Laterally Deliverable Transcatheter Prosthetic Heart Valve and Method for Its Delivery and Anchoring

Abstract

A laterally deliverable prosthetic heart valve includes an outer frame and a flow control member. The outer frame has an above-annular region, a below-annular region, and a trans-annular region therebetween. The flow control member is mounted to the outer frame such that at least a portion of the flow control member is disposed in the trans-annular region. The prosthetic valve has a delivery configuration for lateral delivery via a delivery catheter and is capable of expanding upon release of the prosthetic valve from the delivery catheter. The below-annular region of the outer frame is capable of being in a first configuration when the prosthetic valve is seated in the annulus of a native heart valve and is capable of transitioning to a second configuration after the prosthetic valve is seated in the annulus of the native heart valve.

Description

[0001] Cross-Reference to Related Applications

[0002] This application claims the benefit of the following applications: U.S. Provisional Patent Application No. 62 / 891,956, filed August 26, 2019, entitled "Methods and Apparatus for Temporary Compression of a Proximal Sidewall for Side-Delivered Transcatheter Heart Valve Prosthesis"; U.S. Provisional Patent Application No. 62 / 905,932, filed September 25, 2019, entitled "Methods and Apparatus for Temporary Compression of a Proximal Sidewall for Side-Delivered Transcatheter Heart Valve Prosthesis"; U.S. Provisional Patent Application No. 63 / 014,059, filed April 22, 2020, entitled "Subannular Proximal Tab Projections for Side-Deliverable Transcatheter Prosthetic Valves"; U.S. Provisional Patent Application No. 63 / 016,269, filed April 27, 2020, entitled "Freewall Support Flare and Posterio-Septal Commissure Flare as Subannular Anchor Elements for Side-Deliverable Transcatheter Prosthetic Valves"; and / or U.S. Provisional Patent Application No. 63 / 027,345, filed May 19, 2020, entitled "Side-Deliverable Transcatheter Prosthetic Valves and Method for Delivering and Anchoring the Same", the disclosure of each of the above applications is hereby incorporated by reference in its entirety.

[0003] This application also claims priority to and is a continuation of International Patent Application No. PCT / US2019 / 067010, filed on December 18, 2019, entitled "Transcatheter Deliverable Prosthetic Heart Valves and Methods of Delivery", the disclosure of which is incorporated herein by reference in its entirety.

[0004] This application also claims priority to and is a continuation of International Patent Application No. PCT / US2020 / 015231, filed on January 27, 2020, entitled "Collapsible Inner Flow Control Component for Side-Deliverable Transcatheter Heart Valve Prosthesis", the disclosure of which is incorporated herein by reference in its entirety.

[0005] This application also claims priority to and is a continuation of International Patent Application No. PCT / US2020 / 031390, filed on May 4, 2020, entitled "Cinch Device and Method for Deployment of a Side-Delivered Prosthetic Heart Valve in a Native Annulus", the disclosure of which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION

[0006] The embodiments described herein generally relate to transcatheter prosthetic valves, and more particularly, to side-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 the same.

[0007] Prosthetic heart valves can pose challenges for delivery and deployment within the heart, particularly for delivery through a catheter across a patient's vasculature rather than through surgical methods. Conventional transcatheter prosthetic valve delivery typically involves compressing the valve in the radial direction and loading the valve into a delivery catheter such that the central annulus 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 expands radially outward from the central annulus axis. However, the expansion size (e.g., diameter) of conventional valves can be limited by the inner diameter of the delivery catheter. The competing interest of minimizing the size of the delivery catheter poses a challenge to increasing the expansion diameter of conventional valves (e.g., trying to compress too much material and structure into a very small space). Additionally, the orientation of conventional valves during deployment can create additional challenges when attempting to align the valve with the native valve annulus.

[0008] Some transcatheter prosthetic valves can be configured for lateral and / or orthogonal delivery, which can have an increased expansion diameter compared to conventional valves. For example, during lateral and / or orthogonal delivery, the valve is compressed and loaded into a delivery catheter such that the central annulus axis of the valve is substantially orthogonal to the longitudinal axis of the delivery catheter, which can allow the valve to be laterally compressed and longitudinally extended (e.g., in a direction parallel to the longitudinal axis of the delivery catheter). In some such implementations, it is also necessary to provide an outer portion or valve frame that has a size and / or shape corresponding to the size and / or shape of the annulus of the native valve (e.g., the mitral and / or tricuspid valve of the human heart), while providing an internal flow control component having the following properties: (i) compatible with the lateral compression and / or longitudinal extension experienced during delivery and (ii) having a substantially cylindrical shape that allows for optimal function of the prosthetic valve leaflets included therein. In the case of conventional and / or orthogonally delivered transcatheter prosthetic valves, it is also necessary to provide one or more ways to anchor the valve in the native annulus without substantially increasing the compressed size of the valve.

[0009] Accordingly, there is a need for a laterally deliverable transcatheter prosthetic valve having one or more anchoring elements for fixing the prosthetic valve in the annulus of the native valve and a method for delivering such a prosthetic valve. SUMMARY OF THE INVENTION

[0010] The embodiments described herein are directed to a laterally deliverable transcatheter prosthetic valve having one or more anchoring elements for securing the prosthetic valve to the annulus of an autologous valve and methods of delivering the same. In some embodiments, the laterally deliverable prosthetic valve includes an outer frame having a supra-annular region, a sub-annular region, and a trans-annular region coupled therebetween. A flow control member is mounted to the outer frame such that at least a portion of the flow control member is disposed in the trans-annular region. The prosthetic valve has a delivery configuration for laterally delivering the prosthetic valve via a delivery catheter and is capable of expanding upon release of the prosthetic valve from the delivery catheter. The sub-annular region of the outer frame is capable of being disposed in a first configuration when the prosthetic valve is seated in the annulus of an autologous heart valve and is capable of transitioning to a second configuration after the prosthetic valve is seated in the annulus of an autologous heart valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1A and Figure 1B are schematic front views respectively showing a laterally deliverable transcatheter prosthetic heart valve (also referred to herein as a "prosthetic valve") in an expanded configuration and a compressed configuration.

[0012] Figure 1C and Figure 1D are schematic top views respectively showing the prosthetic valve in an expanded configuration and a compressed configuration Figure 1A and Figure 1B of the prosthetic valve.

[0013] Figure 1E is a schematic illustration of the prosthetic valve deployed within the annulus of an autologous heart valve Figures 1A to 1D of the prosthetic valve.

[0014] Figure 2A and Figure 2B are schematic side views respectively showing the prosthetic valve in a first configuration and a second configuration according to one embodiment.

[0015] Figure 2C and Figure 2D are schematic bottom views and side views respectively showing the prosthetic valve in a second configuration and a third configuration Figures 2A to 2B of the prosthetic valve.

[0016] Figures 3A to 3C is a schematic illustration of the outer frame of a laterally deliverable transcatheter prosthetic heart valve shown in a delivery configuration, a seating configuration, and a deployed configuration respectively according to one embodiment.

[0017] Figure 4 is a perspective illustration of the prosthetic valve according to one embodiment.

[0018] Figure 5 andFigure 6 are various views of the annulus region of the outer support frame of the prosthetic valve shown in Figure 4 .

[0019] Figures 7 to 11 are various views of the transannular region of the outer support frame of the prosthetic valve shown in Figure 4 .

[0020] Figure 12 and Figure 13 are various views of the subannular region of the outer support frame of the prosthetic valve shown in Figure 4 .

[0021] Figure 14 Shows a top perspective view of the inner frame of the flow control component included in the prosthetic valve shown in Figure 4 .

[0022] Figures 15 to 17 Shows various views of the inner frame of Figure 14 shown in a partially folded configuration, a folded configuration, and a folded and compressed configuration, respectively.

[0023] Figure 18 Shows a side view of the inner frame of Figure 14 and is shown as a linear wireframe sheet before being formed into a cylindrical configuration.

[0024] Figure 19 Shows a side perspective view of the inner frame of Figure 14 shown in a cylindrical configuration.

[0025] Figure 20 and Figure 21 are diagrams of a side view and a bottom view, respectively, of the leaflet band of the flow control component having a leaflet pocket sewn into a pericardial tissue structure strip shown in a linear configuration.

[0026] Figure 22 Shows a side perspective view of the leaflet band of Figure 19 shown in a cylindrical configuration suitable for attachment to Figure 20 of the inner frame.

[0027] Figure 23 Shows a side perspective view of a portion of the leaflet band of Figure 20 showing a single leaflet pocket sewn into a structure strip.

[0028] Figure 24 Shows a bottom view of the leaflet band of Figure 20 shown in a cylindrical configuration and showing partial engagement of the leaflets to form a partially closed fluid seal.

[0029] Figure 25And Figure 26 are a schematic cross-sectional side view and a bottom view of a prosthetic valve according to an embodiment, respectively.

[0030] Figure 27 is Figure 25 a schematic cross-sectional side view of a prosthetic valve, and is shown as having an actuator and / or a fastening assembly attached to the prosthetic valve.

[0031] Figure 28 and Figure 29 are diagrams of a side perspective view of a prosthetic valve according to an embodiment with the proximal annulus under-anchoring element in an extended configuration and a contracted configuration, respectively.

[0032] Figure 30 and Figure 31 are diagrams of a bottom perspective view of a prosthetic valve according to an embodiment with the proximal annulus under-anchoring element coupled to an actuator and / or a fastening assembly and shown in an extended configuration and a contracted configuration, respectively.

[0033] Figures 32A to 32E is a Figure 30 bottom perspective view of a prosthetic valve showing a series of transitions of the lower proximal anchoring element from an extended configuration to a contracted configuration.

[0034] Figures 33A to 33C is a side perspective view diagram of a portion of a proximal anchoring element of a prosthetic valve according to an embodiment being coupled and decoupled to an actuator and the like.

[0035] Figure 34 is a proximal perspective view diagram of a prosthetic valve according to an embodiment shown as having a set of protrusions attached to the proximal anchoring element.

[0036] Figure 35 and Figure 36 are proximal perspective view and side view diagrams of a prosthetic valve according to an embodiment shown as having a proximal anchoring element in a first or compressed configuration and having a set of protrusions attached to the proximal anchoring element.

[0037] Figure 37 is a Figure 34 side view diagram of a prosthetic valve shown as having a proximal anchoring element in a second or extended configuration for engaging autologous tissue on the proximal annulus underside of the annulus.

[0038] Figures 38A to 38F are diagrams of the lower wireframe loops of prosthetic valves each having at least a distal anchoring element and a proximal anchoring element according to different embodiments.

[0039] Figure 39 and Figure 40Top and side perspective views, respectively, of a subannular member of an outer support frame of a prosthetic valve according to an embodiment, the prosthetic valve being in a wire loop configuration having distal and proximal anchoring elements each including tissue engaging features.

[0040] Figure 41 Side perspective view of a portion of an outer support frame according to an embodiment, and showing a subannular member having distal and proximal anchoring elements, the distal and proximal anchoring elements having tissue engaging features and being coupled to a transannular member.

[0041] Figure 42A and Figure 42B Top and side views, respectively, of a laser cut workpiece configured to form a subannular member of an outer support frame of a prosthetic valve according to an embodiment.

[0042] Figure 43A and Figure 43B Top and side views, respectively, of a laser cut workpiece configured to form a subannular member of an outer support frame of a prosthetic valve according to an embodiment.

[0043] Figure 44 Side perspective view of a supraannular member of an outer support frame having an outer support ring, an inner support ring, and a central ridge extending between the outer support ring and the inner support ring, the supraannular member being mounted to a supraannular portion (e.g., a cylindrical sidewall member) of a transannular member of the outer support frame and shown above a subannular member of the outer support frame, the subannular member being arranged in a wire loop having shaped distal and proximal anchoring elements, the distal and proximal anchoring elements having apertures for engaging autologous tissue mounted thereon.

[0044] Figure 45A and Figure 45B Top and side views, respectively, of a laser cut design workpiece of a supraannular member of an outer support frame according to an embodiment.

[0045] Figures 46A to 46C Schematic side view of a prosthetic valve according to an embodiment, showing a sequence of retracting the valve into a portion of a delivery and / or retraction system.

[0046] Figures 47A to 47I Top perspective view of a valve sequence diagram according to an embodiment showing a sequence of retracting a prosthetic valve into a portion of a delivery and / or retraction system.

[0047] Figures 48A to 48Cis a sequence diagram showing the subannular flaring on the free wall (left) and septal (right) sides transitioning from an extended configuration ( Figure 48A ) to a retracted configuration ( Figure 48B ) for placement within and / or through the native annulus and substantially back to the extended configuration ( Figure 48C ) to allow the valve to use the subannular flaring as an anchoring mechanism.

[0048] Figure 49A and Figure 49B are sequence diagrams showing a top view of a portion of a prosthetic valve according to one embodiment, and the portion has a subannular member of an outer support frame that is removably coupled to an actuator and is pulled inward to reduce the perimeter or circumference of at least a portion of the prosthetic valve and / or the outer support frame to facilitate deployment of the prosthetic valve within the native annulus.

[0049] Figures 50A to 50C is a bottom perspective view of a laterally delivered transcatheter prosthetic heart valve according to one embodiment, and Figure 50D is a bottom side perspective view of a laterally delivered transcatheter prosthetic heart valve and shows a sequence of actuating one or more portions of the prosthetic valve to reduce the perimeter and / or circumference of the subannular member to facilitate deployment of the valve within the native annulus.

[0050] Figures 51 to 53 are a side perspective view, a top view, and a bottom perspective view, respectively, of a prosthetic valve removably coupled to at least a portion of a delivery and / or actuation system according to one embodiment.

[0051] Figure 54A is a diagram of a laser cut design of a portion of a prosthetic valve including a delivery system-valve attachment point (e.g., path point) according to one embodiment.

[0052] Figures 54B to 54D is Figure 54A a set of diagrams of the delivery system-valve attachment point showing path points having a folding design for removably coupling a prosthetic valve to a portion of a delivery system.

[0053] Figure 55A and Figure 55B depict various views of the delivery-valve attachment point (e.g., path point) of a prosthetic valve according to one embodiment and are shown as having a yoke design for removably coupling a prosthetic valve to a portion of a delivery system.

[0054] Figures 56A to 56CIllustrates various views of a delivery-valve attachment point (e.g., waypoint) of a prosthetic valve according to an embodiment, and is shown having an articulated design for removably coupling the prosthetic valve to a portion of a delivery system.

[0055] Figures 57 to 60 Is a bottom perspective view of a prosthetic valve according to an embodiment, and illustrates the process of transitioning a proximal anchoring element of the prosthetic valve between a first configuration and a second configuration.

[0056] Figures 61 to 64 Is a bottom perspective view of a prosthetic valve according to an embodiment, and illustrates the process of transitioning a proximal anchoring element of the prosthetic valve between a first configuration and a second configuration.

[0057] Figure 65 Is a bottom perspective view of a prosthetic valve according to an embodiment, shows the proximal anchoring element in a compressed configuration, and has a set of protrusions extending from the proximal anchoring element.

[0058] Figures 66 to 68 Are, respectively, a top perspective view, a side perspective view, and a bottom view of a prosthetic valve according to an embodiment, and illustrate an annulus member having an arcuate configuration.

[0059] Figure 69 Is included in Figures 66 to 68 Perspective view of an annulus member in a prosthetic valve of.

[0060] Figure 70 Is a flowchart illustrating a method of deploying a laterally deliverable transcatheter prosthetic valve according to an embodiment.

[0061] Figure 71 Is a flowchart illustrating a method of manufacturing at least a portion of a laterally deliverable transcatheter prosthetic valve according to an embodiment. Detailed Description

[0062] The disclosed embodiments pertain to transcatheter prosthetic heart valves and / or their components, and methods of manufacturing, loading, delivering, and / or deploying transcatheter prosthetic valves and / or their components. In some embodiments, a laterally deliverable prosthetic valve includes an outer frame having an annulus region, a sub-annulus region, and a trans-annulus region coupled therebetween. A flow control component is mounted to the outer frame such that at least a portion of the flow control component is disposed in the trans-annulus region. The prosthetic valve has a delivery configuration for laterally delivering the prosthetic valve via a delivery catheter and is capable of expanding when the prosthetic valve is released from the delivery catheter. The sub-annulus region of the outer frame is capable of being set in a first configuration when the prosthetic valve is seated in the annulus of a native heart valve and is capable of transitioning to a second configuration after the prosthetic valve is seated in the annulus of the native heart valve.

[0063] In some embodiments, a laterally deliverable prosthetic heart valve includes an outer frame and a flow control component. The outer frame has a supra-annular member, an infra-annular member, and a trans-annular member coupled therebetween. The flow control component has an inner frame and a plurality of leaflets mounted within the inner frame. The flow control component is mounted to the outer frame such that a portion of the flow control component is disposed within the trans-annular member.

[0064] In some embodiments, a laterally deliverable prosthetic heart valve has a delivery configuration for lateral delivery via a delivery catheter and is capable of expanding when the prosthetic valve is released from the delivery catheter. The prosthetic valve includes: an outer frame having a supra-annular member that forms an outer ring, an inner ring, and splines coupled to the outer ring and the inner ring; and a flow control component having an inner frame and a plurality of leaflets mounted within the inner frame. The flow control component is mounted to the inner ring of the supra-annular member. When the prosthetic valve is placed into the annulus of a native heart valve, the splines suspend the inner ring on the outer ring to limit the amount of stress transmitted to the flow control component.

[0065] In some embodiments, a laterally deliverable prosthetic heart valve is capable of being compressed for lateral delivery via a delivery catheter of a delivery system and is capable of expanding when released from the delivery catheter. The prosthetic valve includes an outer frame having a supra-annular member, an infra-annular member, and a trans-annular member that couples the supra-annular member to the infra-annular member. The supra-annular member forms an outer ring, an inner ring, and splines coupled to the outer ring and the inner ring. The supra-annular member is capable of being removably coupled to the delivery system. A flow control component having an inner frame and a plurality of leaflets mounted within the inner frame is mounted to the outer frame such that a portion of the flow control component is disposed within the trans-annular member.

[0066] In some embodiments, an outer frame for a prosthetic heart valve includes a supra-annular member, an infra-annular member, and a trans-annular member. The supra-annular member forms an outer ring, an inner ring, and splines that at least partially suspend the inner ring on the outer ring. The outer ring forms a distal supra-annular anchoring element and a proximal supra-annular anchoring element. The inner ring is capable of being coupled to a flow control component having an inner frame and a plurality of leaflets mounted within the inner frame. The infra-annular member forms a distal infra-annular anchoring element and a proximal infra-annular anchoring element. The trans-annular member couples the supra-annular member to the infra-annular member.

[0067] Any of the prosthetic heart valves described herein can be a relatively low-profile, laterally deliverable implantable prosthetic heart valve (also referred to herein as a "prosthetic valve" or simply a "valve"). Any of the prosthetic valves can be a transcatheter prosthetic valve configured to be delivered to the heart via a delivery catheter. The prosthetic valve can at least have an annular outer valve frame and an internal flow control component (e.g., a 2-leaflet or 3-leaflet valve, cannula, etc.) mounted within and / or extending through a central lumen or aperture of the valve frame. The flow control component can be configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction opposite the first direction through an outflow end of the valve. Additionally, the prosthetic valve can include a single anchoring element or multiple anchoring elements configured to anchor the valve in the annulus of an autologous valve.

[0068] Any of the prosthetic valves described herein can be configured to transition between a compressed configuration or delivery configuration for introduction into the body using a delivery catheter and an expanded or deployed configuration for implantation at a desired location in the body. For example, any of the embodiments described herein can be a balloon-expandable prosthetic valve, a self-expanding prosthetic valve, etc.

[0069] Any of the prosthetic valves described herein can be compressible in a longitudinal or orthogonal direction (e.g., along a longitudinal axis) relative to a central axis of the flow control component into a compressed or delivery configuration, which can allow, for example, a large-diameter valve (e.g., having a height of about 5 mm - 60 mm and a diameter of about 20 mm - 80 mm) to be directly delivered into the annulus of an autologous mitral or tricuspid valve and deployed from the inferior vena cava using a 24Fr - 36Fr delivery catheter. The longitudinal axis can be substantially parallel to the longitudinal cylindrical axis of the delivery catheter, which can allow the prosthetic valve to be deployed without the acute approach angles common in traditional transcatheter delivery.

[0070] Any of the prosthetic 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 or delivery configuration of the valve is orthogonal to the direction of blood flow. In some embodiments, the compressed or delivery configuration of the valve is parallel or aligned with the direction of blood flow. In some embodiments, the valve can be compressed into a compressed or delivery configuration in two directions: orthogonal to the direction of blood flow (e.g., laterally) and parallel to the blood flow (e.g., axially). In some embodiments, when in the compressed or delivery configuration and / or the expanded or deployed configuration, the long axis or longitudinal axis is oriented at an angle between 45 degrees and 135 degrees with respect to the first direction.

[0071] Any of the prosthetic valves described herein may include an outer support frame that includes a set of compressible filament units having an orientation and unit geometry that is substantially orthogonal to a central axis to minimize filament unit strain when the outer support frame is in a delivery configuration (e.g., a compressed configuration, a rolled and compressed configuration, or a folded and compressed configuration).

[0072] Any of the outer support frames described herein may have an above-annulus region, a below-annulus region, and a trans-annular region therebetween. The above-annulus region may form, for example, an upper collar portion of the outer support frame and may include any number of features configured to engage native tissue, internal flow control components of the prosthetic valve, and / or delivery, actuator, and / or retrieval mechanisms. The below-annulus region may form, for example, distal and proximal anchoring elements configured to engage sub-annular (ventricular) tissue when the prosthetic valve is seated in the native annulus. The trans-annular region may be coupled between the above-annulus region and the below-annulus region. When the outer support frame is in an expanded configuration, the trans-annular region may form a shape such as a funnel, a cylinder, a truncated cone, or a circular hyperboloid. In some embodiments, the outer support frame is formed of filaments, braided wires, or a laser-cut wire frame and is covered with a biocompatible material. The biocompatible material may cover the outer support frame such that the inner surface is covered with pericardial tissue, the outer surface is covered with a braided synthetic polyester material, and / or the inner surface is covered with pericardial tissue and the outer surface is covered with a braided synthetic polyester material.

[0073] Any of the outer support frames described herein may have a side profile in the shape of a truncated cone having an outer diameter R of 40 mm - 80 mm, an inner diameter r of 20 mm - 60 mm, and a height of 5 mm - 60 mm. In some embodiments, the annulus support frame has a side profile in the shape of an hourglass having a top diameter R1 of 40 mm - 80 mm, a bottom diameter R2 of 50 mm - 70 mm, an inner diameter r of 20 mm - 60 mm, and a height of 5 mm - 60 mm.

[0074] Any of the prosthetic valves described herein may include one or more anchoring elements that extend from, are coupled to, and / or otherwise integral with a portion of the valve frame. For example, any of the prosthetic valves may include a distal anchoring element that may serve as, e.g., a right ventricular outflow tract (“RVOT”) bulge, a left ventricular outflow tract (“LVOT”) bulge, and / or any other suitable bulge, etc. Any of the valves described herein may also include an anchoring element that extends proximally from the valve frame, which may be used, e.g., to anchor the valve to the subannular tissue proximal to the ventricle. The anchoring element may include a wire loop or wire frame, an integrated frame segment, and / or a stent that extends from the tubular frame by about 10 mm - 40 mm, and / or may be formed from any of the foregoing. For example, any of the prosthetic valves described herein may include a valve frame having a silk or laser-cut subannular region or member that forms the distal and proximal anchoring elements.

[0075] Any of the prosthetic valves described herein may also include (i) a distal supra-annular anchoring element that extends from, is attached to, and / or otherwise integral with the distal upper edge of the valve frame, and (ii) a proximal supra-annular anchoring element that extends from, is attached to, and / or otherwise integral with the proximal upper edge of the valve frame. The distal supra-annular and proximal supra-annular anchoring elements may include a wire loop or wire frame that extends from the valve frame by about 2 mm - 20 mm, or is formed therefrom. In some embodiments, the prosthetic valves described herein may include a silk or laser-cut supra-annular region or member that forms the distal supra-annular and proximal supra-annular anchoring elements. The distal supra-annular and proximal supra-annular anchoring elements are configured to be positioned in a supra-annular position in contact with and / or adjacent to the supra-annular tissue of the atrium. In some implementations, the prosthetic valves described herein may be tied or at least partially compressed after being placed in the native annulus such that the proximal supra-annular and distal supra-annular anchoring elements exert a force on the supra-annular tissue, and the proximal sub-annular and distal sub-annular anchoring elements exert an opposing force on the sub-annular tissue, thereby fixing the prosthetic valve in the native annulus. Any of the valves described herein may also include an anterior anchoring element or a posterior anchoring element that extends from and / or is attached to the anterior or posterior side of the valve frame, respectively. Any of the valves described herein may include one or more anchoring elements that are movable, transformable, and / or otherwise reconfigurable, which may facilitate the delivery, deployment, and / or fixation of the valve.

[0076] Any of the prosthetic valves described herein may include an internal flow control component (also referred to herein as a "flow control component") having a leaflet frame on which 2-4 flexible leaflets are mounted. The 2-4 leaflets are configured to permit blood flow in a first direction through the inflow end of the flow control component and to block blood flow in a second direction opposite the first direction through the outflow end of the flow control component. The leaflet frame may include two or more panels of a rhombus or eye-shaped wire unit made of a heat-set shape memory alloy material such as nitinol. The leaflet frame may be configured to be collapsible from a circular or cylindrical configuration to a flat cylinder configuration along a z-axis (e.g., a longitudinal axis) and to be compressible along a perpendicular y-axis (e.g., a central axis) to a compressed configuration. In some implementations, the leaflet frame may include a pair of hinge regions, folding regions, connection points, etc., which may allow the leaflet frame to be folded flat along the z-axis and then the leaflet frame to be compressed along the perpendicular y-axis. The leaflet frame may be, for example, a single-piece structure (e.g., a stress concentration riser and / or any suitable structure configured to allow elastic / non-permanent deformation of the leaflet frame) having two or more active hinges and / or a two-piece structure in which hinge regions are formed using a secondary attachment method (e.g., sutures, fabrics, molded polymer components, etc.).

[0077] In some embodiments, the flow control component in the expanded configuration forms a shape such as a funnel, cylinder, flat cone, or circular hyperboloid. In some embodiments, the flow control component has a leaflet frame with a side profile that is a flat cone, with an outer diameter R of 20 mm - 60 mm, an inner diameter r of 10 mm - 50 mm, where the diameter R is greater than the diameter r, and a height of 5 mm - 60 mm. In some embodiments, the leaflet frame consists of wires, braided wires, or a laser-cut wireframe. In some embodiments, the leaflet frame may have one or more longitudinal supports integrated into or mounted on the leaflet frame and selected from rigid or semi-rigid columns, rigid or semi-rigid ribs, rigid or semi-rigid rods, rigid or semi-rigid panels, and combinations thereof.

[0078] Any of the prosthetic valves and / or their components may be made of any suitable biocompatible material or combination of materials. For example, the outer valve frame, the inner valve frame (e.g., of the internal flow control component), and / or their components may be made of biocompatible metals, metal alloys, polymer-coated metals, etc. Suitable biocompatible metals and / or metal alloys may include stainless steel (e.g., 316L stainless steel), cobalt-chromium (Co-Cr) alloy, nitinol alloy (e.g., ) etc. Additionally, either the outer frame or the inner frame described herein may be made of a nickel-titanium alloy (e.g., formed of a superelastic or shape memory alloy. Suitable polymer coatings can include poly(ethylene vinyl acetate) (PEVA), poly(butyl methacrylate) (PBMA), translute styrene-isoprene-butadiene (SIBS) copolymer, polylactic acid, polyester, polylactide, D-lactide polylactide (DLPLA), poly(lactic-co-glycolic acid) (PLGA), etc. Some such polymer coatings can form suitable drug carrier matrices, such as sirolimus, zotarolimus, biolimus, novolimus, tacrolimus, paclitaxel, probucol, etc.

[0079] Some biocompatible synthetic materials can include (for example) polyesters, polyurethanes, polytetrafluoroethylene (PTFE) (e.g., Teflon), etc. In cases where thin and durable synthetic materials are considered (e.g., for coverings), synthetic polymer materials such as expanded PTFE or polyester can be optionally used. Other suitable materials can optionally include elastomers, thermoplastics, polyurethanes, thermoplastic polycarbonate polyurethanes, polyether polyurethanes, block polyether polyurethanes, silicone polyether polyurethanes, polyetheretherketone (PEEK), silicone-polycarbonate polyurethanes, polypropylene, polyethylene, low-density polyethylene (LDPE), high-density polyethylene (HDPE), ultra-high-density polyethylene (UHDPE), polyolefins, polyethylene glycol, polyethersulfone, 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 (nylon), PTFE, stretched PTFE, expanded PTFE, silicone polymers and / or oligomers, and / or polyesters and block copolymers using the same.

[0080] Any of the outer valve frame, the inner valve frame (e.g., of the flow control component), and / or its parts or components can be partially or completely covered internally or externally by a biocompatible material such as pericardium. The valve frame can also optionally be partially or completely covered externally by a second biocompatible material such as polyester or of. The disclosed embodiments can use tissues, such as biological tissues that are chemically stable pericardial tissues of animals, such as bovine (bovine pericardium), ovine (ovine pericardium), porcine (porcine pericardium), or equine (equine pericardium). Preferably, the tissue is bovine pericardial tissue. Examples of suitable tissues include tissues for products and in, all products are currently used in surgical procedures and are sold in a form generally harvested from cattle less than 30 months old.

[0081] Any of the prosthetic valves and / or any of their components, features, and / or aspects described herein may be similar and / or substantially identical to the prosthetic valves (or their components, features, and / or aspects) described in the following applications: International Patent Application No. PCT / US2019 / 051957 (referred to herein as "the '957 PCT"); International Patent Application No. PCT / US2019 / 067010 (referred to herein as "the '010 PCT"); International Patent Application No. PCT / US2020 / 015231 (referred to herein as "the '231 PCT"); International Patent Application No. PCT / US2020 / 031390 (referred to herein as "the '390 PCT"); U.S. Provisional Patent Application No. 62 / 891,956 (referred to herein as "the '956 provisional"); U.S. Provisional Patent Application No. 62 / 905,932 (referred to herein as "the '932 provisional"); U.S. Provisional Patent Application No. 63 / 014,059 (referred to herein as "the '059 provisional"); U.S. Provisional Patent Application No. 63 / 016,269 (referred to herein as "the '269 provisional"); and / or U.S. Provisional Patent Application Serial No. 63 / 027,345 (referred to herein as "the '345 provisional"), the disclosures of each of the above applications being incorporated herein by reference in their entireties.

[0082] Any of the delivery systems described herein may include a delivery system having a delivery catheter for laterally delivering a laterally deliverable prosthetic valve. The delivery catheter may include an outer shaft having a proximal outer end, a distal outer end, and an outer shaft lumen, wherein the distal outer end is closed by a damage prevention ball mounted thereon. The outer shaft lumen has an inner diameter of 8 mm - 10 mm, sized to accommodate the passage of a laterally deliverable transcatheter prosthetic valve (e.g., an artificial tricuspid valve and / or an artificial mitral valve).

[0083] In some embodiments, a method of manufacturing a laterally deliverable prosthetic heart valve includes forming an annulus upper member of a valve frame from a single workpiece, the annulus upper member having an outer ring, an inner ring, and splines suspending the inner ring on the outer ring. Forming an annulus lower member from a single workpiece, and the annulus lower member having a distal anchoring element and a proximal anchoring element. Forming each of a first sidewall and a second sidewall from a single workpiece, and the first sidewall and the second sidewall being joined to form a transannular member of the valve frame. The annulus upper member is coupled to the annulus upper portion of the transannular member, and the annulus lower member is coupled to the annulus lower portion of the transannular member.

[0084] Any method for manufacturing a prosthetic valve described herein may include using additive or subtractive metal or metal alloy manufacturing to produce, for example, a compressible / dilatable outer support frame and / or a compressible / dilatable inner leaflet frame. Additive metal or metal alloy manufacturing may include, but is not limited to, 3D printing, direct metal laser sintering (powder melting), etc. Subtractive metal or metal alloy manufacturing may include, but is not limited to, lithography, etching, laser sintering / cutting, CNC machining, electrical discharge machining, etc. Additionally, any of the manufacturing processes described herein may include shaping and / or sizing (e.g., heat-setting) a cut or machined workpiece into any suitable shape, size, and / or configuration. For example, either the outer support frame and / or the inner leaflet frame described herein may be cut from one or more workpieces and heat-set into a desired shape, size, and / or configuration. Additionally, any of the frames described herein may include a plurality of individual components formed into a desired shape and joined together to form the frame.

[0085] In some embodiments, a manufacturing process may further include: mounting 2 - 4 flexible leaflets to the inner leaflet frame to jointly form a flow control component; mounting the flow control component within the outer support frame; and / or covering at least a portion of the outer support frame with a pericardial material or similar biocompatible material.

[0086] In some embodiments, a laterally deliverable prosthetic heart valve has: an outer frame having an on - annulus member, an under - annulus member, and a trans - annulus member coupled therebetween; and a flow control component mounted to the outer frame and at least partially disposed within the trans - annulus member. In some implementations, a method of deploying a prosthetic valve in the annulus of an autologous heart valve includes removably coupling the outer frame to a portion of a delivery system. Advancing the prosthetic valve in a delivery configuration through the lumen of a delivery catheter included in the delivery system. The delivery catheter has a distal end that is disposed in the atrium of the heart when advancing the prosthetic valve. Releasing the prosthetic valve from the distal end of the delivery catheter. After releasing the prosthetic valve, placing a proximal anchoring element of the under - annulus member of the outer frame in a first configuration and seating the prosthetic valve in the annulus of the autologous heart valve while the proximal anchoring element is in the first configuration. After seating the prosthetic valve in the annulus, the proximal anchoring element transitions from the first configuration to a second configuration.

[0087] Any method for delivering and / or deploying a prosthetic heart valve as described herein may include orthogonally delivering the prosthetic heart valve to the native annulus of the human heart and may include: (i) advancing a delivery catheter through the inferior vena cava (IVC) via the femoral vein to the tricuspid valve or pulmonary artery of the heart; (ii) advancing the delivery catheter through the superior vena cava (SVC) via the jugular vein to the tricuspid valve or pulmonary artery of the heart; or (iii) advancing the delivery catheter through a transatrial approach (e.g., fossa ovalis or lower) via an IVC-femoral or SVC-jugular approach to the mitral valve of the heart; and (iv) delivering and / or deploying the prosthetic heart valve to the native annulus by releasing the valve from the delivery catheter.

[0088] Any method for delivering a prosthetic valve as described herein may include placing the prosthetic valve in a delivery configuration. The delivery configuration may include at least one of the following: (i) compressing the valve along a central vertical axis to reduce the vertical dimension of the valve from top to bottom to place the valve in the delivery configuration; (ii) unilaterally rolling up the valve from one side of the annulus support frame to place the valve in the delivery configuration; (iii) bilaterally rolling up the valve from two opposite sides of the annulus support frame to place the valve in the delivery configuration; (iv) flattening the valve into two parallel panels substantially parallel to the long axis to place the valve in the delivery configuration; (v) flattening the valve into two parallel panels substantially parallel to the long axis and then rolling up the flattened valve to place the valve in the delivery configuration; or (vi) flattening the valve into two parallel panels substantially parallel to the long axis and then compressing the valve along a central vertical axis to reduce the vertical dimension of the valve from top to bottom to place the valve in the delivery configuration.

[0089] Any method for delivering a prosthetic valve as described herein may include orthogonally delivering the prosthetic valve to a desired location in the body and may include (i) advancing a delivery catheter to the desired location in the body; and (ii) delivering the prosthetic valve to the desired location in the body by releasing the valve from the delivery catheter. The valve is in a compressed or delivery configuration when located in the delivery catheter and transitions to an expanded or released configuration when released from the delivery catheter.

[0090] Any method for delivering a prosthetic valve as described herein may include releasing the valve from a delivery catheter by: (i) pulling the valve out of the delivery catheter using a pulling member (e.g., a wire or a rod) that is releasably attached to a sidewall, drum, or collar and / or an anchoring element (e.g., a distal anchoring element), wherein advancing the pulling member away from the delivery catheter pulls the valve out of the delivery catheter; or (ii) pushing the valve out of the delivery catheter using a pushing member (e.g., a wire, a rod, a catheter, a delivery member, a yoke, etc.) that is releasably attached to a sidewall, drum, or collar and / or an anchoring element (e.g., a proximal anchoring element and / or a distal anchoring element), wherein advancing the pushing member beyond the distal end of the delivery catheter pushes the valve out of the delivery catheter. Additionally, releasing the valve from the delivery catheter allows the valve to transition and / or expand from its delivery configuration to an expanded and / or deployed configuration.

[0091] Any method for delivering and / or deploying a prosthetic valve as described herein may include releasing the valve from a delivery catheter while increasing blood flow during valve deployment by: (i) partially releasing the valve from the delivery catheter to establish blood flow around the partially released valve and blood flow through a flow control member; (ii) completely 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 member and decreased blood flow around the valve; (iii) deploying the valve to a final installed or seated position in the native annulus to transition to a state of complete blood flow through the flow control member and minimal or no blood flow around the valve; and (iv) disconnecting and retracting the positioning catheter, pulling or pushing wire or rod, delivery catheter, actuator, and / or other suitable parts of the delivery system. In some implementations, prior to disconnecting and retracting, any of the methods described herein optionally may include transitioning the valve to a fixed or tied state via an actuator or a part of the delivery system such that the valve contacts the annulus tissue to fix the valve in the native annulus.

[0092] Any method for delivering and / or deploying a prosthetic valve described herein may include positioning the valve or a portion thereof in a desired location relative to native tissue. For example, the method may include positioning a distal anchoring protrusion of a cardiac valve prosthesis into a ventricular outflow tract of a left or right ventricle. In some embodiments, the method may further include positioning a superior distal anchoring protrusion at an annulus location, wherein the superior distal anchoring protrusion provides a downward force on the annulus in the direction of the ventricle, and the distal anchoring protrusion (e.g., an inferior distal anchoring protrusion) provides an upward force under the annulus in the direction of the atrium. In some implementations, the method may include partially inserting the prosthetic valve into the annulus such that a distal portion of the prosthetic valve contacts native annulus tissue while a proximal portion of the prosthetic valve is at least partially compressed and disposed within a delivery catheter. In some embodiments, the method may include rotating a cardiac valve prosthesis about an axis parallel to the plane of the valve annulus using a steerable catheter, a yoke, a set of tethers, an actuator, and / or any other part of a delivery system (or a combination thereof). In some embodiments, the method may include transitioning one or more anchoring elements to a desired position and / or state to engage native tissue surrounding at least a portion of the annulus. In some implementations, one or more tissue anchors may be attached to the valve and native tissue to secure the valve in a desired position.

[0093] Any method for delivering and / or deploying a prosthetic valve and / or any part thereof described herein may be similar and / or substantially the same as one or more methods for delivering and / or deploying a prosthetic valve (or a portion thereof) described in: ‘957 PCT, ‘010 PCT, ‘231 PCT, ‘390 PCT, ‘956 provisional, ‘932 provisional, ‘059 provisional, ‘269 provisional, and / or ‘345 provisional.

[0094] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit 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 in this disclosure shall be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention.

[0095] As used herein, unless the context clearly indicates otherwise, the singular forms “a” and “the” are also intended to include the plural forms. With respect to the use of substantially any plural and / or singular terms herein, the skilled artisan can translate from the plural to the singular and / or from the singular to the plural as appropriate to the context and / or application. Various singular / plural permutations may be expressly set forth herein for clarity.

[0096] In general, the terms used herein and especially the terms used in the appended claims (e.g., the main part of the appended claims) are generally intended to be "open" terms (e.g., the term "including" should be construed as "including but not limited to", the term "having" should be construed as "having at least", etc.). Similarly, the terms "comprises" and / or "comprising" when used in this specification specify the presence of the stated features, integers, steps, operations, elements and / or components, but do not preclude the presence or addition of one or more other features, integers (or fractions thereof), steps, operations, elements, components and / or groups thereof. As used in this document, the term "comprising" means "including (but not limited to)".

[0097] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. It should be understood that in fact any suitable disjunctive conjunction and / or wording presenting two or more alternative terms, whether in the description, claims or drawings, is contemplated to include the possibility of either one of the terms, any one of the terms or both of the terms. For example, the phrase "A or B" will be understood to include the possibility of "A" or "B" or "A and B".

[0098] Unless otherwise expressly specified, all ranges disclosed herein also cover any and all possible sub - ranges and combinations of their sub - ranges. Unless otherwise expressly specified, any listed range should be considered to be fully described and capable of being decomposed into at least equal sub - parts. Those skilled in the art will understand that a range includes each individual member.

[0099] The terms "valve prosthesis", "prosthetic heart valve" and / or "prosthetic valve" may refer to a combination of a frame and leaflets or a flow control structure or component, and may cover a 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., leaving the autologous valve in place).

[0100] The prosthetic valves disclosed herein may include members (e.g., frames) that can be placed within an autologous valve annulus and used as mounting elements for leaflet structures, flow control components or flexible reciprocating sleeves or sleeve - valves. According to an embodiment, it may or may not include such leaflet structures or flow control components. Such members may be referred to herein as "annulus - supporting frames", "tubular frames", "wire frames", "valve frames", "flanges", "collars" and / or any other similar terms.

[0101] The term "flow control component" can, in a non - limiting sense, refer to a leaflet structure of 2, 3, or 4 leaflets having a flexible biocompatible material (such as treated or untreated pericardium) sewn or joined to an annulus support frame to act as a prosthetic heart valve. Such valves can be cardiac valves, such as the tricuspid valve, mitral valve, aortic valve, or pulmonary valve, which open to blood flowing from the atrium to the ventricle during diastole and close due to the contractile ventricular pressure applied to the outer surface. The sequential repetition of opening and closing can be described as "reciprocating". The expected flow control components include a wide variety of (bio)prosthetic artificial heart valves. Artificial bioprosthetic pericardial valves can include artificial bioprosthetic aortic valves, artificial bioprosthetic mitral valves, artificial bioprosthetic tricuspid valves, and artificial bioprosthetic pulmonary valves.

[0102] Any of the disclosed valve embodiments can be delivered by a transcatheter method. The term "transcatheter" is used to define the process of accessing, controlling, and / or delivering a medical device or instrument deployed within the lumen of a catheter into the ventricle (or other desired location in the body), and an article that has been delivered or controlled by such a process. Known transcatheter access includes cardiac access via the lumen of the femoral artery and / or vein, via the lumen of the brachial artery and / or vein, via the lumen of the carotid artery, via the lumen of the jugular vein, via the intercostal (rib) and / or subxiphoid space, etc. Additionally, transcatheter cardiac access can be via the inferior vena cava (IVC), superior vena cava (SVC), and / or via trans - atrial (e.g., the fossa ovalis or lower). Transcatheter can be synonymous with transluminal and is functionally related to the term "percutaneous" when referring to the delivery of a heart valve. As used herein, the term "lumen" can refer to the interior of a cylinder or tube. The term "caliber" can refer to the inner diameter of the lumen.

[0103] The mode of cardiac access can be at least partially based on a "body passage" that defines a blood conduit or vessel within the body, and the specific application of the disclosed embodiments of the prosthetic valve can determine the body passage under discussion. For example, an aortic valve replacement will be implanted within or adjacent to the aortic valve annulus. Similarly, a tricuspid or mitral valve replacement will be implanted at the tricuspid or mitral valve annulus, respectively. While certain features described herein may be particularly advantageous for a given implant site, any of the valve embodiments described herein can be implanted in any body passage unless the combination of features is structurally impossible or excluded by the claim language.

[0104] As used herein, the term "expandable" can refer to a prosthetic heart valve or a component of a prosthetic heart valve that expands from a first delivery size or configuration to a second implant size or configuration. Thus, unless the context clearly indicates otherwise, an expandable structure is not intended to refer to a structure that may experience minor expansion due to, for example, a temperature increase or other such incidental cause. Conversely, "nonexpandable" should not be construed to mean completely rigid or dimensionally stable, as, for example, some minor expansion of a conventional "nonexpandable" heart valve may be observable.

[0105] The prosthetic valves and / or their components disclosed herein are generally capable of transitioning between two or more configurations, states, shapes, and / or arrangements. For example, the prosthetic valves described herein can be capable of "compressing" and / or "expanding" between any suitable number of configurations. Various terms can be used to describe or refer to these configurations and are not intended to be limiting, unless the context clearly dictates otherwise. For example, a prosthetic valve can be described as being in a "delivery configuration," which can be any suitable configuration that permits or is capable of delivering the prosthetic valve. Examples of delivery configurations can include a compressed configuration, a folded configuration, a rolled-up configuration, and / or similar configurations, or any suitable combination thereof. Similarly, a prosthetic valve can be described as being in an "expanded configuration," which can be any suitable configuration that is not explicitly intended for delivering the prosthetic valve. Examples of expanded configurations can include a released configuration, a loosened configuration, an unfolded configuration, a non-delivery configuration, and / or similar configurations, or any suitable combination thereof. Some of the prosthetic valves and / or their components or features described herein can have many additional configurations that can be associated with various modes, levels, states, and / or portions of actuation, deployment, engagement, etc. Examples of such configurations can include an actuated configuration, a seated configuration, a fixed configuration, an engaged configuration, and / or similar configurations, or any suitable combination thereof. While specific examples are provided above, it should be understood that they are not intended to be an exhaustive list of configurations. Other configurations can be possible. Additionally, various terms can be used to describe the same or substantially similar configurations, and thus, the use of a particular term is not intended to be limiting and / or to exclude other terms, unless the terms and / or configurations are mutually exclusive or the context clearly dictates otherwise.

[0106] Generally, conventional delivery of a prosthetic valve can cause the central cylinder axis of the valve to be substantially parallel to the longitudinal axis of the delivery catheter used to deliver the valve. Typically, the valve is compressed in a radial direction relative to the central cylinder axis and advanced through the lumen of the delivery catheter. The valve is deployed from the end of the delivery catheter and expands radially outward from the central cylinder axis. The delivery orientation of the valve generally means that the valve is fully released from the delivery catheter and reoriented relative to the annulus when in the atrium, which can limit the size of the valve in some cases.

[0107] Unless otherwise expressly specified, the prosthetic valves described herein are configured for delivery via a lateral or orthogonal delivery technique. As used herein, the terms "laterally delivered," "lateral delivery," "orthogonal delivery," "orthogonally delivered," etc. may be used interchangeably to describe such delivery methods and / or valves delivered using such methods. Orthogonal delivery of a prosthetic valve may cause the central cylinder axis of the valve to be substantially orthogonal to the longitudinal axis of the delivery catheter. In the case of orthogonal delivery, the valve is compressed (or otherwise reduced in size) in a direction substantially parallel to the central cylinder axis and / or in a transverse direction relative to the central cylinder axis. Thus, the longitudinal axis (e.g., the longitudinal axis) of the orthogonally delivered valve is substantially parallel to the longitudinal axis of the delivery catheter. In other words, the prosthetic valve delivered orthogonally is compressed and / or delivered at an angle of approximately 90 degrees compared to the conventional process of compressing and delivering a transcatheter prosthetic valve. Additionally, in some cases, the orientation of the orthogonally delivered valve relative to the annulus may allow the distal portion of the valve to be at least partially inserted into the annulus of the native heart valve while the proximal portion of the valve remains at least partially within the delivery catheter, thereby avoiding at least some of the size constraints faced by some known conventional delivery techniques. Examples of prosthetic valves configured for orthogonal delivery and the process for delivering such valves are described in detail in the '957 PCT and / or the '010 PCT, which are incorporated herein by reference.

[0108] Mathematically, the term "orthogonal" refers to a 90-degree angle of intersection between two lines or planes. As used herein, the term "substantially orthogonal" refers to a 90-degree angle of intersection plus or minus a suitable tolerance. For example, "substantially orthogonal" may refer to an angle of intersection within the range of 75 degrees to 105 degrees.

[0109] As used herein, the term "tissue anchor" generally refers to a fastening device that attaches a portion of the outer frame of a prosthesis, typically at or near the perimeter of the annulus of a prosthetic valve, to autologous annulus tissue. The tissue anchor can be positioned to avoid piercing tissue and relies only on the compressive force of two plate-like collars or anchor elements on the captured tissue, or the tissue anchor (with or without an integrated fixation wire) can pierce the autologous tissue to provide anchoring, or a combination of both. Embodiments including anchor elements such as plate-like collars can include one or more movable, reconfigurable, and / or actuatable elements, protrusions, projections, skirts, plates, arms, levers, etc. that can be manipulated to engage autologous tissue. Additionally, such anchor elements can include any suitable surface finish, features, and / or analogs that can facilitate engagement with autologous tissue. Embodiments including, for example, a tissue anchor can include a tissue anchor having a fixation mechanism such as a tip, groove, flanged shoulder, lock, one or more holes, etc. In some embodiments, the fixation mechanism can be attached or anchored to a portion of the outer frame by any attachment or anchoring mechanism including a knot, suture, wire crimp, wire lock, cam mechanism, or combination.

[0110] The embodiments and / or various features or advantageous details of the present disclosure are more fully explained with reference to the non-limiting embodiments illustrated in the accompanying drawings and described in detail below. Descriptions of well-known components and processing techniques are omitted so as not to unnecessarily obscure the embodiments of the present disclosure. The same numbers always refer to the same elements.

[0111] The examples and / or embodiments described herein are intended to facilitate an understanding of the structure, function, and / or aspects of the embodiments, the manner in which the embodiments can be practiced, and / or to further enable those skilled in the art to practice the embodiments of the present disclosure. Similarly, the methods and / or manners of using the embodiments described herein are provided by way of example only and are not limiting. Unless the context clearly dictates otherwise, providing a particular use described herein does not exclude other uses. For example, any of the prosthetic valves described herein can be used to replace an autologous valve of the human heart, including, for example, the mitral valve, tricuspid valve, aortic valve, and / or pulmonary valve. Although some of the prosthetic valves are described herein in the context of replacing an autologous mitral valve or autologous tricuspid valve, it should be understood that such prosthetic valves can be used to replace any autologous valve, unless otherwise expressly provided or unless one or more components and / or features would clearly render the prosthetic valve unsuitable for such use to those skilled in the art. Accordingly, the specific examples, embodiments, methods, and / or uses described herein should not be construed as limiting the scope of the present invention or the inventive concepts herein. Rather, the examples and embodiments are provided so that the present disclosure will be thorough and complete and will fully convey the scope of the inventive concepts to those skilled in the art.

[0112] Figures 1A to 1E FIG. 1 is various schematic illustrations of a transcatheter prosthetic valve 100 according to one embodiment. The transcatheter prosthetic valve 100 is configured to be deployed at a desired location within a body (e.g., of a human patient) and to permit blood flow in a first direction through an inflow end of the transcatheter prosthetic valve 100 and to block blood flow in a second direction opposite the first direction through an outflow end of the transcatheter prosthetic valve 100. For example, the transcatheter prosthetic valve 100 may be a transcatheter prosthetic heart valve configured to be deployed within the annulus of a native tricuspid valve or a native mitral valve of the human heart to supplement and / or replace the function of the native valve.

[0113] The transcatheter prosthetic valve 100 (also referred to herein as the "prosthetic valve" or simply the "valve") is capable of compressing and expanding in at least one direction relative to a long axis 102 of the valve 100 (also referred to herein as the "horizontal axis", "longitudinal axis", or "longitudinal axis"). The valve 100 is capable of expanding between a deployed configuration ( Figure 1A , Figure 1C and Figure 1E ) for implantation at a desired location within a body (e.g., the human heart) and a compressed or delivery configuration ( Figure 1B and Figure 1D ) for introduction into the body using a delivery catheter.

[0114] In some embodiments, the valve 100 (and / or at least a portion thereof) may initially be in a generally tubular configuration and may be thermoformed and / or otherwise formed into any desired shape. In some embodiments, the valve 100 may include an upper atrial cuff or flange for atrial sealing, a lower ventricular cuff or flange for ventricular sealing, and a transannular section or region (e.g., a body section, a tubular section, a cylindrical section, etc.) disposed therebetween. The transannular region may have an hourglass-shaped cross-section within approximately 60%-80% of the circumference to conform to the native annulus along the posterior and anterior annulus segments, while remaining substantially perpendicular and flat along 20%-40% of the annulus circumference to conform to the septal annulus segment. Although the valve 100 is shown in Figures 1A to 1E with a given shape, it should be understood that the size and / or shape of the valve 100 (and / or at least a portion thereof) may be based on the size and / or shape of the anatomy of the native tissue.

[0115] For example, the valve 100 can be centered (e.g., radially symmetric with respect to the central y-axis 104), or can be eccentric (e.g., radially asymmetric with respect to the central y-axis 104). In some eccentric embodiments, the valve 100 or its outer frame can have a complex shape determined by the anatomy in which the valve 100 is implanted. For example, in some cases, the valve 100 can be deployed in the tricuspid annulus, which has a peripherally rounded elliptical shape and has substantially perpendicular septal walls, and is known to expand along the anteroposterior line in a diseased state. In some cases, the valve 100 can be deployed in the mitral annulus (e.g., near the anterior leaflet), which has a peripherally rounded elliptical shape and has substantially perpendicular septal walls, and is known to expand in a diseased state. Thus, the valve 100 can have a complex shape that is at least partially determined by the diseased state of the native annulus and / or native valve. For example, in some such embodiments, the valve 100 or its outer frame can have a D shape (when viewed from the top), such that the flat portion can match the anatomy in which the valve 100 is to be deployed.

[0116] As shown, the valve 100 generally includes an annulus support frame 110 and a flow control component 150. Additionally, the valve 100 and / or at least the annulus support frame 110 of the valve 100 can include and / or be coupled to an actuator 170 and / or a delivery system interface 180. In some implementations, the valve 100 and / or aspects and / 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, '010 PCT, '231 PCT, '390 PCT, '932 Provisional, '059 Provisional, and / or '269 Provisional, which are incorporated herein by reference. Accordingly, certain aspects, portions, and / or details of the valve 100 may not be described in further detail herein.

[0117] The annulus support frame 110 (also referred to herein as "tubular frame", "valve frame", "wire frame", "outer frame" or "frame") may have a supra-annular region 120, an infra-annular region 130, and a trans-annular region 112 disposed and / or coupled therebetween. In some embodiments, the supra-annular region 120, the infra-annular region 130, and the trans-annular region 112 may be separate, independent, and / or modular components that are joined together to collectively form the frame 110. In some implementations, such a modular configuration may allow the frame 110 to adapt to a given size and / or shape of the anatomy in which the valve 100 is installed. For example, one or more of the supra-annular region 120, the infra-annular region 130, and / or the trans-annular region 112 may be designed and / or adapted such that the support frame has any desired height, outer diameter, and / or inner diameter, such as any of the heights, outer diameters, and / or inner diameters described above. Additionally, such a modular configuration may allow the frame 110 to be bent, kinked, compressed, folded, rolled up, and / or otherwise reconfigured without plastic or permanent deformation. For example, the frame 110 is capable of being compressed into a compressed or delivery configuration for delivery, and when released, the frame is configured to return to its original shape (uncompressed, expanded, or released configuration).

[0118] The support frame 110 and / or the supra-annular region 120, the infra-annular region 130, and / or the trans-annular region 112 may be formed of any suitable material. In some embodiments, the supra-annular region 120, the infra-annular region 130, and the trans-annular region 112 may be formed of a shape memory or superelastic metal, metal alloy, plastic, etc. For example, the supra-annular region 120, the infra-annular region 130, and the trans-annular region 112 may be formed of nitinol, etc. In some embodiments, the support frame 110 (and / or any of its regions) may be laser cut from a nitinol sheet or tube. In other embodiments, the support frame 110 (and / or any of its regions) may be formed of nitinol wires that are bent, kinked, formed, and / or manipulated into a desired shape. In other embodiments, the support frame 110 (and / or any of its regions) may be formed of a desired material using any suitable additive or subtractive manufacturing process (such as the additive or subtractive manufacturing processes described above). Additionally, the supra-annular region 120, the infra-annular region 130, and the trans-annular region 112 may be coupled to a frame portion of the support frame 110 (e.g., a metal or other structural frame portion), which is in turn covered with a biocompatible material, such as pericardial tissue (e.g., etc.), polymer (e.g., polyester, etc.), etc., as described above.

[0119] The supra-annular region 120 of the frame 110 may be a cuff or collar that can be attached or coupled to the upper edge or upper portion of the trans-annular region 112, and / or may form the cuff or collar, as described in more detail herein. When the valve 100 is deployed within the human heart, the supra-annular region 120 may be an atrial collar that is shaped to conform to the native deployment location. In tricuspid and / or mitral valve replacement, for example, the supra-annular region 120 collar may have portions configured to respectively conform to the native valve and / or surround a portion of the atrial floor of the tricuspid and / or mitral valve. In some implementations, the supra-annular region 120 may be deployed on the atrial floor to direct blood from the atrium into the flow control component 150 of the valve 100 and to provide a seal to prevent blood leakage (paravalvular leakage) around the frame 110.

[0120] In some embodiments, the supra-annular region 120 may be a wireframe laser cut from any suitable material. In some embodiments, the supra-annular region 120 may be formed from a shape memory or superelastic material such as nitinol. In some embodiments, the supra-annular region 120 may be laser cut from a sheet or tube of a shape memory metal alloy such as nitinol and thermally formed, for example, into a desired shape and / or configuration. In some embodiments, forming the supra-annular region 120 in this manner may allow the supra-annular region 120 to bend, kink, fold, compress, and / or otherwise reconfigure without plastic deformation and / or without fatigue that may cause one or more of its parts to fail or break. Additionally, the wireframe of the supra-annular region 120 may be covered with any suitable biocompatible material such as any of the biocompatible materials described above.

[0121] As Figure 1A shown, the supra-annular region 120 includes a distal portion 122 and a proximal portion 124. In some embodiments, the distal portion 122 may be and / or may include a distal supra-annular anchoring element or the like that can engage native tissue on the distal side of the annulus when the prosthetic valve 100 is seated in the annulus. In some embodiments, the proximal portion 124 may be and / or may include a proximal supra-annular anchoring element or the like that can engage native tissue on the proximal side of the annulus when the prosthetic valve 100 is seated in the annulus. In some embodiments, the size of the distal portion 122 and / or the distal supra-annular anchoring element may be designed and / or shaped to correspond to the size and / or shape of the distal portion of the atrial floor of the heart in which the prosthetic valve 100 is disposed. Similarly, the size of the proximal portion 124 and / or the proximal supra-annular anchoring element may be designed and / or shaped to correspond to the size and / or shape of the proximal portion of the atrial floor of the heart.

[0122] Although not shown in Figures 1A to 1Eshown, the supra-annular region 120 can be shaped and / or formed to include any number of features configured to engage autologous tissue and / or one or more other portions of the valve 100, the actuator 170, and / or the delivery system interface 180. For example, in some embodiments, the supra-annular region 120 can include and / or can be formed with an outer portion, an inner portion, and one or more splines disposed between the outer portion and the inner portion. In some implementations, the outer portion can be sized and / or shaped to engage autologous tissue, the inner portion can provide a structure for mounting the flow control component 150 to the support frame 110, and the one or more splines can receive, couple to, and / or otherwise engage the actuator 170 and / or the delivery system interface 180, as described in more detail herein with reference to specific embodiments.

[0123] The sub-annular region 130 of the frame 110 can be a cuff or collar that can be attached or coupled to the lower edge or upper portion of the trans-annular region 112, and / or can form the cuff or collar, as described in more detail herein. When the valve 100 is deployed within the human heart, the sub-annular region 130 can be shaped to conform to the ventricular collar of the autologous deployment location. In tricuspid and / or mitral valve replacement, for example, the sub-annular region 130 or collar can have respective portions configured to conform to the autologous valve and / or surround a portion of the ventricular top layer of the tricuspid and / or mitral valve. In some implementations, the sub-annular region 130 or at least a portion thereof can: engage the ventricular top layer surrounding the autologous annulus to fix the valve 100 within the autologous annulus; prevent the valve 100 from moving out of place; clamp or compress the autologous annulus or adjacent tissue between the supra-annular region 120 and the sub-annular region 130; and / or effect a seal to prevent blood leakage around the frame 110 (perivalvular leakage and / or backflow during cardiac systole).

[0124] In some embodiments, the sub-annular region 130 can be a wireframe laser cut from any suitable material. In some embodiments, the sub-annular region 130 can be formed from a shape memory or superelastic material such as nitinol. In some embodiments, the sub-annular region 130 can be laser cut from a sheet of a shape memory metal alloy such as nitinol and, for example, heat set into a desired shape and / or configuration. In some embodiments, forming the sub-annular region 130 in this manner can allow the sub-annular region 130 to bend, flex, fold, compress, and / or otherwise reconfigure without plastic deformation and / or without fatigue that could cause one or more of its parts to fail or break. Additionally, the wireframe of the sub-annular region 130 can be covered with any suitable biocompatible material such as any of the biocompatible materials described above.

[0125] The subannular region 130 can be shaped and / or formed to include any number of features configured to engage autologous tissue, one or more other parts of the valve 100, and / or the actuator 170. For example, in some embodiments, the subannular region 130 can include and / or can be formed with a distal portion having a distal anchoring element 132 and a proximal portion having a proximal anchoring element 134. In some embodiments, the subannular region 130 can include and / or can be formed with any other suitable anchoring elements (not shown in Figures 1A to 1E ). In some embodiments, the anchoring elements 132 and 134 are formed integrally and / or monolithically with the subannular region 130. The distal anchoring element 132 and the proximal anchoring element 134 of the subannular region 130 can be of any suitable shape, size, and / or configuration, such as any one of the shapes, sizes, and / or configurations described in detail in the '957 PCT, '010 PCT, '231 PCT, '390 PCT, '932 provisional, '059 provisional, or any one of the shapes, sizes, and / or configurations described herein with respect to specific embodiments. For example, the anchoring elements 132 and 134 can extend from a portion of the subannular region 130 by about 10 mm - 40 mm.

[0126] In some embodiments, the distal anchoring element 132 can optionally include a guidewire coupler configured to selectively engage and / or receive a portion of a guidewire or a portion of a guidewire assembly. The guidewire coupler is configured to allow a portion of the guidewire to extend through a bore of the guidewire coupler, thereby allowing the valve 100 to advance forward via or along the guidewire during delivery and deployment. In some embodiments, the guidewire coupler can selectively allow the guidewire to advance through the guidewire coupler while blocking or preventing other elements and / or components such as a pusher.

[0127] The anchoring elements 132 and / or 134 of the subannular region 130 can be configured to engage a desired portion of autologous tissue to mount the valve 100 and / or the support frame 110 to the annulus of the native valve in which it is deployed. For example, in some implementations, the distal anchoring element 132 can be a protrusion or projection that extends from the subannular region 130 and into the RVOT and / or any other suitable tract or portion of the ventricle. In such implementations, the distal anchoring element 132 can be shaped and / or biased such that the distal anchoring element 132 exerts a force on the subannular tissue that can operate to at least partially secure the distal portion of the valve 100 in the native annulus. In some implementations, the proximal anchoring element 134 can be configured to engage the subannular tissue proximal to the native annulus to assist in securing the valve 100 in the annulus.

[0128] In some implementations, at least the proximal anchoring element 134 may be configured to transition, move, and / or otherwise reconfigure between a first configuration and a second configuration, in the first configuration, the proximal anchoring element 134 extends a first amount or distance from the subannular region 130, and in the second configuration, the proximal anchoring element 134 extends a second amount or distance from the subannular region 130. For example, in some embodiments, the proximal anchoring element 134 may have a first configuration and a second configuration, in the first configuration, the proximal anchoring element 134 is in a compressed, contracted, retracted, undeployed, folded, and / or constrained state (e.g., a position close to, adjacent to, and / or in contact with the transannular region 112 of the support frame 110 and / or the supraannular region 120), and in the second configuration, the proximal anchoring element 134 is in a dilated, extended, deployed, unfolded, and / or unconstrained state (e.g., extending away from the transannular region 112). Additionally, in some implementations, the proximal anchoring element 134 may transition in response to actuation of the actuator 170, as described in more detail herein.

[0129] In some implementations, the proximal anchoring element 134 may transition from the first configuration to the second configuration during deployment to selectively engage autologous tissue, tendons, trabeculae, annulus tissue, leaflet tissue, and / or any other anatomical structure to assist in fixing the valve 100 in the native annulus. The proximal anchoring element 134 (and / or the distal anchoring element 132) may include any suitable features, surfaces, components, etc. configured to facilitate engagement between the proximal anchoring element 134 (and / or the distal anchoring element 132) and autologous tissue. For example, in some embodiments, the proximal anchoring element 134 may include one or more features configured to engage autologous tissue, tendons, trabeculae, annulus tissue, leaflet tissue, and / or any other anatomical structure and / or wrap therearound when in the second configuration, as described in more detail herein with reference to specific embodiments.

[0130] The transannular region 112 of the support frame 110 is disposed between the supraannular region 120 and the subannular region 130. In some embodiments, the transannular region 112 may be coupled to each of the supraannular region 120 and the subannular region 130 such that a desired amount of movement and / or flexure therebetween is allowed (e.g., welding, bonding, sewing, tying, etc.). For example, in some implementations, the transannular region 112 and / or portions thereof may be sewn to each of the supraannular region 120 and the subannular region 130 (and / or portions thereof).

[0131] The transannular region 112 can be shaped and / or formed into an annulus, a cylindrical tube, a conical tube, a D-shaped tube, and / or any other suitable annular shape. In some embodiments, the transannular region 112 can have a side profile of any of the following: a flat cone shape, an inverted flat cone shape (narrower at the top and wider at the bottom), a concave cylinder (walls curving inward), a convex cylinder (walls bulging), an angular hourglass, a curved calibrated hourglass, an annulus or cylinder having a flared top, a flared bottom, or both. Additionally, the transannular region 112 can form and / or define a hole or central passage 114 that extends along a central axis 104 (e.g., the y-axis). The central passage 114 (e.g., a central axial lumen or channel) is sized and configured to receive a flow control component 150 across a portion of the diameter of the central passage 114. In some embodiments, the transannular region 112 can have a shape and / or size that is at least partially based on the size, shape, and / or configuration of the supra-annular region 120 and / or the infra-annular region 130 of the support frame 110 and / or the native annulus in which the support frame is configured to be deployed. For example, the transannular region 112 can have an outer peripheral surface for engaging native annulus tissue, and the outer peripheral surface can be tensioned against the inner aspect of the native annulus to provide a structural opening to a weakened native annulus ostium.

[0132] In some embodiments, the transannular region 112 can be a wireframe laser cut from any suitable material. In some embodiments, the transannular region 112 can be formed from a shape memory or superelastic material such as nitinol. In some embodiments, the transannular region 112 can be laser cut from a sheet of a shape memory metal alloy such as nitinol and, for example, heat set into a desired shape and / or configuration. Although not shown in Figures 1A to 1E , in some embodiments, the transannular region 112 can include and / or can be formed with two laser cut halves that can be shaped and / or configured into a desired shape and joined together to form the transannular region 112. The transannular region 112 can be formed to include a set of compressible filament units having an orientation and / or unit geometry that is substantially orthogonal to the central axis 104 ( Figure 1A ) to minimize filament unit strain when the transannular region 112 is in a vertically compressed configuration, a rolled and compressed configuration, or a folded and compressed configuration. In some embodiments, forming the transannular region 112 in this manner can allow the transannular region 112 to respond to lateral folding along the transverse axis 106 ( Figure 1C ) or in the direction of the transverse axis and / or along the central axis 104 ( Figure 1D) or bent, kinked, folded, deformed, and / or otherwise reconfigured (substantially without plastic deformation and / or excessive fatigue) by vertical compression in the direction of the central axis, as described in more detail herein.

[0133] As described above with reference to the supra-annular region 120 and the sub-annular region 130, the wireframe of the trans-annular region 112 can be covered with any suitable biocompatible material such as any of the biocompatible materials described above. In some implementations, the wireframes of the supra-annular region 120, the trans-annular region 112, and the sub-annular region 130 can be flexibly coupled (e.g., sewn) to form the wireframe portion of the support frame 110, which is then covered in the biocompatible material. In other words, the supra-annular region 120, the trans-annular region 112, and the sub-annular region 130 can be covered with the biocompatible material either before or after coupling. In embodiments where the wireframe is covered after coupling, the biocompatible material can facilitate and / or support the coupling between them.

[0134] Although not shown in Figures 1A to 1E The frame 110 can also have and / or form additional functional elements (e.g., coils, anchors, etc.) for attaching accessory components, such as biocompatible covers, tissue anchors, releasable deployment and retrieval controls (e.g., actuator 170, delivery system interface 180, and / or other suitable guides, knobs, attachments, rigging, etc.). In some implementations, the 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, '231 PCT, '390 PCT, '932 provisional, '059 provisional.

[0135] The flow control component 150 can, in a non-limiting sense, refer to a device for controlling the flow of fluid therethrough. In some embodiments, the flow control component 150 can be a leaflet structure having 2, 3, 4 or more leaflets, which is made of a flexible biocompatible material such as treated or untreated pericardium. The leaflets can be sewn or joined to a support structure such as an inner frame, which in turn can be sewn or joined to the outer frame 110. The leaflets can be configured to move between an open state and a closed or substantially sealed state to allow blood to flow through the flow control component 150 in a first direction through the inflow end of the valve 100 and block blood flow in a second direction opposite to the first direction through the outflow end of the valve 100. For example, the flow control component 150 can be configured such that the valve 100 functions as (for example) a heart valve, such as a tricuspid valve, mitral valve, aortic valve or pulmonary valve, which can open to blood flowing from the atrium to the ventricle during diastole of the heart and can close due to the contractile ventricular pressure applied to the outer surface. Repeatedly opening and closing in sequence can be described as "reciprocating".

[0136] The inner frame and / or its parts or aspects can be at least similar in form and / or function to the outer frame 110 and / or its parts or aspects. For example, the inner frame can be a laser-cut frame formed of a shape memory material such as nitinol. Additionally, the inner frame can be compressible for delivery and configured to return to its original (uncompressed) shape upon release (e.g., after delivery). In some embodiments, the inner frame can include and / or form any suitable number of compressible, elastically deformable diamond or eye-shaped wire units, etc. The wire units can have an orientation and unit geometry that is substantially orthogonal to the axis of the flow control component 150 to minimize wire unit strain when the inner frame is in a compressed configuration.

[0137] In some embodiments, the flow control component 150 and / or its inner frame can have a substantially cylindrical or tubular shape when the valve 100 is in a dilated configuration (see, for example Figure 1C ), and can be configured to elastically deform when the valve 100 is placed in a compressed configuration (see, for example Figure 1B and Figure 1D ). Although not shown in Figures 1A to 1E , in some embodiments, the inner frame of the flow control component 150 can include and / or be formed with two halves that can be joined together to allow the inner frame to elastically deform in response to lateral compression or folding along or in the direction of the transverse axis 106 ( Figure 1C ), as described in more detail herein.

[0138] As in Figures 1A to 1DAs shown, the flow control component 150 is installed within the central channel 114 of the frame 110. More specifically, the flow control component 150 is installed and / or coupled to the supra-annular region 120 (e.g., its inner portion), and is configured to extend into and / or through the central channel 114 formed and / or defined by the trans-annular region 112. In some embodiments, the flow control component 150 may be coupled to the supra-annular region 120 via tissue, a biocompatible mesh, one or more braided or knitted fabrics, one or more superelastic or shape memory alloy structures that are sewn, sutured, and / or otherwise fixed to a portion of the supra-annular region 120. In some embodiments, the flow control component 150 may be coupled to the supra-annular region 120 such that a portion of the flow control component 150 is disposed above the supra-annular region 120 and / or otherwise extends beyond the supra-annular region (e.g., extends away from the annulus in the direction of the atrium). In some embodiments, the portion of the flow control component 150 that extends above and / or beyond the supra-annular region 120 may form a ridge, ledge, wall, step, etc. In some implementations, such an arrangement may facilitate the ingrowth of autologous tissue onto the supra-annular region 120 without obstructing the flow control component 150.

[0139] The flow control component 150 may be at least partially disposed within the central channel 114 such that the 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 104 of the frame 110. In some embodiments, the support frame 110 may be arranged such that the flow control component 150 is centered within the central channel 114. In other embodiments, the support frame 110 may be arranged such that the flow control component 150 is off-center within the central channel 114. In some embodiments, the central channel 114 may have a diameter and / or perimeter that is larger than the diameter and / or perimeter of the flow control component 150. Although not shown in Figures 1A to 1E , in some embodiments, the valve 100 may include a spacer or the like that may be disposed within the central channel 114 adjacent to the flow control component 150. In other embodiments, the spacer may be a lid or the like that is coupled to a portion of the frame 110 and is configured to cover a portion of the central channel 114. In some cases, the spacer may be used to facilitate coupling the flow control component 150 to the frame 110.

[0140] In some embodiments, the flow control component 150 (or portions and / or aspects thereof) may be similar to any of the flow control components described, for example, in '231 PCT. Accordingly, the flow control component 150 and / or aspects and / or portions thereof are not described in more detail herein.

[0141] Referring again to Figure 1A, the valve 100 includes and / or is coupled to an actuator 170 and a delivery interface 180. The actuator 170 can be any suitable member, mechanism, and / or device configured to actuate at least a portion of the valve 100. For example, in some embodiments, the actuator 170 and / or a portion of the actuator 170 can be configured to be at least temporarily coupled to the supra-annular region 120 of the support frame 110 (e.g., a spline and / or other portion of the spline) and can be configured to actuate one or more portions of the valve 100. More specifically, the actuator 170 can be configured to actuate at least the proximal anchoring element 134 of the sub-annular region 120 of the support frame 110 to cause the proximal anchoring element 134 to transition between its first configuration and its second configuration. In some implementations, the actuator 170 can include one or more cables, tethers, linkages, joints, connectors, etc., that can apply a force (or can remove the applied force) to a portion of the proximal anchoring element 134, and the force can be operative to cause the proximal anchoring element 134 to transition between the first configuration and the second configuration. For example, the proximal anchoring element 134 of the sub-annular region 130 of the support frame 110 can be formed to be biased in an uncompressed configuration and / or an expanded configuration, and the actuator 170 can be actuated to apply a force via the one or more cables, tethers, etc., and the force can be operative to transition the proximal anchoring element 134 to a compressed configuration and / or a retracted configuration.

[0142] In some implementations, the actuator 170 can be fixed and / or locked when compressing and / or retracting the proximal anchoring element 134 (e.g., the first configuration) to at least temporarily maintain the proximal anchoring element 134 in the first configuration. As described above, in some implementations, the proximal anchoring element 134 can be in the first configuration for delivery and deployment prior to placing the valve 100 in the native annulus. Once the valve 100 is placed in the native annulus, a user can manipulate a portion of the delivery system to actuate the actuator 170. In this example, actuating the actuator 170 can cause the actuator 170 to release and / or remove (e.g., via a cable, tether, etc.) the force applied to the proximal anchoring element 134, thereby allowing the proximal anchoring element 134 to return to its original or biased configuration (e.g., the second configuration), as described above.

[0143] As Figure 1AThe delivery system interface 180 shown in [FIG. 0] may include any number of components having any suitable shape, size, and / or configuration. In some implementations, the delivery system interface 180 may be and / or may include, for example, a distal portion of a delivery system that is configured to deliver the valve 100 to a desired location (e.g., the annulus of a native heart valve) within a patient's body. In some embodiments, the delivery system interface may include a delivery catheter, such as a 12 Fr - 34 Fr delivery catheter, having any suitable corresponding inner lumen diameter sufficient to receive the prosthetic valve 100 in a compressed configuration, as described, for example, in the '957 PCT. Additionally, the delivery system may include an assist catheter, which may be, for example, a multi-lumen catheter configured to engage the valve 100 to advance the valve 100 through the delivery catheter. In some embodiments, each lumen of the multi-lumen assist catheter may include, for example, a cable, tether, and / or any other suitable component associated with and / or included in the actuator 170. Each cable, tether, and / or component may in turn be coupled to a portion of the valve 100 or the support frame 110 and configured to actuate a portion thereof, as described in more detail herein with reference to specific embodiments.

[0144] Additionally, the lumen (e.g., the central lumen) of the multi-lumen assist catheter may include and / or may receive a torque cable and a guide wire. The guide wire extends through the assist catheter and into a desired location relative to native tissue (e.g., the RVOT) to provide a path along which the valve 100 travels during delivery and / or deployment, as described in the '957 PCT. The torque cable may be any suitable cable configured to removably couple to an area 120 on the annulus of the frame 110 (e.g., a path point coupled to and / or formed by the area on the annulus). The torque cable may be a relatively stiff cable configured to facilitate delivery and / or deployment of the valve 100 and retraction of the valve 100, if desired. In this manner, the Figure 1A delivery system interface 180 shown in [FIG. 0] may be a distal portion of a delivery system that includes any of the components described above. Accordingly, the delivery system interface 180 may be used to and / or otherwise facilitate delivery of the valve 100, deployment and / or actuation of the valve 100 or a portion thereof (e.g., the proximal anchoring element 134), and / or retraction of the valve 100. Additionally, the delivery system interface 180 may be configured to decouple, disengage, and / or otherwise release the valve 100 after the valve 100 is deployed in the native annulus, as described in more detail herein with reference to specific embodiments.

[0145] As described above, the valve 100 is capable of compressing and expanding between a deployed configuration and a compressed configuration. The valve 100 may have a first height or dimension along the central axis 104 when in the deployed configuration, and a second height or dimension along the central axis 104 that is less than the first height or dimension when in the compressed configuration. The valve 100 may also be compressed in additional directions. For example, the valve 100 may be compressed along a transverse axis 106 that is perpendicular to both the longitudinal axis 102 and the central axis 104 (e.g., see Figure 1B and Figure 1C ).

[0146] The valve 100 is compressed during delivery of the valve 100 and is configured to expand once released from the delivery catheter. More specifically, the valve 100 is configured to be delivered orthogonally through a catheter to a desired location in the body (e.g., the annulus of a native valve), where the valve 100 is compressed in an orthogonal or transverse direction relative to the dimensions of the valve 100 in the deployed configuration (e.g., along the central axis 104 and / or the transverse axis 106). During delivery, the longitudinal axis 102 of the valve 100 is substantially parallel to the longitudinal axis of the delivery catheter, as described in the '957 PCT.

[0147] The valve 100 is in the deployed configuration before being loaded into the delivery system and after being released from the delivery catheter and deployed or implanted (or ready to be deployed or implanted) at a desired location in the body. When in the deployed configuration as shown in Figure 1A , Figure 1B and Figure 1E , the valve 100 has a range that is greater than the diameter of the lumen of the delivery catheter used to deliver the valve 100 in any direction that is orthogonal or transverse to the longitudinal axis 102 (e.g., along the central axis 104 and / or the transverse axis 106). For example, in some embodiments, the valve 100 may have a deployed height of 5 mm - 60 mm (e.g., along the central axis 104). In some embodiments, the valve 100 may have a deployed diameter length (e.g., along the longitudinal axis 102) and width (e.g., along the transverse axis 106) of about 20 mm - 80 mm or about 40 mm - 80 mm.

[0148] When in the Figure 1C and Figure 1DWhen in the compressed configuration shown, the valve 100 has a range of diameters less than the inner lumen of the delivery catheter in any direction orthogonal or transverse to the longitudinal axis 102 (e.g., along the central axis 104 and / or the transverse axis 106), thereby allowing the valve 100 to be delivered therethrough. For example, in some embodiments, the valve 100 may have a compressed height (e.g., along the central axis 104) and a compressed width (e.g., along the transverse axis 106) of about 6 mm - 15 mm, about 8 mm - 12 mm, or about 9 mm - 10 mm. The valve 100 can be compressed by compression, rolling, folding, and / or any other suitable means or combination thereof, as described in detail in '957 PCT, '010 PCT, '231 PCT, '390 PCT, '932 Provisional, '059 Provisional. In some embodiments, it is contemplated that the length of the valve 100 (e.g., along the longitudinal axis 102) is not compressed for delivery. Instead, in some embodiments, the length of the valve 100 may increase in response to compressing the valve 100 along the central axis 104 and / or the transverse axis 106.

[0149] As Figure 1E shown, the valve 100 can be delivered, for example, to the atrium of the human heart (or any other space or chamber of the human heart) and positioned within the annulus of a native valve such as the pulmonary valve (PV), mitral valve (MV), aortic valve (AV), and / or tricuspid valve (TV). As described above, the valve 100 can be in a compressed configuration and delivered to the annulus via a delivery system, and can be released from the delivery system and allowed to expand to an expanded configuration. For example, the valve 100 can be delivered to the atrium of the human heart and released from a delivery catheter (not shown) via any one of the delivery systems, devices, and / or methods described in detail in '957 PCT, '010 PCT, '231 PCT, '390 PCT, '932 Provisional, '059 Provisional.

[0150] In some implementations, delivery of the valve 100 can include advancing a guidewire into the atrium of the human heart, through the native valve, and to a desired location within the ventricle (e.g., RVOT). After the guidewire is positioned, the delivery catheter can be advanced along and / or via the guidewire and into the atrium (e.g., via the IVC, SVC, and / or transseptal access). In some embodiments, the guidewire coupler of the valve 100 (e.g., included among or on the distal anchoring element 132) can be coupled to the proximal portion of the guidewire, and the valve 100 can be placed in a compressed configuration, thereby allowing the valve 100 to advance along the guidewire and through the inner lumen of the delivery catheter and into the atrium.

[0151] Deployment of the valve 100 may include placing the distal anchoring element 132 of the subannular region 130 below the annulus in a ventricle (RV, LV), while the remainder of the valve 100 is located in an atrium (RA, LA). In some cases, the distal anchoring element 132 may be advanced along a guidewire and / or over a guidewire to a desired location within the ventricle, such as the outflow tract of the ventricle. For example, in some implementations, the valve 100 may be delivered to the annulus of the native tricuspid valve (TV), and at least a portion of the distal anchoring element 132 may be positioned within the RVOT. In other implementations, the valve 100 may be delivered to the annulus of the native mitral valve (MV), and at least a portion of the distal anchoring element 132 may be positioned within the LVOT and / or the distal anchoring element 132 may engage any other suitable location of native tissue, leaflets, chordae, etc.

[0152] In some implementations, the prosthetic valve 100 may be temporarily maintained in a partially deployed state. For example, the valve 100 may be partially inserted into the annulus and held at an angle relative to the annulus to allow blood to flow from the atrium partially through the native annulus around the valve 100 and partially through the valve 100 into the ventricle, which may allow for assessment of valve function.

[0153] The valve 100 may be placed or seated within the annulus (PVA, MVA, AVA, and / or TVA) of a native valve (PV, MV, AV, and / or TV) such that the subannular region 130 (e.g., ventricular collar) is disposed in a subannular position, the transannular region 112 of the valve frame 110 extends through the annulus, and the supraannular region 120 (e.g., atrial collar) remains in a supraannular position. For example, in some embodiments, a delivery system, delivery system interface 180, actuator 170, and / or any other suitable component, tool, etc. may be used to at least push the proximal portion of the valve 100 into the annulus. In some implementations, when the valve 100 is seated within the annulus, the proximal anchoring element 134 may be maintained in its first configuration. For example, as described above, the proximal anchoring element 134 may be in a compressed, contracted, and / or retracted configuration, where the proximal anchoring element 134 contacts, is adjacent to, and / or is near the transannular region 112 of the frame 110 and / or the supraannular region 120, which in turn may limit the total circumference of the subannular region 130 of the frame 110, thereby allowing the subannular region 130 and the transannular region 112 of the frame 110 to be inserted into and / or through the annulus.

[0154] Once positioned, the proximal anchoring element 134 can be transitioned from its first configuration to its second configuration, as described in detail in '010 PCT. For example, in some implementations, a user may manipulate a portion of the delivery system to actuate actuator 170. In some implementations, actuating actuator 170 can release and / or reduce the amount of tension in one or more tether(s), cable(s), connection(s), and / or portion(s) of actuator 170, thereby allowing the proximal anchoring element 134 to transition. Thus, once the valve 100 is positioned in the annulus, the proximal anchoring element 134 can be placed in its second configuration, where the proximal anchoring element 134 contacts, engages, and / or is otherwise disposed adjacent to subannular tissue. In some implementations, the proximal anchoring element 134 can be configured to engage and / or capture native tissue, tendons, trabeculae, annulus tissue, leaflet tissue, etc. when the proximal anchoring element 134 is disposed in the ventricle. For example, in some implementations, after the valve 100 is positioned in the annulus, the proximal anchoring element 134 can transition from a first (compressed) configuration to a second (extended) configuration such that the proximal anchoring element 134 extends around and / or through one or more portions of native tissue, tendons, etc. The proximal anchoring element 134 can then return to the first configuration to capture one or more portions of native tissue, tendons, trabeculae, annulus tissue, leaflet tissue, etc. and / or secure the one or more portions between the proximal anchoring element 134 and a transannular section of (e.g.) the outer frame 110. In other implementations, after the valve 100 is positioned in the native annulus, the proximal anchoring element 134 can be maintained in the second (extended) configuration. In such implementations, for example, the proximal anchoring element 134 can contact and / or engage subannular tissue on the proximal side of the annulus such that the proximal anchoring element and the proximal portion of the atrial collar exert a compressive force on the proximal portion of the annulus tissue.

[0155] In this manner, the distal anchoring element 132 can be configured to engage native tissue on the distal side of the annulus, and the proximal anchoring element 134 can be configured to engage native tissue on the proximal side of the annulus (e.g., when in the second or expanded configuration), thereby securing the valve 100 firmly in the native annulus, as Figure 1E shown. In some implementations, any other or additional portion of the valve can similarly engage native tissue to securely position the valve 100 in the native annulus and / or form a seal between the support frame 110 and the tissue forming the native annulus (e.g., the supra-annular region 120, the transannular region 112, and / or the distal portion 122 and / or proximal portion 124 of one or more other or additional anchoring elements (not shown in Figures 1A to 1E ).

[0156] Although in Figures 1A to 1EAlthough not shown, in some implementations, the valve 100 and / or the delivery system may include one or more tissue anchors that can be used to anchor one or more portions of the valve 100 to the annulus tissue, as described in detail in the '957 PCT. In some embodiments, the tissue anchor may be configured to puncture, pierce, and / or otherwise secure the anchor element 132 and / or 134 and / or the atrial collar to the annulus tissue. In other embodiments, the tissue anchor may be, for example, an atraumatic anchor that is configured to secure the anchor element 132 and / or 134 and / or the atrial collar to the annulus tissue without puncturing, piercing, and / or otherwise traumatizing the native tissue.

[0157] Figures 2A to 2D FIG. is a schematic illustration of an annulus support frame 210 according to one embodiment. The annulus support frame 210 (also referred to herein as the "tubular frame", "valve frame", "wire frame", "outer frame", "support frame", or "frame") may include and / or be coupled to an actuator 270 that is configured to actuate one or more portions of the support frame 210. In some embodiments, the support frame 210 and / or the actuator 270 may be at least substantially similar in form and / or function, respectively, to the support frame 110 and / or the actuator 170 described above with reference to Figures 1A to 1E Accordingly, the parts and / or aspects of the support frame 210 and / or the actuator 270 are not described in more detail herein.

[0158] As shown, the annulus support frame 210 has a supra-annular member and / or region 220, an infra-annular member and / or region 230, and a trans-annular member and / or region 212 disposed and / or coupled therebetween. In Figures 2A to 2DIn the embodiments shown, the supra-annular member and / or region 220, the sub-annular member and / or region 230, and the trans-annular member and / or region 212 are separately, independently, and / or modular components that are jointly coupled to form the frame 210. Each of the supra-annular member and / or region 220, the sub-annular member and / or region 230, and the trans-annular member and / or region 212 (referred to herein as supra-annular, sub-annular, and trans-annular "members") is a wireframe laser cut from any suitable material, such as a shape memory or superelastic material like nitinol. In some implementations, each of the supra-annular member 220, the sub-annular member 230, and the trans-annular member 212 can be laser cut from a nitinol sheet and, for example, heat set into a desired shape and / or configuration. As described above, forming the supra-annular member 220, the sub-annular member 230, and the trans-annular member 212 in this manner can provide the flexibility and / or resistance to the desired amount of plastic or permanent deformation that allows the frame 210 to be folded and / or compressed for delivery. Additionally, the wireframe portions of the supra-annular member 220, the sub-annular member 230, and the trans-annular member 212 can be covered with any suitable biocompatible material, such as any of the biocompatible materials described above.

[0159] In some embodiments, the supra-annular member 220 of the frame 210 can be at least in form and / or function similar to the supra-annular member 120 described above with reference to Figures 1A to 1E For example, the supra-annular member 220 can be and / or can form (e.g.) a cuff or collar that can be attached or coupled to the upper edge or upper portion of the trans-annular member 212. In some implementations, the supra-annular member 220 can be deployed on the atrial floor to direct blood from the atrium into the flow control component mounted to the frame 210, as described in detail above. The supra-annular member 220 can be shaped and / or formed to include any number of features configured to engage autologous tissue and / or one or more other parts of the frame 210 and / or the actuator 270. For example, in some embodiments, the supra-annular member 220 can include and / or can form an outer portion or outer ring, an inner portion or inner ring, and one or more splines disposed between the outer portion or outer ring and the inner portion or inner ring.

[0160] In some embodiments, the outer portion or outer ring (referred to herein as the "outer ring") may be shaped and / or sized to engage native tissue. More specifically, the supra-annular member 220 (or its outer ring) may have a distal portion 222 configured to engage tissue on the distal annulus and a proximal portion 224 configured to engage tissue on the proximal annulus. In some embodiments, the distal and proximal portions 222 and 224 may have a circular and / or curved shape, where the radius of curvature of the proximal portion 224 is greater than the radius of curvature of the distal portion 222. In some implementations, the distal portion 222 may form, for example, a distal superior anchoring element that may engage tissue on the distal annulus to at least partially stabilize the frame 210 and / or secure the frame within the native annulus. Similarly, the proximal portion 224 may form, for example, a proximal superior anchoring element that may engage tissue on the proximal annulus to at least partially stabilize the frame 210 and / or secure the frame within the native annulus.

[0161] The inner portion or inner ring (referred to herein as the "inner ring") of the supra-annular member 220 may be substantially circular and may be coupled to the outer ring and / or suspended from the outer ring by one or more splines. As described in more detail herein with reference to specific embodiments, the inner ring may be coupled to the inner frame of the flow control component to at least partially mount the flow control component to the support frame 210. In some implementations, suspending the inner ring from the outer ring (via one or more splines) may, for example, at least partially isolate at least a portion of the forces associated with the transition of the frame 210 between the expanded configuration and the compressed configuration, as described in more detail herein. Additionally, mounting the flow control component to the inner ring of the supra-annular member 220 similarly at least partially isolates and / or reduces the amount of force transmitted to the flow control component when the frame 210 transitions between its expanded configuration and its compressed configuration.

[0162] One or more splines of the supra-annular member 220 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the supra-annular member 220 may include distal splines and proximal splines. As described above, the splines may be configured to support the inner ring and / or otherwise couple the inner ring to the outer ring. In some embodiments, the supra-annular member 220 may include splines (e.g., proximal splines) configured to receive, couple to, and / or otherwise engage the actuator 270 and / or the delivery system interface. For example, in some embodiments, the proximal splines may form connection points, attachment points, path points, and / or any other suitable features that may be temporarily and / or removably coupled to the actuator 270, as described in more detail herein with reference to specific embodiments.

[0163] In some embodiments, the sub-annular member 230 of the frame 210 may be at least similar in form and / or function to that described above with reference toFigures 1A to 1E The described subannular region 130. For example, the subannular member 230 of the frame 210 can be a cuff or collar that can be attached or coupled to the lower edge or upper portion of the transannular member 212, and / or can form the cuff or collar, as described in more detail herein. When the frame 210 is deployed within the human heart, the subannular member 230 can be a ventricular collar that is shaped to conform to the native deployment location. In tricuspid and / or mitral valve replacement, for example, the subannular member 230 or collar can have portions configured to respectively conform to the native valve and / or surround a portion of the ventricular apex of the tricuspid and / or mitral valve. In some implementations, the subannular member 230 or at least a portion thereof can: engage the ventricular apex surrounding the native annulus to fix the frame 210 within the native annulus; prevent the frame 210 from leaving its in situ position; clamp or compress the native annulus or adjacent tissue between the supraannular member 220 and the subannular member 230; and / or effect a seal to prevent blood leakage around the frame 210 (perivalvular leakage and / or regurgitation during cardiac systole).

[0164] The subannular member 230 can be shaped and / or formed to include any number of features configured to engage native tissue, one or more other portions of the frame 210, and / or the actuator 270. For example, in some embodiments, the subannular member 230 can include and / or can form a distal portion having a distal anchoring element 232 and a proximal portion having a proximal anchoring element 234. In some embodiments, the subannular member 230 can include and / or can form any other suitable anchoring elements (not shown in Figures 2A to 2D ). In some embodiments, the anchoring elements 232 and 234 are formed integrally and / or monolithically with the subannular member 230. The distal anchoring element 232 and the proximal anchoring element 234 of the subannular member 230 can be any suitable shape, size, and / or configuration, such as any one of the shapes, sizes, and / or configurations described in detail in the '957 PCT, '010 PCT, '231 PCT, '390 PCT, '932 provisional, '059 provisional, any one of the shapes, sizes, and / or configurations described above with reference to the valve 100, and / or any one of the shapes, sizes, and / or configurations described herein with respect to specific embodiments.

[0165] In some embodiments, the distal anchoring element 232 may optionally include a guidewire coupler configured to selectively engage and / or receive a portion of a guidewire or a portion of a guidewire assembly. The guidewire coupler is configured to allow a portion of the guidewire to extend through an aperture of the guidewire coupler, thereby allowing the frame 210 to advance over or along the guidewire during delivery and deployment. In some embodiments, the guidewire coupler may selectively allow the guidewire to advance through the guidewire coupler while blocking or preventing other elements and / or components such as a pusher.

[0166] The anchoring elements 232 and / or 234 of the subannular member 230 may be configured to engage a desired portion of the native tissue to mount the frame 210 to the annulus of the native valve in which the frame is deployed. For example, in some implementations, the distal anchoring element 232 may be a protrusion or projection extending from the subannular member 230 and into, for example, the RVOT. In such implementations, the distal anchoring element 232 may be shaped and / or biased such that the distal anchoring element 232 exerts a force on the subannular tissue that is operable to at least partially secure the distal portion of the frame 210 within the native annulus. In some implementations, the proximal anchoring element 234 may be configured to engage the subannular tissue proximal to the native annulus to assist in securing the frame 210 within the annulus.

[0167] In some implementations, at least the proximal anchoring element 234 may be configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal anchoring element 234 extends a first amount or distance from the subannular member 230 and a second configuration in which the proximal anchoring element 234 extends a second amount or distance from the subannular member 230. As described above, the subannular member 230 of the frame 210 may be and / or may for example include a laser cut frame formed from a shape memory material such as nitinol, the laser cut frame being heat set into a desired shape. In some embodiments, heat setting the subannular member 230 may include forming one or more twists in a portion of the laser cut lines, which in turn may allow one or more portions of the subannular member 230 to be biased in different directions and / or orientations. For example, generally, the subannular member 230 of the frame 210 may be formed to provide a high degree of flexibility in a direction that allows the subannular member 230 to be folded and / or compressed (e.g., relative to the longitudinal axis of the subannular member 230). However, in some embodiments, a portion of the subannular member 230 may be twisted and / or otherwise oriented to provide a high degree of flexibility in a direction that allows the proximal anchoring element 234 to be actuated and / or otherwise transition between its first and second configurations (e.g., in a direction orthogonal to the longitudinal axis of the subannular member 230 and orthogonal to the folding and / or compression direction).

[0168] In some embodiments, the proximal anchoring element 234 may be in a compressed, contracted, retracted, undeployed, folded, and / or constrained state when in the first configuration (e.g., a position proximate to, adjacent to, and / or contacting the transannular member 212 and / or the supra-annular member 220 of the support frame 210), and may be in a dilated, extended, deployed, unfolded, and / or unconstrained state when in the second state (e.g., extended away from the transannular member 212). In some embodiments, the proximal anchoring element 234 may be biased and / or heat-set in the second configuration. Additionally, in some implementations, the proximal anchoring element 234 may be transitioned in response to actuation of the actuator 270, as described in more detail herein.

[0169] In some implementations, the proximal anchoring element 234 may transition from the first configuration to the second configuration during deployment to selectively engage autologous tissue, tendon, trabeculae, annulus tissue, leaflet tissue, and / or any other anatomical structure to assist in fixing the frame 210 in the autologous annulus. The proximal anchoring element 234 (and / or the distal anchoring element 232) may include any suitable features, surfaces, members, etc. configured to facilitate engagement between the proximal anchoring element 234 (and / or the distal anchoring element 232) and autologous tissue. For example, in some embodiments, the proximal anchoring element 234 may include one or more features configured to engage autologous tissue, tendon, trabeculae, annulus tissue, leaflet tissue, and / or any other anatomical structure and / or wrap therearound when in the second configuration, as described in more detail herein with reference to specific embodiments.

[0170] In some embodiments, the transannular member 212 of the frame 210 may be at least in form and / or function similar to that described above with reference to Figures 1A to 1EThe described transannular region 112. For example, the transannular member 212 is disposed between the supra-annular member 220 and the sub-annular member 230. In some embodiments, the transannular member 212 may be coupled to each of the supra-annular member 220 and the sub-annular member 230 such that a desired amount of movement and / or flexure therebetween is permitted (e.g., welding, bonding, sewing, tying, etc.). For example, in some implementations, the transannular member domain 212 and / or portions thereof may be sewn to each of the supra-annular member 220 and the sub-annular member 230 (and / or portions thereof). The transannular member 212 may be shaped and / or formed as an annulus, a cylindrical tube, a conical tube, a D-shaped tube, and / or any other suitable annular shape as described above with reference to the transannular member 112. In some embodiments, the transannular member 212 may have a shape and / or size that is at least partially based on the size, shape, and / or configuration of the supra-annular member 220 and / or the sub-annular member 230 of the support frame 210, and the flow control component is configured to be coupled to the support frame 210 and / or the native annulus in which the flow control component is configured to be deployed. For example, the transannular member 212 may have an outer peripheral surface for engaging native annulus tissue, and the outer peripheral surface may be tensioned against the inner aspect of the native annulus to provide a structural opening to the weakened native annulus orifice.

[0171] As described above, the supra-annular member 220, the sub-annular member 230, and the transannular member 212 may be separate and / or modular components that are joined to together form the frame 210. In some embodiments, the supra-annular member 220 is configured to engage the supra-annular tissue of the native valve and may be shaped and / or biased to form a substantially fluid seal with the atrial floor to limit and / or substantially prevent leakage around the frame (e.g., paravalvular leakage). Similarly, the sub-annular member 220 is configured to engage the sub-annular tissue of the native valve and may be shaped and / or biased to form a substantially fluid seal with the ventricular ceiling to limit and / or substantially prevent leakage around the frame. Additionally, in some implementations, the transannular member 212 may have a circumference that is slightly oversized relative to the native annulus tissue and may form at least a partial seal, for example, between the transannular member 212 of the frame 210 and the native tissue of the wall forming the annulus. In such implementations, forming a seal relative to the atrial floor, the ventricular ceiling, and the wall of the annulus may provide redundancy in the case of an incomplete or partial seal formed by one or more of the supra-annular member 220, the sub-annular member 230, and / or the transannular member 212.

[0172] In other implementations, the distal and proximal anchoring elements 232 and 234 can apply forces to the subannular tissue, which can operate to pull the supra-annular member 220 of the frame 210 toward the atrial floor, thereby facilitating the formation of a seal. In such implementations, for example, the subannular member 230 and / or the transannular member 212 do not need to form a seal, or may form a partial seal with the native tissue due to the seal formed by the supra-annular member 220.

[0173] In some implementations, the arrangement of the frame 210 can be such that the supra-annular member 220 and the subannular member 230 provide structural support and / or rigidity, and the transannular member 212 does not need to provide substantial support and / or rigidity. In some such implementations, the transannular member 212 can be configured to couple the supra-annular member 220 to the subannular member 230 and deform easily (elastically) for delivery, rather than providing substantial support and / or rigidity. Additionally, while the transannular member 212 has been described above as being formed of a laser-cut frame covered with a biocompatible material, in other embodiments, the transannular member 212 can be formed of any suitable flexible material, such as pericardial tissue, fabric, polyester, etc. In some such embodiments, forming the flexible material without a laser-cut frame can, for example, reduce the size of the frame 210 when in a compressed configuration, thereby allowing a smaller delivery catheter to be used to deliver the valve. In some embodiments, the frame 210 does not need to include a separate transannular member 212. For example, in these embodiments, a flow control component can be coupled between the supra-annular member 220 and the subannular member 230, thereby allowing further reduction in the size of the valve when in a compressed configuration.

[0174] As Figures 2A to 2D shown, the actuator 270 can be at least temporarily coupled to the supra-annular member 220 and the subannular member 230. In some embodiments, the actuator 270 or a portion thereof can also be at least temporarily coupled to a portion of the transannular member 212. The actuator 270 can be any suitable member, mechanism, and / or device configured to actuate at least a portion of the frame 210. Additionally, a portion of the actuator 270 can extend through a portion of the delivery system for delivering the frame 210 and / or the valve including the frame 210. In this way, a user can manipulate the proximal portion of the actuator 270 to actuate the actuator 270.

[0175] In some embodiments, the actuator 270 and / or a portion of the actuator 270 may be configured to be coupled, at least temporarily, to a spline of the annulus upper member 220 (e.g., an attachment point, a path point, a connector, a threaded coupler, etc.) and may be configured to actuate one or more portions of the frame 210. The actuator 270 may be configured to actuate at least the proximal anchoring element 234 of the annulus lower member 220 that supports the frame 210 to cause the proximal anchoring element 234 to transition between its first configuration and the second configuration (described above).

[0176] In some implementations, the actuator 270 may include one or more cables, tethers, linkages, joints, connectors, etc., which may apply a force (or may remove an applied force) to a portion of the proximal anchoring element 234, and the force may be operable to cause the proximal anchoring element 234 to transition between the first configuration and the second configuration. For example, the actuator 270 may be coupled to a path point of the annulus upper member 220 and the like, and may include one or more tethers, cables, and / or members that extend through the path point and / or one or more openings or apertures and are coupled to the proximal anchoring element 234. In some implementations, the one or more tethers, cables, and / or members may be removably and / or temporarily coupled to the proximal anchoring element 234, as described in (e.g.) ‘010 PCT.

[0177] As described above, the annulus lower member 230 may be formed with proximal anchoring elements 234 that are biased in an uncompressed configuration and / or a dilated configuration. In this way, actuating the actuator 270 may apply a force via one or more cables, tethers, etc., and the force may be operable to transition the proximal anchoring element 234 into a compressed configuration and / or a retracted configuration. More specifically, a user may manipulate a proximal portion of the actuator 270 to actuate a distal portion of the actuator 270 that is coupled to the frame 210. For example, actuating the actuator 270 may cause one or more cables, tethers, and / or members to be pulled in a proximal direction (e.g., away from the frame 210 and / or by increasing the tension therein), as indicated by arrow AA in Figure 2B . Coupling the distal portion of the actuator 270 to the frame 210 may cause the proximal movement of the cable, tether, etc. to pull the proximal anchoring element 234 toward the central axis of the frame 210, as indicated by arrow BB in Figure 2B . Accordingly, actuating the actuator 270 may apply a force to the proximal anchoring element 234, and the force may be operable to place the proximal anchoring element 234 in a compressed configuration, a retracted configuration, a constrained configuration, and / or an actuated configuration, as shown in Figure 2B .

[0178] In some implementations, actuating the actuator 270 can also be operable to pull the subannular member and / or the proximal front segment portion of the transannular wall and the proximal rear segment portion of the subannular member and / or the transannular wall toward or to the longitudinal axis of the valve 200. For example, Figure 2C Illustrated is that actuating the actuator 270 (e.g., moving the actuator 270 or the tether in the AA direction) causes the proximal anchoring element 234 to compress and / or move toward the central portion of the valve frame 210, as indicated by arrow BB, and causes the posterior wall and the anterior wall to compress toward the central portion of the valve frame 210, as indicated by arrow CC. Thus, actuating the actuator 270 can reduce the perimeter of at least the subannular member 230, thereby allowing the desired portion of the valve frame 210 to be inserted into the annulus of the native valve.

[0179] In some implementations, the actuator 270 can be fixed and / or locked when the proximal anchoring element 234 is compressed and / or retracted (e.g., the first configuration) to maintain the proximal anchoring element 234 in the first configuration at least temporarily. As described above, in some implementations, before the frame 210 (or the valve) is placed in the native annulus, the proximal anchoring element 234 can be in the first configuration for delivery and deployment. Once the frame 210 is placed in the native annulus, the user can manipulate the proximal portion of the actuator 270 to actuate and / or release the actuator 270. In this example, the actuation can cause the actuator 270 to release and / or remove at least a portion of the force applied to the proximal anchoring element 234 (e.g., via a cable, a tether, etc.), thereby allowing the proximal anchoring element 234 (and / or one or more portions of the front wall and / or the rear wall) to return to its biased configuration or the second configuration (see, for example Figure 2A ), as described above.

[0180] In some implementations, the actuator 270 can be configured to further actuate the frame 210 after the frame 210 (or the valve) is placed in the native annulus. For example, in some implementations, the user can manipulate the proximal portion of the actuator 270 (e.g., in the same manner as just described or in a different manner) to move one or more cables, tethers, and / or members of the actuator 270 in the proximal direction (e.g., away from the frame 210 and / or by increasing the tension therein), as Figure 2D indicated by arrow DD in. In this example, the proximal anchoring element 234 is in its uncompressed or unactuated state after the frame 210 is placed in the native annulus. The actuator 270 can be coupled to the supraannular member 220, the subannular member 230, and / or the proximal anchoring element 234 such that actuation of the actuator 270 generates a force operable to pull the proximal anchoring element 234 toward the proximal portion 224 of the supraannular member 220, as Figure 2Das indicated by arrow EE in. For example, the actuator 270 can apply a compressive force or the like that is operable to fasten at least a portion of the frame 210.

[0181] As Figure 2D shown in, in some cases, the proximal anchoring element 234 can be bent in the direction of the native annulus (e.g., beyond its biased position), which can facilitate the engagement of the proximal anchoring element 234 with the native tissue and / or the tendons on the proximal side of the native annulus. In some implementations, the force generated by the actuation of the actuator 270 can be operable to pull, move, compress, and / or fasten other portions of the subannular member 230 toward the supra-annular member 220 on the annulus, as Figure 2D indicated by arrow FF in. In some such implementations, the amount of fastening can vary on the frame 210. For example, the amount of fastening at or near the proximal portion of the frame 210 can be greater than the amount of fastening at or near the distal portion of the frame 210. In other implementations, the amount of fastening can be substantially uniform on the frame 210. Additionally, when the frame 210 is placed in the native annulus, at least some of the tissue surrounding the native annulus can be disposed between the supra-annular member 220 and the subannular member 230, and thus, the fastening of the supra-annular member 220 and the subannular member 230 can be operable to squeeze and / or clamp the native tissue between the members 220 and 230. In this way, the fastening can enhance the fixation of the frame 210 in the native annulus.

[0182] Although not shown in Figures 2A to 2D , in some embodiments, the size of the proximal anchoring element 234 can be designed and / or shaped to engage native tissue, tendons, trabeculae, annulus tissue, leaflet tissue, etc. when the frame 210 is fastened against or relative to the native annulus. In some embodiments, the proximal anchoring element 234 can include one or more protrusions, features, ridges, ribs, knobs, knots, beads, loops, etc., which can engage and / or facilitate the engagement of native tissue when the frame 210 is fastened against or relative to the native annulus.

[0183] Although one or more portions of the frame 210 and / or the subannular member 230 were described above as being compressed in response to actuation of the actuator 270 to move inwardly toward the central axis of the frame 210, in other embodiments, the actuator 270 may be removably coupled to one or more portions of the frame 210 and configured to move such portions in any suitable manner. For example, in some implementations, the actuator 270 (e.g., one or more tether chains as described above) may be coupled to the proximal anchoring element 234 such that actuation of the actuator 270 causes the proximal anchoring element 234 to fold or wind the transannular member 212 of the frame 210 in a forward or backward or both directions, depending on the actuation mode. As described above, folding the proximal anchoring element 234 and / or winding the proximal anchoring element 234 around the transannular member 212 may reduce the circumference or diameter of at least the subannular member 230, thereby allowing the frame 210 to be inserted into and / or at least partially through the annulus of a native heart valve.

[0184] Figures 3A to 3C FIG. 3 is a schematic illustration of an annulus support frame 310 according to one embodiment. The annulus support frame 310 (also referred to herein as a "tubular frame", "valve frame", "wire frame", "outer frame", "support frame", or "frame") may include and / or be coupled to an actuator 370 configured to actuate one or more portions of the support frame 310. In some embodiments, the support frame 310 and / or the actuator 370 may be at least substantially similar in form and / or function to the support frames 110, 210 and / or the actuators 170, 270, respectively. Accordingly, portions and / or aspects of the support frame 310 and / or the actuator 370 are not described in more detail herein.

[0185] As shown, the annulus support frame 310 has a supra-annular member and / or region 320, a sub-annular member and / or region 330, and a trans-annular member and / or region 312 disposed and / or coupled therebetween. In Figures 3A to 3CIn the embodiments shown, the supra-annular member and / or region 320, the infra-annular member and / or region 330, and the trans-annular member and / or region 312 are separately, independently, and / or modularly joined together to form the frame 310. Each of the supra-annular member and / or region 320, the infra-annular member and / or region 330, and the trans-annular member and / or region 312 (referred to herein as supra-annular, infra-annular, and trans-annular "members") is a wireframe laser cut from any suitable material, such as a shape memory or superelastic material like nitinol. In some implementations, each of the supra-annular member 320, the infra-annular member 330, and the trans-annular member 312 can be laser cut from a nitinol sheet and, for example, heat set into a desired shape and / or configuration. As described above, forming the supra-annular member 320, the infra-annular member 330, and the trans-annular member 312 in this manner can provide the flexibility and / or resistance to the desired amount of plastic or permanent deformation that allows the frame 310 to be folded and / or compressed for delivery. Additionally, the wireframe portions of the supra-annular member 320, the infra-annular member 330, and the trans-annular member 312 can be covered with any suitable biocompatible material, such as any of the biocompatible materials described above.

[0186] In some embodiments, the supra-annular member 320 of the frame 310 can be at least in form and / or function similar to the supra-annular members 120, 220 described above. For example, the supra-annular member 320 can be and / or can form (e.g.) a cuff or collar that can be attached or joined to the upper edge or upper portion of the trans-annular member 312. The supra-annular member 320 can be shaped and / or formed to include any number of features configured to engage autologous tissue and / or one or more other parts of the frame 310 and / or the actuator 370. For example, the supra-annular member 320 (or its outer ring) can have a distal portion 322 configured to engage the distal supra-annular tissue and a proximal portion 324 configured to engage the proximal supra-annular tissue.

[0187] As described above, the supra-annular member 320 may include and / or form an outer portion or outer ring, an inner portion or inner ring, and one or more splines disposed between the outer portion or outer ring and the inner portion or inner ring. The outer portion or outer ring (referred to herein as the "outer ring") may be shaped and / or sized to engage native tissue. In some implementations, the outer ring may form, for example, one or more upper anchoring elements or supra-annular anchoring elements that may engage supra-annular tissue to at least partially stabilize the frame 310 and / or secure the frame within the native annulus. The inner portion or inner ring of the supra-annular member 320 (referred to herein as the "inner ring") is coupled to the outer ring and / or suspended from the outer ring by one or more splines and may be coupled to the inner frame of the flow control component to at least partially mount the flow control component to the support frame 310, as described above with reference to the supra-annular member 220. The one or more splines of the supra-annular member 320 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the supra-annular member 320 may include distal splines and proximal splines. In some embodiments, the supra-annular member 320 may include splines (e.g., proximal splines) configured to receive, couple to, and / or otherwise engage the actuator 370 and / or the delivery system interface. For example, in Figures 3A to 3C the embodiment shown, the supra-annular member 330 (e.g., its splines) may form waypoints, etc., that may be temporarily and / or removably coupled to and / or receive the actuator 370 and any other suitable part of the delivery system, as described in more detail herein with reference to specific embodiments.

[0188] The sub-annular member 330 of the frame 310 may be at least in form and / or function similar to the sub-annular region and / or member 130, 230 described above. For example, the sub-annular member 330 of the frame 310 may be and / or form a cuff or collar that may be attached or coupled to the lower edge or upper portion of the trans-annular member 312. When the frame 310 is deployed within the human heart, the sub-annular member 330 may be shaped as a ventricular collar that conforms to the native deployment location. In some implementations, the sub-annular member 330 or at least a portion thereof may engage the ventricular apex surrounding the native annulus to secure the frame 310 within the native annulus to prevent the frame 310 from moving out of place and / or to provide a seal to prevent blood leakage around the frame 310 (perivalvular leakage and / or regurgitation during cardiac systole).

[0189] In Figures 3A to 3CThe subannular member 330 included in the frame 310 shown in [description] may include and / or may form a distal portion having a distal anchoring element 332 and a proximal portion having a proximal anchoring element 334. In some embodiments, the subannular member 330 may include and / or may form any other suitable anchoring elements (not shown in [description]). The anchoring elements 332 and 334 are formed integrally and / or monolithically with the subannular member 330. The distal anchoring element 332 and the proximal anchoring element 334 of the subannular member 330 may be of any suitable shape, size, and / or configuration, such as any one of the shapes, sizes, and / or configurations described in detail in '957 PCT, '010 PCT, '231 PCT, '390 PCT, '932 Provisional, '059 Provisional, any one of the shapes, sizes, and / or configurations described above with reference to the valve 100, and / or any one of the shapes, sizes, and / or configurations described herein with respect to specific embodiments. The distal anchoring element 332 may be substantially similar to the distal anchoring elements 132, 232 and is thus not described in more detail herein. Figures 3A to 3C In [description],

[0190] The proximal anchoring element 334 may be configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal anchoring element 334 extends a first amount, distance, and / or direction from the subannular member 330 and a second configuration in which the proximal anchoring element 334 extends a second amount, distance, and / or direction from the subannular member 330. In some embodiments, the proximal anchoring element 334 may be at least substantially similar in form and / or function to the proximal anchoring element 234 described above with reference to Figures 2A to 2D [description]. Such similarities are thus not described in more detail herein.

[0191] In some embodiments, the proximal anchoring element 334 may be in a compressed, contracted, retracted, undeployed, folded, and / or constrained state (e.g., a position close to, adjacent to, and / or in contact with the transannular member 312 of the support frame 310 and / or the supraannular member 320) when in the first configuration, and may be in a dilated, extended, deployed, unfolded, and / or unconstrained state (e.g., extending away from the transannular member 312) when in the second state. In some embodiments, the proximal anchoring element 334 may be biased and / or heat-set in the second configuration. Additionally, in some implementations, the proximal anchoring element 334 may transition in response to actuation of the actuator 370, as described in more detail herein.

[0192] The transannular member 312 is disposed between the supra-annular member 320 and the infra-annular member 330. In some embodiments, the transannular member 312 may be coupled to each of the supra-annular member 320 and the infra-annular member 330 such that a desired amount of movement and / or flexure therebetween is permitted (e.g., welding, bonding, sewing, tying, etc.). In some embodiments, the transannular member 312 of the frame 310 may be at least similar in form and / or function to the transannular regions 112, 212 described above and is thus not described in more detail herein.

[0193] Although the frame 310 was described above as being substantially similar to the frame 210 referenced above Figures 2A to 2D described, the frame 310 differs from the frame 210 in its engagement with the actuator and the movement of the proximal anchoring element 334. As Figures 3A to 3C shown, the actuator 370 may be engaged with the supra-annular member 320 and the infra-annular member 330 at least temporarily. The actuator 370 may be any suitable member, mechanism, and / or device configured to actuate at least a portion of the frame 310. Additionally, a portion of the actuator 370 may extend through a portion of the delivery system for delivering the frame 310 and / or the valve including the frame 310. In this manner, a user may manipulate the proximal portion of the actuator 370 to actuate the actuator 370.

[0194] Figure 3A Shown is the actuator 370 engaged with the frame 310 when the frame 310 is in a compressed or delivery configuration. As described above with reference to the valve 100, the frame 310 may be compressed, folded, and / or otherwise placed in a delivery configuration for lateral delivery via a delivery catheter. Prior to placing the frame 310 in the delivery system, the actuator 370 may be removably coupled to the frame 310 such that the frame 310 (or the valve) and the actuator 370 are advanced together through the delivery catheter. In this embodiment, the actuator 370 may be a tether that extends through a path point 328 defined by the supra-annular member 320, sequentially through one or more attachment points of the infra-annular member 330 (e.g., one or more attachment points on or near the proximal anchoring element 334), and then loops back through the path point 328. Thus, both ends of the tether are proximal to the frame 310 and may be maintained at the proximal side and / or proximal end of the delivery system, allowing an operator to manipulate the actuator 370 (the tether) to actuate the proximal anchoring element 334. Figure 3A Shown is the proximal anchoring element 334 in an extended or unactuated configuration when the frame 310 is in a delivery configuration for lateral delivery through a delivery catheter.

[0195] Figure 3BIt is shown that the actuator 370 is actuated to move the proximal anchoring element 334 from a first position or configuration to a second position or configuration. More specifically, when the frame 310 is released from the delivery catheter, the frame 310 (and / or the valve) can be advanced through the delivery catheter and allowed to expand at least partially. In some implementations, the frame 310 is at least partially inserted into the annulus, while the proximal portion of the frame 310 remains within the delivery catheter. After the frame 310 is completely released from the delivery catheter, the operator can manipulate the proximal portion of the actuator 370 to actuate the distal portion of the actuator 370 coupled to the proximal anchoring element 334.

[0196] For example, actuating the actuator 370 can cause one or more tether lines to be pulled in a proximal direction (e.g., away from the frame 310 and / or by increasing the tension therein), as indicated by the arrow GG in Figure 3B . In the case where the actuator 370 passes through the path point 328 of the supra-annular member 320 (which is not actuated by the actuator 370 in this embodiment), the proximal movement of the cable, tether line, etc. pulls the proximal anchoring element 334 towards the path point 328, as indicated by the arrow HH in Figure 3B . Thus, actuating the actuator 370 can apply a force to the proximal anchoring element 334 that can operate to place the proximal anchoring element 334 in a compressed configuration, a retracted configuration, a constrained configuration, and / or an actuated configuration, as shown in Figure 3B . As described above, placing the proximal anchoring element 334 in a compressed configuration and / or an actuated configuration reduces the perimeter of at least the sub-annular member 330, thereby allowing the sub-annular member 330 to pass through the annulus of the native valve. Although the proximal anchoring element 334 is shown as moving and / or pivoting in the supra-annular direction towards the path point 328, in some implementations, one or more portions of the proximal anchoring element 334 and / or the sub-annular member 330 and / or the trans-annular member 312 can similarly move or pivot towards the path point 328, which in turn can reduce the perimeter of the sub-annular member 330, as described in detail above with reference to the frame 210 shown in Figures 2A to 2D .

[0197] After the frame 310 (or the valve) is placed in the annulus, the actuator 370 can be actuated again and / or otherwise returned to an unactuated state or configuration. Thus, the proximal anchoring element 334 is allowed to return to an extended configuration and / or an unactuated configuration. In the embodiment shown in Figures 3A to 3C , the proximal anchoring element 334 can be biased such that in the extended configuration and / or the unactuated configuration, the proximal anchoring element 334 engages the native sub-annular tissue to at least partially fix the frame 310 in the annulus. Figure 3COnce the frame 310 is placed in the annulus, the operator can manipulate the actuator 370 to remove the actuator 370 from the frame 310. For example, the operator can pull on one end of the tether (e.g., the actuator 370) such that the tether is retracted from the attachment point on the annulus sub-component 330 and the path point 328 on the annulus supra-component 320. Thus, the actuator 370 and / or the delivery system of which the actuator 370 is a part can be withdrawn from the patient while the frame 310 remains in the annulus of the native heart valve.

[0198] The following provides a discussion of certain aspects or embodiments of a laterally deliverable transcatheter prosthetic valve (e.g., a prosthetic valve). The transcatheter prosthetic valves (or aspects and / or parts thereof) described below with respect to specific embodiments can be substantially similar at least in form and / or function to valves 100 and / or 200 (or corresponding aspects and / or parts thereof). Similarly, the valves (or aspects and / or parts thereof) described below can be similar at least in form and / or function to the valves described in detail in '957 PCT, '010 PCT, '231 PCT, '390 PCT, '932 provisional, '059 provisional. Accordingly, certain aspects and / or parts of the specific embodiments may not be described in greater detail herein.

[0199] Figures 4 to 24 Illustrated is a laterally deliverable (orthogonally deliverable) transcatheter prosthetic heart valve 400 (also referred to herein as a "prosthetic valve" or a "valve") according to one embodiment. Figure 4 is a diagrammatic illustration of a top perspective view of the valve 400. In some implementations, the valve 400 can be deployed in the annulus of, for example, a native tricuspid valve and / or mitral valve. The valve 400 is configured to permit blood flow in a first direction through the inflow end of the valve 400 and to block blood flow in a second direction opposite the first direction through the outflow end of the valve 400. For example, the prosthetic valve 400 can be a laterally deliverable transcatheter prosthetic heart valve configured to be deployed within the annulus of a native tricuspid valve or native mitral valve of a human heart to supplement and / or replace the function of the native valve.

[0200] The valve 400 is capable of compressing and expanding in at least one direction with respect to the x-axis of the valve 400 (also referred to herein as the "horizontal axis", "longitudinal axis", "major axis", and / or "longitudinal axis"). The valve 400 is capable of transitioning between an expanded configuration for implantation at a desired location in the body (e.g., the human heart) and a compressed configuration for use with a delivery catheter (in Figure 4Compress and expand between a compressed configuration introduced into the body (not shown in the figure). In some embodiments, when in the expanded configuration and / or the compressed configuration, the horizontal x-axis of the valve 400 is orthogonal (90 degrees), or substantially orthogonal (75 degrees - 105 degrees), or substantially inclined (45 degrees - 135 degrees) to the central (vertical) y-axis. Additionally, the horizontal x-axis of the valve 400 in the compressed configuration is substantially parallel to the longitudinal cylindrical axis of the delivery catheter in which the valve 400 is disposed.

[0201] In some embodiments, the valve 400 has an expanded or deployed height of about 5 mm - 60 mm, about 5 mm - 30 mm, about 5 mm - 20 mm, about 8 mm - 12 mm, or about 8 mm - 10 mm, and an expanded or deployed diameter (e.g., length and / or width) of about 25 mm - 80 mm or about 40 mm - 80 mm. In some embodiments, the valve 400 has a compressed height (y-axis) and width (z-axis) of about 6 mm - 15 mm, about 8 mm - 12 mm, or about 9 mm - 10 mm. In some implementations, it is expected that the length of the valve 400 (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.

[0202] In certain embodiments, the valve 400 is centered or radially symmetric. In other embodiments, the valve 400 is eccentric or radially asymmetric (e.g., along or relative to the y-axis). In some eccentric embodiments, the frame 410 may have a D-shaped cross-section, where the flat portion or surface is configured to substantially match the annulus of the native mitral valve at or near the anterior leaflet. In Figures 4 to 24 the example shown, the valve 400 is eccentric, where one or more components are offset relative to the y-axis or are asymmetric regions.

[0203] The valve 400 includes an external annulus support frame 410 and a collapsible and expandable internal flow control component 450 mounted within the external annulus support frame 410. The external annulus support frame 410 (also referred to herein as the "outer frame") is made of a shape memory material such as nitinol (nitinol) and is thus a self-expanding structure from the compressed configuration to the expanded configuration. As Figure 4 shown, at least the external support frame 410 of the valve 400 is covered, wrapped, and / or surrounded by a biocompatible covering 440. The biocompatible covering 440 can be a mesh material, pericardial tissue, a braided synthetic polyester material, and / or any other suitable biocompatible material, such as the biocompatible materials described above.

[0204] The outer frame 410 has an annuloplasty member 412 and / or a body that circumscribes, forms, and / or defines a central (inner) passageway about and / or along a vertical or central axis (y-axis). The outer frame 410 has an upper annulus member 420 circumferentially attached at the top edge of the annuloplasty member 412 and a lower annulus member 410 circumferentially attached at the bottom edge of the annuloplasty member 412. The upper annulus member 420 is shaped to conform to the native deployment position. For example, in tricuspid valve replacement, the upper annulus member 420 or atrial collar may have a tall posterior wall portion to conform to the septal region of the native valve and may have a distal portion and a proximal portion. The distal portion may be larger than the proximal portion to account for the greater flat space above (atrium) the distal subannular region (e.g., right ventricular outflow tract (RVOT) subannular region). For example, in mitral valve replacement, the upper annulus member 420 of the outer frame 410 may be D-shaped or shaped like a hyperbolic paraboloid to mimic the native structure.

[0205] The expandable and contractible internal flow control component 450 (also referred to herein as "expandable flow control component", "internal flow control component", and / or "flow control component") is mounted within the outer frame 410. The flow control component 450 has a collapsible and compressible inner wireframe 35 (also referred to as "inner leaflet frame" or "inner frame") having two or more folding zones, hinge zones, coupling zones, elastically deformable regions, etc. A set of 2-4 flexible leaflets 461 are mounted within or on the inner frame 451 (not shown in Figure 4 ). In some embodiments, the flow control component 450 has three leaflet 461 tips or pockets mounted within the inner frame 451, as described in more detail herein.

[0206] Like the outer frame 410, the flow control component 450 is collapsible and compressible. For example, the inner frame 451 is capable of folding from a cylindrical configuration to a flat cylinder configuration (or two-layer strip) along the z-axis or in the direction of the z-axis (e.g., capable of folding at the folding zones, etc.), where the folding zones are located on the distal and proximal sides of the inner frame 451. Like the outer frame 410, the flow control component 450 is also capable of being vertically compressed (y-axis) into a shortened or compressed configuration. By folding (compressing) in the direction of the z-axis and vertically compressing along the y-axis, the valve 400 is permitted to maintain a relatively large size along the horizontal (x-axis). In some implementations, the outer frame 410 and the flow control component 450 are reduced along the z-axis until the sidewalls contact or nearly contact. This also allows the outer frame 410 and the flow control component 450 to maintain the radius along the horizontal axis (x-axis) to minimize the number of wire elements that make up the outer and inner frames, which may be damaged by the forces applied during the folding and / or compression required to load into the delivery catheter.

[0207] The flow control component 450 has a diameter and / or perimeter that is smaller than the diameter and / or perimeter of the central channel of the outer frame 410. The flow control component 450 is mounted to or within the outer frame 410 such that the central axis or vertical axis (y-axis) of the inner frame 451 is parallel to the central axis or vertical axis (y-axis) of the outer frame 410. In some embodiments, the y-axis defined by the inner frame 451 is parallel to but offset from the y-axis defined by the outer frame 410 ( Figure 4 ). In some implementations, spacer elements 445 are disposed within and / or across the central channel and may facilitate the mounting of a portion of the flow control component 450 (e.g., an otherwise unsupported portion) to the outer support frame 410 and / or the ingrowth of autologous tissue onto at least a portion of the annulus member 420 of the valve 400. In some embodiments, the spacer elements 445 may be similar to any of the spacer elements described in the '231 PCT.

[0208] In certain embodiments, the inner frame 451 may have a diameter of about 20 mm - 60 mm, the outer frame 410 (or its transannular member 412) may have a diameter of about 40 mm - 80 mm, and the annulus member 420 (or atrial collar) extends beyond the top edge of the transannular member 412 by about 10 mm - 30 mm to provide a seal on the atrial floor to prevent perivalvular leakage (PVL). The flow control component 450 and the outer frame 410 may be collapsible (e.g., in the direction of the z-axis) and / or compressible (e.g., in the direction of the y-axis) to reduce the size of the entire valve 400 to fit within the inner diameter of a delivery catheter (not shown herein) having an inner diameter of 24 Fr - 36 Fr (8 mm - 12 mm). Figure 4 In.

[0209] Figure 5 and Figure 6 is a top perspective view of the annulus member 420 of the outer support frame 410 of the valve 400 shown in Figure 4 . Figure 5 Shows the laser cut frame of the annulus member 420. Figure 6 Shows the laser cut frame of the annulus member 420, where a biocompatible material 426 is coupled to the laser cut frame to facilitate the mounting of the flow control component 450 to the outer frame 410. In some embodiments, the annulus member 420 of the outer frame 410 may be at least substantially similar in form and / or function to the annulus members 120 and / or 220 described above. Accordingly, portions and / or aspects of the annulus member 420 may not be described in further detail herein.

[0210] As shown, the supra-annular member 420 includes a distal portion 422, a proximal portion 424, an outer ring 421, an inner ring 425, and at least one spline 427. In some embodiments, the outer ring 421 may be shaped and / or sized to engage native tissue. For example, the distal portion 422 of the supra-annular member 420 (formed at least in part by the outer ring 421) is configured to engage the distal supra-annular tissue, and the proximal portion 424 (formed at least in part by the outer ring 421) is configured to engage the proximal supra-annular tissue. The distal and proximal portions 422 and 424 may have a circular and / or curved shape, where the radius of curvature of the proximal portion 424 is greater than the radius of curvature of the distal portion 422. The distal portion 422 may form (e.g.) a distal anchoring ring 423, which may engage the distal supra-annular tissue to at least partially stabilize the frame 410 and / or fix the frame in the native annulus. Although not shown in Figure 5 and Figure 6 , the proximal portion 424 may similarly form a proximal upper anchoring element, which may engage the proximal supra-annular tissue to at least partially stabilize the frame 410 and / or fix the frame in the native annulus.

[0211] The inner ring 425 of the supra-annular member 420 may be substantially circular and may be coupled to one or more splines 427 and / or suspended from the outer ring by the one or more splines. As shown in Figure 6 , the inner ring 425 may be coupled to a biocompatible material 426, and the biocompatible material may be used to couple the inner frame 451 of the flow control component 450 to the inner ring 425 of the support frame 410. In some implementations, suspending the inner ring 425 from the outer ring 421 may (e.g.) at least partially isolate the inner ring 425 (and the flow control component 450 coupled to the inner ring 425) from at least a portion of the forces associated with transitioning the frame 410 between the expanded configuration and the compressed configuration, as described above with reference to the frame 210.

[0212] One or more splines 427 of the supra-annular member 420 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the supra-annular member 420 may include a proximal spline 427 and one or more distal splines 427. The distal spline 427 may couple the distal portion of the inner ring 425 to the distal portion of the outer ring 421. Similarly, the proximal spline 427 may couple the proximal portion of the inner ring 425 to the proximal portion of the outer ring 421. In some embodiments, the proximal spline 427 may be configured to receive, couple to, and / or otherwise engage an actuator and / or a portion of a delivery system. For example, the proximal spline 427 includes, forms, and / or may be coupled to a path point 428, which may be used to couple to one or more portions of an actuator and / or a delivery system, as described above with reference to the frames 110 and 210.

[0213] Figures 7 to 11 respectively, a top view, a rear perspective view, a front perspective view, a distal perspective view, and a proximal perspective view of the annuloplasty member 412 of the outer frame 410 of the valve 400 shown in Figure 4 . In some embodiments, the annuloplasty member 420 of the outer frame 410 may be at least substantially similar in form and / or function to the annuloplasty region and / or members 112 and / or 212 described above. Accordingly, portions and / or aspects of the annuloplasty member 412 may not be described in further detail herein.

[0214] The annuloplasty member 412 may be shaped and / or formed as a ring, a cylindrical tube, a conical tube, and / or any other suitable annulus shape. In some embodiments, the annuloplasty member 412 may have a side profile of any of: a concave cylinder (walls curving inward), an angular hourglass, a curved calibrated hourglass, a ring or cylinder with a flared top, a flared bottom, or both. Additionally, the annuloplasty member 412 may form and / or define a hole or central passage 414 extending along a central axis 404 (e.g., the y-axis). The size of the central passage 414 (e.g., the central axial lumen or channel) may be designed and configured to receive a flow control component 450 across a portion of the diameter of the central passage 414. In some embodiments, the annuloplasty member 412 may have a shape and / or size that is at least partially based on the size, shape, and / or configuration of the supra-annular member 420 and / or the infra-annular member 430 of the support frame 410 and / or the native annulus in which the support frame is configured to be deployed, as described above.

[0215] The annuloplasty member 412 may be and / or may include a wireframe laser cut from nitinol, for example, and heat set into a desired shape and / or configuration. The annuloplasty member 412 may be formed to include a set of compressible wire units 413 having an orientation and / or unit geometry that is substantially orthogonal to the central axis extending through the central passage 414 to minimize wire unit strain when the annuloplasty member 412 is in a vertically compressed configuration, a rolled and compressed configuration, or a folded and compressed configuration. As Figures 7 to 11As shown, the transannular member 412 includes a first laser cut half 415 (e.g., the front side) and a second laser cut half 416 (e.g., the back side), which can be formed into a desired shape and joined together to form the transannular member 412. The front side 415 and the back side 416 can be joined at one or more hinge points 417 along the distal and proximal portions of the transannular member 412. More specifically, the front side 415 and the back side 416 can be joined along the distal side of the transannular member 412 via two sutures that form two hinges or connection points 417, and can be joined along the proximal side of the transannular member 412 via one suture that forms a single hinge or connection point 417.

[0216] In some embodiments, forming the transannular member 412 in this manner can allow the transannular member 412 to bend, fold, flex, deform, and / or otherwise reconfigure (substantially without plastic deformation and / or excessive fatigue) in response to lateral folding and / or vertical compression along or in the direction of the transverse axis or z-axis or along or in the direction of the central axis or y-axis. Additionally, joining at the hinge points 417 using sutures can allow a desired amount of slippage between the sutures and the front / back sides 415 / 416, which in turn can limit and / or substantially prevent adhesion, sticking, and / or breakage in response to folding along the transverse axis or z-axis.

[0217] As Figures 7 to 11 shown, the proximal portion of the transannular member 412 includes a single hinge or connection point 417. In some embodiments, the transannular member 412 can define a gap or space 418 below the proximal hinge or connection point 417, which can provide space to allow the proximal anchoring element of the subannular member 430 to transition between a first configuration and a second configuration, as described in more detail herein.

[0218] Figure 12 and Figure 13 are, respectively, a distal perspective view and a top view of the subannular member 430 of the outer frame 410 of the valve 400 shown in Figure 4 As shown. In some embodiments, the subannular member 430 of the frame 410 can be at least similar in form and / or function to the subannular regions and / or members 130 and / or 230 described above. Accordingly, portions and / or aspects of the transannular member 412 may not be described in more detail herein.

[0219] As shown, the subannular member 430 of the frame 410 includes and / or forms a distal portion having a distal anchoring element 432 and a proximal portion having a proximal anchoring element 434. The anchoring elements 432 and 434 are formed integrally and / or monolithically with the subannular member 430. The distal anchoring element 432 and the proximal anchoring element 434 of the subannular member 430 can be of any suitable shape, size, and / or configuration, such as any one of the shapes, sizes, and / or configurations described in detail in '957 PCT, '010 PCT, '231 PCT, '490 PCT, '932 Provisional, '059 Provisional, any one of the shapes, sizes, and / or configurations described above with reference to frame 110 and / or 210, and / or any one of the shapes, sizes, and / or configurations described herein with respect to specific embodiments.

[0220] The distal anchoring element 432 is shown as including a non-damaging end forming a guidewire coupler 433 that is configured to selectively engage and / or receive a portion of a guidewire or a portion of a guidewire assembly. The guidewire coupler 433 is configured, for example, to allow a portion of the guidewire to extend through an opening and / or aperture 435 of the guidewire coupler 433, thereby allowing the frame 410 to advance along or via the guidewire during delivery and deployment. In some embodiments, the guidewire coupler 433 can selectively allow the guidewire to advance through the guidewire coupler while blocking or preventing other elements and / or components such as a pusher.

[0221] The anchoring element 432 and / or 434 is configured to engage a desired portion of the native tissue to mount the frame 410 to the annulus of the native valve in which the frame is deployed. For example, the distal anchoring element 432 can extend (e.g., about 10 mm - 40 mm) from the subannular member 430 and into, for example, the RVOT. The distal anchoring element 432 can be shaped and / or biased such that the distal anchoring element 432 exerts a force on the subannular tissue that can operate to at least partially secure the distal portion of the frame 410 in the native annulus.

[0222] The proximal anchoring element 434 can be configured to engage the subannular tissue proximal to the native annulus to assist in securing the frame 410 in the annulus. More specifically, the proximal anchoring element 434 is configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal anchoring element 434 extends a first amount or distance from the subannular member 430 and a second configuration in which the proximal anchoring element 434 extends a second amount or distance from the subannular member 430. As described above, the subannular member 430 of the frame 410 can be and / or can include, for example, a laser-cut frame formed of a shape memory material such as nitinol that is heat-set into a desired shape and wrapped in a biocompatible material (e.g., asFigure 12 and Figure 13 in the fabric shown in

[0223] As described above, the proximal anchoring element 434 can be in a compressed, contracted, retracted, undeployed, folded, and / or constrained state (e.g., a position close to, adjacent to, and / or in contact with the transannular member 412 and / or the supra-annular member 420 of the support frame 410) when in the first configuration, and can be in a dilated, extended, deployed, unfolded, and / or unconstrained state (e.g., extended away from the transannular member 412) when in the second state. In some embodiments, the proximal anchoring element 434 can be biased and / or heat-set in the second configuration. Additionally, in some implementations, the space 418 defined by the transannular member 412 of the outer frame 410 is configured to provide sufficient space to allow the proximal anchoring element 434 to transition between the first and second configurations.

[0224] Figures 14 to 19 illustrates an inner leaflet frame 451 of a flow control component 450 included in Figure 4 the valve 400 shown in Figure 14 is a diagram of a top perspective view of the inner leaflet frame 451. In some embodiments, the inner leaflet frame 451 is formed by two separate wireframe sheets or members joined at lateral connection points 451 and 453 (e.g., folding zones, elastically deformable regions, joined edge portions, etc.). The inner leaflet frame 451 is shown in a dilated or cylindrical configuration (e.g., before folding and / or compression).

[0225] Figure 15 shows the inner leaflet frame 451 in a partially folded configuration. The inner leaflet frame 451 is shown to have wireframe sidewalls that allow rotation or articulation at least at the lateral connection points 451 and 453. The inner leaflet frame 451 can be configured to fold as shown in response to the valve being folded and / or compressed for delivery. Figure 16 shows the inner leaflet frame 451 in a fully folded configuration. The wireframe sidewalls have rotated, articulated, and / or folded at their lateral connection points 451 and 453.

[0226] Figure 17 shows the inner leaflet frame 451 folded and vertically compressed into a compressed configuration. The wireframe sidewalls can form units (e.g., diamond units, etc.) that can be oriented in the compression direction to allow elastic compression of the inner frame 451. In some embodiments, the inner frame 451 can be vertically compressed into a pleated or accordion (compressed) configuration.

[0227] Figure 18Illustrated is a side view of the inner flap frame 451 of the flow control component 450, shown as a linear wireframe or laser cut sheet, and / or formed as a linear wireframe or laser cut sheet prior to further assembly into a cylindrical structure. Figure 19 The inner flap frame 451 is shown in a cylindrical structure or configuration (or conical structure or configuration), where the edge portions of the linear wireframe sheet are joined or coupled at lateral connection points 451 and 453 (e.g., hinge regions, fold regions, etc.). Additionally, the inner flap frame 451 can be expanded (e.g., driven, formed, bent, etc.) from a linear sheet configuration into a cylindrical structure or configuration.

[0228] Although Figures 14 to 19 The inner flap frame 451 is depicted as including two wireframe sheets, members, and / or halves joined and / or joined through to form two hinge points at two hinge points, but in some embodiments, the inner flap frame can be formed of a single component or more than two components, which are heat set, machined, and / or otherwise joined to form and / or define one or more hinge points. For example, the inner flap frame can be formed of a single nitinol tube and can have hinge points formed by heat setting the material in a desired manner. As another example, the inner flap frame can be made of a sheet of material (e.g., nitinol) and formed into a substantially cylindrical shape, where the free ends of the material are joined (e.g., via sutures) to form a single hinge point. In these examples, a second hinge point opposite the sutured hinge point can be formed by heat setting or machining the material in a desired manner. As yet another example, the inner flap frame can be made of more than two sheets or members joined together (e.g., via sutures) to form a corresponding number of hinge points.

[0229] Figures 20 to 24 Illustrated is a structural band 460 of pericardial tissue, where the flap pocket 461 is sewn into the structural band 460. Figure 20 And Figure 21 Are respectively a side view and a bottom view of the structural band 460 and the flap pocket 461 prior to assembly into a cylindrical flap component and prior to installation on and / or into the inner frame 451 to form an expandable (foldable, compressible) flow control component 450.

[0230] Figure 22 Illustrated is a side perspective view of the structural band 460 formed of pericardial tissue, where the flap pocket 461 is sewn into the structural band 460, and after assembly into a cylindrical flap configuration, the flap pocket 461 is disposed on the inner surface of the structural band 460.

[0231] Figure 23Diagram of a side perspective view of a structural band 460 of the pericardial tissue, showing a single leaflet pocket 461 sewn into the structural band 460. The leaflet pocket 461 is shown with a portion of the leaflet pocket 461 joined to the structural band 460 such that the open edge 463 extends outwardly and the sewn edge 462 forms a closed top parabolic edge providing attachment.

[0232] Figure 24 Diagram of a bottom view of the flow control component 450. The cylindrical structural band 460 and the leaflet component 461 are shown partially joined to form a closed fluid seal.

[0233] As described above, any of the prosthetic valves described herein may include a proximal anchoring element or protrusion that can be activated and / or actuated by any suitable means. In some implementations, the proximal anchoring element and / or protrusion can be activated in a manner similar to that described in the '390 PCT, '932 provisional, and / or '269 provisional, which are incorporated herein by reference.

[0234] For example, Figures 25 to 27 Illustrated is a prosthetic valve 500 according to one embodiment. The valve 500 includes an outer support frame 510 and a flow control component 550 mounted therein. The outer support frame includes a supra-annular member 520, an infra-annular member 530, and a trans-annular member, portion, and / or region 512 coupled therebetween. The infra-annular member 530 includes a distal anchoring element 532 and a proximal anchoring element 534.

[0235] Figure 25 Is a schematic cross-sectional side view and shows how the perimeter (circumference) of the trans-annular region 512 of the valve 500 can be tied inwards. This allows the valve 500 to be designed to have a trans-annular circumference greater than the standard size, for example 5%-20%, often 10%-15%, to facilitate a tight fit of the valve within the native annulus and provide a good seal to prevent perivalvular leakage (PVL). The tying process pulls the proximal sidewall 519 inwards and reduces the circumference of the trans-annular region 512. This allows an oversized valve to drop into the native annulus during valve deployment. Then, once the valve is positioned as desired, the trans-annular region 512 is pushed outwards and / or otherwise allowed to expand to its full or nearly full circumference, and thereby form a tight sealing fit of the prosthetic valve within the native annulus. In some implementations, the proximal anchoring element 534 of the infra-annular member 530 can also be tied inwards and / or upwards together with and / or independently of the trans-annular region 512.

[0236] Figure 26is a schematic bottom view of valve 500 and shows how the perimeter (circumference) of the transannular region 512, which may be tied inwards at or near the proximal end of valve 500, as indicated by the arrows and dashed lines. In some implementations, this may allow for an oversized transannular circumference (e.g., sized between about 5%-20% larger), which may facilitate a tight fit of valve 500 within the native annulus and provide a good seal to prevent perivalvular leakage (PVL).

[0237] Figure 27 is a schematic cross-sectional side view of valve 500 and shows how the perimeter (circumference) of the transannular region 512 of valve 500 may be tied inwards. An actuator 570, such as a tie chain, etc., is shown as a non-limiting mechanism for performing the tying process. Actuator 570 (or a portion thereof) may travel from a delivery catheter (not shown) through path guides, path points, attachment points, through holes, eyelets, and / or any other suitable components (referred to herein as "path points 528"). In this embodiment, actuator 570 (e.g., a tie chain) travels through path points 528 through supra-annular member 520 to be mounted on the proximal sidewall 519 of the transannular region 512 and / or on the proximal anchoring element 534 of sub-annular member 530 at one or more attachment points 536. Actuating actuator 570 (e.g., pulling the tie chain proximally, towards the operator) pulls inwards the proximal sidewall 519 of the transannular region 512 and reduces the circumference of the transannular region 512. In some implementations, this allows for an oversized valve 500 to drop into the native annulus during deployment of valve 500. Then, once valve 500 is positioned as desired, actuator 570 may be actuated (e.g., the tie chain may be advanced or retracted / released) to push the proximal sidewall 519 of the transannular region 512 outwards and / or otherwise allow the transannular region 512 to expand to its full or nearly full circumference, and thereby form a tight sealing fit of the prosthetic valve 500 within the native annulus. Similarly, proximal anchoring element 534 may be actuated (e.g., by actuator 570) together with or independently of the transannular region 512.

[0238] Figure 28 and Figure 29 are diagrams of side views of a laterally deliverable prosthetic valve 600 in the extended configuration and the retracted configuration of a lower proximal anchoring element 634, respectively, according to one embodiment. Figure 28 Illustrates a valve replacement 600 having an outer frame 610, wherein a flow control component 650 is mounted within the outer frame. Outer frame 610 includes a supra-annular member 620, a sub-annular member 630, and a transannular member 612 coupled therebetween. In this embodiment, sub-annular member 630 and transannular member 612 may be used together for the lower proximal anchoring element 634. Figure 28The proximal anchoring element 634 is shown in an extended configuration. Figure 29 The proximal anchoring element 634 is shown in a retracted configuration, where the subannular member 630 and the transannular member 612 have a reduced perimeter, thereby allowing the valve 600 to be deployed within the annulus of the native valve. After the valve 600 is deployed and / or seated within the annulus, the proximal anchoring element 634 can transition back to or towards the extended configuration. Although not shown, in some embodiments, the valve 600 can be removably coupled to a delivery system and / or an actuator, and the delivery system and / or actuator can be manipulated to transition the proximal anchoring element 634 between the extended configuration and the retracted configuration.

[0239] Figure 30 , Figure 31 and Figures 32A to 32E is a bottom view illustration of a laterally delivered prosthetic valve 700 according to one embodiment, and shows the proximal anchoring element 734 in a first configuration and a second configuration and / or transitioning between the first configuration and the second configuration. Figure 30 Illustrated is a prosthetic valve 700 having an outer frame 710 and an internal flow control component 750 mounted within the outer frame. The frame 710 includes a supra-annular member 720 and a sub-annular member 730. The supra-annular member 720 includes a bulge 745 extending across the supra-annular member 720. The sub-annular member 730 includes a proximal anchoring element 734. Figure 30 The proximal anchoring element 734 is shown in a first unactuated and / or expanded configuration. Figure 31 The proximal anchoring element 734 is shown in a second actuated and / or compressed configuration. The valve 700 is removably coupled to an actuator 770, which can be and / or can include one or more tether chains that are attached to attachment points 736 on the proximal anchoring element 734. In this embodiment, a portion of the actuator 770 can extend through a waypoint or other opening in the bulge 745 to be coupled to the attachment point 736. Additionally, the actuator 770 can include a support member 771, etc., which is coupled to the valve within the valve 700 and / or in proximity to the internal flow control component 750. The support member 771 can support at least a portion of the actuator 770 (e.g., the tether chain) to limit, for example, the amount of force applied to the bulge 745 when the actuator 770 is actuated. Figures 32A to 32E is a time series of illustrations of the prosthetic valve 700, showing the actuator 770 being actuated to transition the proximal anchoring element 736 from the first unactuated and / or expanded configuration to the second actuated and / or compressed configuration.

[0240] As described above, any of the prosthetic valves described herein can be delivered via a delivery system and can be configured to engage the delivery system in any suitable manner. In some implementations, the prosthetic valve can be configured to engage the delivery system in a manner similar to that described in '010 PCT, which is incorporated herein by reference.

[0241] For example, Figures 33A to 33C FIG. 5 shows a side perspective view of a laterally delivered transcatheter prosthetic heart valve 800 and an actuator 870 according to one embodiment. The valve 800 has a frame 810 that has a collar 820 (e.g., an annulus on-member), a distal anchoring element 832, and a proximal anchoring element 834 (e.g., a wire loop anchoring element and / or any other suitable type of anchoring element). The frame 810 defines a path point 828. The collar 820 includes and / or forms an attachment point 829. Although the path point 828 is shown along the body of the frame 810, in other embodiments, the collar 820 and / or any other suitable portion of the valve 800 can form and / or define the path point 828. Similarly, although the attachment point 829 is shown along the collar 820, in other embodiments, the body of the frame 810 and / or any other suitable portion of the valve 800 can include the attachment point 829.

[0242] In Figures 33A to 33C the embodiment shown in FIG. 6, the actuator 870 is arranged as a tension member or the like. The actuator 870 includes a lead 841 that is configured to be coupled to and / or pass through an attachment point 836 of the proximal anchoring element 834. The lead 841 includes a first end having and / or forming a first coupling feature 844 and a second end having and / or forming a second coupling feature 844. The coupling features can be any suitable configuration. For example, in this embodiment, the first coupling feature 844 is and / or forms a loop, an eyelet, an opening, etc., and the second coupling feature 842 is and / or forms a ball, a protrusion, a knob, a knot, etc. The actuator 870 can be and / or can include any suitable cable, tether, thread, catheter, tube, etc. In some implementations, the actuator 870 can be used as (e.g.) a pusher or the like that is configured to push the valve 800 and / or otherwise advance the valve through the delivery system.

[0243] In this embodiment, the actuator 870 includes a first cable 847 having an end that forms a threaded coupler configured to engage and / or couple to an attachment point 829 formed by a collar (e.g., a threaded nut, etc.). The actuator 870 includes a second cable 848 having an end that forms a receiving member configured to receive and / or removably couple to the second end of the lead 841. For example, the receiving member of the second cable 848 and the coupling feature 842 formed by the second end of the lead 841 may be a ball-and-cup coupling mechanism. Additionally, the actuator 870 may include and / or form an outer sheath or conduit configured to at least partially house the first cable 847 and the second cable 848.

[0244] Figure 33A The actuator 870 is shown before being coupled to the valve 800 and / or the lead 841. The lead 841 is shown passing through a portion of the valve 800 and the path point 828, looping around or through the attachment point 836 of the proximal anchoring element 834, and back through the path point 828 and a portion of the valve 800 such that the first end 844 and the second end 842 are each outside the valve 800 and / or above or proximal to the collar 820.

[0245] Figure 33B The end of the first cable 847 of the actuator 870 is shown coupled to the attachment point 829 of the collar 820, for example, via a threaded connection. The first coupling feature 844 of the lead 841 is coupled to the first cable 847 (e.g., the first coupling feature 844 may be a ring disposed on or around the first cable 847). In some implementations, the actuator 870 may be used as a proximal pusher by coupling the first cable 847 to the attachment point 829 formed by the collar 820. For example, a substantially fixed portion of the first cable 847 may extend from the actuator 870 (e.g., the outer sheath) such that a distal force or thrust applied to the actuator 870 via the first cable 847 pushes the valve 800. With the first coupling feature 844 coupled to the first cable 847, the first end of the lead 841 remains in a relatively fixed position relative to the valve 800. The second cable 848 of the actuator 870 is shown coupled to the second coupling feature 842 of the lead 841 (e.g., via a ball-and-cup coupling mechanism, etc.). Thus, while the actuator 870 and / or the first cable 847 may be used to push the valve 800, a tensile force or pull may be applied to the second cable 848, which may pull the second end of the lead 841 in the proximal direction, thereby tightening the lead. Accordingly, the lead 841 may maintain the proximal anchoring element 834 in its first configuration during deployment.

[0246] Figure 33CShows a first cable 847 that is decoupled from an attachment point 829 of the collar 820 and a first coupling feature 844 at the first end of the lead 841. A second coupling feature 842 at the second end of the lead 841 may remain coupled to a second cable 848. After the valve has been deployed, the actuator 870 is pulled to remove the actuator 870 and the lead 841 from the valve 800 and the delivery system. With the actuator 870 removed, the proximal anchoring element 834 is allowed to transition to its second configuration.

[0247] As described above, any of the prosthetic valves described herein may include a proximal anchoring element or protrusion that may transition between two or more configurations and / or may include one or more engagement features configured to engage autologous tissue to secure the proximal anchoring element or protrusion to the autologous tissue. In some implementations, the proximal anchoring element or protrusion may be similar to and / or may include engagement features similar to any of the engagement features described in the '059 provisional and / or '269 provisional incorporated herein by reference.

[0248] For example, Figure 34 is a proximal perspective view illustration of a laterally delivered transcatheter prosthetic heart valve 900 (also referred to herein as "prosthetic valve 900") according to one embodiment. The prosthetic valve 900 includes a flow control component 950 mounted within a central aperture of an outer frame 910. In this embodiment, the flow control component 950 is shown in an offset position (e.g., distally located). Additionally, the flow control component 950 is shown mounted to the outer frame 910 such that a portion of the flow control component 950 is above the drum 945 of the frame 910. In some embodiments, the flow control component 950 provides normal flow (e.g., associated with and / or from a 29 mm valve) while filling an overstretched native annulus with the outer frame 910.

[0249] The outer frame 910 includes an annulus - above member 920 (e.g., an upper wire - frame portion) and an annulus - below member 930 (e.g., a lower wire - frame portion), and a trans - annular member 912 that forms a set of peripheral walls defining a trans - annular section of the prosthetic valve 900. The annulus - above member 920 and the annulus - below member 930 may also support the valve without the side walls of the suture unit and, alternatively, have a pericardial tissue side wall strung between the annulus - above member 920 and the annulus - below member 930. The annulus - below member 930 includes and / or forms a distal anchoring element 932 and a proximal anchoring element 934. The distal anchoring element 932 is shown as having a guide - wire coupler 933 at its distal end portion. The proximal anchoring element 934 is shown as having an atraumatic circular protrusion 931 attached thereto. The protrusion 931 on the proximal anchoring element 934 can engage autologous tissue to snare or capture tendons, leaflets, trabeculae, papillae, or annulus tissue, and, like a button in a buttonhole, the protrusion 931 will anchor and secure the proximal anchoring element 934 to the autologous sub - annulus tissue. The protrusion 931 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the protrusion 931 is a protrusion, bead, barb, bulge, knob, rib, loop, hook, bend, or otherwise formed portion of the proximal anchoring element 934, etc.

[0250] The annulus - above member 920 forms an atrial collar of the outer frame 910 and is shown as having a distal atrial panel for matching autologous anatomy. A bulge 945 is shown as extending above or across the annulus - above member 920 and filling an area within the central aperture of the outer frame 910 that is not otherwise filled or occupied by the flow - control member 950. The bulge 945 can also be used to provide a purposeful / intentional back - flow when needed to accommodate the functional requirements of a given patient and can be sealed / stitched closed at a later time. The bulge 945 can also provide a suture entry location for a pacemaker device, which is typically used in conjunction with the prosthetic valve. For example, the bulge 945 can optionally include an opening 928A, which can serve as a back - flow opening and / or for passing any suitable device, suture, lead, etc. from the atrium to the ventricle of the heart. In some embodiments, the bulge 945 can include a pop - off cap, baffle, membrane, fabric, plug, etc., which can be at least temporarily attached to the bulge 945 and removed if utilization of the opening 928A is required based on the patient's anatomy or needs.

[0251] The waypoint 928 is shown as a drum 945 within the inner segment of the atrial collar 920. The waypoint 928 can provide an opening, a port, etc., through which one or more components of the delivery system can extend. For example, the delivery system can include an actuator, a guidewire catheter, and / or any other suitable component that can be inserted into and extend through the waypoint 928. Although not shown, the actuator can be coupled to the proximal anchoring element and configured to transition the proximal anchoring element between two or more positions, configurations, states, etc. The guidewire catheter can be traversed by a guidewire to provide sufficient rigidity to allow the valve 900 to be advanced along the guidewire. Additionally, the guidewire catheter can extend beneath the valve 900 (e.g., beneath the flow control component 950) and through the guidewire coupler 933 of the distal anchoring element 932.

[0252] In some embodiments, a pusher cable, etc., can pass through the waypoint 928 and engage the guidewire coupler 933. In these embodiments, the pusher cable is used to eject the valve 900 from the delivery catheter and is directly delivered to a predetermined position by riding on top of a pre-placed guidewire laid within the lumen of the pusher cable. Although the guidewire can pass through the guidewire coupler 933, the pusher cable cannot pass through the opening in the guidewire coupler 933. This allows the practitioner to push the pusher cable while effecting advancement of and retraction of the valve 900 along and from the delivery catheter, thereby avoiding problems associated with pushing a flexible article along a tube and causing unwanted compression within the delivery catheter and attendant damage to the prosthetic valve 900.

[0253] Figures 35 to 37Various views of at least a portion of a laterally deliverable transcatheter prosthetic heart valve 1000 (also referred to herein as "prosthetic valve") according to one embodiment. The outer support frame 1010 of the valve 1000 includes an annulus supra member 1020 (e.g., atrial collar), a transannular member 1012, and an annulus infra member 1030. The annulus supra member or atrial collar 1020 forms an upper atrial anchoring structure and is connected to the transannular component frame 1012, which in turn is connected to the annulus infra member 1030. The frame 1010 can be any oval or cylindrical configuration. In some embodiments, at least a portion of the frame 1010 (e.g., the transannular component 1012) is composed of two wire mesh panels that are joined to form an oval or cylindrical configuration. Making at least a portion of the frame from two panels allows the structure to fold onto itself from front to back to provide the compression needed to fit into a delivery catheter. Making it from horizontal units allows the panels to be compressed vertically. In some embodiments, the outer frame 1010 can include a cylindrical curtain of treated pericardium that is attached to upper and lower rings of wire. The outer frame 1010 is shown having support filament unit structures on the anterior and septal sidewalls. In some embodiments, the outer frame 1010 is discontinuous and includes open space segments and does not have support filament unit structures at the proximal end of the valve.

[0254] Figures 35 to 37 The annulus infra member 1030 is shown having a protrusion 1031 attached to a collapsible proximal protrusion or proximal anchoring element 1034. Figure 35 and Figure 36 The proximal anchoring element 1034 is shown in a first configuration (e.g., deployed configuration). The proximal anchoring element 1034 can be, for example, partially retracted to facilitate deployment and / or placement of the valve 1000 in the native annulus. Figure 37 The proximal anchoring element is shown in an extended configuration for compressing native tissue between the underside of the atrial collar 1020 and the proximal anchoring element 1034.

[0255] Figures 38A to 38F Diagram of an annulus infra member 1130 of an outer support frame for a laterally deliverable transcatheter prosthetic heart valve according to one embodiment. The annulus infra member 1130 is shown having a distal anchor element 1132 and a proximal anchor element 1134, the distal anchor element having a guidewire coupler 1133 attached thereto, and the proximal anchor element having one or more protrusions 1131. In this embodiment, the annulus infra member 1130 can be monolithic and made from a single laser cut of nitinol.

[0256] The subannular member 1130 is thermoformed to upwardly bias the distal anchoring element 1132 and downwardly bias the proximal anchoring element 1134. Thus, when delivering the valve via a guidewire, the guidewire can extend through the guidewire coupler 1133 and, in some cases, the distal anchoring element 1132 can be straightened along the guidewire during delivery. When the guidewire is removed, the bias on the distal anchoring element 1132 can cause the distal anchoring element 1132 to bend, spring up, and / or otherwise be upwardly biased to clamp or pinch the native subannular tissue against the prosthetic valve.

[0257] The subannular member 1130 is also thermoformed to bias the proximal anchor. Thus, when deploying the valve, the proximal anchoring element 1134 is folded and retracted to reduce the perimeter of the prosthetic valve, and thus the prosthetic valve can be placed into the native annulus where the transannular section of the valve seals the inner surface of the native annulus. When the proximal anchoring element 1134 is released, the proximal anchoring element 1134 will spring outwards and upwards to resume its heat-set shape, which will cause the proximal anchoring element 1134 to engage and wedge into the native subannular tissue. The protrusions 1131 on the proximal anchoring element 1134 will then entrap or capture tendons, leaflets, trabeculae, papillae, or annulus tissue, and, like a button in a buttonhole, the protrusions will anchor and secure the proximal anchoring element 1134 to the native subannular tissue.

[0258] In Figure 38A the subannular member 1130 shown has three (3) circular protrusions. Figure 38B Shown is a subannular member 1230 having three (3) annular protrusions, two (2) open loops, and one (1) closed loop according to one embodiment. Figure 38C Shown is a subannular member 1330 having one (1) centrally located closed-loop protrusion according to one embodiment. Figure 38D Shown is a subannular member 1430 having two (2) open-loop protrusions according to one embodiment. Figure 38E Shown is a subannular member 1530 having two (2) closed-loop protrusions according to one embodiment. Figure 38F is a diagram of a subannular member 1630 having an extendable distal anchoring element and a proximal anchoring element according to one embodiment, the subannular member having a tuft 1638 for a laterally deliverable transcatheter prosthetic heart valve. Figure 38F Shown is a closed-loop protrusion 1631 positioned adjacent to the tissue tuft 1638. The tissue tuft 1638 is used to provide a non-damaging surface to avoid tissue damage or "cheese slicer" problems that can occur due to tissue micromotion against non-ingrowth prosthetic components.

[0259] Figure 39 and Figure 40Top and side view illustrations, respectively, of an integrated laser cut subannular member 1730 having a distal anchoring element 1732 (e.g., RVOT bulge) and a proximal anchoring element 1734 (e.g., proximal bulge). Figure 39 The distal anchoring element 1732 in an offset position (11 o'clock) and the proximal anchoring element 1734 having six (6) annular protrusions 1731 for engaging native subannular tissue are shown. The distal end of the distal anchoring element 1732 includes free ends 1739A, 1739B that can be clamped to a desired length and then joined to use the same laser cut pattern for various valve sizes. Bead or serration 1737 may be included, and / or the bead or serration is joined to the distal anchoring element 1734. The bead or serration 1737 allows securing of a guidewire coupler (cone) (not shown) when the bead or serration 1737 engages an internal ratchet within the guidewire coupler. The bead or serration 1737 also provides a suture anchor for future placement of sutures around and through the guidewire coupler. Figure 40 It is shown that the subannular member 1730 can be configured to conform to native anatomy, such as a partial hyperbolic paraboloid shape.

[0260] Figure 41 A side view illustration of an integrated laser cut subannular member 1830 having a combination of a distal anchoring element 1832 (e.g., RVOT bulge) and a proximal anchoring element 1834 (e.g., proximal bulge), and having a transannular member 1812 (e.g., wireframe peripheral sidewall) mounted thereon. Figure 41 It is shown that the transannular member 1812 or the subannular member 1830 can have an integrated inverted V shape (caret) on its distal side. Figure 41 An embodiment is shown where the distal portion of the distal anchoring element 1832 forms a continuous loop. Protrusions 1831 are shown mounted on the proximal anchoring element 1834. Figure 41 It is also shown that the transannular member 1812 can have a set of silk units that are about 2 or 2 1 / 2 diamonds in height and an above-annular section including flared diamond silk units that provide a section for joining the transannular member 1812 to an above-annular member (not shown) of a valve frame.

[0261] Figure 42A and Figure 42BTop view and side profile view diagrams of a laser cut product of an annuloplasty subcomponent 1930 with a continuous loop design, the continuous loop design having two junctions for forming a pair of integrated laser cut annuloplasty subcomponents 1930, the pair of integrated laser cut annuloplasty subcomponents having a combination of a distal anchoring element 1932 (e.g., RVOT projection) and a proximal anchoring element 1934 (e.g., proximal projection). FIG. 42 shows that the annuloplasty subcomponent 1930 can be manufactured (laser cut) as a single continuous piece.

[0262] Figure 43A and Figure 43B Top view and side profile view diagrams of a laser cut product for manufacturing an integrated laser cut annuloplasty subcomponent 2030 having free ends 2039A, 2039B, a distal anchoring element 2032 (e.g., RVOT projection), and a proximal anchoring element 2034 (e.g., proximal projection). Bead wires 2037 and protrusions 2031 are shown on the annuloplasty subcomponent 2030. In some implementations, the laser cut annuloplasty subcomponent 2030 provides additional opportunities to vary the cross-sectional width and thickness to optimize stiffness along the flexible regions (as compared to a wire with a fixed cross-section). This also allows for an integrated geometry for engaging projections (“scallops”) to provide additional fixation force by capturing the native leaflets. Additionally, one or more portions of the laser cut product can be distorted during heat setting to govern and / or control the direction of flexibility of these portions. For example, the laser cut product can be twisted at or near the proximal anchoring element to set and / or control the direction of flexibility associated with moving the proximal anchoring element between two or more positions and / or configurations.

[0263] Figure 44 Is a partial exploded side perspective view of an outer support frame 2110 according to one embodiment. The outer support frame 2110 includes an annulus supracomponent 2120 (e.g., an upper valve frame) configured to have a wire loop leading to a central ridge of an inner support ring, the annulus supracomponent being mounted on a transannular member 2112 (e.g., a cylindrical sidewall member), the annulus supracomponent being shown above an annuloplasty subcomponent 2130 (e.g., a lower valve frame), the annuloplasty subcomponent being configured to have a wire loop with a shaped distal anchoring element 2132 and a proximal anchoring element 2134, the proximal anchoring element having a leaflet capture feature 2131 (e.g., an eyelet) formed on the proximal end.

[0264] Figure 45A and Figure 45B Top view and side view diagrams of a laser cut design workpiece for one or more annulus supracomponents 2220 of an outer support frame according to one embodiment. For example, Figure 45AShows a laser cut design workpiece including four (4) supra-annular members 220. After being laser cut, the supra-annular members 2220 can be separated and heat set into supra-annular members having a desired shape, size, and / or configuration. In this embodiment, the supra-annular members 2220 can be set to include and / or form an outer ring 2221, an inner ring 2225, and at least one spline 2227. The spline 2227 can form and / or define path points 2228 that are configured to couple to and / or receive a portion of a delivery system.

[0265] Figures 46A to 46C Is a diagram according to the present invention showing a series of three (3) images of retrieving a prosthetic valve 2300 back into a delivery / retrieval catheter 2384, where the longitudinal axis of the catheter 2384 does not parallel the central blood flow axis through the valve 2300 as in a conventional replacement valve, but approaches from the side (i.e., orthogonally) with respect to the orientation of the blood flow through the valve 2300.

[0266] Figure 46A Shows the distal end 2387 of a delivery / retrieval catheter 2384 entering the atrium of the heart (e.g., via the inferior vena cava using trans-femoral delivery, etc.). Figure 46B Shows how an elongate connection member 2388 (e.g., a guide wire, control pusher, steerable catheter, yoke, tension member, suture, tether, retrieval tool, etc.) is connected to the proximal side of the valve 2300 (e.g., connected to a delivery system-valve attachment point, path point, connector, etc.). In some implementations, the elongate connection member 2388 has been attached to the valve 2300 (e.g., for delivering the valve 2300 to the annulus).

[0267] In some implementations, the retrieval process (or a portion thereof) can be performed during an initial valve deployment / delivery procedure and while the valve 2300 is still attached and / or connected to the elongate connection member 2388. For example, due to a problem or medical issue identified by an interventional physician that requires retrieving or at least partially retrieving a previously deployed valve 2300, the retrieval process can be performed to at least partially retract the prosthetic valve 2300. In other implementations, the retrieval process (or a portion thereof) can be performed after the valve 2300 has been deployed and disconnected from the elongate connection member 2388. In such implementations, the elongate connection member 2388 can be reconnected to the valve 2300 (or a new elongate connection member can be connected to the valve 2300). In some implementations, attachment and / or connection can be assisted by using radio markers on the elongate connection member 2388 and on the proximal portion of the valve 2300.

[0268] Figure 46CIllustrated is the valve 2300 being pulled into the delivery / retrieval catheter 2384. For example, the proximal end of the valve 2300 can be pulled into the distal portion 2387 of the catheter 2384 using the elongate connection member 2388. In some implementations, the distal portion 2387 of the catheter 2384 can be and / or can include a compression tip having one or more features for assisting in compressing and retracting the valve 2300, such as a surface coating, helical beads, helical channels, etc. on the inner surface of the distal portion 2387 of the catheter 2384 to assist in compressing and retracting the valve 2300 into the catheter 2300. As shown, the valve 2300 is folded and compressed into the catheter 2384 with the elongate connection member 2388 attached, such that in some cases, the delivery catheter 2384 can be withdrawn and the valve 2300 retrieved from the patient.

[0269] Figures 47A - 47I is a diagram according to the present invention showing a series of nine (9) images of retrieving the valve 2400 from an autologous annulus model and retrieving it into the delivery / retrieval catheter 2484, wherein the longitudinal axis of the catheter 2484 is orthogonal to the orientation of the frame and flow control (valve leaflet) components of the valve 2400.

[0270] Figure 47A Illustrated is the distal portion of the delivery / retrieval catheter 2484 having an elongate connection member 2488 (e.g., guide wire, control pusher, steerable catheter, yoke, tension member, suture, tether, retrieval tool, etc.) attached to the proximal portion 2408 of the prosthetic valve 2400. Figure 47A Illustrated is a relatively large diameter valve (e.g., 65mm x 45mm tubular frame (110mm x 72mm (including atrial collar))) at least partially disposed within an opening corresponding to and / or representing the annulus of an autologous heart valve, wherein a 29mm flow control component is mounted within the tubular frame of the valve 2400.

[0271] Figure 47B Illustrated is the prosthetic valve 2400 being pulled into the delivery / retrieval catheter 2484, with approximately 10%-20% of the valve 2400 being compressed within the lumen of the catheter 2484. Figure 47B Illustrated is how the prosthetic valve 2400 is designed to fold front side approaching rear side and is designed to be vertically compressed such that the large valve is compressed within a standard sized trans-femoral catheter (e.g., 24Fr - 32Fr, or a catheter of approximately 28Fr). For definition, the French size can be converted to millimeters by dividing by 3, such that a 24Fr catheter has an inner diameter of approximately 8mm, a 30Fr catheter has an inner diameter of approximately 10mm, and so on.

[0272] Figure 47CShows the prosthetic valve 2400 being pulled into the delivery / retrieval catheter 2484, where approximately 20%-30% of the valve 2400 is compressed within the lumen of the catheter 2484. For example, Figure 47C Shows a proximal anchoring position at least partially received within the catheter 2484.

[0273] Figure 47D Shows the prosthetic valve 2400 being pulled into the delivery / retrieval catheter 2484, where approximately 30%-40% of the valve 2400 is compressed within the lumen of the catheter 2484. For example, Figure 47D Shows the atrial collar and / or the annulus member of the valve frame beginning to fold inwardly towards the longitudinal axis (not shown).

[0274] Figure 47E and Figure 47F Shows the prosthetic valve 2400 being pulled into the delivery / retrieval catheter 2484, where approximately 50%-60% of the valve 2400 is compressed within the lumen of the catheter 2484. Figure 47E and Figure 47F Shows how the valve 2400 is at least partially retracted from the opening (annulus) and the valve 2400 has begun to be vertically compressed.

[0275] Figures 47G to 47I Shows the valve 2400 continuing to be pulled into the lumen of the delivery / retrieval catheter 2484, where approximately 70%, 80%, and over 90% of the valve 2400 are shown to be compressed within the lumen of the catheter 2484, respectively. Figures 47G to 47I Shows how the valve 2400 continues to fold and / or compress and retract into the delivery / retrieval catheter 2484.

[0276] Figures 48A to 48C Illustrates at least a portion of a process for deploying a prosthetic valve 2500 according to one embodiment. Figure 48A and Figure 48B Shows a prosthetic valve 2500 having an outer support frame, the outer support frame including an annulus member 2520, a sub-annulus member 2530, and a trans-annular member 2512. The sub-annulus member 2520 may include sub-annular flares 2503 and 2504 on the free wall side (left) and the septal (right) side, respectively, and the sub-annular flares may transition between an extended configuration ( Figure 48A ) and a retracted position ( Figure 48B ) to allow the valve 2500 to slide over the native annulus. Figure 48C Shows the valve 2500 being deployed, seated, and / or otherwise extended through the native annulus and the sub-annular flares 2503 and 2504 on the free wall side (left) and the septal (right) side, respectively, from the retracted position ( Figure 48B)Transition to an extended position or transition toward an extended position. Accordingly, the subannular bells 2503 and 2504 extend radially to allow the valve 2500 to use the subannular bells 2503 and 2504 as an anchoring mechanism (e.g., against autologous tissue forming and / or defining the native annulus). Any of the actuation methods described herein may be used to actuate the subannular bells 2503 and 2504.

[0277] Figure 49A and Figure 49B is a sequence of diagrams showing a top view of a portion of a prosthetic valve 2600 having a subannular member 2630, which may have and / or form a wire loop (and attached sidewalls) that is pulled inward to reduce the perimeter or circumference of the valve body to facilitate deployment of the valve 2600 in the native annulus. Figure 49A and Figure 49B shows that the valve 2600 can be advanced through a delivery catheter 2682 and removably coupled to an actuator 2670, such as one or more tethers, sutures, tension members, cords, etc. The actuator 2670 can be used to actuate the subannular member 2630 and / or any other suitable portion of the valve 2600 (e.g., by pulling the actuator 2670 in the proximal direction), and the actuator can be delivered with the prosthetic valve 2600 via the delivery catheter 2682. The actuator 2670 can be coupled to the subannular member 2630 via an attachment point 2681. The subannular member 2630 is shown as having a distal anchoring element 2632 and a proximal anchoring element 2634. In some implementations, the actuator 2670 can also be used to actuate the proximal anchoring element 2634 and / or the distal anchoring element 2632. In some implementations, once the valve 2600 is deployed in the annulus of the native valve, the actuator 2670 can be removed from or decoupled from the valve 2600 and retracted through the delivery catheter 2682.

[0278] Figures 50A to 50DA sequence of diagrams showing a bottom view of a prosthetic valve 2700 removably coupled to an actuator 2770 for actuating one or more portions of the valve 2700 according to one embodiment. The valve 2700 has a subannular member 2730, which may have and / or form a wire loop (and be attached to the sidewall), the wire loop being pulled inwards to reduce the perimeter or circumference of at least the subannular member 2730 to facilitate deployment of the valve 2700 in the native annulus. In this embodiment, the actuator 2770 may be and / or may include a set of tethers, tension members, sutures, cables, and / or any other suitable connectors that can be attached to one or more attachment points (e.g., proximal anchoring elements of the subannular member 2730) along the subannular member 2730. The actuator 2770 may also include and / or may be at least partially disposed within a catheter that can be inserted through a dynamic path point, opening, attachment point, through-hole, etc. formed by the supra-annular member of the valve frame. In some implementations, the actuator 2770 may be and / or may include a separate tether for actuating (e.g., folding) the proximal anchoring element, a separate tether for actuating (e.g., folding) the septal sidewall, and / or a separate tether for actuating (e.g., folding) the free wall sidewall.

[0279] Figures 50A to 50DShows a set of tethers of an actuator 2770 extending from a catheter that extends through a valve frame and / or is at least partially disposed below an annulus member of the valve frame. For example, the tethers may pass through a relatively small dynamic path point catheter and may be actuated outside the patient's body to manipulate the proximal anchoring element, the subannular member 2730, and / or the shape of the valve 2700 to facilitate placement of the proximal portion of the valve 2700 into the native annulus. In some implementations, during delivery, the dynamic path point catheter may be proximal to the compressed valve 2700 within the delivery catheter to avoid the dynamic path point catheter stacking on top of the compressed valve 2700 within the delivery catheter. Actuators (e.g., one tether, two tethers, three tethers, four tethers, five tethers, six tethers, seven tethers, eight tethers, nine tethers, ten tethers, or more, each of which may be removably coupled to one or more attachment points on the valve 2700) with a single tether or multiple tethers are contemplated within the scope of the present invention. The actuator 2770 and / or the tethers may be equipped with a disconnect element to allow retraction of the actuator 2770 and / or the tethers after the valve 2700 is deployed and secured in the native annulus. The dynamic path point catheter may also be included in and / or housed within a portion of the delivery system, such as a pusher catheter, etc., whereby the dynamic path point catheter may descend to a subannular position through a path point, through-hole, opening, etc. of the valve 2700, while the pusher catheter or other portion of the delivery system is too large to pass through the path point. Thus, a pusher catheter or other portion of the delivery system may be used to control the placement of at least a portion of the valve 2700. For example, a pusher catheter or other portion of the delivery system may be pushed down onto the surface of the annulus member to place the proximal portion of the valve 2700 into the native annulus when the subannular member 2730 is in an actuated configuration.

[0280] Figure 50A Is a bottom perspective view of the valve 2700 and the actuator 2770 and shows the subannular member 2730 in at least a partially extended or unactuated configuration. Figure 50B Is a bottom perspective view of the valve 2700 and the actuator 2770 and shows a partially actuated subannular member 2730 such that (e.g.) the proximal anchoring element of the subannular member 2730 is pulled toward the dynamic path point catheter and / or the flow control component of the valve 2700. Figure 50C Is a bottom perspective view of the valve 2700 and the actuator 2770 and shows the subannular member 2730 in a compressed, folded, and / or actuated configuration such that the proximal anchoring element and, for example, the proximal portion of the septal wall sidewall and the free wall sidewall of the valve 2700 are pulled toward the dynamic path point catheter and / or the flow control component of the valve 2700. Figure 50Dis a side perspective inverted view of the valve 2700 and actuator 2770, and shows the subannular member 2730 in an actuated configuration, with the dynamic path point catheter extending beneath the supra-annular member of the valve frame, and the tether being retracted or pulled towards the dynamic path point catheter and / or retracted or pulled into the dynamic path point catheter. Figure 50D Shows that the dynamic path point catheter can also be used to pull the valve down into the ventricle (e.g., via the retracted tether), thus avoiding the need to push the compressible valve into the native annulus.

[0281] Figures 51 to 53 Are a side perspective view, a top view, and a bottom view, respectively, of a laterally deliverable transcatheter prosthetic valve 2800 removably coupled to a delivery system 2880 according to one embodiment. The valve 2800 includes a valve frame 2810 and a flow control component 2850 mounted therein. The valve frame 2810 includes a supra-annular member 2820, a sub-annular member 2830, and a trans-annular member 2812 connecting the supra-annular member 2820 to the sub-annular member 2830. The delivery system 2880 and / or at least a portion of the delivery system 2880 includes a delivery catheter 2884 through which the valve 2800 is delivered into the atrium of the heart. The delivery system 2880 also includes an attachment member 2888 that is capable of removably coupling to the valve 2800. Figures 51 to 53 Shows an attachment member 2888 having a wishbone or yoke configuration, but other configurations are possible. The attachment member 2888 can be coupled to and / or included in the distal portion of a multi-lumen steerable catheter that can be used to deliver one or more components of the valve 2800 and / or the delivery system 2880.

[0282] Figure 51 and Figure 52 Shows the attachment member 2888 (e.g., yoke) in contact with the supra-annular member 2820 of the valve frame 2810. In some embodiments, the attachment member 2888 can contact and / or be removably coupled to the drum or trans-annular member 2812 of the frame 2810. In other embodiments, the attachment member 2888 can contact and / or be coupled to any suitable portion of the valve 2800. The attachment member 2888 can be removably coupled to the valve 2800 via sutures, tethers, cables, clips, connectors, and / or any other removable coupling. For example, Figure 51 and Figure 52Shown is an attachment member 2871 of a valve 2800 coupled to and / or extending from an on - annulus member 2820. In some embodiments, the attachment member 2871 of the valve 2800 can be a tether, suture, cable, frame structure, etc., that can be coupled to the wireframe portion of the on - annulus member 2820 or (e.g.) a bulge or biocompatible covering and / or extend from the wireframe portion or bulge or biocompatible covering. In these embodiments, the attachment member 2888 of the delivery system 2880 can be removably coupled (e.g., via suture, tether, and / or any other removable coupling) to the attachment member 2871 of the valve 2800.

[0283] Figure 51 and Figure 52 Further shown is a guidewire catheter 2885 of the delivery system 2880 that extends through a path point or opening in, for example, the on - annulus member 2830 and / or its bulge and extends through a guidewire coupler 2833 of the distal anchoring element 2832 of the sub - annulus member 2830. Figure 53 Shown is the guidewire catheter 2885 extending beneath a flow control component 2850 of the valve 2800. During delivery, the guidewire catheter 2885 can extend through the valve 2800 (as Figure 53 shown) and be advanced forward along a guidewire that has been placed in a desired location within the heart. Thus, delivering the valve 2800 in a compressed configuration through a delivery catheter 2884 includes advancing the guidewire catheter 2885 along the guidewire. The guidewire catheter 2885 can extend through the guidewire coupler 2833 of the distal anchoring element 2832 (e.g., the distal end of the guidewire catheter 2885 can be distal to the guidewire coupler by about 0.1 cm to about 1.0 cm or more).

[0284] The guidewire catheter 2885 can be stiff enough to, for example, limit and / or define (at least in part) the range of motion of the valve 2800 during delivery. For example, the guidewire catheter 2885 can define an axis about which the valve 2800 can rotate during delivery but can substantially limit or resist movement of the valve 2800 in other directions. In some implementations, the arrangement of the attachment member 2888 (e.g., a yoke) and the guidewire catheter 2885 can allow for better control of the position of the valve 2800 during delivery. One or more portions of the guidewire catheter 2885 and / or the valve 2800 can also include radiopaque markers to allow for enhanced visualization during image - guided delivery.

[0285] Figure 53Further shown is an actuator 2870 (or at least a portion of actuator 2870) included in a part of the delivery system 2880. Actuator 2870 can be and / or can include, for example, one or more tethers, sutures, cables, tension members, laces, etc. removably coupled to one or more attachment points on the valve 2800. For example, a tether is shown removably coupled to the proximal anchoring element 2834 of the subannular member 2830. Actuator 2870 (e.g., a tether) can be used to actuate the proximal anchoring element 2834 between two or more configurations, positions, states, etc. Figure 53 Shown is the proximal anchoring element 2834 in an expanded or unactuated configuration. During deployment, an operator can actuate a proximal portion of the actuator 2870 (e.g., disposed outside the body) to, for example, pull a tether in a proximal direction, thereby folding or compressing the proximal anchoring element 2834 toward the flow control component 2850. Actuation of the actuator 2870 can also fold, compress, and / or pull the proximal portions of the posterior and anterior walls of the transannular member 2812 inwardly toward the flow control component 2850. After deploying the valve 2800 in the annulus of the native valve, the actuator 2870 can be removed from the valve 2800 or decoupled from the valve, the guidewire catheter 2885 (and the guidewire extending therethrough) can be retracted through a waypoint or opening in the supraannular member 2820, and the portion of the delivery system 2880 can be decoupled from the valve 2800 and withdrawn from the patient, leaving the deployed prosthetic valve 2800 in place in the annulus of the native heart valve.

[0286] Figures 54A to 54D Are various views of a delivery system-valve attachment point 2928 according to one embodiment. Figure 54A Is a perspective illustration of a part of a laser cut design for a supraannular member 2920, showing at least a portion of the delivery system-valve attachment point 2928. The delivery system-valve attachment point 2928 can be, for example, a waypoint bend design that includes and / or is coupled to a bend member 2928A that is removably coupled to a part of the delivery system (e.g., via a threaded connection or any suitable form of connection). The waypoint bend design of the delivery system-valve attachment point 2928 can achieve a relatively high pivot angle and can limit and / or reduce the loading angle / force. Figure 54B Shows the bend member 2928A, which can be a laser cut component included in a laser cut design for a supraannular member 2890 or can be laser cut separately. Figure 54CShown is a folding member 2928A that is coupled to an annulus upper member 2920 using threads perpendicular to the top surface of the folding member 2828A to form a delivery system-valve attachment point 2928. The folding member 2928A can be coupled via sutures, rivets, screws, bolts, adhesives, and / or any other suitable coupling. Figure 54D Shown is the folding member 2928A being folded into the interior of the valve during loading. Although the folding member 2928A is described as separate from and coupled to the annulus upper member 2920, in other embodiments, the folding member 2928A (or at least a portion thereof) can be integrally formed with the annulus upper member 2920. For example, the folding member 2928A can be an inner and / or concentric portion of a spline included in the annulus upper member 2920.

[0287] Figure 55A and Figure 55B are a perspective view and a top view, respectively, of a delivery system-valve attachment point 3028 according to one embodiment. The delivery system-valve attachment point 3028 can be, for example, a path point yoke design, which can achieve a relatively high pivot angle and limit and / or reduce the loading angle / force. The delivery system-valve attachment point 3028 can be a single component, which is formed, for example, from nitinol wire or laser cut from a nitinol sheet and heat set for #4-40 threads for attachment to a portion of the delivery system. The delivery system-valve attachment point 3028 can be formed separately from the annulus upper member and coupled to the annulus upper member after each component has been formed. The delivery system-valve attachment point 3028 can be movably coupled to any other suitable portion, such as a spline, outer ring, and / or annulus upper member.

[0288] Figures 56A to 56C are various views of a delivery system-valve attachment point 3128 according to one embodiment. The delivery system-valve attachment point 3128 can be, for example, a path point hinge design, which can achieve a relatively high pivot angle (e.g., greater than 90 degrees) and limit and / or reduce the loading angle / force. The delivery system-valve attachment point 3128 includes a plurality of portions that can be press fit, welded, and / or otherwise coupled together, and the plurality of portions can have and / or can form threads for a #4-40 screw. In some cases, the delivery system-valve attachment point 3128 can include a coupler having a minimum outer dimension of approximately 0.140”. The delivery system-valve attachment point 3128 can be formed separately from the annulus upper member and coupled to the annulus upper member after each component has been formed. The delivery system-valve attachment point 3128 can be movably coupled to, for example, a spline of the annulus upper member (or other suitable portion of the annulus upper member).

[0289] Figures 57 to 60Is a bottom perspective view of a prosthetic valve 3200 according to an embodiment, and illustrates the process of transitioning the proximal anchoring element 3234 of the prosthetic valve 3200 between a first configuration and a second configuration. The valve 3200 is shown as including an outer support frame 3210 and a flow control component 3250 mounted within a central region of the outer support frame 3210. The frame 3210 is shown as having at least an annulus-on member 3220 and an annulus-under member 3230. The annulus-on member 3220 and the annulus-under member 3230 may be similar to any of the annulus-on and annulus-under members described above. Accordingly, certain aspects and / or features may not be described in more detail herein.

[0290] Figure 57 The annulus-under member 3230 is shown as having and / or forming a distal anchoring element 3232 and a proximal anchoring element 3234. The annulus-on member 3220 is shown as including splines 3227 (e.g., extending between an outer ring and an inner ring of the annulus-on member 3220 (not shown)), which define path points 3228 at or near a proximal portion of the annulus-on member 3220. The annulus-on member 3220 is further shown as including a drum 3445, which extends between and / or is coupled to the inner and outer rings of the annulus-on member 3220 and covers a space not otherwise occupied by the flow control component 3250. The annulus-on member 3220 (or its inner ring) is shown as being coupled to the flow control component 3250, which is offset distally relative to the valve 3200.

[0291] The valve 3200 is configured to engage at least a portion of a delivery system 3280 or to be engaged by the at least a portion, etc. The delivery system 3280 may include any suitable components for delivering, retrieving, deploying, moving, manipulating, actuating one or more parts of the valve 3200 and / or otherwise interacting with the one or more parts. In this embodiment, the delivery system 3280 may include, for example, one or more catheters. For example, the delivery system 3280 may include a delivery catheter through which the valve 3200 is delivered to the annulus of an autologous heart valve. The delivery system 3280 may also include one or more steerable catheters, control catheters, multi-lumen catheters, etc., or combinations thereof. In some embodiments, the delivery system 3280 may include a multi-lumen control catheter having a distal portion configured to removably engage and / or couple to one or more parts of the valve 3200 to facilitate delivery, deployment, and / or retrieval of the valve 3200. Although in Figures 57 to 60Although not shown, the delivery system 3280 may further include a guidewire catheter that may be advanced over a guidewire during delivery and / or deployment. In such implementations, the guidewire catheter may pass through the path point 3228 below the flow control member 3250 and through the guidewire coupler of the distal anchoring element, as described above with reference to the valve 2800 shown in Figures 51 to 53 as described.

[0292] Figure 57 The delivery system 3280 including an actuator 3270 is further shown. The actuator 3270 may be similar to the actuators described above with reference to, for example, 170, 270, and / or 370. For example, the actuator 3270 may be and / or may include a tether that extends through the path point 3228 of the spline 3227 and through one or more attachment points 3236 that are coupled to and / or formed along the subannular member 3230. The tether in turn passes through the attachment 3236 and extends back along the path point 3228 in the proximal direction. Thus, both ends of the tether may be maintained outside the body, allowing the user to manipulate the tether (actuator 3270). In this embodiment, the tether is shown passing through a plurality of attachment points 3236 at or along the proximal anchoring element 3234 of the subannular member 3230 such that actuation of the actuator 3270 (e.g., the tether) causes at least the proximal anchoring element 3234 to transition and / or move between a first configuration and a second configuration. The tether may pass through the attachment point 3236 in any suitable manner, which in turn may control and / or determine the manner in which the proximal anchoring element 3234 transitions or moves. Additionally, the attachment point 3236 may be formed of any suitable material that may facilitate the passage of the tether through or around it. For example, the attachment point 3236 may include and / or be integrally formed with a laser-cut wireframe of the subannular member 3220 (e.g., like an eyelet, etc.). In other embodiments, the attachment point 3236 may be a suture loop and / or ring formed in or by a biocompatible fabric that at least partially wraps the subannular member 3220. In other embodiments, the attachment point 3236 may be formed of a biocompatible polymer such as polyethylene. In some such embodiments, the biocompatible material may be, for example, a self-lubricating polymer composite that may facilitate the movement of the tether through the attachment point 3236.

[0293] Figure 57 The proximal anchoring element 3234 is shown in a first or unactuated configuration, where the tether (actuator 3270) passes through the attachment points 3236 in a serpentine manner in turn. Figure 58 and Figure 59Shown is the proximal anchoring element 3234 as it transitions from a first unactuated configuration toward a second actuated configuration in response to actuation of the actuator 3270 (e.g., pulling on the tether in a proximal direction and / or in a direction otherwise causing tensioning along the length of the tether). Figure 60 Shown is the proximal anchoring element 3234 in the second actuated configuration.

[0294] In Figures 57 to 60 the embodiment shown in, the actuator 3270 engages the proximal anchoring element 3234 such that one of the attachment points 3236 on the front side or free wall side of the subannular member 3230 acts as a pivot point about which the proximal anchoring element 3234 rotates, folds, rolls up, etc., at least in part. In other embodiments, the actuator 3270 may engage the proximal anchoring element 3234 such that an attachment point 3236 on the back side or spacer side of the subannular member 3230 acts as the pivot point. In other words, the proximal anchoring element 3234 may rotate, fold, roll up, pivot, swing, and / or otherwise move toward the front side or the back side of the valve 3200, depending on how the actuator 3270 engages the attachment point 3236 of the proximal anchoring element 3234.

[0295] Figure 59 and Figure 60 Also shown is a protrusion 3246, which is included on and / or formed by the proximal anchoring element 3234. In some implementations, the protrusion 3246 may contact autologous subannular tissue to facilitate proximal fixation of the valve 3200 in the annulus of the native valve. More specifically, the protrusion 3246 may be positioned along and / or adjacent to the proximal anchoring element 3234 and may rotate, swing, pivot, and / or otherwise move with the proximal anchoring element 3234 in response to actuation of the actuator 3270. In some implementations, the placement of the protrusion 3246 may be such that when the proximal anchoring element 3234 is moved (e.g., from a compressed configuration to a deployed configuration after the valve 3200 has been deployed and / or seated in the annulus), the protrusion 3246 moves or slides behind (e.g., at the commissures, posterior or spacer leaflets, tendons, trabeculae, and / or any other desired portion of the autologous tissue). Although one protrusion 3246 is shown in Figure 59 and Figure 60 in other embodiments, the proximal anchoring element 3234 may include two or more protrusions 3246, which may be arranged and / or otherwise act as hooks, etc., to hook onto or behind autologous tissue, thereby fixing the proximal anchoring element 3234 to the autologous subannular tissue.

[0296] Figures 61 to 64Is a bottom perspective view of a prosthetic valve 3300 according to one embodiment, and illustrates the process of transitioning the proximal anchoring element 3334 of the prosthetic valve 3300 between a first configuration and a second configuration. The valve 3300 is shown as including an outer support frame 3310 and a flow control component 3350 mounted within a central region of the outer support frame 3310. The frame 3310 is shown as having at least an annulus supra member 3320 and an annulus infra member 3330. The annulus supra member 3320 and the annulus infra member 3330 can be similar to any of the annulus supra and annulus infra members described above. Thus, certain aspects and / or features may not be described in more detail herein.

[0297] Figure 61 The annulus supra member 3320 is shown as including splines 3327 at or near the inner ring of the annulus supra member 3320 (e.g., extending between the outer and inner rings of the annulus supra member 3320 (not shown)). The annulus supra member 3320 is further shown as including a drum 3445 that extends between and / or is coupled to the inner and outer rings of the annulus supra member 3320 and covers a space not otherwise occupied by the flow control component 3350. The annulus supra member 3320 (or its inner ring) is shown as being coupled to the flow control component 3350, which is offset distally relative to the valve 3300.

[0298] The valve 3300 is configured to engage at least a portion of a delivery system 3380 or to be engaged by the at least a portion, etc. The delivery system 3380 can include any suitable components for delivering, retrieving, deploying, moving, manipulating, actuating one or more parts of the valve 3300 and / or otherwise interacting with the one or more parts. In this embodiment, the delivery system 3380 can include, for example, one or more catheters. For example, the delivery system 3380 can include a delivery catheter through which the valve 3300 is delivered to the annulus of a native heart valve. The delivery system 3380 can also include one or more steerable catheters, control catheters, multi-lumen catheters, etc., or combinations thereof. In some embodiments, the delivery system 3380 can include a multi-lumen control catheter having a distal portion configured to removably engage and / or couple to one or more parts of the valve 3300 (e.g., the outer or inner ring of the annulus supra member 3320, the drum of the annulus supra member 3320, the splines 3327 of the annulus supra member 3320, one or more anchoring elements of the annulus infra member 3330, and / or any other part of the valve 3300). For example, Figures 61 to 64An attachment member 3388 (e.g., a yoke, a forked bone, etc.) coupled to and / or integrated into the distal end of a multi-lumen control catheter is shown. The attachment member 3388 may be removably coupled to an annulus upper member 3320 (e.g., a drum 3445 and / or a spline 3327). Although not shown in Figures 61 to 64 , in some embodiments, the attachment member 3388 may be removably coupled to the drum 3345 of the annulus upper member 3320 via one or more tethers, sutures, and / or retractable / retrievable connectors.

[0299] Figure 61 An actuator 3370 is shown, which includes and / or is configured as a tether that, for example, extends through a distal portion of the spline 3327 and through one or more attachment points 3336 that are coupled to and / or formed along an annulus lower member 3330. Although not shown, in some embodiments, the spline 3327 may form and / or define a path point through which the tether extends at or near a flow control member 3350. The position of the path point may be at least partially based on the size of the valve 3300, where a smaller valve has a path point at a more distal position relative to the path point of a larger valve. In some embodiments, through-holes, baffles, openings, ports, etc. may be formed in the drum 3445 to allow the tether to pass therethrough (e.g., the spline 3327 does not define a path point). The tether is shown passing sequentially through the attachment points 3336 of a proximal anchoring element 3334 and extending back in a proximal direction through the drum 3345 and / or the spline 3327 such that both ends of the tether are maintained outside the body, allowing a user to manipulate the tether (actuator 3370). Thus, actuation of the actuator 3370 (e.g., the tether) causes at least the proximal anchoring element 3334 to transition and / or move between a first configuration and a second configuration. The tether may pass through the attachment points 3336 in any suitable manner, which in turn may control and / or determine the manner in which the proximal anchoring element 3334 transitions or moves.

[0300] Figure 61 The proximal anchoring element 3334 in a first or unactuated configuration is shown, where the tether (actuator 3370) passes sequentially through the attachment points 3336 in a serpentine manner. Figure 62 And Figure 63 The proximal anchoring element is shown when the proximal anchoring element 3334 transitions from a first unactuated configuration toward a second actuated configuration in response to actuation of the actuator 3370 (e.g., pulling the tether in a proximal direction and / or in a direction that otherwise causes tension along the length of the tether). Figure 64 The proximal anchoring element 3334 in a second actuated configuration is shown. In Figures 61 to 64In the embodiments shown, the actuator 3370 engages the proximal anchoring element 3334 such that one of the attachment points 3336 acts as a pivot point about which the proximal anchoring element 3334 rotates, folds, rolls, etc., at least in part (e.g., an attachment point 3336 on the front or back side of the subannular member 3320, as described above with reference to valve 3200).

[0301] Figure 63 And Figure 64 A protrusion 3346 is also shown, which is included on and / or formed by the proximal anchoring element 3334. In some implementations, the protrusion 3346 may contact the native subannular tissue to facilitate proximal fixation of the valve 3300 within the annulus of the native valve. More specifically, the protrusion 3346 may be positioned along and / or adjacent to the proximal anchoring element 3334 and may rotate, swing, pivot, and / or otherwise move with the proximal anchoring element 3334 in response to actuation of the actuator 3370. In some implementations, the placement of the protrusion 3346 may be such that when the proximal anchoring element 3334 is moved (e.g., from a compressed configuration to a dilated configuration after the valve 3300 has been deployed and / or seated in the annulus), the protrusion 3346 moves or slides behind (e.g., at commissures, posteriorly, or between leaflets, chords, trabeculae, and / or any other desired portion of the native tissue). Although one protrusion 3346 is shown in Figure 63 And Figure 64 In other embodiments, the proximal anchoring element 3334 may include two or more protrusions 3346, which may be arranged as and / or otherwise act as hooks, etc., to hook onto or behind the native tissue, thereby fixing the proximal anchoring element 3334 to the native subannular tissue.

[0302] Figure 65 is a bottom perspective view of a prosthetic valve 3400 according to one embodiment, which shows the proximal anchoring element 3434 in a compressed configuration and having a set of protrusions 3449 extending from the proximal anchoring element 3434. The valve 3400 is configured to engage at least a portion of a delivery system 3480 or to be engaged by the at least a portion, etc. The delivery system 3480 may include any suitable components for delivering, retrieving, deploying, moving, manipulating, actuating one or more parts of the valve 3400 and / or otherwise interacting with the one or more parts. In this embodiment, the delivery system 3480 may include, for example, one or more catheters and an actuator 3470 (as described above with reference to delivery systems 3280 and 3380).

[0303] Figure 65Illustrated is a valve 3400 having an outer support frame 3410 and a flow control member 3450 mounted within a central region of the outer support frame 3410. The frame 3410 is shown as having at least an annulus superior member 3420 and an annulus inferior member 3430. The annulus superior member 3420 and the annulus inferior member 3430 may be similar to any of the annulus superior and annulus inferior members described above. Accordingly, certain aspects and / or features may not be described in more detail herein.

[0304] The annulus inferior member 3430 includes and / or forms a proximal anchoring element 3434 that is capable of moving between at least a first, unactuated and / or expanded configuration and a second, actuated, folded and / or compressed configuration. Figure 65 Shown is the proximal anchoring element 3434 in a second or actuated configuration. As described above with reference to proximal anchoring elements 3234 and 3334, a tether that includes and / or forms at least a portion of the actuator 3470 passes serially in a serpentine manner through a set of attachment points 3436 of the proximal anchoring element 3434. In Figure 65 the illustrated embodiment, the actuator 3470 engages the proximal anchoring element 3434 such that one of the attachment points 3436 (e.g., an attachment point 3436 on the free wall side of the valve 3400) acts as a pivot point about which the proximal anchoring element 3434 rotates, folds, rolls up, etc., at least in part (e.g., an attachment point 3436 on the front or back side of the annulus inferior member 3420, as described above with reference to valve 3200).

[0305] Figure 65 Further shown is a protrusion 3446 included on and / or formed by the proximal anchoring element 3434, which may be similar to the protrusions 3246 and 3346 described above. The proximal anchoring element 3434 is also shown as including and / or forming a set of anchors, protrusions, hooks, arms, extensions, etc. (referred to herein as "hooks 3449"). In some implementations, the hooks 3449 may extend from the proximal anchoring element 3434 and may be bent, angled, and / or oriented such that when the proximal anchoring element 3434 rotates, swings, pivots, and / or otherwise moves in response to actuation of the actuator 3470 (e.g., moves from a second, folded and / or compressed configuration toward a first, deployed and / or expanded configuration after the valve 3400 has been deployed and / or seated in the annulus), the hooks 3449 move or slide behind (e.g.) commissures, posterior or septal leaflets, tendons, trabeculae, and / or any other desired portion of autologous tissue.

[0306] Although the proximal anchoring element 3434 is shown as including two hooks 3449, in other embodiments, the proximal anchoring element 3434 may include one hook 3449, two hooks 3449, or more than two hooks 3449, which may be arranged and / or otherwise configured to hook onto or behind the native tissue, thereby fixing the proximal anchoring element 3434 to the subannular native tissue. Although the hooks 3449 are shown as extending, for example, in a direction associated with the movement of the proximal anchoring element 3434 from a compressed configuration to a dilated configuration (e.g., toward the posterior or septal side of the valve 3400), in other embodiments, the hooks 3449 may be oriented in the opposite direction or any suitable combination of directions. Additionally, although the hooks 3449 are shown as relatively elongated extensions, in other embodiments, the hook or set of hooks may have any suitable shape, size, and / or configuration. For example, in some embodiments, the proximal anchoring element 3434 may include a serrated edge portion with blunt serrations, teeth, hooks, ridges, protrusions, etc.

[0307] Figures 66 to 69 are various views of a laterally deliverable prosthetic valve 3500 according to one embodiment, and illustrate a portion of the supra-annular member 3520 having an arcuate configuration. The valve 3500 is shown as including an outer support frame 3510 and a flow control component 3550 mounted within a central region of the outer support frame 3510. The frame 3510 is shown as having at least a supra-annular member 3520, an infra-annular member 3530, and a trans-annular member 3512 coupled therebetween. The frame 3510 and / or aspects thereof may be similar to any of the frames and / or aspects described above. Accordingly, certain aspects and / or features may not be described in greater detail herein.

[0308] The valve 3500 is shown as having an infra-annular member 3530 that has and / or forms a distal anchoring element 3532 and a proximal anchoring element 3534. The distal anchoring element 3532 includes a guidewire coupler 3533 that may receive a guidewire and / or a guidewire catheter through an opening, aperture, hole, port, etc. defined by the guidewire coupler 3533. In some implementations, the guidewire catheter may extend beyond the distal anchoring element 3532 and may have and / or provide sufficient rigidity to allow the valve 3500 to advance along the guidewire through the lumen of the guidewire catheter. The proximal anchoring element 3534 may be, for example, a movable anchoring element configured to move and / or otherwise transition (e.g., via an actuator) between a first configuration and a second configuration to reduce the perimeter of the infra-annular member 3520 during delivery and / or deployment.

[0309] The proximal anchoring element 3534 can be configured to move from a first extended configuration ( Figure 66 ) to a second compressed configuration in any suitable direction, at least in part based on how the proximal anchoring element 3534 is coupled to the actuator. For example, the proximal anchoring element 3534 can move inwardly toward the flow control member 3550, upwardly toward the supra-annular member 3520 and / or portions thereof, and / or toward the anterior or posterior side of the valve 3500. Additionally, in instances where the trans-annular member 3512 of the frame 3510 is coupled to the sub-annular member 3530, in some implementations, actuation of the actuator can move one or more portions of the trans-annular member 3512.

[0310] The supra-annular member 3520 is shown as having a laser-cut frame (e.g., formed of a shape memory material such as nitinol) wrapped or covered in a biocompatible material. The supra-annular member 3520 includes a distal portion 3522, a proximal portion 3524, an outer ring 3521, an inner ring 3525, and at least one spline 3527. In some embodiments, the outer ring 3521 can be shaped and / or sized to engage native tissue. For example, the distal portion 3522 of the supra-annular member 3520 (formed at least in part by the outer ring 3521) is configured to engage distal supra-annular tissue, and the proximal portion 3524 (formed at least in part by the outer ring 3521) is configured to engage proximal supra-annular tissue. The distal and proximal portions 3522 and 3524 can have a circular and / or curved shape, where the radius of curvature of the proximal portion 3524 is greater than the radius of curvature of the distal portion 3522. The distal portion 3522 and / or the proximal portion 3524 can form (e.g.) a distal supra-annular anchoring element and / or a proximal supra-annular anchoring element, each of which can engage supra-annular tissue to at least partially stabilize the frame 3510 and / or secure the frame in the native annulus.

[0311] The inner ring 3525 of the supra-annular member 3520 can have an elliptical or teardrop shape and can be coupled to and / or suspended from the outer ring 3521 by one or more splines 3527. The inner ring 3525 can be coupled to the flow control member 3550 via (e.g.) a biocompatible material 3526. The inner ring 3525 is shown coupled to the flow control member 3550 such that the flow control member 3550 is offset distally relative to the valve 3500. In some implementations, suspending the inner ring 3525 from the outer ring 3521 can (e.g.) at least partially isolate the inner ring 3525 (and the flow control member 3550 coupled to the inner ring 3525) from at least a portion of the forces associated with transitioning the frame 3510 between the expanded and compressed configurations (e.g., during delivery and / or deployment).

[0312] One or more splines 3527 of the supra-annular member 3520 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the supra-annular member 3520 can include proximal splines 3527 that define path points 3528. The path points 3528 can be (e.g.) openings, holes, apertures, ports, connectors, sealable / rescalable entry points, etc. configured to at least temporarily couple to and / or receive a portion of a delivery system. For example, in some implementations, the portion of the delivery system can at least include an actuator and a guidewire catheter.

[0313] The supra-annular member 3520 is further shown to include a drum 3545 that extends between and / or is coupled to the outer ring 3521 and the inner ring 3525 and covers a space not otherwise occupied by the flow control member 3550. Figure 66 The drum 3545 is shown having and / or forming a set of spokes 3545A that can be used to increase the rigidity of the drum 3545. The spokes 3545A can be (e.g.) sutures that are sewn into the drum 3545 to increase the rigidity of the drum 3545 and / or otherwise modify the deformation pattern of the drum 3545 during, for example, systole, which in turn can enhance the performance of the valve 3500 and / or reduce fatigue in or along the drum 3545. Although specifically shown in Figure 66 , the spokes 3545A can be arranged in any suitable manner that results in an increase in the rigidity of the drum. For example, the spokes 3545A can be arranged longitudinally, transversely, and / or at an angle relative to the longitudinal or transverse direction. In other embodiments, the spokes 3545A can be arranged in a cross-hatched pattern and / or any other suitable pattern.

[0314] Figure 66 The drum 3545 is further shown to include an attachment member 3571 that can facilitate temporary attachment to a portion of the delivery system. The attachment member 3571 can be (e.g.) a braided wire, suture, tether, cable, etc. As described above, in some implementations, the delivery system can include a control or steerable catheter that can include an integrated yoke or other suitable removable connector. More specifically, the attachment member 3571 can include a set of loops 3572 through which a set of tethers can pass to removably couple the yoke of the delivery system to the valve 3500. The tethers can be passed through the loops 3572 such that each end of the tether is maintained outside the patient's body, thereby allowing an operator to manipulate the tethers to control the contact between the yoke and the drum 3545.

[0315] Although the attachment member 3571 is shown as being coupled to the drum 3545 at or near the proximal edge of the drum 3545, in other embodiments, the attachment member 3571 may be coupled to the drum 3545 at any suitable location (e.g., a proximal location adjacent to the flow control member 3550, a distal location as shown in Figure 66 or any suitable location therebetween). Although the attachment member 3571 has been described above as being coupled to the drum 3545, in other embodiments, any portion of the valve 3500 may include the attachment member 3571. In some embodiments, for example, the annulus upper member 3520 may include a laser cut portion of a wireframe that extends across a portion of the outer annulus 3525 (e.g., perpendicular to the spline 3527).

[0316] Figures 66 to 69 The spline 3527 of the annulus upper member 3520 having an arcuate shape and / or configuration is further shown. Figure 67 And Figure 68 are a side view and a bottom view, respectively, of the valve 3500, showing the spline 3527 protruding away from the annulus lower member 3520, and Figure 69 is a top perspective view showing the laser cut frame of the annulus upper member 3520 having a spline 3527 with an arcuate configuration. In some implementations, the arcuate spline 3527 may apply a force to the drum 3545 that bends the drum 3545 into an arcuate shape and increases the tension on the area of the drum 3545. The increased tension in turn increases the relative rigidity of the drum 3545, which may reduce and / or limit the amount of deformation of the drum during, for example, diastole or systole, thereby enhancing the performance of the valve 3500 and / or reducing fatigue in or along the drum 3545. In other words, the pressure generated on the atrial side of the drum 3545 during atrial contraction (diastole) is not sufficient to reverse the arcuate configuration of the drum 3545 (i.e., no oil can shape deflection will occur) due to the arcuate spline 3527. The arcuate configuration of the drum 3545 can also withstand the greater pressure generated on the ventricular side of the drum 3545 during ventricular contraction (systole) without substantial deflection. Additionally, the arcuate shape in the spline 3527 may position the waypoint 3528 at a desired angle and / or orientation to facilitate the insertion or retrieval of one or more portions of a delivery system through the waypoint 3528.

[0317] Figure 70FIG. 0 is a flow chart depicting a method 10 of deploying a laterally deliverable transcatheter prosthetic valve according to one embodiment. The laterally deliverable transcatheter prosthetic valve may be similar and / or substantially the same as any of the prosthetic valves described herein. For example, the prosthetic valve may include an outer support frame and an (inner) flow control component mounted in and / or to the outer support frame. The outer support frame may include, for example, an annulus supra component or region, an annulus infra component or region, and a transannular component or region coupled therebetween. As described above, the flow control component is mounted to the outer support frame such that it extends through a portion of the transannular component or region.

[0318] Method 10 includes removably coupling, at 11, the annulus supra component of the outer frame to a portion of a delivery system. For example, in some embodiments, the annulus supra component may include an attachment member or the like that may be used to temporarily couple the delivery system to the valve, as described above with reference to the valve 3500 shown in Figures 66 to 69 FIG. In other embodiments, the annulus supra component may form and / or define an attachment point, a path point, and / or any other suitable coupler that may be removably coupled to a portion of the delivery system.

[0319] At 12, the prosthetic valve in a delivery configuration is advanced through the lumen of a delivery catheter included in the delivery system while the distal end of the delivery catheter is disposed in the atrium of the heart. As described above with reference to valve 100, the prosthetic valve may be placed in a delivery configuration and loaded into the lumen of the delivery catheter. In some cases, placing the valve in a delivery configuration may include, for example, folding the valve in a lateral direction or along a transverse axis and compressing the valve in an axial or blood flow direction or along the central axis of the valve. In some cases, the annulus supra component of the outer frame is removably coupled to a portion of the delivery system prior to being advanced through the lumen of the delivery catheter. In some such cases, for example, the portion of the delivery system may be used to advance the prosthetic valve in a delivery configuration through the lumen of the delivery catheter.

[0320] At 13, the prosthetic valve is released from the distal end of the delivery catheter. In some cases, the prosthetic valve may be partially released from the delivery catheter to allow the distal portion of the valve (e.g., the distal anchoring element of the annulus infra component) to be inserted into the annulus of the native valve prior to fully releasing the valve. In other cases, the prosthetic valve may be fully released from the delivery catheter prior to inserting a portion of the prosthetic valve into the annulus. Additionally, releasing the prosthetic valve allows the released portion (or the entire valve) to transition from a delivery configuration to an expanded or deployed configuration.

[0321] At 14, after releasing the prosthetic valve, the proximal anchoring element of the subannular member of the outer frame is placed in a first configuration. As described above with reference to frames 210 and 310 at least, the proximal anchoring element can be placed in the first configuration in response to actuation of an actuator removably coupled to the proximal anchoring element. For example, the actuator can be one or more tether chains, and the one or more tether chains can be tightened to actuate, move, and / or otherwise place the proximal anchoring element in the first configuration. Additionally, when the proximal anchoring element is in the first configuration, at least the perimeter and / or circumference of the subannular member is reduced to a size similar to or less than the perimeter and / or circumference of the annulus. Thus, at 15, with the proximal anchoring element in the first configuration, the prosthetic valve is seated in the annulus of the native heart valve.

[0322] At 16, after seating the prosthetic valve in the annulus, the proximal anchoring element transitions from the first configuration to a second configuration. For example, in some implementations, the actuator can be actuated to move the proximal anchoring element from the first configuration to the second configuration. In some implementations, a user or operator can reduce the tension force in one or more tether chains, thereby allowing the proximal anchoring element to return to a biased or expanded state or configuration. In some implementations, the actuator can be actuated such that the proximal anchoring element moves from the first (compressed) configuration through an extended configuration and into a cinched configuration, where native tissue on the proximal side of the annulus is compressed or pinched between the proximal anchoring element of the subannular member and the proximal portion of the supra-annular member, thereby fixing the valve in the annulus. In some implementations, once the valve is seated and / or fixed in the annulus of the native valve, portions of the delivery system can be decoupled from and / or removed from the valve and withdrawn from the patient's body.

[0323] Figure 71 is a flowchart of a method 20 for manufacturing at least a portion of a laterally deliverable transcatheter prosthetic valve according to one embodiment. The prosthetic valve can be similar to any of the prosthetic valves (or portions thereof) described herein. For example, the prosthetic valve can be similar to the valve 3400 described above with reference to Figures 66 to 69 the valve 3400 described above.

[0324] Method 20 includes forming an annulus upper member of a valve frame from a single workpiece at 21, the annulus upper member having an outer ring, an inner ring, and splines that suspend the inner ring on the outer ring. As described above, the annulus upper member can be and / or can include a wireframe laser cut from a single workpiece (e.g., a nitinol sheet or tube) and then heat set into a desired shape. In some embodiments, the outer ring can have a size, shape, and / or configuration that is at least partially based on the anatomy of the atrium in which the outer ring is to be disposed. The inner ring can be suspended on the outer ring, and the inner ring can have a size and / or shape that is at least partially based on the size or configuration of an (inner) flow control component configured to be mounted to the inner ring. In some embodiments, for example, the inner ring can be oval or teardrop shaped, the inner ring being wide enough to receive a flow control component passing therethrough. The splines are configured to at least partially suspend the inner ring on the outer ring. In some embodiments, the splines can form and / or define path points configured to engage and / or receive a portion of a delivery system during delivery and / or deployment.

[0325] At 22, an annulus lower member of the valve frame is formed from a single workpiece, and the annulus lower member has a distal anchoring element and a proximal anchoring element. As described above, the annulus lower member can be and / or can include a wireframe laser cut from a single workpiece (e.g., a nitinol sheet or tube) and then heat set into a desired shape. For example, the annulus lower member can be (heat set) into a closed loop such that the distal anchoring element extends from a distal portion of the annulus lower member and the proximal anchoring element extends from a proximal portion of the annulus lower member. As described above, in some cases, the distal anchoring element can include and / or can form one or more features, protrusions, eyelets, etc. that can facilitate engagement with native tissue during deployment. In some cases, the proximal anchoring element is formed to be capable of moving and / or transitioning between two or more configurations, as described in detail above. In some cases, forming the annulus lower member optionally can include forming one or more twists along one or more portions of the annulus lower member, the one or more twists being capable of controlling and / or determining the direction and / or extent of movement associated with the proximal anchoring element.

[0326] At 23, each of the first sidewall and the second sidewall is formed from a single workpiece. In some embodiments, the first sidewall and the second sidewall can be the first and second halves of a transannular member of an outer frame. As described above, the sidewalls can be and / or can include a wireframe laser cut from a single workpiece (such as a nitinol sheet or tube) and then heat set into a desired shape (such as an arcuate shape, a semi-cylindrical shape, a curved hyperbolic or parabolic shape (or cross-sectional shape), etc.). The sidewalls can include any number of rows of filament units oriented in a direction parallel to the direction of blood flow through the valve (such as parallel to the central axis). In some embodiments, such orientation can allow the sidewalls to compress when the frame is in a delivery configuration.

[0327] At 24, the first sidewall and the second sidewall are coupled to form a transannular member of the valve frame. As described above, the coupling of the sidewalls can form one or more hinge points between the first sidewall and the second sidewall. In some embodiments, the sidewalls can be sutured and / or otherwise coupled along the distal filament units and the proximal filament units. In some embodiments, the shape of the sidewalls is such that two hinge points are formed on the distal side of the transannular member and one hinge point is formed on the proximal side of the transannular member. Additionally, the shape and / or configuration of the transannular member is such that the longitudinal axis of the valve passes through the hinge points, thereby allowing the transannular member to fold in the direction of the transverse axis (orthogonal to the longitudinal axis) and / or otherwise along the transverse axis, as described above with reference to valve 100.

[0328] At 25, an annulus superior member is coupled to the annulus superior portion of the transannular member. In some embodiments, the transannular member has an hourglass shape, where the annulus superior portion flares outward (such as toward or towards the outer ring of the annulus superior member). In some embodiments, coupling the annulus superior member to the transannular member includes suturing the upper row of filament units or a row of filament units on the annulus superior to the outer ring of the annulus superior member.

[0329] At 26, an annulus inferior member is coupled to the annulus inferior portion of the transannular member. In some embodiments, the transannular member has an hourglass shape, where the annulus inferior portion flares outward (such as toward or towards the annulus inferior member). In some embodiments, coupling the annulus inferior member to the transannular member includes suturing the lower row of filament units or a row of filament units on the annulus inferior to the annulus inferior member.

[0330] In some embodiments, method 20 can further include wrapping and / or covering the annulus inferior member, the annulus superior member, and the transannular member of the wireframe in a biocompatible material (such as a biocompatible fabric, pericardium, etc.). In some cases, the annulus inferior member, the annulus superior member, and / or the transannular member can be wrapped and / or covered before or after the coupling steps at 25 and 26.

[0331] Numerous modifications and variations can be made without departing from its spirit and scope, which will be apparent to those skilled in the art. In addition to the methods and apparatuses recited herein, methods and apparatuses that are functionally equivalent within the scope of the present disclosure will be apparent to those skilled in the art in light of the foregoing description. Such modifications and variations are intended to fall within the scope of the present disclosure. It should be understood that the present disclosure is not limited to the specific methods, reagents, compounds, compositions, or biological systems, which can, of course, vary. It will also be understood that the terminology used herein is for the purpose of describing particular embodiments and is not intended to be limiting.

[0332] While the various embodiments have been described above, it should be understood that the embodiments have been presented by way of example only and not limitation. Various changes in form and / or detail may be made without departing from the scope and / or without altering its function and / or advantages, unless otherwise expressly provided. Where the above schematic diagrams and / or embodiments indicate particular components arranged in a particular orientation or position, the arrangement of the components may be modified.

[0333] Although the various embodiments have been described as having particular combinations of features and / or components, other embodiments having any combination of features and / or components are possible, except for mutually exclusive combinations, in accordance with any of the embodiments described herein. The embodiments described herein may include various combinations and / or sub-combinations of the functions, components, and / or features of the different embodiments described.

[0334] Where the above methods indicate that particular events occur in a particular order, the ordering of the particular events may be modified. Additionally, where possible, some of the events may be performed concurrently in parallel processes, as well as performed sequentially as described above.

Claims

1. A prosthetic heart valve capable of lateral delivery, the prosthetic heart valve comprising: An outer frame having an upper annulus region, a lower annulus region, and a transannular region connecting the upper annulus region and the lower annulus region, the transannular region defining a central passage extending along a central axis of the prosthetic heart valve, the transannular region including a wireframe forming a plurality of cells oriented in a direction of the central axis, the wireframe having a first half and a second half coupled to the first half, and a proximal hinge and a distal hinge formed between the first half and the second half; and a flow control member mounted to the outer frame such that at least a portion of the flow control member is disposed within the central passage, the prosthetic heart valve being compressible along the central axis and foldable along a transverse axis of the prosthetic heart valve orthogonal to the central axis to place the prosthetic heart valve in a delivery configuration for lateral delivery via a delivery catheter, in the delivery configuration for lateral delivery a longitudinal axis of the prosthetic heart valve orthogonal to both the central axis and the transverse axis being parallel to a longitudinal axis of the delivery catheter, the longitudinal axis of the prosthetic heart valve extending through the proximal hinge and the distal hinge formed by the transannular region; and the prosthetic heart valve being expandable from the delivery configuration along the central axis and the transverse axis upon release of the prosthetic heart valve from the delivery catheter to transition to a deployed configuration, the lower annulus region of the outer frame being capable of being in a first configuration when the prosthetic heart valve is seated in an annulus of a native heart valve and capable of transitioning to a second configuration after the prosthetic heart valve is seated in the annulus of the native heart valve.

2. The prosthetic heart valve according to claim 1, wherein the perimeter of the subannular region in the first configuration is smaller than the perimeter of the subannular region in the second configuration.

3. The prosthetic heart valve according to claim 1, wherein the subannular region forms a distal anchoring element and a proximal anchoring element, and the proximal anchoring element is capable of moving between a first position and a second position to cause the subannular region to transition between the first configuration and the second configuration.

4. The prosthetic heart valve according to claim 3, wherein the perimeter of the subannular region when the proximal anchoring element is in the first position is smaller than the perimeter of the subannular region when the proximal anchoring element is in the second position.

5. The prosthetic heart valve according to claim 3, wherein the proximal anchoring element is capable of moving between the first position, the second position, and a third position to cause the subannular region to transition between the first configuration, the second configuration, and a third configuration accordingly. When the prosthetic heart valve is in the delivery configuration, the subannular region is in the third configuration.

6. The prosthetic heart valve according to claim 3, wherein the supraannular region forms a spline, and the spline is configured to removably engage a part of a delivery system.

7. The prosthetic heart valve according to claim 6, wherein the spline defines path points, and the path points are configured to receive an actuator included in the part of the delivery system, and the actuator is capable of being removably coupled to the proximal anchoring element.

8. The prosthetic heart valve according to claim 7, wherein the proximal anchoring element is capable of moving between the first position and the second position in response to actuation of the actuator.

9. The prosthetic heart valve according to claim 8, wherein actuation of the actuator causes the proximal anchoring element to move between the first position and the second position, and (i) causes the proximal portion of the anterior wall of the transannular region to move relative to the spline, and (ii) causes the proximal portion of the posterior wall of the transannular region to move relative to the spline.

10. The prosthetic heart valve according to claim 9, wherein the proximal portions of the anterior wall and the posterior wall move closer to or farther from the longitudinal axis of the prosthetic heart valve in response to actuation of the actuator.

11. The prosthetic heart valve according to claim 3, wherein the distance between the proximal side of the supra-annular region and the proximal anchoring element located at the second position is less than the thickness of the annular tissue on the proximal side of the annulus.

12. The prosthetic heart valve according to claim 1, wherein the sub-annular region forms a proximal anchoring element having at least one protrusion that allows engagement with autologous tissue on the proximal side of the annulus when the sub-annular region is in the second configuration.

13. The prosthetic heart valve according to claim 1, wherein the proximal portion of the wireframe in the trans-annular region defines a notch.

14. The prosthetic heart valve according to claim 13, wherein the proximal hinge includes one hinge point and the distal hinge includes two hinge points.

15. The prosthetic heart valve according to claim 13, wherein the sub-annular region forms a proximal anchoring element that is movable to transition the sub-annular region between the first configuration and the second configuration, and the notch increases the flexibility of the proximal side of the prosthetic heart valve to allow the proximal anchoring element to move relative to the wireframe in the trans-annular region.

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