial valves described in Examples 1 to 12, wherein the first flange is configured to be positioned proximal to the native valve and the second flange is configured to be positioned distal to the native valve.

[0202] Example 14: An artificial valve according to any example described herein, particularly the artificial valves described in Examples 1 to 13, wherein the first flange is configured to be positioned on the atrial side of the native mitral valve or native tricuspid valve, and the second flange is configured to be positioned on the ventricular side of the native mitral valve or native tricuspid valve.

[0203] Example 15: An artificial valve according to any example described herein, particularly the artificial valves described in Examples 1 to 14, wherein the first flange is configured to anchor to calcification of the native valve and the second flange is configured to anchor to calcification of the native valve.

[0204] Example 16: A method comprising the step of deploying an artificial valve onto a natural valve, the artificial valve comprising one or more artificial valve leaflets configured to be positioned within a flow channel and a valve body configured to support the one or more artificial valve leaflets, the valve body comprising a proximal anchor having a first flange configured to extend radially outwardly from the flow channel and a distal anchor having a second flange configured to extend radially outwardly from the flow channel.

[0205] Example 17: The method according to any example described herein, particularly the method according to Example 16, wherein the first flange comprises a first disk and the second flange comprises a second disk.

[0206] Example 18: The method according to any example described herein, particularly the method according to Example 16 or Example 17, wherein the first flange comprises a mesh and the second flange comprises a mesh.

[0207] Example 19: The method according to any example described herein, particularly the method according to Examples 16 - 18, wherein the first flange and the second flange each comprise an inflatable body.

[0208] Example 20: The method according to any example described herein, particularly the method according to Examples 16 - 19, wherein the first flange and the second flange each comprise a compressible cloth or a compressible foam.

[0209] Example 21: The method according to any example described herein, particularly the method according to Examples 16 - 20, wherein the valve body comprises a frame and the first flange and the second flange each comprise a ridge of the frame.

[0210] Example 22: Any of the embodiments described herein, particularly the methods described in Examples 16-21, wherein the valve body includes a frame, and the first flange and the second flange each have an end portion configured to project radially outward from the frame and to be angled toward each other, and the frame has a cutout portion.

[0211] Example 23: Any of the embodiments described herein, particularly the methods described in Examples 16-22, wherein the first flange is configured to be positioned proximal to the native valve and the second flange is configured to be positioned distal to the native valve.

[0212] Example 24: Any of the embodiments described herein, particularly the methods described in Examples 16-23, wherein the first flange is configured to be positioned on the atrial side of the native mitral valve or native tricuspid valve, and the second flange is configured to be positioned on the ventricular side of the native mitral valve or native tricuspid valve.

[0213] Example 25: Any of the embodiments described herein, particularly the methods described in Examples 16-24, wherein the first flange is configured to anchor to calcification of the native valve and the second flange is configured to anchor to calcification of the native valve.

[0214] Example 26: An artificial valve configured to be deployed relative to a native valve, the artificial valve including one or more artificial valve leaflets configured to be positioned within a flow channel, and a valve body configured to support the one or more artificial valve leaflets, the valve body including an atrial anchor that forms a ring surrounding the flow channel.

[0215] Example 27: Any of the embodiments described herein, particularly the artificial valve described in Example 26, wherein the ring includes an upper surface configured to face in an atrial direction and a lower surface configured to face the opposing side of the upper surface and in a ventricular direction, and the artificial valve further includes an adapter positioned on the lower surface.

[0216] Example 28: The prosthesis of any example described herein, particularly the artificial valve described in Example 27, wherein the adaptor comprises one or more inflatable bodies or foams.

[0217] Example 29: The prosthesis of any example described herein, particularly the artificial valve described in Examples 26 - 28, wherein the ring extends radially outward from the flow channel.

[0218] Example 30: The prosthesis of any example described herein, particularly the artificial valve described in Examples 26 - 29, wherein the ring comprises a disk.

[0219] Example 31: The prosthesis of any example described herein, particularly the artificial valve described in Examples 26 - 30, further comprising one or more through - bodies configured to anchor the valve body to the native valve through the ring.

[0220] Example 32: The prosthesis of any example described herein, particularly the artificial valve described in Examples 26 - 31, wherein the ring has a tubular shape and the one or more artificial valve leaflets are coupled to the ring and configured to overlap one or more native valve leaflets of the native valve.

[0221] Example 33: The prosthesis of any example described herein, particularly the artificial valve described in Examples 26 - 32, wherein the atrial anchor comprises a gasket.

[0222] Example 34: The prosthesis of any example described herein, particularly the artificial valve described in Example 33, wherein the gasket is conformable and configured to conform to the shape of calcification of the native valve.

[0223] Example 35: The prosthesis of any example described herein, particularly the artificial valve described in Examples 26 - 34, wherein the atrial anchor is configured to anchor to the calcification of the native valve.

[0224] Example 36: A method comprising the step of deploying an artificial valve relative to a native valve, said artificial valve comprising one or more artificial valve leaflets configured to be positioned within a flow channel, and a valve body configured to support said one or more artificial valve leaflets, said valve body comprising an atrial anchor forming a ring surrounding said flow channel.

[0225] Example 37: The method according to any of the examples described herein, particularly the method described in Example 36, wherein said ring comprises an upper surface configured to face in the atrial direction and a lower surface configured to face on the opposite side of said upper surface and in the ventricular direction, and said artificial valve further comprises an adapter positioned on said lower surface.

[0226] Example 38: The method according to any of the examples described herein, particularly the method described in Example 37, wherein said adapter comprises one or more of an inflatable body or foam.

[0227] Example 39: The method according to any of the examples described herein, particularly the methods described in Examples 36 - 38, wherein said ring extends radially outwardly from said flow channel.

[0228] Example 40: The method according to any of the examples described herein, particularly the methods described in Examples 36 - 39, wherein said ring comprises a disk.

[0229] Example 41: The method according to any of the examples described herein, particularly the methods described in Examples 36 - 40, further comprising one or more through - bodies configured to anchor said valve body to said native valve through said ring.

[0230] Example 42: The method according to any of the examples described herein, particularly the methods described in Examples 36 - 41, wherein said ring has a tubular shape and said one or more artificial valve leaflets are coupled to the ring and configured to overlap one or more native valve leaflets of said native valve.

[0231] Example 43: The method according to any of the examples described herein, particularly the method described in Examples 36 to 42, wherein the atrial anchor comprises a gasket.

[0232] Example 44: The method according to any of the examples described herein, particularly the method described in Example 43, wherein the gasket is conformable and configured to conform to the shape of calcification of the native valve.

[0233] Example 45: The method according to any of the examples described herein, particularly the method described in Examples 36 to 44, wherein the atrial anchor is configured to anchor ring to the calcification of the native valve.

[0234] Example 46: An artificial valve system configured to be deployed in a native valve, the artificial valve system comprising one or more artificial valve leaflets configured to be positioned within a flow channel, a valve body supporting the one or more artificial valve leaflets and surrounding the flow channel, and a dock having a first end portion and a second end portion and comprising an extended body configured to form a crescent shape, the first end portion including a first through-body configured to anchor ring to heart tissue, the second end portion including a second through-body configured to anchor ring to heart tissue, the dock being configured to dock with the valve body, the dock.

[0235] Example 47: The artificial valve according to any of the examples described herein, particularly the artificial valve described in Example 46, wherein the first through-body comprises a screw.

[0236] Example 48: The artificial valve according to any of the examples described herein, particularly the artificial valve described in Example 46 or 47, wherein the valve body includes an outer surface with a sealing surface.

[0237] Example 49: The artificial valve according to any of the examples described herein, particularly the artificial valve described in Examples 46 to 48, wherein the dock extends around a radially outward surface of the leaflet of the native valve and is configured to position the leaflet between the dock and the outer surface of the valve body.

[0238] Example 50: An artificial valve according to any of the examples described herein, particularly the artificial valves described in Examples 46-49, wherein the dock is configured to be deployed against a native mitral valve or a native tricuspid valve.

[0239] Example 51: A method comprising the step of deploying a dock proximal to a native valve, the dock comprising an elongated body having a first end portion and a second end portion and configured to form a crescent shape, the first end portion including a first penetrator configured to be anchored to heart tissue, the second end portion including a second penetrator configured to be anchored to heart tissue; and the step of deploying a valve body supporting one or more artificial valve leaflets onto the dock.

[0240] Example 52: A method according to any of the examples described herein, particularly the method described in Example 51, wherein the first penetrator comprises a screw.

[0241] Example 53: A method according to any of the examples described herein, particularly the method described in Example 51 or Example 52, wherein the valve body includes an outer surface with a sealing surface.

[0242] Example 54: A method according to any of the examples described herein, particularly the methods described in Examples 51-53, wherein the dock extends around a radially outward surface of the leaflet of the native valve, and the leaflet is positioned between the dock and the outer surface of the valve body.

[0243] Example 55: A method according to any of the examples described herein, particularly the methods described in Examples 51-54, further comprising the step of deploying the dock against a native mitral valve or a native tricuspid valve.

[0244] Example 56: An artificial valve configured to be deployed in a native valve, the artificial valve comprising: one or more artificial valve leaflets configured to be positioned within a flow channel; and a valve body configured to support the one or more artificial valve leaflets, the valve body including an outer perimeter that includes a first portion forming at least one quarter of the outer perimeter and a second portion forming the remaining portion of the outer perimeter, the valve body including one or more distal anchors protruding from the second portion and lacking distal anchors protruding from the first portion.

[0245] Example 57: The artificial valve according to any of the examples described herein, particularly the artificial valve described in Example 56, wherein each of the one or more distal anchors is configured to latch onto the distal tip of a leaflet of the native valve.

[0246] Example 58: The artificial valve according to any of the examples described herein, particularly the artificial valve described in Example 56 or Example 57, wherein the first portion includes a sealing surface configured to form a seal with the native valve.

[0247] Example 59: The artificial valve according to any of the examples described herein, particularly the artificial valves of Examples 56 - 58, wherein the first portion forms at least half of the outer perimeter.

[0248] Example 60: The artificial valve according to any of the examples described herein, particularly the artificial valves described in Examples 56 - 59, wherein the artificial valve is configured to be deployed in a mitral valve and the first portion includes a posterior portion of the valve body.

[0249] Example 61: A method comprising the step of deploying an artificial valve in a native valve, the artificial valve comprising: one or more artificial valve leaflets configured to be positioned within a flow channel; and a valve body configured to support the one or more artificial valve leaflets, the valve body including an outer perimeter that includes a first portion forming at least one quarter of the outer perimeter and a second portion forming the remaining portion of the outer perimeter, the valve body including one or more distal anchors protruding from the second portion and lacking distal anchors protruding from the first portion.

[0250] Example 62: The method according to any of the examples described herein, particularly the method described in Example 61, wherein each of the one or more distal anchors is configured to latch onto the distal tip of the cusp of the native valve.

[0251] Example 63: The method according to any of the examples described herein, particularly the method described in Example 61 or Example 62, wherein the first portion comprises a sealing surface configured to form a seal with the native valve.

[0252] Example 64: The method according to any of the examples described herein, particularly the method described in Examples 61 - 63, wherein the first portion forms at least half of the outer circumference.

[0253] Example 65: The method according to any of the examples described herein, particularly the method described in Examples 61 - 64, further comprising the step of deploying the prosthetic valve as a mitral valve, wherein the first portion comprises a rear portion of the valve body.

[0254] Example 66: A prosthetic valve configured to be deployed in a native valve, the prosthetic valve comprising one or more prosthetic valve cusps configured to be positioned within a flow channel, and a valve body including a sealing body configured to support the one or more prosthetic valve cusps and having a first portion and a second portion, wherein the first portion obstructs fluid flow at the height of the valve body, the second portion is at the height of the first portion and is circumferentially offset from the position of the first portion, and the second portion is recessed at the circumferentially offset position to allow fluid to flow.

[0255] Example 67: The prosthetic valve according to any of the examples described herein, particularly the prosthetic valve described in Example 66, wherein the valve body includes a frame including a plurality of openings coupled by a plurality of struts, and the sealing body at the circumferentially offset position does not cover at least one of the plurality of openings to allow fluid to pass through.

[0256] Example 68: An artificial valve according to any of the examples described herein, particularly the artificial valve described in Example 66 or Example 67, wherein the valve body includes a frame recessed at a circumferentially offset position.

[0257] Example 69: An artificial valve according to any of the examples described herein, particularly the artificial valve described in Examples 66 - 68, wherein the sealing body includes a sealing skirt.

[0258] Example 70: An artificial valve according to any of the examples described herein, particularly the artificial valve described in Examples 66 - 69, wherein the artificial valve is configured to be deployed as a mitral valve, and the circumferentially offset position includes a front portion of the valve body.

[0259] Example 71: A method comprising the step of deploying an artificial valve into a native valve, the artificial valve comprising one or more artificial valve leaflets configured to be positioned within a flow channel and a valve body comprising a sealing body configured to support the one or more artificial valve leaflets and having a first portion and a second portion, the first portion obstructing fluid flow at the height of the valve body, the second portion being at the height of the first portion and at a circumferentially offset position from the position of the first portion, and the second portion being recessed at the circumferentially offset position to allow fluid to flow.

[0260] Example 72: An artificial valve according to any of the examples described herein, particularly the method described in Example 71, wherein the valve body includes a frame including a plurality of openings coupled by a plurality of struts, and the sealing body at the circumferentially offset position does not cover at least one of the plurality of openings to allow fluid to pass through.

[0261] Example 73: A method according to any of the examples described herein, particularly the method described in Example 71 or Example 72, wherein the valve body includes a frame recessed at a circumferentially offset position.

[0262] Example 74: The method according to any of the examples described herein, particularly the method described in Examples 71-73, wherein the sealing body comprises a sealing skirt.

[0263] Example 75: The method according to any of the examples described herein, particularly the method described in Examples 71-74, further comprising the step of deploying the artificial valve into a mitral valve, wherein the circumferentially offset position includes a front portion of the valve body.

[0264] Example 76: An artificial valve configured to be deployed into a native valve, the artificial valve comprising: one or more artificial valve leaflets configured to be positioned within a flow channel; a valve body configured to support the one or more artificial valve leaflets; and at least one distal anchor coupled to the valve body, the at least one distal anchor including a hinge forming a loop and a straight portion configured to extend radially outward from the loop.

[0265] Example 77: The artificial valve according to any of the examples described herein, particularly the artificial valve described in Example 76, wherein the straight portion is configured to rotate proximally around the hinge.

[0266] Example 78: The artificial valve according to any of the examples described herein, particularly the artificial valve described in Example 76 or Example 77, wherein the straight portion is positioned between the loop and the tip of the at least one distal anchor, and the tip is angled with respect to the straight portion.

[0267] Example 79: The artificial valve according to any of the examples described herein, particularly the artificial valve described in Examples 76-78, wherein the loop protrudes radially inward.

[0268] Example 80: The artificial valve according to any of the examples described herein, particularly the artificial valve described in Examples 76-79, wherein the at least one distal anchor comprises an arm, and the loop is positioned between the straight portion and a coupling portion configured to couple the loop to the valve body.

[0269] Example 81: A method comprising the step of deploying an artificial valve onto a native valve, the artificial valve comprising: one or more artificial valve leaflets configured to be positioned within a flow channel; a valve body configured to support the one or more artificial valve leaflets; and at least one distal anchor coupled to the valve body, the at least one distal anchor including a hinge forming a loop and a straight portion configured to extend radially outwardly from the loop.

[0270] Example 82: The method according to any of the examples described herein, particularly the method described in Example 81, wherein the straight portion is configured to rotate proximally around the hinge.

[0271] Example 83: The method according to any of the examples described herein, particularly the method described in Example 81 or Example 82, wherein the straight portion is positioned between the loop and the tip of the at least one distal anchor, and the tip is angled with respect to the straight portion.

[0272] Example 84: The method according to any of the examples described herein, particularly the methods described in Examples 81 - 83, wherein the loop protrudes radially inwardly.

[0273] Example 85: The method according to any of the examples described herein, particularly the methods described in Examples 81 - 84, wherein the at least one distal anchor includes an arm, and the loop is positioned between the straight portion and a coupling portion configured to couple the loop to the valve body.

[0274] Example 86: A compression system for a heart, the compression system comprising: a first compressor configured to be positioned on a first side of the ventricular septum of the heart adjacent to the left ventricular outflow tract; a second compressor configured to be positioned on a second side of the ventricular septum or on the free wall of the right ventricle of the heart; and a tether configured to compress the first compressor and the second compressor together to increase the size of the left ventricular outflow tract.

[0275] Example 87: The compression system according to any of the examples described herein, particularly the compression system described in Example 86, wherein the first compressor and the second compressor each comprise a disk.

[0276] Example 88: The compression system according to any of the examples described herein, particularly the compression system described in Example 86 or Example 87, wherein the first compressor is configured to apply a force to the ventricular septum to move the ventricular septum towards the right ventricle.

[0277] Example 89: The compression system according to any of the examples described herein, particularly the compression systems described in Examples 86 - 88, wherein the first compressor is configured to apply a force to the ventricular septum to reduce the thickness of the ventricular septum.

[0278] Example 90: The compression system according to any of the examples described herein, particularly the compression systems described in Examples 86 - 89, wherein the second compressor is configured to be compressed and pass through an opening in the ventricular septum through which the tether passes.

[0279] Example 91: A method comprising deploying a first compressor on a first side of the ventricular septum of the heart proximate to the left ventricular outflow tract, deploying a second compressor on a second side of the ventricular septum or on the free wall of the right ventricle of the heart, and applying tension to a tether extending between the first compressor and the second compressor to compress the first compressor and the second compressor together to increase the size of the left ventricular outflow tract.

[0280] Example 92: The method according to any of the examples described herein, particularly the method described in Example 91, wherein the first compressor and the second compressor each comprise a disk.

[0281] Example 93: The method according to any of the examples described herein, particularly the method described in Example 91 or Example 92, wherein the first compressor applies a force to the ventricular septum to move the ventricular septum towards the right ventricle.

[0282] Example 94: The method according to any of the examples described herein, particularly the methods described in Examples 91 to 93, wherein the first compressor applies a force to the ventricular septum to reduce the thickness of the ventricular septum.

[0283] Example 95: The method according to any of the examples described herein, particularly the methods described in Examples 91 to 94, wherein the second compressor passes through the opening in the ventricular septum through which the tether passes.

[0284] Example 96: A system for a heart, the system being configured to be deployed within the heart proximate to the left ventricular outflow tract of the heart and including a stent having a flow channel through which fluid passes through the left ventricular outflow tract.

[0285] Example 97: The system according to any of the examples described herein, particularly the system described in Example 96, further comprising an anchor extending from the stent and configured to anchor to the leaflets of the mitral valve of the heart.

[0286] Example 98: The system according to any of the examples described herein, particularly the system described in Example 96 or Example 97, further comprising an artificial valve coupled to the stent and configured to be implanted in the mitral valve of the heart.

[0287] Example 99: The system according to any of the examples described herein, particularly the systems described in Examples 96 to 98, wherein the stent is configured to pass through the tissue of the inner ventricular wall to form a tunnel within the inner ventricular wall.

[0288] Example 100: The system according to any of the examples described herein, particularly the system described in Example 99, wherein the first end portion of the stent is configured to form a first opening of a flow channel proximate to the aortic valve of the heart, and the second portion of the stent is configured to oppose the first opening and form a second opening on the surface of the inner ventricular wall.

[0289] Example 101: A method comprising the step of deploying a stent proximate to the left ventricular outflow tract of the heart, the stent including a flow channel for fluid to pass through the left ventricular outflow tract.

[0290] Example 102: The method according to any of the examples described herein, particularly Example 101, wherein an anchor extends from the stent and the anchor to the leaflet tip of the mitral valve of the heart.

[0291] Example 103: The method according to any of the examples described herein, particularly Example 101 or Example 102, wherein an artificial valve is coupled to the stent and implanted in the mitral valve of the heart.

[0292] Example 104: The method according to any of the examples described herein, particularly Examples 101 to 103, wherein the stent passes through the tissue of the inner ventricular wall to form a tunnel within the inner ventricular wall.

[0293] Example 105: The method according to any of the examples described herein, particularly Example 104, wherein a first end portion of the stent forms a first opening of a flow channel proximate to the aortic valve of the heart, and a second portion of the stent forms a second opening on the surface of the inner ventricular wall opposite the first opening.

[0294] Example 106: A system for the heart, the system comprising a first artificial heart valve configured to be implanted in the aortic valve of the heart and a second artificial heart valve coupled to the first artificial heart valve and configured to be implanted in the mitral valve of the heart.

[0295] Example 107: The system according to any of the examples described herein, particularly Example 106, wherein the tether couples the first artificial heart valve to the second artificial heart valve and is configured to extend over the native valve leaflet tip of the mitral valve.

[0296] Example 108: The system according to any of the embodiments described herein, particularly the system described in Example 107, wherein the tether is configured to latch onto the natural valve leaflet tip of the native valve.

[0297] Example 109: The system according to any of the embodiments described herein, particularly the systems described in Examples 106 - 108, wherein the first artificial heart valve includes one or more artificial valve leaflets coupled to a frame.

[0298] Example 110: The system according to any of the embodiments described herein, particularly the systems described in Examples 106 - 109, wherein the second artificial heart valve includes one or more artificial valve leaflets coupled to a frame.

[0299] Example 111: A method comprising transplanting the first artificial heart valve into the aortic valve of the heart and transplanting the second artificial heart valve into the mitral valve of the heart, wherein the second artificial heart valve is coupled to the first artificial heart valve.

[0300] Example 112: The method according to any of the embodiments described herein, particularly the method described in Example 111, wherein the tether couples the first artificial heart valve to the second artificial heart valve and extends over the natural valve leaflet tip of the mitral valve.

[0301] Example 113: The method according to any of the embodiments described herein, particularly the method described in Example 112, wherein the tether latches onto the natural valve leaflet tip.

[0302] Example 114: The method according to any of the embodiments described herein, particularly the methods described in Examples 111 - 113, wherein the first artificial heart valve includes one or more artificial valve leaflets coupled to a frame.

[0303] Example 115: The method according to any of the embodiments described herein, particularly the methods described in Examples 111 - 114, wherein the second artificial heart valve includes one or more artificial valve leaflets coupled to a frame.

[0304] Example 116: An artificial valve configured to be deployed in a natural valve of the heart, the artificial valve comprising: one or more artificial valve leaflets configured to be positioned within a flow channel; a valve body configured to support the one or more artificial valve leaflets; and at least one distal arm coupled to the valve body and configured to apply a force to a ventricular septum between a left ventricle and a right ventricle of the heart.

[0305] Example 117: The artificial valve according to any example described herein, particularly Example 116, wherein the at least one distal arm is configured to apply a force to the ventricular septum to increase a size of a left ventricular outflow tract of the heart.

[0306] Example 118: The artificial valve according to any example described herein, particularly Example 116 or Example 117, wherein the at least one distal arm is configured to extend across a left ventricular outflow tract of the heart from a mitral valve of the heart.

[0307] Example 119: The artificial valve according to any example described herein, particularly Examples 116 - 118, further comprising a plurality of distal anchors, each having a length shorter than the at least one distal arm.

[0308] Example 120: The artificial valve according to any example described herein, particularly Examples 116 - 119, wherein the valve body includes a proximal anchor comprising a flange configured to extend radially outward from the flow channel.

[0309] Example 121: A method comprising deploying an artificial valve in a natural valve, the artificial valve comprising: one or more artificial valve leaflets configured to be positioned within a flow channel; a valve body configured to support the one or more artificial valve leaflets; and at least one distal arm coupled to the valve body and configured to apply a force to a ventricular septum between a left ventricle and a right ventricle of the heart.

[0310] Example 122: The method according to any of the examples described herein, particularly the method described in Example 121, wherein the at least one distal arm applies a force to the ventricular septum to increase the size of the left ventricular outflow tract of the heart.

[0311] Example 123: The method according to any of the examples described herein, particularly the method of Example 121 or Example 122, wherein the at least one distal arm extends across the left ventricular outflow tract of the heart from the mitral valve of the heart.

[0312] Example 124: The method according to any of the examples described herein, particularly the method described in Examples 121-123, further comprising a plurality of distal anchors, each having a length shorter than the at least one distal arm.

[0313] Example 125: The method according to any of the examples described herein, particularly the method described in Examples 121-124, wherein the valve body includes a proximal anchor having a flange configured to extend radially outward from the flow channel.

[0314] Any feature in any of the Examples 1 to 125 mentioned above, including but not limited to, is applicable to all other aspects and Examples identified herein, including but not limited to any of the Examples 1 to 125 mentioned above. Moreover, any feature in any of the various Examples, including but not limited to any of the Examples 1 to 125 mentioned above, can be independently combined in any manner, partially or wholly, with respect to other Examples described herein. For example, one, two, three or more Examples can be combined wholly or partially. Further, any feature in any of the various Examples, including but not limited to any of the Examples 1 to 125 mentioned above, can be optional with respect to other Examples. Any Example related to a method may be executed by a system or device of another Example, and any aspect or Example related to a system or device can be configured to execute a method of another aspect or another Example, including but not limited to any of the Examples 1 to 125 mentioned above.

[0315] Finally, although each aspect of this specification is emphasized by reference to specific Examples, those skilled in the art will readily understand that each of these disclosed Examples is merely for the purpose of exemplifying the principles of the subject matter disclosed herein. Thus, it will be understood that the subject matter disclosed is not limited in any way by a particular methodology, protocol and / or reagent, etc. as described herein. Therefore, various modifications or changes, or alternative configurations of the subject matter of this disclosure can be implemented in accordance with the teachings herein without departing from the spirit of this specification. Finally, the terms used herein are for the purpose of describing only specific Examples and are not intended to limit the scope of the systems, devices and methods as disclosed herein, which is defined only by the claims. Thus, the systems, devices and methods are not strictly limited to those illustrated and described.

[0316] Specific embodiments of systems, apparatuses, and methods are described herein, including the best mode known to the inventors as of the filing date of this application, when practicing these embodiments. It will be apparent to those skilled in the art that variations of the specific embodiments described herein will be apparent upon reading the foregoing description. The inventors expect those skilled in the art to appropriately employ such variations, and the inventors intend for the systems, apparatuses, and methods to be practiced in a manner different from that specifically described herein. Accordingly, the systems, apparatuses, and methods include all modifications and equivalents of the subject matter recited in the appended claims as permitted by applicable law. Moreover, unless otherwise indicated herein or otherwise clearly contradicted by context, all possible combinations of the above-described examples in all possible variations thereof are included by the systems, apparatuses, and methods.

[0317] Groupings of alternative embodiments, elements, or steps related to systems, apparatuses, and methods should not be construed as limitations. Each group member can be referenced and claimed individually or in any combination with other group members disclosed herein. It is contemplated that one or more members of a group can be included in or deleted from the group for reasons of convenience and / or patentability. When such inclusion or deletion occurs, this specification is considered to include the modified group and thus meets the descriptions of all Markush groups used in the appended claims.

[0318] Unless otherwise indicated, all numbers expressing features, items, amounts, parameters, characteristics, terms, and the like used in this specification and the claims are to be understood as being modified in all instances by the term "about." As used herein, the term "about" means that such features, items, amounts, parameters, characteristics, or terms, while subject to variation, are approximations that can perform the desired operation or process described herein.

[0319] In the context of describing systems, devices, and methods (especially in the context of the following claims), the terms "a," "an," "the," and similar reference terms are to be construed to cover both the singular and the plural unless otherwise indicated herein or unless the context clearly dictates otherwise. All methods described herein can be performed in any suitable order unless otherwise indicated herein or unless the context clearly dictates otherwise. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended merely to more clearly illustrate the systems, devices, and methods and is not intended to limit the scope of the claimed systems, devices, and methods. No language in this specification should be construed as indicating any non-claimed element as essential to the practice of the systems, devices, and methods.

[0320] All patents, patent publications, and other publications referenced and identified in this specification are hereby incorporated by reference in their entirety for the purpose of disclosing and describing the compositions and methodologies described in such publications, which may be used, for example, in connection with systems, devices, and methods. Only those publications that were disclosed prior to the filing date of this application are provided. In this regard, it should not be construed that the inventors have any right to claim priority based on such prior disclosures or for any other reason. All statements as to the date or representation or content of these documents are based on the information available to the applicant and do not contribute to any determination as to the date or accuracy of the content of such documents.

Claims

1. An artificial valve for replacing a calcified natural valve, wherein the artificial valve is An internal support stent having an inlet end portion and an outlet end portion, wherein the internal support stent is made from a shape memory material, A valve portion positioned within the passage of the internal support stent, wherein the valve portion comprises a plurality of valve leaflets made from the pericardium, and the valve portion allows blood to flow through the passage in one direction in order to replace the function of the calcified natural valve, An external fitting structure enclosing the internal support stent, comprising a first flange and a second flange, wherein the first flange and the second flange are each made of mesh and fitted to anchor to the calcified natural valve, the first flange fitted to be positioned proximal to the calcified natural valve, and the second flange fitted to be positioned distal to the calcified natural valve, Equipped with, An artificial valve in which the external fitting structure is adapted to fit the calcification on the calcified natural valve.

2. The artificial valve according to claim 1, wherein the first flange includes a first disc and the second flange includes a second disc.

3. The artificial valve according to claim 2, wherein the outer fitting structure is fitted to expand radially outward to an extended configuration, and the first disc includes a first end portion and a second end portion, and a projection portion for projecting radially outward from the first end portion and the second end portion, and the first end portion and the second end portion are fitted to move toward each other as the outer fitting structure expands radially outward to the extended configuration.

4. The artificial valve according to claim 3, wherein the first end portion and the second end portion are adapted to move toward each other in the axial direction when the outer fitting structure expands radially outward to the expanded configuration.

5. The artificial valve according to claim 3, wherein the protruding portion includes a loop of material.

6. The artificial valve according to claim 1, wherein the internal support stent has a substantially cylindrical configuration and an expandable configuration, and the first flange and the second flange are adapted to be housed in the cylindrical configuration and to move radially outward in the expandable configuration, respectively.

7. The artificial valve according to claim 1, wherein the first flange is fitted to be positioned on the atrial side of the calcified natural valve, and the second flange is fitted to be positioned on the ventricular side of the calcified natural valve.

8. The artificial valve according to claim 1, wherein the valve portion comprises an insert adapted to dock with the internal support stent.

9. An artificial valve for replacing a calcified natural valve, wherein the artificial valve is A support structure for deployment upstream of the calcified natural valve, comprising an atrial anchor that forms a ring around the flow channel, Multiple valve leaflets are provided, which are made from the pericardium connected to the support structure and are arranged within the passage of the support structure to provide unidirectional blood flow. An artificial valve equipped with [the necessary components].

10. The artificial valve according to claim 9, wherein the ring includes an upper surface facing the atrial direction and a lower surface facing the opposite side of the upper surface and the ventricle direction, and the artificial valve further includes a fitting positioned on the lower surface.

11. The artificial valve according to claim 10, wherein the compatible body includes one or more inflatable bodies or foams.

12. The artificial valve according to claim 9, wherein the ring extends radially outward from the flow channel and comprises a disk.

13. The artificial valve according to claim 9, wherein the ring has a tubular shape, and the plurality of valve leaflets are connected to the ring and fitted to overlap the natural valve leaflets of the calcified natural valve.

14. The artificial valve according to claim 13, wherein each of the plurality of valve leaflets includes a distal end portion having a barb for anchoring to calcification downstream of the natural valve leaflet.

15. A system comprising an artificial valve for implantation within a natural valve, wherein the artificial valve is A support structure having an outer circumference, comprising a first portion forming at least one-quarter of the outer circumference and a second portion forming the remaining portion of the outer circumference, comprising one or more distal anchors for capturing natural valve leaflets protruding from the second portion, and lacking distal anchors protruding from the first portion, One or more artificial valve leaflets to be positioned within the flow channel of the support structure, A system equipped with these features.

16. The system according to claim 15, wherein each of the one or more distal anchors includes a hinge that forms a loop and a straight portion configured to extend radially outward from the loop.

17. The system according to claim 15, wherein the first portion protrudes from the outer circumference and comprises one or more barbs for anchoring with the natural valve, the artificial valve is for deploying into the calcified valve, and the first portion includes a rear portion of the support structure.

18. The system according to claim 15, wherein the first portion forms at least half of the outer circumference.

19. The system further comprises a compression system for the heart, the compression system, A first compression body to be positioned on a first side surface of the interventricular septum of the heart adjacent to the left ventricular outflow tract, A second compression body to be positioned on the second side surface of the interventricular septum or on the free wall of the right ventricle of the heart, To improve the flow through the left ventricular outflow tract, a tether is provided to reduce the distance between the first and second compressors, The system according to claim 15, including the system described in claim 15.

20. The system according to claim 19, wherein the first compressor and the second compressor each comprise a disk, and the second compressor is compressed and adapted to pass through the opening of the interventricular septum through which the tether passes.

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