Laterally deliverable transcatheter prosthetic valve and method for delivering and anchoring same

Abstract

The invention relates to a laterally deliverable transcatheter prosthetic valve and a method for delivering and anchoring the same. A laterally deliverable prosthetic valve includes an outer frame, a flow control component mounted within the outer frame, and an anchoring element coupled to a distal side of the outer frame. The prosthetic valve is collapsible along the longitudinal axis and compressible along the central axis into a compressed configuration for lateral delivery through the delivery catheter, and is expandable to an expanded configuration when released from the delivery catheter. An end of the anchoring element is configured to engage a guidewire. The anchoring element extends during deployment to allow the anchoring element to capture at least one of the autologous leaflets or chordae and, in response to detachment of the guidewire from the end, transitions to a folded configuration to secure the at least one of the autologous leaflets or chordae between the anchoring element and the distal side of the outer frame.

Description

[0001] This application is a divisional application of application for an invention patent filed on March 13, 2020, entitled “LATERALLY-DELIVERABLE TRANSCATHETER MITRAL VALVE PROSTHESIS AND METHOD FOR DELIVERING AND ANCHORING THE SAME” 202080031726.5.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application is a continuation of U.S. Patent Application Serial No. 16 / 438,434, filed June 11, 2019, entitled “Distal Subannular Anchoring Tab for Side-Delivered Transcatheter Mitral Valve Prosthesis,” which claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 62 / 818,108, filed March 14, 2019, entitled “Distal Anchoring Tab for Orthogonal Transcatheter Mitral Valve Prosthesis”; and is a continuation of U.S. Patent Application Serial No. 16 / 442,504, filed June 16, 2019, entitled “A2 Clip for Side-Delivered Transcatheter Mitral Valve Prosthesis,” which claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 62 / 818,109, filed March 14, 2019, entitled “A2 Clip for Orthogonal Transcatheter Mitral Valve Prosthesis”; and is a continuation of U.S. Patent Application Serial No. 16 / 445,210, filed June 19, 2019, entitled “Proximal, Distal, and Anterior Anchoring Tabs for Side-Delivered Transcatheter Mitral Valve Prosthesis,” which claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 62 / 818,688, filed March 14, 2019, entitled “Proximal, Distal, and Anterior Anchoring Tabs for Orthogonal Transcatheter Mitral Valve Prosthesis,” the disclosures of each of which are incorporated by reference in their entirety.

[0004] This application also claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 62 / 818,742, filed March 14, 2019, entitled “A1-P1 Targeting Guide Wire Delivery Systems for Orthogonal Transcatheter Mitral Valve Prosthesis,” the disclosure of which is incorporated by reference herein in its entirety. BACKGROUND

[0005] The embodiments described herein generally relate to transcatheter prosthetic valves, and more particularly to laterally deliverable transcatheter prosthetic valves having one or more anchoring elements for securing the prosthetic valve in an annulus of a native valve and methods of delivery thereof.

[0006] Prosthetic heart valves present challenges for delivery and deployment within the heart, particularly for delivery through a catheter through a patient’s vasculature rather than by a surgical approach. Delivery of conventional transcatheter prosthetic valves generally includes radially compressing the valve and loading the valve into a delivery catheter such that the central annular axis of the valve is parallel to the longitudinal axis of the delivery catheter. The valve is deployed from the end of the delivery catheter and expanded radially outward from the central annular axis. However, the expanded size (e.g., diameter) of conventional valves is limited by the inner diameter of the delivery catheter. The competing interests of minimizing the delivery catheter size present challenges to increasing the expanded diameter of conventional valves (e.g., trying to compress too much material and structure into too small a space). Additionally, the orientation of conventional valves during deployment presents additional challenges when trying to align the valve with the native valve annulus.

[0007] Some transcatheter prosthetic valves can be configured for lateral and / or orthogonal delivery, which can have an increased expanded diameter relative to traditional valves. For example, in lateral and / or orthogonal delivery, the valve and / or valve frame is compressed and loaded into a delivery catheter such that a central annular axis of the valve and / or valve frame is substantially orthogonal to a longitudinal axis of the delivery catheter, which can allow the valve to be compressed laterally and extended longitudinally (e.g., in a direction parallel to the longitudinal axis of the delivery catheter). In some such implementations, it is further desirable to provide an outer portion or valve frame having a size and / or shape comparable to that of the annulus of a native valve (e.g., the mitral and / or tricuspid valve of a human heart), while providing an inner flow control component that (i) is compatible with lateral compression and / or longitudinal extension experienced during delivery, and (ii) has a substantially cylindrical shape that allows the prosthetic valve leaflets included therein to have optimal functionality. For transcatheter prosthetic valves of traditional and / or orthogonal delivery, it is also desirable to provide one or more ways of anchoring the valve in the native annulus without significantly increasing the compressed size of the valve.

[0008] Accordingly, there is a need for laterally deliverable transcatheter prosthetic valves having one or more anchoring elements for securing the prosthetic valve in the annulus of a native valve and methods of delivering such prosthetic valves. SUMMARY

[0009] Embodiments described herein relate to laterally deliverable transcatheter prosthetic valves having one or more anchoring elements for securing the prosthetic valve in the annulus of a native valve and methods of delivering such prosthetic valves. In some embodiments, a laterally deliverable prosthetic heart valve includes an outer frame having a peripheral wall encircling a central passage extending along a central axis and a flow control component mounted within the central passage. The flow control component includes an inner frame and a set of leaflets coupled to the inner frame. The prosthetic valve is foldable along a longitudinal axis and compressible along the central axis to place the prosthetic valve in a compressed configuration for delivery through a delivery catheter. The longitudinal axis is substantially parallel to a longitudinal axis of the delivery catheter when the prosthetic valve is disposed in the delivery catheter. The prosthetic valve is configured to transition into an expanded configuration when the prosthetic valve is released from the delivery catheter. The prosthetic valve further includes a distal anchoring element having a first end coupled to a distal side of the peripheral wall of the outer frame and a second end opposite the first end. The second end is configured to selectively engage a guidewire to allow the distal anchoring element to advance along the guidewire during deployment of the prosthetic valve. The distal anchoring element is in an extended configuration during deployment to allow the distal anchoring element to capture at least one of a native leaflet or chordae tendinae. In response to the guidewire disengaging from the second end, the distal anchoring element transitions into a folded configuration in which the at least one of the native leaflet or chordae tendinae is secured between the distal anchoring element and the distal side of the peripheral wall. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1A and FIG. 1B are illustrations of front schematic views of a laterally delivered transcatheter prosthetic heart valve (also referred to herein as a "prosthetic valve") according to an embodiment and shown in an expanded configuration and a compressed configuration, respectively.

[0011] FIG. 1C and FIG. 1D yes FIG. 1A and FIG. 1B and are illustrations of top schematic views of a prosthetic valve shown in an expanded configuration and a compressed configuration, respectively.

[0012] FIG. 1E It is deployed within the annulus of the native heart valve FIGS. 1A-1D Illustration of a schematic diagram of a prosthetic valve.

[0013] FIG. 2A is an illustration of a top view of a native mitral valve showing the approximate locations of the leaflet areas A1-A2-A3 and P1-P2-P3.

[0014] FIG. 2B and FIG. 2C Illustrations of a side perspective view and an exploded view, respectively, of a laterally deliverable transcatheter prosthetic heart valve with an extendable distal anchoring element, according to an embodiment.

[0015] FIG. 3A and FIG. 3B Illustrations of side perspective and exploded views, respectively, of a laterally deliverable transcatheter prosthetic heart valve having an extendable distal anchoring element and anterior anchoring element, according to an embodiment.

[0016] FIG. 4A and FIG. 4B Illustrations of side perspective and exploded views, respectively, of a laterally deliverable transcatheter prosthetic heart valve having extendable distal and proximal anchoring elements, according to embodiments.

[0017] FIG. 5A and FIG. 5B Illustrations of a side perspective view and an exploded view, respectively, of a laterally deliverable transcatheter prosthetic heart valve having an extendable distal anchoring element, an anterior anchoring element, and a proximal anchoring element, according to an embodiment.

[0018] FIG. 6A and FIG. 6B Illustrations of side perspective and exploded views, respectively, of a laterally deliverable transcatheter prosthetic heart valve having extendable distal and anterior anchoring elements, according to embodiments.

[0019] FIGS. 7A-7D is a series of illustrations showing the process of capturing autologous tissue by the distal anchoring elements of a laterally deliverable transcatheter prosthetic heart valve according to an embodiment.

[0020] FIG. 7E is FIGS. 7A-7D is a top view illustration of a laterally deliverable transcatheter prosthetic heart valve of

[0021] FIG. 8 is a top view illustration of a laterally deliverable transcatheter prosthetic heart valve having multiple anchoring elements according to an embodiment.

[0022] FIG. 9A is an illustration of a cross-sectional view of a human heart showing the relative positions of the mitral valve, tricuspid valve, aortic valve, and pulmonary valve.

[0023] FIG. 9B is an illustration of a cutaway side view of a human heart having a transseptal (femoral artery / inferior vena cava (IVC) or superior vena cava (SVC)) delivery catheter passing from the right atrium to the left atrium to access the mitral valve according to an embodiment.

[0024] FIG. 10 and FIG. 11 are illustrations of perspective and side perspective views, respectively, of a guide wire passing through the IVC to access the autologous valve annulus and wrapping under or around the autologous A2 leaflet according to an embodiment.

[0025] FIGS. 12-16 are various illustrations of the process of delivering and deploying a laterally deliverable transcatheter prosthetic heart valve in, for example, an autologous mitral valve according to an embodiment.

[0026] FIG. 17A and FIG. 17B are illustrations of side perspective views of a laterally deliverable transcatheter prosthetic heart valve according to an embodiment deployed in an autologous annulus (indicated in dashed lines), with the anterior anchoring elements in extended and retracted positions, respectively.

[0027] FIG. 18A and FIG. 18B are illustrations of side perspective views of a laterally deliverable transcatheter prosthetic heart valve according to an embodiment deployed in an autologous annulus (indicated in dashed lines), with the anterior anchoring elements in extended and retracted positions, respectively.

[0028] FIG. 19A and FIG. 19Bis an illustration of a side perspective view of a laterally deliverable transcatheter prosthetic heart valve according to an embodiment, the prosthetic heart valve being deployed in a native valve annulus (indicated in dashed lines), with the anterior anchoring elements in extended and retracted positions, respectively.

[0029] FIG. 20 and 21 are illustrations of a side view and a top view, respectively, of a laterally deliverable transcatheter prosthetic heart valve according to an embodiment, the transcatheter prosthetic heart valve having distal anchoring elements extending from a valve body.

[0030] FIG. 22 is an illustration of a prosthetic valve of FIG. 20 in a compressed configuration and disposed within a delivery catheter.

[0031] FIG. 23 is an illustration of a prosthetic valve of FIG. 20 in a partially expanded configuration and partially released from a delivery catheter.

[0032] FIG. 24 is an illustration of a cutaway side view of a human heart according to an embodiment and showing a laterally deliverable transcatheter prosthetic heart valve deployed in a native valve.

[0033] FIGS. 25A-25E illustrates various views of a process of placing a laterally deliverable transcatheter prosthetic heart valve into a compressed configuration, delivering the compressed prosthetic valve via a delivery catheter, and partially releasing the prosthetic valve from the delivery catheter for deployment in a native valve, according to an embodiment.

[0034] FIGS. 26A-26C illustrates various views of a process of placing a laterally deliverable transcatheter prosthetic heart valve into a compressed configuration and loading the compressed prosthetic valve into a delivery catheter, according to an embodiment.

[0035] FIGS. 27A-27C illustrates various views of a process of placing a laterally deliverable transcatheter prosthetic heart valve into a compressed configuration and loading the compressed prosthetic valve into a delivery catheter, according to an embodiment.

[0036] FIGS. 28A-28C illustrates various views of a process of placing a laterally deliverable transcatheter prosthetic heart valve into a compressed configuration and loading the compressed prosthetic valve into a delivery catheter, according to an embodiment.

[0037] FIGS. 29A-29C illustrates various views of a process of placing a laterally deliverable transcatheter prosthetic heart valve into a compressed configuration and loading the compressed prosthetic valve into a delivery catheter, according to an embodiment.

[0038] FIG. 30is an illustration of a top perspective view of an inner frame of a flow control component included in a prosthetic valve according to an embodiment.

[0039] FIGS. 31-33 is shown FIG. 30 is an illustration of various views of an inner frame of a flow control component included in a prosthetic valve according to an embodiment and shown in a partially collapsed configuration, a collapsed configuration, and a collapsed and compressed configuration, respectively.

[0040] FIG. 34 is an illustration of a side view of an inner frame of a flow control component included in a prosthetic valve according to an embodiment and shown in a linear wireframe sheet prior to forming a cylindrical configuration.

[0041] FIG. 35 is an illustration of a side perspective view of an inner frame of FIG. 34 shown in a cylindrical configuration.

[0042] FIG. 36 is an illustration of a side view of a leaflet band of an inner flow control component and shown in a linear configuration with leaflet pockets sewn into a structural band of pericardial tissue.

[0043] FIG. 37 is an illustration of a bottom view of a leaflet band of FIG. 36 and shown in a linear configuration.

[0044] FIG. 38 is an illustration of a side perspective view of a leaflet band of FIG. 36 and FIG. 37 and shown in a cylindrical configuration of an inner frame of FIG. 35 .

[0045] FIG. 39 is an illustration of a side perspective view of a portion of a leaflet band of FIG. 36 showing a single leaflet pocket sewn into a structural band.

[0046] FIG. 40 is an illustration of a bottom view of a leaflet band of FIGS. 36-39 in a cylindrical configuration showing partial coaptation of leaflets for forming a partially closed fluid seal.

[0047] FIGS. 41A-41D is shown

[0048] FIGS. 42A-42C is shown

[0049] FIGS. 43A-43C Various views showing a process of converting a laterally deliverable transcatheter prosthetic heart valve into a compressed configuration for delivery according to embodiments are shown.

[0050] FIG. 44A is an illustration of a top view of a laterally deliverable transcatheter prosthetic heart valve in a compressed configuration and disposed within a delivery catheter according to embodiments.

[0051] FIG. 44B is an illustration of a top perspective view of a prosthetic heart valve of FIG. 44A

[0052] FIG. 45 is an illustration of a cutaway side view of a human heart having a transseptal delivery catheter passing from the right atrium to the left atrium to access a mitral valve according to embodiments.

[0053] FIG. 45 is an illustration of a side view of a human heart having a transseptal (femoral artery / IVC or SVC) delivery catheter passing from the right atrium to the left atrium to access a mitral valve according to embodiments.

[0054] FIG. 46 is an illustration showing a process of capturing autologous tissue using distal anchoring elements of a laterally deliverable transcatheter prosthetic heart valve according to embodiments.

[0055] FIGS. 47-49 is an illustration of a side perspective view showing a process of deploying a laterally deliverable transcatheter prosthetic heart valve according to embodiments.

[0056] FIGS. 50A-50D Various views of an anterior anchoring element included in a laterally deliverable transcatheter prosthetic heart valve according to embodiments and shown in a first configuration, a second configuration, a third configuration, and a fourth configuration, respectively, are shown.

[0057] FIGS. 51A-51G Various anchors for anchoring a portion of a laterally deliverable transcatheter prosthetic heart valve to autologous tissue are shown, each according to a different embodiment.

[0058] FIG. 52 is an illustration of a side perspective view of a laterally deliverable transcatheter prosthetic heart valve having a plurality of anterior anchoring elements according to embodiments.

[0059] FIG. 53 is an illustration of a side perspective view of a laterally deliverable transcatheter prosthetic heart valve having a plurality of anterior anchoring elements according to embodiments.

[0060] FIG. 54 ​is an illustration of a side perspective view of a laterally deliverable transcatheter prosthetic heart valve having a distal anchoring element with graduated stiffness according to an embodiment.

[0061] FIG. 55A is an illustration of a side perspective view of a laterally deliverable transcatheter prosthetic heart valve having a distal anchoring element and a proximal anchoring element according to an embodiment.

[0062] FIG. 55B is an illustration of a side perspective view of a prosthetic heart valve of FIG. 55A deployed in the annulus of a native valve.

[0063] FIG. 56A is an illustration of a side perspective view of a laterally deliverable transcatheter prosthetic heart valve having a distal anchoring element and a proximal anchoring element according to an embodiment.

[0064] FIG. 56B is an illustration of a side perspective view of a prosthetic heart valve of FIG. 56A deployed in the annulus of a native valve.

[0065] FIG. 57A is an illustration of a side perspective view of a laterally deliverable transcatheter prosthetic heart valve having a distal anchoring element and a proximal anchoring element according to an embodiment.

[0066] FIG. 57B is an illustration of a side perspective view of a prosthetic heart valve of FIG. 57A deployed in the annulus of a native valve.

[0067] FIG. 58A is an illustration of a guidewire delivery catheter according to an embodiment, which provides access to an Al-Pl target region, e.g., of a native valve.

[0068] FIG. 58B is an illustration of a magnified view of a portion of a guidewire delivery catheter of FIG. 58A .

[0069] FIG. 59 is an illustration of a circumferential balloon disposed around an end of a delivery catheter according to an embodiment.

[0070] FIG. 60 is an illustration of a side view of a distal end of a sheath according to an embodiment, which is included in a delivery system and has a side port for delivery of a guidewire to an Al-Pl target region, e.g., of a native valve.

[0071] FIG. 61 is an illustration of a cross-sectional view of a sheath of FIG. 60 that engages native tissue and allows a guidewire to be delivered through a side port.

[0072] FIG. 62 is an illustration of a side perspective view of a laterally deliverable transcatheter prosthetic heart valve having a septal tether configured to secure the prosthetic heart valve in an annulus of a native valve, in accordance with an embodiment.

[0073] FIG. 63 is an illustration of a cross-sectional view of a laterally deliverable transcatheter prosthetic heart valve secured in an annulus of a native valve, in accordance with an embodiment.

[0074] FIG. 64 is an illustration of a side view of a portion of a delivery system having a docking receptacle with a keyed feature and / or a tissue grasping feature for anchoring to a free wall of native tissue, in accordance with an embodiment.

[0075] FIG. 65 is an illustration of a magnified view of at least a portion of a tissue grasping feature of FIG. 64 shown anchored to a free wall.

[0076] FIG. 66 is a flowchart illustrating a method of deploying a laterally deliverable transcatheter prosthetic heart valve in an annulus of a native valve, in accordance with an embodiment. DETAILED DESCRIPTION

[0077] Disclosed embodiments relate to transcatheter prosthetic heart valves and / or components thereof, and methods of manufacturing, loading, delivering, and / or deploying the transcatheter prosthetic valves and / or components thereof. In some embodiments, a laterally deliverable prosthetic heart valve includes an outer frame having a peripheral wall that surrounds a central passage extending along a central axis, and a flow control component mounted within the central passage. The flow control component includes an inner frame and a set of leaflets coupled to the inner frame. The prosthetic valve is foldable along a longitudinal axis and compressible along the central axis to place the prosthetic valve in a compressed configuration for delivery through a delivery catheter. The longitudinal axis is substantially parallel to a longitudinal axis of the delivery catheter when the prosthetic valve is disposed in the delivery catheter. The prosthetic valve is configured to transition into an expanded configuration when the prosthetic valve is released from the delivery catheter. The prosthetic valve further includes a distal anchoring element having a first end coupled to a distal side of the peripheral wall of the outer frame and a second end opposite the first end. The second end is configured to selectively engage a guidewire to allow the distal anchoring element to advance along the guidewire during deployment of the prosthetic valve. The distal anchoring element is in an extended configuration during deployment to allow the distal anchoring element to capture at least one of an autologous leaflet or chordae tendinae. In response to the guidewire disengaging from the second end, the distal anchoring element transitions into a folded configuration in which the at least one of the autologous leaflet or chordae tendinae is secured between the distal anchoring element and the distal side of the peripheral wall.

[0078] In some embodiments, a laterally deliverable prosthetic heart valve includes an outer frame having a peripheral wall that surrounds a central passage extending along a central axis, and a flow control component mounted within the central passage. The flow control component includes an inner frame and a set of leaflets coupled to the inner frame. The prosthetic valve is foldable along a longitudinal axis and compressible along the central axis to place the prosthetic valve in a compressed configuration for delivery through a delivery catheter. The longitudinal axis is substantially parallel to a longitudinal axis of the delivery catheter when the prosthetic valve is disposed in the delivery catheter. The prosthetic valve is configured to transition into an expanded configuration when the prosthetic valve is released from the delivery catheter. The prosthetic valve further includes a distal anchoring element coupled to a distal side of the peripheral wall of the outer frame and an anterior anchoring element coupled to an anterior side of the peripheral wall. The distal anchoring element is releasably coupled to a guidewire and configured to advance along the guidewire when in an extended configuration to capture at least one of a distal autologous leaflet or distal chordae tendinae. When released from the guidewire, the distal anchoring element transitions into a folded configuration to secure the distal autologous leaflet or distal chordae tendinae between the distal anchoring element and the distal side of the peripheral wall. The anterior anchoring element includes a sleeve and an anterior clip at least partially disposed in the sleeve. The anterior clip is transitionable between a first configuration in which the anterior clip extends from the sleeve in a direction of the central axis to allow the anterior clip to capture at least one of an anterior autologous leaflet or anterior chordae tendinae, and a second configuration in which the anterior clip is at least partially retracted into the sleeve to secure the anterior autologous leaflet or anterior chordae tendinae between the anterior clip and the anterior side of the peripheral wall.

[0079] Any of the prosthetic heart valves described herein can be a relatively low profile, laterally deliverable implantable prosthetic heart valve. Any of the prosthetic heart valves can be a transcatheter prosthetic heart valve configured to be delivered into the heart through a delivery catheter. The prosthetic heart valve can have at least one annulus-external valve frame and an internal flow control component (e.g., a 2-leaflet or 3-leaflet valve, a sleeve, etc.) mounted in the valve frame. Additionally, the prosthetic heart valve can include a single anchoring element or multiple anchoring elements configured to anchor the valve in the annulus of a native valve.

[0080] Any of the prosthetic heart valves described herein can be configured to transition between an expanded configuration and a compressed configuration. For example, any of the embodiments described herein can be a balloon-expandable prosthetic heart valve, a self-expanding prosthetic heart valve, etc.

[0081] Any of the prosthetic heart valves described herein can be compressed into a compressed configuration in a longitudinal or normal direction relative to a central axis of the flow control component, which can allow large diameter valves (e.g., having a height of about 5-60 mm and a diameter of about 20-80 mm) to be directly delivered and deployed from a lower vena cava into the annulus of a native mitral or tricuspid valve using, for example, a 24-36 Fr delivery catheter without needing to be delivered and deployed from the delivery catheter at an acute access angle.

[0082] Any of the prosthetic heart valves described herein can have a central axis that is coaxial or at least substantially parallel to the direction of blood flow through the valve. In some embodiments, the compressed configuration of the valve is orthogonal to the direction of blood flow. In some embodiments, the compressed configuration of the valve is parallel or aligned with the direction of blood flow. In some embodiments, the valve can be compressed to the compressed configuration in two directions - a direction orthogonal to the direction of blood flow (e.g., lateral) and a direction parallel to the direction of blood flow (e.g., axial). In some embodiments, the long or longitudinal axis is oriented at an intersection angle of 45 to 135 degrees to a first direction when in the compressed and / or expanded configuration.

[0083] Any of the prosthetic heart valves described herein can include an external support frame comprising a set of compressible wire cells having an orientation and cell geometry that is substantially normal to the central axis to minimize wire cell strain when the external support frame is in a compressed, rolled and compressed, or folded and compressed configuration.

[0084] In some embodiments, the outer support frame has a lower body portion and an upper collar portion. The lower body portion forms a shape such as a funnel shape, a cylindrical shape, a flat conical shape, or a circular hyperboloid when the outer support frame is in the expanded configuration. In some embodiments, the outer support frame is formed of wire, braided wire, or laser cut wire frame and is covered by a biocompatible material. The biocompatible material can be covered such that the inner surface is covered by pericardial tissue, the outer surface is covered by a braided synthetic polyester material, and / or the inner surface is covered by pericardial tissue and the outer surface is covered by a braided synthetic polyester material.

[0085] In some embodiments, the outer support frame has a flat conical lateral profile with an outer diameter R of 40-80 mm, an inner diameter r of 20-60 mm, and a height of 5-60 mm. In some embodiments, the annulus support frame has an hourglass shape lateral profile with a top diameter R1 of 40-80 mm, a bottom diameter R2 of 50-70 mm, an inner diameter r of 20-60 mm, and a height of 5-60 mm.

[0086] Any of the prosthetic heart valves described herein can include one or more anchoring elements extending from a sidewall of the valve frame. For example, any of the prosthetic heart valves can include a distal anchoring element that can function as, for example, a right ventricular outflow tract (“RVOT”) tab or a left ventricular outflow tract (“LVOT”) tab. Any of the valves described herein can also include an anchoring element extending from a proximal side of the valve frame that can be used, for example, to anchor the valve to the space under the proximal annulus. Any of the valves described herein can also include an anterior anchoring element or a posterior anchoring element extending from an anterior side or a posterior side of the valve frame, respectively. The anchoring elements can include or be formed of a wire loop or wire frame extending about 10-40 mm away from the tubular frame, an integrated frame portion, and / or a stent.

[0087] Any of the prosthetic heart valves described herein can include (i) an upper anchoring element attached to an upper edge of a distal end of the tubular frame, the upper anchoring element can include or consist of a wire loop or wire frame extending about 2-20 mm away from the tubular frame; and (ii) a lower anchoring element extending from a distal side of the tubular frame (e.g., to function as an RVOT tab), the lower anchoring element can include or consist of a wire loop or wire frame extending about 10-40 mm away from the tubular frame.

[0088] Any of the prosthetic heart valves described herein can include a distal lower anchoring element configured to be positioned in the RVOT of the right ventricle and a proximal lower anchoring element configured to be positioned in a subannular position in contact with and / or adjacent to tissue below the annulus of the right ventricle. The transcatheter prosthetic heart valve can also include a distal upper anchoring element configured to be positioned in a supraannular position in contact with and / or adjacent to tissue above the annulus of the right atrium. The distal upper anchoring element can provide a downward force above the annulus in a direction along the right ventricle, and the distal and proximal lower anchoring elements can provide an upward force below the annulus in a direction along the right atrium.

[0089] Any of the prosthetic heart valves described herein can include an inner flow control component having a leaflet frame with 2-4 flexible leaflets mounted thereon. The 2-4 leaflets are configured to allow blood to flow through an inflow end of the flow control component in a first direction and to block blood from flowing through an outflow end of the flow control component in a second direction opposite the first direction. The leaflet frame can include two or more diamond or eye-shaped wire unit panels made of a heat-set shape memory alloy material such as Nitinol. The leaflet frame can be configured to be foldable along a z-axis (e.g., a longitudinal axis) from a circular or cylindrical configuration into a flattened cylindrical configuration, and compressible along a perpendicular y-axis (e.g., a central axis) into a compressed configuration. In some embodiments, the leaflet frame can include a pair of hinge regions, folding regions, connection points, etc. that can allow the leaflet frame to be folded along the z-axis before the leaflet frame is compressed along the perpendicular y-axis. For example, the inner frame can be a single piece structure with two or more active hinges (e.g., stress concentrator lifters and / or any suitable structure configured to allow the inner frame to elastically / non-permanently deform). In other embodiments, the inner frame can be a two-piece structure where the hinge regions are formed using a second attachment method (e.g., sutures, braids, molded polymer components, etc.).

[0090] In some embodiments, the inner flow control component in the expanded configuration forms a shape such as a funnel, a cylinder, a flat round cone, or a circular hyperboloid. In some embodiments, the inner flow control component has a leaflet frame with a flat round cone shape having an outer diameter R of 20-60 mm, an inner diameter r of 10-50 mm (where the diameter R is greater than the diameter r), and a height of 5-60 mm. In some embodiments, the leaflet frame is composed of wire, braided wire, or laser cut wire. In some embodiments, the leaflet frame can have one or more longitudinal supports integrated into or mounted on it, the supports being selected from the group consisting of rigid or semi-rigid posts, rigid or semi-rigid ribs, rigid or semi-rigid rods, rigid or semi-rigid panels, and combinations thereof.

[0091] Any of the prosthetic heart valves and / or any components, features, and / or aspects thereof described herein can be similar and / or substantially identical to the prosthetic heart valves (or components, features, and / or aspects thereof) described in International Patent Application No. PCT / US2019 / 051957, filed September 19, 2019, entitled “Transcatheter Deliverable Prosthetic Heart Valves and Method of Delivery” (referred to herein as “‘957 PCT”), International Patent Application No. PCT / US2019 / 067010, filed December 18, 2019, entitled “Transcatheter Deliverable Prosthetic Heart Valves and Methods of Delivery” (referred to herein as “‘010 PCT”), and / or International Patent Application No. PCT / US2020 / 015231, filed January 27, 2020, entitled “Collapsible Inner Flow Control Component for Side-Deliverable Transcatheter Heart Valve Prosthesis” (referred to herein as “‘231 PCT”), the disclosures of which are incorporated by reference herein in their entireties.

[0092] In some embodiments, the prosthetic valve can be configured for deployment, for example, in the annulus of a native mitral valve. The use of a laterally deliverable transcatheter mitral valve replacement allows for a relatively larger diameter valve to be delivered and deployed from the inferior vena cava through the septum into the mitral valve without requiring an overly large diameter catheter, nor requiring delivery and deployment from the catheter at an acute angle of approach.

[0093] In some embodiments, the prosthetic mitral valve can include one or more anchoring elements configured to secure the prosthetic valve in the annulus of a native valve. For example, a prosthetic mitral valve, such as those described herein, can include a distal anchoring element, a proximal anchoring element, and one or more anterior or posterior anchoring elements (e.g., anterior Al, A2, or A3 anchoring elements and / or posterior PI, P2, or P3 anchoring elements).

[0094] In some embodiments, the prosthetic mitral valve includes a distal anchoring tab that (i) extends around the posterior leaflet and / or chordae tendinae using a guidewire to capture native mitral leaflet and / or chordal tissue, and (ii) is allowed to retract upon withdrawal of the guidewire to pin the native tissue against the sidewall of the valve. In some embodiments, the valve further includes a proximal anchoring element configured to anchor the proximal side of the valve using a tab or ring deployed to the A3-P3 (proximal) commissure region of the native mitral valve. In some embodiments, the valve further includes an A2 clip similarly configured to extend or deploy (e.g., by guidewire or self-actuation) to capture native mitral leaflet and / or chordal tissue, and to pin the native tissue against the sidewall of the valve upon withdrawal of the guidewire and / or upon otherwise causing the A2 clip to retract or refold. In some embodiments, the A2 clip can be formed from woven polyethylene, treated pericardial tissue, ePTFE, or nitinol, and can have one or more radiopaque markers.

[0095] In some embodiments, a delivery system for delivering a laterally deliverable prosthetic heart valve can include a catheter that can deliver a guidewire directly to the A1-P1 commissure region of a native mitral valve. In some implementations, targeting the A1-P1 commissure region can allow a laterally deliverable valve, such as those described herein, to be guided to the target region by the delivery catheter for successful deployment of the valve.

[0096] Any of the delivery systems described herein can include a guidewire catheter that can be used independently of the valve delivery catheter. In some embodiments, the guidewire catheter has a custom shape that articulates the distal tip of the guidewire catheter to the A1 / P1 commissure behind the posterior native leaflet. In some embodiments, the guidewire catheter can be used prior to insertion of the valve delivery catheter, or can be threaded through the valve delivery catheter prior to loading the valve, and can exit directly through the main lumen via a side port in communication with the main lumen. After placement of the guidewire, the guidewire catheter can be removed from the patient.

[0097] Any of the delivery systems described herein can include a delivery catheter for a laterally deliverable prosthetic heart valve, the catheter including an outer shaft having an outer proximal portion, an outer distal portion, and an outer shaft lumen, wherein the outer distal portion is closed by an atraumatic ball mounted thereon. The outer shaft lumen has an inner diameter of 8-10 mm sized for a laterally deliverable transcatheter prosthetic heart valve (e.g., a prosthetic tricuspid valve and / or a prosthetic mitral valve) to pass therethrough.

[0098] Any method of manufacturing a prosthetic heart valve described herein can include using additive or subtractive metal or metal alloy manufacturing to produce a self-expanding outer support frame having a central passage and a peripheral wall encircling a central vertical axis. A collapsible flow control component is mounted within the outer support frame and is configured to allow blood to flow through an inflow end of the valve in a first direction and to prevent blood from flowing through an outflow end of the valve in a second direction opposite the first direction. The flow control component has a leaflet frame having 2-4 flexible leaflets mounted thereto. The leaflet frame can be formed using additive or subtractive metal or metal alloy manufacturing. Additive metal or metal alloy manufacturing can be 3D printing, direct metal laser sintering (powder melting), etc. Subtractive metal or metal alloy manufacturing is photolithography, laser sintering / cutting, CNC machining, electrical discharge machining, etc. In some embodiments, the manufacturing process can further include mounting the flow control component within the outer support frame and covering an outer surface of the outer support frame with a pericardial material or similar biocompatible material.

[0099] Any method for delivering a prosthetic heart valve described herein can include at least one of (i) compressing the valve along a central vertical axis to reduce a vertical dimension of the valve from top to bottom, thereby placing the valve in a compressed configuration, (ii) unilaterally rolling the valve into the compressed configuration from one side of the annulus support frame, (iii) bilaterally rolling the valve into the compressed configuration from two opposite sides of the annulus support frame, (iv) unfolding the valve into two parallel panels that are substantially parallel to the long axis, (v) unfolding the valve into two parallel panels that are substantially parallel to the long axis and then rolling the unfolded valve into the compressed configuration, or (vi) unfolding the valve into two parallel panels that are substantially parallel to the long axis and then compressing the valve along a central vertical axis to reduce a vertical dimension of the valve from top to bottom, thereby placing the valve in a compressed configuration.

[0100] Any method for delivering a prosthetic heart valve described herein can include orthogonal delivery of the prosthetic heart valve to a desired location within the body, the orthogonal delivery comprising (i) advancing a delivery catheter to the desired location within the body, and (ii) delivering the prosthetic heart valve to the desired location within the body by releasing the valve from the delivery catheter. When in the delivery catheter, the valve is in a compressed configuration, and when released from the delivery catheter, the valve transitions into an expanded configuration.

[0101] Any method for delivering a prosthetic heart valve described herein can include releasing the valve from the delivery catheter by (i) using a pulling member (e.g., a pull wire or a pull rod) releasably connected to a side wall, a drum, or a collar and / or an anchoring element (e.g., a distal anchoring element) to pull the valve out of the delivery catheter, wherein advancing the pulling member away from the delivery catheter pulls the compressed valve out of the delivery catheter, or (ii) using a pushing member (e.g., a wire, a rod, a catheter, a delivery member, etc.) releasably connected to a side wall, a drum, or a collar and / or an anchoring element (e.g., a distal anchoring element) to push the valve out of the delivery catheter, wherein advancing the pushing member out of the delivery catheter pushes the compressed valve out of the delivery catheter.

[0102] In some embodiments, a method for deploying a laterally deliverable prosthetic heart valve into a patient includes advancing a guidewire to an atrium, through a plane defined by an annulus of a native valve, and behind native leaflets of the native valve. The prosthetic valve is advanced in an orthogonal compressed configuration through a lumen of a delivery catheter and into the atrium. The prosthetic valve includes a distal anchoring element releasably coupled to the guidewire such that the prosthetic valve advances along a portion of the guidewire. The prosthetic valve is released from the delivery catheter to allow at least a portion of the prosthetic valve to transition into an expanded configuration such that the distal anchoring element is in an extended configuration upon release. The prosthetic valve advances along the guidewire to (i) place the distal anchoring element in a position behind the native leaflets and (ii) seat the prosthetic valve in the annulus of the native valve. The guidewire is withdrawn to release the distal anchoring element to a folded position to allow the distal anchoring element to capture at least one of the native leaflets or chordae tendineae and secure the native leaflets or chordae tendineae between the distal anchoring element of the prosthetic valve and a peripheral wall.

[0103] Any method for delivering and / or deploying a prosthetic heart valve described herein can include releasing the valve from the delivery catheter while increasing blood flow during deployment of the valve by (i) partially releasing the valve from the delivery catheter to establish blood flow around the partially released valve and through a flow control component; (ii) fully releasing the valve from the delivery catheter while maintaining attachment to the valve to transition to a state of increased blood flow through the flow control component and reduced blood flow around the valve; (iii) deploying the valve into a final installed position in a native annulus to transition to a state of full blood flow through the flow control component and minimal or no blood flow around the valve; and (iv) disconnecting and withdrawing the positioning catheter, pull wire or pull rod, or push wire or push rod, and / or the delivery catheter.

[0104] Any of the methods for delivering and / or deploying a prosthetic heart valve described herein can include positioning the valve or a portion thereof relative to autologous tissue at a desired location. For example, the method can include positioning a distal anchoring tab of the heart valve prosthesis in the ventricular outflow tract of the left or right ventricle. In some embodiments, the method can further include positioning the upper distal anchoring tab to an above annulus position, where the upper distal anchoring tab provides an above annulus direction force in the ventricular direction and the distal anchoring tab (e.g., lower distal anchoring tab) provides a below annulus direction force in the atrial direction. In some embodiments, the method can include rotating the heart valve prosthesis along an axis parallel to the plane of the valve annulus using a steerable catheter. In some embodiments, the method can include anchoring one or more tissue anchors attached to the valve into autologous tissue to secure the valve at the desired location.

[0105] Any of the methods for delivering and / or deploying a prosthetic heart valve described herein can include orthogonal delivery of the prosthetic heart valve to an autologous annulus of a human heart, the orthogonal delivery comprising at least one of: (i) advancing a delivery catheter via a femoral vein through the inferior vena cava (IVC) to the tricuspid valve annulus or pulmonary artery of the heart, (ii) advancing via a jugular vein through the superior vena cava (SVC) to the tricuspid valve annulus or pulmonary artery of the heart, or (iii) advancing via an IVC-femoral vein or SVC-jugular vein approach, through a transatrial approach (e.g., fossa ovalis or lower), to the mitral valve annulus of the heart; and (iv) delivering and / or deploying the prosthetic heart valve to the autologous annulus by releasing the valve from the delivery catheter.

[0106] In some embodiments, a method for delivering and / or deploying a prosthetic heart valve described herein onto a native mitral valve can include advancing a guidewire transseptally to the left atrium, through the annular plane of the A1 / P1 junction to a location behind the native posterior (e.g., P2) leaflet of the patient’s mitral valve. A delivery catheter containing the valve in an orthogonal compressed configuration is advanced to the patient’s left atrium as a delivery catheter, with the distal anchoring tab of the valve threaded over the guidewire. In some embodiments, an A2 clip can optionally be threaded onto the guidewire. The valve is released from the delivery catheter with the distal anchoring tab in an open configuration and tracking over the guidewire during release. The valve is advanced over the guidewire to move the distal side anchoring tab to a location behind the native posterior leaflet and seat the valve in the native annulus. The guidewire is withdrawn to release the distal anchoring tab to a folded position, allowing the tab to capture and sandwich the native leaflet and / or chordae between the folded tab of the valve and the peripheral wall. In some embodiments, the method can optionally include withdrawing the guidewire to an A2 clip release location to release the A2 clip to an open position, allowing the A2 clip to capture and sandwich the native leaflet and / or chordae between the A2 clip and the peripheral wall of the annulus support frame.

[0107] In some embodiments, the method can include delivering and / or deploying the valve at least partially via a single fixed curved catheter, a single deflectable catheter, an outer fixed curved catheter with an inner deflectable catheter, an outer fixed curved catheter with an inner deflectable catheter, and an outer deflectable catheter with an inner fixed curved catheter.

[0108] Any method for delivering and / or deploying a prosthetic heart valve described herein and / or any portion thereof can be similar to and / or substantially the same as one or more methods for delivering and / or deploying a prosthetic heart valve (or one or more portions thereof) described in the ‘957 PCT, the ‘010 PCT, and / or the ‘231 PCT.

[0109] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the full scope of the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Nothing herein is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate this disclosure by virtue of prior application.

[0110] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. With respect to the use of any plural and / or singular term herein, those skilled in the art can translate from the plural to the singular and / or from the singular to the plural, depending on the context and / or application. Various singular / plural arrangements can be explicitly set forth herein for purposes of clarity.

[0111] In general, the terms used herein, especially in the appended claims (for example, in the body of the appended claims), are to be interpreted in an “open” manner (for example, the term “including” is to be interpreted as “including but not limited to,” the term “having” is to be interpreted as “having at least,” and the like). Similarly, the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. As used in this document, the term “comprising” means “including, but not limited to.”

[0112] As used herein, the term “and / or” or the phrase “selected from the group consisting of” or the phrase “selected from one or more of the group consisting of” includes any and all combinations of one or more of the associated listed items. It will be understood that almost any disjunctive word and / or phrase, for example, in the claims, for example, the phrases “comprising A or B” and “comprising A and B” are to be interpreted to express the possibility of including A alone, B alone, or both A and B. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.”

[0113] Unless otherwise expressly stated, all ranges disclosed herein are also intended to encompass any and all sub-ranges of the same, and the endpoints of such ranges are to be included in the ranges themselves. Any listed range can be expressed as a range including any and all sub-ranges unless otherwise stated. As will be understood by one of ordinary skill in the art, ranges include each individual member.

[0114] The terms "valve prosthesis," "prosthetic heart valve," and / or "prosthetic valve" can refer to a combination of a frame and leaflets or flow control structures or components, and can encompass complete replacement of an anatomical part (e.g., a new mechanical valve replacing an autologous valve), as well as a medical device that replaces and / or assists, repairs or improves an existing anatomical part (e.g., an autologous valve left in place).

[0115] The disclosed valves include a member (e.g., a frame) that can be seated within an autologous valve annulus and can serve as a mounting element for a leaflet structure, a flow control component, or a flexible shuttle or sleeve valve. Depending on the embodiment, it can or can not include such a leaflet structure or flow control component. Such a member can be referred to herein as a "annulus support frame," "tubular frame," "wire frame," "valve frame," "flange," "collar," and / or any other similar term.

[0116] The term "flow control component" can refer, in a non-limiting sense, to a leaflet structure of flexible biocompatible material (e.g., processed or unprocessed pericardium sewn or attached to an annulus support frame) having 2 leaflets, 3 leaflets, 4 leaflets that functions as a prosthetic heart valve. Such a valve can be a heart valve, such as a tricuspid valve, a mitral valve, an aortic valve, or a pulmonary valve, that opens to blood flow from atrium to ventricle during diastole and closes when ventricular systolic pressure is applied to the outer surface. The repeated opening and closing in sequence can be described as "shuttling." Flow control components are contemplated to include a variety of (bio)prosthetic artificial heart valves. Bio-prosthetic pericardial valves can include bio-prosthetic aortic valves, bio-prosthetic mitral valves, bio-prosthetic tricuspid valves, and bio-prosthetic pulmonary valves.

[0117] Any of the disclosed valve embodiments can be delivered by a trans-catheter route. The term "trans-catheter" is used to define the process of accessing, controlling, and / or delivering a medical device or instrument into a catheter lumen that is deployed into a heart chamber (or other desired location within the body), as well as items that have been delivered or controlled by such a process. Known trans-catheter routes include trans-femoral and / or trans-femoral vein, trans-brachial artery and / or trans-brachial vein, trans-carotid artery, trans-carotid vein, trans-intercostal (ribs) and / or trans-sub-xiphoid space, and the like, heart routes. In addition, trans-catheter heart routes can be via the inferior vena cava (IVC), superior vena cava (SVC), and / or via trans-atrial (e.g., fossa ovalis or lower). Trans-catheter can be synonymous with transluminal and functionally related to the term "trans-dermal" as it relates to the delivery of a heart valve. The term "lumen" as used herein can refer to the interior of a cylinder or tube. The term "bore" can refer to the internal diameter of a lumen.

[0118] The mode of cardiac access can be based at least in part on the "body passageway" that can be used to define a blood conduit or vessel within the body, the particular application of a disclosed prosthetic valve embodiment dictating the body passageway in question. For example, an aortic valve replacement will be implanted within or adjacent to the aortic annulus. Likewise, a tricuspid or mitral valve replacement will be implanted at the tricuspid or mitral annulus. Certain features can be particularly advantageous for one or the other implantation site. However, unless the combination is structurally impossible, or excluded by the claim language, any valve embodiment described herein can be implanted in any body passageway.

[0119] As used herein, the term "expandable" can refer to a heart valve component that is capable of expanding from a first delivery diameter to a second implanted diameter. Thus, an expandable structure does not mean a structure that can undergo slight expansion due to a temperature increase or other incidental cause. Rather, "non-expandable" should not be interpreted to mean completely rigid or dimensionally stable, as some degree of slight expansion can be observed, for example, with conventional "non-expandable" heart valves.

[0120] Any disclosed valve embodiment can be delivered by traditional transcatheter delivery techniques or by orthogonal delivery techniques. For example, traditional delivery of a prosthetic valve can entail having a central annular axis of the valve substantially parallel to a longitudinal axis of a delivery catheter. Typically, the valve is compressed in a radial direction relative to the central cylindrical axis and advanced through a lumen of the delivery catheter. The valve is deployed from an end of the delivery catheter and expands radially outward from the central annular axis.

[0121] As used herein, the terms "laterally delivered," "laterally deliver," "orthogonally delivered," "orthogonally deliver," and the like are used interchangeably to describe such delivery methods and / or valves delivered using such methods. Lateral or orthogonal delivery of a prosthetic valve can entail having a central annular axis of the valve substantially orthogonal to a longitudinal axis of a delivery catheter. With orthogonal delivery, the valve is compressed (or otherwise reduced in size) in a direction substantially parallel to the central cylindrical axis and / or in a transverse direction relative to the central cylindrical axis. As such, a longitudinal axis (e.g., a longitudinal axis) of an orthogonally delivered valve is substantially parallel to a longitudinal axis of a delivery catheter. In other words, in contrast to the traditional process of compressing and delivering a transcatheter prosthetic valve, an orthogonally delivered prosthetic valve is compressed and / or delivered at an angle of approximately 90 degrees. Moreover, prosthetic valves configured for orthogonal delivery and processes for delivering such valves are described in detail in the '957 PCT and / or '010 PCT, incorporated by reference above.

[0122] In mathematics, the term "orthogonal" refers to an intersection angle of 90 degrees between two lines or two planes. As used herein, the term "substantially orthogonal" refers to an intersection angle of 90 degrees plus or minus an appropriate tolerance. For example, "substantially orthogonal" can refer to an intersection angle ranging from 75 degrees to 105 degrees.

[0123] As used herein, the term "tissue anchor" generally refers to a fastening device that connects a portion of the outer frame of a prosthesis to autologous annular tissue, typically located at or near the periphery of the annulus of a prosthetic valve. The tissue anchor can be positioned to avoid piercing the tissue and rely solely on the compressive force of the two plate-like annular rings on the captured tissue, or the tissue anchor (with or without an integrated fixing wire) can pierce the autologous tissue to provide anchoring, or the tissue anchor can be presented as a combination of the two. The tissue anchor can have a fixing mechanism, such as a prong, a groove, a flanged shoulder, a lock, one or more holes, etc. In some embodiments, the fixing mechanism can be attached or anchored to a portion of the outer frame by any attachment or anchoring mechanism, including a knot, a suture, a wire curl, a wire lock, a cam mechanism, or a combination.

[0124] Any prosthetic valve and / or its components can be made of any suitable biocompatible material or combination of materials. For example, the outer valve frame, the inner valve frame (e.g., the inner valve frame of the inner flow control component), and / or its components can be made of biocompatible metals, metal alloys, metals coated with polymers, etc. Suitable biocompatible metals and / or metal alloys can include stainless steel (e.g., 316L stainless steel), cobalt-chromium (Co-Cr) alloys, nickel-titanium alloys (e.g., NiTi alloys), and the like. ) etc. In addition, any outer or inner frame described herein may be made of a superelastic or shape memory alloy such as nickel titanium alloy (e.g. ) is formed. Suitable polymer coatings may include polyethylene vinyl acetate (PEVA), polybutyl methacrylate (PBMA), trans-styrene isoprene butadiene (SIBS) copolymer, polylactic acid, polyester, polylactide, D-lactic acid polylactic acid (DLPLA), polylactic-co-glycolic acid (PLGA), and the like. Some such polymer coatings may form suitable carrier matrices for drugs (e.g., sirolimus, zotarolimus, Biolimus, novolimus, tacrolimus, paclitaxel, probucol, and the like).

[0125] Some biocompatible synthetic materials can include, for example, polyesters, polyurethanes, polytetrafluoroethylene (PTFE) (e.g., Teflon), and the like. When considering thin, durable synthetic materials (e.g., for covering), synthetic polymeric materials such as expanded PTFE or polyester can optionally be used. Other suitable materials can optionally include elastomers, thermoplastics, polyurethanes, thermoplastic polycarbonate urethanes, polyether urethanes, segmented polyether urethanes, silicone polyether urethanes, polyether ether ketone (PEEK), silicone-polycarbonate urethanes, polypropylene, polyethylene, low density polyethylene (LDPE), high density polyethylene (HDPE), ultra-high density polyethylene (UHDPE), polyolefins, polyethylene glycol, polyether sulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, polyesters, polyethylene terephthalate (PET) (e.g., Dacron), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide / glycolide) copolymer (PDLA), silicone polyesters, polyamides (nylons), PTFE, elongated PTFE, expanded PTFE, siloxane polymers and / or oligomers, and / or polylactones, and block copolymers using the same.

[0126] Any of the external valve frame, the internal valve frame (e.g., the internal valve frame of the flow control component), and / or portions or components thereof can be partially or completely covered with a biocompatible material, such as pericardium, on the inside or outside. The valve frame can also optionally be partially or completely covered on the outside with a second biocompatible material, such as a polyester or ) on the outside. The disclosed embodiments can use tissue, such as biological tissue that is chemically stabilized pericardial tissue of an animal such as a cow (bovine pericardium), a sheep (ovine pericardium), a pig (porcine pericardium), or a horse (equine pericardium). Preferably, the tissue is bovine pericardium tissue. Examples of suitable tissue include the products and All of the tissue used in the products currently used in surgical procedures and marketed as being harvested from cows generally less than 30 months.

[0127] The embodiments herein and their various features or advantageous details will be explained more fully with reference to the non-limiting embodiments shown in the accompanying drawings and described in detail in the following description. The description of known components and processing techniques has been omitted to avoid unnecessarily obscuring the embodiments herein. The embodiments used herein are merely for the purpose of facilitating understanding of the manner in which the embodiments herein may be implemented, and further to enable those skilled in the art to implement the embodiments herein. Therefore, the embodiments should not be construed as limiting the scope of the embodiments herein. On the contrary, these embodiments are provided to make this disclosure comprehensive and complete, and to fully convey the scope of the inventive concept to those skilled in the art. Throughout the text, identical numerals represent identical elements.

[0128] FIGS. 1A-1E 1 is an illustration of various schematic diagrams of a transcatheter prosthetic valve 102 according to an embodiment. The transcatheter prosthetic valve 102 is configured to be deployed in a desired location within a body (e.g., the body of a human patient) and to allow blood to flow through an inflow end of the transcatheter prosthetic valve 102 in a first direction and to prevent blood from flowing through an outflow end of the transcatheter prosthetic valve 102 in a second direction opposite to the first direction. For example, the transcatheter prosthetic valve 102 can be a transcatheter prosthetic heart valve configured to be deployed within the annulus of a native tricuspid valve or a native mitral valve of a human heart to supplement and / or replace the functioning of the native valve.

[0129] Transcatheter prosthetic valve 102 (also referred to herein as a "prosthetic valve" or simply "valve") is compressible and expandable in at least one direction relative to a long axis 111 (also referred to herein as a "horizontal axis," "longitudinal axis," or "longitudinal axis") of valve 102. The valve 102 is in an expanded configuration (e.g., a "valve") for implantation at a desired location within the body (e.g., a human heart). FIG. 1A 、 FIG. 1C and FIG. 1E ) and a compressed configuration for introduction into the body using a delivery catheter 172 ( FIG. 1B and FIG. 1D ) is compressible and expandable.

[0130] In some embodiments, the valve 102 can be centered, or radially symmetric. In other embodiments, the valve 102 can be eccentric, or radially asymmetric with respect to the y-axis or central axis 113. In some eccentric embodiments, the valve 102 (or an outer frame thereof) can have a D-shape (as viewed from the top), and thus a flat portion can match the anatomy in which the valve 102 is to be deployed. For example, in some cases, the valve 102 can be deployed in a tricuspid annulus, and can have a complex shape determined by the anatomy in which the valve 102 is installed. In the tricuspid annulus, the circumference of the tricuspid valve can be a circular ellipse, the septal wall is known to be substantially vertical, and the tricuspid valve is known to enlarge along the anteroposterior line in a diseased state. In other cases, the valve 102 can be deployed in a mitral annulus (e.g., near the anterior leaflet), and can have a complex shape determined by the anatomy in which the valve 102 is installed. For example, in the mitral annulus, the circumference of the mitral valve can be a circular ellipse, the septal wall is known to be substantially vertical, and the mitral valve is known to enlarge in a diseased state.

[0131] In some embodiments, the valve 102 (and / or at least a portion thereof) can begin in a generally tubular configuration, and can be heat-shaped and / or otherwise shaped into any desired shape. In some embodiments, the valve 102 can include an upper atrial cuff or flange for atrial sealing and a lower transannular portion (e.g., a body portion, a tubular portion, a cylindrical portion, etc.) having an hourglass cross-section over about 60-80% of the circumference to conform to the native annulus along the posterior and anterior annular segments, while remaining substantially vertically flat along 20-40% of the annular circumference to conform to the septal annular segment. Although the valve 102 is shown in FIGS. 1A-1E as having a given shape, it should be understood that the size and / or shape of the valve 102 (and / or at least a portion thereof) can be based on the size and / or shape of the anatomy of the native tissue.

[0132] As shown, the valve 102 generally includes an annulus support frame 110 and a flow control component 150. Additionally, the valve 102 and / or at least the annulus support frame 110 of the valve 102 optionally can include one or more anchoring elements. For example, in the embodiment shown in FIGS. 1A-1E the annulus support frame 110 includes at least a distal anchoring element 132. In other embodiments, the annulus support frame 110 can optionally include a proximal anchoring element 134, an anterior anchoring element 135, and / or any other suitable anchoring element FIGS. 1A-1EIn some embodiments, the distal anchor element 132, the proximal anchor element 134, and the anterior anchor element 135 can be lower anchor elements, and the valve 102 and / or the annulus support frame 110 can include one or more upper anchor elements (e.g., a distal upper anchor element, a proximal upper anchor element, etc. (not shown)). In some embodiments, the valve 102 and / or aspects or portions thereof can be similar and / or substantially identical to the valves (and / or their corresponding aspects or portions) described in detail in the ‘957 PCT, the ‘010 PCT, and / or the ‘231 PCT, incorporated by reference above. Accordingly, certain aspects, portions, and / or details of the valve 102 can not be described in further detail herein.

[0133] The annulus support frame 110 (also referred to herein as a “tubular frame,” a “valve frame,” a “wire frame,” an “outer frame,” or a “frame”) can have or can define a bore or central passage 114 extending along a central axis 113 (e.g., a y-axis). The central passage 114 (e.g., a central axial lumen or passage) can be sized and configured to receive the flow control component 150 over a portion of the diameter of the central passage 114. The frame 110 can have an outer circumferential surface for engaging native annulus tissue, which can be tensioned against an inner aspect of a native annulus to provide structural continuity to a weakened native annulus ring.

[0134] The frame 110 includes a cuff or collar (not shown) and spans an annulus portion, a body portion, and / or a tubular portion (not shown). The cuff or collar (referred to herein as a “collar”) can be attached to and / or can form an upper edge of the frame 110. The collar can be an atrial collar when the valve 102 is deployed within a human heart. The collar can be shaped to conform to a native deployment site. For example, in a mitral valve replacement, the collar can have varying portions to conform to a native valve and / or a portion of an atrial floor surrounding a mitral valve. In some embodiments, the collar will have distal and proximal upper collar portions. The distal collar portion can be larger than the proximal upper collar portion, accounting for annulus geometry, supra-annular geometry, and / or sub-annular geometry. Examples of collars are described below with reference to particular embodiments.

[0135] The frame 110 can optionally have a separate atrial cuff attached to the upper (atrial) rim of the frame 110 for deployment on the atrial floor for directing blood from the atrium into the flow control component 150 and for sealing against blood leakage (paravalvular leakage) around the frame 110. The frame 110 can also optionally have a separate ventricular cuff attached to the lower (ventricular) rim of the frame 110 for deployment in the ventricle just below the native valve annulus for preventing regurgitation leakage during heart contraction, for preventing the valve 102 from moving out during heart contraction, for clamping or compressing the native valve annulus or adjacent tissue against the atrial cuff or collar, and / or optionally for attaching to the flow control component 150 and supporting the flow control component. Some embodiments can have both an atrial cuff and a ventricular cuff, while other embodiments include a single atrial cuff, a single ventricular cuff, or no additional cuff structure. In some embodiments, the atrial cuff and / or the ventricular cuff can be formed separately from the transannular portion or body portion of the frame 110 and can be coupled to the transannular portion by any suitable coupling method (e.g., suturing, bonding, welding, etc.). In other embodiments, the atrial cuff and / or the ventricular cuff can be integrally and / or monolithically formed with the transannular portion or body portion of the frame 110.

[0136] The frame 110 and / or at least the transannular portion or body portion thereof can be a ring, a cylindrical tube, a conical tube, a D-shaped tube, and / or any other suitable annular shape. In some embodiments, the frame 110 and / or at least the transannular portion or body portion thereof can have a side profile that is a flat cone shape, an inverted flat cone shape (narrower at the top, wider at the bottom), a concave cylinder (walls curved inward), a convex cylinder (walls bulging outward), an angular hourglass, a curved graduated hourglass, a ring or cylinder with a flared top, a flared bottom, or both. The frame 110 can have a height in a range of about 5 mm to 60 mm, can have an outer diameter dimension R in a range of about 20 mm to 80 mm, and can have an inner diameter dimension in a range of about 21 mm to 79 mm, taking into account the thickness of the frame 110 (e.g., the wire material forming the frame 110).

[0137] Frame 110 can be compressible for delivery, and when released, it is configured to return to its original (uncompressed) shape. Frame 110 can be built as a wire, braided wire, or laser cut wire frame. In some embodiments, frame 110 can include and / or can form a set of compressible wire elements having an orientation and element geometry that is substantially orthogonal to central vertical axis 113 to minimize wire element strain when frame 110 is in a vertically compressed configuration, a rolled and compressed configuration, or a folded and compressed configuration. In some implementations, frame 110 can include and / or can be formed of shape memory elements, allowing frame 110 to self-expand. In some cases, suitable shape memory materials can include durable and biocompatible metals and / or plastics. For example, frame 110 can be made of a super-elastic metal wire such as Nitinol wire or other functionally equivalent materials. In some embodiments, frame 110 can be formed of stainless steel, cobalt-chrome alloy, titanium, and / or other functionally equivalent metals and / or alloys. In other embodiments, frame 110 can be formed of any suitable material, and can be expanded from a compressed configuration using a transcatheter expansion balloon or the like.

[0138] Frame 110 can also have and / or form additional functional elements (e.g., loops, anchors, etc.) for attaching accessory components, such as biocompatible coverings, tissue anchors, releasable deployment and retrieval control guides, knobs, attachments, rigging, etc. Frame 110 can optionally be covered, in whole or in part, internally or externally, with a biocompatible material such as pericardium, polyester, and / or the like. In some implementations, frame 110 (or aspects and / or portions thereof) can be structurally and / or functionally similar to the frames (or corresponding aspects and / or portions thereof) described in detail in '957 PCT, '010 PCT, and / or '231 PCT.

[0139] As described above, the frame 110 and / or the valve 102 can include at least a distal anchor element 132. In some embodiments, the frame 110 and / or the valve 102 can include the distal anchor element 132 as well as a proximal anchor element 134 and / or an anterior anchor element 135. The anchor elements of the valve 102 and / or the frame 110 can be any suitable shape, size, and / or configuration, such as any of those described in detail in the '957 PCT, the '010 PCT, and / or the '231 PCT, and / or any of those described herein with respect to particular embodiments. For example, the distal, proximal, and anterior anchor elements 132, 134, and 135 can be lower anchor elements (e.g., coupled to and / or included in a lower portion of the frame 110). In some embodiments, the frame 110 and / or the valve 102 can also optionally include one or more distal upper anchor elements, one or more proximal upper anchor elements, and / or one or more any other suitable anchor elements. The anchor elements of the frame 110 can include and / or can be formed from a wire loop or wire frame extending about 10-40 mm away from the frame 110, an integrated frame portion, and / or a stent.

[0140] In some embodiments, the frame 110 can optionally include a guidewire coupler 133 configured to selectively engage and / or receive a portion of a guidewire or a portion of a guidewire assembly. In certain embodiments, the distal lower anchor element 132 can form and / or can include a feature forming the guidewire coupler 133. In other embodiments, the guidewire coupler 133 can be attached to any suitable portion of the frame 110, to the proximal anchor element 134, to the anterior anchor element 135, and / or to any other anchor element and / or feature of the frame 110 (e.g., a distal or proximal upper anchor element). In some embodiments, the guidewire coupler 133 is configured to allow a portion of a guidewire to extend through a bore of the guidewire coupler 133, thereby allowing the valve 102 to be advanced over or along the guidewire. In some embodiments, the guidewire coupler 133 can selectively allow a guidewire to be advanced therethrough while blocking or preventing other elements and / or components, such as a pusher, etc.

[0141] In some embodiments, the distal anchor element 132 can include the guidewire coupler 133 and can be configured to transition between one or more states and / or configurations based at least in part on interaction with a guidewire. For example, in some embodiments, the distal anchor element 132 can have and / or can be placed in an extended configuration when a guidewire is coupled to and / or otherwise extends through the guidewire coupler 133, and can have and / or can be placed in a collapsed or folded configuration when the guidewire is released from the guidewire coupler 133.

[0142] The anchoring elements 132, 134, and 135 of the valve 102 can be configured to engage desired portions of autologous tissue to install the frame 110 into the annulus of an autologous valve in which the valve 102 is deployed. For example, in some embodiments, the distal anchoring element 132 can extend from a lower distal side of the frame 110 and into the RVOT or LVOT. In such embodiments, the distal anchoring element 132 can be shaped and / or biased such that the distal anchoring element 132 exerts a force on tissue below the annulus that is operable to at least partially secure a distal portion of the valve 102 in the autologous annulus. In some embodiments, the proximal anchoring element 134 can be, for example, a proximal lower anchoring element and can be configured to engage tissue below the annulus on a proximal side of the autologous annulus to help secure the valve 102 in the annulus. Likewise, the anterior anchoring element 134 can be an anterior lower anchoring element that can engage tissue below the annulus on an anterior side of the autologous annulus to help secure the valve 102 in the annulus.

[0143] In some embodiments, the distal anchoring element 132, the proximal anchoring element 134, and / or the anterior anchoring element 135 can be configured to transition, move, and / or otherwise reconfigure between a first configuration in which the anchoring element 132, 134, and / or 135, respectively, extends a first amount or distance from the frame 110 and a second configuration in which the anchoring element 132, 134, and / or 135, respectively, extends a second amount or distance from the frame 110. For example, in some embodiments, the anchoring element 132, 134, and / or 135 can have a first configuration in which the anchoring element 132, 134, and / or 135 is in a compressed, undeployed, folded, and / or constrained state (e.g., a position proximate, adjacent, and / or contacting the transannular portion of the frame 110) and a second configuration in which the anchoring element 132, 134, and / or 135 is in an expanded, extended, deployed, unfolded, and / or unconstrained state (e.g., extending from the transannular portion of the frame 110). As described in further detail herein, any of the anchoring elements 132, 134, and / or 135 can be actuated between and / or otherwise transition between the first configuration and the second configuration during deployment to selectively engage autologous tissue, chordae, and / or any other anatomical structure to help secure the valve 102 in the autologous annulus.

[0144] Flow control component 150 can refer, in a non-limiting sense, to a device for controlling fluid flow therethrough. In some embodiments, flow control component 150 can be a leaflet structure having 2-leaflet, 3-leaflet, 4-leaflet, or more leaflets, made of a flexible biocompatible material such as treated or untreated pericardium. The leaflets can be sewn or attached to a support structure such as an inner frame, which in turn can be sewn or attached to outer frame 110. For example, in some embodiments, flow control component 150 can be coupled to frame 110 (e.g., to a drum, collar portion, across the annulus portion, etc.) by tissue, a biocompatible mesh, one or more woven or knitted fabrics, one or more super-elastic or shape memory alloy structures that are sewn, stitched, and / or otherwise secured to a portion of the frame. In some embodiments, flow control component 150 (or portions and / or aspects thereof) can be similar to any of the flow control components described in, for example, '231 PCT.

[0145] In some embodiments, flow control component 150 and / or its inner frame can have a substantially cylindrical or tubular shape (see, e.g., FIG. 1C ) when valve 102 is in an expanded configuration, and can be configured to elastically deform (see, e.g., FIG. 1B and FIG. 1D ) when valve 102 is in a compressed configuration. The inner frame and / or portions or aspects thereof can be similar in at least form and / or function to outer frame 110 and / or portions or aspects thereof. For example, the inner frame can be compressed to facilitate delivery, and when released, is configured to return to its original (uncompressed) shape. The inner frame can be formed of a shape memory element that allows the inner frame to self-expand. In some cases, suitable shape memory materials can include durable and biocompatible metals and / or plastics, such as Nitinol.

[0146] The inner frame of flow control component 150 can be similar in at least form and / or function to the inner frame of flow control component 150 described in '231 PCT. For example, the inner frame can be built as a wire, braided wire, or laser cut wire frame. In some embodiments, the inner frame can include and / or can form a set of compressible wire units having an orientation and unit geometry that is substantially normal to the axis of flow control component 150 to minimize wire unit strain when the inner frame is in a compressed configuration. In some embodiments, the inner frame can have and / or can form any suitable number of elastically deformable diamond or eye-shaped wire units, etc. While in FIGS. 1A-1ENot shown, but in some embodiments, the internal frame can include and / or can be formed with two halves that can be coupled together to allow the internal frame to elastically deform or fold along or in the direction of the transverse axis 115 in response to lateral compression, as further described in detail herein.

[0147] The flow control component 150 can be mounted within the frame 110 and configured to allow blood to flow through the inflow end of the valve in a first direction and to prevent blood from flowing through the outflow end of the valve in a second direction opposite to the first direction. For example, the flow control component 150 can be configured such that the valve 102 functions as a heart valve, such as a tricuspid valve, a mitral valve, an aortic valve, or a pulmonary valve, which can open to blood flowing from the atria to the ventricles during diastole and can close due to ventricular systolic pressure applied to the outer surface. This repeated opening and closing in sequence can be described as "reciprocating."

[0148] like FIGS. 1A-1D As shown, the flow control component 150 is mounted within the central channel 114 of the frame 110. More specifically, the flow control component 150 can be mounted within the central channel 114 such that an axis of the flow control component 150 extending in the direction of blood flow through the flow control component 150 is substantially parallel to the central axis 113 of the frame 110. In some embodiments, the flow control component 150 can be centered within the central channel 114 of the frame 110. In other embodiments, the flow control component 150 can be positioned at an off-center position within the central channel 114. In some embodiments, the central channel 114 can have a diameter and / or circumference that is greater than the diameter and / or circumference of the flow control component 150. Although in FIGS. 1A-1E 150. Although not shown, in some embodiments, the valve 102 can include a spacer or the like that can be positioned within the central passage 114 adjacent the flow control component 150. In other embodiments, the spacer can be a cover or the like that is coupled to a portion of the frame 110 and configured to cover a portion of the central passage 114. In some cases, the spacer can be used to facilitate coupling of the flow control component 150 to the frame 110.

[0149] As described above, the valve 102 is compressible and expandable between an expanded configuration and a compressed configuration. The valve 102 can have a first height or dimension along the central axis 113 when in the expanded configuration, and can have a second height or dimension along the central axis 113 that is less than the first height or dimension when in the compressed configuration. The valve 102 can also be compressed in other directions. For example, the valve 102 can be compressed along a transverse axis 115 that is perpendicular to both the longitudinal axis 111 and the central axis 113 (see, e.g., FIG. 1 ). FIG. 1D ).

[0150] Valve 102 is compressed during delivery of valve 102 and is configured to expand once released from a delivery catheter. More specifically, valve 102 is configured to be delivered transcatheterly to a desired location within the body (e.g., an annulus of a native valve) at which valve 102 is compressed in an orthogonal or transverse direction (e.g., along central axis 113 and / or transverse axis 115) relative to the size of valve 102 in an expanded configuration. During delivery, longitudinal axis 111 of valve 102 is substantially parallel to a longitudinal axis of a delivery catheter. In orthogonal delivery, longitudinal axis 111 is oriented at an intersection angle between 45 degrees and 135 degrees (e.g., perpendicular or about 90 degrees) relative to central axis 113 and in a substantially parallel orientation relative to a longitudinal cylindrical axis of the delivery catheter.

[0151] Valve 102 is in an expanded configuration prior to being loaded into a delivery catheter and / or after being released from a delivery catheter and deployed or implanted (or ready to be deployed or implanted) at a desired location in the body. The shape of the expanded valve 102 can be a large diameter shortened cylinder with an extended collar (e.g., a skirt). When in the expanded configuration as shown in FIG. 1A , FIG. 1C and FIG. 1E Valve 102 has an extent in any direction orthogonal or transverse to longitudinal axis 111 (e.g., along central axis 113 and / or transverse axis 115) that is greater than an inner lumen diameter of a delivery catheter used to deliver valve 102 when in the expanded configuration as shown. For example, in some embodiments, valve 102 can have an expanded height (e.g., along central axis 113) of 5-60 mm. In certain embodiments, valve 102 can have an expanded height including, for example, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, and 60 mm, and / or any size or fraction of a size therebetween. In some embodiments, valve 102 can have an expanded diameter length (e.g., along longitudinal axis 111) and width (e.g., along transverse axis 115) of about 20-80 mm or about 40-80 mm. In certain embodiments, valve 102 can have an expanded length and / or width including, for example, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, and 80 mm, and / or any size or fraction of a size therebetween.

[0152] When in the expanded configuration as shown in FIG. 1B and FIG. 1DIn the illustrated compressed configuration, the valve 102 has a degree of height (e.g., along the central axis 113) and width (e.g., along the transverse axis 115) that is less than the diameter of the delivery catheter lumen in any direction orthogonal or transverse to the longitudinal axis 111, thereby allowing the valve 102 to be delivered therethrough. For example, in some embodiments, the valve 102 can have a compressed height (e.g., along the central axis 113) and a compressed width (e.g., along the transverse axis 115) of about 6-15 mm, about 8-12 mm, or about 9-10 mm. In certain embodiments, the valve 102 can have a compressed height and / or width including, for example, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, and 15 mm, and / or any size or fraction of a size therebetween. The valve 102 can be compressed by compression, rolling, folding, and / or any other suitable manner or combination thereof, as described in detail in '957 PCT, '010 PCT, and / or '231 PCT. In some embodiments, it is contemplated that the length of the valve 102 (e.g., along the longitudinal axis 111) is not compressed for delivery. Rather, in some embodiments, the length of the 102 can increase in response to compression of the valve 102 along the central axis 113 and / or the transverse axis 115.

[0153] Although not shown in FIGS. 1A-1E , in some implementations, the delivery system can include one or more features or components configured to deliver the valve 102 to a desired location within the body (e.g., an annulus of a native valve). For example, the delivery system can include a delivery catheter, a positioning tool, and a guidewire. The delivery system can be configured to deliver the compressed valve 102 and / or a portion of the valve 102 (e.g., the compressed frame 110 or the compressed flow control component 150) orthogonally to a desired location within the body (e.g., an annulus of a native tricuspid valve and / or an annulus of a native mitral valve of a human heart). For example, the delivery catheter can be 12-34 Fr with any suitable corresponding lumen diameter and / or a lumen diameter sufficient to receive the prosthetic valve 102 in the compressed configuration. In some implementations, the delivery system and / or aspects or portions thereof can be substantially similar in at least form, function, and / or operation to those described in detail in '957 PCT, '010 PCT, and / or '231 PCT.

[0154] As FIG. 1EAs shown, valve 102 can be delivered into, for example, an atrium of a human heart, and positioned within an annulus of a native valve, such as a pulmonary valve (PV), a mitral valve (MV), an aortic valve (AV), and / or a tricuspid valve (TV). As described above, valve 102 can be in a compressed configuration, delivered to the annulus by a delivery system, and released from the delivery system and allowed to expand to an expanded configuration. For example, valve 102 can be delivered into an atrium of a human heart and released from a delivery catheter (not shown) by any of the delivery systems, devices, and / or methods described in detail in '957 PCT, '010 PCT, and / or '231 PCT.

[0155] In some embodiments, delivery of valve 102 can include advancing a guidewire into an atrium of a human heart, through a native valve, and to a desired location within a ventricle (e.g., RVOT or LVOT). After positioning the guidewire, a delivery catheter can be advanced along and / or over the guidewire and into the atrium (e.g., via an IVC, an SVC, and / or a transseptal approach). In some implementations, guidewire coupler 136 can be coupled to a proximal portion of the guidewire, and valve 102 can be placed in a compressed configuration, allowing valve 102 to be advanced along the guidewire and through a lumen of the delivery catheter and into the atrium.

[0156] Deployment of valve 102 can include placing distal anchoring element 132 (e.g., distal lower anchoring element 132) in a ventricle (RV, LV) below the annulus, while the remaining portion of valve 102 is in an atrium (RA, LA). In some cases, distal anchoring element 132 can be advanced over and / or along a guidewire to a desired location within a ventricle (e.g., an outflow tract of a ventricle). For example, in some embodiments, valve 102 can be delivered to an annulus of a native tricuspid valve (TV), and at least a portion of distal anchoring element 132 can be positioned in the RVOT. In other embodiments, valve 102 can be delivered to an annulus of a native mitral valve (MV), and at least a portion of distal anchoring element 132 can be positioned in the LVOT.

[0157] In some embodiments, the distal anchoring element 132 can be placed and / or transitioned from the first or collapsed configuration to the second or extended configuration during delivery and / or deployment prior to the valve 102 being fully seated in the native annulus. In some embodiments, the distal anchoring element 132 can be in the second or extended configuration, for example, due to the guidewire coupler 136 being coupled to and / or otherwise engaged with the guidewire. Thus, the distal anchoring element 132 can be in the second or extended configuration when the distal anchoring element 132 is inserted through the native annulus and into the ventricle. In some cases, the distal anchoring element 132 can extend around and / or through one or more portions of native tissue, chordae tendinae, etc., which can allow the distal anchoring element 132 to capture and / or engage the native tissue, chordae tendinae, etc., at which point the distal anchoring element 132 transitions and / or returns to the first configuration, as described in further detail herein.

[0158] In some embodiments, the prosthetic valve 102 can be temporarily held in a partially deployed state. For example, the valve 102 can be partially inserted into the annulus and held at an angle relative to the annulus to allow blood to partially flow from the atrium to the ventricle through the native valve annulus around the valve 102, and partially through the valve 102, which can allow for assessment of valve function.

[0159] The valve 102 can be placed or seated in the annulus (PVA, MVA, AVA, and / or TVA) of a native valve (PV, MV, AV, and / or TV) such that the trans-annular portion of the valve frame 110 extends through the annulus and into the ventricle, while the collar (e.g., atrial collar) remains at a position above the annulus in the atrium (for a tricuspid or mitral valve annulus, or the aorta (for an aortic annulus), or the pulmonary artery (for a pulmonary annulus)). For example, in some embodiments, a positioning tool and / or pusher (not shown) can be used to push at least a proximal portion of the valve 102 into the annulus. In some embodiments, the proximal anchoring element 134 can be held in its first configuration when the valve 102 is seated in the annulus. For example, as described above, the proximal anchoring element 134, when in the first configuration, can be in contact with, adjacent to, and / or proximate to the trans-annular portion of the frame 110, which in turn can limit the entire circumference of the lower portion of the frame 110, thereby allowing the trans-annular portion of the frame 110 to be inserted through the annulus.

[0160] Once deployed, the proximal anchoring element 134 can be transitioned from its first configuration to its second configuration, as described in detail in the '010 PCT. Thus, once the valve 102 is deployed in the annulus, the proximal anchoring element 134 can be placed in its second configuration in which it contacts, engages the tissue below the valve and / or is otherwise disposed adjacent to the tissue below the valve. In some embodiments, the proximal anchoring element 134 can be configured to engage and / or capture autologous tissue, chordae tendinae, and the like when the proximal anchoring element 134 is disposed in the ventricle. For example, in some embodiments, after the valve 102 is deployed in the annulus, the proximal anchoring element 134 can be transitioned from the first (compressed) configuration to the second (extended) configuration such that the proximal anchoring element 134 extends around and / or through one or more portions of autologous tissue, chordae tendinae, and the like. The proximal anchoring element 134 can then be returned to the first configuration to capture and / or secure one or more portions of autologous tissue, chordae tendinae, and the like between the proximal anchoring element 134 and the transannular portion of, for example, the outer frame 110. In other embodiments, after the valve 102 is deployed in the autologous annulus, the proximal anchoring element 134 can be maintained in the second (extended) configuration. In such embodiments, the proximal anchoring element 134 can contact and / or engage the tissue below the annulus on the proximal side of the annulus, for example, such that the proximal anchoring element and the proximal portion of the atrial cuff exert a compressive force on the proximal portion of the annulus tissue.

[0161] In embodiments in which the valve 102 includes the optional anterior anchoring element 135, the anterior anchoring element 135 can be in a first (compressed or retracted) configuration prior to the valve 102 being fully deployed in the autologous annulus, as described above with reference to the proximal anchoring element 134. As such, the circumference of the transannular portion can be small enough to allow the transannular portion to be inserted through the annulus of the autologous valve. Once deployed, the anterior anchoring element 135 can be transitioned from its first configuration to its second (extended) configuration. For example, in some embodiments, the valve 102 and / or the frame 110 can include a sleeve, conduit, tube, channel, or the like in which a first portion of the anterior anchoring element 135 is disposed when in the first configuration and a second portion of the anchoring element 135, smaller than the first portion, is disposed within the sleeve, conduit, tube, channel, or the like when transitioned to the second configuration. In other words, the anterior anchoring element 135 can extend from the sleeve, conduit, tube, channel, or the like when in the second configuration.

[0162] In some embodiments, the front anchoring element 135 can form a hook or clip when in the second configuration. For example, the front anchoring element 135 can be formed of a shape memory alloy or the like that is biased or heat-set into the shape or configuration of a hook or clip. In some embodiments, this arrangement can allow the front anchoring element 135 to extend around and / or through a portion of autologous tissue, chordae tendineae, etc. The front anchoring element 135 can then be actuated, transformed, moved back to the first (compressed or folded) configuration from the second (extended) configuration. For example, the front anchoring element 135 can be retracted or at least partially retracted into a cannula, catheter, tube, channel, etc. of the valve 102. When the anterior anchoring element 135 is positioned around autologous tissue, chordae tendinea, etc., positioned through autologous tissue, tendon, etc. and / or the anterior anchoring element 135 is otherwise engaged with autologous tissue, tendon, etc., the transition of the anterior anchoring element 135 from the second configuration to the first configuration may cause the anterior anchoring element 135 to capture and / or secure at least a portion of the autologous tissue, chordae tendinea, etc. between the anterior anchoring element 135 and, for example, the trans-annular portion of the frame 110.

[0163] Thus, the distal anchoring element 132 can be configured to engage autologous tissue on the distal side of the annulus, the proximal anchoring element 134 can be configured to engage autologous tissue on the proximal side of the annulus, and the anterior anchoring element 135 can be configured to engage autologous tissue on the anterior side of the annulus, thereby securely positioning the valve 102 in the autologous annulus, as shown in FIG. FIG. 1E shown.

[0164] Although not in FIGS. 1A-1E , but in some embodiments, the valve 102 and / or the delivery system can include one or more tissue anchors that can be used to anchor one or more portions of the valve 102 to the annular tissue, as described in detail in '957 PCT. In some embodiments, the tissue anchors can be configured to pierce, puncture, and / or otherwise secure the anchoring elements 132, 134, and / or 135 and / or the atrial collar to the annular tissue. In other embodiments, the tissue anchors can be, for example, trauma anchors that are configured to secure the anchoring elements 132, 134, and / or 135 and / or the atrial collar to the annular tissue without piercing, puncturing, and / or otherwise traumatizing native tissue.

[0165] The following provides a discussion of certain aspects or embodiments of laterally deliverable transcatheter prosthetic valves (e.g., prosthetic heart valves). The transcatheter prosthetic valves (or aspects or portions thereof) described below with respect to specific embodiments may be similar in at least form and / or function to those described above with reference to the embodiments of the present invention. FIGS. 1A-1EThe described valve 102 and / or respective aspects or portions of the valve 102 are substantially similar. Similarly, the valves (or aspects or portions thereof) described below can be similar in at least form and / or function to the valves described in detail in the '957 PCT, the '010 PCT, and / or the '231 PCT. Accordingly, certain aspects and / or portions of particular embodiments are not described in further detail herein.

[0166] Any of the prosthetic valves described herein can be used to replace an autologous valve of a human heart, including, for example, a mitral valve, a tricuspid valve, an aortic valve, and / or a pulmonary valve. While examples of particular valves are described herein, it should be understood that they are given by way of example only and not by way of limitation. Thus, while some prosthetic valves are described herein as being configured to replace an autologous mitral valve or an autologous tricuspid valve, it should be understood that such prosthetic valves can be used to replace any autologous valve unless otherwise explicitly stated, or unless it would be clear to one of ordinary skill in the art that one or more components and / or features would otherwise render the prosthetic valve unsuitable for such use.

[0167] In some embodiments, the laterally deliverable transcatheter prosthetic heart valve can be configured to replace, for example, an autologous mitral valve of a human heart. FIG. 2A is an illustration of a top view of an autologous mitral valve, showing the approximate locations of the autologous leaflet anterior (A) regions Al-A2-A3 and the autologous leaflet posterior (P) regions PI-P2-P3.

[0168] FIG. 2B and FIG. 2C are illustrations of a side perspective view and an exploded view, respectively, of a laterally deliverable (orthogonally deliverable) transcatheter prosthetic heart valve 202 (also referred to herein as a "prosthetic valve" or "valve") according to an embodiment. In some implementations, the valve 202 can be deployed in, for example, an annulus of an autologous mitral valve. The valve 202 is configured to allow blood to flow in a first direction through an inflow end of the valve 202 and to prevent blood from flowing in a second direction opposite the first direction through an outflow end of the valve 202. For example, the prosthetic valve 202 can be a laterally deliverable transcatheter prosthetic heart valve configured to be deployed within an annulus of an autologous tricuspid valve or an autologous mitral valve of a human heart to supplement and / or replace the functioning of the autologous valve.

[0169] The valve 202 is compressible and expandable in at least one direction relative to an x-axis (also referred to herein as a "horizontal axis," a "longitudinal axis," a "long axis," and / or a "longitudinal axis") of the valve 202. The valve 202 is expandable from a compressed configuration for implantation at a desired location within a body (e.g., a human heart) to an expanded configuration for use in the body. FIG. 2B and FIG. 2CThe valve 202 is configured to compress and expand between compressed and expanded configurations for introduction into the body (not shown). In some embodiments, the horizontal x-axis of the valve 202 is orthogonal (90 degrees), or substantially orthogonal (75-105 degrees), or substantially oblique (45-135 degrees) to the central (vertical) y-axis when in the expanded and / or compressed configurations. Further, the horizontal x-axis of the valve 202 in the compressed configuration is substantially parallel to the longitudinal cylindrical axis of the delivery catheter in which the valve 202 is disposed.

[0170] In some embodiments, the valve 202 has an expanded or deployed height of about 5-60 mm, about 5-30 mm, about 5-20 mm, about 8-12 mm, or about 8-10 mm, and an expanded or deployed diameter (e.g., length and / or width) of about 25-80 mm or about 40-80 mm. In certain embodiments, the expanded or deployed diameter (e.g., length and / or width) can be about 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, and 80 mm (or any value or fraction of a value therebetween). In some embodiments, the valve 202 has a compressed height (y-axis) and width (z-axis) of about 6-15 mm, about 8-12 mm, or about 9-10 mm. In preferred embodiments, the length of the valve 202 (e.g., along the x-axis) is not compressed or otherwise reduced, as it can extend along the length of the central cylindrical axis of the delivery catheter.

[0171] In certain preferred embodiments, the valve 202 is centered or radially symmetric. In other preferred embodiments, the valve 202 is off-centered or radially asymmetric (e.g., along or with respect to the y-axis). In some off-centered embodiments, the cross-section of the frame 210 can be D-shaped, with a flat portion or surface configured to substantially match the annulus of the native mitral valve leaflets at or near the anterior leaflet.

[0172] Valve 202 includes an annulus-outer support frame 210 and a collapsible flow control member 250 mounted within annulus-outer support frame 210. Annulus-outer support frame 210 (also referred to herein as an "outer frame") is made of a shape memory material, such as a nickel-titanium alloy, e.g., nitinol, and is thus a self-expanding structure from a compressed configuration to an expanded configuration. Outer frame 210 has a trans-annular and / or body portion 212 that encircles, forms, and / or defines a central (inner) passage 214 about and / or along a vertical or central axis (y-axis), and has an atrial collar 220 attached circumferentially at a top edge of trans-annular and / or body portion 212 of outer frame 210. Atrial collar 220 is shaped to conform to the native deployment site. For example, in a tricuspid replacement, atrial collar 220 can have a high posterior wall portion to conform to the crux region of the native valve, and can have distal and proximal upper collar portions. The distal upper collar portion can be larger than the proximal upper collar portion to occupy more flat space above the area under the ventricular outflow tract (VOT) annulus (in the atrium). For example, in a mitral replacement, annulus collar 220 and / or outer frame 210 can be D-shaped or shaped similar to a hyperbolic paraboloid to mimic the native anatomy.

[0173] Outer frame 210 further has a proximal side 219 and a distal side 222. A distal anchoring element 232 (e.g., a super-elastic wire loop distal tab) is coupled to and / or extends from distal side 222. In some embodiments, distal anchoring element 232 is an integrated tab that is integrally built with body portion 212 of outer frame 210. Distal anchoring element 232 can vary in size and shape. For example, in some embodiments, distal anchoring element 232 (e.g., a right VOT tab) can be long enough to reach the inlet of the pulmonary artery (in the case of a tricuspid replacement).

[0174] In other embodiments, distal anchoring element 232 is shaped to conform to the Al commissure region of a mitral valve. For example, in some embodiments, distal anchoring element 232 can be about 10-40 mm in length. In addition, distal anchoring element 232 can be a reconfigurable distal anchoring element 232 that is configured to transition between, for example, a compressed, collapsed, and / or folded configuration (e.g., a first configuration) and an extended or deployed configuration (e.g., a second configuration).

[0175] For example, in some embodiments, the distal anchoring element 232 is configured to travel over a guidewire (not shown) inserted near the A1 leaflet / commisur of the mitral valve. In some embodiments, the guidewire is pre-positioned around the native mitral leaflet and / or chordae, particularly the A2 leaflet, to facilitate over-wire placement of the distal anchoring element 232 around the "backside" of the A2 leaflet, thereby clamping the native A2 leaflet against the frame 210. In some embodiments, the distal anchoring element 232 can be configured in an extended configuration to reach around the P2 and / or P3 leaflets of the native mitral valve and / or chordae associated therewith, and can be transitioned into a compressed configuration to capture and / or pin the native tissue, chordae, etc. between the distal anchoring element 232 and the transannular portion 212 of the outer frame 210.

[0176] As shown in FIG. 2, at least the outer support frame 210 of the valve 202 is covered, wrapped, and / or encased by a biocompatible covering 240. The biocompatible covering 240 can be a mesh material, pericardial tissue, a woven synthetic polyester material, and / or any other suitable biocompatible material, such as those described above. FIG. 2C A collapsible (internal) flow control member 250 is mounted within the outer frame 210. The flow control member 250 has a foldable and compressible internal wire frame 252 (also referred to as an "internal leaflet frame" or "internal frame") having two or more fold zones, hinge zones, coupling zones, elastically deformable zones, etc. A set of 2-4 flexible leaflets 261 are mounted in or on the internal frame 252. In some embodiments, the flow control member 250 has three leaflet 261 cusps or pockets mounted within the internal frame 252.

[0177]

[0178] ​Like the outer frame 210, the inner flow control member 250 is foldable and compressible. For example, the inner frame 252 is foldable along or in the direction of the z-axis from a cylindrical configuration (e.g., foldable at fold regions, etc.) into a flattened cylindrical configuration (or two-layered band), with the fold regions on the distal side and on the proximal side of the inner frame 252. Like the outer frame 210, the flow control member 250 is also vertically (y-axis) compressible to a shortened or compressed configuration. By folding (compressing) in the z-axis direction and vertically compressing in the y-axis direction, the valve 202 is allowed to maintain a relatively large dimension along the horizontal (x-axis). In some embodiments, the outer frame 210 and the flow control member 250 are reduced along the z-axis until the sidewalls contact or nearly contact. This also allows the outer frame 210 and the flow control member 250 to maintain a radius along the horizontal axis (x-axis) to minimize the number of wire units that make up the outer frame and the inner frame that can be damaged by the forces exerted during folding and / or compression that can be necessary to load into a delivery catheter.

[0179] The diameter and / or circumference of the flow control member 250 is less than the diameter and / or circumference of the central passage 214 of the outer frame 210. The flow control member 250 is mounted to or within the outer frame 210 such that the central or vertical axis (y-axis) of the inner frame 252 is parallel to the central or vertical axis (y-axis) of the outer frame 210. In some embodiments, the y-axis defined by the inner frame 252 is parallel to but offset from the y-axis defined by the outer frame 210. FIG. 2B In some embodiments, the spacer element 230 is disposed within the central passage 214 and can assist in mounting a portion of the flow control member 250 (e.g., an additional unsupported portion) to the outer support frame 210. In some embodiments, the spacer element 230 can be a cylindrical tube or frame configured to support a portion of the flow control member 250. In other embodiments, the spacer element 230 can be any suitable shape, size, and / or configuration. The spacer element 230 can be a covered or uncovered wire ring or the like that can be coupled to and / or integrated with the barrel or collar of the frame 210.

[0180] In some embodiments, the spacer element 230 can also provide controlled regurgitation of the valve 202. For example, in some embodiments, the spacer 230 can not be covered or covered with a fluid permeable mesh, cloth, and / or biocompatible material. In some embodiments, the uncovered spacer 230 can be subsequently plugged (e.g., once regurgitation is no longer needed for the proper functioning of the patient's heart) with an inserted stent, covering, plug, etc. In some embodiments, the spacer element 230 can be used for pacemaker wiring, or for punching holes for planned partial regurgitation. In embodiments that guarantee planned partial regurgitation, the use of an uncovered spacer 230 instead of the spacer element 230 provides controlled regurgitation of the valve. Once the patient no longer needs regurgitation, the uncovered spacer 230 can be subsequently plugged with a subsequently inserted stent or covering or plug.

[0181] In some embodiments, the spacer element 230 can be similar or substantially identical to the inner frame 252 of the flow control component 250, without leaflets mounted therein. In other embodiments, the spacer element 230 can include leaflets mounted therein (e.g., similar in form and / or configuration to the leaflets 261 or different in form and / or configuration from the leaflets 261). Similarly, the valve 202 can include two flow control components 250, each acting as a spacer relative to the other flow control component 250.

[0182] In certain embodiments, the inner frame 252 can have a diameter of about 25-30 mm, the outer frame 210 can have a diameter of about 50-80 mm, and the atrial cuff 220 can extend about 20-30 mm beyond the top edge of the outer frame to provide a seal on the atrial floor against paravalvular leakage (PVL). The flow control component 250 and the outer frame 210 can be foldable (e.g., in the direction of the z-axis) and / or compressible (e.g., in the direction of the y-axis) to reduce the profile of the entire valve 202 to fit within the inner diameter of a 24-36 Fr (inner diameter of 8-12 mm) delivery catheter (not shown in FIGS. 1-3). FIG. 2B and FIG. 2C In certain embodiments, the inner frame 252 can have a diameter of about 25-30 mm, the outer frame 210 can have a diameter of about 50-80 mm, and the atrial cuff 220 can extend about 20-30 mm beyond the top edge of the outer frame to provide a seal on the atrial floor to against paravalvular leakage (PVL). The flow control component 250 and the outer frame 210 can be foldable (e.g., in the direction of the z-axis) and / or compressible (e.g., in the direction of the y-axis) to reduce the profile of the entire valve 202 to fit within the inner diameter of a 24-36 Fr (inner diameter of 8-12 mm) delivery catheter (not shown in FIGS. 1-3).

[0183] FIG. 3A and FIG. 3Bare side perspective and exploded views of a laterally deliverable (orthogonally deliverable) transcatheter prosthetic heart valve 302 (also referred to herein as a "prosthetic valve" or "valve") according to embodiments. In some implementations, the valve 302 can be deployed in an annulus of a native mitral valve, for example. The valve 302 is configured to allow blood to flow through an inflow end of the valve 302 in a first direction and to prevent blood from flowing through an outflow end of the valve 302 in a second direction opposite the first direction. The valve 302 is compressible and expandable between a compressed configuration for introduction into a body using a delivery catheter (not shown in FIGS. 1A-1C) and an expanded configuration for implantation in a valve annulus of a target valve (e.g., in a human heart). FIG. 3A and FIG. 3B

[0184] The valve 302 includes an annulus-external support frame 310 and a collapsible flow control component 350 mounted within the annulus-external support frame 310. The annulus-external support frame 310 (also referred to herein as an "external frame") is made of a shape memory material, such as a nickel-titanium alloy, e.g., nitinol, and thus is a self-expanding structure from a compressed configuration to an expanded configuration. At least a portion of the external frame 310 is covered, wrapped, and / or surrounded by a biocompatible covering 340, such as those described above.

[0185] The external frame 310 has a trans-annular and / or body portion 312 that encircles, forms, and / or defines a central (internal) passage 314 about and / or along a vertical or central axis (y-axis), and has an atrial cuff 320 attached circumferentially at a top edge of the trans-annular and / or body portion 312 of the external frame 310. The external frame 310 has a proximal end side 319 and a distal end side 322.

[0186] The collapsible (internal) flow control component 350 is mounted within the external frame 310 adjacent to the covered or uncovered spacer 330. The flow control component 350 has an internal frame 352 with two or more folded regions, hinged regions, coupled regions, elastically deformable regions, etc. A set of 2-4 flexible leaflets 361 is mounted in or on the internal frame 352. Like the external frame 310, the internal flow control component 350 is foldable and compressible. The flow control component 350 is mounted to or within the external frame 310 such that a central or vertical axis (y-axis) of the internal frame 352 is coaxial and / or at least parallel (e.g., parallel but offset) to a central axis (y-axis) of the external frame 310.

[0187] FIG. 3A and FIG. 3B ​Further shown is that the valve 302 includes a distal anchor element 332 and a proximal anchor element 334. The distal anchor element 332 (e.g., a super-elastic wire loop distal tab) is coupled to and / or extends from a distal side 322 of the outer frame 310, and the proximal anchor element 334 (e.g., a super-elastic wire loop proximal tab) is coupled to and / or extends from a proximal side 319 of the outer support frame 310. In some embodiments, the distal anchor element 332 and the proximal anchor element 334 can be integral tabs that are integrally built with the main body portion 312 of the outer frame 310. The size and shape of the anchor elements 332 and 334 can vary. For example, in some embodiments, the distal anchor element 332 is shaped to conform to the Al commissure region of a mitral valve. In some embodiments, the proximal anchor element 334 is shaped to conform to the A3 commissure region of a mitral valve.

[0188] In some embodiments, at least the distal anchor element 332 is transitionable between, for example, a compressed, collapsed, and / or folded configuration (e.g., a first configuration) and an extended or deployed configuration (e.g., a second configuration). In the extended configuration, the distal anchor element 332 can reach around the P2 and / or P3 leaflets of the native mitral valve and / or chordae associated therewith, and when transitioned into the compressed configuration, the distal anchor element 332 can capture and / or pin the native tissue, chordae, etc. between the distal anchor element 332 and the transannular portion 312 of the outer frame 310.

[0189] FIG. 4A and FIG. 4B are illustrations of side perspective and exploded views, respectively, of a laterally deliverable (orthogonally deliverable) transcatheter prosthetic heart valve 402 (also referred to herein as a “prosthetic valve” or “valve”) according to embodiments. In some implementations, the valve 402 can be deployed in, for example, the annulus of a native mitral valve. The valve 402 is configured to allow blood to flow in a first direction through an inflow end of the valve 402 and to prevent blood from flowing in a second direction opposite the first direction through an outflow end of the valve 402. The valve 402 is compressible and expandable between a compressed configuration for introduction into a body using a delivery catheter (not shown in FIGS. 1A and IB) and an expanded configuration for implantation in a valve annulus of a target valve (e.g., in a human heart). FIG. 4A and FIG. 4B

[0190] ​Valve 402 includes an annulus-external support frame 410 and a collapsible flow control component 450 mounted within annulus-external support frame 410. Annulus-external support frame 410 (also referred to herein as an “external frame”) is made of a shape memory material such as nickel-titanium alloy, e.g., Nitinol, and is thus a self-expanding structure from a compressed configuration to an expanded configuration. At least a portion of external frame 410 is covered, wrapped, and / or encircled by a biocompatible covering 440 such as those described above.

[0191] External frame 410 has a trans-annular and / or body portion 412 that encircles, forms, and / or defines a central (internal) passageway 414 about and / or along a vertical or central axis (y-axis), and has an atrial cuff 420 attached circumferentially at a top edge of trans-annular and / or body portion 412 of external frame 410. External frame 410 has a proximal end side 419 and a distal end side 422.

[0192] Collapsible (internal) flow control component 450 is mounted within external frame 410 adjacent to covered or uncovered partition 430. Flow control component 450 has an internal frame 452 with two or more folded regions, hinged regions, coupled regions, elastically deformable regions, etc. A set of 2-4 flexible leaflets 461 is mounted in or on internal frame 452. Like external frame 410, internal flow control component 450 is foldable and compressible. Flow control component 450 is mounted onto or within external frame 410 such that a central or vertical axis (y-axis) of internal frame 452 is coaxial and / or at least parallel (e.g., parallel but offset) to the central axis (y-axis) of external frame 410.

[0193] FIG. 4A And FIG. 4BFurther shown, the valve 402 includes a distal anchor element 432, an anterior anchor element 435, and a sleeve 436. The distal anchor element 432 (e.g., a super-elastic wire loop distal tab) is coupled to and / or extends from the distal side 422. In some embodiments, the distal anchor element 432 is an integrated tab that is integrally built with the main portion 412 of the outer frame 410. In some embodiments, the distal anchor element 432 is configured in a shape that conforms to the A1 commissure region of the native mitral valve, and can transition between, for example, a compressed, collapsed, and / or folded configuration (e.g., a first configuration) and an extended or deployed configuration (e.g., a second configuration). In some embodiments, the distal anchor element 432 can be configured in the extended configuration to reach around the P2 and / or P3 leaflets of the native mitral valve and / or the chordae associated therewith, and can be transitioned into the compressed configuration to capture and / or pin the native tissue, chordae, etc. between the distal anchor element 432 and the transannular portion 412 of the outer frame 410.

[0194] The anterior anchor element 435 and the sleeve 436 are mounted on the anterior side of the transannular portion 412 of the outer frame 410. At least a portion of the anterior anchor element 435 is disposed in the sleeve 436. The anterior anchor element 435 is reconfigurable between a first configuration (e.g., retracted) and a second configuration (e.g., extended). In some embodiments, the anterior anchor element 435 can be extended (e.g., to the second configuration) under the annulus during deployment of the valve 402 (e.g., after the valve 402 is at least partially seated in the annulus) such that a portion of the anterior anchor element 435 extends from the sleeve 436 to engage and / or capture native leaflet tissue (e.g., A2 leaflets, tissue, chordae, etc.). The anterior anchor element 435 can be retracted (e.g., to the first configuration) to capture and secure the tissue between the anterior anchor element 435 and the transannular portion 412 of the outer frame 410.

[0195] In some embodiments, the anterior anchor element 435 can be actuated and / or transitioned using a steerable catheter and / or guidewire. In some embodiments, the anterior anchor element 435 and / or the sleeve 436 can include imaging markers, etc. that can help guide the steerable catheter or guidewire to the anterior anchor element 435. While the anterior anchor element 435 is described as moving, actuating, and / or transitioning relative to the sleeve 436, in some embodiments, the sleeve 436 can be retracted or moved relative to the anterior anchor element 435 to expose a greater portion of the anterior anchor element 435 to allow the anterior anchor element 435 to engage native tissue. In some embodiments, both the anterior anchor element 435 and the sleeve 436 can be actuated, transitioned, moved, and / or reconfigured.

[0196] In some embodiments, the use of front anchoring elements 435 on one side (A2) and wrap-around distal anchoring elements 432 on the opposite side (P2) can provide oppositional anchoring and fixation, and can reduce micromotion and promote ingrowth success of the valve.

[0197] FIG. 5A and FIG. 5B are illustrations of side perspective and exploded views, respectively, of a laterally deliverable (orthogonally deliverable) transcatheter prosthetic heart valve 502 (also referred to herein as “prosthetic valve” or “valve”) according to an embodiment. In some embodiments, the valve 502 can be deployed in an annulus of a native mitral valve, for example. The valve 502 is configured to allow blood to flow through an inflow end of the valve 502 in a first direction and to prevent blood from flowing through an outflow end of the valve 502 in a second direction opposite the first direction. The valve 502 is compressible and expandable between a compressed configuration for introduction into a body using a delivery catheter (not shown in FIGS. 1A and 1B) and an expanded configuration for implantation in a valve annulus of a target valve (e.g., in a human heart). FIG. 5A and FIG. 5B are illustrations of side perspective and exploded views, respectively, of a laterally deliverable (orthogonally deliverable) transcatheter prosthetic heart valve 502 (also referred to herein as “prosthetic valve” or “valve”) according to an embodiment. In some embodiments, the valve 502 can be deployed in an annulus of a native mitral valve, for example. The valve 502 is configured to allow blood to flow through an inflow end of the valve 502 in a first direction and to prevent blood from flowing through an outflow end of the valve 502 in a second direction opposite the first direction. The valve 502 is compressible and expandable between a compressed configuration for introduction into a body using a delivery catheter (not shown in FIGS. 1A and 1B) and an expanded configuration for implantation in a valve annulus of a target valve (e.g., in a human heart).

[0198] The valve 502 includes an annulus-external support frame 510 and a collapsible flow control member 550 mounted within the annulus-external support frame 510. The annulus-external support frame 510 (also referred to herein as “external frame”) is made of a shape memory material, such as a nickel-titanium alloy, e.g., nitinol, and is therefore a self-expanding structure from a compressed configuration to an expanded configuration. At least a portion of the external frame 510 is covered, wrapped, and / or encased by a biocompatible covering 540, such as those described above.

[0199] The external frame 510 has a trans-annular and / or body portion 512 that encircles, forms, and / or defines a central (internal) passage 514 about and / or along a vertical or central axis (y-axis), and has an atrial cuff 520 attached circumferentially at a top edge of the trans-annular and / or body portion 512 of the external frame 510. The external frame 510 has a proximal end side 519 and a distal end side 522.

[0200] A collapsible (internal) flow control member 550 is mounted within the outer frame 510 adjacent to the covered or uncovered spacer 530. The flow control member 550 has an internal frame 552 with two or more folded regions, hinged regions, coupled regions, elastically deformable regions, etc. A set of 2-4 flexible leaflets 561 is mounted in or on the internal frame 552. Like the outer frame 510, the internal flow control member 550 is foldable and compressible. The flow control member 550 is mounted to or within the outer frame 510 such that the central or vertical axis (y-axis) of the internal frame 552 is coaxial and / or at least parallel (e.g., parallel but offset) to the central axis (y-axis) of the outer frame 510.

[0201] FIG. 5A and FIG. 5B It is further shown that the valve 502 includes a distal anchor element 532, a proximal anchor element 534, an anterior anchor element 535, and a sleeve 536. The distal anchor element 532 (e.g., a super-elastic wire loop distal tab) is coupled to and / or extends from the distal side 522 of the outer support frame 510, and the proximal anchor element 534 (e.g., a super-elastic wire loop proximal tab) is coupled to and / or extends from the proximal side 519 of the outer support frame 510. In some embodiments, the distal anchor element 532 and the proximal anchor element 534 can be integrated tabs that are integrally built with the main body portion 512 of the outer frame 510. The anterior anchor element 535 and the sleeve 536 are mounted on the anterior side of the transannular portion 512 of the outer frame 510. At least a portion of the anterior anchor element 535 is disposed in the sleeve 536. The size and shape of the anchor elements 532, 534, and / or 535 can vary. For example, in some embodiments, the distal anchor element 532 is configured to conform to the Al commissure region of the mitral valve; the proximal anchor element 534 is configured to conform to the A3 commissure region of the mitral valve; and the anterior proximal anchor element 535 is configured to conform to the A2 commissure region of the mitral valve.

[0202] In some embodiments, the distal anchor element 532 can transition between, for example, a compressed, contracted, and / or collapsed configuration (e.g., a first configuration) and an extended or deployed configuration (e.g., a second configuration). In the extended configuration, the distal anchor element 532 can reach around the P2 and / or P3 leaflets of the native mitral valve and / or the chordae associated therewith, and when transitioned into the compressed configuration, the distal anchor element 532 can capture and / or pin the native tissue, chordae, etc. between the distal anchor element 532 and the transannular portion 512 of the outer frame 510.

[0203] In some embodiments, the anterior anchoring element 535 can be reconfigurable between a first configuration (e.g., retracted) and a second configuration (e.g., extended). In some implementations, the anterior anchoring element 535 can be caused to extend (e.g., to the second configuration) under the annulus during deployment of the valve 502 (e.g., after at least partial seating of the valve 502 in the annulus) such that a portion of the anterior anchoring element 535 extends from the sleeve 536 to engage and / or capture autologous leaflet tissue (e.g., A2 leaflet, tissue, chordae, etc.). The anterior anchoring element 535 can be caused to retract (e.g., to the first configuration) to capture and secure the tissue between the anterior anchoring element 535 and the transannular portion 512 of the outer frame 510. In some embodiments, the distal anchoring element 532 and / or the anterior anchoring element 535 can be actuated and / or transitioned using a steerable catheter and / or guidewire. In some implementations, causing the guidewire to retract can allow the distal anchoring element 532 and / or the anterior anchoring element 535 to transition from, for example, an extended configuration to a retracted or collapsed configuration.

[0204] FIG. 6A and FIG. 6B are illustrations of side perspective and exploded views, respectively, of a laterally deliverable (orthogonally deliverable) transcatheter prosthetic heart valve 602 (also referred to herein as “prosthetic valve” or “valve”) according to an embodiment. In some implementations, the valve 602 can be deployable in an annulus of a native mitral valve. The valve 602 is configured to allow blood to flow in a first direction through an inflow end of the valve 602 and to prevent blood from flowing in a second direction opposite the first direction through an outflow end of the valve 602. The valve 602 is compressible and expandable between a compressed configuration for introduction into a body using a delivery catheter (not shown in FIGS. 1A-1C) and an expanded configuration for implantation in a valve of a target valve (e.g., in a human heart). FIG. 6A and FIG. 6B are illustrations of side perspective and exploded views, respectively, of a laterally deliverable (orthogonally deliverable) transcatheter prosthetic heart valve 602 (also referred to herein as “prosthetic valve” or “valve”) according to an embodiment. In some implementations, the valve 602 can be deployable in an annulus of a native mitral valve. The valve 602 is configured to allow blood to flow in a first direction through an inflow end of the valve 602 and to prevent blood from flowing in a second direction opposite the first direction through an outflow end of the valve 602. The valve 602 is compressible and expandable between a compressed configuration for introduction into a body using a delivery catheter (not shown in FIGS. 1A-1C) and an expanded configuration for implantation in a valve of a target valve (e.g., in a human heart).

[0205] The valve 602 includes an annulus-external support frame 610 and a collapsible flow control member 650 mounted within the annulus-external support frame 610. The annulus-external support frame 610 (also referred to herein as “outer frame”) is made of a shape memory material, such as a nickel-titanium alloy, e.g., nitinol, and is thus a self-expanding structure from a compressed configuration to an expanded configuration. At least a portion of the outer frame 610 is covered, wrapped, and / or encased by a biocompatible covering 640, such as those described above.

[0206] The outer frame 610 has a transannular and / or body portion 612 that encircles, forms, and / or defines a central (internal) passageway 614 about and / or along a vertical or central axis (y-axis), and has an atrial cuff 620 attached circumferentially at a top edge of the transannular and / or body portion 612 of the outer frame 610. The outer frame 610 has a proximal side 619 and a distal side 622.

[0207] A collapsible (internal) flow control member 650 is mounted within the outer frame 610 adjacent to the covered or uncovered spacer 630. The flow control member 650 has an internal frame 652 with two or more folded regions, hinge regions, coupled regions, elastically deformable regions, etc. A set of 2-4 flexible leaflets 661 is mounted in or on the internal frame 652. Like the outer frame 610, the internal flow control member 650 is foldable and compressible. The flow control member 650 is mounted on or within the outer frame 610 such that the central or vertical axis (y-axis) of the internal frame 652 is coaxial and / or at least parallel (e.g., parallel but offset) to the central axis (y-axis) of the outer frame 610.

[0208] FIG. 6A And FIG. 6B It is further shown that the valve 602 includes a distal anchor element 632, a proximal anchor element 634, and an anterior anchor element 635. The distal anchor element 632 (e.g., a super-elastic wire loop distal tab) is coupled to and / or extends from the distal side 622 of the outer support frame 610, and the proximal anchor element 634 (e.g., a super-elastic wire loop proximal tab) is coupled to and / or extends from the proximal side 619 of the outer support frame 610. In some embodiments, the distal anchor element 632 and the proximal anchor element 634 can be integrated tabs that are integrally built with the body portion 612 of the outer frame 610. In FIG. 6A And FIG. 6B In the illustrated embodiment, the anterior anchor element 635 is not disposed in a sleeve, as described above with reference to the anchor element 535. Rather, the anterior anchor element 635 is mounted on the anterior side of the transannular portion 612 of the outer frame 610 by one or more attachment points 638.

[0209] The anchor elements 632, 634, and / or 635 can vary in size and shape. For example, in some embodiments, the distal anchor element 632 is shaped to conform to the Al commissure region of a mitral valve; the proximal anchor element 634 is shaped to conform to the A3 commissure region of a mitral valve; and the anterior proximal anchor element 635 is shaped to conform to the A2 commissure region of a mitral valve.

[0210] In some embodiments, the distal anchoring element 632 can transition between, for example, a compressed, collapsed, and / or folded configuration (e.g., a first configuration) and an extended or deployed configuration (e.g., a second configuration). In the extended configuration, the distal anchoring element 632 can reach around the P2 and / or P3 leaflets of the native mitral valve and / or chordae associated therewith, and when transitioned into the compressed configuration, the distal anchoring element 632 can capture and / or pin the native tissue, chordae, etc. between the distal anchoring element 632 and the transannular portion 612 of the outer frame 610.

[0211] In some embodiments, the anterior anchoring element 635 can reconfigure between a first configuration (e.g., retracted) and a second configuration (e.g., extended). In some implementations, the anterior anchoring element 635 can be extended (e.g., to the second configuration) under the annulus during valve 602 deployment to engage and / or capture native leaflet tissue (e.g., A2 leaflet, tissue, chordae, etc.). The anterior anchoring element 635 can be retracted (e.g., to the first configuration) to capture and secure the tissue between the anterior anchoring element 635 and the transannular portion 612 of the outer frame 610. In some embodiments, the distal anchoring element 632 and / or the anterior anchoring element 635 can be actuated and / or transitioned using a steerable catheter and / or guidewire. In some implementations, retracting the guidewire can allow the distal anchoring element 632 and / or the anterior anchoring element 635 to transition from, for example, an extended configuration to a retracted or folded configuration.

[0212] FIGS. 7A-7E is a series of illustrations of the prosthetic valve 702 showing capture of native tissue P1, P2 by the distal anchoring element 732. FIG. 7A shows the distal anchoring element 732 being advanced over the guidewire 785 to a desired position relative to the native tissue P1, P2. FIG. 7B shows the distal anchoring element 732 in the desired position and withdrawal of the guidewire 785. As the guidewire 785 is withdrawn, the distal anchoring element 732 is actuated and / or retracted (e.g., the distal anchoring element 732 can be a shape memory device, etc.). FIG. 7C shows the distal anchoring element 732 pulling the native tissue P1, P2 against the distal wall of the outer frame 710 of the valve 702. FIG. 7D shows complete capture of the native tissue P1, P2 and anchoring of the valve 702, with the distal anchoring element 732 pressing the native tissue against the outer frame 710 to promote ingrowth of the valve and reduce micromotion thereof. FIG. 7E shows that in some implementations, the distal anchoring element 732 can be configured to wrap substantially all or a relatively large portion of the valve 702 to capture P1 / A1, P2, and P3 / A3 native tissue.

[0213] FIG. 8 is an illustration of a top view of a laterally deliverable transcatheter prosthetic valve 802 according to embodiments. The prosthetic valve 802 has an outer frame 810 and a flow control component 850 mounted therein. The outer frame 810 is eccentric, having a D-shape that can conform to a native annulus (e.g., of a native mitral valve). The outer frame 810 can also be slightly oversized (e.g., by about 10-15% for a particular patient anatomy, as determined by pre-operative planning and intra- or pre-operative imaging).

[0214] The outer frame 810 includes and / or is coupled to a distal anchor element 832 that is navigable over a guidewire 885. In addition, the prosthetic valve 802 and / or the outer frame 810 includes or is coupled to a proximal anchor element 834, an anterior anchor element 835, and two posterior anchor elements 837. FIG. 8 Also shown is a positioning tool 890 (e.g., a catheter, such as a guidewire catheter) that is capable of engaging and / or transforming any of the anchor elements 832, 834, 835, and / or 837 to capture native leaflets and / or chordae. In some embodiments, the positioning tool 890 can first push the valve 802 out of a delivery catheter (not shown), second can steer and / or position the valve 802 within the annulus, or direct and / or position one or more of the anchor elements 832, 834, 835, and / or 837 relative to the annulus. In some embodiments, one or more posterior anchor elements 837 can be configured to engage and / or contact a portion of the distal anchor element 832 that is wrapped around the posterior side of the valve 802. In such embodiments, the one or more posterior anchor elements 837 can secure the distal anchor element 832 in a desired (e.g., wrapped) configuration.

[0215] FIG. 8 Further shown is that in some embodiments, the outer frame 810 can include a distal stabilizing element 832A proximal to the distal anchor element 832. In some embodiments, the distal stabilizing element 832A can contact tissue under the annulus to stabilize, reduce, and / or minimize undesirable rotation or twisting of the valve 802 relative to the annulus.

[0216] FIG. 9A is an illustration of a cross-sectional view of a human heart according to embodiments, showing the relative positions of the mitral valve (MV), tricuspid valve (TV), aortic valve (AV), and pulmonary valve (PV).

[0217] FIG. 9Bis an illustration of a side view of a human heart having a transseptal (femoral artery / IVC or SVC) delivery catheter 972 passing from the right atrium through the left atrium to access the mitral valve. The delivery catheter 972 can be used, for example, to orthogonally or laterally deliver a transcatheter prosthetic mitral valve, such as any of those described herein.

[0218] FIG. 10 and FIG. 11 are illustrations of a side perspective view and a side view, respectively, of a delivery catheter 1072 (or guidewire 1085) according to an embodiment, which accesses a native valve through the IVC and winds under and / or around the native A2 leaflet to access, for example, the P2 position of the native valve.

[0219] FIGS. 12-16 is a variety of illustrations of the process of delivering and deploying a laterally deliverable transcatheter prosthetic heart valve 1102 in, for example, a native mitral valve according to an embodiment. FIG. 12 shows a guidewire 1185 according to an embodiment guiding a prosthetic valve 1102 to the Al leaflet, with the valve 1102 in a compressed configuration within a delivery catheter 1172. The prosthetic valve 1102 includes a distal anchoring element 1132 that is disposed over or threaded over the guidewire 1185 to guide the distal anchoring element 1132 (and thereby the valve 1102) to the desired deployment location.

[0220] FIG. 13 shows the distal anchoring element 1132 deployed in the Al position of a native mitral valve. The valve 1102 is shown in a partially deployed stage, partially egressed from the delivery catheter 1172.

[0221] FIG. 14 shows the outer frame 1110 of the prosthetic valve 1102, the atrial collar 1120, the flow control component 1150, and the spacer 130. The valve 1102 is shown fully egressed from the delivery catheter 1172 and temporarily positioned in the Al position (the atrial collar around the annulus of the mitral valve) at an upward angle with the distal anchoring element 132. This angled positioning avoids a pop-off effect and allows the prosthetic valve 1102 to engage with blood flow while the native mitral valve continues to work. The proximal anchoring element 1134 is shown positioned over the annulus prior to being hard jammed into place on the proximal side of the valve 1102 to anchor the proximal side of the valve 1102.

[0222] FIG. 15 is a top view showing the prosthetic valve 1102 deployed in the native annulus (the dashed line is visible). FIG. 16is a side perspective view of a prosthetic valve 1102 deployed in a native annulus (visible in dotted line). The flow control member 1150 is shown offset within the outer frame 1110 and disposed distal within the outer frame 1110 relative to the spacer 1130. The distal anchoring elements 1132 are shown wrapped around a portion of native tissue to secure the native tissue against the transannular portion of the outer frame 1110.

[0223] FIG. 17A and FIG. 17B is a side perspective view of a laterally deliverable transcatheter prosthetic heart valve 1202 according to an embodiment, the prosthetic heart valve 1202 deployed in a native valve, e.g., native mitral valve annulus (visible in dotted line). The prosthetic valve 1202 includes an outer frame 1210 having a flow control member 1250 mounted within a central passage of the outer frame 1210 and a spacer 1230 mounted adjacent the flow control member 1250. The valve 1202 further includes distal anchoring elements 1232 coupled to and / or extending from a distal side of the outer frame 1210 and anterior anchoring elements 1235 coupled to and / or extending from an anterior side of the outer frame 1210.

[0224] FIG. 17A is shown deployed in an annulus with the distal anchoring elements 1232 wrapped around a portion of native tissue to secure the native tissue against the transannular portion of the outer frame 1210. The anterior anchoring elements 1235 are shown in an extended configuration to engage native tissue, e.g., A2 leaflet, chordae, etc. FIG. 17B is shown with the anterior anchoring elements 1235 in a retracted or compressed configuration in which the anterior anchoring elements 1235 secure at least a portion of the A2 leaflet, chordae, and / or anterior native tissue against the transannular portion of the outer frame 1210.

[0225] FIG. 18A and FIG. 18Bis a side perspective view of a laterally deliverable transcatheter prosthetic heart valve 1302 according to an embodiment, the prosthetic heart valve 1302 deployed in the annulus of a native valve, e.g., a native mitral valve (visible in dotted line). The prosthetic valve 1302 includes an outer frame 1310 having a flow control component 1350 mounted within a central passage of the outer frame 1310 and a spacer 1330 mounted adjacent the flow control component 1350. The valve 1302 further includes a distal anchor element 1332 coupled to and / or extending from a distal side of the outer frame 1310, a proximal anchor element 1334 coupled to and / or extending from a proximal side of the outer frame 1310, and an anterior anchor element 1335 coupled to and / or extending from an anterior side of the outer frame 1310.

[0226] FIG. 18A The valve 1302 is shown deployed in the annulus with the distal anchor element 1332 extending from the outer frame 1310 and engaging native tissue on a distal side of the annulus, and the proximal anchor element 1334 extending from the outer frame 1310 and engaging native tissue on a proximal side of the annulus. The anterior anchor element 1335 is shown in an extended configuration to engage native tissue, e.g., the A2 leaflet, chordae, etc. FIG. 18B The anterior anchor element 1335 is shown in a retracted or compressed configuration in which the anterior anchor element 1335 secures at least a portion of the A2 leaflet, chordae, and / or anterior native tissue against the transannular portion of the outer frame 1310.

[0227] FIG. 19A and FIG. 19B is a side perspective view of a laterally deliverable transcatheter prosthetic heart valve 1402 according to an embodiment, the prosthetic heart valve 1402 deployed in the annulus of a native valve, e.g., a native mitral valve (visible in dotted line). The prosthetic valve 1402 includes an outer frame 1410 having a flow control component 1450 mounted within a central passage of the outer frame 1410 and a spacer 1430 mounted adjacent the flow control component 1450. The valve 1402 further includes a distal anchor element 1432 coupled to and / or extending from a distal side of the outer frame 1410, a proximal anchor element 1434 coupled to and / or extending from a proximal side of the outer frame 1410, and an anterior anchor element 1435 coupled to and / or extending from an anterior side of the outer frame 1410.

[0228] FIG. 19AValve 1402 is shown deployed in an annulus, with distal anchoring elements 1432 wrapped around a portion of native tissue to secure the native tissue against the trans-annular portion of outer frame 1410. Proximal anchoring elements 1334 are shown extending from outer frame 1310 and engaging native tissue on the proximal side of the annulus. Anterior anchoring elements 1435 are shown in an extended configuration to engage native tissue, such as the A2 leaflet, chordae, and / or the like. FIG. FIG. 19B Anterior anchoring elements 1435 are shown in a retracted or compressed configuration, with the anterior anchoring elements 1435 securing at least a portion of the A2 leaflet, chordae, and / or anterior native tissue against the trans-annular portion of outer frame 1410.

[0229] FIGS. 20-24 are various illustrations of a process of delivering and deploying a laterally deliverable transcatheter prosthetic heart valve 1502 in, for example, a native mitral valve according to embodiments. FIG. FIG. 20 is a side view of prosthetic valve 1502 in an expanded configuration with distal anchoring elements 1532 extending from an outer frame 1510 of the prosthetic valve 1502. The outer frame 1510 is also shown to include and / or be coupled to an atrial cuff 1520.

[0230] FIG. 21 is a top view of prosthetic valve 1502 in an expanded configuration showing distal anchoring elements 1532 extending from outer frame 1510, atrial cuff 1520 coupled into and / or included in outer frame 1510, and a flow control member 1550 mounted within a central passage of outer frame 1510.

[0231] FIG. 22 is a side view of prosthetic valve 1502 in a compressed configuration disposed within a delivery catheter 1572 for delivery into an atrium of a heart. The valve 1502 is in an orthogonal folded and / or compressed configuration that allows the valve 1502 to be advanced through a lumen of the delivery catheter 1572.

[0232] FIG. 23 is a side view of prosthetic valve 1502 partially released from the delivery catheter 1572 for deployment. The valve 1502 is configured to transition from a compressed configuration to an expanded configuration when the valve 1502 is released from the delivery catheter 1572. In addition, distal anchoring elements 1532 are shown extending in a distal direction from the valve 1502.

[0233] FIG. 24is a side view of a delivery catheter 1572 at least partially disposed in an atrium of a heart, shown with a valve 1502 partially released from the delivery catheter 1572. Distal anchoring elements 1532 are shown traveling over and / or along a guidewire 1585 during capture of autologous tissue (e.g., one or more autologous leaflets and / or chordae tendinae).

[0234] FIGS. 25A-25E A laterally delivered transcatheter prosthetic heart valve 1602 is shown according to an embodiment, shown being transitioned into a compressed configuration, loaded into a delivery catheter 1672 for transcatheter delivery into an autologous valve annulus of a heart, and partially released from the delivery catheter 1672 for deployment into the autologous valve annulus.

[0235] FIG. 25A The valve 1602 is shown in a folded configuration along the z-axis (from front to back when viewed from a wider side). FIG. 25A An outer frame 1610 is shown with a flow control component 1650 and a spacer 1630 disposed within a central passageway of the outer frame 1610. Distal anchoring elements 1632 are shown extending from a distal side of the outer frame 1610. Collar 1620 of the outer frame 1610 is shown folded / flattened at proximal and distal articulation points or fold regions 1619 and 1622. The flow control component 1650 is shown including leaflets 1661 mounted within a folded / flattened inner frame 1652.

[0236] FIG. 25B The valve 1602 is shown in a vertically compressed configuration. For example, the valve 1602 is folded laterally (e.g., in the direction of the z-axis, at articulation points and / or fold regions 1619 and 1622 of the outer frame 1610) and compressed vertically (e.g., in the direction of the y-axis). The flow control component 1650 and the spacer 1630 are also folded and compressed. FIG. 25B A guidewire 1685 is also shown, which can be twisted through a guidewire coupler 1633 of the distal anchoring elements 1632.

[0237] FIG. 25C The valve 1602 is shown partially loaded into a delivery catheter 1672. The outer frame 1610, the folded collar 1620, the spacer 1630, and the flow control component 1650 with leaflets 1661 and inner frame 1652 are in and / or transitioning into a folded and compressed configuration.

[0238] FIG. 25D is an end view of the delivery catheter 1672 showing the loaded valve 1602 in a folded and compressed configuration.

[0239] FIG. 25E The folded and compressed valve 1602 is released from the delivery catheter 1672 and begins to transition from the folded and compressed configuration to an expanded configuration for deployment into a native valve annulus. The guidewire coupler 1633 of the distal anchoring element 1632 is shown disposed or threaded over the guidewire 1685.

[0240] FIGS. 26A-26C A laterally delivered transcatheter prosthetic heart valve 1702 is shown according to an embodiment, shown being transitioned into a compressed configuration and loaded into a delivery catheter 1772 for transcatheter delivery into a native valve annulus of a heart.

[0241] FIG. 26A The valve 1702 is shown in a folded configuration along the z-axis (from anterior to posterior when viewed from a wider side). FIG. 26A An outer frame 1710 is shown with a flow control component 1750 and a spacer 1730 disposed within a central passageway of the outer frame 1710. A distal anchoring element 1732 is shown extending from a distal side of the outer frame 1710. An anterior anchoring element 1735 is shown mounted to an anterior side of the outer frame 1710. The anterior anchoring element 1735 is in a non-extended or unactuated configuration. A collar 1720 of the outer frame 1710 is shown folded / flat at proximal and distal articulation points or fold regions 1719 and 1722. The flow control component 1750 is shown including leaflets 1761 mounted within a folded / flat inner frame 1752.

[0242] FIG. 26B The valve 1702 is shown in a vertically compressed configuration. For example, the valve 1702 is folded laterally (e.g., in the direction of the z-axis, at articulation points and / or fold regions 1719 and 1722 of the outer frame 1710) and compressed vertically (e.g., in the direction of the y-axis). The flow control component 1750 and the spacer 1730 are also folded and compressed. The anterior anchoring element 1735 is shown compressed vertically in response to the vertical compression of the outer frame 1710. FIG. 26B A guidewire 1785 is also shown, which can be threaded through the guidewire coupler 1733 of the distal anchoring element 1732.

[0243] FIG. 26C The valve 1702 is shown partially loaded into the delivery catheter 1772. The outer frame 1710 with the anterior anchoring element 1735, the folded collar 1720, the spacer 1730, and the flow control component 1750 with the leaflets 1761 and the inner frame 1752 are in a folded and compressed configuration and / or are being transitioned into a folded and compressed configuration.

[0244] FIGS. 27A-27C A laterally delivered transcatheter prosthetic heart valve 1802 is shown according to an embodiment, shown being transitioned into a compressed configuration and loaded into a delivery catheter 1872 for transcatheter delivery to a native valve annulus of a heart.

[0245] FIG. 27A The valve 1802 is shown in a folded configuration along the z-axis (from a wider side view, from front to back). FIG. 27A An outer frame 1810 is shown with a flow control component 1850 and a spacer 1830 disposed within a central passageway of the outer frame 1810. Distal anchoring elements 1832 are shown extending from a distal side of the outer frame 1810, and proximal anchoring elements 1834 are shown extending from a proximal side of the outer frame 1810. A collar 1820 of the outer frame 1810 is shown folded / flat at proximal and distal articulation points or fold regions 1819 and 1822. The flow control component 1850 is shown including leaflets 1861 mounted within a folded / flat inner frame 1852.

[0246] FIG. 27B The valve 1802 is shown in a vertically compressed configuration. For example, the valve 1802 is folded laterally (e.g., in the direction of the z-axis, at articulation points and / or fold regions 1819 and 1822 of the outer frame 1810) and compressed vertically (e.g., in the direction of the y-axis). The flow control component 1850 and the spacer 1830 are also folded and compressed. The anterior anchoring elements 1835 are shown compressed vertically in response to the vertical compression of the outer frame 1810. FIG. 27B A guidewire 1885 is also shown, which can be threaded through a guidewire coupler 1833 of the distal anchoring elements 1832.

[0247] FIG. 27C The valve 1802 is shown partially loaded into the delivery catheter 1872. The outer frame 1810, the folded collar 1820, the spacer 1830, and the flow control component 1850 with leaflets 1861 and inner frame 1852 are in a folded and compressed configuration and / or are being transitioned into a folded and compressed configuration.

[0248] FIGS. 28A-28C A laterally delivered transcatheter prosthetic heart valve 1902 is shown according to an embodiment, shown being transitioned into a compressed configuration and loaded into a delivery catheter 1972 for transcatheter delivery to a native valve annulus of a heart.

[0249] FIG. 28AThe valve 1902 is shown in a folded configuration along the z-axis (from the wider side, from front to back). FIG. 28A The outer frame 1910 is shown with a flow control component 1950 and a spacer 1930 disposed within a central passageway of the outer frame 1910. A distal anchoring element 1932 is shown extending from a distal side of the outer frame 1910, and a proximal anchoring element 1934 is shown extending from a proximal side of the outer frame 1910. An anterior anchoring element 1935 is shown mounted to an anterior side of the outer frame 1910. The anterior anchoring element 1935 is in a non-extended or unactuated configuration. The collar 1920 of the outer frame 1910 is shown folded / flat at proximal and distal articulation points or fold regions 1919 and 1922. The flow control component 1950 is shown including leaflets 1961 mounted within a folded / flat inner frame 1952.

[0250] FIG. 28B The valve 1902 is shown in a vertically compressed configuration. For example, the valve 1902 is folded laterally (e.g., in the direction of the z-axis, at articulation points and / or fold regions 1919 and 1922 of the outer frame 1910) and compressed vertically (e.g., in the direction of the y-axis). The flow control component 1950 and the spacer 1930 are also folded and compressed. The anterior anchoring element 1935 is shown compressed vertically in response to the vertical compression of the outer frame 1910. FIG. 28B A guidewire 1985 is also shown, which can be threaded through a guidewire coupler 1933 of the distal anchoring element 1932.

[0251] FIG. 28C The valve 1902 is shown partially loaded into a delivery catheter 1972. The outer frame 1910 with the anterior anchoring element 1935, the folded collar 1920, the spacer 1930, and the flow control component 1950 with the leaflets 1961 and the inner frame 1952 are in a folded and compressed configuration and / or are transitioning into a folded and compressed configuration.

[0252] FIGS. 29A-29C A laterally delivered transcatheter prosthetic heart valve 2002 is shown according to embodiments, shown transitioning into a compressed configuration and loaded into a delivery catheter 2072 for transcatheter delivery to a native valve annulus of a heart.

[0253] FIG. 29A The valve 2002 is shown in a folded configuration along the z-axis (from the wider side, from front to back). FIG. 29AAn outer frame 2010 is shown with a flow control component 2050 and a spacer 2030 disposed within a central channel of the outer frame 2010. A distal anchor element 2032 is shown extending from a distal side of the outer frame 2010, and a proximal anchor element 2034 is shown extending from a proximal side of the outer frame 2010. An anterior anchor element 2035 is shown mounted to an anterior side of the outer frame 2010. The anterior anchor element 2035 is in a non-extended or unactuated configuration. The collar 2020 of the outer frame 2010 is shown folded / flat at proximal and distal articulation points or fold regions 2019 and 2022. The flow control component 2050 is shown including leaflets 2061 mounted within a folded / flat inner frame 2052.

[0254] FIG. 29B A valve 2002 is shown in a vertical compression configuration. For example, the valve 2002 is folded laterally (e.g., in the direction of the z-axis, at articulation points and / or fold regions 2019 and 2022 of the outer frame 2010) and compressed vertically (e.g., in the direction of the y-axis). The flow control component 2050 and the spacer 2030 are also folded and compressed. The anterior anchor element 2035 is shown compressed vertically in response to the vertical compression of the outer frame 2010. FIG. 29B A guidewire 2085 is also shown, which can be threaded through a guidewire coupler 2033 of the distal anchor element 2032.

[0255] FIG. 29C A valve 2002 is shown partially loaded into a delivery catheter 2072. The outer frame 2010 with the anterior anchor element 2035, the folded collar 2020, the spacer 2030, and the flow control component 2050 with the leaflets 2061 and the inner frame 2052 are in a folded and compressed configuration and / or are transitioning into a folded and compressed configuration.

[0256] FIGS. 30-33 An inner leaflet frame 2152 of a flow control component is shown, according to embodiments. FIG. 30 A top perspective view of the inner leaflet frame 2152 is shown. In some embodiments, the inner leaflet frame 2152 is formed from two separate wire frame sheets or members that are coupled at lateral connection points 2165 and 2166 (e.g., fold regions, elastically deformable regions, coupled edge portions, etc.). The inner leaflet frame 2152 is shown in an expanded or cylindrical configuration (e.g., prior to folding and / or compression).

[0257] FIG. 31An inner leaflet frame 2152 is shown in a partially folded configuration. The inner leaflet frame 2152 is shown with wire frame sidewalls that allow for rotation or articulation at least at lateral connection points 2165 and 2166. The inner leaflet frame 2152 can be configured to fold as shown in response to the valve being folded and / or compressed for delivery. FIG. 32 An inner leaflet frame 2152 is shown in a fully folded configuration. The wire frame sidewalls have been rotated, articulated and / or folded at their lateral connection points 2165 and 2166.

[0258] FIG. 33 An inner leaflet frame 2152 is shown folded and vertically compressed into a compressed configuration. The wire frame sidewalls can form cells (e.g., diamond cells, etc.) that can be oriented in a compression direction to allow for elastic compression of the inner frame 2152. In some embodiments, the inner frame 2152 can be vertically compressed into a crumpled or accordion (compressed) configuration.

[0259] FIGS. 34-40 One or more portions of an inner flow control component 2250 according to an embodiment are shown. FIG. 34 is an illustration of a side view of an inner leaflet frame 2252 that is a flow control component. The inner leaflet frame 2252 is configured and / or otherwise formed as a linear wire frame sheet prior to being further assembled into a cylindrical structure. FIG. 35 An inner leaflet frame 2252 is shown in a cylindrical structure or configuration (or conical structure or configuration) where edge portions of the linear wire frame sheet are connected or coupled at lateral connection points 2265 and 2266 (e.g., hinge regions, fold regions, etc.). In addition, the inner leaflet frame 2252 can be expanded (e.g., driven, shaped, bent, etc.) from the linear sheet configuration into the cylindrical structure or configuration.

[0260] FIG. 36 and FIG. 37 are a side view and a bottom view, respectively, showing a structural band 2264 of pericardial tissue with leaflet pockets 2261 sewn into the structural band 2264 prior to assembly into a cylindrical leaflet component and / or prior to mounting on and / or within an inner frame 2252 to form a collapsible (foldable, compressible) flow control component 2250.

[0261] FIG. 38 is an illustration of a side perspective view of a structural band 2264 of pericardial tissue with leaflet pockets 2261 sewn into the structural band 2264 after assembly into a cylindrical leaflet configuration, the leaflet pockets 2261 disposed on an inner surface of the structural band 2264.

[0262] FIG. 39is an illustration of a side perspective view of a portion of a structural band 2264 of pericardial tissue showing a single leaflet pocket 2261 stitched into the structural band 2264. The leaflet pocket 2261 is shown with coaptation of the leaflet pocket 2261 with a portion of the structural band 2264 such that the open edge 2263 extends outwardly and the stitched edge 2262 forms a closed top parabolic edge that provides attachment.

[0263] FIG. 40 is an illustration of a bottom view of a flow control component 2250. The cylindrical structural band 2264 and leaflet component 2261 are shown with coaptation toward forming a closed fluid seal.

[0264] FIGS. 41A-41D various views showing the process of transitioning a laterally deliverable transcatheter prosthetic heart valve and / or its outer frame into a compressed configuration for delivery according to embodiments.

[0265] FIG. 41A is an illustration of a top perspective view of an outer frame 2310 of a valve 2302 in a cylindrical configuration, the outer frame 2310 is shown at the beginning of a folding and compression process of the outer frame 2310. Although not shown in FIG. 41A , in some embodiments, the outer frame 2310 can receive a flow control component 2350 within a central channel of the outer frame 2310 prior to folding and compression (e.g., the outer frame 2310 and flow control component are folded, compressed and delivered together). In other embodiments, the outer frame 2310 can be delivered independently of a flow control component. In such embodiments, the flow control component can undergo a similar folding and compression process and can be installed in the outer frame 2310 (e.g., in an atrium of a heart) after delivery.

[0266] FIG. 41B is a top perspective view of an outer frame 2310 in a partially folded configuration, where the side walls of the outer frame 2310 are rotated or hinged at lateral connection points or hinge points 2319 and 2322. FIG. 41C is a side view of an outer frame 2310 in a fully folded, flat configuration, where the frame side walls are rotated or hinged at their lateral connection points or hinge portions 2319 and 2322. FIG. 41D is a side view of an outer frame 2310 in a folded and vertically compressed configuration, where the frame side walls are vertically compressed to be in a crumpled or accordion-like configuration. In some embodiments, the outer frame 2310 in a folded and compressed configuration can have dimensions that allow the outer frame 2310 to be delivered through a delivery catheter.

[0267] FIGS. 42A-42CVarious views showing the process of transitioning a laterally deliverable transcatheter prosthetic heart valve and / or its outer frame into a compressed configuration for delivery according to embodiments are shown. Figure 42A is a top perspective view of the outer frame 2410 of the valve in a partially folded configuration, where the side walls of the outer frame 2410 are rotated or hinged at the lateral connection points or hinge points 2419 and 2422. The outer frame 2410 includes at least a front anchoring element 2435, which can be configured to bend or fold when the outer frame 2410 is transitioned into a folded and compressed configuration. Figure 42B is a side view of the outer frame 2410 in a fully folded flat configuration, where the frame side walls are rotated or hinged at their lateral connection points or hinge portions 2419 and 2422. Figure 42C is a side view of the outer frame 2410 in a folded and vertically compressed configuration, where the frame side walls are vertically compressed into a crumpled or accordion-like configuration. The front anchoring element 2435 is similarly vertically compressed when the outer frame 2410 is compressed. In some embodiments, the outer frame 2410 in the folded and compressed configuration can have dimensions that allow the outer frame 2410 to be delivered through a delivery catheter.

[0268] Figures 43A-43C Various views showing the process of transitioning a laterally deliverable transcatheter prosthetic heart valve and / or its outer frame into a compressed configuration for delivery according to embodiments are shown. Figure 43A is a top perspective view of the outer frame 2510 of the valve in a partially folded configuration, where the side walls of the outer frame 2510 are rotated or hinged at the lateral connection points or hinge points 2519 and 2522. The outer frame 2510 includes at least a distal anchoring element 2532 and a proximal anchoring element 2534. The distal anchoring element 2532 includes a guidewire coupler 2533, which can receive and / or be disposed around a portion of a guidewire (not shown) to allow the outer frame 2510 to be advanced to a desired location within the body. Figure 43B is a side view of the outer frame 2510 in a fully folded flat configuration, where the frame side walls are rotated or hinged at their lateral connection points or hinge portions 2519 and 2522. Figure 43C is a side view of the outer frame 2510 in a folded and vertically compressed configuration, where the frame side walls are vertically compressed into a crumpled or accordion-like configuration. In some embodiments, the outer frame 2510 in the folded and compressed configuration can have dimensions that allow the outer frame 2510 to be delivered through a delivery catheter. The arrangement of the distal anchoring element 2532 and the proximal anchoring element 2534 can be such that the anchoring elements 2532 and 2534 extend substantially in a longitudinal direction (e.g., along the x-axis), and thus can remain unfolded and / or uncompressed during delivery.

[0269] Figure 44A and Figure 44B A valve 2602 according to an embodiment is shown. Figure 44A is an illustration of a top view of a valve 2602 shown in a compressed configuration and disposed (e.g., orthogonally loaded) within a delivery catheter 2672. The valve 2602 includes an outer frame 2610 having a distal anchor element 2632 extending forward along the x-axis and a proximal anchor element 2634 extending or trailing back along the x-axis. A flow control component 2650 is shown disposed within the outer frame 2610. Figure 44B is an illustration of a top view of the valve 2602 partially released from the delivery catheter 2672. The distal anchor element 2632 is shown guiding the valve 2602 (along a guidewire 2685) to a deployed position. The flow control component 2650 is shown beginning to open and showing two of the three leaflets 2661 opening from a folded flat configuration, with the third leaflet opening from a folded configuration in which it folded back on itself while in the delivery catheter 2672.

[0270] Figure 45 and Figure 46 is an illustration showing a process of capturing autologous tissue using a distal anchor element of a laterally deliverable transcatheter prosthetic heart valve 2702 according to an embodiment. In some cases, the process can include the following steps: (1) providing a foldable, compressible orthogonally prosthetic mitral valve 2702 (FIG. 26), (2) laterally loading the valve 2702 into a delivery catheter 2772, (3) and advancing the valve 2702 over a pre-placed guidewire 2785 through the IVC or SVC, which guidewire 2785 can be twisted onto the distal anchor element 2732. The process then proceeds to (4) partially ejecting the straightened end of the distal anchor element 2732 of the valve 2702 from the delivery catheter 2772, (5) capturing, for example, a P2 leaflet and / or chordae by partially withdrawing the guidewire 2785 to collapse or allow the distal anchor element 2732 to collapse into a pre-curved, biased, or original configuration Figure 46 , (6) partially ejecting the valve 2702 to allow a set of prosthetic leaflets to begin to function and to check for paravalvular leakage (PVL), (7) positioning the valve 2702 in the annulus of the autologous valve, and (8) completing the deployment of the valve 2702 in the autologous annulus.

[0271] Figures 47-49 is a side perspective view of a laterally deliverable transcatheter prosthetic heart valve 2802 according to an embodiment, showing a deployment process. Figure 47A valve 2802 with an anterior anchoring element 2835 in a folded, compressed, and / or unactuated position is shown. The anterior anchoring element 2835 is mounted to the anterior side of the valve 2802 (or its outer frame) through any number of attachment points 2838. A positioning tool 2890 (e.g., steerable catheter / wire) is shown deploying the engagement portion 2939 of the anterior anchoring element 2835.

[0272] Figure 48 A positioning tool 2890 is shown placing the engagement portion 2839 of the anterior anchoring element 2835 in an extended position to engage and / or capture leaflet tissue. The attachment points 2838 secure a portion of the anterior anchoring element 2835 such that when the engagement portion 2839 is extended, it creates a springing force to capture the captured tissue between the engagement portion 2839 of the valve 2802 and a portion of the outer frame. Figure 49 The anterior anchoring element 2835 is shown returning to a folded and / or compressed configuration with a portion of the anterior leaflet tissue and / or chordae tendineae disposed between the engagement portion 2839 and the outer frame.

[0273] Figures 50A-50D Various views of an anterior anchoring element included in a laterally deliverable transcatheter prosthetic heart valve according to embodiments and shown in a first configuration, a second configuration, a third configuration, and a fourth configuration, respectively, are shown. Figure 50A An anterior anchoring element 2935 with an engagement portion 2939 and at least partially packed in a sheath 2936 prior to deployment is shown. An attachment point 2938 is shown proximal to the engagement portion 2939 and configured to mount the anterior anchoring element 2935 to an outer frame of a valve and / or a sleeve 2936 which in turn is mounted to the outer frame. Figure 50B An anterior anchoring element 2935 is shown extending in a ventricular direction along a central (y) axis. The attachment point 2938 is positioned above the engagement portion 2939 of the anterior anchoring element 2935. The engagement portion 2939 is shown folded and / or non-extended at a sub-annular position. Figure 50C An anterior anchoring element 2935 is shown fully deployed to capture anterior tissue. The attachment point 2938 is positioned above the engagement portion 2939 of the anterior anchoring element 2935. The engagement portion 2939 is shown deployed and extended at a sub-annular position to capture autologous tissue. Figure 50DThe leading anchor element 2935 is shown captured tissue in a folded and / or retracted position where the tissue (not shown) is pinned against the peripheral wall of the outer frame. In the retracted position, the attachment point 2938 is positioned relatively proximate to the engagement portion 2939 of the leading anchor element 2935. The engagement portion 2939 is shown in a partially deployed and / or partially extended configuration (e.g., a captured configuration).

[0274] Figures 51A-51G Side perspective views of various anchors and / or anchor loop configurations for anchoring a portion of a laterally deliverable transcatheter prosthetic heart valve to autologous tissue are shown, each according to different embodiments. The anchor and / or anchor loop configurations can be included in, for example, a leading anchor element and / or any other suitable anchoring element of a prosthetic valve. For example, Figure 51A A post-type hook 3039 is shown; Figure 51B A loop-type hook 3139 is shown; Figure 51C A paddle-type hook 3239 is shown; Figure 51D A double loop-type hook 3339 is shown; Figure 51E A footer-type hook 3439 is shown; Figure 51F A curved loop-type hook 3539 is shown with an optional locking nut 3531; and Figure 51G A curved loop-type hook 3639 is shown with an optional locking nut 3651.

[0275] Figure 52 And Figure 53 is a side perspective view of a laterally deliverable transcatheter prosthetic heart valve 3702 having a distal anchor element 3732, a proximal anchor element 3734, and a plurality of leading anchor elements 3735A and 3735B, according to embodiments. The valve 3702 possesses an outer frame 3710 having an atrial collar 3720 and a flow control component 3750 mounted within a central passage of the outer frame 3710. The distal anchor element 3732 extends from a distal side of the outer frame 3710 and includes a guidewire coupler 3733 that can receive a guidewire for delivering the valve 3702 to a desired location and / or can be threaded over the guidewire. The distal anchor element 3732 can provide subannular anchoring on a distal side of the annulus and, in some implementations, can wrap around a posterior or portion of the native valve. The proximal anchor element 3734 extends from a proximal side of the outer frame 3710 and provides subannular anchoring on a proximal side of the annulus. The valve 3702 includes two leading anchor elements 3735A and 3735B mounted to a front side of the outer frame 3710. Figure 52 The two leading anchor elements 3735A and 3735B are shown in a folded, non-extended, and / or non-actuated configuration. Figure 53Two anterior anchor elements 3735A and 3735B are shown in an extended configuration to engage and / or capture anterior native tissue and / or chordae tendinae. The anterior anchor elements 3735A and 3735B can be retracted from the extended configuration to secure and / or pin the native tissue and / or chordae tendinae against the outer frame 3710.

[0276] Figure 54 is a side view of a laterally deliverable, transcatheter prosthetic heart valve 3802 according to an embodiment. The valve 3802 includes, for example, a graduated stiffness distal anchor element 3832 having a softer stiffness in a location or site near or adjacent to an outer frame 3810 of the valve 3802 and a harder stiffness in a portion or site distal from the outer frame 3810. The valve 3802 is shown with an offset flow control member 3850. While the valve 3802 is shown as having a distal anchor element 3832 with a graduated stiffness, in other embodiments, the valve 3802 can include a distal anchor element 3832 with a graduated stiffness and / or a proximal anchor element with a similar or different graduated stiffness.

[0277] Figure 55A is a side view of a laterally deliverable, transcatheter prosthetic heart valve 3802 according to an embodiment. The valve 3902 includes an outer frame 3910 having a distal anchor element 3932 extending from a distal side of the outer frame 3910 and a proximal anchor element 3934 extending from a proximal side of the outer frame 3910. A flow control member 3950 is shown mounted at an offset location within a central passage of the outer frame 3910. The anchor elements 3932 and 3934 are, for example, single piece structures that are wrapped around the outer frame 3910 of the valve 3902. Figure 55B is a cutaway side view of a heart showing the valve 3902 deployed in an annulus of a native valve. The anchor elements 3932 and 3934 cooperate to provide anchoring force on the valve 3902, for example, in a downward direction.

[0278] Figure 56A is a side view of a laterally deliverable, transcatheter prosthetic heart valve 3802 according to an embodiment. The valve 4002 includes an outer frame 4010 having a distal anchor element 4032 extending from a distal side of the outer frame 4010 and a proximal anchor element 4034 extending from a proximal side of the outer frame 4010. A flow control member 4050 is shown mounted at an offset location within a central passage of the outer frame 4010. The anchor elements 4032 and 4034 are, for example, independent elements that are each wrapped around a portion of the outer frame 4010 and include portions or fingers that are capable of engaging native tissue. Figure 56Bis a cross-sectional side view of a heart showing a valve 4002 deployed in an annulus of a native valve. The anchoring elements 4032 and 4034 are shown with portions or fingers that are wrapped around native tissue, such as chordae tendinae. In some embodiments, the anchoring elements 4032 and 4034 can be intertwined in the native chordae tendinae to promote ingrowth and secure the anchors.

[0279] Figure 57A is a side view of a laterally deliverable transcatheter prosthetic heart valve 3802 according to an embodiment. The valve 4102 includes an outer frame 4110 having distal anchoring elements 4132 extending from a distal side of the outer frame 4110 and proximal anchoring elements 4134 extending from a proximal side of the outer frame 4110. A flow control component 4150 is shown mounted at an offset position within a central passage of the outer frame 4110. The anchoring elements 4132 and 4134 are, for example, independent elements that each wrap around a portion of the outer frame 4110 and include curved loop portions and / or ends that are capable of engaging native tissue. Figure 57B is a cross-sectional side view of a heart showing a valve 4102 deployed in an annulus of a native valve. The anchoring elements 4132 and 4134 are shown with curved loop portions or ends that are wrapped around native tissue, such as chordae tendinae, to promote ingrowth and secure the anchors.

[0280] Figure 58A is an illustration of a guidewire delivery catheter 4287 that provides access to, for example, an Al-P1 target region of a native valve. A guidewire 4285 can extend out of a side port of the guidewire delivery catheter 4287 and can provide a path for positioning a valve at a desired location, such as an Al-P1 target location. Figure 58B is an illustration of a magnified view of a portion of the guidewire delivery catheter 4287.

[0281] Figure 59 is an illustration of a delivery catheter 4372 that provides access to, for example, an atrium of a heart. The delivery catheter 4372 can be, for example, a 28 Fr delivery catheter with an end thereof, such as an atrium-exposed end, disposed in the atrium. A circumferential balloon 4373 is shown inflated around the atrium-exposed end of the delivery catheter 4372 to temporarily secure the delivery catheter 4372 to the atrial wall.

[0282] Figure 60is a cross-sectional side view of a portion of a heart according to an embodiment, showing a guidewire delivery catheter 4487 extending into a cardiac volume. The guidewire delivery catheter 4487 is shown extending through the native valve annulus and into the left ventricle. A guidewire 4485 is shown extending from the guidewire delivery catheter 4487 to a target Al-P1 region. Figure 61 is an enlarged cross-sectional view of the guidewire delivery catheter 4487. The guidewire delivery catheter 4487 is shown having an atraumatic closed end 448 that defines and / or includes a side port 4489 to allow the guidewire 4485 to extend out of the distal end of the guidewire delivery catheter 4487 without causing trauma to native tissue.

[0283] Figure 62 is a perspective side view of a laterally deliverable transcatheter prosthetic heart valve 4502 according to an embodiment. The valve 4502 is shown having a septal tether that includes a relatively rigid elongated member 4592 that is attached at its ends to anchors 4593 (e.g., paddle anchors, etc.). The septal tether can be used to hold the deployed valve 4502 in place in the annulus of a native mitral valve, for example, by placing the anchors 4593 in trans-septal membrane punctures for trans-septal delivery from the IVC to the left atrium. Figure 63 is a cross-sectional view of a heart showing the deployed valve 4502 in place in the annulus of a native mitral valve.

[0284] Figure 64 is a cross-sectional view of a heart according to an embodiment showing a guidewire delivery catheter 4687 (or positioning tool) inserted into the left atrium of the heart. A guidewire 4685 is shown extending from the guidewire delivery catheter 4687. A distal portion of the guidewire 4685 is shown having a docking receptacle 4694 with a keyed tissue grasping feature 4695 for anchoring to the free wall of the left ventricle. Figure 65 is an enlarged cross-sectional view of a heart showing the docking receptacle 4694 anchored to the free wall of the left ventricle.

[0285] Figure 66is a flowchart illustrating a method 10 of deploying a laterally deliverable transcatheter prosthetic heart valve in an annulus of a native valve in accordance with embodiments. The prosthetic valve can be any of the valves disclosed herein. For example, the valve can have (i) an outer frame having one or more of a distal anchoring element, a proximal anchoring element, and / or one or more anterior anchoring elements, and (ii) a flow control component mounted within the outer frame, the flow control component configured to allow blood to flow in a single direction through an inflow end of the valve and to prevent blood from flowing in an opposite direction through an outflow end of the valve. The valve can be delivered by, for example, lateral or orthogonal delivery. For example, the valve can be delivered by any of the processes and / or methods described in detail herein and / or in the '957 PCT.

[0286] The method 10 includes, at 11, advancing a guidewire to the atrium, through a plane defined by an annulus of a native valve, and behind native leaflets of the native valve. In some embodiments, the native valve can be a native tricuspid valve or a native mitral valve. At 12, the prosthetic valve is advanced in an orthogonally compressed configuration through a lumen of a delivery catheter and along the guidewire into the atrium. For example, in some embodiments, the prosthetic valve can include a distal anchoring element having, for example, a guidewire coupler that is capable of engaging and / or being disposed on or around the guidewire. In some embodiments, the guidewire coupler can be a damage control ball disposed at an end of the distal anchoring element, the damage control ball defining an opening configured to receive the guidewire.

[0287] At 13, the prosthetic valve is released from the delivery catheter to allow at least a portion of the prosthetic valve to transition into an expanded configuration, with the distal anchoring element of the prosthetic valve in an extended configuration. In some embodiments, for example, the distal anchoring element can be a reconfigurable anchoring element that can be in an extended configuration during delivery and / or deployment, and configured to transition into a compressed or folded configuration to secure the prosthetic valve in the annulus of the native valve.

[0288] At 14, the prosthetic valve is advanced along the guidewire to place the distal anchoring element at a location behind the native leaflet and seat the prosthetic valve in the annulus of the native valve. For example, the native valve can be a native tricuspid valve, and the native leaflet can be the posterior (e.g., P2) leaflet. At 15, the guidewire is withdrawn to release the distal anchoring element from the extended position to the collapsed position, allowing the distal anchoring element to capture at least one of the native leaflet or chordae and secure the native leaflet or chordae between the distal anchoring element and the peripheral wall of the prosthetic valve. For example, in some embodiments, the distal anchoring element can be a biased, self-folding, and / or self-contracting anchoring element that can return to the collapsed position when the guidewire is withdrawn. In some embodiments, the distal anchoring element can have a length sufficient to capture a desired amount of native tissue and / or chordae, thereby securing at least the distal end of the prosthetic valve in the native annulus.

[0289] It will be apparent to those skilled in the art that numerous and various modifications can be made without departing from the spirit and scope of the application. Other embodiments of the methods and apparatuses within the scope of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the methods and apparatuses disclosed herein. Such modifications and variations are intended to be included within the scope of the claims. The disclosure is to be limited only by the terms of the claims and the full scope of equivalents that are properly inured to such claims. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds, compositions or biological systems, which can of course vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0290] While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where the described methods indicate certain events occurring in certain order, the ordering of certain events can be modified. Additionally, certain events can occur in parallel processes. Where certain events can not be performed in the exact order described, the order of certain events can be modified.

[0291] Where the schematic diagrams and / or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components can be modified. While embodiments have been particularly shown and described, it will be understood that various changes can be made in form and details. Any part of the apparatus and / or method described herein can be combined in any combination, except where mutually exclusive combinations are involved.

[0292] Embodiments described herein can include various combinations and / or subcombinations of the functions, components and / or features of the different embodiments described. Various and other features and functions can be added to the many embodiments disclosed. Each of the various and other features and functions can be used alone or in combination with one or more other features and functions.

Claims

1. A laterally deliverable prosthetic heart valve, comprising: an outer frame having a peripheral wall defining a central channel extending along a central axis of the outer frame, the outer frame having a distal subannular anchoring element extending from the peripheral wall, the distal subannular anchoring element having a guidewire coupler configured to receive a guidewire; and a flow control member mounted within the central channel of the outer frame, the flow control member having an inner frame and a set of leaflets coupled to the inner frame, The prosthetic valve is configured to fold along the longitudinal axis and compress along the central axis to place the prosthetic valve in a compressed configuration for lateral delivery into the heart via a delivery catheter, wherein the guidewire coupler is advanced away from the central axis and along the guidewire as the prosthetic valve is advanced through the delivery catheter. The prosthetic valve is configured to transition to an expanded configuration when released from a delivery catheter, the distal subannular anchoring element is configured to be in an extended configuration during deployment of the prosthetic valve into the annulus of the native valve, and the distal subannular anchoring element is configured to transition to a folded configuration in response to withdrawal of the guidewire from the guidewire coupler to secure at least one of the native leaflet tissue and chordae tendineae between the distal subannular anchoring element and the distal wall of the outer frame.

2. The prosthetic valve of claim 1 , further comprising: A proximal anchoring element is coupled to the proximal wall of the outer frame, the proximal anchoring element being configured to secure a proximal portion of the prosthetic valve to proximal subannular tissue when the prosthetic valve is positioned within the annulus of a native valve.

3. The prosthetic valve according to claim 2, wherein: The proximal anchoring element is configured to transition from a first configuration to a second configuration to secure the proximal portion of the prosthetic valve to proximal subannular tissue.

4. The prosthetic valve of claim 1 , further comprising: An anterior anchoring element coupled to the anterior wall of the external frame, the anterior anchoring element including a coupling portion configured to transition between a first configuration in which the coupling portion extends in the direction of the central axis to allow the coupling portion to engage at least one of the anterior autologous leaflet and the anterior chordae tendineae, and a second configuration in which the coupling portion at least partially retracts to allow the coupling portion to capture and secure the anterior autologous leaflet or the anterior chordae tendineae between the anterior anchoring element and the anterior wall.

5. A prosthetic valve as described in claim 4, wherein the anterior anchoring element includes a sleeve, the engaging portion is at least partially disposed in the sleeve and extends from the sleeve when in the first configuration, and the engaging portion is at least partially retracted into the sleeve when in the second configuration to capture and fix the anterior autologous leaflet or the anterior chordae tendineae between the anterior anchoring element and the anterior wall.

6. The prosthetic valve of claim 4, wherein the engagement portion of the anterior anchoring element is a clip.

7. The prosthetic valve of claim 4, wherein the anterior anchoring element is a wire and the engagement portion of the anterior anchoring element is a reconfigurable portion of the wire.

8. The prosthetic valve of claim 1 , further comprising: An atrial ring is coupled to the atrial rim portion of the outer frame, the atrial ring being configured to contact supra-annular tissue when the prosthetic valve is positioned in the annulus of a native valve.

9. The prosthetic valve according to claim 1, wherein: The prosthetic valve is configured for deployment into the annulus of a native mitral valve.

10. A laterally deliverable prosthetic heart valve, comprising: an outer frame defining a central channel extending along a central axis of the outer frame, the outer frame having a distal subannular anchoring element extending from a distal wall of the outer frame, the distal subannular anchoring element having a guidewire coupler configured to be threaded onto a guidewire; and a flow control member mounted within the central channel of the outer frame, the flow control member having an inner frame and a set of leaflets coupled to the inner frame, The prosthetic valve is configured to be placed in a compressed configuration for delivery into a heart via a delivery catheter such that: (i) the central axis is perpendicular to an axis extending through a lumen of the delivery catheter, and (ii) the distal subannular anchoring element is distal to the central axis as the prosthetic valve is advanced through the lumen of the delivery catheter; The distal subannular anchoring element is configured to engage at least one of the autologous leaflet tissue and the chordae tendineae when the prosthetic valve is positioned in the annulus of the native valve, and the distal subannular anchoring element is further configured to secure at least one of the autologous leaflet tissue and the chordae tendineae between the distal subannular anchoring element and the distal wall of the outer frame in response to withdrawal of the guidewire from the guidewire coupler.

11. The prosthetic valve according to claim 10, wherein: The distal subannular anchoring element is in an extended configuration during deployment of the prosthetic valve into the annulus and is configured to transition to a collapsed configuration in response to withdrawal of the guidewire from the guidewire coupler.

12. The prosthetic valve of claim 10, further comprising: A proximal anchoring element is coupled to the proximal wall of the outer frame, the proximal anchoring element being configured to secure a proximal portion of the prosthetic valve to proximal subannular tissue when the prosthetic valve is positioned in the annulus of a native valve.

13. The prosthetic valve of claim 12, wherein: The proximal anchoring element is configured to transition from a first configuration to a second configuration after the prosthetic valve is positioned in the annulus to secure the proximal portion of the prosthetic valve to proximal subannular tissue.

14. The prosthetic valve of claim 10, further comprising: An anterior anchoring element coupled to the anterior wall of the outer frame, the anterior anchoring element being in a first configuration to engage at least one of the anterior native leaflet and the anterior chordae tendineae when the prosthetic valve is positioned in the annulus, the anterior anchoring element being configured to transition to a second configuration to secure the anterior native leaflet or the anterior chordae tendineae between the anterior anchoring element and the anterior wall of the outer frame.

15. A prosthetic valve as described in claim 14, wherein the anterior anchoring element includes a sleeve, the anterior anchoring element extends from the sleeve when in the first configuration, and the anterior anchoring element is at least partially retracted into the sleeve when in the second configuration to fix the anterior autologous leaflet or the anterior chordae tendineae between the anterior anchoring element and the anterior wall.

16. The prosthetic valve of claim 14, wherein the anterior anchoring element comprises at least one of a clip and a reconfigurable wire.

17. The prosthetic valve of claim 14, wherein: The anterior anchoring element is temporarily coupled to a guidewire, the anterior anchoring element being configured to transition from the first configuration to the second configuration when the guidewire is withdrawn from both the guidewire coupler and the anterior anchoring element.

18. The prosthetic valve of claim 10, further comprising: An atrial ring is coupled to the atrial rim portion of the outer frame, the atrial ring being configured to contact supra-annular tissue when the prosthetic valve is positioned in the annulus of a native valve.

19. The prosthetic valve of claim 10, wherein: The prosthetic valve is configured for deployment into the annulus of a native mitral valve.

20. A laterally deliverable prosthetic heart valve, the prosthetic valve comprising: an outer frame defining a central channel extending along a central axis of the outer frame, the outer frame having a distal anchoring element extending from a distal wall of the outer frame and a front anchoring element extending from a front wall of the outer frame, a distal portion of the distal anchoring element being configured to releasably couple to a guidewire; and a flow control member mounted within the central channel of the outer frame, the flow control member having an inner frame and a set of leaflets coupled to the inner frame, the prosthetic valve being configured to be placed in a compressed configuration for lateral delivery into the heart via a delivery catheter, wherein the central axis is perpendicular to an axis extending through a lumen of the delivery catheter, and wherein the distal anchoring element is distal to the central axis as the prosthetic valve is advanced through the lumen of the delivery catheter; the distal anchoring element being configured to be in an extended configuration when the prosthetic valve is positioned in the annulus of the native valve, the distal anchoring element being configured to transition to a collapsed configuration in response to release from the guidewire to secure the posterior native leaflet or posterior chordae between the distal anchoring element and a distal wall of the outer frame; and The anterior anchoring element is configured to transition from an extended configuration to a retracted configuration after the prosthetic valve is positioned in the annulus to secure at least one of the anterior native leaflet and the anterior chordae between the anterior anchoring element and the anterior wall of the outer frame.

21. The prosthetic valve of claim 20, wherein: The distal anchoring element includes a guidewire coupler disposed at a distal portion of the distal anchoring element, the guidewire coupler being configured to releasably receive a guidewire.

22. The prosthetic valve of claim 21, wherein: When the prosthetic valve is in the compressed configuration and positioned in the delivery catheter for lateral delivery, the distal anchoring element is configured distal to the central axis and the guidewire coupler is configured to be threaded onto the guidewire.

23. The prosthetic valve of claim 21, wherein: An anterior anchoring element is temporarily coupled to the guidewire, the anterior anchoring element being configured to transition from an extended configuration to a compressed configuration in response to being released from the guidewire.

24. The prosthetic valve of claim 23, wherein: Releasing the guidewire includes withdrawing the guidewire from the guidewire coupler and the front anchoring element.

25. The prosthetic valve of claim 20, further comprising: A proximal anchoring element extends from a proximal wall of the outer frame, the proximal anchoring element being configured to transition from a first configuration to a second configuration to secure a proximal portion of the prosthetic valve to proximal subannular tissue.

26. The prosthetic valve of claim 20, wherein: The anterior anchoring element includes a sleeve, and the portion of the anterior anchoring element is configured to at least partially extend from the sleeve when in an extended configuration, and is configured to at least partially retract into the sleeve when in a retracted configuration to secure the anterior autologous leaflet or the anterior chordae tendineae between the anterior anchoring element and the anterior wall of the external frame.

27. The prosthetic valve of claim 26, wherein the portion of the anterior anchoring element comprises a clip.

28. The prosthetic valve of claim 20, wherein the anterior anchoring element is a wire and the portion of the anterior anchoring element is a reconfigurable portion of the wire.

29. The heart valve of claim 20, wherein: The outer frame includes an annular wall defining the central channel, the distal wall is a distal portion of the annular wall, and the front wall is a front portion of the annular wall. The prosthetic valve further includes: An atrial ring is coupled to the atrial rim portion of the annular wall of the outer frame, the atrial ring being configured to contact supra-annular tissue when the prosthetic valve is positioned within the annulus of a native valve.

30. The prosthetic valve of claim 20, wherein: The prosthetic valve is configured for deployment into the annulus of a native mitral valve.

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