Systems and methods for treating calcified heart valves

Abstract

Devices, systems, and methods for prosthetic valves are provided. The implantation site, in embodiments, may include a native heart valve or another implantation site. Embodiments may be utilized for improved anchoring and sealing of flow (e.g., paravalvular leaks) with a native heart valve having calcification. Embodiments may include disrupting calcification in the native heart valve to improve deployment into the native heart valve.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 359,686, filed July 8, 2022, the entire contents of each of which are incorporated herein by reference.

[0002] background Certain features in the present disclosure relate generally to implants, including prosthetic valves, for deployment. [Background technology]

[0003] Human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, essentially function as one-way valves that operate in sync with the heartbeat. The valves allow blood to flow downstream but prevent blood from flowing upstream. Affected heart valves exhibit defects such as valve stenosis or regurgitation, impairing the valve's ability to control blood flow. Such defects reduce the heart's blood-pumping efficiency and can lead to debilitating and life-threatening conditions. For example, valve dysfunction can lead to symptoms such as cardiac hypertrophy and ventricular dilation. Consequently, considerable efforts have been made to develop methods and devices for repairing or replacing dysfunctional heart valves.

[0004] Prosthetic valves exist to correct problems associated with malfunctioning heart valves. For example, mechanical, tissue-based prosthetic heart valves can be used to replace malfunctioning native heart valves. Recently, significant efforts have been made to develop replacement heart valves, particularly tissue-based replacement heart valves that can be delivered less traumatically to patients compared to open-heart surgery. Replacement valves are designed to be delivered by minimally invasive, and even percutaneous, techniques.

[0005] These replacement valves are often intended to allow fluid flow through them while sealing or blocking fluid flow outside the replacement valve (paravalvular leak (PVL)). Such sealing problems can be exacerbated if the native heart valve has an irregular shape or calcification that can reduce the likelihood of a proper seal around the replacement valve. Irregular shape or calcification can also reduce the likelihood of a proper anchoring of the replacement valve to the native heart valve. Summary of the Invention

[0006] The prosthetic valve embodiments disclosed herein may be directed to improvements in prosthetic valves. Such prosthetic valves may, in embodiments, include replacement heart valves. The embodiments may be utilized for improved anchoring and sealing of flow (e.g., paravalvular leaks) with native heart valves having calcification. The embodiments may reduce the likelihood of obstruction of the left ventricular outflow tract (LVOT) of the heart, whether resulting from implantation of the prosthetic valve or otherwise. Various other improvements have been disclosed.

[0007] Examples disclosed herein may include a system for a heart, which may include a prosthetic valve configured to be deployed to a native valve of the heart and configured to deliver shock waves to disrupt calcification in the native valve.

[0008] Examples disclosed herein may include a system for implanting a prosthetic heart valve into a calcified native valve. The system may include a prosthetic heart valve including a support structure having inlet and outlet end portions and a passageway, and a valve portion positioned within the passageway of the support structure, the valve portion including multiple leaflets made from pericardium and allowing unidirectional blood flow through the passageway to replace the function of the native heart valve, and a delivery catheter for delivering the prosthetic heart valve to the calcified native valve, the delivery catheter including an actuation mechanism for vibrating the support structure, thereby reducing calcification of the calcified heart valve.

[0009] Examples disclosed herein may include a delivery system for a heart that includes a first inflatable body configured to expand a prosthetic valve positioned on the first inflatable body to deploy the prosthetic valve into the native valve, and a second inflatable body surrounding the first inflatable body and configured to transmit shock waves to disrupt calcification in the native valve.

[0010] Examples disclosed herein may include a system for implanting a prosthetic heart valve into a calcified native valve. The system may include a prosthetic heart valve including a support structure having an inlet end portion, an outlet end portion, and a passageway, and a valve portion positioned within the passageway of the support structure, the valve portion including multiple leaflets made from pericardium and allowing unidirectional blood flow through the passageway to replace the function of the native heart valve. The system may include a delivery catheter for the prosthetic heart valve including an elongate shaft, a first expandable body coupled to the elongate shaft, the first expandable body adapted to expand the prosthetic heart valve when the prosthetic heart valve is positioned on the first expandable body to deploy the prosthetic heart valve into the native valve, a second expandable body coupled to the elongate shaft, the second expandable body adapted to transmit vibrations to disrupt calcification in the calcified native valve, and an actuator for generating the vibrations of the second expandable body.

[0011] Examples disclosed herein may include methods that include reducing calcification of a native heart valve and deploying a prosthetic heart valve over the native heart valve.

[0012] Examples disclosed herein may include a method including determining an implantation site configuration in a native heart valve having calcification, where the implantation site is for a prosthetic heart valve, and selecting a distal anchor configuration for the prosthetic heart valve based on the determined implantation site configuration.

[0013] Examples herein may include a prosthetic valve configured to be deployed in a native valve of a heart. The prosthetic valve may include one or more prosthetic leaflets configured to be positioned within a flow channel, a valve body configured to support the one or more prosthetic leaflets, and at least one anchor coupled to the valve body and including one or more barbs or pads configured to engage calcifications of the native valve to anchor the calcifications.

[0014] Examples may include a method including deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic leaflets configured to be positioned within a flow channel, a valve body configured to support the one or more prosthetic leaflets, and at least one anchor coupled to the valve body and including one or more barbs or pads configured to engage calcifications of the native valve to anchor the calcifications.

[0015] Examples herein may include a prosthetic valve configured to be deployed in a native valve of a heart. The prosthetic valve may include one or more prosthetic leaflets configured to be positioned within a flow channel, and a valve body configured to support the one or more prosthetic leaflets, the valve body including an outer surface including a conformable anchoring surface configured to conform to the shape of calcifications of the native valve for anchoring to the native valve.

[0016] Examples may include a method including deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic leaflets configured to be positioned within a flow channel, and a valve body configured to support the one or more prosthetic leaflets, the valve body including an outer surface including a conformable anchoring surface configured to conform to the shape of calcifications on the native valve for anchoring to the native valve.

[0017] Examples herein may include a prosthetic valve configured to be deployed in a native valve of a heart. The prosthetic valve may include one or more prosthetic leaflets configured to be positioned within a flow channel, and a valve body including an atrial anchor configured to support the one or more prosthetic leaflets and including a flange configured to extend radially outward from the flow channel.

[0018] Examples herein may include a prosthetic heart valve configured to be deployed into a native heart valve. The prosthetic heart valve may include a support structure having inlet and outlet end portions and a passageway, the support structure including an atrial anchor including a flange for extending radially outward from the passageway. The prosthetic heart valve may include a valve portion positioned within the passageway of the support structure, the valve portion including multiple leaflets made from pericardium, allowing blood to flow unidirectionally through the passageway to replace the function of the native heart valve.

[0019] Examples may include a method including deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic leaflets configured to be positioned within a flow channel, and a valve body including an atrial anchor configured to support the one or more prosthetic leaflets and including a flange configured to extend radially outward from the flow channel.

[0020] Examples herein may include a prosthetic valve configured to be deployed in a native valve of a heart. The prosthetic valve may include a valve body and a helical body coupled to the valve body and configured to move between an open state and a closed state to control fluid flow through the valve body.

[0021] Examples may include a method including deploying a prosthetic valve to a native valve. The prosthetic valve may include a valve body and a helical body coupled to the valve body and configured to move between an open state and a closed state to control fluid flow through the valve body.

[0022] Examples herein may include a prosthetic heart valve configured to be deployed into a native heart valve. The prosthetic heart valve may include a support structure having a passageway, and a helical body coupled to the support structure, positioned within the passageway, and adapted to move between an open state and a closed state to control blood flow through the support structure.

[0023] Examples disclosed herein may include a system for a heart that may include a prosthetic heart valve configured to be deployed in a mitral valve of the heart, and an anchor coupled to the prosthetic heart valve and configured to be deployed in a left atrial appendage of the heart.

[0024] Examples disclosed herein may include a prosthetic mitral heart valve system for a heart. The system may include a prosthetic mitral heart valve including a support structure having inlet and outlet end portions and a passageway, and a valve portion positioned within the passageway of the support structure, the valve portion including multiple leaflets made from pericardium and allowing unidirectional blood flow through the passageway to replace the function of the native mitral heart valve. The system may include an anchor for deployment in the left atrial appendage of the heart, the anchor coupled to the prosthetic mitral heart valve for anchoring the prosthetic mitral heart valve within the native mitral heart valve.

[0025] Examples disclosed herein may include a method that includes deploying a prosthetic heart valve in a mitral valve of a heart and deploying an anchor for the prosthetic heart valve in a left atrial appendage of the heart.

[0026] Examples disclosed herein may include a method that includes implanting a prosthetic valve in a pulmonary vein of the heart to prevent fluid flow to the lungs.

[0027] Examples disclosed herein may include a stent for a heart, the stent may include an outer stent configured to be deployed adjacent to the left ventricular outflow tract of the heart, and an inner stent positioned within the outer stent and including a flow channel for fluid to pass through the left ventricular outflow tract.

[0028] Examples disclosed herein may include a method that includes deploying a stent adjacent to the left ventricular outflow tract of a heart, where the stent may include an outer stent and an inner stent positioned within the outer stent and including a flow channel through which fluid passes through the left ventricular outflow tract.

[0029] Examples disclosed herein may include a system for a heart that includes a prosthetic heart valve configured to be implanted in a valve of the heart, and an anchor coupled to the prosthetic heart valve and including a ventricular chamber configured to extend in a ventricle of the heart.

[0030] Examples disclosed herein may include a method including deploying a prosthetic heart valve in a valve of the heart and deploying an anchor for the prosthetic heart valve in a ventricle of the heart, the anchor comprising a ventricular chamber.

[0031] Examples disclosed herein may include a method that includes tethering the leaflets of a native mitral heart valve or removing at least a portion of the leaflets of a native mitral heart valve to reduce obstruction of the left ventricular outflow tract of a heart by the leaflets of the native mitral heart valve.

[0032] Examples disclosed herein may include a cutter for at least a portion of a leaflet of a heart valve, the cutter comprising: a first jaw having a proximal end portion and a distal end portion, the first jaw having a wedge shape converging on an apex of the distal end portion of the first jaw; a second jaw having a proximal end portion and a distal end portion, the second jaw having a wedge shape converging on an apex of the distal end portion of the second jaw; and one or more teeth positioned on one or more of the first jaw or the second jaw and configured to cut at least a portion of the leaflet of the heart valve when the first jaw closes with the second jaw.

[0033] Examples disclosed herein may include a prosthetic mitral heart valve system for a heart. The system may include a prosthetic mitral heart valve including a support structure having inlet and outlet end portions and a passageway, and a valve portion positioned within the passageway of the support structure, the valve portion including multiple leaflets made from pericardium and allowing unidirectional blood flow through the passageway to replace the function of the native mitral heart valve. The system may include a tether for tethering the leaflets of the native mitral heart valve to reduce obstruction by the leaflets of the native mitral heart valve of the left ventricular outflow tract of the heart. [Brief explanation of the drawings]

[0034] The features and advantages of the systems, apparatus, and methods disclosed herein will become apparent as they become more clearly understood with reference to the specification, claims, and accompanying drawings.

[0035] [Figure 1A] FIG. 1A shows a top perspective view of a prosthetic valve according to an embodiment of the present disclosure. [Figure 1B] FIG. 1B shows a bottom perspective view of the prosthetic valve shown in FIG. 1A. [Figure 2] FIG. 2 shows a schematic cross-sectional side view of the prosthetic valve shown in FIG. 1A. [Figure 3] FIG. 3 shows a schematic diagram of the delivery device approaching the implantation site. [Figure 4] FIG. 4 shows a schematic side cross-sectional view of the prosthetic valve shown in FIG. 1A deployed over a native heart valve. [Figure 5] FIG. 5 shows a schematic side cross-sectional view of a native heart valve with calcification. [Figure 6A] FIG. 6A shows a schematic side cross-sectional view of a delivery device approaching an implantation site. [Figure 6B] FIG. 6B shows a schematic side cross-sectional view of the delivery device shown in FIG. 6A with the outer expandable body in an expanded state. [Figure 6C] FIG. 6C shows a schematic cross-sectional side view of the delivery device shown in FIG. 6A with the outer expandable body in an expanded state. [Figure 6D] FIG. 6D shows a schematic cross-sectional side view of the delivery device shown in FIG. 6A with an implant positioned thereon. [Figure 6E] FIG. 6E shows a schematic side cross-sectional view of the delivery device shown in FIG. 6A with the inner expandable body in an expanded state. [Figure 6F] FIG. 6F shows a schematic side cross-sectional view of a prosthetic valve deployed over a native heart valve. [Figure 6G] FIG. 6G shows a side cross-sectional view of the delivery device approaching the implantation site. [Figure 6H] FIG. 6H shows a side cross-sectional view of the delivery device shown in FIG. 6G with the expandable body in an expanded state. [Figure 6I] FIG. 61 shows a side cross-sectional view of the delivery device shown in FIG. 6G advanced from the position shown in FIG. 6H. [Figure 6J] FIG. 6J shows a side cross-sectional view of the delivery device shown in FIG. 6G with the expandable body in an expanded state. [Figure 7A] FIG. 7A shows a side view of the delivery device approaching the implantation site. [Figure 7B] FIG. 7B shows a side view of the prosthetic valve deployed at the implantation site. [Figure 7C] FIG. 7C shows a side view of the frame of the prosthetic valve shown in FIG. 7B. [Figure 7D] FIG. 7D shows a side view of the prosthetic valve shown in FIG. 7B deployed at the implantation site. [Figure 7E] FIG. 7E shows a side view of the prosthetic valve shown in FIG. 7B deployed at the implantation site. [Figure 7F] FIG. 7F shows a side cross-sectional view of a prosthetic valve including one or more actuators. [Figure 7G] FIG. 7G shows a side cross-sectional view of the prosthetic valve shown in FIG. 7F deployed at the implantation site. [Figure 7H] FIG. 7H shows a side cross-sectional view of a prosthetic valve including one or more actuators. [Figure 7I] FIG. 7I shows a side cross-sectional view of the prosthetic valve shown in FIG. 7H deployed at the implantation site. [Figure 7J] FIG. 7J shows a side cross-sectional view of the prosthetic valve with the actuator applied to the prosthetic valve. [Figure 7K] FIG. 7K shows a side view of the prosthetic valve shown in FIG. 7J deployed at the implantation site. [Figure 7L] FIG. 7L shows a side cross-sectional view of the prosthetic valve with the actuator applied to the prosthetic valve. [Figure 8] FIG. 8 shows a side view of calcification in a destroyed heart valve. [Figure 9A] 9A to 9C each show a side view of the anchor. [Figure 9B] Same as above. [Figure 9C] Same as above. [Figure 10A] FIG. 10A shows a schematic cross-sectional side view of the anchor and calcification. [Figure 10B] FIG. 10B shows a schematic side cross-sectional view of the anchor shown in FIG. 10A anchored in a calcification. [Figure 11A] FIG. 11A shows a schematic cross-sectional side view of the anchor and calcification. [Figure 11B] FIG. 11B shows a schematic side cross-sectional view of the anchor shown in FIG. 11A anchored in a calcification. [Figure 11C] FIG. 11C shows a schematic cross-sectional side view of the anchor and calcification. [Figure 12A] FIG. 12A shows a perspective view of the prosthetic valve. [Figure 12B] FIG. 12B shows a schematic cross-sectional side view of the prosthetic valve shown in FIG. 12A. [Figure 13] FIG. 13 shows a schematic side cross-sectional view of a prosthetic valve deployed over a native heart valve. [Figure 14] FIG. 14 shows a schematic side cross-sectional view of a prosthetic valve deployed over a native heart valve. [Figure 15] FIG. 15 shows a schematic side cross-sectional view of a prosthetic valve deployed over a native heart valve. [Figure 16A] FIG. 16A shows a perspective view of the prosthetic valve. [Figure 16B]FIG. 16B shows a side view of the prosthetic valve shown in FIG. 16A deployed at the implantation site and in a closed state. [Figure 16C] FIG. 16C shows a side view of the prosthetic valve shown in FIG. 16A deployed at the implantation site and in an open state. [Figure 17A] FIG. 17A shows a side view of the prosthetic valve deployed at the implantation site and in an open state. [Figure 17B] FIG. 17B shows a side view of the prosthetic valve of FIG. 17A in a closed state. [Figure 18] FIG. 18 shows a schematic side cross-sectional view of a native heart valve in the left atrial appendage (LAA) and a prosthetic valve deployed on an anchor. [Figure 19] FIG. 19 shows a schematic side cross-sectional view of a prosthetic valve deployed in a pulmonary vein. [Figure 20] FIG. 20 shows a schematic side cross-sectional view of a prosthetic valve deployed over a native heart valve. [Figure 21] FIG. 21 shows a schematic side cross-sectional view of a stent deployed adjacent to the left ventricular outflow tract. [Figure 22] FIG. 22 shows a schematic side cross-sectional view of a prosthetic valve deployed in an aortic valve and a prosthetic valve deployed in a mitral valve. [Figure 23A] FIG. 23A shows a schematic side cross-sectional view of a cutter approaching the leaflets of a native heart valve. [Figure 23B] FIG. 23B shows a perspective view of the cutter approaching the leaflets of the native heart valve. [Figure 23C] FIG. 23C shows a perspective view of the cutter cutting the leaflets of the native heart valve. [Figure 24A] FIG. 24A shows a side cross-sectional view of a cutter approaching the leaflets of a native heart valve. [Figure 24B] FIG. 24B shows a view of the surface of the leaflets of a native heart valve with cutters applied to the leaflets. [Figure 24C] FIG. 24C shows a side view of the cutter shown in FIG. 24A with the jaws open. [Figure 24D] FIG. 24D shows a side view of the cutter shown in FIG. 24A with the jaws closed. [Figure 24E]FIG. 24E shows a view of the surface of the leaflets of a native heart valve with cutters applied to the leaflets. [Figure 25A] FIG. 25A shows a schematic side cross-sectional view of a cutter approaching the leaflets of a native heart valve. [Figure 25B] FIG. 25B shows a schematic side cross-sectional view of the cutter approaching the leaflets of the native heart valve. [Figure 25C] FIG. 25C shows a schematic side cross-sectional view of the leaflets of a native heart valve with a snare. [Figure 26] FIG. 26 shows a schematic side cross-sectional view of a cutter approaching the leaflets of a native heart valve. [Figure 27] FIG. 27 shows a schematic side cross-sectional view of a cutter approaching a chord. [Figure 28A] FIG. 28A shows the leaflets of a heart valve anchored to the ventricular wall. [Figure 28B] FIG. 28B shows the leaflets of the heart valve shown in FIG. 28A anchored to the ventricular wall with the prosthetic valve deployed over the native valve. DETAILED DESCRIPTION OF THE INVENTION

[0036] 1A shows a perspective view of a prosthetic valve 10 in the form of a replacement or prosthetic heart valve. The prosthetic valve 10 may be configured to be deployed within a portion of a patient's body. For example, the prosthetic valve 10 may be deployed within the annulus of a native valve, which may include a native mitral valve or a native tricuspid valve. In embodiments, other implantation locations may be utilized, such as within the aortic or pulmonary valve, or within other valves or other locations within the patient's body, as desired.

[0037] The prosthetic valve 10 may include a proximal end 12 or inlet end portion, a distal end 14 or outlet end portion (shown in FIG. 2 ), and a length therebetween. The prosthetic valve 10 may further include one or more prosthetic valve leaflets 16, or a valve portion having multiple prosthetic valve leaflets 16, configured to be positioned in a flow channel or passageway to control flow through the valve 10. The flow channel or passageway may be provided by a support structure 15 of the valve 10. The support structure 15 may form the proximal end 12 or inlet end portion and the distal end 14 or outlet end portion of the prosthetic valve 10. The prosthetic valve leaflets 16 may be configured to move between open and closed states to mimic and replace the behavior of the leaflets of a native valve. The valve portion may be positioned within the passageway of the support structure 15 and allow unidirectional blood flow through the passageway to replace the function of a native heart valve. The prosthetic valve leaflets 16 may be made of pericardium or another material, as desired.

[0038] In embodiments, the prosthetic valve leaflets 16 may be coupled to a valve body or support structure 15, which may be configured to surround and support the valve portion and one or more prosthetic valve leaflets 16. The support structure 15 may include a stent or frame or support frame (e.g., a valve frame or inner frame or inner support stent 18 and an outer frame or outer support stent 20, among other frame forms) and a seal 11. The valve frame or inner frame or inner support stent 18 is shown in FIG. 1B and in cross section in FIG. 2. The outer frame or outer support stent 20 is shown in FIGS. 1A and 2. The outer frame or outer support stent 20 may be part of the seal 11 and may be separate from the inner support stent 18. The outer support stent 20 may surround the inner support stent 18.

[0039] 1A and 2, the prosthetic valve 10 may include one or more anchors 17 that may be coupled to the prosthetic valve leaflets 16. The anchors 17 may each be configured to anchor the prosthetic valve leaflets 16, which may include a native valve, to a portion of the patient's heart. The anchors 17 may be particularly configured to anchor to the leaflets of the native valve of the patient's heart. The anchors 17 may extend around the leaflets of the native valve to anchor to the leaflets of the native valve. The anchors 17 may comprise distal anchors positioned at the distal end 14 or outlet end portion of the valve 10, or may be positioned at another location, as desired, in embodiments.

[0040] Each anchor 17 may be configured as a protruding arm configured to extend distally and then curve proximally toward the anchor tip of the anchor 17. With such a configuration, the anchor 17 may extend around the distal tip of the native valve leaflet, hook onto the distal tip of the native valve leaflet, and be positioned radially outward of the outward-facing surface of the native valve leaflet. The anchor 17 may be configured, for example, in a hook-like configuration as shown in FIGS. 1A-2. Thus, the anchor 17 may resist forces applied to the valve 10 in the atrial or proximal direction and anchor the valve 10 within the native valve annulus. Other configurations of the anchor 17 may be utilized in embodiments as desired.

[0041] The prosthetic valve leaflets 16 may surround a passageway or flow channel 25 and may move between an open state and a closed state to control flow through the passageway or flow channel 25, as shown in FIG. 2. As shown in FIG. 2, the proximal end of the prosthetic valve 10 may include the inflow end of the prosthetic 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 leaflets 16 may be positioned about a central axis 61 of the prosthetic valve 10. An inner support stent 18 and an outer support stent 20 may each surround the central axis 61 of the prosthetic valve 10.

[0042] Referring again to FIG. 1A , the prosthetic valve 10 may include a sealing body 11. The sealing body 11 may be positioned radially outward from the prosthetic valve's leaflets 16 and may be configured to seal against a portion of the native valve. The sealing body 11 may include an outer surface of the valve 10. The sealing body 11 may define the outer diameter of the valve 10 and may include the outer periphery of the valve 10. The sealing body 11 may include a proximal portion having a proximal end 31 and a distal portion having a distal end 33 (shown in FIG. 2 ).

[0043] 2, sealing body 11 may include an outer frame or support stent 20 and a sealing skirt 24, or in embodiments may include only a frame or only a sealing skirt, as desired. Outer support stent 20 may be positioned radially outward from inner frame or support stent 18. Sealing skirt 24 may be coupled to outer support stent 20 and may comprise an outer portion of sealing body 11, as shown in FIG. 1A.

[0044] The sealing skirt 24 may be made of a material that is resistant to fluid flow therethrough, such as a cloth material, a woven material, or other material such as a polymer, or other material that is resistant to fluid flow therethrough. The material may include a woven material. A variety of materials for the skirt 24 may be utilized as desired.

[0045] The sealing body 11 may be configured to abut a portion of the patient's heart to reduce fluid flow. The skirt portion 24 may be configured to seal against a portion of the annulus of the native valve. For example, the sealing body 11 may abut against a face of the leaflet of the patient's native valve to reduce fluid flow between the sealing body 11 and the native valve leaflet. The sealing body 11 may be configured to abut other portions of the patient's heart to reduce fluid flow, as desired.

[0046] In embodiments, the sealing body 11 may be flexible to allow movement and conformance to the annulus of the native valve.

[0047] 3 illustrates the advancement of a delivery system 70, or delivery catheter, to deploy the prosthetic valve 10 at an implantation site. The delivery system 70 may include an elongate shaft 72 having a proximal portion and a distal portion, the proximal portion coupled to a housing in the form of a handle 74. The delivery system 70 may be advanced through the patient's vascular system, which may include, for example, the femoral vein as shown in FIG. 3. In embodiments, other introduction techniques may be utilized, including transapical, and including via a surgical technique such as open-chest or open-heart surgery.

[0048] In embodiments, the prosthetic valve 10 may be positioned within an implant-retaining region of the delivery system 70 and may be covered or otherwise retained by a capsule prior to deployment. The prosthetic valve 10 may be deployed as a self-expanding prosthesis. The self-expanding prosthesis may be made of a shape-memory material. The shape-memory material may include nitinol, or in embodiments, may have other configurations (such as other configurations disclosed herein). However, in embodiments, the prosthetic valve may be a balloon-expandable prosthesis (e.g., positioned on an inflatable body or balloon upon entry into the patient's body, or slid onto an inflatable body or balloon within the patient's body), or may be mechanically expanded, or may have other deployed configurations.

[0049] Delivery system 70 can be advanced through an atrium of the heart and passed transseptally to another atrium (e.g., from the right atrium to the left atrium) to reach the implantation site. Such a delivery approach can be utilized, for example, for access to the native mitral valve. In embodiments, delivery system 70 can extend to the right atrium for tricuspid valve access, or other delivery approaches to other implantation sites can be utilized, as desired.

[0050] The prosthetic valve 10 may be held in a compressed configuration within the capsule of the delivery system 70. The anchors 17 may be advanced and deployed radially outward from the capsule.

[0051] 4 shows the prosthetic valve 10 deployed in a native valve 80 (e.g., a native mitral valve). The sealing body 11 can extend radially outward and contact the inward-facing surfaces of the native valve leaflets 82. The anchors 17 can be hooked onto the native valve leaflets 82 such that the tips of the anchors 17 are located radially outward of the native valve leaflets 82.

[0052] In embodiments, a configuration of the native valve 80 that includes calcification may interfere with the ability of the prosthetic valve to properly deploy at the implantation site. For example, calcification may interfere with the ability of the prosthetic valve to seal with the native valve. Calcification may interfere with the ability of the prosthetic valve to anchor to the native valve. The native valve 80 may include, for example, a calcified native mitral valve. Calcification may result in obstruction of the left ventricular outflow tract (LVOT) 282, as shown in FIG. 21 , for example, upon implantation of a prosthetic valve into a native mitral valve with calcification. Calcification may also have other undesirable effects on the implantation of the prosthetic valve or on other treatments of the native valve or the heart.

[0053] For example, with reference to Figure 5, calcifications 84 may be present beneath or radially outward of the outward-facing surface of a leaflet 83 of a native heart valve 88 (e.g., a calcified native mitral valve). Such calcifications 84 may impede the ability of anchor 17, shown in Figure 4, to anchor to native valve leaflet 83, for example, to latch around native valve leaflet 83. Calcifications 84 may block anchor 17 from being positioned radially outward of the outer surface of leaflet 83 in a desired manner.

[0054] The calcifications 86 may be located radially inward of the leaflets 83. For example, the calcifications 86 may be located on the inner-facing surfaces of the leaflets 83 or may protrude inward toward the flow channel between the leaflets 83. In embodiments, the calcifications 86 may be located on the annulus of the native heart valve 88 or within the atrium of the heart. Such calcifications 86 may interfere with the ability of the prosthetic valve to seal or anchor to the native valve. An irregularly shaped annulus may result, which may interfere with the ability of the prosthetic valve to deploy in a desired manner to the native heart valve 88. The calcifications may be in the mitral valve and may include mitral annular calcification (MAC).

[0055] In embodiments, calcification may be beneficially reduced to reduce the likelihood of adverse effects upon deployment of the prosthetic valve or adverse effects on cardiac operation generally. Figures 6A-6F show an example of a delivery system 90 or delivery catheter that may be utilized in embodiments herein.

[0056] The delivery system 90 or delivery catheter may include a first inflatable body 92 and a second inflatable body 94. The first inflatable body 92 may be configured to expand the prosthetic valve when the prosthetic valve is positioned on the first inflatable body 92 to deploy the prosthetic valve into the native valve. The second inflatable body 94 may surround the first inflatable body 92 and may be configured to transmit vibrations to disrupt calcification in the native valve. The delivery system 90 or delivery catheter may be for deployment of a prosthetic valve.

[0057] First expandable body 92 and second expandable body 94 may each be coupled to an elongate shaft 96 of a delivery device or delivery catheter, similar to elongate shaft 72 shown in FIG.

[0058] The distal end portion of the elongate shaft 96 may be shown in FIG. 6A , and the proximal end portion of the elongate shaft 96 may be coupled to a handle similar to the handle 74 shown in FIG. 3 . The handle may include a control mechanism (as represented by the control knob shown in FIG. 3 ) that may be for controlling the deflection of the elongate shaft 96 for navigation through a patient's vasculature. The control mechanism may be configured to position the expandable bodies 92, 94 in a desired orientation relative to the implantation site. The first expandable body 92 and the second expandable body 94 may each be coupled to the distal end portion of the elongate shaft 96.

[0059] The first expandable body 92 may include a proximal end portion 98, a distal end portion 100, and a central portion 102. The proximal end portion 98 may be coupled to the elongate shaft 96, and the distal end portion 100 may be coupled to the elongate shaft 96. The central portion 102 may bound a cavity 104 that may be configured to receive a fluid for inflating the first expandable body 92. The cavity 104 may be in fluid communication with a first fluid conduit 106 that may extend along the elongate shaft 96. A port 108 may enable fluid transfer between the first fluid conduit 106 and the cavity 104. The first fluid conduit 106, in embodiments, may comprise a lumen of the elongate shaft 96. The first fluid conduit 106 may receive fluid from a reservoir, for example, that passes fluid along the lumen of the elongate shaft 96.

[0060] The second expandable body 94 may extend over the first expandable body 92. The first expandable body 92 may be positioned within the second expandable body 94. The second expandable body 94 may include a proximal end portion 110, a distal end portion 112, and a central portion 114. The proximal end portion 110 may be positioned proximal to the proximal end portion 98 of the first expandable body 92 and may be coupled to the elongate shaft 96. The distal end portion 112 may be positioned distal to the distal end portion 100 of the first expandable body 92 and may be coupled to the elongate shaft 96.

[0061] The central portion 114 of the second expandable body 94 may bound a cavity 116 that may be configured to receive a fluid for inflating the second expandable body 94. The cavity 116 may be in fluid communication with a second fluid conduit 118 that may extend along the elongate shaft 96. The second fluid conduit 118 may extend around the first fluid conduit 106 such that the elongate shaft 96 has a dual lumen configuration. The second fluid conduit 118 may receive fluid from a reservoir, for example, by passing fluid along the lumen of the second fluid conduit 118. Other configurations may be utilized in embodiments. A port 121 may allow fluid transfer between the second fluid conduit 118 and the cavity 116. The second fluid conduit 118 may comprise the lumen of the elongate shaft 96, in embodiments.

[0062] The second expandable body 94 may be configured to expand independently of the first expandable body 92. For example, the second fluid conduit 118 may be configured to deliver fluid to expand the second expandable body 94 without expanding the first expandable body 92. A fluid control device (e.g., a syringe or other form of fluid control device) may be utilized to independently control fluid flow to the first expandable body 92 and the second expandable body 94. The fluid control device may provide fluid from one or more reservoirs, as desired.

[0063] The second expandable body 94, in embodiments, can be more conformable than the first expandable body 92. The second expandable body 94 can be more conformable to conform to the shape of the native valve, which may include calcification. The first expandable body 92 can be less conformable than the second expandable body 94 to support a prosthetic valve that can be positioned over and expanded by the first expandable body 92.

[0064] In embodiments, second expandable body 94 may be configured to transmit vibrations to break up calcifications. The vibrations may, in embodiments, include acoustic pressure waves. The acoustic pressure waves may, in embodiments, include ultrasound waves. The ultrasound waves may, in embodiments, include shock waves. Various other forms of vibration or wave frequencies may be utilized to produce desired results in embodiments (e.g., low frequency waves less than ultrasound frequencies may be utilized in embodiments, and high frequency waves may be utilized). The vibrations may be configured to break up calcifications into particles in a process similar to lithotripsy. One or more actuators 123 may be utilized, for example, to generate the vibrations of second expandable body 94.

[0065] In embodiments, the actuator 123 may have various forms. For example, the actuator 123 may include an electrode 125. The electrode 125 may be configured to excite or vaporize the fluid filling the second expandable body 94 to generate vibrations of the second expandable body 94. The electrode 125 may, for example, generate an electric arc or spark when a voltage is applied to the electrode 125. The electric arc or spark may vaporize a portion of the fluid filling the second expandable body 94 (e.g., a portion of the fluid adjacent to the electrode 125), and the gas pressure of the vaporization may generate vibrations of the second expandable body 94. The vibrations may propagate through the fluid to the outer surface of the second expandable body 94, applying vibrations to calcified native valves. Other forms of actuators or other methods of using actuators may be utilized in embodiments.

[0066] Electrical conduits 120, 122 may extend to electrode 125 to provide electrical energy to electrode 125, which generates an electric arc or spark. A positive electrical conduit 120 and a negative electrical conduit 122 may be provided to generate the resulting electric arc or spark. Conduits 120, 122 may be coupled to respective electrodes 125 in embodiments. Electrical conduits 120, 122 may extend along elongate shaft 96 and be adapted to provide electrical energy to electrode 125. Similar electrical conduits may extend to other electrodes 127 (shown in FIG. 6A ), which may be positioned elsewhere within second expandable body 94. Electrodes 125, 127 may be configured as rings extending around elongate shaft 96 or may have other configurations in embodiments.

[0067] The proximal end portions of the electrical conduits 120, 122 may be coupled to contacts 124, 126 of a controller 128 (shown in FIG. 6C ), which may be configured to cause the actuator 123 to transmit vibrations to the calcification. The controller 128 may receive power from a power source 131 (e.g., a battery or a power connector such as a mains connector) to provide power to the actuator 123. For example, the controller 128 may control the amplitude and frequency of the electrical energy (e.g., current or voltage) applied to the electrodes 125, 127 to generate the vibrations (e.g., shock waves) applied to the calcification and the duration for which the vibrations are applied to the calcification. The controller 128 may provide the electrical energy that results in an ultrasonic frequency of vibrations from the second expandable body 94. The controller 128 may operate on user input or, in some embodiments, automatically.

[0068] The second expandable body 94 can be utilized in a process to destroy calcification to provide a reduced-calcification implantation site for a prosthetic valve. Calcification can be completely removed from the native heart valve, or partially removed to provide an improved implantation site for a prosthetic valve. Calcification can be removed from a calcified native mitral valve, in some embodiments (or other native valves, as desired).

[0069] 6B, the second expandable body 94 may be positioned at the implantation site and expanded. Fluid may fill the cavity 116, expanding the second expandable body 94. The second expandable body 94 may conform to the shape of the native valve and the calcifications of the native valve (e.g., calcifications 86, which may be inside the leaflets of the native valve, and calcifications 84, which may be outside the leaflets of the native valve). The first expandable body 92 may remain unexpanded at this point or may be partially expanded, as desired.

[0070] 6C, the second expandable body 94 can transmit vibrations to break up the calcifications 86, 84. The actuator 123 can generate the vibrations that are transmitted through the fluid filling the cavity 116. The controller 128 can control the generation of the vibrations in the second expandable body 94. The vibrations can be applied for a desired period of time to completely or partially remove the calcifications. In an embodiment, the vibrations can be generated on the surface of the second expandable body 94.

[0071] In an embodiment, a sensor 133 may be provided that can be used to image the reduction of calcification. The sensor 133 may, for example, comprise an imaging sensor (e.g., fluoroscopy or ultrasound, or a combination thereof) that images the reduction of calcification. In an embodiment, the sensor 133 may be configured to image the position of the second expandable body 94 to determine the reduction of calcification. The sensor 133 may image the size or diameter of the second expandable body 94 after or during the calcification reduction process. The second expandable body 94 may include, for example, one or more imaging markers (e.g., radiopaque material or immunogenic markers) that can be imaged to determine the size or diameter of the second expandable body 94. A user may determine whether the calcification has been sufficiently reduced based on the output from the sensor 133. In an embodiment, the output from the sensor 133 may be provided as feedback to the controller 128 of the controller 128 to automatically generate vibrations from the second expandable body 94 and / or to stop generating vibrations once a sufficient amount of calcification has been removed. Other configurations may be utilized in embodiments.

[0072] Once the desired amount of calcification has been destroyed, the prosthetic valve 130 can be positioned on the first inflatable body 92 and thus on the second inflatable body 94. For example, the prosthetic valve 130 can comprise a balloon-expandable valve and can be slid onto the second inflatable body 94 with the prosthetic valve 130 in an undeployed or unexpanded configuration. The prosthetic valve 130 can include any feature disclosed herein with respect to the prosthetic valve, including any feature of the prosthetic valve 10 or other prosthetic valves disclosed herein. In embodiments, the prosthetic valve 130 can lack anchors 17 as disclosed with respect to the prosthetic valve 10, or can include such anchors (or other forms of anchors). The prosthetic valve 10 can comprise a single-frame prosthetic valve 130, as well as a multi-frame prosthetic valve, as disclosed with respect to the valve 10.

[0073] The second expandable body 94 may be deflated before the prosthetic valve 130 is slid onto the second expandable body 94. The second expandable body 94 may have an outer surface configured to slide the prosthetic valve 130 over the outer surface in vivo. FIG. 6D , for example, shows the prosthetic valve 130 on the second expandable body 94. The second expandable body 94 is positioned within a flow channel or passageway of the prosthetic valve 130. The first expandable body 92 may be configured to expand the prosthetic valve 130 positioned on the first expandable body 92 and the second expandable body 94. The first expandable body 92 may then be inflated via the first fluid conduit 106, expanding the prosthetic valve 130 and the second expandable body 94 and deploying the prosthetic valve 130 at the implantation site.

[0074] 6E shows the first expandable body 92 being inflated, for example, via the first fluid conduit 106. The first expandable body 92 may expand radially outward, correspondingly expanding the second expandable body 94 radially outward and the prosthetic valve 130. The prosthetic valve 130 may be deployed into place due to the expansion of the first expandable body 92. In an embodiment, a sensor 133 may be utilized to image the diameter of the prosthetic valve 130 during implantation. The sensor 133 may include an imaging sensor for imaging the diameter of the prosthetic valve 130. The output from the sensor 133 may be utilized to determine the resulting diameter of the prosthetic valve 130 and whether proper deployment has occurred.

[0075] The first expandable body 92 can be deflated and removed from the implantation site along with the second expandable body 94. The elongate shaft 96 can be withdrawn from the implantation site, removing the first expandable body 92 and the second expandable body 94.

[0076] 6F, for example, shows the prosthetic valve 130 deployed at an implantation site, which may have calcification completely or partially removed from the site.

[0077] A variety of systems and methods may be utilized in the embodiments.

[0078] 6G-6J show an embodiment in which a first expandable body 92 is axially spaced apart from a second expandable body 94 along an elongate shaft 135 of a delivery system or delivery catheter. The mechanism of the embodiment of Figures 6G-6J, like the mechanism of Figures 6A-6F, may otherwise operate in a similar manner.

[0079] The second expandable body 94 can be advanced, for example, to be positioned adjacent the calcifications 84, 86 of the native valve. Fluid can inflate the second expandable body 94 to create an expanded state, for example, as shown in FIG. 6H. The actuator 123 can be utilized to generate vibrations to disrupt the calcification in a manner similar to that described herein. The sensor 133 can be utilized to image the reduction of calcification in a manner similar to that disclosed herein.

[0080] The second expandable body 94 may be deflated, after which the elongate shaft 135 may be advanced distally, as shown in FIG. 6I. The first expandable body 92 may be positioned at the implantation site such that, upon expansion of the first expandable body 92, the prosthetic valve 130 is provided in the desired location. The first expandable body 92 may be inflated (as shown in FIG. 6J), implanting the prosthetic valve 130 at the desired implantation site. A sensor 133 may be utilized to image the diameter of the prosthetic valve 130 during implantation, as disclosed herein.

[0081] 6G-6J may advantageously allow the prosthetic valve 130 to remain on the first expandable body 92 during the calcification reduction process of the second expandable body 94. In this manner, the prosthetic valve 130 need not be slid onto the first expandable body 92, but may remain on the first expandable body 92 during the calcification reduction process of the second expandable body 94. In embodiments, the prosthetic valve 130 may even be slid onto the first expandable body 92 during the implantation procedure.

[0082] 6A-6J may be used alone or in combination with features of any other embodiment herein. Variations of the systems and methods may be used in the embodiments.

[0083] 7A-7L illustrate examples in which a prosthetic valve may be configured to be deployed onto a native heart valve and may be configured to transmit vibrations to reduce calcification of the native valve. The vibrations may disrupt calcification in the native valve. In examples, the utilized prosthetic valve may comprise a self-expanding or self-expanding valve, or may be configured to expand when an electric current is applied to the frame of the prosthetic valve. Other forms of prosthetic valves (e.g., balloon-expandable or mechanically expandable) may be utilized in examples.

[0084] 7A, a prosthetic valve 140 may be positioned within a capsule 142 of a delivery device or catheter, such as the delivery device or catheter shown in FIG. 3. The capsule 142 may retain the prosthetic valve therein. Once the capsule 142 is in a desired position relative to the implantation site, the capsule 142 may be retracted, allowing the prosthetic valve to be deployed. In embodiments, other forms of retention devices may be utilized to retain the prosthetic valve prior to deployment.

[0085] 7B shows a housed capsule 142. The prosthetic valve 140 may remain undeployed or unexpanded, or may begin to self-expand upon release from the capsule 142. In embodiments, the prosthetic valve 140 may transmit vibrations to disrupt calcification in the native valve.

[0086] For example, the delivery device of the delivery catheter may include an actuation mechanism 143 that vibrates the support structure, thereby reducing calcification of a calcified native valve. For example, the prosthetic valve 140 may include a support structure 141. The support structure 141 may be configured similar to any of the support structure embodiments disclosed herein. The support structure 141 may include a support frame, which may be configured similar to any of the frame embodiments disclosed herein. A support frame 153 is shown, for example, in FIG. 7C . The actuation mechanism 143 may be configured to transmit energy to the support structure 141 to cause the support structure 141 to generate vibrations.

[0087] The actuation mechanism 143 may include one or more electrical terminals 145, 147 for applying electrical energy to the support structure. The electrical terminals 145, 147 may be configured to electrically connect with corresponding terminals on the support structure 141 (or support frame 153). The electrical terminals 145, 147 may connect with electrical conduits 144, 146, which may be configured to couple to electrical contacts 148, 150 of the controller 152. The electrical conduits 144, 146 may extend along the elongate shaft of the delivery system or delivery catheter. Proximal end portions of the electrical conduits 144, 146 may be coupled to the electrical contacts 148, 150 of the controller 152.

[0088] The controller 152 may receive power from a power source 158 (eg, a battery or a power connector such as a mains connector).

[0089] In some embodiments, controller 152 may be configured to control the vibrations via current to support frame 153, which may cause movement of support frame 153. FIG. 7C , for example, illustrates support frame 153 of prosthetic valve 140 (sealing body or sealing skirt 155 is omitted from FIG. 7C ). Support frame 153, in some embodiments, may be configured to support one or more prosthetic valve leaflets (not shown). Support frame 153 may surround a passageway or flow channel within which one or more prosthetic valve leaflets are positioned. In some embodiments, support frame 153 may support sealing skirt 155. Support frame 153, in some embodiments, may comprise an outer frame or outer support stent, or other form of frame. In some embodiments, support frame 153, in some embodiments, may comprise an inner frame or inner support stent, or other form of frame. Prosthetic valve 140, in some embodiments, may include one or more distal anchors 161. Distal anchor 161 may, in some embodiments, be configured to extend over the tips of the native valve leaflets or may have another configuration.

[0090] The support frame 153, in some embodiments, may include a shape memory material that can move in response to an electrical current applied to the support frame 153. The shape memory material may have a variety of forms, including soft superelastic nitinol, platinum-iridium, or shape memory nitinol, among others. The electrical current applied to the support frame 153 may be used to generate vibrations from the frame that may be used to disrupt calcification in the native valve.

[0091] The controller 152 may control energy delivered to the support structure 141 to vibrate it. The controller 152 may, for example, vary the amount of current applied to the support frame 153. The current may be provided by a power source 158 delivered to the support frame 153. The controller 152 may control the amplitude and frequency of the current applied to the support frame 153 to generate the vibrations. The controller 152 may apply a pulsatile current to the frame. The vibrations generated by the prosthetic valve 140 may, in some embodiments, include acoustic pressure waves. The acoustic pressure waves may, in some embodiments, include ultrasound waves. The ultrasound waves may, in some embodiments, include shock waves. Waves of various other forms or frequencies may be utilized to generate the desired results, in some embodiments (e.g., low-frequency waves less than ultrasound frequencies may be utilized, and high-frequency waves may be utilized). The vibrations may be generated by heat provided from the current applied to the support frame 153, with the resulting vibrations being generated by movement of the support frame 153. The vibration may be utilized to completely or partially destroy calcifications 86, 84 shown in Figure 7B. Terminals 145, 147 may couple controller 152 to support frame 153 for transmitting electrical current thereto.

[0092] In embodiments, electrical terminals 145, 147 may include removable terminals that can be released from support frame 153 following the implantation procedure. For example, terminals 145, 147 may be magnetically coupled or coupled with removable clips, clamps, or other forms of coupling to support frame 153. In this manner, terminals 145, 147 and electrical conduits 144, 146 may be removed after implantation.

[0093] The vibrations generated by the prosthetic valve 140 may completely or partially remove calcification at the implantation site. In this manner, reduced calcification may result, which may improve the deployment of the prosthetic valve 140. In some embodiments, a sensor 133 may be utilized to image the diameter of the prosthetic valve 140 during implantation. The sensor 133 may include an imaging sensor for imaging the diameter of the prosthetic valve 140. The output from the sensor 133 may be utilized to determine the resulting diameter of the prosthetic valve 140 and whether proper deployment has occurred. In some embodiments, the output from the sensor 133 may be provided as feedback to the controller 152 of the diameter of the prosthetic valve 140. The feedback may be utilized to cause the controller 152 to automatically generate vibrations from the prosthetic valve 140 and / or to stop generating vibrations once a sufficient amount of calcification has been removed. Other configurations may be utilized in some embodiments.

[0094] 7D, the prosthetic valve 140 can be deployed into a native valve with reduced calcification. The electrical terminals 145, 147 can be removed from the prosthetic valve 140, if desired. For example, the configuration shown in FIG. 7E can result.

[0095] In embodiments, the current applied to the frame can be configured to control the expansion of the frame. For example, the frame can be configured to expand in response to a current applied to the frame, which can generate heat. As shown in FIG. 7B , the prosthetic valve 140 can have a first diameter 154. A current can be applied to the frame to expand the prosthetic valve to a larger second diameter 156, as shown in FIG. 7D . Current applied to the support frame 153 via the actuation mechanism 143 can cause the support frame 153 to expand. Electrical energy applied to the support frame 153 can increase the diameter of the support frame 153. In embodiments, the current can be controlled by the controller 152 to generate a desired expansion of the support frame 153. For example, expansion can be initiated or stopped by the controller 152. A user can determine that expansion should be stopped based on, for example, mispositioning of the prosthetic valve 140 or other conditions that may require stopping the expansion. Accordingly, the controller 152 can stop or reduce the current to the frame, which can stop the expansion. At a desired point, the controller 152 may initiate expansion to complete the expansion or deployment of the prosthetic valve 140. In an embodiment, the rate of expansion may be controlled by the controller 152. The controller 152 may automatically control the expansion, which may be based on feedback signals received from sensors or forms of visualization of the deployment. The output from the sensor 133 may be provided as feedback to the controller 152 of the diameter of the prosthetic valve 140, for example.

[0096] The controlled expansion of the prosthetic valve 140 may allow the size of the prosthetic valve 140 to be set during expansion. In this manner, the prosthetic valve 140 may be large enough to reduce the likelihood of paravalvular leak (PVL), but not so large as to create excessive forces or conduction disturbances at the implantation site.

[0097] In embodiments, expansion of the support frame by an electric current may be utilized alone or in combination with vibrations generated by the prosthetic valve 140. Similarly, vibrations generated by the prosthetic valve may be utilized alone or in combination with expansion of the support frame by an electric current. In embodiments, the prosthetic heart valve may be expanded within the native heart valve, and vibrations may be applied from the prosthetic heart valve to reduce calcification of the heart valve.

[0098] In embodiments, the support frame may include a dock for receiving an insert having the leaflets of the prosthetic valve. In embodiments, the support frame may be coupled to the leaflets of the prosthetic valve upon implantation in a patient's body.

[0099] Other forms of actuation mechanisms for transmitting energy to the support structure to cause the support structure to generate vibrations to reduce calcification of the calcified native valve may be provided in embodiments.

[0100] 7F-7I illustrate, for example, a configuration in which the support structure of a prosthetic valve includes one or more actuators for generating vibrations to reduce calcification of a calcified native valve. Various forms of actuators may be utilized. FIGS. 7F and 7G illustrate, for example, an actuator 163 in the form of an electrode 165 that may be configured to excite or vaporize a fluid filling one or more expandable bodies 167 to generate vibrations of the expandable bodies 167, in a manner similar to actuator 123. For example, electrode 165 may generate an electric arc or spark when a voltage is applied to electrode 165. The electric arc or spark may vaporize a portion of the fluid filling one or more expandable bodies 167 (e.g., a portion of the fluid adjacent to electrode 165), and the gas pressure of the vaporization may generate vibrations of the expandable bodies 167. The vibrations may propagate through the fluid to the outer surface of the expandable bodies 167, applying vibrations to the calcified native valve. Other forms of actuators, or other methods of using actuators, may be utilized in embodiments.

[0101] Prosthetic valve 169 may be configured similarly to other forms of prosthetic valves disclosed herein (including prosthetic valve 10), unless otherwise noted. Prosthetic valve 169 may include a support structure 186, which may include, for example, a support frame 188. Support frame 188, in some embodiments, may include an outer support stent and / or an inner support stent. Support structure 186 may support valve portions, which may be configured similarly to other forms of valve portions disclosed herein, including the use of multiple prosthetic valve leaflets. Support structure 186, in some embodiments, may include a sealing skirt 245. One or more anchors 247 may be utilized, which may be configured similarly to anchors 17 or may have other configurations in some embodiments.

[0102] The actuator 163 and expandable body 167 are preferably positioned on the support structure 186 in a location that applies vibrations to the calcifications 84, 86 from the outer surface 179 of the support structure 186. The outer surface 179 of the support structure 186 may be for contacting the calcifications of the native valve. For example, in some embodiments, the actuator 163 and expandable body 167 may be positioned between the support frame 188 and the sealing skirt 245. The sealing skirt 245 may be on the expandable body 167. The expandable body 167 may transmit vibrations through the sealing skirt 245 to the calcifications 86, 84. In some embodiments, the actuator 163 and expandable body 167 may be positioned radially outward of the sealing skirt 245 to apply vibrations to the calcifications 84, 86. For example, one or more of the expandable bodies 167 may include a tube or ring extending around the sealing skirt 245. In embodiments, the one or more expandable bodies 167 may include tubes or rings that extend around the support frame 188 and within the sealing skirt 245. Other configurations of the one or more expandable bodies 167 or locations of the one or more expandable bodies 167 may be utilized in embodiments.

[0103] One or more expandable bodies 167 may be provided in an inflated state at the time of deployment, or may be filled at the time of implantation via one or more fluid conduits from a delivery system or delivery catheter. One or more expandable bodies 167 may remain inflated after implantation, or may be drained of fluid after their use to remove calcification.

[0104] The actuator 163 may include one or more electrical terminals 181 that may be configured to provide electrical energy to the actuator 163. The electrical terminals 181 may be electrically coupled to the actuator 163 via one or more electrical conduits 183 that may extend along a support structure 186 between the actuator 163 and the electrical terminals 181.

[0105] The delivery system or delivery catheter may include an actuation mechanism 185 for transmitting energy to the support structure 186 to cause the support structure 186 to generate vibrations to reduce calcification of the calcified native valve. The actuation mechanism 185 may include one or more electrical terminals 187 for electrical communication with one or more electrical terminals 181 of the actuator 163. The electrical terminals 187 may extend to a controller (which may be powered by a power source 131), such as the controller 128 shown in FIG. 6C , to control the actuator 163 in a manner similar to the controller 128. The controller may control the energy transmitted to the support structure 186 to vibrate the support structure. The electrical terminals 187 may be coupled to electrical conduits 189, 191, which may extend to the controller in a manner similar to the electrical conduits 120, 122. The electrical conduits 189, 191 may, in some embodiments, extend along the elongate shaft of the delivery system or delivery catheter. Electrical terminal 187 may include a removable terminal that can be released from electrical terminal 181 following the implantation procedure. For example, electrical terminal 187 may be magnetically coupled or coupled with a removable clip, clamp, or other form of coupler to electrical terminal 181. In this manner, electrical terminal 187 and electrical conduits 189, 191 may be removed after implantation.

[0106] Actuator 163 may be operated to destroy calcification in a manner similar to that discussed with respect to actuator 123. Electrical energy may be provided to actuator 163 in a controlled manner via a controller (which may be controller 128). A desired amount of calcification may be reduced in the process. In embodiments, a sensor 133 may be provided that may be used to image the reduction of calcification. Sensor 133 may operate similarly as disclosed herein. For example, sensor 133 may image the diameter of prosthetic valve 169. Output from sensor 133 may be provided as feedback to the controller of the controller to automatically generate vibrations from one or more expandable bodies 167 and / or to cease generating vibrations once a sufficient amount of calcification has been removed. Other configurations may be utilized in embodiments.

[0107] The resulting configuration of the prosthetic valve 169 is shown in Figure 7G.

[0108] In embodiments, the use of actuator 163 may be combined with the configuration shown in FIG. 7D, in which an electric current is applied to the support frame to control the expansion of the support frame. Actuator 163 may be operated to reduce calcification of the native valve, and an electric current may be applied to the support frame to increase the diameter of the support frame. In embodiments, actuator 163 may be utilized alone.

[0109] The type of actuator utilized may vary in embodiment.

[0110] 7H and 71 show variations in which, for example, one or more actuators 195 may comprise piezoelectric actuators. Actuators 195 may be positioned in locations similar to those disclosed for actuator 163 and expandable body 167. Actuators 195 may be positioned, for example, to apply vibrations to calcifications from outer surface 197 of support structure 199 of prosthetic valve 201. Prosthetic valve 201 may otherwise be configured similarly to prosthetic valve 169.

[0111] The piezoelectric actuator may include a piezoelectric material 251 and a pressing surface 261 for applying vibrations to the calcifications produced by the piezoelectric material 251. A voltage applied to the piezoelectric material 251 and supplied from electrical terminals 263 via electrical conduits 265 may be utilized. A controller (similar to controller 128) and power source 131 may provide electrical energy to the piezoelectric material 251 to generate vibrations at a desired frequency (which may be an ultrasonic frequency). The actuator 195 may be utilized to reduce calcifications in a manner similar to that disclosed with respect to the other forms of actuators described herein.

[0112] In an embodiment, the sensor 133 may be utilized for feedback to a controller in a manner similar to that disclosed herein. In an embodiment, the piezoelectric actuator may be utilized as a sensor to determine the amount of force applied to the calcification. Such a sensor signal may be utilized as feedback to a controller to determine the force applied to the calcification. The controller may control the operation of the piezoelectric actuator based on the feedback received from the piezoelectric actuator (e.g., change the frequency of vibration or stop operation of the piezoelectric actuator based on the feedback). Figure 7I illustrates the resulting configuration of the prosthetic valve 201 in an embodiment. The electrical contacts 211 from the actuation mechanism of the delivery system or delivery catheter may be detached during deployment.

[0113] The use of actuator 195 may be combined with the configuration shown in FIG. 7D, in which an electric current is applied to the support frame to control the expansion of the support frame. Actuator 195 may be operated to reduce calcification of the native valve, and an electric current may be applied to the support frame to increase the diameter of the support frame. In embodiments, actuator 195 may be utilized alone.

[0114] 7F-7I, in some embodiments, may include acoustic pressure waves. Acoustic pressure waves may include ultrasound waves. Ultrasound waves may include shock waves. Waves of various other forms or frequencies may be used to produce desired results in some embodiments (e.g., low frequency waves less than ultrasound frequencies may be used in some embodiments, and high frequency waves may be used).

[0115] Other forms of actuation mechanisms for transmitting energy to the support structure to cause the support structure to generate vibrations to reduce calcification of the calcified native valve may be provided in embodiments.

[0116] 7J-7L show, for example, variations in which the actuation mechanism is adapted to apply vibrations to the support frame 215 to vibrate the support frame 215, thereby reducing calcification of the calcified native valve. The support frame 215 can transmit the vibrations to reduce calcification of the calcified native valve. The actuation mechanism can include one or more forms of actuators disclosed herein or other forms of actuators.

[0117] For example, with reference to FIG. 7J , actuation mechanism 221 may include an actuator in the form of an electrode 223 that may be configured to excite or vaporize a fluid filling expandable body 225 to generate vibrations of expandable body 225 in a manner similar to actuator 123. For example, electrode 223 may generate an electric arc or spark when a voltage is applied to electrode 223. The electric arc or spark may vaporize a portion of the fluid filling expandable body 225 (e.g., a portion of the fluid adjacent electrode 223), and the gas pressure of the vaporization may generate vibrations of expandable body 225. The vibrations may propagate through the fluid to the exterior surface of expandable body 225, applying vibrations to support frame 215. Other forms of actuators or other methods of using actuators may be utilized in embodiments.

[0118] The actuation mechanism 221 may include a support 277 , such as a control arm or other form of support, for controlling the position of the expandable body 225 .

[0119] The inflatable body 225 can be applied to the support frame 215 to apply vibrations to the support frame 215. The inflatable body 225 can be positioned, for example, against the proximal or inlet end portion 229 of the prosthetic valve 231. Other application locations (e.g., the distal or outlet end portions) can be utilized as desired. The inflatable body 225 can contact the support frame 215 or can be applied to a sealing skirt, with the vibrations transmitting through the sealing skirt to the support frame 215.

[0120] Vibrations applied to the support frame 215 may propagate through the support frame 215 and apply vibrations or shock waves to the calcification of the native valve. The vibrations or shock waves may reduce the calcification of the native valve.

[0121] Prosthetic valve 231 may be configured similarly to other prosthetic valves disclosed herein, including prosthetic valve 10 or other forms of prosthetic valves. Vibrations may propagate along the outer support stent for application directly to calcifications or another portion of the support frame, as desired.

[0122] In embodiments, actuation mechanism 221 may include a portion of a delivery system or delivery catheter utilized to deploy prosthetic valve 231. Support 277 may extend from the delivery catheter, for example, and apply expandable body 225 to support frame 215. A separate device may, in embodiments, apply expandable body 225 to support frame 215. Actuation of actuator 221 may be controlled via a controller utilizing methods disclosed herein. Feedback from sensor 133 to the controller may further be utilized in accordance with methods disclosed herein.

[0123] The use of actuation mechanism 221 may be combined with the configuration shown in FIG. 7D, in which an electric current is applied to the support frame to control the expansion of the support frame. The actuator may be operated to reduce calcification of the native valve, and an electric current may be applied to the support frame to increase the diameter of the support frame. In embodiments, actuation mechanism 221 may be utilized alone. The resulting configuration of prosthetic valve 231 is shown in FIG. 7k.

[0124] The configuration of the actuator utilized in Figure 7J can be varied as desired. Figure 7L illustrates the use of an actuation mechanism 279 in the form of, for example, a piezoelectric actuator 281 to apply vibrations to support frame 215. Actuation mechanism 279 can otherwise operate in a similar manner as disclosed with respect to actuation mechanism 221.

[0125] Variations of the systems and methods may be utilized in embodiments. The vibrations created in Figures 7J-7L may, in embodiments, include acoustic pressure waves. The acoustic pressure waves may, in embodiments, include ultrasound waves. The ultrasound waves may, in embodiments, include shock waves. Waves of various other forms or frequencies may be utilized to produce desired results in embodiments (e.g., low frequency waves less than ultrasound frequencies may be utilized in embodiments, and high frequency waves may be utilized).

[0126] The systems, methods, and devices may be used with mitral or tricuspid valves, or other valve configurations as desired. The features in the embodiments of Figures 7A-7L may be used alone or in combination with features in any other embodiment herein.

[0127] Variations of the systems and methods disclosed herein may be provided.

[0128] FIG. 8 illustrates a system that may utilize a cutter 151, such as a sintering device or laser, to reduce calcification of a native heart valve. The cutter 151 may be positioned on a catheter or otherwise positioned and may be movable to be placed at a desired location relative to the calcification. The cutter 151 may be utilized to reduce the calcification by smoothing or fracturing the calcification, as desired. For example, FIG. 8 illustrates a cutter 151 in the form of a laser that destroys calcification 157 for removal from the implantation site.

[0129] Cutter 151 may be utilized to provide a desired shape of the calcification or to partially or completely remove the calcification. For example, cutter 151 may be utilized to cut protruding portions 159 of calcification 157 to reduce the likelihood that such protruding portions 159 will interfere with the deployment of the prosthetic valve. Thick or stuck calcification may be cut or smoothed. In embodiments, sections of native valve calcification or the entire calcification may be cut or smoothed.

[0130] In some embodiments, an embolic capture device 168a may be utilized that can capture calcifications released from the native valve. The embolic capture device 168a may comprise, for example, a filter (e.g., a body with pores) that can allow blood to pass through and capture the calcifications. The filter may be shaped as a receptacle that can retain the released calcifications. The calcifications retained by the embolic capture device 168a may be removed after the calcifications in the native heart valve are reduced. In some embodiments, the embolic capture device 168a may comprise a first embolic capture device 168a, and a second embolic capture device 168b may be utilized. The embolic capture device 168b may be positioned on the upstream or atrial side of the native valve, and the embolic capture device 168a may be positioned on the downstream or ventricular side of the native valve. The embolic capture device 168b may be coupled to the cutter 151, extend radially outward from the cutter 151, or another configuration may be utilized in some embodiments. In an embodiment, only one of the devices 168a, 168b may be utilized.

[0131] Calcification can be removed from a mitral valve, or a tricuspid valve, or another type of valve, as desired. In embodiments, a prosthetic heart valve can be deployed over a native heart valve, as desired.

[0132] The features of the embodiment of FIG. 8 may be used alone or in combination with any other embodiment herein.

[0133] In embodiments, anchors that may be utilized to anchor a prosthetic valve to an implantation site may be customized according to the configuration of the implantation site in a native heart valve having calcification. For example, the configuration of the implantation site may be determined. The determination may be made in various manners. In embodiments, the configuration may be determined based on imaging of the implantation site. In embodiments, the configuration may be determined based on demographic or statistical information of the patient (e.g., age, weight, medical history, among others). The configuration of the distal anchor of the prosthetic heart valve may be selected based on the determined configuration of the implantation site.

[0134] For example, Figures 9A-9C illustrate variations in distal anchors that may be selected. Figure 9A illustrates a distal anchor 160 that may be positioned distal to the calcification and extend horizontally so as not to rest on the leaflets of the native valve. The anchor 160 may extend over the distal tip of the leaflet. Such an anchor 160 may be selected when the implantation site is determined to have calcification 84a radially outward of the leaflet, as shown in Figure 8, for example. Figure 9B illustrates an example of an anchor 162 that may be angled proximally to account for partial calcification 84b positioned radially outward of the leaflet, as shown in Figure 8, for example. Figure 9C illustrates an example of an anchor 164 that includes barbs 166 for engaging the calcification, if desired.

[0135] The configuration of the distal anchors can be selected based on the determined configuration of the implantation site. The configuration of the distal anchors can be selected, after which the selected anchors can be attached to a support structure, or the entire prosthetic valve can be selected to provide the desired configuration of the selected anchors. The prosthetic valve can be deployed with anchors having the selected configuration. The configuration of the distal anchors can be selected based on the shape of the calcifications in the native heart valve. The configuration of the distal anchors can be selected to anchor into the calcifications in the native heart valve.

[0136] In embodiments, the configuration of the distal anchor may be selected from a set including a plurality of different configurations of distal anchors.

[0137] In embodiments, the distal anchor may be adjusted based on the selected configuration. For example, the anchor 162 shown in FIG. 9B may be adjusted to extend horizontally, as shown in FIG. 9A, to account for calcification, if desired. The anchor 162 may be bent to extend horizontally from the configuration shown in FIG. 9B to the configuration shown in FIG. 9A. Angle adjustment of the distal anchor may be provided relative to the frame of the support structure.

[0138] The anchor may comprise a distal anchor that may be coupled to support structure 15, as shown in Figures 1A-1C, and may be utilized in place of or in combination with anchor 17 shown in Figures 1A-1C. In some embodiments, the anchor may be coupled to other forms of support structure. The prosthetic valve, in some embodiments, may be configured to be deployed in a mitral or tricuspid valve.

[0139] Various other configurations of distal anchors may be utilized in embodiments, and the features of the embodiment of Figures 9A-9C may be utilized alone or in combination with any other embodiment herein.

[0140] 10A and 10B show an example of an anchor 170 that may include barbs 172 that may be configured to engage a calcification 174 of a native valve to anchor to the calcification 174. The barbs 172 may be positioned on arms 176 that may be configured to extend radially outward from a support structure 178 to engage the calcification.

[0141] The arm 176 may have a distal end portion 171 coupled to a distal end portion 173 of the support structure 178. The arm 176 may extend from the distal end portion 171 to a proximal end portion 175 of the arm 176. The arm 176 may extend proximally radially outward from the support structure 178 (which may be configured similarly to the support structure 15 shown in FIGS. 1A-1C). The arm 176 may be configured to rotate outward from the support structure 178 to be positioned within the inward-facing surface of the native valve leaflet 177 and to engage the calcification 174.

[0142] 10B, the arms 176 can pivot about the distal end portion 171 to move radially outward from the support structure 178. The arms 176 can move radially outward so that the barbs 172 engage the calcification 174. When anchored to the calcification, the arms 176, including the proximal end portion 175, can be positioned within the inward-facing surfaces of the native valve leaflets 177.

[0143] In some embodiments, the configuration of the anchor may be varied. For example, Figures 11A-11B show one embodiment of an anchor 180 having arms 182 that may be configured to rotate proximally to engage a calcification 84, which may be positioned radially outward of the inner-facing surface of a heart valve leaflet 83 when anchored to the calcification. Figure 11B shows the rotation of arms 182, for example, so that barbs 184 can engage calcification 84. Arms 182 may be positioned radially outward of a native valve leaflet 83.

[0144] 11C, in some embodiments, anchor 249 may include pad 193. Pad 193 may include a conformable body configured to conform to the shape of calcification 174. Pad 193 may include, for example, a fabric body or an expandable body. Other forms of pads may be utilized in some embodiments. A pad may be utilized with anchor 170 shown in FIGS. 10A and 10B or anchor 180 shown in FIGS. 11A and 11B.

[0145] The anchor may include a distal anchor that can be coupled to the support structure 15, as shown in FIGS. 1A-1C, and may be utilized in place of or in combination with anchor 17 shown in FIGS. 1A-1C. The anchor, and a proximal end portion of the anchor, may be configured to be biased outward from the support structure. The support structure may support one or more prosthetic valve leaflets positioned within the flow channel or passageway. At least one anchor may be coupled to the support structure and may include one or more barbs or pads configured to engage calcifications of the native valve to anchor the calcification. In embodiments, the anchor may be coupled to other forms of support structure.

[0146] In some embodiments, other forms of anchoring may be utilized. The features of the embodiment of Figures 10A-11C may be utilized alone or in combination with any other embodiment herein.

[0147] 12A-12B show one embodiment of a prosthetic valve 190 including a support structure 192 having an outer surface 194 including a conformable anchoring surface configured to conform to the shape of the calcifications of the native valve for anchoring to the native valve.

[0148] The support structure 192 may include, for example, a conformable outer fabric or may contain a fluid. The support structure 192 may include, for example, a chamber 196 that may be configured to hold a fluid. The chamber 196 may have flexible walls that comprise the outer surface 194 of the support structure 192. Thus, the outer surface 194 may conform to the shape of the native valve, which may include calcification, for example, as shown in FIG. 12B. The conformable anchoring surface may be configured to deflect radially inward to conform to the shape of the calcification.

[0149] The fluid may include a liquid (such as saline), or in some embodiments, a hydrogel or other form of gel. Other forms of fluid may be utilized in some embodiments. Other forms of filler materials disclosed herein may be utilized.

[0150] The chamber 196 may be positioned on a frame 198 of the support structure 192. Thus, the frame 198 may be positioned radially inward of a conformable anchoring surface of the chamber 196. The chamber 196 may cover the entire outer surface of the frame 198 or only a portion of it (e.g., as shown in FIG. 12A).

[0151] In embodiments, outer surface 194 may include an anchoring surface of prosthetic valve 190, which may lack additional anchors (e.g., distal anchors or atrial anchors). In this manner, a reduced likelihood of interference of such additional anchors with calcification positioned radially outward of native valve leaflets 83 may be provided.

[0152] The support structure 192 may be configured to support the leaflets of one or more prosthetic valves configured to be positioned within a flow channel or passageway.

[0153] The features of Figures 12A and 12B may be used alone or in combination with any other features herein.

[0154] 13 illustrates an embodiment of a prosthetic valve 200 that includes a support structure 202 having an atrial anchor 204 that includes a flange configured to extend radially outward from a flow channel or passageway 206 of the prosthetic valve 200. In an embodiment, the atrial anchor 204 may include an expandable body that forms a ring around the passageway 206. The expandable body may be configured to conform to the shape of a calcification 208 that may be present in a native heart valve.

[0155] The expandable body, in some embodiments, can be filled with a fluid, can be filled in vivo, or can be filled prior to insertion into the patient's body. The expandable body, in some embodiments, can be configured to form a fluid seal with the calcification 208.

[0156] In embodiments, the filler material may include a hardenable material. The filler material may be configured to harden over time to enhance sealing of the expandable body. The hardenable material may be introduced into the expandable body at a first, relatively low viscosity and converted to a second, relatively high viscosity. The viscosity increase may be achieved by various UV-initiated polymerization reactions, various catalyst-initiated polymerization reactions, or other chemical systems. The goal of the viscosity increase process may be to achieve a hardness anywhere from a gel to a rigid structure, depending on the desired performance.

[0157] The hardenable material may include an epoxy. The epoxy may be hardened by mixing the materials together, which when combined will harden. A curing catalyst may be provided at the time of implantation or thereafter. The hardenable material may be biocompatible and may be able to conform to the shape of the local native valve. In embodiments, the hardenable material may be bioabsorbable.

[0158] In embodiments, the fill material may be radiopaque for visualization during implantation. Radiopaque materials may be added during filling, for example, as part of the curing process.

[0159] In embodiments, the filler material may include a gel or foam, which may be biocompatible and configured to harden over time. The gel or foam may be inserted into the expandable body or may be provided in a capsule that dissolves upon implantation to allow expansion.

[0160] In embodiments, gels may be utilized that can be produced via polymer precipitation from a biocompatible solvent. Various siloxanes may also be utilized as swelling gels. Other gel systems that may be utilized include phase change systems that gel upon heating or cooling from an initial liquid or thixotropic state. Gels may also include thixotropic materials that undergo sufficient shear thinning so that they can be easily injected through fluid conduits yet remain gel-like at zero or low shear rates.

[0161] In embodiments, the filler material may include a foaming agent, which may create pressure within the expandable body.

[0162] Any of the filling materials disclosed herein may be biocompatible in embodiments and, if desired, bioabsorbable. A bioabsorbable sealing body may improve sealing by tissue adhesion to the native valve.

[0163] The atrial anchor 204 may be configured to resist distal or ventricular forces applied to the prosthetic valve 200 .

[0164] The support structure 202 may support a valve portion as disclosed herein. For example, the support structure 202 may support one or more prosthetic valve leaflets 228 that may be positioned within the passageway 206. The support structure 202 may have an inlet end portion 205 and an outlet end portion 207 as disclosed herein.

[0165] In embodiments, support structure 202 may further include a plurality of barbs 203 that may extend radially outward from passageway 206. The plurality of barbs 203 may protrude from an outer surface of support structure 202 and may anchor prosthetic valve 200 in place. Barbs 203 may be configured to resist proximal or atrial forces applied to support structure 202. For example, barbs 203 may be angled proximally in embodiments. In embodiments, atrial anchor 204 may be omitted and barbs 203 may be utilized alone.

[0166] The features of Figure 13 may be used alone or in combination with any other features described herein. A variety of other forms of anchors may be used in embodiments.

[0167] 14 illustrates an embodiment of a prosthetic valve 210 including a support structure 212 having an atrial anchor 214 including a flange configured to extend radially outward from a flow channel or passageway 216 of the prosthetic valve 210. The atrial anchor 214, in embodiments, may include a ledge that forms a ring around the flow channel or passageway 216. The ledge, in embodiments, may include a sealing surface that may be configured to seal with a calcification 208 of the native valve and conform to the shape of the calcification 208 that may be present in the native heart valve. The support structure 212 may support valve portions as disclosed herein. For example, the support structure 212 may support one or more prosthetic valve leaflets 213 that may be positioned within the passageway 216. The support structure 212 may have an inlet end portion 267 and an outlet end portion 269 as disclosed herein.

[0168] The atrial anchor 214 may be configured to resist distal or ventricular forces applied to the prosthetic valve 210 .

[0169] In embodiments, support structure 212 may be coupled to anchor 218, which may be configured to anchor to the ventricular wall. Anchor 218 may be configured to anchor to the apex of the ventricle or another portion of the ventricle, as desired. Anchor 218 may be positioned externally of the ventricular wall or may engage with the interior surface of the ventricular wall, as desired. In embodiments, anchor 218 may be deployed on a transcatheter, utilizing an intraventricular approach. For example, a delivery device may approach from the mitral valve to an implantation site on the ventricle. In embodiments, other approaches (e.g., a transapical approach) may be utilized.

[0170] Anchor 218 may be coupled to support structure 212 by tether 219. Tether 219 may include a conformal body that may allow tension to be applied to the tether without deforming the heart. Tether 219 may include a cord, wire, or braid, or may have another form, as desired. Tether 219 may include a shape memory material, such as Nitinol, or may have another form, as desired. Anchor 218 and tether 219 may resist forces applied to support structure 212 in a proximal or atrial direction.

[0171] The mechanism of FIG. 14 may be used alone or in combination with any other mechanism herein.

[0172] 15 illustrates an embodiment of a prosthetic valve 220 that includes a support structure 222 having an atrial anchor 224 that includes a flange configured to extend radially outward from a flow channel or passageway 226 of the prosthetic valve 220. The atrial anchor 224, in embodiments, can include a ledge that forms a ring around the passageway 226. The ledge, in embodiments, can include a sealing surface that can be configured to seal with a calcification 208 of the native valve and conform to the shape of the calcification 208 that may be present in the native heart valve.

[0173] The atrial anchor 224 can be configured to resist distal or ventricular forces applied to the prosthetic valve 220. In embodiments, one or more penetrators 227 can be utilized that can anchor the prosthetic valve 220 to the heart valve. For example, the one or more penetrators 227 can comprise screws, barbs, or clips that can be anchored to the heart valve, which can include anchoring to calcifications 208. The one or more penetrators 227 can be configured to pass through the atrial anchor 224 that comprises a flange to secure the support structure to the native valve.

[0174] The support structure 222 may extend proximally or toward the atrium from the atrial anchor 224. For example, the support structure 222 may be positioned annularly above to reduce the possibility of interference with the native valve leaflets 209. One or more prosthetic valve leaflets 271 may be positioned proximal to the atrial anchor 224.

[0175] Support structure 222 may support a valve portion as disclosed herein. For example, support structure 222 may support one or more prosthetic valve leaflets 271 that may be positioned within passageway 226. Support structure 222 may have an inlet end portion 229 and an outlet end portion 278 as disclosed herein.

[0176] The mechanism of FIG. 15 may be used alone or in combination with any other mechanism herein.

[0177] 16A-16C illustrate one embodiment of a prosthetic valve 230 including a support structure 232 and a helical body 234 coupled to the support structure 232 and configured to move between an open state and a closed state to control fluid or blood flow through the support structure 232. The support structure 232 may include a passageway that is shown closed in FIG. 16A and open in FIG. 16C. FIG. 16A illustrates the helical body 234 in a closed state.

[0178] Support structure 232 may include a ring that may extend around helical body 234 and may be configured to be positioned on the atrial side of the heart valve. The ring may include a flat ring having a thin profile, and the ring thickness 236 may be the same as the thickness of helical body 234 in some embodiments. In some embodiments, the ring may have a different thickness than helical body 234. The ring may be configured to be anchored to the valve annulus by one or more penetrators 238 (shown in FIG. 16B ). Penetrators 238 may be configured to pass through anchoring portions 239 of support structure 232 for anchoring to the native valve annulus.

[0179] The spiral body 234 may comprise arms that form a spiral and have a radially inner portion 233 and a radially outer portion 235 positioned radially outward of portion 233. An intermediate portion 237 may be positioned between the radially inner portion 233 and the radially outer portion 235. One or more wraps of the arms may form the spiral configuration. The radially outer portion 235 may have a larger diameter than the radially inner portion 233, which may have a larger diameter than the intermediate portion 237. The radially outer portion 235 may be coupled to the support structure 232, and the radially inner portion 233 and the intermediate portion 237 may move distally relative to the support structure 232.

[0180] For example, referring to FIG. 16B, the prosthetic valve 230 may be in a closed state, with the helical body 234 in the configuration shown in FIG. 16A. The edges of the helical body 234 may contact each other to form a valve seal. The passageway of the support structure 232 may be closed. The radially inner portion 233 may be flush with the radially outer portion 235 in the closed state.

[0181] When diastolic pressure is applied to the helical body 234, the radially inner portion 233, along with the intermediate portion 237 and the radially outer portion 235, may extend distally or toward the ventricle. The helical body 234 may move distally to move from a closed state to an open state. The radially inner portion 233 may be distal to the radially outer portion 235 in the open state. A gap 241 may exist between the portions 233, 237, 235 that may allow fluid flow therethrough. The gap 241 may be formed when the helical body 234 moves to the open state. When a contraction pressure is applied to the prosthetic valve 230, the helical body 234 may move to the closed state shown in FIG. 16B. The gap 241 may close when the helical body 234 is in the closed state. Fluid (e.g., blood) forces may cause the helical body 234 to move between the open and closed states. The helical body 234 may be cyclically moved between an open state and a closed state.

[0182] The distance 243 that the helical body 234 extends can vary in embodiments. For example, referring to FIG. 16C , the distance 243 can be shorter than the length of the leaflets 209 of the native valve in an open state. The distance 243 can vary in embodiments. For example, FIG. 17A shows an example of a prosthetic valve 240 including a helical body 242 that can extend a distance 244 that can be the length of or proximal to the leaflets 209 of the native valve in an open state. The helical body 242 can retract proximally or toward the atrium to close the prosthetic valve 240. In an example, as shown in FIG. 17B , the helical body 242 can retract and avoid interfering with or contacting the leaflets 209 as it moves to the closed state.

[0183] 17A and 17B, the support structure 246 may include a ring that may be anchored to the atrial wall. One or more penetrators 248 may be anchored to the atrial wall. The penetrators 248 may include screws, barbs, or clips. In some embodiments, one or more sutures may be utilized to anchor the support structure 246 to the atrial wall.

[0184] The prosthetic valves disclosed herein may be deployed as mitral or tricuspid valves, or other types of valves, as desired. In embodiments, other types of prosthetic valves and anchors may be utilized. The features of Figures 16-17B may be utilized alone or in combination with any of the other features described herein.

[0185] 18 illustrates an embodiment of a system 250 for a heart. The system 250 may include a prosthetic heart valve 252 configured to be implanted in a mitral valve of the heart. An anchor 254 may be coupled to the prosthetic heart valve 252 and configured to be implanted in a left atrial appendage 256 of the heart. The anchor 254 may be configured to hold the leaflets of the prosthetic valve in place within the mitral valve of the heart. The anchor 254 is coupled to the prosthetic heart valve 252 to anchor the prosthetic heart valve 252 within the native mitral valve.

[0186] In embodiments, anchor 254 may include a stent that may be configured to be deployed in left atrial appendage 256. The stent may be inserted into left atrial appendage 256 and anchored to left atrial appendage 256. In embodiments, anchor 254 may have other configurations, as desired.

[0187] A tether 258 may connect the anchor 254 to the prosthetic heart valve 252. The tether 258 may extend into the left atrium of the heart. The tether 258 may comprise a rigid body that may hold the prosthetic heart valve 252 in place within the mitral valve.

[0188] Thus, the prosthetic heart valve 252 may lack a direct anchor to the mitral valve or mitral valve calcifications, as the anchor 254 may provide anchoring to the prosthetic heart valve 252. The prosthetic heart valve 252 may include one or more prosthetic valve leaflets 253 coupled to a support structure 255. The support structure 255 may support a valve portion as disclosed herein. For example, the support structure 255 may support one or more prosthetic valve leaflets 253, which may be positioned within a passageway of the support structure 255. The support structure 255 may have an inlet end portion 257 and an outlet end portion 259 as disclosed herein. The support structure 255 may be configured similarly to other forms of support structures as disclosed herein.

[0189] The features of Figure 18 may be used alone or in combination with any other features described herein. In embodiments, other forms of prosthetic valves and anchors may be used.

[0190] FIG. 19 illustrates an embodiment in which one or more prosthetic valves 260 are implanted in a pulmonary vein 262. The implantation can prevent fluid flow to the lungs. The implantation can prevent backflow from entering the lungs. A reduction in fluid accumulation in the lungs may occur. For example, the prosthetic valve 260 can be comprised of a frame coupled to one or more prosthetic valve leaflets to prevent fluid flow to the lungs and allow fluid flow from the lungs to the left atrium 264. The prosthetic valve 260 can be configured to open in the direction of flow toward the left atrium of the heart. Such a configuration can be utilized in situations in which the mitral valve 266 has calcification and a prosthetic valve may not be implanted therein. One or more prosthetic valves can be implanted in one or more pulmonary veins 262. In an embodiment, the configuration illustrated in FIG. 19 can be utilized in combination with a prosthetic mitral heart valve implanted in the mitral valve.

[0191] The features of Figure 19 may be used alone or in combination with any other features described herein. In embodiments, other forms of prosthetic valves and anchors may be used.

[0192] 20 illustrates an embodiment including a prosthetic heart valve 270 and an anchor 272 coupled to the prosthetic heart valve 270 and including a ventricular chamber configured to extend into a ventricle of the heart. The prosthetic heart valve 270 may be configured to be implanted in a valve of the heart, which may include the mitral valve. The prosthetic heart valve 270 may include one or more prosthetic valve leaflets 275. The ventricular chamber may form a channel from the mitral valve to the caval valve. The ventricular chamber may direct blood flow from the atrium to the inflow region of the caval valve 274.

[0193] The ventricular chamber may be compliant and configured to be compressed by the left ventricle during systole and expanded during diastole.

[0194] The ventricular chamber may include a portion 273 configured to be positioned within a left ventricular outflow tract (LVOT) 282. In embodiments, the ventricular chamber may be configured to support and maintain patency of the heart's left ventricular outflow tract (LVOT) 282. In embodiments, other systems, devices, and methods may be utilized to reduce obstruction of the LVOT 282.

[0195] 21 shows an embodiment of a stent 280 that can be positioned in the left ventricle LVOT 282. The stent 280 can be deployed adjacent to the aortic valve 274 and can have an outflow adjacent to the aortic valve 274.

[0196] The stent 280 may include an outer stent 284 for anchoring. The outer stent 284 may be configured to be deployed adjacent to the LVOT 282. The outer stent 284 may be self-expandable and may be made of a shape-memory material (such as nitinol or another form of material). The outer stent 284 may include one or more anchoring arms 286 that may be configured to anchor the stent 280 in place. The anchoring arms 286 may anchor the outer stent 284 adjacent to the LVOT 282.

[0197] The stent 280 may include an inner stent 288 that may be positioned within the outer stent 284. The inner stent 288 may comprise a balloon-expandable inner stent and may include a flow channel 290 for fluid to pass through the left ventricular outflow tract 282.

[0198] The stent 280 may be configured to maintain patency of the left ventricular outflow tract 282 during deployment of the prosthetic mitral valve 292 into the native mitral valve 294 .

[0199] 22 illustrates an embodiment in which a prosthetic aortic valve 300 may have an extender body 302 that extends into the left ventricle 276 to maintain patency of the left ventricular outflow tract 282 during deployment of the prosthetic mitral valve 292 into the native mitral valve 294. The extender body 302 may have a length such that the mitral valve leaflets 303 can contact the outer surface of the extender body 302 to avoid obstructing the LVOT 282.

[0200] Other systems, devices, and methods may be utilized to reduce obstruction of the LVOT 282.

[0201] 23A-28B illustrate an exemplary method of tethering the leaflets of a native mitral heart valve or removing at least a portion of the leaflets of a native heart valve to reduce obstruction of the left ventricular outflow tract 282 of the heart by the leaflets of the native heart valve.

[0202] Figure 23A, for example, shows a cutter 304 approaching a native heart valve leaflet 306. With reference to Figure 23B, the cutter 304 can include a cutting surface 308 and a retaining tube 310 that can be configured to hold all or a portion of the native heart valve leaflet 306. With reference to Figure 23C, the cutter 304 can close on the native heart valve leaflet 306 to cut and remove all or a portion of the native heart valve leaflet 306. The native heart valve leaflet 306 can be positioned within the tube 310 in vivo.

[0203] All or a portion of the native heart valve leaflets 306 may be removed to reduce obstruction by the native heart valve leaflets 306 of the left ventricular outflow tract 282 of the heart.

[0204] 24A-24D illustrate one embodiment of a cutter 311 that may be utilized in embodiments herein. Cutter 311 may include cutting jaws including a first jaw 312 and a second jaw 314. Side views of cutter 311 are shown in FIGS. 24A, 24C, and 24D. An orthogonal view is shown in FIG. 24B.

[0205] 24B , first jaw 312 may have a wedge shape that converges onto an apex 316 at a distal end portion 318 of first jaw 312. First jaw 312 may have a proximal end portion 319. Second jaw 314 may have a similar configuration to first jaw 312. Pivot 331 may couple proximal end portion 319 of first jaw 312 to the proximal end portion of second jaw 314, with first jaw 312 configured to pivot relative to second jaw 314 about the pivot.

[0206] The wedge shape of the first jaw 312 and the second jaw 314 can enable the jaws 312, 314 to form a wedge-shaped cut in the native valve leaflet 306. With reference to FIG. 24C , one or more teeth 320, 322 can be positioned on one or more of the first jaw 312 or the second jaw 314 and configured to cut at least a portion of the heart valve when the first jaw 312 closes with the second jaw 314. The cut in the native valve leaflet 306 can be wedge-shaped, for example, as shown in FIG. 24E . The first jaw 312 can each include a first edge 325 and an opposing edge 327 extending from a proximal end portion 319 to a distal end portion 318 of the first jaw 312. Second jaw 314 may include a second edge 329 and an opposing edge that each extends from a proximal end portion to a distal end portion of second jaw 314. One or more teeth may extend along one or more of first edge 325 or second edge 329.

[0207] A wedge-shaped portion of the native heart valve leaflet 306 can be removed to reduce obstruction of the left ventricular outflow tract 282 of the heart by the native heart valve leaflet 306. For example, a space 323 (shown in FIG. 24B ) between the tines 320, 322 can retain a portion of the native heart valve leaflet 306 being cut for removal of such portion upon removal of the cutter 311 from the heart. The space 323 can be positioned between a first edge 325 and an opposing edge 327 of the first jaw 312. The space of the second jaw 314 can be positioned between a second edge 329 and an opposing edge of the second jaw 314.

[0208] 25A shows an embodiment in which a grasping snare 330 may be utilized to grasp the native heart valve leaflets 306. The grasping snare 330 may be inserted through the mitral valve annulus to grasp the native heart valve leaflets 306. A cutter in the form of a cutting snare 332 may be utilized to sever the native heart valve leaflets 306 at the desired location.

[0209] 25B, for example, shows a grasping snare 330 grasping a leaflet 306 of a native heart valve. The grasping snare 330 can hold the leaflet 306 taut as a cutting snare 332 cuts the leaflet 306. The grasping snare 330 can continue to hold the leaflet 306 as it is withdrawn from the heart.

[0210] FIG. 25C, for example, shows severed leaflet 306 being extracted by grasping snare 330.

[0211] Figure 26 shows an embodiment in which a grasping snare 330 or cutting snare 332 can be accessed from the aortic valve. The leaflets 306 can be cut in a manner similar to the leaflets 306 shown in Figure 25C.

[0212] 27, in an embodiment, chordae 334 attached to the valve leaflets 306 may be severed in addition to the valve leaflets 306. For example, a grasping snare 330 may grasp the chordae 334 adjacent to a papillary muscle 336 of the heart. A cutting snare 332 may sever the chordae 334 between the papillary muscle 336 and the grasping snare 330. The valve leaflets 306 may be severed in a similar manner as shown in FIGS.

[0213] 28A and 28B illustrate an exemplary method of tethering the leaflets 306 of a native mitral heart valve to reduce obstruction by the leaflets 306 of a left ventricular outflow tract 282 of a heart. A tether 338 can be configured to pass through the leaflets 306. The tether 338 can be configured to tether the leaflets 306 of the native mitral heart valve to reduce obstruction by the leaflets 306 of a left ventricular outflow tract 282 of a heart.

[0214] 28A , a first end portion 340 of the tether 338 can be positioned at the base of the leaflet 306 and anchored to the interior-facing surface of the leaflet 306. The tether 338 can be adapted for anchoring to the leaflet 306 of a native mitral heart valve. The tether 338 can pass through the leaflet 306 to extend over the exterior-facing surface of the leaflet 306 and over the distal tip 342 of the leaflet 306. The tether 338 can have, for example, an extension body at the end of the tether 338 that prevents removal of the tether 338 from the leaflet 306 of the native mitral heart valve. The tether 338 can pass across the mitral inflow tract 346 to anchor to an opposing wall 348 of the heart. The opposing wall 348 can include a ventricular wall. The tether 338 can include barbs or other forms of anchors to anchor to the ventricular wall.

[0215] 28B , the tether 338 can be cinched to pull the leaflets 306 away from the left ventricular outflow tract 282. In this manner, when the prosthetic mitral valve 350 is deployed in the mitral valve, the likelihood of the leaflets 306 obstructing the left ventricular outflow tract 282 can be reduced. The prosthetic mitral valve 350 can be configured similarly to any other form of prosthetic valve disclosed herein. For example, the prosthetic mitral valve 350 can include a support structure 352 that can support the valve portions disclosed herein. For example, the support structure 352 can support one or more prosthetic valve leaflets 354 that can be positioned within the passageway of the support structure 352. The support structure 352 can have an inlet end portion 356 and an outlet end portion 358 as disclosed herein.

[0216] Variations of the systems and methods disclosed herein may be provided.

[0217] Prosthetic valve embodiments, as disclosed herein, may be utilized in the mitral valve, or in other deployment locations such as the native tricuspid valve, or, unless otherwise specified, in the aortic or pulmonary valve, or other implantation sites.

[0218] The features of the embodiments may be used alone or in combination with other features disclosed herein.

[0219] Various variations of the embodiments disclosed herein may be provided. Features of the embodiments may be modified, substituted, omitted, or combined between embodiments as desired. Combinations of features between embodiments may be provided as desired. Combinations of features may be provided between embodiments with other features of those embodiments omitted as desired.

[0220] The implants disclosed herein may include prosthetic heart valves or other forms of implants, such as stents or filters, among other things, diagnostic devices. The implant may be an expandable implant configured to move from a compressed or undeployed state to an expanded or deployed state. The implant may be a compressible implant configured to be compressed inward to have a reduced profile, moving the implant to the compressed or undeployed state.

[0221] Various forms of delivery devices may be utilized with the embodiments disclosed herein. The delivery devices disclosed herein may also be utilized in aortic, mitral, tricuspid, and pulmonary replacement and repair. Delivery devices may include, among other things, delivery devices for delivering other forms of implants, such as stents or filters, or diagnostic devices, among other things.

[0222] The implants and systems disclosed herein can be used in transcatheter mitral or tricuspid valve implantation, and in transaortic valve implantation (TAVI) or replacement of other native heart valves (e.g., pulmonary valves). The delivery devices and systems disclosed herein can be used for transarterial access, including transfemoral access, to a patient's heart. The delivery devices and systems can be used in transcatheter percutaneous procedures, including transarterial procedures, which can be transfemoral or transcarotid. Transapical procedures, among others, can also be used. Other procedures can be used as desired.

[0223] Additionally, the methods herein are not limited to those specifically described, but may include methods utilizing the systems and devices disclosed herein. Method steps may be modified, omitted, or added using the systems, devices, and methods disclosed herein. Examples disclosed herein may include, in some embodiments, systems for implantation within the human body.

[0224] For purposes of this specification, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any manner. Instead, the present disclosure covers all novel and non-obvious features and aspects of the various disclosed embodiments, in various combinations with each other and in various subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor are the disclosed embodiments required to exhibit any one or more particular advantages or solve any problems. Features, elements, or combinations of one embodiment can be combined with other embodiments herein. [Example]

[0225] Example 1: A system for a heart, the system comprising a prosthetic valve configured to be deployed in a native valve of the heart and configured to deliver shock waves to destroy calcification in the native valve.

[0226] Example 2: The system of any embodiment herein, particularly embodiment 1, wherein the prosthetic valve includes a frame configured to support one or more prosthetic valve leaflets.

[0227] Example 3: The system of any embodiment herein, particularly embodiment 2, wherein the frame surrounds a flow channel in which the leaflets of one or more prosthetic valves are positioned.

[0228] Example 4: The system of any embodiment herein, particularly embodiments 1-3, further comprising a sealing skirt and a frame supporting the sealing skirt.

[0229] Example 5: The system of any of the embodiments herein, particularly embodiments 1-4, further comprising a frame and one or more distal anchors configured to anchor the frame to the native valve.

[0230] Example 6: The system of any embodiment herein, particularly embodiment 5, wherein the one or more distal anchors are each configured to extend across the tips of the leaflets of the native valve.

[0231] Example 7: The system of any of the embodiments herein, particularly embodiments 1-6, wherein the prosthetic valve comprises a frame comprising a shape memory material.

[0232] Example 8: The system of any of the embodiments herein, particularly embodiments 1-7, wherein the prosthetic valve comprises a frame comprising nitinol.

[0233] Example 9: The system of any of the embodiments herein, particularly embodiments 1-8, wherein the prosthetic valve has a diameter, and the prosthetic valve is configured such that an electrical current applied to the prosthetic valve increases the diameter.

[0234] Example 10: The system of any of the embodiments herein, particularly embodiments 1-9, further comprising a controller configured to apply an electrical current to the prosthetic valve to generate shock waves.

[0235] Example 11: The system of any embodiment herein, particularly embodiment 10, further comprising one or more terminals coupling the control device to the prosthetic valve for transmitting electrical current to the prosthetic valve.

[0236] Example 12: The system of any of the embodiments herein, particularly embodiment 10 or embodiment 11, wherein the controller is configured to vary the amount of current applied to the prosthetic valve.

[0237] Example 13: The system of any of the embodiments herein, particularly embodiments 10-12, wherein the control device is configured to apply a pulsatile current to the prosthetic valve.

[0238] Example 14: The system of any embodiment herein, particularly embodiments 1-13, wherein the shock waves comprise ultrasonic shock waves.

[0239] Example 15: The system of any of the embodiments herein, particularly embodiments 1-14, wherein the prosthetic valve is configured to be deployed in a mitral valve or tricuspid valve of the heart.

[0240] Example 16: 1. A delivery system for a heart, comprising: a first inflatable body configured to expand a prosthetic valve positioned on the first inflatable body to deploy the prosthetic valve into a native valve; and a second inflatable body surrounding the first inflatable body and configured to transmit shock waves to destroy calcification in the native valve.

[0241] Example 17: The delivery system of any embodiment herein, particularly embodiment 16, further comprising an elongate shaft of the delivery device, wherein the first expandable body and the second expandable body are each coupled to the elongate shaft.

[0242] Example 18: The delivery system of any example herein, particularly example 17, further comprising a control mechanism for controlling deflection of the elongate shaft.

[0243] Example 19: The delivery system of any of the embodiments herein, particularly embodiments 16-18, wherein the first expandable body is configured to expand a prosthetic valve positioned on the first expandable body and on the second expandable body.

[0244] Example 20: The delivery system of any of the embodiments herein, particularly embodiments 16-19, wherein the second expandable body has an outer surface and is configured to slide the prosthetic valve over the outer surface in vivo.

[0245] Example 21: The delivery system of any of the Examples herein, particularly Examples 16-20, wherein the first expandable body comprises a proximal end portion and a distal end portion, the second expandable body comprises a proximal end portion and a distal end portion, the proximal end portion of the second expandable body being proximal to the proximal end portion of the first expandable body, and the distal end portion of the second expandable body being distal to the distal end portion of the first expandable body.

[0246] Example 22: The delivery system of any of the embodiments herein, particularly embodiments 16-21, wherein the second expandable body is more compliant than the first expandable body.

[0247] Example 23: The delivery system of any of the embodiments herein, particularly embodiments 16-22, further comprising a controller configured to control the generation of shock waves for the second inflatable body.

[0248] Example 24: The delivery system of any of the embodiments herein, particularly embodiments 16-23, wherein the shock waves comprise ultrasonic shock waves.

[0249] Example 25: The delivery system of any of the embodiments herein, particularly embodiments 16-24, wherein the first inflatable body is configured to deploy the prosthetic valve into a mitral valve or tricuspid valve of the heart.

[0250] Example 26: A method comprising reducing calcification of a native heart valve and deploying a prosthetic heart valve over the native heart valve.

[0251] Example 27: The method of any example herein, particularly example 26, further comprising utilizing a laser or sintering device to reduce calcification of the native heart valve.

[0252] Example 28: The method according to any of the Examples herein, particularly Example 26 or Example 27, further comprising reducing calcification of the native heart valve by smoothing the calcification.

[0253] Example 29: The method according to any of the Examples herein, particularly Examples 26-28, further comprising reducing calcification of the native heart valve by crushing the calcification.

[0254] Example 30: The method of any of the Examples herein, particularly Examples 26-29, further comprising applying shock waves to the calcification to reduce the calcification.

[0255] Example 31: The method of any embodiment herein, particularly embodiment 30, further comprising utilizing an expandable body to apply shock waves to the calcification.

[0256] Example 32: The method of any of the examples herein, particularly example 30 or example 31, further comprising utilizing a prosthetic heart valve to apply shock waves to the calcification.

[0257] Example 33: The method described in any of the Examples herein, particularly Examples 26-32, further comprising expanding the prosthetic heart valve into the native heart valve and applying shock waves through the prosthetic heart valve to reduce calcification of the native heart valve.

[0258] Example 34: The method of any of the embodiments herein, particularly embodiments 26-33, further comprising utilizing an embolus capture device to capture calcifications released from the native heart valve.

[0259] Example 35: The method according to any of the examples herein, particularly any of Examples 26 to 34, wherein the native heart valve comprises a mitral valve or a tricuspid valve.

[0260] Example 36: 1. A method comprising: determining a configuration of an implantation site in a native heart valve having calcification, the implantation site being for a prosthetic heart valve; and selecting a configuration of a distal anchor of the prosthetic heart valve based on the determined configuration of the implantation site.

[0261] Example 37: The method of any example herein, particularly example 36, further comprising adjusting the distal anchor based on the determined configuration of the implantation site.

[0262] Example 38: The method of any embodiment herein, particularly embodiment 37, wherein the prosthetic heart valve comprises a frame, and wherein adjusting the distal anchor comprises changing the angle of the distal anchor relative to the frame.

[0263] Example 39: The method of any of the embodiments herein, particularly embodiments 36-38, further comprising selecting a configuration of a distal anchor of the prosthetic heart valve from a set comprising a plurality of different configurations of distal anchors.

[0264] Example 40: The method of any of the examples herein, particularly examples 36-39, further comprising coupling a distal anchor to the valve body of the prosthetic heart valve.

[0265] Example 41: The method of any of the embodiments herein, particularly embodiments 36-40, further comprising selecting a configuration of the distal anchor based on the shape of the calcification in the native heart valve.

[0266] Example 42: The method of any of the Examples herein, particularly Examples 36-41, further comprising selecting a distal anchor configuration for anchoring to calcification in the native heart valve.

[0267] Example 43: The method of any of the embodiments herein, particularly embodiments 36-42, wherein the distal anchor is configured to extend over the distal tips of the leaflets of the native heart valve.

[0268] Example 44: The method of any of the Examples herein, particularly Examples 36-43, further comprising imaging the implantation site to determine the configuration of the implantation site.

[0269] Example 45: The method according to any of the examples herein, particularly any of Examples 36-44, wherein the native heart valve comprises a mitral valve or a tricuspid valve.

[0270] Example 46: 1. A prosthetic valve configured to be deployed in a native valve of a heart, the prosthetic valve comprising: 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 anchor coupled to the valve body, the anchor including one or more barbs or pads configured to engage calcifications of the native valve to anchor the calcifications.

[0271] Example 47: 10. The prosthetic valve of any of the embodiments herein, particularly embodiment 46, wherein the valve body includes a distal end portion and a proximal end portion, and the at least one anchor comprises an arm having a first end portion coupled to the distal end portion of the valve body and a second end portion extending proximally from the first end portion of the arm.

[0272] Example 48: The prosthetic valve of any of the embodiments herein, particularly embodiment 47, wherein the second end portion is configured to be positioned within the inward-facing surface of the leaflet of the heart valve when anchored to the calcification.

[0273] Example 49: The prosthetic valve of any of the embodiments herein, particularly embodiment 47 or embodiment 48, wherein the second end portion is biased to extend outward from the valve body.

[0274] Example 50: The prosthetic valve of any of the embodiments herein, particularly embodiments 47-49, wherein the second end portion is configured to be positioned radially outward of the inner-facing surface of the leaflet of the heart valve when anchored to the calcification.

[0275] Example 51: 1. A method comprising: deploying a prosthetic valve on a native valve, the prosthetic valve comprising: one or more prosthetic leaflets configured to be positioned within a flow channel; a valve body configured to support the one or more prosthetic leaflets; and at least one anchor coupled to the valve body, the anchor comprising one or more of a barb or pad configured to engage calcification of the native valve to anchor the calcification.

[0276] Example 52: The method of any embodiment herein, particularly embodiment 51, wherein the valve body includes a distal end portion and a proximal end portion, and the at least one anchor includes an arm having a first end portion coupled to the distal end portion of the valve body and a second end portion extending proximally from the first end portion of the arm.

[0277] Example 53: The method of any embodiment herein, particularly embodiment 52, wherein the second end portion is configured to be positioned within an inward-facing surface of a leaflet of the heart valve when anchored to the calcification.

[0278] Example 54: The method of any one of the embodiments herein, particularly embodiment 52 or embodiment 53, wherein the second end portion is biased outward from the valve body.

[0279] Example 55: The method of any of the embodiments herein, particularly embodiments 52-54, wherein the second end portion is configured to be positioned radially outward of the inner-facing surface of the leaflet of the heart valve when anchored to the calcification.

[0280] Example 56: 1. A prosthetic valve configured to be deployed in a native valve of a heart, the prosthetic valve comprising: one or more prosthetic valve leaflets configured to be positioned within a flow channel; and a valve body configured to support the one or more prosthetic valve leaflets, the valve body including an outer surface including a conformable anchoring surface configured to conform to the shape of calcifications of the native valve for anchoring to the native valve.

[0281] Example 57: The prosthetic valve of any embodiment herein, particularly embodiment 56, wherein the conformable anchoring surface comprises a surface of a chamber configured to retain a fluid.

[0282] Example 58: The prosthetic valve of any example herein, particularly example 57, wherein the fluid comprises a hydrogel.

[0283] Example 59: The prosthetic valve of any of the embodiments herein, particularly embodiments 56-58, wherein the conformable anchoring surface is configured to deflect radially inward to conform to the shape of the calcification.

[0284] Example 60: The prosthetic valve of any of the embodiments herein, particularly embodiments 56-59, wherein the valve body includes a frame positioned radially inward of the conformable anchoring surface.

[0285] Example 61: 1. A method comprising: deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic leaflets configured to be positioned within a flow channel; and a valve body configured to support the one or more prosthetic leaflets, the valve body including an outer surface including a conformable anchoring surface configured to conform to the shape of calcifications on the native valve for anchoring to the native valve.

[0286] Example 62: The method of any embodiment herein, particularly embodiment 61, wherein the conformable anchoring surface comprises a surface of a chamber configured to retain a fluid.

[0287] Example 63: The method of any example herein, particularly example 62, wherein the fluid comprises a hydrogel.

[0288] Example 64: The method of any of the embodiments herein, particularly embodiments 61-63, wherein the conformable anchoring surface is configured to deflect radially inward to conform to the shape of the calcification.

[0289] Example 65: The method of any embodiment herein, particularly embodiments 61-64, wherein the valve body includes a frame positioned radially inward of the conformable anchoring surface.

[0290] Example 66: 1. A prosthetic valve configured to be deployed in a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets configured to be positioned within a flow channel; and a valve body including an atrial anchor configured to support the one or more prosthetic valve leaflets, the atrial anchor including a flange configured to extend radially outward from the flow channel.

[0291] Example 67: The prosthetic valve of any embodiment herein, particularly embodiment 66, wherein the flange comprises an expandable body.

[0292] Example 68: The prosthetic valve of any embodiment herein, particularly embodiment 67, wherein the expandable body comprises a ring extending around the valve body.

[0293] Example 69: The prosthetic valve of any of the embodiments herein, particularly embodiments 66-68, wherein the valve body comprises a plurality of barbs extending radially outward from the flow channel.

[0294] Example 70: The prosthetic valve of any of the embodiments herein, particularly embodiments 66-69, further comprising an anchor configured to anchor to the ventricular wall and a tether configured to couple the anchor to the valve body.

[0295] Example 71: The prosthetic valve of any of the embodiments herein, particularly embodiment 70, wherein the tether comprises a compliant tether configured to resist atrial-directed forces applied to the valve body.

[0296] Example 72: The prosthetic valve of any of the embodiments herein, particularly embodiments 66-71, wherein one or more prosthetic valve leaflets are positioned proximal to the atrial anchor.

[0297] Example 73: The prosthetic valve of any of the embodiments herein, particularly embodiments 66-72, wherein the valve body is positioned proximal to the atrial anchor.

[0298] Example 74: The prosthetic valve described in any of the examples herein, particularly examples 66 to 73, further comprising one or more penetrating bodies configured to pass through the flange to anchor the valve body to the native valve.

[0299] Example 75: The prosthetic valve of any of the embodiments herein, particularly embodiments 66-74, wherein the prosthetic valve is configured to be deployed in a mitral valve or tricuspid valve of the heart.

[0300] Example 76: 1. A method comprising: deploying a prosthetic valve into a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets configured to be positioned within a flow channel; and a valve body including an atrial anchor configured to support the one or more prosthetic valve leaflets, the atrial anchor including a flange configured to extend radially outward from the flow channel.

[0301] Example 77: The method of any embodiment herein, particularly embodiment 76, wherein the flange comprises an expandable body.

[0302] Example 78: The method of any embodiment herein, particularly embodiment 77, wherein the expandable body comprises a ring extending around the valve body.

[0303] Example 79: The method of any embodiment herein, particularly embodiments 76-78, wherein the valve body includes a plurality of barbs extending radially outward from the flow channel.

[0304] Example 80: The method of any of the embodiments herein, particularly embodiments 76-79, further comprising an anchor configured to anchor to the ventricular wall and a tether configured to couple the anchor to the valve body.

[0305] Example 81: The method of any embodiment herein, particularly embodiment 80, wherein the tether comprises a compliant tether configured to resist atrial-directed forces applied to the valve body.

[0306] Example 82: The method of any of the embodiments herein, particularly embodiments 76-81, wherein one or more prosthetic valve leaflets are positioned proximal to the atrial anchor.

[0307] Example 83: The method of any of the embodiments herein, particularly embodiments 76-82, wherein the valve body is positioned proximal to the atrial anchor.

[0308] Example 84: The method of any of the embodiments herein, particularly embodiments 76-83, further comprising one or more penetrators configured to pass through the flange to anchor the valve body to the native valve.

[0309] Example 85: The method of any of the Examples herein, particularly Examples 76-84, wherein the prosthetic valve is deployed in a mitral or tricuspid valve of the heart.

[0310] Example 86: 1. A prosthetic valve configured to be deployed in a native valve, the prosthetic valve comprising: a valve body; and a helical body coupled to the valve body and configured to move between an open state and a closed state to control fluid flow through the valve body.

[0311] Example 87: The prosthetic valve of any embodiment herein, particularly embodiment 86, wherein the helical body is configured to move distally to move from the closed state to the open state.

[0312] Example 88: The prosthetic valve described in any of the examples herein, particularly example 86 or example 87, wherein the spiral body includes arms that form a spiral and have a radially inner portion and a radially outer portion, the radially inner portion being coplanar with the radially outer portion in the closed state.

[0313] Example 89: The prosthetic valve of any embodiment herein, particularly embodiment 88, wherein the radially inner portion is distal to the radially outer portion in the open state.

[0314] Example 90: An artificial valve as described in any of the examples herein, particularly example 88 or example 89, wherein one or more gaps between the radially inner portion and the radially outer portion are formed when the spiral body is moved to an open state, and the one or more gaps are closed when the spiral body is in a closed state.

[0315] Example 91: The prosthetic valve of any of the embodiments herein, particularly embodiments 86-90, wherein the helical body is configured to move cyclically between an open state and a closed state.

[0316] Example 92: The prosthetic valve of any of the embodiments herein, particularly embodiments 86-91, wherein a fluid force is configured to move the helical body between the open and closed states.

[0317] Example 93: The prosthetic valve of any of the embodiments herein, particularly embodiments 86-92, wherein the valve body comprises a ring extending around the helical body.

[0318] Example 94: The prosthetic valve of any of the embodiments herein, particularly embodiments 86-93, further comprising one or more penetrating bodies configured to pass through the valve body to anchor the valve body to the native valve.

[0319] Example 95: The prosthetic valve of any of the embodiments herein, particularly embodiments 86-94, wherein the prosthetic valve is configured to be deployed in a mitral valve or tricuspid valve of the heart.

[0320] Example 96: 1. A method comprising: deploying a prosthetic valve on a native valve, the prosthetic valve comprising a valve body and a helical body coupled to the valve body and configured to move between an open state and a closed state to control fluid flow through the valve body.

[0321] Example 97: The method of any embodiment herein, particularly embodiment 96, wherein the helical body is configured to move distally to move from the closed state to the open state.

[0322] Example 98: The method of any example herein, particularly example 96 or example 97, wherein the helical body includes arms that form a helix and have a radially inner portion and a radially outer portion, the radially inner portion being coplanar with the radially outer portion in the closed state.

[0323] Example 99: The method of any embodiment herein, particularly embodiment 98, wherein the radially inner portion is distal to the radially outer portion in the open state.

[0324] Example 100: The method of any of the embodiments herein, particularly embodiment 98 or embodiment 99, wherein one or more gaps between the radially inner portion and the radially outer portion are formed when the helical body is moved to an open state, and the one or more gaps are closed when the helical body is in a closed state.

[0325] Example 101: The method of any embodiment herein, particularly embodiments 96-100, wherein the helical body is configured to move cyclically between an open state and a closed state.

[0326] Example 102: The method of any of the embodiments herein, particularly embodiments 96-101, wherein the fluid force is configured to move the helical body between the open and closed states.

[0327] Example 103: The method of any embodiment herein, particularly embodiments 96-102, wherein the valve body comprises a ring extending around the helical body.

[0328] Example 104: The method of any of the embodiments herein, particularly embodiments 96-103, further comprising one or more penetrators configured to pass through the valve body to anchor the valve body to the native valve.

[0329] Example 105: The method of any of the embodiments herein, particularly embodiments 96-104, wherein the prosthetic valve is configured to be deployed in a mitral valve or tricuspid valve of the heart.

[0330] Example 106: 1. A system for a heart, comprising: a prosthetic heart valve configured to be deployed in a mitral valve of the heart; and an anchor coupled to the prosthetic heart valve and configured to be deployed in a left atrial appendage of the heart.

[0331] Example 107: A system described in any of the embodiments herein, particularly embodiment 106, wherein the tether connects the prosthetic heart valve to the anchor and is configured to extend into the left atrium of the heart.

[0332] Example 108: The system of any of the embodiments herein, particularly embodiment 106 or embodiment 107, wherein the anchor comprises a stent.

[0333] Example 109: The system described in any of the embodiments herein, particularly embodiments 106-108, wherein the prosthetic heart valve includes one or more prosthetic valve leaflets coupled to a frame.

[0334] Example 110: The system described in any of the embodiments herein, particularly embodiments 106-109, wherein the anchor is configured to hold the prosthetic heart valve in place within the mitral valve of the heart.

[0335] Example 111: A method comprising: deploying a prosthetic heart valve in a mitral valve of the heart; and deploying an anchor for the prosthetic heart valve in a left atrial appendage of the heart.

[0336] Example 112: The method of any of the embodiments herein, particularly embodiment 111, wherein the tether is configured to connect the prosthetic heart valve to the anchor and extend into the left atrium of the heart.

[0337] Example 113: The method of any embodiment herein, particularly embodiment 111 or embodiment 112, wherein the anchor comprises a stent.

[0338] Example 114: The method of any of the embodiments herein, particularly embodiments 111-113, wherein the prosthetic heart valve comprises one or more prosthetic valve leaflets coupled to a frame.

[0339] Example 115: The method of any of the embodiments herein, particularly embodiments 111-114, wherein the anchor is configured to hold the prosthetic heart valve in place within the mitral valve of the heart.

[0340] Example 116: A method comprising implanting a prosthetic valve in a pulmonary vein of the heart to prevent fluid flow to the lungs.

[0341] Example 117: The method described in any embodiment herein, particularly embodiment 116, wherein the prosthetic valve comprises a frame coupled to one or more prosthetic valve leaflets.

[0342] Example 118: The method described in any of the embodiments herein, particularly embodiment 116 or embodiment 117, wherein the prosthetic valve is configured to open in the flow direction toward the left atrium of the heart.

[0343] Example 119: The method of any of the examples herein, particularly examples 116-118, further comprising implanting a plurality of prosthetic valves in a plurality of pulmonary veins of the heart.

[0344] Example 120: The method of any of the examples herein, particularly examples 116-119, wherein the mitral valve of the heart contains calcification.

[0345] Example 121: A stent for a heart comprising: an outer stent configured to be deployed adjacent to a left ventricular outflow tract of the heart; and an inner stent positioned within the outer stent and including a flow channel for fluid to pass through the left ventricular outflow tract.

[0346] Example 122: The stent of any embodiment herein, particularly embodiment 121, wherein the inner stent is balloon expandable.

[0347] Example 123: The stent of any of the embodiments herein, particularly embodiment 121 or embodiment 122, wherein the outer stent is self-expanding.

[0348] Example 124: The stent of any of the examples herein, particularly examples 121-123, wherein the outer stent is made of a shape memory material.

[0349] Example 125: The stent of any of the Examples herein, particularly Examples 121-124, wherein the outer stent comprises one or more anchoring arms for anchoring the outer stent adjacent the left ventricular outflow tract.

[0350] Example 126: 1. A method comprising: deploying a stent adjacent to a left ventricular outflow tract of a heart, the stent comprising: an outer stent; and an inner stent positioned within the outer stent and including a flow channel through which fluid passes through the left ventricular outflow tract.

[0351] Example 127: The method of any embodiment herein, particularly embodiment 126, wherein the inner stent is balloon expandable.

[0352] Example 128: The method of any of the embodiments herein, particularly embodiment 126 or embodiment 127, wherein the outer stent is self-expanding.

[0353] Example 129: The method of any of the examples herein, particularly examples 126-128, wherein the outer stent is made of a shape memory material.

[0354] Example 130: The method of any of the embodiments herein, particularly embodiments 126-129, wherein the outer stent comprises one or more anchoring arms for anchoring the outer stent adjacent to the left ventricular outflow tract.

[0355] Example 131: A system for a heart comprising: a prosthetic heart valve configured to be implanted in a valve of the heart; and an anchor coupled to the prosthetic heart valve and including a ventricular chamber configured to extend in a ventricle of the heart.

[0356] Example 132: The system described in any embodiment herein, particularly embodiment 131, wherein the ventricular chamber is configured to be compressed by a ventricle of the heart.

[0357] Example 133: The system described in any of the embodiments herein, particularly embodiment 131 or embodiment 132, wherein the prosthetic heart valve is configured to be positioned within the mitral valve of the heart and the ventricular chamber is configured to form a channel from the mitral valve to the vena cava valve of the heart.

[0358] Example 134: The system described in any of the embodiments herein, particularly embodiments 131-133, wherein the ventricular chamber includes a portion configured to be positioned within the left ventricular outflow tract of the heart.

[0359] Example 135: The system of any of the embodiments herein, particularly embodiments 131-134, wherein the prosthetic heart valve comprises one or more prosthetic valve leaflets.

[0360] Example 136: A method comprising: deploying a prosthetic heart valve in a valve of the heart; and deploying an anchor for the prosthetic heart valve in a ventricle of the heart, the anchor including a ventricular chamber.

[0361] Example 137: The method of any embodiment herein, particularly embodiment 136, wherein the ventricular chamber is configured to be compressed by a ventricle of the heart.

[0362] Example 138: The method described in any of the embodiments herein, particularly embodiment 136 or embodiment 137, wherein the prosthetic heart valve is configured to be positioned within a mitral valve of the heart, and the ventricular chamber is configured to form a channel from the mitral valve to a vena cava valve of the heart.

[0363] Example 139: The method of any of the embodiments herein, particularly embodiments 136-138, wherein the ventricular chamber comprises a portion configured to be positioned within the left ventricular outflow tract of the heart.

[0364] Example 140: The method of any of the examples herein, particularly examples 136-139, wherein the prosthetic heart valve comprises one or more prosthetic valve leaflets.

[0365] Example 141: 1. A method comprising tethering the leaflets of a native mitral heart valve or removing at least a portion of the leaflets of the native mitral heart valve to reduce obstruction of the left ventricular outflow tract of the heart by the leaflets of the native mitral heart valve.

[0366] Example 142: The method of any example herein, particularly example 141, further comprising removing an entire leaflet of the native mitral heart valve.

[0367] Example 143: The method according to any of the examples herein, particularly example 141 or example 142, further comprising removing a wedge-shaped portion of the leaflet of the native mitral heart valve.

[0368] Example 144: The method of any of the embodiments herein, particularly embodiments 141-143, further comprising utilizing a cutting snare to remove at least a portion of the leaflets of the native mitral heart valve.

[0369] Example 145: The method of any of the embodiments herein, particularly embodiments 141-144, further comprising utilizing a cutting snare to sever the chordae attached to the leaflets of the native mitral heart valve.

[0370] Example 146: The method of any of the embodiments herein, particularly embodiments 141-145, further comprising utilizing cutting jaws to remove at least a portion of the leaflets of the native mitral heart valve.

[0371] Example 147: The method of any of the examples herein, particularly examples 141-146, further comprising positioning at least a portion of a leaflet of a native mitral heart valve within a vessel in vivo.

[0372] Example 148: The method of any of the examples herein, particularly examples 141-147, further comprising passing a tether through the leaflets of the native mitral heart valve and anchoring the tether to the ventricular wall to tether the leaflets of the native mitral heart valve.

[0373] Example 149: The method of any of the embodiments herein, particularly embodiments 141-148, further comprising deploying a prosthetic heart valve to a mitral valve comprising the leaflets of a native mitral heart valve.

[0374] Example 150: The method of any of the examples herein, particularly examples 141-149, wherein the mitral valve, including the leaflets of a native mitral heart valve, has calcification.

[0375] Example 151: 1. A cutter for at least a portion of a leaflet of a heart valve, the cutter comprising: a first jaw having a proximal end portion and a distal end portion, the first jaw having a wedge shape converging on an apex of the distal end portion of the first jaw; a second jaw having a proximal end portion and a distal end portion, the second jaw having a wedge shape converging on an apex of the distal end portion of the second jaw; and one or more teeth positioned on one or more of the first jaw or the second jaw, the teeth being configured to cut at least a portion of the leaflet of the heart valve when the first jaw closes with the second jaw.

[0376] Example 152: A cutter as described in any example herein, particularly example 151, wherein the first jaw includes a first edge extending from a proximal end portion to a distal end portion of the first jaw, the second jaw includes a second edge extending from a proximal end portion to a distal end portion of the second jaw, and one or more teeth extending along one or more of the first edge or the second edge.

[0377] Example 153: The cutter of any embodiment herein, particularly embodiment 152, wherein the one or more teeth are positioned on the first edge and the second edge.

[0378] Example 154: A cutter as described in any of the embodiments herein, particularly embodiment 152 or embodiment 153, wherein the first jaw includes a third edge extending from a proximal end portion of the first jaw opposite the first edge to a distal end portion thereof, and at least a portion of a leaflet of the heart valve is configured to be held between the first edge and the third edge.

[0379] Example 155: The cutter of any embodiment herein, particularly embodiments 151-154, further comprising a pivot connecting a proximal end portion of the first jaw to a proximal end portion of the second jaw, wherein the first jaw is configured to pivot about the pivot relative to the second jaw.

[0380] Any of the features of any of the embodiments, including but not limited to any of the above-mentioned embodiments 1-155, are applicable to all other aspects and embodiments identified herein, including but not limited to any of the above-mentioned embodiments 1-155. Furthermore, any of the features of any of the various embodiments, including but not limited to any of the above-mentioned embodiments 1-155, may be independently combinable in any way, partially or fully, with other embodiments described herein; for example, one, two, or more embodiments may be fully or partially combinable. Furthermore, any of the features of the various embodiments, including but not limited to any of the above-mentioned embodiments 1-155, may be optional with respect to other embodiments. Any embodiment of a method may be performed by a system or device of another embodiment, and any aspect or embodiment of a system or device may be configured to perform a method of another embodiment or embodiment, including but not limited to any of the above-mentioned embodiments 1-155.

[0381] In summary, while aspects of the present specification are emphasized by reference to specific examples, it will be understood that those skilled in the art will readily recognize that these disclosed examples are merely illustrative of the principles of the subject matter disclosed herein. Accordingly, it will be understood that the disclosed subject matter is not limited in any way to the particular methodology, protocols, and / or reagents, etc., described herein. Accordingly, various modifications or variations on the disclosed subject matter or alternative configurations can be made in accordance with the teachings herein without departing from the spirit of the specification. Finally, the terminology used herein is for the purpose of describing particular examples only and is not intended to limit the scope of the systems, devices, and methods disclosed herein, which are defined solely by the claims. Accordingly, the systems, devices, and methods are not limited to that precisely as shown and described.

[0382] Particular embodiments of the systems, devices, and methods are described herein, including the best modes known to the inventors for carrying out the same. Of course, variations on these described embodiments will become apparent to those skilled in the art upon reading the foregoing description. The inventors anticipate that skilled artisans will adopt such variations as appropriate, and the inventors intend for the systems, devices, and methods to be practiced otherwise than as specifically described herein. Accordingly, the systems, devices, 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 clearly contradicted by context, combinations of the above-described examples in all possible variations thereof are encompassed by the systems, devices, and methods.

[0383] Groupings of alternative embodiments, elements, or steps of systems, devices, and methods are not to be construed as limitations. Members of each group may be referenced and claimed individually or in any combination with members of other groups disclosed herein. It is contemplated that one or more members of a group may be included within, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion is made, the specification is deemed to include the modified group, and thus fulfills the recitation of all Markush groups used in the appended claims.

[0384] Unless otherwise indicated, all numbers expressing features, items, quantities, parameters, characteristics, terms, and the like used in the specification and claims are to be understood in all instances as being modified by the term "about." As used herein, the term "about" means that the feature, item, quantity, parameter, characteristic, or term so qualified encompasses approximations that may vary but may still perform the desired operation or process described herein.

[0385] The terms "a," "an," "the," and similar reference words, as used in the context of describing systems, devices, and methods (particularly in the context of the claims below), should be construed to cover both the singular and the plural unless otherwise indicated herein or clearly contradicted by context. All methods described herein may be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. The use of any and all example or exemplary language (e.g., "etc.") as provided herein is merely to more clearly illustrate the systems, devices, and methods and does not pose a limitation on the scope of the otherwise claimed systems, devices, and methods. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the systems, devices, and methods.

[0386] All patents, patent publications, and other publications referenced or identified herein are individually and explicitly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described therein that may be used in connection with the systems, apparatus, and methods. These publications are provided only as they are disclosed prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventors are not entitled to retroactively advancing such disclosure by virtue of prior invention or for any other reason. All statements as to the date or contents of these documents are based on the information available to the applicant and do not constitute any admission as to the correctness of the dates or contents of these documents.

Claims

1. 1. A system for implanting a prosthetic heart valve into a calcified native valve, comprising: a support structure having inlet and outlet end portions and a passageway; the prosthetic heart valve including: a valve portion positioned within the passage of the support structure, the valve portion comprising a plurality of leaflets made from pericardium, the valve portion allowing unidirectional blood flow through the passage to replace the function of a native heart valve; a delivery catheter for delivering the prosthetic heart valve to the calcified native valve, the delivery catheter including an actuation mechanism for vibrating the support structure, thereby reducing calcification of the calcified native valve.

2. The system of claim 1 , wherein the support structure includes an actuator for generating vibration of the support structure, thereby reducing the calcification of the calcified native valve.

3. The system of claim 2 , wherein the actuator comprises an electrode or a piezoelectric actuator for vaporizing a fluid within an expandable body positioned on the support structure.

4. 4. The system of claim 2 or claim 3, wherein the support structure includes an outer surface for contacting the calcification of the calcified native valve, and the actuator is adapted to apply the vibration to the calcification from the outer surface.

5. The system of any of claims 2 to 4, wherein the actuation mechanism includes one or more electrical terminals for electrical communication with one or more electrical terminals of the actuator.

6. 6. The system of claim 1, wherein the support structure includes a support frame, and the actuation mechanism is adapted to apply vibrations to the support frame to vibrate the support structure, thereby reducing the calcification of the calcified native valve.

7. 7. The system of claim 6, wherein the actuation mechanism includes an electrode for vaporizing a fluid in an inflatable body applied to the support frame to apply the vibration to the support frame, or a piezoelectric actuator adapted to apply the vibration to the support frame.

8. 8. The system of claim 1, wherein the support structure includes a support frame made of a shape memory material, and the actuation mechanism includes one or more electrical terminals for applying electrical energy to the support frame to expand the support frame.

9. The system of claim 8 , wherein the support frame has a diameter, and the support frame is adapted such that the electrical energy applied to the support frame increases the diameter.

10. The system of any preceding claim, wherein the actuation mechanism includes a controller for controlling energy transferred to the support structure to cause the support structure to vibrate.

11. 11. The system of claim 10, further comprising one or more sensors for providing feedback of the diameter of the prosthetic heart valve to the controller.

12. The system of any preceding claim, wherein the support structure generates acoustic pressure waves.

13. The system of claim 12 , wherein the acoustic pressure waves are ultrasonic waves.

14. The system of claim 13 , wherein the ultrasound waves are shock waves.

15. The system according to any one of claims 1 to 14, wherein the prosthetic heart valve is a prosthetic mitral heart valve.

16. 1. A system for implanting a prosthetic heart valve into a calcified native valve, comprising: a support structure having inlet and outlet end portions and a passageway; the prosthetic heart valve including: a valve portion positioned within the passage of the support structure, the valve portion comprising a plurality of leaflets made from pericardium, the valve portion allowing unidirectional blood flow through the passage to replace the function of a native heart valve; A delivery catheter for the prosthetic heart valve, comprising: A long, slender shaft and a first expandable body coupled to the elongate shaft, the first expandable body adapted to expand the prosthetic heart valve when the prosthetic heart valve is positioned on the first expandable body to deploy the prosthetic heart valve into the native valve; a second expandable body coupled to the elongate shaft and adapted to transmit vibrations to disrupt calcification in the calcified native valve; a delivery catheter comprising an actuator for generating the vibration of the second expandable body.

17. 17. The system of claim 16, wherein the first expandable body is axially spaced from the second expandable body on the elongate shaft.

18. The system of claim 16 , wherein the first expandable body is positioned within the second expandable body.

19. 19. The system of any of claims 16 to 18, wherein the first expandable body is configured to expand the prosthetic heart valve positioned on the first expandable body and the second expandable body.

20. The system of any of claims 16 to 19, wherein the second expandable body has an outer surface and is configured to slide the prosthetic heart valve over the outer surface in vivo.

21. the first inflatable body includes a proximal end portion and a distal end portion; the second inflatable body includes a proximal end portion and a distal end portion; The system of any of claims 16 to 20, wherein the proximal end portion of the second expandable body is proximal to the proximal end portion of the first expandable body and the distal end portion of the second expandable body is distal to the distal end portion of the first expandable body.

22. The system of any of claims 16 to 21, wherein the second expandable body is more compliant than the first expandable body.

23. The system of any of claims 16 to 22, further comprising a controller configured to control the generation of vibrations in the second inflatable body.

24. 24. The system of any of claims 16 to 23, wherein the actuator comprises an electrode adapted to vaporize a fluid filling the second expandable body to generate the vibration of the second expandable body.

25. 25. The system of claim 24, further comprising one or more electrical conduits extending along the elongate shaft and adapted to provide electrical energy to the electrodes.

26. The system of any of claims 16 to 25, wherein the second expandable body is adapted to conform to the shape of the calcification of the calcified native valve.

27. A system according to any one of claims 16 to 26, wherein the vibrations comprise acoustic pressure waves.

28. 28. The system of claim 27, wherein the acoustic pressure waves are ultrasonic waves.

29. 30. The system of claim 28, wherein the ultrasound waves are shock waves.

30. The system according to any one of claims 16 to 29, wherein the prosthetic heart valve is a prosthetic mitral heart valve.

31. 1. A prosthetic mitral heart valve system for a heart, comprising: a support structure having inlet and outlet end portions and a passageway; a prosthetic mitral heart valve including a valve portion positioned within the passage of the support structure, the valve portion comprising a plurality of leaflets made from pericardium and allowing blood to flow unidirectionally through the passage to replace the function of a native mitral heart valve; an anchor for deployment in the left atrial appendage of the heart, the anchor coupled to the prosthetic mitral heart valve to anchor the prosthetic mitral heart valve within the native mitral heart valve.

32. 32. The system of claim 31, wherein a tether connects the prosthetic mitral heart valve to the anchor and is adapted to extend into the left atrium of the heart.

33. 33. The system of claim 31 or claim 32, wherein the anchor comprises a stent.

34. 1. A prosthetic heart valve configured to be deployed in a native heart valve, comprising: a support structure having a passageway; a spiral body coupled to the support structure and positioned within the passageway, the spiral body adapted to move between an open state and a closed state to control blood flow through the support structure.

35. the helical body includes arms that form a helix and have a radially inner portion and a radially outer portion, the radially inner portion being coplanar with the radially outer portion in the closed state; 35. The prosthetic heart valve of claim 34, wherein one or more gaps between the radially inner portion and the radially outer portion are formed when the helical body is moved to the open state, and the one or more gaps are closed when the helical body is in the closed state.

36. further comprising one or more penetrators configured to pass through the support structure to anchor the support structure to the native heart valve; 36. The prosthetic heart valve of claim 34 or claim 35, wherein the support structure comprises a ring extending around the helical body.

37. 1. A prosthetic heart valve configured to be deployed in a native heart valve, comprising: a support structure having inlet and outlet end portions and a passageway, the support structure including an atrial anchor with a flange for extending radially outward from the passageway; a valve portion positioned within the passage of the support structure, the valve portion comprising a plurality of leaflets made from pericardium, the valve portion allowing blood to flow unidirectionally through the passage to replace the function of the native heart valve.

38. 38. The prosthetic heart valve of claim 37, wherein the flange comprises an expandable body, the expandable body comprising a ring extending around the support structure.

39. 39. The prosthetic heart valve of claim 37 or claim 38, wherein the support structure includes a plurality of barbs extending radially outward from the support structure for anchoring the prosthetic heart valve to the native heart valve.

40. 1. A cutter for at least a portion of a leaflet of a heart valve, comprising: a first jaw including a proximal end portion and a distal end portion, the first jaw having a wedge shape converging onto an apex of the distal end portion of the first jaw; a second jaw including a proximal end portion and a distal end portion, the second jaw having a wedge shape converging onto an apex of the distal end portion of the second jaw; one or more teeth positioned on one or more of the first jaw or the second jaw and configured to sever the at least a portion of a leaflet of the heart valve when the first jaw closes with the second jaw.

41. 41. The cutter of claim 40, wherein the first jaw includes a first edge extending from the proximal end portion to the distal end portion of the first jaw, and the second jaw includes a second edge extending from the proximal end portion to the distal end portion of the second jaw, and the one or more teeth extend along one or more of the first edge or the second edge.

42. 42. The cutter of claim 41, wherein the one or more teeth are positioned on the first edge and the second edge.

43. 1. A prosthetic mitral heart valve system for a heart, comprising: a support structure having inlet and outlet end portions and a passageway; a prosthetic mitral heart valve including: a valve portion positioned within the passage of the support structure, the valve portion comprising a plurality of leaflets made from pericardium and allowing blood to flow unidirectionally through the passage to replace the function of a native mitral heart valve; a tether for tethering the leaflets of the native mitral heart valve to reduce obstruction of the left ventricular outflow tract of the heart by the leaflets of the native mitral heart valve.

44. 44. The system of claim 43, wherein the tether is adapted for anchoring to a ventricular wall to tether the leaflets of the native mitral heart valve.

45. 45. The system of claim 43 or claim 44, wherein the tether is adapted to anchor to a leaflet of the native mitral heart valve.

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