Systems and methods for treating calcified heart valves

Abstract

The invention relates to devices, systems, and methods for prosthetic valves. In an example, the implant site may include a native heart valve or another implant site. Examples may be used to improve anchoring and flow (e.g., perivalvular leakage) sealing if a native heart valve has calcification. Examples may include dissociating a calcification of a native heart valve to improve deployment to the native heart valve.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 359,686, filed on July 8, 2022, the entire contents of each of which are hereby incorporated by reference. Technical Field

[0003] Certain features of the present disclosure are generally directed to implants that include prosthetic valves for deployment. Background Art

[0004] The valves of the human heart, including the aortic valve, pulmonary valve, mitral valve, and tricuspid valve, function essentially like one-way valves that operate in sync with the pumping heart. The valves allow blood to flow downstream, but prevent blood from flowing upstream. Diseased heart valves exhibit damage, such as valve narrowing or regurgitation, which inhibits the valve's ability to control blood flow. Such damage reduces the heart's efficiency in pumping blood and can lead to debilitating and life-threatening conditions. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilatation. Therefore, a great deal of effort has been made to develop methods and devices for repairing or replacing damaged heart valves.

[0005] Prostheses exist to correct problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged native heart valves. Recently, a great deal of effort has been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, that can be delivered with less trauma to the patient than by open heart surgery. Replacement valves are designed to be delivered by minimally invasive surgery and even percutaneous surgery.

[0006] These replacement valves are generally designed to allow fluid to flow through them while sealing or blocking fluid flow on the outside of the replacement valve (paravalvular leakage (PVL)). Such sealing problems may increase if the native heart valve has an irregular shape or has calcifications around the replacement valve that may reduce the likelihood of a proper seal. The irregular shape or calcifications may also reduce the likelihood that the replacement valve will be properly anchored to the native heart valve. Summary of the invention

[0007] Examples of prosthetic valves disclosed herein may relate to improvements in prosthetic valves. In examples, such prosthetic valves may include replacement heart valves. Examples may be used to improve anchoring and flow (e.g., paravalvular leak) sealing in the presence of calcifications in native heart valves. Examples may reduce the likelihood of left ventricular outflow tract (LVOT) obstruction of the heart, whether caused by implantation of a prosthetic valve or other causes. Various other improvements are disclosed.

[0008] Examples disclosed herein may include a system for a heart. The system may include a prosthetic valve configured to be deployed to a native valve of the heart and configured to transmit shock waves to break down calcification of the native valve.

[0009] Examples disclosed herein may include a system for implanting a prosthetic heart valve within a calcified native valve. The system may include: the prosthetic heart valve, which includes a support structure having an inlet end portion and an outlet end portion and a passageway, and a valve portion positioned within the passageway of the support structure, wherein the valve portion includes a plurality of leaflets made of pericardium, wherein the valve portion permits blood to flow through the passageway in one direction 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 actuating mechanism for vibrating the support structure to reduce calcification of the calcified heart valve.

[0010] Examples disclosed herein may include a delivery system for a heart. The delivery system may include: a first expandable body configured to expand a prosthetic valve positioned on the first expandable body to deploy the prosthetic valve to a native valve; and a second expandable body surrounding the first expandable body and configured to transmit shock waves to decompose calcification of the native valve.

[0011] Examples disclosed herein may include a system for implanting a prosthetic heart valve in a calcified native valve. The system may include the prosthetic heart valve, the prosthetic heart valve comprising: a support structure having an inlet end portion and an outlet end portion and a passage; and a valve portion positioned in the passage of the support structure, wherein the valve portion includes a plurality of leaflets made of pericardium, wherein the valve portion permits blood to flow through the passage in one direction to replace the function of the native heart valve. The system may include a delivery catheter for the prosthetic heart valve, the delivery catheter comprising: an elongated shaft, and a first expandable body, a second expandable body, and an actuator, the first expandable body being coupled to the elongated shaft and being 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 to the native valve, the second expandable body being coupled to the elongated shaft and being adapted to transmit vibrations to decompose the calcification of the calcified native valve, the actuator being used to generate the vibrations of the second expandable body.

[0012] Examples disclosed herein may include a method comprising: reducing calcification of a native heart valve; and deploying a prosthetic heart valve to the native heart valve.

[0013] Examples disclosed herein may include a method comprising: determining a configuration of an implantation site at a native heart valve having calcification, the implantation site 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.

[0014] Examples disclosed herein may include a prosthetic valve configured to be deployed to a native valve of the heart. The prosthetic valve may include: one or more prosthetic valve leaflets configured to be positioned in 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 and including one or more of a barb or pad configured to engage a calcification of the native valve to anchor to the calcification.

[0015] Examples disclosed herein may include a method comprising deploying a prosthetic valve to a native valve. The prosthetic valve may include: one or more prosthetic valve leaflets configured to be positioned in 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 and including one or more of a barb or pad configured to engage a calcification of the native valve to anchor to the calcification.

[0016] Examples disclosed herein may include a prosthetic valve configured to be deployed to a native valve of the heart. The prosthetic valve may include: one or more prosthetic valve leaflets configured to be positioned in a flow channel; and a valve body configured to support the one or more prosthetic valve leaflets and including an outer surface, the outer surface including a conformable anchoring surface configured to fit the shape of the calcification of the native valve to anchor to the native valve.

[0017] Examples disclosed herein may include a method comprising deploying a prosthetic valve to a native valve. The prosthetic valve may include: one or more prosthetic valve leaflets configured to be positioned in a flow channel; and a valve body configured to support the one or more prosthetic valve leaflets and including an outer surface, the outer surface including a conformable anchoring surface configured to conform to the shape of a calcification of the native valve to anchor to the native valve.

[0018] Examples disclosed herein may include a prosthetic valve configured to be deployed as a native valve of the heart. The prosthetic valve may include: one or more prosthetic valve leaflets configured to be positioned in a flow channel; and a valve body configured to support the one or more prosthetic valve leaflets, the valve body including an atrial anchor, the atrial anchor including a flange configured to extend radially outward from the flow channel.

[0019] Examples disclosed herein may include a prosthetic heart valve configured to be deployed to a native heart valve. The prosthetic heart valve may include a support structure having an inlet end portion and an outlet end portion and a passageway, wherein the support structure includes an atrial anchor, the 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, wherein the valve portion includes a plurality of leaflets made of pericardium, wherein the valve portion permits blood to flow through the passageway in one direction to replace the function of the native heart valve.

[0020] Examples disclosed herein may include a method comprising deploying a prosthetic valve to a native valve. The prosthetic valve may include: one or more prosthetic valve leaflets configured to be positioned in a flow channel; and a valve body configured to support the one or more prosthetic valve leaflets, the valve body including an atrial anchor, the atrial anchor including a flange configured to extend radially outward from the flow channel.

[0021] Examples disclosed herein may include a prosthetic valve configured to be deployed as a native valve of the heart. The prosthetic valve may include: a valve body; and a spiral 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 disclosed herein may include a method comprising deploying a prosthetic valve to a native valve. The prosthetic valve may include a valve body and a helix 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.

[0023] Examples disclosed herein may include a prosthetic heart valve configured to be deployed to a native heart valve. The prosthetic heart valve may include: a support structure having a passage; and a helix coupled to the support structure and positioned within the passage, the helix being adapted to move between an open state and a closed state to control blood flow through the support structure.

[0024] Examples disclosed herein may include a system for a heart. The system may include: a prosthetic heart valve configured to be deployed in a mitral valve of a heart; and an anchor coupled to the prosthetic heart valve and configured to be deployed in a left atrial appendage of the heart.

[0025] Examples disclosed herein may include a prosthetic mitral heart valve system for a heart. The system may include a prosthetic mitral heart valve, the prosthetic mitral heart valve including: a support structure having an inlet end portion and an outlet end portion and a passage; and a valve portion positioned within the passage of the support structure, wherein the valve portion includes a plurality of leaflets made of pericardium, wherein the valve portion permits blood to flow through the passage in one direction to replace the function of a native mitral heart valve. The system may include an anchor for deployment in a left atrial appendage of the heart, wherein the anchor is coupled to the prosthetic mitral heart valve for anchoring the prosthetic mitral heart valve within the native mitral heart valve.

[0026] Examples disclosed herein may include a method comprising: deploying a prosthetic heart valve to a mitral valve of a heart; and deploying an anchor of the prosthetic heart valve to a left atrial appendage of the heart.

[0027] Examples disclosed herein may include a method comprising implanting a prosthetic valve at a pulmonary vein of a heart to block fluid flow to the lungs.

[0028] Examples disclosed herein may include a stent for a heart. The stent may include: an outer stent configured to be deployed near 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.

[0029] Examples disclosed herein may include a method comprising deploying a stent proximate a left ventricular outflow tract of a heart, the stent comprising: an outer stent and an inner stent positioned within the outer stent and comprising a flow channel for fluid to pass through the left ventricular outflow tract.

[0030] Examples disclosed herein may include a system for a heart. The system may include: a prosthetic heart valve configured to be implanted in a valve of a heart; and an anchor coupled to the prosthetic heart valve and including a ventricular chamber configured to extend with a ventricle of the heart.

[0031]

[0013] Examples disclosed herein can include a method comprising: deploying a prosthetic heart valve to a valve of a heart; and deploying an anchor of the prosthetic heart valve to a ventricle of the heart, the anchor comprising a ventricular chamber.

[0032] Examples disclosed herein may include a method comprising tethering or removing at least a portion of a native mitral heart valve leaflet to reduce obstruction of a left ventricular outflow tract of a heart by the native mitral heart valve leaflet.

[0033] Examples disclosed herein may include a cutter for at least a portion of a heart valve leaflet, the cutter comprising: a first jaw comprising a proximal portion and a distal portion, the first jaw having a wedge shape converging at an apex at the distal portion of the first jaw; a second jaw comprising a proximal portion and a distal portion, the second jaw having a wedge shape converging at an apex at the distal 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 the portion of the heart valve leaflet when the first jaw is closed with the second jaw.

[0034] Examples disclosed herein may include a prosthetic mitral heart valve system for a heart. The system may include a prosthetic mitral heart valve, the prosthetic mitral heart valve including: a support structure having an inlet end portion and an outlet end portion and a passage; and a valve portion positioned within the passage of the support structure, wherein the valve portion includes a plurality of leaflets made of pericardium, wherein the valve portion permits blood to flow through the passage in one direction to replace the function of a native mitral heart valve. The system may include a tether for tethering the native mitral heart valve leaflets to reduce obstruction of the left ventricular outflow tract of the heart caused by the native mitral heart valve leaflets. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The features and advantages of the systems, devices and methods as disclosed herein will also become better understood with reference to the specification, claims and drawings, in which:

[0036] Figure 1A An upper perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0037] Figure 1B Show Figure 1A Bottom perspective view of the prosthetic valve shown in .

[0038] Figure 2 Show Figure 1A Schematic side cross-section of the prosthetic valve shown in .

[0039] Figure 3 Schematic diagram showing the delivery device approaching the implantation site.

[0040] Figure 4 Show Figure 1ASchematic side cross-section of a prosthetic valve deployed to a native heart valve is shown in .

[0041] Figure 5 Schematic side cross-section of a native heart valve with calcification is shown.

[0042] Fig. 6A A schematic side cross-sectional view showing the delivery device approaching an implantation site.

[0043] Figure 6B Show Fig. 6A A schematic side cross-sectional view of a delivery device shown in FIG. 1 with the outer expandable body expanded.

[0044] Figure 6C Show Fig. 6A A schematic side cross-sectional view of a delivery device shown in FIG. 1 with the outer expandable body expanded.

[0045] Fig.6D Show Fig. 6A A schematic side cross-sectional view of a delivery device shown in FIG. 1 with an implant positioned thereon.

[0046] Fig. 6E Show Fig. 6A A schematic side cross-sectional view of a delivery device shown in FIG. 1 with the inner expandable body expanded.

[0047] Fig. 6F Schematic side cross-section showing a prosthetic valve deployed to a native heart valve.

[0048] Figure 6G A side cross-sectional view of the delivery device is shown approaching an implantation site.

[0049] Figure 6H Show Figure 6G Side cross-sectional view of the delivery device shown in , with the expandable body expanded.

[0050] Fig.6I Shown from Figure 6H The position shown in the figure is advanced Figure 6G Side cross-sectional view of the delivery device shown in .

[0051] Figure 6J Show Figure 6G Side cross-sectional view of the delivery device shown in , with the expandable body expanded.

[0052] Fig. 7A A side view of the delivery device approaching an implantation site is shown.

[0053] Figure 7B A side view of a prosthetic valve is shown deployed to an implantation site.

[0054] Figure 7C Show Figure 7B Side view of the frame of the prosthetic valve shown in .

[0055] Fig.7D Shown deployed to implant site Figure 7B Side view of the prosthetic valve shown in .

[0056] Fig. 7E Shown deployed to implant site Figure 7B Side view of the prosthetic valve shown in .

[0057] Figure 7F Shown is a side cross-sectional view of a prosthetic valve incorporating one or more actuators.

[0058] Figure 7G Shown deployed to implant site Figure 7F Side cross-sectional view of a prosthetic valve.

[0059] Figure 7H Shown is a side cross-sectional view of a prosthetic valve incorporating one or more actuators.

[0060] Fig.7I Shown deployed to implant site Figure 7H Side cross-sectional view of a prosthetic valve.

[0061] Figure 7J A side cross-sectional view of a prosthetic valve is shown with an actuator applied to the prosthetic valve.

[0062] Figure 7K Shown deployed to implant site Figure 7J Side view of the prosthetic valve shown in .

[0063] Figure 7L A side cross-sectional view of a prosthetic valve is shown with an actuator applied to the prosthetic valve.

[0064] Figure 8 Side view showing calcification of a decomposed heart valve.

[0065] Figures 9A-9C Each shows a side view of an anchor.

[0066] Fig. 10A Schematic side cross-section showing the anchor and calcification.

[0067] Fig. 10B Shown anchored to calcification Fig. 10A Schematic side cross-section of the anchor shown in .

[0068] Fig.11A Schematic side cross-section showing the anchor and calcification.

[0069] Fig. 11B Shown anchored to calcification Fig.11A Schematic side cross-section of the anchor shown in .

[0070] Fig. 11C Schematic side cross-section showing the anchor and calcification.

[0071] Fig. 12A A perspective view of a prosthetic valve is shown.

[0072] Fig. 12B Show Fig. 12A Schematic side cross-section of the prosthetic valve shown in .

[0073] Fig.13 Schematic side cross-section showing a prosthetic valve deployed to a native heart valve.

[0074] Fig.14 Schematic side cross-section showing a prosthetic valve deployed to a native heart valve.

[0075] Fig.15 Schematic side cross-section showing a prosthetic valve deployed to a native heart valve.

[0076] Fig.16A A perspective view of a prosthetic valve is shown.

[0077] Fig. 16B Shown deployed to implant site and in closed position Fig.16A Side view of the prosthetic valve shown in .

[0078] Fig. 16C Shown deployed to implant site and in open position Fig.16A Side view of the prosthetic valve shown in .

[0079] Fig.17A A side view of a prosthetic valve is shown deployed to an implantation site and in an open state.

[0080] Fig. 17B Shown in closed state Fig.17A Side view of a prosthetic valve.

[0081] Fig.18 Schematic side cross-section showing a prosthetic valve deployed to a native heart valve and an anchor in the left atrial appendage (LAA).

[0082] Fig.19 A schematic side cross-sectional view of a prosthetic valve deployed into a pulmonary vein is shown.

[0083] Fig. 20 Schematic side cross-section showing a prosthetic valve deployed to a native heart valve.

[0084] Fig.21 A schematic side cross-section diagram showing a stent deployed adjacent to the left ventricular outflow tract.

[0085] Fig. 22 Schematic side cross-sections showing a prosthetic valve deployed to an aortic valve and a prosthetic valve deployed to a mitral valve.

[0086] Fig.23A A schematic side cross-sectional view showing a cutter approaching a native heart valve leaflet.

[0087] Fig. 23B A perspective view showing a cutter approaching native heart valve leaflets.

[0088] Fig.23C A perspective view showing a cutter cutting native heart valve leaflets.

[0089] Fig.24A A side cross-sectional view of a cutter approaching a native heart valve leaflet is shown.

[0090] Fig. 24B A view of the surface of a native heart valve leaflet is shown with a cutter applied to the leaflet.

[0091] Fig.24C Show Fig.24A Side view of the cutter shown in , with the jaws open.

[0092] Fig.24D Show Fig.24A Side view of the cutter shown in , with the jaws closed.

[0093] Fig.24E A view showing the surface of a native heart valve leaflet with a cutter applied to the leaflet.

[0094] Fig.25A A schematic side cross-sectional view showing a cutter approaching a native heart valve leaflet.

[0095] Fig.25B A schematic side cross-sectional view showing a cutter approaching a native heart valve leaflet.

[0096] Fig.25C Schematic side cross-section showing a snagged native heart valve leaflet.

[0097] Fig.26 A schematic side cross-sectional view showing a cutter approaching a native heart valve leaflet.

[0098] Fig. 27 Schematic side cross-section showing a cutter approaching the chordae tendineae.

[0099] Fig.28AThe heart valve leaflets are shown anchored to the ventricular wall.

[0100] Fig.28B Shown anchored to the ventricular wall Fig.28A Heart valve leaflets shown in , with a prosthetic valve deployed to a native valve. DETAILED DESCRIPTION

[0101] Figure 1A A perspective view of a prosthetic valve 10 in the form of a replacement heart valve or a prosthetic heart valve is shown. The prosthetic valve 10 can be configured to be deployed within a portion of a patient's body. For example, the prosthetic valve 10 can be deployed to the annulus of a native valve, which can include a native mitral valve or a native tricuspid valve. In an example, other implantation locations can be used, such as within the aortic valve or pulmonary valve, or other valves or locations within the patient's body as needed.

[0102] The prosthetic valve 10 may include a proximal end 12 or inlet end portion and a distal end 14 or outlet end portion (at Figure 2 ) and the length therebetween. The prosthetic valve 10 may also include a valve portion or a plurality of prosthetic valve leaflets 16 having one or more prosthetic valve leaflets 16, which are configured to be positioned in a flow channel or passage for controlling flow through the valve 10. The flow channel or passage may be provided by a support structure 15 of the valve 10. The support structure 15 may form a proximal end 12 or inlet end portion of the prosthetic valve 10 and a distal end 14 or outlet end portion of the prosthetic valve 10. The prosthetic valve leaflets 16 may be configured to move between an open state and a closed state to mimic and replace the operation of a native valve leaflet. The valve portion may be positioned within the passage of the support structure 15 and may allow blood to flow through the passage in one direction to replace the function of a native heart valve. As desired, the prosthetic valve leaflets 16 may be made of pericardium or another material.

[0103] In an example, 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 support frame or a support frame (e.g., a valve frame or an inner frame or an inner support support 18 and an outer frame or an outer support support 20, as well as other forms of frames) and a sealing body 11. Figure 1B In Figure 2 The valve frame or inner frame or inner support stent 18 is shown in cross-sectional view. Figure 1A and 2 An outer frame or outer support bracket 20 is shown in FIG. The outer frame or outer support bracket 20 can be a part of the sealing body 11 and can be spaced apart from the inner support bracket 18. The outer support bracket 20 can surround the inner support bracket 18.

[0104] refer to Figure 1A and 2 , the prosthetic valve 10 may include one or more anchors 17 that can be connected to the prosthetic valve leaflets 16. The anchors 17 can each be configured to anchor the prosthetic valve leaflets 16 to a portion of the patient's heart, which portion may include a native valve. The anchors 17 can specifically be configured to anchor to the native valve leaflets of the patient's heart. The anchors 17 can extend around the native valve leaflets to anchor to the native valve leaflets. The anchors 17 may include a distal anchor positioned at the distal end 14 or outlet end portion of the valve 10, or in an example, may be positioned at another location as desired.

[0105] Each anchor 17 can be configured as a protruding arm that is configured to extend distally and then bend in the proximal direction to the tip of a corresponding one of the anchors 17. Such a configuration can allow the anchor 17 to extend around the native valve leaflet and around the distal tip of the leaflet to hook the distal tip of the native valve leaflet and be positioned radially outside the outward-facing surface of the leaflet of the native valve. For example, the anchor 17 can be configured to be in a hooking configuration, such as Figure 1A-2 Thus, the anchor 17 can resist forces applied to the valve 10 in the atrial or proximal direction and can anchor the valve 10 to the native valve annulus. Other configurations of the anchor 17 can be used in an example as desired.

[0106] The prosthetic valve leaflets 16 may surround a passageway or flow channel 25, such as Figure 2 , and can be moved between an open state and a closed state to control the flow through the passage or flow channel 25. Figure 2 As shown in , the proximal end of the prosthetic valve 10 may include the inflow end of the valve 10, and the distal end of the prosthetic valve 10 may include the outflow end, but other configurations may be utilized as desired. The prosthetic valve leaflets 16 may be positioned around the central axis 61 of the prosthetic valve 10. The inner support stent 18 and the outer support stent 20 may each surround the central axis 61 of the prosthetic valve 10.

[0107] Reference again Figure 1A , the prosthetic valve 10 may include a sealing body 11. The sealing body 11 may be positioned radially outward from the prosthetic valve 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 an outer diameter of the valve 10 and may include an outer periphery of the valve 10. The sealing body 11 may include a proximal portion having a proximal end 31, and may include a distal portion (at the distal end 33) having a distal end 33. Figure 2 (marked in).

[0108] refer to Figure 2In a cross-sectional view of the seal body 11, the seal body 11 may include a frame or outer frame or outer support bracket 20 and a sealing skirt 24, or in an example, may include only a frame or only a sealing skirt as desired. The outer support bracket 20 may be positioned radially outward from the inner frame or inner support bracket 18. The sealing skirt 24 may be coupled to the outer support bracket 20 and may include an outer portion of the seal body 11, such as Figure 1A as shown in .

[0109] The sealing skirt 24 can be made of a material that resists fluid flow therethrough, such as cloth, woven material, or other material, such as a polymer or other material that resists fluid flow therethrough. The material can include fabric. A variety of materials can be used for the skirt 24 as desired.

[0110] The sealing body 11 can be configured to abut a portion of the patient's heart to reduce fluid flow. The skirt 24 can be configured to seal a portion of the native valve annulus. For example, the sealing body 11 can abut the surface of the patient's native valve leaflets to reduce fluid flow between the sealing body 11 and the native valve leaflets. The sealing body 11 can be configured to abut other portions of the patient's heart to reduce fluid flow as needed.

[0111] In an example, the sealing body 11 may be flexible to allow movement and conformity to the native valve annulus.

[0112] Figure 3 The advancement of a delivery system 70 or delivery catheter for deploying the prosthetic valve 10 to an implantation site is shown. The delivery system 70 may include an elongated shaft 72 having a proximal portion and a distal portion, wherein the proximal portion is coupled to a housing in the form of a handle 74. The delivery system 70 may be advanced through the vasculature of a patient, which may include Figure 3 Other access methods may be used in embodiments, including transapical, or through surgical approaches such as thoracotomy or open heart surgery.

[0113] In an example, the prosthetic valve 10 can be positioned within an implant retention area of ​​the delivery system 70 and can be covered with a capsule or can be otherwise retained prior to deployment. The prosthetic valve 10 can be deployed as a self-expanding prosthesis. The self-expanding prosthesis can be made of a shape memory material. The shape memory material can include nitinol, or can have other forms (e.g., other forms disclosed herein) in an example. However, in an example, the prosthetic valve can be a balloon-expandable prosthesis (e.g., positioned on an expandable body or balloon when entering the patient's body, or slid onto an expandable body or balloon in the patient's body), or can be mechanically deployed, as well as other forms of deployment.

[0114] The delivery system 70 can be advanced to be delivered into an atrium of the heart and can be delivered transseptally into another atrium (e.g., from the right atrium to the left atrium) to reach the implantation site. For example, this delivery approach can be used for mitral native valve access. In an example, the delivery system 70 can be extended to the right atrium for tricuspid valve access, or other delivery approaches to other implantation sites can be used in an example as needed.

[0115] Prosthetic valve 10 may be retained in a compressed configuration within the enclosure of delivery system 70. Anchor 17 may be advanced and may be deployed radially outward from the enclosure.

[0116] Figure 4 The prosthetic valve 10 is shown deployed to a native valve 80 (e.g., a native mitral valve). The sealing body 11 can extend radially outward to contact the inwardly facing surface of the native valve leaflets 82. The anchor 17 can be hooked on the native valve leaflets 82 so that the tip of the anchor 17 is positioned radially outside of the native valve leaflets 82.

[0117] In an example, the configuration of the native valve 80 containing calcifications may hinder the ability of the prosthetic valve to be properly deployed to the implantation site. For example, the calcifications may hinder the ability of the prosthetic valve to seal with the native valve. The calcifications may hinder the ability of the prosthetic valve to anchor to the native valve. For example, the native valve 80 may include a calcified native mitral valve. For example, upon implanting the prosthetic valve into a native mitral valve having calcifications, the calcifications may cause, for example, Fig.21 282. Calcification may cause other undesirable effects in the implantation of prosthetic valves or other treatments of the native valve or heart.

[0118] For example, refer to Figure 5 Calcification 84 may be present below or radially outside the outward-facing surface of the leaflets 83 of a native heart valve 88 (e.g., a calcified native mitral valve). Such calcification 84 may impede, for example, Figure 4 The ability of the anchor 17 shown in FIG. 8 to hook around the native valve leaflets 83 to anchor to the native valve leaflets 83. Calcification 84 may prevent the anchor 17 from being positioned radially outward of the outward-facing surface of the leaflets 83 in a desired manner.

[0119] Calcification 86 may be located radially inward of leaflets 83. For example, calcification 86 may be located on the inwardly facing surface of leaflets 83, or may protrude inwardly toward the flow channel between leaflets 83. In an example, calcification 86 may be located on the annulus of a native heart valve 88, or may be located within the atrium of the heart. Such calcification 86 may hinder the ability of the prosthetic valve to seal or anchor to the native valve. An irregularly shaped annulus may result, which may hinder the ability of the prosthetic valve to be deployed to the native heart valve 88 in a desired manner. Calcification may be at the mitral valve, and may include mitral annular calcification (MAC).

[0120] In an example, calcification may be advantageously reduced to reduce the likelihood of adversely affecting deployment of a prosthetic valve or adversely affecting the operation of the heart generally. Figures 6A-6F An example of a delivery system 90 or delivery catheter that may be utilized in the examples herein is shown.

[0121] The delivery system 90 or delivery catheter may include a first expandable body 92 and a second expandable body 94. The first expandable body 92 may be configured to expand the prosthetic valve when the prosthetic valve is positioned on the first expandable body 92 to deploy the prosthetic valve to the native valve. The second expandable body 94 may surround the first expandable body 92 and may be configured to transmit vibrations to decompose calcification of the native valve. The delivery system 90 or delivery catheter may be used to deploy the prosthetic valve.

[0122] The first expandable body 92 and the second expandable body 94 can each be coupled to an elongated shaft 96 of a delivery device or delivery catheter, similar to Figure 3 The elongated shaft 72 is shown in FIG.

[0123] The distal end portion of the elongated shaft 96 may be Fig. 6A and the proximal end portion of the elongated shaft 96 may be coupled to Figure 3 The handle may include a control mechanism (such as Figure 3 ), the control mechanism can be used to control the deflection of the elongated shaft 96 for navigation through the patient's vascular system. The control mechanism can 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 can each be coupled to a distal portion of the elongated shaft 96.

[0124] The first expandable body 92 may include a proximal portion 98 and a distal portion 100 and a central portion 102. The proximal portion 98 may be coupled to the elongated shaft 96, and the distal portion 100 may be coupled to the elongated shaft 96. The central portion 102 may define a cavity 104, which may be configured to receive a fluid for expanding the first expandable body 92. The cavity 104 may be in fluid communication with a first fluid conduit 106 that may extend along the elongated shaft 96. The port 108 may allow fluid transfer between the first fluid conduit 106 and the cavity 104. In an example, the first fluid conduit 106 may include a lumen of the elongated shaft 96. For example, the first fluid conduit 106 may receive fluid from a reservoir that transfers fluid along the lumen of the elongated shaft 96.

[0125] The second expandable body 94 may extend above 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 portion 110 and a distal portion 112 and a central portion 114. The proximal portion 110 may be positioned proximal to the proximal portion 98 of the first expandable body 92 and may be coupled to the elongated shaft 96. The distal portion 112 may be positioned distal to the distal portion 100 of the first expandable body 92 and may be coupled to the elongated shaft 96.

[0126] The central portion 114 of the second expandable body 94 may define a cavity 116, which may be configured to receive a fluid for expanding the second expandable body 94. The cavity 116 may be in fluid communication with a second fluid conduit 118 that may extend along the slender shaft 96. The second fluid conduit 118 may extend around the first fluid conduit 106 so that the slender shaft 96 has a double lumen configuration. For example, the second fluid conduit 118 may receive fluid from a reservoir that transfers fluid along the lumen of the second fluid conduit 118. Other configurations may be used in examples. The port 121 may allow fluid transfer between the second fluid conduit 118 and the cavity 116. In an example, the second fluid conduit 118 may include a lumen of the slender shaft 96.

[0127] The second expandable body 94 can be configured to expand independently of the first expandable body 92. For example, the second fluid conduit 118 can 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) can be used to independently control the flow of fluid to the first expandable body 92 and the second expandable body 94. The fluid control device can provide fluid from one or more reservoirs as needed.

[0128] In an example, the second expandable body 94 may be more compliant than the first expandable body 92. The second expandable body 94 may be more compliant to conform to the shape of a native valve that may contain calcifications. The first expandable body 92 may be less compliant than the second expandable body 94 to support a prosthetic valve that may be positioned on and deployed by the first expandable body 92.

[0129] In an example, the second expandable body 94 can be configured to transmit vibrations to break down calcifications. In an example, the vibrations can include acoustic pressure waves. In an example, the acoustic pressure waves can include ultrasonic waves. In an example, ultrasonic waves can include shock waves. In an example, various other forms of vibrations or waves of frequencies can be used to produce the desired results (for example, in an example, low-frequency waves less than ultrasonic frequencies can be used, and high-frequency waves can be used). The vibrations can be configured to break down calcifications into particles in a process similar to lithotripsy. For example, one or more actuators 123 can be used to generate vibrations of the second expandable body 94.

[0130] In an example, the actuator 123 may have various forms. The actuator 123 may include, for example, an electrode 125. The electrode 125 may be configured to excite or evaporate the fluid filling the second expandable body 94 to generate vibrations of the second expandable body 94. For example, when a voltage is applied to the electrode 125, the electrode 125 may generate an arc or a spark. The arc or the spark may evaporate a portion of the fluid filling the second expandable body 94 (e.g., a portion of the fluid adjacent to the electrode 125), wherein the evaporated gas pressure generates vibrations of the second expandable body 94. The vibrations may propagate through the fluid to the outer surface of the second expandable body 94 and apply the vibrations to the calcification of the native valve. In an example, other forms of actuators or other methods of using actuators may be utilized.

[0131] The electrical conduits 120, 122 may extend to the electrode 125 for providing electrical energy to the electrode 125 that generates the arc or spark. A positive electrical conduit 120 and a negative electrical conduit 122 may be provided to generate the resulting arc or spark. In an example, the conduits 120, 122 may be coupled to the respective electrodes 125. The electrical conduits 120, 122 may extend along the elongated shaft 96 and may be adapted to provide electrical energy to the electrode 125. Similar electrical conduits may extend to other electrodes 127 (which may be positioned at other locations within the second expandable body 94). Fig. 6A ). The electrodes 125, 127 may be configured as a ring extending around the elongated shaft 96, or may have other configurations in examples.

[0132] The proximal end portions of the electrical conduits 120, 122 may be coupled to contacts 124, 126 of a controller 128 ( Figure 6C), the controller 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) for providing 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 vibrations (e.g., shock waves) applied to the calcification and the duration of the vibrations applied to the calcification. The controller 128 may provide electrical energy to generate ultrasonic frequencies of vibrations from the second expandable body 94. The controller 128 may operate based on user input, or may operate automatically in an instance.

[0133] The second expandable body 94 can be used in the process of breaking down calcification to provide a calcification-reduced implantation site for a prosthetic valve. Calcification can be completely removed from a native heart valve, or can be partially removed to provide an improved implantation site for a prosthetic valve. In an example, calcification can be removed from a calcified native mitral valve (or from other native valves as desired).

[0134] For example, refer to Figure 6B , the second expandable body 94 can be positioned at the implantation site and can be expanded. Fluid can fill the cavity 116 to expand the second expandable body 94. The second expandable body 94 can conform to the shape of the native valve and conform to the calcification of the native valve (for example, the calcification 86 inside the leaflet of the native valve and the calcification 84 outside the leaflet of the native valve). The first expandable body 92 can remain unexpanded at this time, or can be partially expanded as needed.

[0135] refer to Figure 6C , the second expandable body 94 can transmit vibrations to break down the calcifications 86, 84. The actuator 123 can generate vibrations transmitted by the fluid filling the cavity 116. The controller 128 can control the generation of vibrations of the second expandable body 94. The vibrations can be applied for a desired duration to completely or partially remove the calcifications. In an example, the vibrations can be generated on the surface of the second expandable body 94.

[0136] In an example, a sensor 133 may be provided that can be used to image the reduction of calcifications. For example, the sensor 133 may include an imaging sensor (e.g., fluoroscopy or ultrasound or a combination thereof) that images the reduction of calcifications. In an example, the sensor 133 may be configured to image the position of the second expandable body 94 to determine the reduction of calcifications. 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, for example, include one or more imaging markers (e.g., radiopaque materials or echogenic markers) that can be imaged to determine the size or diameter of the second expandable body 94. A user may determine whether sufficient calcifications have been reduced based on the output from the sensor 133. In an example, the output from the sensor 133 may be provided as feedback to the controller 128 for the controller 128 to automatically generate vibrations from the second expandable body 94 and / or stop generating vibrations after removing a sufficient amount of calcifications. Other configurations may be used in an example.

[0137] With the desired amount of calcification decomposed, the prosthetic valve 130 can be positioned on the first expandable body 92 and correspondingly on the second expandable body 94. For example, the prosthetic valve 130 may include a balloon-expandable valve and may be slid on the second expandable body 94, wherein the prosthetic valve 130 is in an undeployed or unexpanded configuration. The prosthetic valve 130 may include any features disclosed herein with respect to a prosthetic valve, including any features of the prosthetic valve 10 or other prosthetic valves disclosed herein. In an example, the prosthetic valve 130 may not have the anchor 17 disclosed with respect to the prosthetic valve 10, or may include such an anchor (or other forms of anchors). The prosthetic valve 10 may include a single-frame prosthetic valve 130, and may include a multi-frame prosthetic valve disclosed with respect to the valve 10.

[0138] 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 on the outer surface in vivo. Fig.6D The prosthetic valve 130 is shown on the second expandable body 94. The second expandable body 94 is positioned within the flow channel or passageway of the prosthetic valve 130. The first expandable body 92 can 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 can then be expanded via the first fluid conduit 106 to expand the prosthetic valve 130 and the second expandable body 94 and deploy the prosthetic valve 130 to the implantation site.

[0139] For example, Fig. 6EThe first expandable body 92 is shown to have been expanded by the first fluid conduit 106. The first expandable body 92 can expand radially outward and correspondingly expand the second expandable body 94 and the prosthetic valve 130 radially outward. The prosthetic valve 130 can be deployed in place due to the expansion of the first expandable body 92. In an example, the sensor 133 can be used to image the diameter of the prosthetic valve 130 after implantation. The sensor 133 may include an imaging sensor for imaging the diameter of the prosthetic valve 130. The output from the sensor 133 can be used to determine the resulting diameter of the prosthetic valve 130 and whether proper deployment has occurred.

[0140] The first expandable body 92 can be deflated and can be removed from the implantation site along with the second expandable body 94. The elongated shaft 96 can be withdrawn from the implantation site to remove the first expandable body 92 and the second expandable body 94.

[0141] For example, Fig. 6F A prosthetic valve 130 is shown deployed to an implantation site. Calcifications at the implantation site may be completely or partially removed from the site.

[0142] In examples, variations of the systems and methods may be utilized.

[0143] Figure 6G-6J An example is shown where the first expandable body 92 is axially spaced apart from the second expandable body 94 along the elongated axis 135 of the delivery system or delivery catheter. Figure 6G-6J The features of the examples may additionally be Figures 6A-6F The features operate in a similar manner.

[0144] For example, the second expandable body 94 can be advanced to be positioned adjacent to the calcifications 84, 86 of the native valve. The fluid can expand the second expandable body 94 to produce an expanded state, for example Figure 6H As shown in . Actuator 123 can be used to generate vibrations to break up calcifications in a similar manner as described herein. Sensor 133 can be used to image the reduction of calcifications in a similar manner as disclosed herein.

[0145] The second expandable body 94 can be deflated and the elongated shaft 135 can then be advanced distally, such as Fig.6I The first expandable body 92 can be positioned at the implantation site so that after the first expandable body 92 is deployed, the prosthetic valve 130 is provided in a desired position. The first expandable body 92 can be expanded (eg Figure 6J ) to implant the prosthetic valve 130 at the desired implantation site. The sensor 133 can be used to image the diameter of the prosthetic valve 130 after implantation, as disclosed herein.

[0146] Figure 6G-6JThe features of can 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. Thus, the prosthetic valve 130 does not need to be slid onto the first expandable body 92, but can remain on the first expandable body 92 during the calcification reduction process of the second expandable body 94. In an example, the prosthetic valve 130 can still be slid onto the first expandable body 92 during the implantation process.

[0147] Figures 6A-6J Features of the examples may be used alone or in combination with features of any other examples herein. In the examples, variations of the systems and methods may be utilized.

[0148] Figures 7A-7L Examples are shown in which a prosthetic valve can be configured to be deployed to a native valve of the heart and can be configured to transmit vibrations to reduce calcification of the native valve. The vibrations can break down calcification of the native valve. In examples, the prosthetic valve utilized can include a self-expanding or self-deploying valve, or can be configured to expand when an electric current is applied to the frame of the prosthetic valve. In examples, other forms of prosthetic valves (e.g., balloon expandable or mechanically expandable) can be utilized.

[0149] refer to Fig. 7A , the prosthetic valve 140 may be positioned in a delivery device or delivery catheter—e.g. Figure 3 In the embodiment of the present invention, the delivery device or delivery catheter shown in FIG. 1 is a capsule 142 of a delivery device or delivery catheter shown in FIG. The capsule 142 can hold the prosthetic valve therein. After the capsule 142 is placed in the desired position relative to the implantation site, the capsule 142 can be retracted to allow the prosthetic valve to be deployed. In an example, other forms of retaining devices can be used to hold the prosthetic valve before deployment.

[0150] For example, Figure 7B The capsule 142 is shown retracted. The prosthetic valve 140 may remain undeployed or undeployed, or may begin to self-expand after being released from the capsule 142. In an example, the prosthetic valve 140 may transmit vibrations to break down calcification of the native valve.

[0151] For example, the delivery device of the delivery catheter may include an actuation mechanism 143 that causes the support structure to vibrate, thereby reducing calcification of the calcified native valve. For example, the prosthetic valve 140 may include a support structure 141. The support structure 141 may be configured similarly to any example of a support structure disclosed herein. The support structure 141 may include a support frame that may be configured similarly to any example of a frame disclosed herein. For example, in Figure 7C The support frame 153 is labeled. The actuation mechanism 143 can be configured to transmit energy to the support structure 141 to cause the support structure 141 to vibrate.

[0152] 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 be electrically connected to corresponding terminals on the support structure 141 (or on the support frame 153). The electrical terminals 145, 147 may be connected to electrical conduits 144, 146, which may be configured to be coupled to electrical contacts 148, 150 of the controller 152. The electrical conduits 144, 146 may extend along the elongated axis of the delivery system or delivery catheter. The proximal portion of the electrical conduits 144, 146 may be coupled to the electrical contacts 148, 150 of the controller 152.

[0153] The controller 152 may receive power from a power source 158 (eg, a battery or a power connector, such as a mains connector).

[0154] In an example, the controller 152 can be configured to control the vibration via an electric current to the support frame 153, which can cause movement of the support frame 153. For example, Figure 7C The support frame 153 of the prosthetic valve 140 is shown with the sealing body or sealing skirt 155 excluded. Figure 7C ). In an example, the support frame 153 may be configured to support one or more prosthetic valve leaflets (not shown). The support frame 153 may surround a passage or flow channel in which one or more prosthetic valve leaflets are located. In an example, the support frame 153 may support the sealing skirt 155. In an example, the support frame 153 may include an outer frame or outer support stent or other form of frame. In an example, the support frame 153 may include an inner frame or inner support stent or other form of frame in an example. In an example, the prosthetic valve 140 may include one or more distal anchors 161. The distal anchor 161 may be configured to extend over the tip of the leaflet of the native valve, or may have another configuration in an example.

[0155] In an example, the support frame 153 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 can have various forms, including soft superelastic nitinol, platinum iridium, or shape memory nitinol, etc. The electrical current applied to the support frame 153 can be used to generate vibrations from the frame, which can be used to break down calcifications of the native valve.

[0156] The controller 152 can control the energy delivered to the support structure 141 to cause the support structure 141 to vibrate. For example, the controller 152 can change the amount of current applied to the support frame 153. The current can be provided by the power supply 158, which is delivered to the support frame 153. The controller 152 can control the amplitude and frequency of the current applied to the support frame 153 to produce vibrations. The controller 152 can apply a pulsating current to the frame. In an example, the vibrations generated by the prosthetic valve 140 may include acoustic pressure waves. In an example, the acoustic pressure waves may include ultrasonic waves. In an example, the ultrasonic waves may include shock waves. In an example, various other forms or frequencies of waves may be used to produce the desired results (for example, in an example, low frequency waves less than the ultrasonic frequency may be used, and high frequency waves may be used). The vibrations may be generated by the heat provided from the current applied to the support frame 153, wherein the resulting vibrations are generated due to the movement of the support frame 153. The vibrations can be used to fully or partially decompose Figure 7B Calcifications 86, 84 are shown in FIG. Terminals 145, 147 may couple controller 152 to support frame 153 to transmit current to support frame 153.

[0157] In an example, the electrical terminals 145, 147 may include releasable terminals that can be released from the support frame 153 after the implantation process. For example, the terminals 145, 147 may be magnetically coupled to the support frame 153 or coupled to the support frame by a releasable clip, clamp or other form of coupling. Thus, the terminals 145, 147 and the electrical conduits 144, 146 can be removed after implantation.

[0158] The vibrations generated by the prosthetic valve 140 can completely or partially remove calcifications at the implantation site. As a result, calcifications can be reduced, which can improve the deployment of the prosthetic valve 140. In an example, the sensor 133 can be used to image the diameter of the prosthetic valve after the prosthetic valve 140 is implanted. The sensor 133 may include an imaging sensor for imaging the diameter of the prosthetic valve 140. The output from the sensor 133 can be used to determine the resulting diameter of the prosthetic valve 140 and whether proper deployment has occurred. In an example, the output from the sensor 133 can be provided to the controller 152 as feedback of the diameter of the prosthetic valve 140. The feedback can be used for the controller 152 to automatically generate vibrations from the prosthetic valve 140 and / or stop generating vibrations after removing a sufficient amount of calcification. Other configurations can be used in examples.

[0159] refer to Fig.7D , the prosthetic valve 140 can be deployed, for example, to a native valve having reduced calcification. If desired, the electrical terminals 145, 147 can be removed from the prosthetic valve 140. For example, Fig. 7E The configuration shown in .

[0160] In an example, 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 the current applied to the frame, which can generate heat. Figure 7B As shown in FIG. 1 , the prosthetic valve 140 may have a first diameter 154. An electrical current may be applied to the frame to cause the prosthetic valve to expand to a Fig.7D 156. The current applied to the support frame 153 via the actuation mechanism 143 may cause the support frame 153 to expand. The electrical energy applied to the support frame 153 may increase the diameter of the support frame 153. In an example, the current may be controlled by the controller 152 to produce the desired expansion of the support frame 153. For example, the expansion may be initiated by the controller 152 or may be stopped by the controller 152. For example, the user may determine that the expansion should be stopped based on the incorrect positioning of the prosthetic valve 140 or other conditions that may require the expansion to be stopped. Therefore, the controller 152 may stop or reduce the current to the frame, which may stop the expansion. At the desired time, the controller 152 may start the expansion to complete the expansion or deployment of the prosthetic valve 140. In an example, the expansion rate may be controlled by the controller 152. The controller 152 may automatically control the expansion, which may be based on a feedback signal received from a sensor or a visualization of the deployment. For example, the output from the sensor 133 may be provided to the controller 152 as feedback of the diameter of the prosthetic valve 140.

[0161] Controlled deployment of the prosthetic valve 140 can allow for setting the size of the prosthetic valve 140 during deployment. Thus, the prosthetic valve 140 can be large enough to reduce the likelihood of paravalvular leak (PVL), but not so large as to create undue forces or conduction interference at the implantation site.

[0162] In an example, the expansion of the support frame caused by the current can be used alone or in combination with the vibrations generated by the prosthetic valve 140. Similarly, the vibrations generated by the prosthetic valve can be used alone or in combination with the expansion of the support frame caused by the current. In an example, the prosthetic heart valve can be deployed in the native heart valve, and the vibrations can be applied from the prosthetic heart valve to reduce calcification of the heart valve.

[0163] In an example, the support frame can include a docking piece for receiving an insert having prosthetic valve leaflets. In an example, the support frame can be coupled to the prosthetic valve leaflets when the prosthetic valve leaflets are implanted in a patient.

[0164] In an example, other forms of actuation mechanisms for transmitting energy to a support structure to cause vibrations in the support structure for reducing calcification of a calcified native valve may be provided.

[0165] For example, Figure 7F-7IA configuration is shown in which the support structure of the prosthetic valve includes one or more actuators for generating vibrations to reduce calcification of the calcified native valve. Various forms of actuators may be utilized. For example, Figure 7F and 7G An actuator 163 in the form of an electrode 165 is shown, which can be configured to excite or vaporize the fluid filling one or more expandable bodies 167 in a manner similar to the actuator 123 to produce vibrations of the expandable body 167. For example, when a voltage is applied to the electrode 165, the electrode 165 can generate an arc or spark. The arc or spark can cause a portion of the fluid filling one or more expandable bodies 167 (e.g., a portion of the fluid adjacent to the electrode 165) to evaporate, wherein the vaporized gas pressure produces vibrations of the expandable body 167. The vibrations can propagate through the fluid to the outer surface of the expandable body 167 and apply the vibrations to the calcification of the native valve. In examples, other forms of actuators or other methods of using actuators can be utilized.

[0166] Unless otherwise stated, the prosthetic valve 169 may be configured similarly to other forms of prosthetic valves disclosed herein, including the prosthetic valve 10. For example, the prosthetic valve 169 may include a support structure 186, which may include a support frame 188. In an example, the support frame 188 may include an outer support stent and / or an inner support stent. The support structure 186 may support a valve portion, which may be configured similarly to other forms of valve portions disclosed herein, including the use of multiple prosthetic valve leaflets. In an example, the support structure 186 may include a sealing skirt 245. One or more anchors 247 may be utilized, which may be configured similarly to the anchor 17, or may have other forms in an example.

[0167] The actuator 163 and the expandable body 167 are preferably positioned at a certain position on the support structure 186 to apply vibrations from the outer surface 179 of the support structure 186 to the calcifications 84, 86. The outer surface 179 of the support structure 186 can be used to contact the calcifications of the native valve. For example, the actuator 163 and the expandable body 167 can be positioned between the support frame 188 and the sealing skirt 245 in an example. The sealing skirt 245 can cover the expandable body 167. The expandable body 167 can transmit vibrations through the sealing skirt 245 and to the calcifications 86, 84. In an example, the actuator 163 and the expandable body 167 can be positioned radially outside the sealing skirt 245 to apply vibrations to the calcifications 84, 86. For example, one or more expandable bodies 167 may include a tube or ring extending around the sealing skirt 245. In an example, the one or more expandable bodies 167 may include a tube or ring extending around the support frame 188 and inside the sealing skirt 245. In an example, other configurations of the one or more expandable bodies 167 or the location of the one or more expandable bodies 167 may be utilized.

[0168] One or more expandable bodies 167 may be provided in an expanded state when deployed, or may be filled via one or more fluid conduits from a delivery system or delivery catheter when implanted. One or more expandable bodies 167 may remain expanded after implantation, or may be drained of fluid after it is used to remove calcifications.

[0169] The actuator 163 may include one or more electrical terminals 181, which 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, which may extend between the actuator 163 and the electrical terminals 181 along the support structure 186.

[0170] The delivery system or delivery catheter may include an actuation mechanism 185 for transmitting energy to the support structure 186 to vibrate the support structure 186 for reducing calcification of the calcified native valve. The actuation mechanism 185 may include one or more electrical terminals 187 for electrical conduction with one or more electrical terminals 181 of the actuator 163. The electrical terminals 187 may extend to a controller, such as Figure 6C, the controller 128 shown in FIG. 1 (which may be powered by the power source 131) may be provided 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 cause the support structure to vibrate. The electrical terminal 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. In an example, the electrical conduits 189, 191 may extend along the elongated axis of the delivery system or delivery catheter. The electrical terminal 187 may include a releasable terminal that may be released from the electrical terminal 181 after the implantation process. For example, the electrical terminal 181 may be magnetically coupled to the electrical terminal 181 or coupled to the electrical terminal by a releasable clip, clamp, or other form of connector. Thus, the electrical terminal 187 and the electrical conduits 189, 191 may be removed after implantation.

[0171] The actuator 163 can be operated to break down the calcification in a similar manner as discussed with respect to the actuator 123. Electrical energy can be provided to the actuator 163 in a controlled manner via a controller (which can be the controller 128). During the process, a desired amount of calcification can be reduced. In an example, a sensor 133 can be provided that can be used to image the reduction of calcification. The sensor 133 can operate similarly as disclosed herein. For example, the sensor 133 can image the diameter of the prosthetic valve 169. The output from the sensor 133 can be provided as feedback to the controller for the controller to automatically generate vibrations from one or more expandable bodies 167 and / or stop generating vibrations after a sufficient amount of calcification has been removed. Other configurations can be used in examples.

[0172] exist Figure 7G The resulting configuration of prosthetic valve 169 is shown in .

[0173] In an example, the use of the actuator 163 may be combined with Fig.7D , wherein current is applied to the support frame to control the expansion of the support frame. Actuator 163 is operable to reduce calcification of the native valve, and current can be applied to the support frame to increase the diameter of the support frame. In an example, only actuator 163 can be utilized.

[0174] In examples, the form of actuator utilized may vary.

[0175] For example, Figure 7H and Fig.7I A variation is shown in which one or more actuators 195 may include a piezoelectric actuator. Actuators 195 may be positioned in a similar position as disclosed in connection with actuator 163 and expandable body 167. Actuators 195 may be positioned, for example, to apply vibrations to the calcification from an outer surface 197 of a support structure 199 of a prosthetic valve 201. Prosthetic valve 201 may be configured in other ways similar to prosthetic valve 169.

[0176] The piezoelectric actuator may include a piezoelectric material 251 and a pressing surface 261 for applying vibrations generated by the piezoelectric material 251 to the calcification. A voltage applied to the piezoelectric material 251 and supplied from an electrical terminal 263 via an electrical conduit 265 may be utilized. A controller (similar to the controller 128) and a power source 131 may provide electrical energy to the piezoelectric material 251 to generate vibrations of a desired frequency (which may be an ultrasonic frequency). The actuator 195 may be used to reduce calcification in a similar manner as disclosed with respect to other forms of actuators described herein.

[0177] In an example, the sensor 133 can be used to provide feedback to the controller in a similar manner as disclosed herein. In an example, the piezoelectric actuator can be used as a sensor for determining the amount of force applied to the calcification. Such sensor signals can be used as feedback to the controller to determine the force applied to the calcification. The controller can control the operation of the piezoelectric actuator based on the feedback received from the piezoelectric actuator (e.g., changing the frequency of vibration or stopping the operation of the piezoelectric actuator based on the feedback). Fig.7I The resulting configuration of the prosthetic valve 201 in the example is shown. The electrical terminals 211 from the actuation mechanism of the delivery system or delivery catheter may be removed after deployment.

[0178] The use of the actuator 195 can be combined with Fig.7D , wherein current is applied to the support frame to control the expansion of the support frame. Actuator 195 is operable to reduce calcification of the native valve, and current can be applied to the support frame to increase the diameter of the support frame. In an example, only actuator 195 can be utilized.

[0179] In the example, Figure 7F-7I The vibrations generated in the embodiment may include acoustic pressure waves. In an example, the acoustic pressure waves may include ultrasonic waves. In an example, the ultrasonic waves may include shock waves. In an example, various other forms or frequencies of waves may be utilized to produce the desired results (e.g., in an example, low frequency waves less than ultrasonic frequencies may be utilized, and high frequency waves may be utilized).

[0180] In an example, other forms of actuation mechanisms for transmitting energy to a support structure to cause vibrations in the support structure for reducing calcification of a calcified native valve may be provided.

[0181] For example, Figure 7J-7L A variation is shown in which the actuation mechanism is adapted to apply vibrations to the support frame 215 to vibrate the support frame 215, thereby reducing the calcification of the calcified native valve. The support frame 215 can transmit vibrations to reduce the calcification of the calcified native valve. The actuation mechanism can include one or more forms of actuators disclosed herein or other forms of actuators.

[0182] For example, refer to Figure 7J , the actuation mechanism 221 may include an actuator in the form of an electrode 223, which may be configured to excite or vaporize the fluid filling the expandable body 225 in a manner similar to the actuator 123 to produce vibrations of the expandable body 225. For example, when a voltage is applied to the electrode 223, the electrode 223 may generate an arc or spark. The arc or spark may cause a portion of the fluid filling the expandable body 225 (e.g., a portion of the fluid adjacent to the electrode 223) to evaporate, wherein the vaporized gas pressure produces vibrations of the expandable body 225. The vibrations may propagate through the fluid to the outer surface of the expandable body 225 and apply the vibrations to the support frame 215. In examples, other forms of actuators or other methods of using actuators may be utilized.

[0183] The actuation mechanism 221 may include a support member 277 , such as a control arm or other form of support member, for controlling the position of the expandable body 225 .

[0184] The expandable body 225 can be applied to the support frame 215 to apply vibrations to the support frame 215. For example, the expandable body 225 can be positioned against the proximal portion or inlet end portion 229 of the prosthetic valve 231. Other application locations (e.g., distal portion or outlet end portion) can be utilized as desired. The expandable body 225 can contact the support frame 215 or can be applied to the sealing skirt, wherein the vibrations are transmitted to the support frame 215 through the sealing skirt.

[0185] The vibration applied to the support frame 215 may propagate through the support frame 215 and apply vibration or shock waves to the calcification of the native valve. The vibration or shock waves may reduce the calcification of the native valve.

[0186] Prosthetic valve 231 can be configured similarly to other forms of prosthetic valves disclosed herein, including prosthetic valve 10 or other forms of prosthetic valves. Vibrations can be propagated along the outer support stent to be applied directly to the calcification or another portion of the support frame as desired.

[0187] In an example, the actuator 221 may include a portion of a delivery system or delivery catheter for deploying the prosthetic valve 231. For example, the support 277 may extend from the delivery catheter to apply the expandable body 225 to the support frame 215. In an example, a separate device may apply the expandable body 225 to the support frame 215. The operation of the actuator may be controlled via a controller using the methods disclosed herein. According to the methods disclosed herein, feedback from the sensor 133 to the controller may be further utilized.

[0188] The use of the actuation mechanism 221 can be combined with Fig.7DThe configuration presented in , wherein current is applied to the support frame to control the expansion of the support frame. The actuator is operable to reduce calcification of the native valve, and current can be applied to the support frame to increase the diameter of the support frame. In an example, only the actuator mechanism 221 can be utilized. In Figure 7K The resulting configuration of prosthetic valve 231 is shown in .

[0189] Figure 7J The configuration of the actuator used in can be changed as required. For example, Figure 7L An actuation mechanism 279 in the form of a piezoelectric actuator 281 is shown for applying vibrations to the support frame 215. The actuation mechanism 279 may otherwise operate in a similar manner as disclosed with respect to the actuation mechanism 221.

[0190] In examples, variations of the systems and methods may be utilized. In examples, Figure 7J-7L The vibrations generated in the embodiment may include acoustic pressure waves. In an example, the acoustic pressure waves may include ultrasonic waves. In an example, the ultrasonic waves may include shock waves. In an example, various other forms or frequencies of waves may be utilized to produce the desired results (e.g., in an example, low frequency waves less than ultrasonic frequencies may be utilized, and high frequency waves may be utilized).

[0191] The systems, methods and devices may be used with the mitral valve or tricuspid valve, or other types of valves as desired. Figures 7A-7L Features of the examples may be used alone or in combination with features of any other examples herein.

[0192] Variations of the systems and methods disclosed herein may be provided.

[0193] Figure 8 A system is shown in which a cutter 151, such as a sintering device or a laser, can be used to reduce calcifications of a native heart valve. The cutter 151 can be positioned on a catheter, or can be positioned in other ways, and can be moved to be placed in a desired position relative to the calcification. The cutter 151 can be used to reduce calcifications by smoothing the calcifications or fragmenting the calcifications as desired. For example, Figure 8 A cutter 151 in the form of a laser is shown which fragments the calcification 157 for removal from the implantation site.

[0194] The cutter 151 can be used to provide a desired shape to the calcification, or can be used to partially or completely remove the calcification. For example, the cutter 151 can be used to cut a protruding portion 159 of the calcification 157 to reduce the likelihood that such a protruding portion 159 will interfere with the deployment of the prosthetic valve. Thick or jagged calcifications can be cut or smoothed. In an example, a portion or the entire calcification of the native valve can be cut or smoothed.

[0195] In an example, an embolic capture device 168a may be utilized that can capture calcification released from a native valve. For example, the embolic capture device 168a may include a filter (e.g., a porous body) that allows blood to pass through and capture calcification. The filter may be shaped as a container that can hold the released calcification. The calcification held by the embolic capture device 168a may be removed after reducing the calcification of the native heart valve. In an example, the embolic capture device 168a may include 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 and may extend radially outward from the cutter 151, or another configuration may be used in an example. In an example, only one of the devices 168a, 168b may be utilized.

[0196] Calcification can be removed from the mitral or tricuspid valve or another form of valve as needed.In an example, a prosthetic heart valve can be deployed to a native heart valve as needed.

[0197] Figure 8 Features of the examples may be used alone or in combination with features of any other examples herein.

[0198] In an example, an anchor that can be used to anchor a prosthetic valve to an implant site can be customized based on the configuration of the implant site at a native heart valve having calcification. For example, the configuration of the implant site can be determined. The determination can be made in a variety of ways. In an example, the configuration can be determined based on imaging of the implant site. In an example, the configuration can be determined based on demographic or statistical information of the patient (e.g., age, weight, medical history, etc.). The configuration of the distal anchor of the prosthetic heart valve can be selected based on the determined configuration of the implant site.

[0199] For example, Figures 9A-9C Alternative distal anchor variations are shown. Fig. 9A A distal anchor 160 is shown, which can extend horizontally to be positioned distal to the calcification and not hook onto the native valve leaflets. The anchor 160 can extend over the distal tip of the leaflets. If the implantation site is determined to be, for example, Figure 8 Such an anchor 160 may be selected if the radially outer side of the leaflet is shown to have calcification 84a. Fig. 9B An example of an anchor 162 is shown, which may be angled proximally to account for locations such as Figure 8 The radially outer portion of the leaflet is shown as calcified 84b. Fig. 9C An example of an anchor 164 is shown that includes barbs 166 for engaging calcifications as desired.

[0200] The configuration of the distal anchor may be selected based on the determined configuration of the implant site. The configuration of the distal anchor may be selected and then the selected anchor may be attached to a support structure, or the entire prosthetic valve may be selected to provide the desired configuration of the selected anchor. The prosthetic valve may be deployed with the anchor having the selected configuration. The configuration of the distal anchor may be selected based on the shape of the calcification at the native heart valve. The configuration of the distal anchor may be selected to anchor to the calcification at the native heart valve.

[0201] In an example, the configuration of the distal anchor can be selected from a set comprising a plurality of different configurations of the distal anchor.

[0202] In an example, the distal anchor can be adjusted based on the selected configuration. Fig. 9B The anchor 162 shown in FIG. 1 can be adjusted as needed. Fig. 9A The anchor 162 may be bent to extend horizontally from Fig. 9B The configuration shown in the figure extends horizontally to Fig. 9A The configuration shown in . Adjustment of the angle of the distal anchor relative to the frame of the support structure can be provided.

[0203] The anchors may include a distal anchor that may be coupled to the support structure 15, such as Figure 1A -1C, and may be used instead of or in conjunction with Figure 1A -1C is used with the anchor 17 shown. In examples, the anchor may be coupled to other forms of support structures. In examples, the prosthetic valve may be configured to be deployed to the mitral valve or the tricuspid valve.

[0204] In examples, various other configurations of distal anchors can be utilized. Figures 9A-9C Features of the examples may be used alone or in combination with features of any other examples herein.

[0205] Figures 10A-10B An example of an anchor 170 is shown, which 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.

[0206] The arm 176 may have a distal portion 171 coupled to a distal portion 173 of a support structure 178. The arm 176 may extend proximally from the distal portion 171 to a proximal portion 175 of the arm 176. The arm 176 may extend from the support structure 178 (which may be connected to the distal portion 173 of the support structure 178). Figure 1A-1C) extends proximally from the radially outer side of the support structure 15. The arm 176 can be configured to be positioned inside the inwardly facing surface of the native valve leaflet 177 and rotated outwardly from the support structure 178 to engage the calcification 174.

[0207] For example, refer to Fig. 10B , the arm 176 can pivot about the distal portion 171 to move radially outward from the support structure 178. The arm 176 can move radially outward for the barb 172 to engage the calcification 174. The arm 176 including the proximal portion 175 can be positioned inwardly of the inwardly facing surface of the native valve leaflet 177 when anchored to the calcification.

[0208] In examples, the configuration of the anchors may vary. For example, Figures 11A-11B An example of an anchor 180 is shown having arms 182 that can be configured to rotate proximally to engage the calcification 84, which arms can be positioned radially outward of the inward-facing surfaces of the heart valve leaflets 83 when anchored to the calcification. Fig. 11B Rotation of the arms 182 is shown to allow the barbs 184 to engage the calcification 84. The arms 182 can be positioned radially outward of the leaflets 83 of the native valve.

[0209] refer to Fig. 11C In an example, the anchor 249 may include a pad 193. The pad 193 may include a conformable body configured to conform to the shape of the calcification 174. For example, the pad 193 may include a fabric body or an expandable body. In an example, other forms of pads may be utilized. The pad may be Figures 10A-10B The anchor 170 shown in FIG. 1 is used with or with Figures 11A-11B The anchor 180 shown in FIG.

[0210] The anchors may include a distal anchor that may be coupled to the support structure 15, such as Figure 1A -1C, and may be used instead of or in conjunction with Figure 1A -1C. The anchor 17 shown in Figure 1C can be used. The anchor and the proximal portion of the anchor can be configured to be biased outward from the support structure. The support structure can support one or more prosthetic valve leaflets positioned in the flow channel or passage. At least one anchor can be connected to the support structure and can include one or more of a barb or pad configured to engage the calcification of the native valve to anchor to the calcification. In an example, the anchor can be connected to other forms of support structures.

[0211] In examples, other forms of anchoring may be utilized. Figures 10A-11C Features of the examples may be used alone or in combination with features of any other examples herein.

[0212] Figures 12A-12BAn example of a prosthetic valve 190 is shown comprising a support structure 192 having an outer surface 194 including a conformable anchoring surface configured to conform to the shape of a calcification of a native valve to anchor to the native valve.

[0213] The support structure 192 may include, for example, a conformable outer fabric, or may include 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 a flexible wall including an outer surface 194 of the support structure 192. Thus, the outer surface 194 may conform to the shape of a native valve that may include calcifications, for example Fig. 12B The conformable anchoring surface can be configured to deflect radially inward to conform to the shape of the calcification.

[0214] The fluid may include a liquid (e.g., saline), or in an example may include a hydrogel or other form of gel. In an example, other forms of fluids may be utilized. Other forms of filler materials disclosed herein may be used.

[0215] The chamber 196 can be positioned on the frame 198 of the support structure 192. Thus, the frame 198 can be positioned radially inward of the conformable anchoring surface of the chamber 196. The chamber 196 can cover the entire outer surface of the frame 198 or only a portion (e.g., Fig. 12A ).

[0216] In an example, the outer surface 194 may include an anchoring surface for the prosthetic valve 190, and the prosthetic valve 190 may not have additional anchors (e.g., distal anchors or atrial anchors). Thus, the possibility of calcification located radially outside of the native valve leaflets 83 interfering with such additional anchors may be reduced.

[0217] Support structure 192 may be configured to support one or more prosthetic valve leaflets configured to be positioned in a flow channel or passageway.

[0218] Fig. 12A and 12B The features of may be used alone or in combination with the features of any other example herein.

[0219] Fig.13 An example of a prosthetic valve 200 is shown that includes a support structure 202 having an atrial anchor 204 including a flange configured to extend radially outward from a flow channel or passageway 206 of the prosthetic valve 200. In an example, the atrial anchor 204 can include an expandable body that forms a ring around the passageway 206. The expandable body can be configured to conform to the shape of a calcification 208 that may be present at a native heart valve.

[0220] The expandable body can be filled with a fluid in an example, and can be filled in vivo, or can be filled prior to insertion into a patient in an example. In an example, the expandable body can be configured to form a fluid seal with the calcification 208 .

[0221] In an example, the filling material may include a hardenable material. The filling material may be configured to harden over time to enhance the seal of the expandable body. The hardenable material may be introduced into the expandable body at a relatively low first viscosity and converted to a relatively high second viscosity. The increase in viscosity may be achieved by various UV-initiated or catalyst-initiated polymerization reactions or other chemical systems. Depending on the desired properties, the end point of the viscosity enhancement process may result in any hardness from a gel to a rigid structure.

[0222] The hardenable material may include an epoxy resin. The epoxy resin may be hardened by mixing a material that hardens when combined. A hardening catalyst may be delivered during or after implantation. The hardenable material may be biocompatible and may conform to the shape of a local native valve. In an embodiment, the hardenable material may be bioabsorbable.

[0223] In an example, the filler material can be radiopaque to facilitate visualization during implantation. For example, the radiopaque material can be added during filling as part of the hardening process.

[0224] In an example, the filler material may include a gel or foam, which may be biocompatible and may be configured to harden over time. The gel or foam may be inserted into the expandable body, or may be provided in a shell that dissolves after implantation to allow expansion.

[0225] In embodiments, gels may be utilized that can be prepared by precipitating a polymer from a biocompatible solvent. Various silicones may also be used as swelling gels. Other gel systems that may be utilized may include phase change systems that gel upon heating or cooling from their initial liquid or thixotropic state. Gels may also include thixotropic materials that undergo sufficient shear thinning so that they can be easily injected through a fluid conduit, but are also gel-like at zero or low shear rates.

[0226] In an embodiment, the filling material may include a foaming agent. The foaming agent may generate pressure within the expandable body.

[0227] Any of the filling materials disclosed herein may be biocompatible in embodiments and, if desired, bioabsorbable.The bioabsorbable sealing body may improve sealing by adhering to the tissue of the native valve.

[0228] The atrial anchor 204 can be configured to resist distal or ventricular forces applied to the prosthetic valve 200 .

[0229] The support structure 202 can support a valve portion, as disclosed herein. For example, the support structure 202 can support one or more prosthetic valve leaflets 228 that can be positioned within the passageway 206. The support structure 202 can have an inlet end portion 205 and an outlet end portion 207, as disclosed herein.

[0230] In an example, the support structure 202 may also include a plurality of barbs 203 that may extend radially outward from the passage 206. The plurality of barbs 203 may protrude from the outer surface of the support structure 202 and may anchor the prosthetic valve 200 in place. The barbs 203 may be configured to resist proximal forces or atrial forces applied to the support structure 202. For example, in an example, the barbs 203 may be angled proximally. In an example, the atrial anchor 204 may not be included and only the barbs 203 may be used.

[0231] Fig.13 The features of can be used alone or in combination with the features of any other examples herein. In the examples, various other forms of anchors can be utilized.

[0232] Fig.14 An example of a prosthetic valve 210 comprising a support structure 212 is shown, the support structure having an atrial anchor 214 including a flange configured to extend radially outward from a flow channel or passage 216 of the prosthetic valve 210. In an example, the atrial anchor 214 may include a shelf forming a ring around the flow channel or passage 216. In an example, the shelf may include a sealing surface that may be configured to seal with calcification 208 of a native valve and conform to the shape of calcification 208 that may be present at the native heart valve. The support structure 212 may support a valve portion, as disclosed herein. For example, the support structure 212 may support one or more prosthetic valve leaflets 213 that may be positioned within the passage 216. The support structure 212 may have an inlet end portion 267 and an outlet end portion 269, as disclosed herein.

[0233] The atrial anchor 214 can be configured to resist distal or ventricular forces applied to the prosthetic valve 210 .

[0234] In an example, the support structure 212 can be coupled to an anchor 218, which can be configured to be anchored to the ventricular wall. The anchor 218 can be configured to be anchored to the apex of the ventricle or another portion of the ventricle as desired. The anchor 218 can be positioned outside the ventricular wall, or can be engaged with the inner surface of the ventricular wall as desired. In an example, the anchor 218 can be deployed via a catheter, and a ventricular approach can be utilized. For example, the delivery device can approach the implantation site on the ventricle from the mitral valve. In an example, other approaches (e.g., a transapical approach) can be utilized.

[0235] The anchor 218 can be coupled to the support structure 212 with a tether 219. The tether 219 can include a flexible body that can allow tension to be applied to the tether without causing deformation of the heart. The tether 219 can include a cable, wire, or braid, or can have another form as desired. The tether 219 can include a shape memory material such as nitinol, or can have another form as desired. The anchor 218 and tether 219 can resist forces applied to the support structure 212 applied in a proximal or atrial direction.

[0236] Fig.14 The features of may be used alone or in combination with the features of any other example herein.

[0237] Fig.15 An example of a prosthetic valve 220 is shown that includes a support structure 222 having an atrial anchor 224 including a flange configured to extend radially outward from a flow channel or passageway 226 of the prosthetic valve 220. In an example, the atrial anchor 224 can include a shelf that forms a ring around the passageway 226. In an example, the shelf can include a sealing surface that can be configured to seal with calcification 208 of a native valve and conform to the shape of calcification 208 that may be present at a native heart valve.

[0238] The atrial anchor 224 can be configured to resist distal or ventricular forces applied to the prosthetic valve 220. In an example, one or more penetrating bodies 227 can be utilized that can anchor the prosthetic valve 220 to the heart valve. For example, the one or more penetrating bodies 227 can include screws, barbs, or clips that can anchor to the heart valve, which can include anchoring to the calcification 208. The one or more penetrating bodies 227 can be configured to pass through the atrial anchor 224 including a flange to anchor the support structure to the native valve.

[0239] The support structure 222 can extend proximally or in the atrial direction from the atrial anchor 224. For example, the support structure 222 can be positioned on the annulus to reduce the possibility of interfering with the native valve leaflets 209. One or more prosthetic valve leaflets 271 can be positioned proximal to the atrial anchor 224.

[0240] The support structure 222 can support a valve portion, as disclosed herein. For example, the support structure 222 can support one or more prosthetic valve leaflets 271 that can be positioned within the passageway 226. The support structure 222 can have an inlet end portion 229 and an outlet end portion 278, as disclosed herein.

[0241] Fig.15 The features of may be used alone or in combination with the features of any other example herein.

[0242] Figures 16A-16CAn example of a prosthetic valve 230 is shown, which includes a support structure 232 and a helix 234 coupled to the support structure 232 and configured to move between an open state and a closed state to control fluid flow or blood flow through the support structure 232. The support structure 232 may include Fig.16A Shown as closed but Fig. 16C The open pathway is shown in the middle. Fig.16A The helix 234 is shown in a closed state.

[0243] The support structure 232 may include a ring that extends around the spiral body 234 and may be configured to be positioned on the atrial side of the heart valve. In an example, the ring may include a flat ring with a thin profile, and the thickness 236 of the ring may be the same as the thickness of the spiral body 234. In an example, the ring may have a different thickness than the spiral body 234. The ring may be configured to utilize one or more penetrating bodies 238 (in Fig. 16B The penetrating body 238 can be configured to pass through the anchoring portion 239 of the support structure 232 to be anchored to the valve annulus of the native valve.

[0244] The helical body 234 may include an arm forming a helix and having a radially inward portion 233 and a radially outward portion 235 positioned radially outward of the portion 233. An intermediate portion 237 may be positioned between the radially inward portion 233 and the radially outward portion 235. One or more windings of the arm may form a helical configuration. The radially outward portion 235 may have a larger diameter than the intermediate portion 237, which may have a larger diameter than the radially inward portion 233. The radially outward portion 235 may be coupled to the support structure 232, and the radially inward portion 233 and the intermediate portion 237 may be movable distally relative to the support structure 232.

[0245] For example, refer to Fig. 16B , the prosthetic valve 230 can be in a closed state, wherein the spiral body 234 is in Fig.16A The configuration shown in . The edges of the spiral body 234 can contact each other to form a seal of the valve. The passage of the support structure 232 can be closed. In the closed state, the radially inward portion 233 can be coplanar with the radially outward portion 235.

[0246] When diastolic pressure is applied to spiral 234, radially inward portion 233 may extend distally or in the ventricular direction together with middle portion 237 and radially outward portion 235. Spiral 234 may move distally to move from a closed state to an open state. In the open state, radially inward portion 233 may be distal to radially outward portion 235. A gap 241 may exist between portions 233, 237, 235, which may allow fluid to flow therethrough. When spiral 234 moves to the open state, gap 241 may be formed. When systolic pressure is applied to prosthetic valve 230, spiral 234 may move to a closed state, such as Fig. 16B When the spiral body 234 is in the closed state, the gap 241 can be closed. The force of the fluid (e.g., blood) can move the spiral body 234 between the open state and the closed state. The spiral body 234 can move between the open state and the closed state cyclically.

[0247] In an example, the distance 243 that the helical body 234 opens can vary. Fig. 16C , the distance 243 may be less than the length of the native valve leaflets 209 in the open state. In an embodiment, the distance 243 may vary. For example, Fig.17A An example of a prosthetic valve 240 is shown that includes a spiral 242 that can extend to a distance 244 that is the length of the native valve leaflets 209 that can be in or near an open state. The spiral 242 can be retracted proximally or in the atrial direction to close the prosthetic valve 240. In an example, as shown in FIG. Fig. 17B As shown in FIG, the helix 242 can be retracted and can avoid obstructing or contacting the leaflets 209 as they move to a closed state.

[0248] exist Figures 17A-17B In an example, the support structure 246 may include a ring that can be anchored to the atrial wall. One or more penetrating bodies 248 can be anchored to the atrial wall. The penetrating bodies 248 can include screws, barbs, or clips. In an example, one or more sutures can be used to anchor the support structure 246 to the atrial wall.

[0249] The prosthetic valve disclosed herein can be deployed to the mitral valve or tricuspid valve or another form of valve as desired. In examples, other forms of prosthetic valves and anchors can be utilized. The features of Figures 16-17B can be used alone or in combination with the features of any other examples herein.

[0250] Fig.18An example of a system 250 for a heart is shown. The system 250 may include a prosthetic heart valve 252 configured to be implanted in the mitral valve of the heart. An anchor 254 may be coupled to the prosthetic heart valve 252 and configured to be implanted in the left atrial appendage 256 of the heart. The anchor 254 may be configured to hold the prosthetic valve leaflets in place in the mitral valve of the heart. The anchor 254 is coupled to the prosthetic heart valve 252 for anchoring the prosthetic heart valve 252 within the native mitral valve.

[0251] In an example, the anchor 254 can include a stent that can be configured to be deployed to the left atrial appendage 256. The stent can be inserted into the left atrial appendage 256 and can be anchored to the left atrial appendage 256. In an example, the anchor 254 can have other forms as desired.

[0252] Tether 258 can couple anchor 254 to prosthetic heart valve 252. Tether 258 can extend within the left atrium of the heart. Tether 258 can include a rigid body that can hold prosthetic heart valve 252 in place within the mitral valve.

[0253] Thus, the prosthetic heart valve 252 may not have an anchor directly to the mitral valve or calcification of the mitral valve, as the anchor 254 may provide anchoring for 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 that 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 disclosed herein.

[0254] Fig.18 The features of can be used alone or in combination with the features of any other examples herein. In examples, other forms of prosthetic valves and anchors can be utilized.

[0255] Fig.19 An example is shown in which one or more prosthetic valves 260 are implanted within a pulmonary vein 262. Implantation can prevent fluid flow to the lungs. Implantation can prevent backflow into the lungs. Fluid accumulation that occurs within the lungs can be reduced. For example, the prosthetic valve 260 can be configured to have a frame that is coupled to one or more prosthetic valve leaflets to prevent fluid flow to the lungs and can allow fluid to flow from the lungs to the left atrium 264. The prosthetic valve 260 can be configured to open in a flow direction toward the left atrium of the heart. Such a configuration can be used in situations where the mitral valve 266 has calcification and a prosthetic valve may not be implanted therein. One or more prosthetic valves can be implanted into one or more pulmonary veins 262. In an example, Fig.19The configuration shown in may be used in combination with a prosthetic mitral heart valve implanted into the mitral valve.

[0256] Fig.19 The features of can be used alone or in combination with the features of any other examples herein. In examples, other forms of prosthetic valves and anchors can be utilized.

[0257] Fig. 20 An example is shown that includes a prosthetic heart valve 270 and an anchor 272, the anchor being coupled to the prosthetic heart valve 270 and including a ventricular chamber configured to extend within a ventricle of the heart. The prosthetic heart valve 270 can be configured to be implanted in a valve of the heart, which valve can include a mitral valve. The prosthetic heart valve 270 can include one or more prosthetic valve leaflets 275. The ventricular chamber can form a passage from the mitral valve to the aortic valve. The ventricular chamber can direct blood flow from the atrium to the inflow area of ​​the aortic valve 274.

[0258] The ventricular chambers may be configured to be compliant and to be compressed by the left ventricle during systole and to expand during diastole.

[0259] The ventricular chamber can include a portion 273 configured to be positioned in a left ventricular outflow tract (LVOT) 282. In an example, the ventricular chamber can be configured to support and maintain patency of the left ventricular outflow tract (LVOT) 282 of the heart. In an example, other systems, devices, and methods can be used to reduce obstruction of the LVOT 282.

[0260] Fig.21 An example of a stent 280 that can be positioned in the LVOT 282 of the left ventricle is shown. The stent 280 can be deployed proximate to the aortic valve 274 and can have an outflow port proximate to the aortic valve 274.

[0261] The stent 280 may include an outer stent 284 for anchoring. The outer stent 284 may be configured to be deployed near the LVOT 282. The outer stent 284 may be self-expandable and may be made of a shape memory material (e.g., 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 near the LVOT 282.

[0262] Stent 280 can include an inner stent 288 positionable within outer stent 284. Inner stent 288 can include a balloon expandable inner stent and can include a flow channel 290 for fluid to pass through left ventricular outflow tract 282.

[0263] The stent 280 may be configured to maintain patency of the left ventricular outflow tract 282 during deployment of the prosthetic mitral valve 292 to the native mitral valve 294 .

[0264] Fig. 22 An example is shown in which a prosthetic aortic valve 300 may have an extension body 302 extending into the left ventricle 276 to maintain patency of the left ventricular outflow tract 282 during deployment of the prosthetic mitral valve 292 to the native mitral valve 294. The extension body 302 may have a certain length so that the mitral valve leaflets 303 may contact the outer surface of the extension body 302 to avoid blocking the LVOT282.

[0265] Other systems, devices, and methods may be used to reduce obstruction of the LVOT 282 .

[0266] Figures 23A-28B An exemplary method is shown of tethering native mitral heart valve leaflets or removing at least a portion of native heart valve leaflets to reduce obstruction of a left ventricular outflow tract 282 of a heart by the native heart valve leaflets.

[0267] For example, Fig.23A Cutter 304 is shown approaching native heart valve leaflets 306. Fig. 23B As shown in , cutter 304 may include a cutting surface 308 and a retaining tube 310, which may be configured to retain all or a portion of a native heart valve leaflet 306. Fig.23C As shown, the cutter 304 can seal against the native heart valve leaflets 306 to cut and remove the whole or a portion of the native heart valve leaflets 306. The native heart valve leaflets 306 can be located within the tube 310 in vivo.

[0268] All or a portion of the native heart valve leaflets 306 may be removed to reduce obstruction of the left ventricular outflow tract 282 of the heart by the native heart valve leaflets 306 .

[0269] Figures 24A-24D An example of a cutter 311 that can be used in the examples herein is shown. The cutter 311 may include a cutting jaw that includes a first jaw 312 and a second jaw 314. A side view of the cutter 311 is shown in FIG. Fig.24A , 24C and 24D. Fig. 24B An orthogonal view is shown in FIG.

[0270] refer to Fig. 24B , the first jaw 312 can have a wedge shape converging on an apex 316 at a distal portion 318 of the first jaw 312. The first jaw 312 can have a proximal portion 319. The second jaw 314 can have a similar configuration to the first jaw 312. The pivot 331 can couple the proximal portion 319 of the first jaw 312 to the proximal portion of the second jaw 314, wherein the first jaw 312 is configured to pivot relative to the second jaw 314 about the pivot.

[0271] The wedge-shaped shape of the first jaw 312 and the second jaw 314 can allow the jaws 312, 314 to form a wedge-shaped cutout of the native valve leaflets 306. Fig.24C , one or more teeth 320, 322 may be positioned on one or more of the first jaw 312 or the second jaw 314 and configured to cut at least the portion of the heart valve when the first jaw 312 and the second jaw 314 are closed. The cutout of the native valve leaflet 306 may be wedge-shaped, for example Fig.24E . The first jaw 312 may include a first edge 325 and an opposing edge 327, each of which extends from a proximal portion 319 to a distal portion 318 of the first jaw 312. The second jaw 314 may include a second edge 329 and an opposing edge, each of which extends from a proximal portion to a distal portion of the second jaw 314. One or more teeth may extend along one or more of the first edge 325 or the second edge 329.

[0272] The wedge-shaped portion of the native heart valve leaflet 306 can be removed to reduce the obstruction of the left ventricular outflow tract 282 of the heart caused by the native heart valve leaflet 306. For example, the space 323 ( Fig. 24B The space 323 of the first jaw 312 can be positioned between the first edge 325 and the opposite edge 327 of the first jaw 312. The space of the second jaw 314 can be positioned between the second edge 329 and the opposite edge of the second jaw 314.

[0273] Fig.25A An example is shown in which a grasping collar 330 may be used to grasp the native heart valve leaflets 306. The grasping collar 330 may be inserted through the mitral valve annulus and may grasp the native heart valve leaflets 306. A cutter in the form of a cutting collar 332 may be used to cut the native heart valve leaflets 306 at a desired location.

[0274] For example, Fig.25B A grabbing collar 330 is shown having grabbed a native heart valve leaflet 306. The grabbing collar 330 can hold the leaflet 306 taut as the cutting collar 332 cuts the leaflet 306. The grabbing collar 330 can continue to hold the leaflet 306 as the leaflet 306 is removed from the heart.

[0275] For example, Fig.25C The cut leaflet 306 is shown being removed by the capture loop 330 .

[0276] Fig.26 An example of an aortic valve accessible from a grasping loop 330 or a cutting loop 332 is shown. The leaflets 306 may be Fig.25CThe leaflets 306 shown in FIG. 3 are cut in a similar manner.

[0277] refer to Fig. 27 In an example, in addition to the leaflets 306, chordae tendineae 334 attached to the leaflets 306 may also be cut. For example, the grabbing loop 330 may grab the chordae tendineae 334 of the papillary muscles 336 near the heart. The cutting loop 332 may cut the chordae tendineae 334 between the papillary muscles 336 and the grabbing loop 330. The leaflets 306 may be pressed Figures 25A-26 Cut in a similar manner as shown in .

[0278] Figures 28A-28B An exemplary method is shown for tethering native mitral heart valve leaflets 306 to reduce obstruction of the heart's left ventricular outflow tract 282 by the leaflets 306. Tethers 338 may be configured to pass through the leaflets 306. Tethers 338 may be configured to tether native mitral heart valve leaflets 306 to reduce obstruction of the heart's left ventricular outflow tract 282 by the leaflets 306.

[0279] refer to Fig.28A , a first end portion 340 of the tether 338 may be positioned at the base of the leaflet 306 and may be anchored to the inwardly facing surface of the leaflet 306. The tether 338 may be adapted to be anchored to the native mitral heart valve leaflet 306. The tether 338 may pass through the leaflet 306 to extend over the outwardly facing surface of the leaflet 306 and over the distal tip 342 of the leaflet 306. For example, the tether 338 may have an enlarged body at the end of the tether 338 that hinders the removal of the tether 338 from the native mitral heart valve leaflet 306. The tether 338 may pass through the mitral inflow tract 346 to anchor to an opposing wall 348 of the heart. The opposing wall 348 may include a ventricular wall. The tether 338 may include a barb or other form of anchor to anchor to the ventricular wall.

[0280] refer to Fig.28B , the tether 338 can be tightened to pull the leaflet 306 away from the left ventricular outflow tract 282. As a result, when the prosthetic mitral valve 350 is deployed to the mitral valve, the possibility of the leaflet 306 blocking 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, which can support a valve portion as 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.

[0281] Variations of the systems and methods disclosed herein may be provided.

[0282] Examples of prosthetic valves may be used in the mitral valve disclosed herein, or may be used in other deployment locations, such as a native tricuspid valve or other deployment locations, unless otherwise specified. Deployment to the aortic valve or pulmonary valve, or other implantation sites may be utilized.

[0283] Features of the examples may be used alone or in combination with other features disclosed herein.

[0284] Various modifications of the examples disclosed herein may be provided. Between examples, features of the examples may be modified, replaced, excluded, or combined as needed. Combinations of features between examples may be provided as needed. Combinations of features between examples may be provided, and other features of such examples may be excluded as needed.

[0285] Implants disclosed herein may include prosthetic heart valves or other forms of implants, such as stents or filters, or diagnostic devices, etc. The implant may be an expandable implant configured to move from a compressed or unexpanded state to an expanded or deployed state. The implant may be a compressible implant configured to compress inwardly to have a reduced outer profile and move the implant to a compressed or unexpanded state.

[0286] Various forms of delivery devices can be used in the examples disclosed herein. Delivery devices as disclosed herein can also be used for replacement and repair of the aorta, mitral valve, tricuspid valve and pulmonary artery. Delivery devices may include delivery devices for delivering other forms of implants, such as stents or filters, or diagnostic devices, etc.

[0287] The implants and systems disclosed herein can be used for transcatheter mitral or tricuspid valve implantation, as well as 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 the patient's heart. The delivery devices and systems can be used for transcatheter percutaneous surgery, including transarterial surgery, which can be transfemoral or transjugular. In addition, transapical surgery can also be used. Other surgeries can be used as needed.

[0288] In addition, the methods herein are not limited to the specifically described methods and may include methods utilizing the systems and devices disclosed herein. The steps of the methods may be modified, eliminated, or added using the systems, devices, and methods disclosed herein. In an example, the examples disclosed herein may include a system for implantation in a human body.

[0289] For the purpose of this description, certain aspects, advantages and novel features of examples of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as limiting in any way. On the contrary, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, together and in various combinations and sub-combinations of each other. The methods, devices and systems are not limited to any specific aspect or feature or combination thereof, and the disclosed examples do not require the presence of any one or more specific advantages or problem solving. Features, elements or combinations of an example can be combined into other examples herein.

[0290] Example 1: A system for a heart, the system comprising: a prosthetic valve configured to be deployed to a native valve of the heart and configured to transmit shock waves to break down calcification of the native valve.

[0291] Example 2: The system of any example herein, particularly Example 1, wherein the prosthetic valve comprises a frame configured to support one or more prosthetic valve leaflets.

[0292] Example 3: The system of any example herein, particularly example 2, wherein the frame surrounds the flow channel in which the one or more prosthetic valve leaflets are located.

[0293] Example 4: The system according to any example herein, especially examples 1-3, further comprising a sealing skirt and a frame supporting the sealing skirt.

[0294] Example 5: The system according to any example herein, in particular examples 1-4, further comprising a frame and one or more distal anchors configured to anchor the frame to the native valve.

[0295] Example 6: The system of any example herein, particularly Example 5, wherein the one or more distal anchors are each configured to extend over the tips of leaflets of the native valve.

[0296] Example 7: The system of any example herein, particularly examples 1-6, wherein the prosthetic valve comprises a frame comprising a shape memory material.

[0297] Example 8: The system of any example herein, particularly examples 1-7, wherein the prosthetic valve comprises a frame comprising nitinol.

[0298] Example 9: The system of any example herein, particularly examples 1-8, wherein the prosthetic valve has a diameter, and the prosthetic valve is configured such that an electric current applied to the prosthetic valve increases the diameter.

[0299] Example 10: The system according to any example herein, in particular examples 1-9, further comprising a controller configured to apply an electric current to the prosthetic valve to generate the shock waves.

[0300] Example 11: The system of any example herein, particularly Example 10, further comprising coupling the controller to one or more terminals of the prosthetic valve to transmit the current to the prosthetic valve.

[0301] Example 12: The system of any example herein, particularly example 10 or example 11, wherein the controller is configured to vary the amount of the current applied to the prosthetic valve.

[0302] Example 13: The system according to any example herein, in particular examples 10-12, wherein the controller is configured to apply a pulsating current to the prosthetic valve.

[0303] Example 14: The system according to any example herein, especially examples 1-13, wherein the shock wave comprises an ultrasonic shock wave.

[0304] Example 15: The system of any example herein, particularly examples 1-14, wherein the prosthetic valve is configured to be deployed to a mitral valve or a tricuspid valve of the heart.

[0305] Example 16: A delivery system for a heart, the delivery system comprising: a first expandable body, which is configured to expand a prosthetic valve positioned on the first expandable body to deploy the prosthetic valve to a native valve; and a second expandable body, which surrounds the first expandable body and is configured to transmit shock waves to decompose calcifications of the native valve.

[0306] Example 17: The delivery system of any example herein, particularly Example 16, further comprising an elongated shaft of the delivery device, and wherein the first expandable body and the second expandable body are each coupled to the elongated shaft.

[0307] Example 18: The delivery system according to any example herein, in particular Example 17, further comprising a control mechanism for controlling the deflection of the elongated shaft.

[0308] Example 19: The delivery system of any example herein, particularly Examples 16-18, wherein the first expandable body is configured to cause the prosthetic valves positioned on the first expandable body and the second expandable body to expand.

[0309] Example 20: The delivery system of any example herein, particularly examples 16-19, wherein the second expandable body has an outer surface and is configured to slide the prosthetic valve onto the outer surface in vivo.

[0310] Example 21: A delivery system according to any example herein, in particular Examples 16-20, wherein: the first expandable body comprises a proximal portion and a distal portion; the second expandable body comprises a proximal portion and a distal portion; and the proximal portion of the second expandable body is proximal to the proximal portion of the first expandable body, and the distal portion of the second expandable body is distal to the distal portion of the first expandable body.

[0311] Example 22: The delivery system of any example herein, particularly examples 16-21, wherein the second expandable body is more compliant than the first expandable body.

[0312] Example 23: The delivery system of any example herein, particularly examples 16-22, further comprising a controller configured to control the generation of shock waves for the second expandable body.

[0313] Example 24: The delivery system of any example herein, in particular examples 16-23, wherein the shock waves comprise ultrasonic shock waves.

[0314] Example 25: The delivery system of any example herein, particularly Examples 16-24, wherein the first expandable body is configured to deploy the prosthetic valve to a mitral valve or a tricuspid valve of the heart.

[0315] Example 26: A method comprising: reducing calcification of a native heart valve; and deploying a prosthetic heart valve to the native heart valve.

[0316] Example 27: The method according to any example herein, in particular Example 26, further comprising reducing the calcification of the native heart valve using a laser or a sintering device.

[0317] Example 28: The method according to any example herein, in particular example 26 or example 27, further comprising reducing the calcification of the native heart valve by smoothing the calcification.

[0318] Example 29: The method according to any example herein, in particular examples 26-28, further comprising reducing the calcification of the native heart valve by fragmenting the calcification.

[0319] Example 30: The method according to any example herein, especially examples 26-29, further comprising applying shock waves to the calcification to reduce the calcification.

[0320] Example 31: The method according to any example herein, especially example 30, further comprising applying the shock wave to the calcification using an expandable body.

[0321] Example 32: The method according to any example herein, in particular example 30 or example 31, further comprising applying the shock waves to the calcification using the prosthetic heart valve.

[0322] Example 33: The method according to any example herein, in particular examples 26-32, further comprising deploying the prosthetic heart valve in the native heart valve and applying shock waves from the prosthetic heart valve to reduce the calcification of the native heart valve.

[0323] Example 34: The method according to any example herein, in particular examples 26-33, further comprising using an embolic capture device to capture calcification released from the native heart valve.

[0324] Example 35: The method according to any example herein, in particular examples 26-34, wherein the native heart valve comprises a mitral valve or a tricuspid valve.

[0325] Example 36: A method comprising: determining a configuration of an implantation site at a native heart valve having calcification, the implantation site 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.

[0326] Example 37: The method according to any example herein, in particular Example 36, further comprising adjusting the distal anchor based on the determined configuration of the implantation site.

[0327] Example 38: The method of any example herein, particularly Example 37, wherein the prosthetic heart valve comprises a frame, and the adjusting of the distal anchor comprises changing an angle of the distal anchor relative to the frame.

[0328] Example 39: The method of any example herein, particularly Examples 36-38, further comprising selecting the configuration of the distal anchor of the prosthetic heart valve from a set comprising a plurality of different configurations of distal anchors.

[0329] Example 40: The method of any example herein, particularly examples 36-39, further comprising coupling the distal anchor to a valve body of the prosthetic heart valve.

[0330] Example 41: The method according to any example herein, in particular examples 36-40, further comprising selecting the configuration of the distal anchor based on the shape of the calcification at the native heart valve.

[0331] Example 42: The method according to any example herein, in particular examples 36-41, further comprising selecting the configuration of the distal anchor to anchor to a calcification at the native heart valve.

[0332] Example 43: The method of any example herein, particularly examples 36-42, wherein the distal anchor is configured to extend over the distal tips of the leaflets of the native heart valve.

[0333] Example 44: The method according to any example herein, especially examples 36-43, further comprising imaging the implantation site to determine the configuration of the implantation site.

[0334] Example 45: The method according to any example herein, in particular examples 36-44, wherein the native heart valve comprises a mitral valve or a tricuspid valve.

[0335] Example 46: A prosthetic valve configured to be deployed to a native valve of the heart, the prosthetic valve comprising: one or more prosthetic valve leaflets configured to be positioned in a flow channel; a valve body configured to support the one or more prosthetic valve leaflets; and at least one anchor connected to the valve body and comprising one or more of barbs or pads configured to engage calcification of the native valve to anchor to the calcification.

[0336] Example 47: A prosthetic valve according to any example herein, in particular Example 46, wherein the valve body includes a distal portion and a proximal portion, and the at least one anchor includes an arm having a first end portion connected to the distal portion of the valve body and a second end portion extending proximally from the first end portion of the arm.

[0337] Example 48: The prosthetic valve of any example herein, particularly Example 47, wherein the second end portion is configured to be positioned inwardly of an inwardly facing surface of a heart valve leaflet when anchored to the calcification.

[0338] Example 49: The prosthetic valve of any example herein, particularly Example 47 or Example 48, wherein the second end portion is biased to extend outwardly from the valve body.

[0339] Example 50: The prosthetic valve of any example herein, particularly Examples 47-49, wherein the second end portion is configured to be positioned radially outward of an inward-facing surface of a heart valve leaflet when anchored to the calcification.

[0340] Example 51: A method comprising: deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets configured to be positioned in a flow channel; a valve body configured to support the one or more prosthetic valve leaflets; and at least one anchor connected to the valve body and comprising one or more of barbs or pads configured to engage calcification of the native valve to anchor to the calcification.

[0341] Example 52: A method according to any example herein, in particular Example 51, wherein the valve body includes a distal portion and a proximal portion, and the at least one anchor includes an arm having a first end portion connected to the distal portion of the valve body and a second end portion extending proximally from the first end portion of the arm.

[0342] Example 53: The method of any example herein, particularly Example 52, wherein the second end portion is configured to be positioned inwardly of an inwardly facing surface of a heart valve leaflet when anchored to the calcification.

[0343] Example 54: The method of any example herein, particularly Example 52 or Example 53, wherein the second end portion is biased to extend outwardly from the valve body.

[0344] Example 55: The method of any example herein, particularly examples 52-54, wherein the second end portion is configured to be positioned radially outward of an inward-facing surface of a heart valve leaflet when anchored to the calcification.

[0345] Example 56: A prosthetic valve configured to be deployed to a native valve of the heart, the prosthetic valve comprising: one or more prosthetic valve leaflets configured to be positioned in a flow channel; and a valve body configured to support the one or more prosthetic valve leaflets and including an outer surface comprising a conformal anchoring surface configured to fit the shape of a calcification of the native valve to anchor to the native valve.

[0346] Example 57: The prosthetic valve of any example herein, particularly Example 56, wherein the conformable anchoring surface comprises a surface configured to retain a chamber for a fluid.

[0347] Example 58: The prosthetic valve of any example herein, in particular Example 57, wherein the fluid comprises a hydrogel.

[0348] Example 59: The prosthetic valve of any example herein, particularly Examples 56-58, wherein the conformable anchoring surface is configured to deflect radially inward to conform to the shape of the calcification.

[0349] Example 60: The prosthetic valve of any example herein, particularly Examples 56-59, wherein the valve body comprises a frame positioned radially inward of the conformable anchoring surface.

[0350] Example 61: A method comprising: deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets configured to be positioned in a flow channel; and a valve body configured to support the one or more prosthetic valve leaflets and comprising an outer surface, the outer surface comprising a conformal anchoring surface configured to fit the shape of a calcification of the native valve to anchor to the native valve.

[0351] Example 62: A method according to any example herein, in particular Example 61, wherein the conformable anchoring surface comprises a surface of a chamber configured to hold a fluid.

[0352] Example 63: A method according to any example herein, especially Example 62, wherein the fluid comprises a hydrogel.

[0353] Example 64: The method of any example herein, in particular examples 61-63, wherein the conformable anchoring surface is configured to deflect radially inward to conform to the shape of the calcification.

[0354] Example 65: The method of any example herein, particularly Examples 61-64, wherein the valve body comprises a frame positioned radially inward of the conformable anchoring surface.

[0355] Example 66: A prosthetic valve configured to be deployed to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets configured to be positioned in a flow channel; and a valve body configured to support the one or more prosthetic valve leaflets, the valve body including an atrial anchor comprising a flange configured to extend radially outward from the flow channel.

[0356] Example 67: The prosthetic valve of any example herein, in particular Example 66, wherein the flange comprises an expandable body.

[0357] Example 68: The prosthetic valve of any example herein, particularly Example 67, wherein the expandable body comprises a ring extending around the valve body.

[0358] Example 69: The prosthetic valve of any example herein, particularly Examples 66-68, wherein the valve body comprises a plurality of barbs extending radially outward from the flow channel.

[0359] Example 70: The prosthetic valve of any example herein, particularly Examples 66-69, further comprising an anchor configured to anchor to a ventricular wall and a tether configured to couple the anchor to the valve body.

[0360] Example 71: The prosthetic valve of any example herein, particularly Example 70, wherein the tether comprises a compliant tether configured to resist forces applied to the valve body in an atrial direction.

[0361] Example 72: The prosthetic valve of any example herein, particularly Examples 66-71, wherein the one or more prosthetic valve leaflets are positioned proximal to the atrial anchor.

[0362] Example 73: The prosthetic valve of any example herein, particularly Examples 66-72, wherein the valve body is positioned proximal to the atrial anchor.

[0363] Example 74: The prosthetic valve according to any example herein, in particular Examples 66-73, further comprises one or more penetrating bodies configured to pass through the flange to anchor the valve body to the native valve.

[0364] Example 75: The prosthetic valve of any example herein, in particular Examples 66-74, wherein the prosthetic valve is configured to be deployed to a mitral valve or a tricuspid valve of the heart.

[0365] Example 76: A method comprising: deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets configured to be positioned in a flow channel; and a valve body configured to support the one or more prosthetic valve leaflets, the valve body including an atrial anchor, the atrial anchor comprising a flange configured to extend radially outward from the flow channel.

[0366] Example 77: A method according to any example herein, especially Example 76, wherein the flange includes an expandable body.

[0367] Example 78: The method of any example herein, particularly Example 77, wherein the expandable body comprises a ring extending around the valve body.

[0368] Example 79: A method according to any example herein, in particular examples 76-78, wherein the valve body comprises a plurality of barbs extending radially outward from the flow channel.

[0369] Example 80: The method of any example herein, particularly Examples 76-79, further comprising an anchor configured to anchor to a ventricular wall and a tether configured to couple the anchor to the valve body.

[0370] Example 81: The method of any example herein, particularly Example 80, wherein the tether comprises a compliant tether configured to resist forces applied to the valve body in an atrial direction.

[0371] Example 82: The method of any example herein, particularly Examples 76-81, wherein the one or more prosthetic valve leaflets are positioned proximal to the atrial anchor.

[0372] Example 83: The method of any example herein, particularly Examples 76-82, wherein the valve body is positioned proximal to the atrial anchor.

[0373] Example 84: The method according to any example herein, in particular examples 76-83, further comprising one or more penetrating bodies configured to pass through the flange to anchor the valve body to the native valve.

[0374] Example 85: The method of any example herein, particularly Examples 76-84, wherein the prosthetic valve is deployed to a mitral valve or a tricuspid valve of the heart.

[0375] Example 86: A prosthetic valve configured to be deployed to 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.

[0376] Example 87: The prosthetic valve of any example herein, particularly Example 86, wherein the helical body is configured to move distally to move from the closed state to the open state.

[0377] Example 88: A prosthetic valve according to any example herein, in particular Example 86 or Example 87, wherein the helical body comprises arms forming a helix and having a radially inward portion and a radially outward portion, and in the closed state, the radially inward portion is coplanar with the radially outward portion.

[0378] Example 89: The prosthetic valve of any example herein, particularly Example 88, wherein in the open state, the radially inward portion is distal to the radially outward portion.

[0379] Example 90: A prosthetic valve according to any example herein, in particular Example 88 or Example 89, wherein when the helix moves to the open state, one or more gaps are formed between the radially inward portion and the radially outward portion, and when the helix is ​​in the closed state, the one or more gaps are closed.

[0380] Example 91: The prosthetic valve of any example herein, in particular examples 86-90, wherein the helical body is configured to cyclically move between the open state and the closed state.

[0381] Example 92: The prosthetic valve of any example herein, particularly Examples 86-91, wherein the fluid force is configured to move the helical body between the open state and the closed state.

[0382] Example 93: The prosthetic valve of any example herein, in particular examples 86-92, wherein the valve body comprises a ring extending around the helical body.

[0383] Example 94: The prosthetic valve according to any example herein, in particular Examples 86-93, further comprises one or more penetrating bodies configured to pass through the valve body to anchor the valve body to the native valve.

[0384] Example 95: The prosthetic valve of any example herein, in particular examples 86-94, wherein the prosthetic valve is configured to be deployed to a mitral valve or a tricuspid valve of the heart.

[0385] Example 96: A method comprising: deploying a prosthetic valve to a native valve, the prosthetic valve comprising: a valve body; and a helical body connected to the valve body and configured to move between an open state and a closed state to control fluid flow through the valve body.

[0386] Example 97: A method according to any example herein, in particular Example 96, wherein the helical body is configured to move distally to move from the closed state to the open state.

[0387] Example 98: A method according to any example herein, in particular example 96 or example 97, wherein the helical body comprises an arm forming a helix and having a radially inward portion and a radially outward portion, and in the closed state, the radially inward portion is coplanar with the radially outward portion.

[0388] Example 99: A method according to any example herein, in particular Example 98, wherein in the open state, the radially inward portion is distal to the radially outward portion.

[0389] Example 100: A method according to any example herein, in particular Example 98 or Example 99, wherein when the spiral moves to the open state, one or more gaps are formed between the radially inward portion and the radially outward portion, and when the spiral is in the closed state, the one or more gaps are closed.

[0390] Example 101: A method according to any example herein, especially examples 96-100, wherein the helix is ​​configured to cyclically move between the open state and the closed state.

[0391] Example 102: A method according to any example herein, in particular examples 96-101, wherein the fluid force is configured to move the helical body between the open state and the closed state.

[0392] Example 103: A method according to any example herein, in particular examples 96-102, wherein the valve body includes a ring extending around the helix.

[0393] Example 104: The method according to any example herein, in particular Examples 96-103, further comprising one or more penetrating bodies, wherein the one or more penetrating bodies are configured to pass through the valve body to anchor the valve body to the native valve.

[0394] Example 105: The method of any example herein, particularly Examples 96-104, wherein the prosthetic valve is deployed to the mitral valve or tricuspid valve of the heart.

[0395] Example 106: A system for a heart, the system 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.

[0396] Example 107: The system of any example herein, particularly Example 106, wherein a tether couples the prosthetic heart valve to the anchor and is configured to extend within the left atrium of the heart.

[0397] Example 108: A system according to any example herein, particularly Example 106 or Example 107, wherein the anchor comprises a bracket.

[0398] Example 109: The system of any example herein, particularly Examples 106-108, wherein the prosthetic heart valve comprises one or more prosthetic valve leaflets coupled to a frame.

[0399] Example 110: The system of any example herein, particularly Examples 106-109, wherein the anchor is configured to hold the prosthetic heart valve in place in the mitral valve of the heart.

[0400] Example 111: A method comprising: deploying a prosthetic heart valve to a mitral valve of a heart; and deploying an anchor for the prosthetic heart valve to a left atrial appendage of the heart.

[0401] Example 112: The method of any example herein, particularly Example 111, wherein a tether couples the prosthetic heart valve to the anchor and is configured to extend within a left atrium of the heart.

[0402] Example 113: A method according to any example herein, particularly Example 111 or Example 112, wherein the anchor comprises a bracket.

[0403] Example 114: A method according to any example herein, in particular examples 111-113, wherein the prosthetic heart valve comprises one or more prosthetic valve leaflets coupled to a frame.

[0404] Example 115: The method of any example herein, particularly Examples 111-114, wherein the anchor is configured to hold the prosthetic heart valve in place in the mitral valve of the heart.

[0405] Example 116: A method comprising: implanting a prosthetic valve in a pulmonary vein of a heart to prevent fluid flow to the lungs.

[0406] Example 117: A method according to any example herein, in particular Example 116, wherein the prosthetic valve comprises a frame coupled to one or more prosthetic valve leaflets.

[0407] Example 118: The method of any example herein, particularly Example 116 or Example 117, wherein the prosthetic valve is configured to open in a flow direction toward the left atrium of the heart.

[0408] Example 119: The method of any example herein, particularly Examples 116-118, further comprising implanting multiple prosthetic valves in multiple pulmonary veins of the heart.

[0409] Example 120: A method according to any example herein, in particular examples 116-119, wherein a mitral valve of the heart contains calcification.

[0410] Example 121: A stent for a heart, the stent comprising: an outer stent configured to be deployed near a left ventricular outflow tract of the heart; and an inner stent positioned within the outer stent and comprising a flow channel for fluid to pass through the left ventricular outflow tract.

[0411] Example 122: The stent according to any example herein, in particular Example 121, wherein the inner stent is balloon expandable.

[0412] Example 123: A stent according to any example herein, in particular example 121 or example 122, wherein the outer stent is self-expandable.

[0413] Example 124: A stent according to any example herein, in particular examples 121-123, wherein the outer stent is made of a shape memory material.

[0414] Example 125: The stent according to any example herein, in particular examples 121-124, wherein the outer stent comprises one or more anchoring arms for anchoring the outer stent near the left ventricular outflow tract.

[0415] Example 126: A method comprises deploying a stent proximate a left ventricular outflow tract of a heart, the stent comprising: an outer stent, and an inner stent positioned within the outer stent and comprising a flow channel for fluid to pass through the left ventricular outflow tract.

[0416] Example 127: A method according to any example herein, in particular Example 126, wherein the inner stent is balloon expandable.

[0417] Example 128: A method according to any example herein, in particular Example 126 or Example 127, wherein the outer support is self-expandable.

[0418] Example 129: A method according to any example herein, especially examples 126-128, wherein the outer support is made of a shape memory material.

[0419] Example 130: The method according to any example herein, in particular examples 126-129, wherein the exostent comprises one or more anchoring arms for anchoring the exostent proximal to the left ventricular outflow tract.

[0420] Example 131: A system for a heart, the system 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 comprising a ventricular chamber configured to extend with a ventricle of the heart.

[0421] Example 132: The system of any example herein, in particular Example 131, wherein the ventricular chamber is configured to be compressed by a ventricle of the heart.

[0422] Example 133: A system according to any example herein, particularly Example 131 or Example 132, wherein the prosthetic heart valve is configured to be positioned in a mitral valve of the heart and the ventricular chamber is configured to form a passage from the mitral valve of the heart to the aortic valve.

[0423] Example 134: The system of any example herein, particularly Examples 131-133, wherein the ventricular chamber includes a portion configured to be positioned within a left ventricular outflow tract of the heart.

[0424] Example 135: A system according to any example herein, in particular examples 131-134, wherein the prosthetic heart valve comprises one or more prosthetic valve leaflets.

[0425] Example 136: A method comprising: deploying a prosthetic heart valve to a valve of a heart; and deploying an anchor for the prosthetic heart valve to a ventricle of the heart, the anchor comprising a ventricular chamber.

[0426] Example 137: The method according to any example herein, in particular Example 136, wherein the ventricular chamber is configured to be compressed by the ventricle of the heart.

[0427] Example 138: A method according to any example herein, particularly Example 136 or Example 137, wherein the prosthetic heart valve is configured to be positioned in a mitral valve of the heart and the ventricular chamber is configured to form a passage from the mitral valve of the heart to an aortic valve.

[0428] Example 139: A method according to any example herein, in particular examples 136-138, wherein the ventricular chamber includes a portion configured to be positioned within the left ventricular outflow tract of the heart.

[0429] Example 140: A method according to any example herein, in particular examples 136-139, wherein the prosthetic heart valve comprises one or more prosthetic valve leaflets.

[0430] Example 141: A method comprising: tethering or removing at least a portion of a native mitral heart valve leaflet to reduce obstruction of a left ventricular outflow tract of a heart by the native mitral heart valve leaflet.

[0431] Example 142: The method according to any example herein, in particular Example 141, further comprising removing the entirety of the native mitral heart valve leaflets.

[0432] Example 143: The method according to any example herein, in particular example 141 or example 142, further comprising removing a wedge-shaped portion of the native mitral heart valve leaflet.

[0433] Example 144: The method according to any example herein, in particular examples 141-143, further comprising removing at least the portion of the native mitral heart valve leaflets using a cutting snare.

[0434] Example 145: The method according to any example herein, in particular Examples 141-144, further comprising cutting chordae tendineae attached to the leaflets of the native mitral heart valve using a cutting snare.

[0435] Example 146: The method according to any example herein, in particular examples 141-145, further comprising removing at least the portion of the native mitral heart valve leaflets using cutting jaws.

[0436] Example 147: The method of any example herein, in particular examples 141-146, further comprising positioning at least said portion of said native mitral heart valve leaflets within a tube within the body.

[0437] Example 148: The method according to any example herein, in particular Examples 141-147, further comprising: passing a tether through the native mitral heart valve leaflets; and anchoring the tether to the ventricular wall to tether the native mitral heart valve leaflets.

[0438] Example 149: The method of any example herein, particularly Examples 141-148, further comprising deploying a prosthetic heart valve to a mitral valve comprising the native mitral heart valve leaflets.

[0439] Example 150: The method of any example herein, in particular examples 141-149, wherein the mitral valve comprising the native mitral heart valve leaflets has calcifications.

[0440] Example 151: A cutter for at least a portion of a heart valve leaflet, the cutter comprising: a first jaw comprising a proximal portion and a distal portion, the first jaw having a wedge shape converging at an apex at the distal portion of the first jaw; a second jaw comprising a proximal portion and a distal portion, the second jaw having a wedge shape converging at an apex at the distal 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 the portion of the heart valve leaflet when the first jaw is closed with the second jaw.

[0441] Example 152: A cutter according to any example herein, in particular Example 151, wherein the first jaw includes a first edge extending from the proximal portion of the first jaw to the distal portion, and the second jaw includes a second edge extending from the proximal portion of the second jaw to the distal portion, and the one or more teeth extend along one or more of the first edge or the second edge.

[0442] Example 153: The cutter of any example herein, in particular example 152, wherein the one or more teeth are positioned on the first edge and the second edge.

[0443] Example 154: A cutter according to any example herein, in particular Example 152 or Example 153, wherein the first jaw includes a third edge opposite to the first edge, the third edge extending from the proximal portion of the first jaw to the distal portion, and at least the portion of the heart valve leaflet is configured to be retained between the first edge and the third edge.

[0444] Example 155: The cutter according to any example herein, in particular Examples 151-154, further includes a pivot connecting the proximal portion of the first jaw to the proximal portion of the second jaw, and the first jaw is configured to pivot relative to the second jaw about the pivot.

[0445] Any feature of any instance of any one of the first to 155 instances mentioned above is applicable to all other aspects and instances identified herein, including but not limited to any instance of any one of the first to 155 instances mentioned above. In addition, any feature of the instance in various instances of any one of the first to 155 instances mentioned above can be partially or completely independently combined with other instances described herein in any way, for example, one, two or three or more instances can be completely or partially combined. In addition, any feature of various instances of any one of the first to 155 instances mentioned above can become the optional items of other instances. Any instance of the method can be performed by the system or device of another instance, and any aspect or instance of the system or device can be configured to perform another aspect or instance, including but not limited to the method of any instance of any one of the first to 155 instances mentioned above.

[0446] Finally, it should be understood that, although the aspects of this specification are highlighted by reference to specific examples, it will be readily understood by those skilled in the art that these disclosed examples are merely illustrations of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is by no means limited to the specific methods, schemes and / or reagents described herein, etc. Therefore, without departing from the spirit of this specification, various modifications or changes or alternative configurations can be made to the disclosed subject matter according to the teachings of this article. Finally, the terms used herein are only used for the purpose of describing specific examples and are not intended to limit the scope of the systems, devices and methods disclosed herein, which are limited only by the claims. Therefore, the systems, devices and methods are not limited to the precise content as shown and described.

[0447] Certain examples of systems, devices and methods are described herein, including the best modes known to the inventors for performing these examples. Of course, after reading the foregoing description, variations to these described examples will become apparent to those of ordinary skill in the art. The inventors expect that skilled technicians will appropriately adopt such variations, and the inventors intend to practice systems, devices and methods with systems, devices and methods different from those specifically described herein. Therefore, the systems, devices and methods include all modifications and equivalents of the subject matter described in the appended claims as allowed by applicable law. In addition, unless otherwise specified herein or clearly contradictory to the context, systems, devices and methods cover any combination of the above examples in all possible variations thereof.

[0448] The grouping of alternative examples, elements or steps of the described systems, devices and methods should not be construed as limiting. Each group member may be referenced and claimed individually or in any combination with other group members disclosed herein. For the purpose of convenience and / or patentability, it is expected that one or more members of a group may be included in or deleted from the group. When any such inclusion or deletion is made, the specification is deemed to contain the modified group, thereby satisfying the written description of all Markush groups used in the appended claims.

[0449] Unless otherwise indicated, all numbers expressing features, items, amounts, parameters, properties, terms and the like used in the specification and claims are to be understood as being modified in all instances by the term “about.” As used herein, the term “about” means that the feature, item, amount, parameter, property or term so defined encompasses approximate values ​​that may vary but are capable of performing the desired operation or process discussed herein.

[0450] Unless otherwise specified herein or clearly contradicted by context, the terms "a", "an", "the" and similar indicators used in the context of describing systems, devices and methods (particularly in the context of the following claims) should be interpreted to cover both the singular and the plural. Unless otherwise specified herein or clearly contradicted by context in other ways, all methods described herein can be performed in any suitable order. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended only to better illustrate the systems, devices and methods and does not limit the scope of the claimed systems, devices and methods. No language in this specification should be interpreted as indicating any unclaimed element that is essential to the practice of the systems, devices and methods.

[0451] All patents, patent publications and other publications cited and identified in this specification are individually and explicitly incorporated herein by reference in their entirety for the purpose of describing and disclosing compositions and methods that may be used in combination with systems, devices and methods, such as those described in such publications. These publications are provided solely for the purpose of providing the disclosures prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventor has the right to precede such disclosures by virtue of prior inventions or for any other reason. All statements about the dates or contents of these documents are based on 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. A system for implanting a prosthetic heart valve in a calcified native valve, the system comprising: The prosthetic heart valve comprises: a support structure having an inlet end portion and an outlet end portion and a passageway, and a valve portion positioned within the passageway of the support structure, wherein the valve portion includes a plurality of leaflets made from pericardium, wherein the valve portion permits blood to flow through the passageway in one direction to replace the function of a native heart valve; as well as A delivery catheter for delivering the prosthetic heart valve to the calcified native valve includes 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 comprises an actuator for generating vibrations of the support structure, thereby reducing the calcifications of the calcified native valve.

3. A system according to claim 2, wherein the actuator comprises an electrode for vaporizing a fluid within an expandable body located on the support structure, or comprises a piezoelectric actuator.

4. The system of claim 2 or claim 3, wherein the support structure comprises 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 one of claims 2-4, wherein the actuation mechanism comprises one or more electrical terminals for electrical conduction with one or more electrical terminals of the actuator.

6. The system of any one of claims 1-5, wherein the support structure comprises a support frame, and the actuation mechanism is adapted to apply vibrations to the support frame to vibrate the support structure, thereby reducing the calcifications of the calcified native valve.

7. A system according to claim 6, wherein the actuation mechanism comprises an electrode for vaporizing a fluid within an expandable body applied to the support frame to apply the vibration to the support frame, or comprises a piezoelectric actuator suitable for applying the vibration to the support frame.

8. The system of any one of claims 1-7, wherein the support structure comprises a support frame made of a shape memory material, and the actuation mechanism comprises one or more electrical terminals for applying electrical energy to the support frame to cause the support frame to expand.

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 one of claims 1-9, wherein the actuation mechanism comprises a controller for controlling energy delivered to the support structure to cause the support structure to vibrate.

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 one of claims 1-11, 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 ultrasonic waves are shock waves.

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

16. A system for implanting a prosthetic heart valve in a calcified native valve, the system comprising: The prosthetic heart valve comprises: a support structure having an inlet end portion and an outlet end portion and a passageway, and a valve portion positioned within the passageway of the support structure, wherein the valve portion includes a plurality of leaflets made from pericardium, wherein the valve portion permits blood to flow through the passageway in one direction to replace the function of a native heart valve; as well as A delivery catheter for the prosthetic heart valve, the delivery catheter comprising: Slender shaft, and a first expandable body coupled to the elongated shaft and 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 to the native valve, a second expandable body coupled to the elongated shaft and adapted to transmit vibrations to break down calcification of the calcified native valve, and An actuator for generating said vibration of said second expandable body.

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

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

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

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

21. The system according to any one of claims 16 to 20, wherein: The first expandable body comprises a proximal portion and a distal portion; The second expandable body comprises a proximal portion and a distal portion; and 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 one of claims 16-21, wherein the second expandable body is more compliant than the first expandable body.

23. The system of any one of claims 16-22, further comprising a controller configured to control generation of the vibration of the second expandable body.

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

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

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

27. The system of any one of claims 16-26, wherein the vibrations comprise acoustic pressure waves.

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

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

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

31. A prosthetic mitral heart valve system for a heart, the system comprising: A prosthetic mitral heart valve comprising: a support structure having an inlet end portion and an outlet end portion and a passageway, and a valve portion positioned within the passageway of the support structure, wherein the valve portion includes a plurality of leaflets made from pericardium, wherein the valve portion permits blood to flow through the passageway in one direction to replace the function of a native mitral heart valve; as well as An anchor for deployment in a left atrial appendage of the heart, wherein the anchor is coupled to the prosthetic mitral heart valve for anchoring the prosthetic mitral heart valve within the native mitral heart valve.

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

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

34. A prosthetic heart valve configured to be deployed to a native heart valve, the prosthetic heart valve comprising: a support structure having a passageway; as well as A helix is ​​coupled to the support structure and positioned within the passageway, the helix being adapted to move between an open state and a closed state to control blood flow through the support structure.

35. The prosthetic heart valve of claim 34, wherein the helical body comprises arms forming a helix and having a radially inward portion and a radially outward portion, and wherein in the closed state, the radially inward portion is coplanar with the radially outward portion, and When the spiral body moves to the open state, one or more gaps are formed between the radially inward portion and the radially outward portion, and when the spiral body is in the closed state, the one or more gaps are closed.

36. The prosthetic heart valve of claim 34 or claim 35, further comprising one or more penetrating bodies configured to penetrate the support structure to anchor the support structure to the native heart valve; and Wherein the support structure comprises a ring extending around the helix.

37. A prosthetic heart valve configured to be deployed to a native heart valve, the prosthetic heart valve comprising: a support structure having an inlet end portion and an outlet end portion and a passageway, wherein the support structure includes an atrial anchor, the atrial anchor including a flange for extending radially outward from the passageway; as well as A valve portion is positioned within the passageway of the support structure, wherein the valve portion includes a plurality of leaflets made of pericardium, wherein the valve portion permits blood to flow through the passageway in one direction to replace the function of the native heart valve.

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

39. A prosthetic heart valve according to claim 37 or claim 38, wherein the support structure comprises a plurality of barbs extending radially outwardly from the support structure for anchoring the prosthetic heart valve to the native heart valve.

40. A cutter for at least a portion of a heart valve leaflet, the cutter comprising: a first jaw comprising a proximal portion and a distal portion, the first jaw having a wedge shape converging at an apex at the distal portion of the first jaw; a second jaw comprising a proximal portion and a distal portion, the second jaw having a wedge shape converging at an apex at the distal portion of the second jaw; as well as One or more teeth positioned on one or more of the first jaw or the second jaw and configured to cut at least the portion of the heart valve leaflet when the first jaw is closed with the second jaw.

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

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

43. A prosthetic mitral heart valve system for a heart, the system comprising: A prosthetic mitral heart valve comprising: a support structure having an inlet end portion and an outlet end portion and a passageway, and a valve portion positioned within the passageway of the support structure, wherein the valve portion includes a plurality of leaflets made from pericardium, wherein the valve portion permits blood to flow through the passageway in one direction to replace the function of a native mitral heart valve; as well as A tether is used to tether native mitral heart valve leaflets to reduce obstruction of the left ventricular outflow tract of the heart caused by the native mitral heart valve leaflets.

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

45. A system according to claim 43 or claim 44, wherein the tether is adapted to be anchored to the native mitral heart valve leaflets.

Images