Laterally deliverable transcatheter artificial valves and methods for delivering and securing them.

Abstract

To provide a side-deliverable transcatheter prosthetic valve including one or more anchoring elements for anchoring the prosthetic valve within an annulus of a native valve.SOLUTION: A side-deliverable transcatheter prosthetic valve includes an outer frame, a flow control component mounted within the outer frame, and an anchoring element coupled to a distal side of the outer frame. The prosthetic valve is foldable along a longitudinal axis and compressible along a central axis to a compressed configuration for side delivery via a delivery catheter and is expandable to an expanded configuration when released from the delivery catheter. An end portion of the anchoring element is configured to engage a guide wire. The anchoring element is extended during deployment to allow the anchoring element to capture at least one of native leaflet or chordae and, in response to the guide wire being disengaged from the end portion, transitions to a folded configuration to secure at least one of the native leaflet or the chordae between the anchoring element and the distal side of the outer frame.SELECTED DRAWING: Figure 25E

Description

[Technical Field]

[0001] Cross-reference of related applications This application is a continuation of U.S. Patent Application No. 16 / 438,434, filed on June 11, 2019, titled "Distal Subannular Anchoring Tab for Side-Delivered Transcatheter Mitral Valve Prosthesis," claiming priority and benefits to U.S. Provisional Patent Application No. 62 / 818,108, filed on March 14, 2019, titled "Distal Anchoring Tab for Orthogonal Transcatheter Mitral Valve Prosthesis," and also claims priority and benefits to U.S. Provisional Patent Application No. 62 / 818,109, filed on March 14, 2019, titled "A2 Clip for Side-Delivered Transcatheter Mitral Valve Prosthesis," filed on June 16, 2019. This is a continuation application of U.S. Patent Application No. 16 / 442,504 entitled "Prosthesis," and a continuation application of U.S. Patent Application No. 62 / 818,688 entitled "Proximal, Distal, and Anterior Anchoring Tabs for Side-Delivered Transcatheter Mitral Valve Prosthesis," filed on 19 June 2019, claiming priority and benefits thereof to U.S. Provisional Patent Application No. 62 / 818,688 entitled "Proximal, Distal, and Anterior Anchoring Tabs for Orthogonal Transcatheter Mitral Valve Prosthesis," filed on 14 March 2019, the disclosures of each of these are incorporated herein by reference in their entirety.

[0002] This application also claims priority and the benefit of U.S. Provisional Patent Application No. 62 / 818,742, filed Mar. 14, 2019, entitled "A1-P1 Targeting Guide Wire Delivery Systems for Orthogonal Transcatheter Mitral Valve Prosthesis", the disclosure of which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION

[0003] The embodiments described herein generally relate to transcatheter heart valves, and more specifically to a lateral deliverable transcatheter heart valve having one or more fixation elements for securing the heart valve within the annulus of a native valve, and methods for delivering the same.

[0004] Artificial heart valves can pose challenges for delivery and deployment within the heart, particularly for catheter-based delivery through a patient's vasculature rather than through a surgical approach. Conventional transcatheter heart valve delivery generally involves compressing the valve radially and loading the valve within 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 expanded 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 challenges to increasing the expanded diameter of conventional valves (e.g., trying to compress excessive material and structure into too little space). Further, the orientation of conventional valves during deployment can present additional challenges when attempting to align the valve with the native annulus.

[0005] Some transcatheter prosthetic valves may be configured for lateral and / or orthogonal delivery, which may have an increased expansion diameter compared to conventional valves. For example, in lateral and / or orthogonal delivery, the valve and / or valve frame is compressed and loaded into the delivery catheter, so that the central annular axis of the valve and / or valve frame is substantially orthogonal to the longitudinal axis of the delivery catheter, thereby allowing the valve to be compressed laterally and expanded longitudinally (e.g., in a direction parallel to the longitudinal axis of the delivery catheter). In some such implementations, it is even more desirable to provide an outer portion or valve frame having a size and / or shape corresponding to the size and / or shape of the annular of the own valve (e.g., the mitral valve and / or tricuspid valve of the human heart), while providing an internal flow control component having a substantially cylindrical shape that (i) accommodates the lateral compression and / or longitudinal expansion it undergoes during delivery and (ii) allows for optimal function of the prosthetic valve leaflet housed inside. It is also desirable to provide one or more methods for securing a valve within the annulus of an annulus using conventional and / or orthogonally delivered transcatheter prosthetic valves without substantially increasing the compression size of the valve.

[0006] Therefore, there is a need for a transcatheter prosthetic valve that can be delivered laterally and has one or more fixation elements for securing the prosthetic valve within the annulus of the native valve, and a method for delivering such a prosthetic valve. [Overview of the Initiative]

[0007] Embodiments described herein relate to laterally deliverable transcatheter prostheses having one or more fixation elements for securing the prosthese prostheses within the annulus of a native valve, and methods for delivering them. In some embodiments, the laterally deliverable prosthetist includes an outer frame having an outer wall circumscribing a central channel extending along a central axis, and a flow control component mounted within the central channel. This flow control component includes an inner frame and a set of leaflets coupled to the inner frame. The prosthetist is foldable along its longitudinal axis and compressible along its central axis to mount the prosthetist in a compressed configuration for delivery via a delivery catheter. The longitudinal axis is substantially parallel to the longitudinal axis of the delivery catheter when the prosthetist is positioned within the delivery catheter. The prosthetist is configured to transition to an expanded configuration when the prosthetist is released from the delivery catheter. The prosthetist further includes a distal fixation element having a first end coupled to the distal side of the outer wall of the outer frame and a second end opposite to the first end. This second end is configured to selectively engage with the guidewire, allowing the distal fixation element to advance along the guidewire during the deployment of the prosthetic valve. The distal fixation element is in an extended configuration during deployment, which allows it to capture at least one of the self-leaflet or notochord. In response to the guidewire being disengaged from the second end, the distal fixation element transitions to a folded configuration in which at least one of the self-leaflet or notochord is fixed between the distal fixation element and the distal side of the outer wall. [Brief explanation of the drawing]

[0008] [Figure 1A] This is a schematic front view of a lateral delivery transcatheter artificial heart valve (also referred to herein as an "artificial valve") according to one embodiment, shown in an expanded configuration. [Figure 1B] This is a schematic front view of a lateral delivery transcatheter artificial heart valve (also referred to herein as "artificial valve") according to one embodiment, shown in a compressed configuration. [Figure 1C] Figure 1A is a schematic top view of the artificial valve, shown in its expanded configuration. [Figure 1D] Figure 1B is a schematic top view of the artificial valve, shown in its compression configuration. [Figure 1E] These are schematic diagrams of the artificial valve shown in Figures 1A-1D, deployed within the annulus of the native heart valve. [Figure 2A] This is an example of a top view of a self-adopted mitral valve showing the approximate locations of leaflet regions A1-A2-A3 and P1-P2-P3. [Figure 2B] This is an example of a lateral perspective view of a transcatheter artificial heart valve that can be delivered laterally and has an extendable distal fixation element, according to one embodiment. [Figure 2C] This is an example of an exploded assembly diagram of a transcatheter artificial heart valve that can be delivered laterally and has an extendable distal fixation element, according to one embodiment. [Figure 3A] This is an example of a lateral perspective view of a transcatheter artificial heart valve that can be delivered laterally and has an extendable distal fixation element and an anterior fixation element, according to one embodiment. [Figure 3B] This is an example of an exploded assembly diagram of a transcatheter artificial heart valve that can be delivered laterally and has an extendable distal fixation element and an anterior fixation element, according to one embodiment. [Figure 4A] This is an example of a lateral perspective view of a transcatheter artificial heart valve that can be delivered laterally and has an extendable distal fixation element and a proximal fixation element, according to one embodiment. [Figure 4B] This is an example of an exploded assembly diagram of a transcatheter artificial heart valve that can be delivered laterally and has an extendable distal fixation element and a proximal fixation element, according to one embodiment. [Figure 5A] This is an example of a lateral perspective view of a transcatheter artificial heart valve that can be delivered laterally, having an extendable distal fixation element, an anterior fixation element, and a proximal fixation element, according to one embodiment. [Figure 5B] This is an example of an exploded assembly diagram of a transcatheter artificial heart valve that can be delivered laterally, having an extendable distal fixation element, anterior fixation element, and proximal fixation element, according to one embodiment. [Figure 6A] This is an example of a lateral perspective view of a transcatheter artificial heart valve that can be delivered laterally and has an extendable distal fixation element and an anterior fixation element, according to one embodiment. [Figure 6B] This is an example of an exploded assembly diagram of a transcatheter artificial heart valve that can be delivered laterally and has an extendable distal fixation element and an anterior fixation element, according to one embodiment. [Figure 7A] This is a series of examples illustrating a process for a distal fixation element of a transcatheter-deliverable transcatheter-artificial heart valve that captures self-tissue, according to one embodiment. [Figure 7B] This is a series of examples illustrating a process for a distal fixation element of a transcatheter-deliverable transcatheter-artificial heart valve that captures self-tissue, according to one embodiment. [Figure 7C] This is a series of examples illustrating a process for a distal fixation element of a transcatheter-deliverable transcatheter-artificial heart valve that captures self-tissue, according to one embodiment. [Figure 7D] This is a series of examples illustrating a process for a distal fixation element of a transcatheter-deliverable transcatheter-artificial heart valve that captures self-tissue, according to one embodiment. [Figure 7E] Figures 7A-7D are illustrative top views of a laterally deliverable transcatheter artificial heart valve, showing a distal fixation element wrapped around the artificial valve to capture self-tissue, according to one embodiment. [Figure 8] This is an example of a top view of a transcatheter artificial heart valve that can be delivered laterally and has a number of fixing elements, according to one embodiment. [Figure 9A] This is an example of a cross-sectional view of a human heart showing the relative locations of the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. [Figure 9B] This is an example of a cross-section lateral view of a human heart having a transseptal (transfemoral / inferior vena cava (IVC) or superior vena cava (SVC)) delivery catheter that traverses from the right atrium to the left atrium to access the mitral valve, according to one embodiment. [Figure 10] This is a perspective view illustrating one embodiment of a guidewire that accesses the valve annulus of the self-valve through the IVC and wraps around or under the self-A2 leaflet. [Figure 11] This is an example of a side perspective view of a guidewire, according to one embodiment, that accesses the valve annulus of the self-valve through the IVC and wraps around or under the self-A2 leaflet. [Figure 12] Examples of processes for delivering and deploying a side - deliverable trans - catheter artificial heart valve, according to one embodiment, into, for example, the native mitral valve. [Figure 13] Examples of processes for delivering and deploying a side - deliverable trans - catheter artificial heart valve, according to one embodiment, into, for example, the native mitral valve. [Figure 14] Examples of processes for delivering and deploying a side - deliverable trans - catheter artificial heart valve, according to one embodiment, into, for example, the native mitral valve. [Figure 15] Examples of processes for delivering and deploying a side - deliverable trans - catheter artificial heart valve, according to one embodiment, into, for example, the native mitral valve. [Figure 16] Examples of processes for delivering and deploying a side - deliverable trans - catheter artificial heart valve, according to one embodiment, into, for example, the native mitral valve. [Figure 17] A and B are examples of side - perspective views of a side - deliverable trans - catheter artificial heart valve deployed within a native valve annulus (shown in dashed lines) having front - fixing elements in an extended position and a retracted position, respectively, according to one embodiment. [Figure 18] A and B are examples of side - perspective views of a side - deliverable trans - catheter artificial heart valve deployed within a native valve annulus (shown in dashed lines) having front - fixing elements in an extended position and a retracted position, respectively, according to one embodiment. [Figure 19] A and B are examples of side - perspective views of a side - deliverable trans - catheter artificial heart valve deployed within a native valve annulus (shown in dashed lines) having front - fixing elements in an extended position and a retracted position, respectively, according to one embodiment. [Figure 20] An example of a side - view of a side - deliverable trans - catheter artificial heart valve having a distal - fixing element extending from the valve body, according to one embodiment. [Figure 21] An example of a top - view of a side - deliverable trans - catheter artificial heart valve having a distal - fixing element extending from the valve body, according to one embodiment. [Figure 22]Figure 20 shows an example of an artificial valve in a compressed configuration, positioned within a delivery catheter. [Figure 23] Figure 20 shows an example of an artificial valve that is in a partially expanded configuration and partially free from the delivery catheter. [Figure 24] This is an example of a cross-sectioned lateral view of a human heart according to one embodiment, showing a transcatheter-deliverable artificial heart valve deployed within the native valve. [Figure 25A] Figures 25A to 25E illustrate various diagrams of the process according to one embodiment for placing a laterally deliverable transcatheter artificial heart valve in a compressed configuration, delivering the compressed artificial valve via a delivery catheter, and partially releasing the artificial valve from the delivery catheter to deploy it into the native valve. [Figure 25B] Figures 25A to 25E illustrate various diagrams of the process according to one embodiment for placing a laterally deliverable transcatheter artificial heart valve in a compressed configuration, delivering the compressed artificial valve via a delivery catheter, and partially releasing the artificial valve from the delivery catheter to deploy it into the native valve. [Figure 25C] Figures 25A to 25E illustrate various diagrams of the process according to one embodiment for placing a laterally deliverable transcatheter artificial heart valve in a compressed configuration, delivering the compressed artificial valve via a delivery catheter, and partially releasing the artificial valve from the delivery catheter to deploy it into the native valve. [Figure 25D] Figures 25A to 25E illustrate various diagrams of the process according to one embodiment for placing a laterally deliverable transcatheter artificial heart valve in a compressed configuration, delivering the compressed artificial valve via a delivery catheter, and partially releasing the artificial valve from the delivery catheter to deploy it into the native valve. [Figure 25E] Figures 25A to 25E illustrate various diagrams of the process according to one embodiment for placing a laterally deliverable transcatheter artificial heart valve in a compressed configuration, delivering the compressed artificial valve via a delivery catheter, and partially releasing the artificial valve from the delivery catheter to deploy it into the native valve. [Figure 26] Figures A to C illustrate various processes relating to the placement of a laterally deliverable transcatheter artificial heart valve in a compressed configuration and the loading of the compressed artificial valve into a delivery catheter, according to one embodiment. [Figure 27] Figures A to C illustrate various processes relating to the placement of a laterally deliverable transcatheter artificial heart valve in a compressed configuration and the loading of the compressed artificial valve into a delivery catheter, according to one embodiment. [Figure 28] Figures A to C illustrate various processes relating to the placement of a laterally deliverable transcatheter artificial heart valve in a compressed configuration and the loading of the compressed artificial valve into a delivery catheter, according to one embodiment. [Figure 29] Figures A to C illustrate various processes relating to the placement of a laterally deliverable transcatheter artificial heart valve in a compressed configuration and the loading of the compressed artificial valve into a delivery catheter, according to one embodiment. [Figure 30] This is an example of a top perspective view of the inner frame of a flow control component housed within an artificial valve according to one embodiment. [Figure 31] Various diagrams of the inner frame in Figure 30 are illustrated and shown in a partially folded configuration. [Figure 32] Various diagrams of the inner frame in Figure 30 are illustrated and shown in their folded configuration. [Figure 33] Various diagrams of the inner frame in Figure 30 are illustrated, showing both folded and compressed configurations. [Figure 34] This is an example of a side view of the inner frame of a flow control component, shown as a linear wireframe sheet before it is housed in an artificial valve and formed into a cylinder, according to one embodiment. [Figure 35] Figure 34 is an example of a side perspective view of the inner frame, shown in a cylinder configuration. [Figure 36] This is an example of a side view of a leaflet band of an internal flow control component having a leaflet pocket, which is sutured within a structural band of pericardial tissue and shown in a linear configuration. [Figure 37]Figure 36 is an example of a bottom view of the leaflet band, shown as a linear configuration. [Figure 38] Figures 36 and 37 are illustrative side perspective views of the leaflet band, shown in a cylinder configuration suitable for coupling with the inner frame of Figure 35. [Figure 39] Figure 36 is an example of a side perspective view of a portion of a leaflet band, showing a single leaflet pocket sewn into the structural band. [Figure 40] Figures 36-39 show examples of bottom views of leaflet bands in a cylinder configuration, illustrating partial joining of leaflets to form a partially closed fluid seal. [Figure 41] Figures A through D illustrate various diagrams illustrating the process of transitioning a laterally deliverable transcatheter artificial heart valve to a compressed configuration for delivery, according to one embodiment. [Figure 42] Figures A through C illustrate various diagrams illustrating the process of transitioning a laterally deliverable transcatheter artificial heart valve to a compressed configuration for delivery, according to one embodiment. [Figure 43] Figures A through C illustrate various diagrams illustrating the process of transitioning a laterally deliverable transcatheter artificial heart valve to a compressed configuration for delivery, according to one embodiment. [Figure 44] Figure A is an example of a top view of a transcatheter artificial heart valve capable of lateral delivery, compressed and arranged within a delivery catheter, according to one embodiment. Figure B is an example of a top perspective view of the artificial heart valve of Figure 44A, partially released from the delivery catheter. [Figure 45] An example of a cross-sectional lateral view of a human heart with a transseptal delivery catheter traversing from the right atrium to the left atrium to access the mitral valve, according to one embodiment. An example of a lateral view of a human heart with a transseptal (transfemoral / IVC or SVC) delivery catheter traversing from the right atrium to the left atrium to access the mitral valve, according to one embodiment. [Figure 46] This is an example illustrating a process using a laterally deliverable distal fixation element of a transcatheter artificial heart valve for capturing self-tissue, according to one embodiment. [Figure 47] A side perspective view illustrating the process of deploying a transcatheter-deliverable artificial heart valve according to one embodiment is shown. [Figure 48] A side perspective view illustrating the process of deploying a transcatheter-deliverable artificial heart valve according to one embodiment is shown. [Figure 49] A side perspective view illustrating the process of deploying a transcatheter-deliverable artificial heart valve according to one embodiment is shown. [Figure 50] Figures A to D illustrate various diagrams of anterior fixation elements housed within a laterally deliverable transcatheter artificial heart valve according to one embodiment, and shown as a first configuration, a second configuration, a third configuration, and a fourth configuration, respectively. [Figure 51] Figures A through G illustrate various side perspective views of anchors for securing a portion of a laterally deliverable transcatheter artificial heart valve to the patient's own tissue, each representing a different embodiment. [Figure 52] This is an example of a side perspective view of a transcatheter artificial heart valve that can be delivered laterally and has a plurality of anterior fixing elements, according to one embodiment. [Figure 53] This is an example of a side perspective view of a transcatheter artificial heart valve that can be delivered laterally and has a plurality of anterior fixing elements, according to one embodiment. [Figure 54] This is an example of a side perspective view of a transcatheter artificial heart valve that can be delivered laterally and has a distal fixing element with gradient rigidity, according to one embodiment. [Figure 55] A is an example of a lateral perspective view of a transcatheter prosthetic heart valve that can be delivered laterally and has distal and proximal fixation elements according to one embodiment. B is an example of a lateral perspective view of the prosthetic heart valve of Figure 55A deployed within the annulus of the native valve. [Figure 56] A is an example of a lateral perspective view of a transcatheter prosthetic heart valve that can be delivered laterally and has distal and proximal fixation elements, according to one embodiment. B is an example of a lateral perspective view of the prosthetic heart valve of Figure 56A deployed within the annulus of the native valve. [Figure 57]A is an example of a lateral perspective view of a transcatheter prosthetic heart valve that can be delivered laterally and has distal and proximal fixation elements, according to one embodiment. B is an example of a lateral perspective view of the prosthetic heart valve of Figure 57A deployed within the annulus of the native valve. [Figure 58] A is an example of a guidewire delivery catheter that provides access to, for example, the A1-P1 target region of a self-valve, according to one embodiment. B is an example of a magnified view of a portion of the guidewire delivery catheter in Figure 58A. [Figure 59] This is an example of a surrounding balloon arranged around the end of a delivery catheter, according to one embodiment. [Figure 60] This is an example of a side view of the distal end of a sheath housed within a delivery system and having a lateral port for delivering a guidewire, for example, to the A1-P1 target region of a self-valve, according to one embodiment. [Figure 61] Figure 60 shows an example of a cross-sectional view of the sheath, which engages with the self-organizing tissue and allows the lateral ports to deliver the guidewire. [Figure 62] This is an example of a laterally deliverable transcatheter artificial heart valve having a septal tether configured to secure the artificial heart valve within the annulus of the native valve, according to one embodiment. [Figure 63] This is an example of a cross-sectional view of a transcatheter artificial heart valve that can be delivered laterally according to one embodiment, and is fixed within the annulus of the native valve. [Figure 64] This is an example of a side view of a portion of a delivery system having a docking receptacle with key-like and / or tissue-grasping features for fixing to an open wall of self-organic tissue, according to one embodiment. [Figure 65] This is an example of a magnified view of at least a portion of the tissue gripping feature shown in Figure 64, which is shown as being fixed to an empty wall. [Figure 66] This flowchart illustrates a method for deploying a transcatheter-deliverable artificial heart valve into the annulus of a native valve, according to one embodiment. [Modes for carrying out the invention]

[0009] The disclosed embodiments relate to transcatheter prosthetic heart valves and / or components thereof, as well as methods for manufacturing, loading, delivering, and / or deploying transcatheter prosthetic valves and / or components thereof. In some embodiments, a laterally deliverable prosthetic heart valve includes an outer frame having an outer wall circumscribing a central channel extending along a central axis, and a flow control component mounted within the central channel. This flow control component includes an inner frame and a set of leaflets coupled to the inner frame. The prosthetic valve is foldable along its longitudinal axis and compressible along its central axis to mount the prosthetic valve in a compressed configuration for delivery through a delivery catheter. The longitudinal axis is substantially parallel to the longitudinal axis of the delivery catheter when the prosthetic valve is positioned within the delivery catheter. The prosthetic valve is configured to transition to an expanded configuration when the prosthetic valve is released from the delivery catheter. The prosthetic valve further includes a distal fixation element having a first end coupled to the distal side of the outer wall of the outer frame and a second end opposite to the first end. This second end is configured to selectively engage with the guidewire, allowing the distal fixation element to advance along the guidewire during the deployment of the prosthetic valve. The distal fixation element is in an extended configuration during deployment, which allows it to capture at least one of the self-leaflet or notochord. In response to the guidewire being disengaged from the second end, the distal fixation element transitions to a folded configuration in which at least one of the self-leaflet or notochord is fixed between the distal fixation element and the distal side of the outer wall.

[0010] In some embodiments, a laterally deliverable artificial heart valve includes an outer frame having an outer wall circumscribing a central channel extending along a central axis, and a flow control component mounted within the central channel. This flow control component includes an inner frame and a set of leaflets coupled to the inner frame. The artificial valve is foldable along its longitudinal axis and compressible along its central axis to mount the valve in a compressed configuration for delivery via a delivery catheter. The longitudinal axis is substantially parallel to the longitudinal axis of the delivery catheter when the artificial valve is positioned within the delivery catheter. The artificial valve is configured to transition to an expanded configuration when the artificial valve is released from the delivery catheter. The artificial valve further includes a distal fixation element coupled to the distal side of the outer wall of the outer frame and an anterior fixation element coupled to the anterior side of the outer wall. The distal fixation element is releasably coupled to a guidewire and is configured to advance along the guidewire when in an extended configuration to capture at least one of the distal self-leaflet or the distal notochord. The distal fixation element, when released from the guidewire, transitions to a folded configuration to fix the distal self-leaflet or distal notochord between the distal fixation element and the distal side of the outer wall. The anterior fixation element includes a sleeve and an anterior clip at least partially disposed within the sleeve. The anterior clip can transition between a first configuration in which the anterior clip extends from the sleeve in the direction of the central axis, allowing the anterior clip to capture at least one of the anterior self-leaflet or anterior notochord, and a second configuration in which the anterior clip at least partially retracts into the sleeve, fixing the anterior self-leaflet or anterior notochord between the anterior clip and the anterior side of the outer wall.

[0011] Any of the artificial heart valves described herein may be relatively small profile, laterally deliverable, and implantable. Any of these artificial heart valves may be transcatheter artificial heart valves configured to be delivered into the heart via a delivery catheter. An artificial heart valve may have at least an annular lateral valve frame and an internal flow control component (e.g., a 2-leaflet or 3-leaflet valve, sleeve, etc.) mounted within the valve frame. In addition, an artificial heart valve may include one or more fixation elements configured to secure the valve within the annulus of the own valve.

[0012] Any of the artificial heart valves described herein may be configured to transition between an expansion configuration and a compression configuration. For example, any of the embodiments described herein may be a balloon-inflatable artificial heart valve, a self-expanding artificial heart valve, and the like.

[0013] Any of the artificial heart valves described herein may be compressible into a compression configuration longitudinally or perpendicularly to the central axis of the flow control component, thereby enabling, for example, the direct delivery and deployment of a large-diameter valve (e.g., having a height of approximately 5–60 mm and a diameter of approximately 20–80 mm) from the inferior vena cava into the annulus of the native mitral or tricuspid valve, without using a 24–36 Fr delivery catheter and without delivery and deployment from the delivery catheter at an acute approach angle.

[0014] Any of the artificial heart valves described herein may have a central axis that is coaxial with, or at least substantially parallel to, the direction of blood flow through the valve. In some embodiments, the compression configuration of the valve is perpendicular to the direction of blood flow. In some embodiments, the compression configuration of the valve is parallel to or aligned with the direction of blood flow. In some embodiments, the valve can be compressed into a compression configuration in two directions: perpendicular to the direction of blood flow (e.g., lateral) and parallel to the blood flow (e.g., axial). In some embodiments, when in the compression configuration and / or expansion configuration, the major axis or longitudinal axis is oriented at an intersection angle of 45 to 135 degrees with respect to the first direction.

[0015] Any of the artificial heart valves described herein may include an external support frame comprising a set of compressible wire cells having an orientation and cell geometry substantially orthogonal to a central axis, which can minimize wire cell strain when the external support frame is in a compression configuration, a rolled compression configuration, or a folded compression configuration.

[0016] In some embodiments, the outer support frame has a lower body portion and an upper collar portion. The lower body portion forms a shape such as a funnel, cylinder, flattened cone, or circular hyperboloid when the outer support frame is in an extended configuration. In some embodiments, the outer support frame is formed from wire, braided wire, or laser-cut wire frame and covered with a biocompatible material. This biocompatible material may be covered such that the inner surface is covered with pericardial tissue and the outer surface is covered with a woven synthetic polyester material, and / or the inner surface is covered with pericardial tissue and the outer surface is covered with a woven synthetic polyester material.

[0017] In some embodiments, the outer support frame has a flattened conical side profile having an outer diameter R of 40 to 80 mm, an inner diameter r of 20 to 60 mm, and a height of 5 to 60 mm. In some embodiments, the valve ring support frame has an hourglass-shaped side profile having an upper diameter R1 of 40 to 80 mm, a bottom diameter R2 of 50 to 70 mm, an inner diameter r of 20 to 60 mm, and a height of 5 to 60 mm.

[0018] Any of the artificial heart valves described herein may include one or more fixation elements extending from the side wall of the valve frame. For example, any of the artificial heart valves may include a distal fixation element, which may be used, for example, as a right ventricular outflow duct ("RVOT") tab or a left ventricular outflow duct ("LVOT") tab. Any of the valves described herein may also include a fixation element extending from the proximal side of the valve frame, which may be used to fix the valve, for example, in the subannular space of the proximal valve. Any of the valves described herein may also include anterior or posterior fixation elements extending from the anterior or posterior side of the valve frame, respectively. These fixation elements may include, and / or be formed from, wire loops or wire frames, integrated frame portions, and / or stents extending about 10 to 40 mm away from the tubular frame.

[0019] Any of the artificial heart valves described herein may include: (i) an upper fixing element attached to the distal upper end of a tubular frame, which may include, or may be formed from, a wire loop or wire frame extending about 2 to 20 mm away from the tubular frame; and (ii) a lower fixing element extending from the distal side of the tubular frame (for example, used as an RVOT tab), which may include, and / or may be formed from, a wire loop or wire frame extending about 10 to 40 mm away from the tubular frame.

[0020] Any of the artificial heart valves described herein may include a distal lower fixation element configured to be positioned within the RVOT of the right ventricle, and a proximal lower fixation element configured to be positioned in contact with and / or adjacent to the subannular tissue of the right ventricle. Transcatheter artificial heart valves may also include a distal upper fixation element configured to be positioned in contact with and / or adjacent to the suprannular tissue of the right atrium. The distal upper fixation element can provide an annular-upper force toward the right ventricle, and the distal and proximal lower fixation elements can provide an annular-upper force toward the right atrium.

[0021] Any artificial heart valve described herein may include an internal flow control component having a leaflet frame with two to four flexible leaflets mounted on top. These two to four leaflets are configured to allow blood flow in a first direction through the inlet end of the flow control component and to block blood flow in a second direction opposite to the first direction through the outlet end of the flow control component. The leaflet frame may include two or more panels of rhomboid or pupil-shaped wire cells made of a heat-set shape memory alloy material such as Nitinol. The leaflet frame may be configured to be foldable along the z-axis (e.g., longitudinal axis) from a rounded or cylindrical configuration to a flattened cylindrical configuration, and to be compressible along the perpendicular y-axis (e.g., central axis) to a compression configuration. In some implementations, the leaflet frame may include a pair of hinge portions, folding portions, connection points, etc., which may allow the leaflet frame to be flattened along the z-axis before it is compressed along the perpendicular y-axis. The inner frame can be a single-piece structure having, for example, two or more integrally molded hinges (e.g., stress concentration risers, and / or any suitable structure configured to allow elastic / non-permanent deformation of the inner frame). In other implementations, the inner frame may be a two-piece structure in which the hinge portion is formed using a secondary attachment method (e.g., stitching, fabric, molded polymer components, etc.).

[0022] In some embodiments, the internal flow control component in the extended configuration forms a shape such as a funnel, cylinder, flattened cone, or circular hyperboloid. In some embodiments, the internal flow control component has a leaflet frame having a flattened conical side profile with an outer diameter R of 20 to 60 mm and an inner diameter r of 10 to 50 mm, where the diameter R is greater than the diameter r and the height is 5 to 60 mm. In some embodiments, the leaflet frame consists of wire, braided wire, or laser-cut wire. In some embodiments, the leaflet frame may have one or more longitudinal supports integrated therein or mounted thereon, selected from rigid or semi-rigid columns, rigid or semi-rigid ribs, rigid or semi-rigid batons, rigid or semi-rigid panels, and combinations thereof.

[0023] Any of the artificial heart valves described herein, and / or any of their components, features, and / or aspects, are subject to International Patent Application PCT / US2019 / 051957, titled "Transcatheter Deliverable Prosthetic Heart Valves and Method of Delivery" (hereinafter referred to as "'957PCT"), filed on 19 September 2019; International Patent Application PCT / US2019 / 067010, titled "Transcatheter Deliverable Prosthetic Heart Valves and Methods of Delivery" (hereinafter referred to as "'010PCT"), filed on 18 December 2019; and / or "Collapsible Inner Flow Control Component for Side-Deliverable Transcatheter Heart Valve" filed on 27 January 2020. Artificial heart valves (or their components, features, and / or aspects) described in international patent application PCT / US2020 / 015231 entitled “Prosthesis” (hereinafter referred to as “'231PCT”) may be similar to, and / or substantially the same as, those described herein, and the disclosures of the above references are incorporated herein by reference in their entirety.

[0024] In some implementations, the prosthetic valve may be configured, for example, for deployment within the annulus of the native mitral valve. The use of a laterally deliverable transcatheter mitral valve replacement unit allows a relatively large-diameter valve to be delivered and deployed transseptally into the mitral valve from the inferior vena cava without requiring an extra-large diameter catheter or a sharp-angled approach from the catheter.

[0025] In some embodiments, the artificial mitral valve may include one or more fixation elements configured to secure the artificial valve within the annulus of the natural valve. For example, an artificial mitral valve as described herein may include a distal fixation element, a proximal fixation element, and one or more anterior or posterior fixation elements (e.g., anterior A1, A2, or A3 fixation elements and / or posterior PI, P2, or P3 fixation elements).

[0026] In some embodiments, the artificial mitral valve includes a distal fixation tab, which (i) extends around the posterior leaflet and / or notochord using a guidewire to capture the self-mitral valve leaflet and / or notochord tissue, and (ii) shortens when the guidewire is withdrawn to pin the self-tissue against the sidewall of the valve. In some embodiments, the valve further includes a proximal fixation element configured to fix the proximal side of the valve using a tab or loop that unfolds in the A3-P3 (proximal) commissure region of the self-mitral valve. In some embodiments, the valve further includes an A2 clip, which is configured to similarly extend or unfold (e.g., via a guidewire or self-actuated) to capture the leaflet and / or notochord tissue of the self-mitral valve, and also pin the self-tissue against the sidewall of the valve when the guidewire is withdrawn and / or when the A2 clip is retracted or refolded. In some embodiments, the A2 clip may be formed from braided polyethylene, treated pericardial tissue, ePTFE, or nitinol, and may have one or more radiopaque markers.

[0027] In some embodiments, a delivery system for delivering a laterally deliverable artificial heart valve may include a catheter that can deliver a guidewire directly to the A1-P1 commissure of the native mitral valve. In some implementations, by targeting the A1-P1 commissure region, a laterally deliverable valve, as described herein, can be directed to the target region via the delivery catheter to achieve valve deployment.

[0028] Any of the delivery systems described herein may include a guidewire catheter that can be used independently of the valve delivery catheter. In some embodiments, the guidewire catheter has a custom shape that connects the distal end of the guidewire catheter to the A1 / P1 commissure facing posterior to the posterior self-leaflet. In some embodiments, the guidewire catheter may be used before insertion of the valve delivery catheter or may be passed through the valve delivery catheter before loading the valve, and can exit straight through the main lumen through a lateral port communicating with the main lumen. After the guidewire has been placed, the guidewire catheter can be removed from the patient.

[0029] Any of the delivery systems described herein may include a delivery catheter for a laterally deliverable artificial heart valve, the delivery catheter may include an outer shaft having an outer proximal end, an outer distal end, and an outer shaft lumen, the outer distal end being closed with a non-traumatic ball fitted thereon. The outer shaft lumen has an inner diameter of 8 to 10 mm, sized to allow a laterally delivered transcatheter artificial heart valve (e.g., an artificial tricuspid valve and / or artificial mitral valve) to pass through its outer shaft lumen.

[0030] Any method for manufacturing an artificial heart valve described herein may include generating a self-expanding outer support frame having a central channel and an outer outer wall circumscribing a central vertical axis, using additive or subtractive metal or metal alloy manufacturing. A collapsible flow control component is mounted within the outer support frame and configured to allow blood flow in a first direction through the valve's inlet end and to block blood flow in a second direction opposite to the first direction through the valve's outlet end. The flow control component has a leaflet frame with two to four flexible leaflets mounted on it. This leaflet frame may be formed using additive or subtractive metal or metal alloy manufacturing. Additive metal or metal alloy manufacturing may include 3D printing, direct metal laser sintering (powder melting), etc. Subtractive metal or metal alloy manufacturing may include photolithography, laser sintering / cutting, CNC machining, electrostatic discharge machining, etc. In some embodiments, the manufacturing process may further include mounting flow control components within an outer support frame and covering the outer surface of the outer support frame with pericardial material or a similar biocompatible material.

[0031] Any method for delivering an artificial heart valve as described herein 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 and mounting the valve in a compressed configuration; (ii) rolling the valve unilaterally into a compressed configuration from one side of an annular support frame; (iii) rolling the valve bilaterally into a compressed configuration from two opposing sides of annular support frame; (iv) flattening the valve into two parallel panels substantially parallel to the long axis; (v) flattening the valve into two parallel panels substantially parallel to the long axis and then rolling the flattened valve into a compressed 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 and mounting the valve in a compressed configuration.

[0032] Any method for delivering an artificial heart valve described herein may include orthogonal delivery of an artificial heart valve to a desired location in the body, comprising (i) advancing a delivery catheter to a desired location in the body, and (ii) delivering the artificial heart valve to the desired location in the body by releasing the valve from the delivery catheter. The valve is in a compressed configuration when it is in the delivery catheter and transitions to an expanded configuration when it is released from the delivery catheter.

[0033] Any method for delivering an artificial heart valve as described herein may include (i) pulling the valve out of the delivery catheter using a tensile member (e.g., a wire or rod) releasably connected to a sidewall, drum or collar and / or a fixing element (e.g., a distal fixing element), thereby advancing the tensile member away from the delivery catheter, thereby pulling out the compressed valve, or (ii) pushing the valve out of the delivery catheter using an extrusion member (e.g., a wire, rod, catheter, delivery member, etc.) releasably connected to a sidewall, drum or collar and / or a fixing element (e.g., a distal fixing element), thereby pushing out the compressed valve, or (ii) releasing the valve from the delivery catheter by pushing the extrusion member out of the delivery catheter.

[0034] In some embodiments, a method for deploying a laterally deliverable prosthetic heart valve to a patient involves advancing a guidewire into the atrium through a plane defined by the annulus of the progenitor valve and behind the progenitor leaflet of the progenitor valve. The prosthetic valve advances into the atrium through the lumen of the delivery catheter in an orthogonal compression configuration. The prosthetic valve includes a distal fixation element that is releasably coupled to the guidewire, and for this purpose, the prosthetic valve advances along a portion of the guidewire. The prosthetic valve is released from the delivery catheter, allowing at least a portion of the prosthetic valve to transition to an expanded configuration, and as a result, the distal fixation element is in an extended configuration after release. The prosthetic valve advances along the guidewire to (i) position the distal fixation element behind the progenitor leaflet, and (ii) seat the prosthetic valve within the annulus of the progenitor valve. The guidewire is withdrawn, releasing the distal fixation element into its folded position, allowing the distal fixation element to capture at least one of the autologous leaflet or notochord, thereby fixing the autologous leaflet or notochord between the distal fixation element and the outer wall of the prosthetic valve.

[0035] Any method for delivering and / or deploying an artificial heart valve as described herein may include: (i) partially releasing the valve from the delivery catheter to establish blood flow around the partially released valve and through the flow control components; (ii) fully releasing the valve from the delivery catheter while maintaining attachment to the valve to transition to a state in which blood flow through the flow control components is increased and blood flow around the valve is decreased; (iii) deploying the valve to its final placement position within the annulus to complete blood flow through the flow control components and transition to a state in which blood flow around the valve is minimized or absent; and (iv) releasing the valve from the delivery catheter while increasing blood flow during valve deployment by detaching and withdrawing the positioning catheter and pulling or pushing the wire or rod and / or delivery catheter.

[0036] Any method for delivering and / or deploying an artificial heart valve described herein may include positioning the valve or a portion thereof in a desired position relative to the patient's own tissue. For example, the method may include positioning the distal fixation tab of the valvular prosthesis in the ventricular outflow duct of the left or right ventricle. In some embodiments, the method may further include positioning the upper distal fixation tab on the annulus, where the upper distal fixation tab applies a downward force on the annulus toward the ventricle, and the distal fixation tab (e.g., the lower distal fixation tab) applies an upward force below the annulus toward the atrium. In some embodiments, the method may include rotating the valvular prosthesis using a maneuverable catheter along an axis parallel to the plane of the valve annulus. In some embodiments, the method may include fixing the valve in a desired position by securing one or more tissue anchors attached to the valve within the patient's own tissue.

[0037] Any method for delivering and / or deploying an artificial heart valve described herein may include orthogonal delivery of the artificial heart valve to the annulus of the human heart, the orthogonal delivery of which includes at least one of the following: (i) advancing a delivery catheter through the femoral vein and the inferior vena cava (IVC) to the tricuspid valve or pulmonary artery of the heart; (ii) advancing a delivery catheter through the jugular vein and the superior vena cava (SVC) to the tricuspid valve or pulmonary artery of the heart; or (iii) advancing a transatrial approach (e.g., fossa ovalis or inferior) through an IVC-femoral or SVC-cervical approach to the mitral valve of the heart; and (iv) delivering and / or deploying the artificial heart valve to the annulus of the heart by releasing the valve from the delivery catheter.

[0038] In some embodiments, a method for delivering and / or deploying an artificial heart valve described herein to a patient's own mitral valve may include advancing a guidewire transseptally into the left atrium through the annular plane at the A1 / P1 commissure to a position posterior to the patient's own posterior (e.g., P2) leaflet of the patient's mitral valve. A delivery catheter housing the valve in an orthogonal compression configuration advances the delivery catheter into the patient's left atrium, and the distal fixation tab of the valve is screwed onto the guidewire. In some embodiments, an A2 clip may be optionally screwed onto the guidewire. The valve is released from the delivery catheter, and the distal fixation tab is in an open configuration, tracking the guidewire during release. The valve advances along the guidewire, moving the distal fixation tab to a position posterior to the patient's own posterior leaflet, and seating the valve within the patient's own annulus. The guidewire is withdrawn to release the distal fixation tab to the folded position, allowing the tab to capture the self-leaflet and / or self-notochord, and enabling the self-leaflet and / or notochord to be sandwiched between the folded tab and the outer wall of the valve. In some embodiments, the method may optionally include pulling the guidewire back to the A2 clip release position to release the A2 clip to the open position, which may enable the A2 clip to capture the self-leaflet and / or self-notochord, and enable the self-leaflet and / or notochord to be sandwiched between the A2 clip and the outer wall of the valve ring support frame.

[0039] In some embodiments, the method may include, at least in part, delivering and / or deploying a valve via a single fixed-flex catheter, a single deflectable catheter, an outer fixed-flex catheter having an inner fixed-flex catheter, an outer fixed-flex catheter having an inner deflectable catheter, and an outer deflectable catheter having an inner fixed-flex catheter.

[0040] Any method for delivering and / or deploying an artificial heart valve and / or any part thereof as described herein may be similar to, and / or substantially the same as, one or more methods for delivering and / or deploying an artificial heart valve (or part thereof) as described in '957PCT, '010PCT, and / or '231PCT.

[0041] The technical terms used herein are for the sole purpose of describing specific embodiments and are not intended to limit the entire scope of the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art. Nothing in this disclosure should be construed as acknowledging that the embodiments described herein do not have prior rights to such disclosures for the sake of prior art.

[0042] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. With regard to any substantially plural and / or singular use of terms herein, those skilled in the art can convert from plural to singular and / or singular to plural as appropriate to the context and / or use. Various singular / plural substitutions may be explicitly stated herein for clarity.

[0043] In general, terms used herein, particularly in the appended claims (e.g., the text of the appended claims), are intended to be “open” terms (for example, the term “includes” should be interpreted as “includes, but not limited to,” and the term “has” should be interpreted as “has at least,” etc.). Similarly, where used herein, the terms “comprises” and / or “comprising” specify the presence of described features, completes (or parts thereof), steps, actions, elements, and / or components, but do not exclude the presence or addition of one or more other features, completes (or parts thereof), steps, actions, elements, components, and / or groups thereof. Where used herein, the term “includes” means “includes, but not limited to.”

[0044] Where used herein, the terms “and / or” or the expressions “selected from” or “selected from the group consisting of” or “selected from one or more of” include any combination of one or more of the related enumerated items and all combinations thereof. It should be understood that substantially any disjunctive “and / or” expression indicating two or more alternative terms, whether in the specification, claims, or drawings, should be understood to construed as constituting the possibility of including one of the terms, either of the terms, or both of the terms. For example, the expression “A or B” is understood to include the possibilities of “A” or “B” or “A and B.”

[0045] All scopes disclosed herein also include, unless expressly otherwise specified, all possible subscopes and combinations thereof. Any scope enumerated should be recognized as sufficiently representative and enabling that the same scope is classified as part of at least an equal part unless otherwise specified. As a person skilled in the art will understand, the scope includes each individual member.

[0046] The terms “valve prosthesis,” “artificial heart valve,” and / or “prosthetic valve” may refer to a combination of a frame and leaflet or flow control structure or component, and may encompass both complete replacement of an anatomical part (e.g., a new mechanical valve replacing the native valve) and medical devices that replace and / or assist, repair, or improve an existing anatomical part (e.g., the native valve is left in place).

[0047] The disclosed valve includes members (e.g., frames) that may be seated within their own ring and may be used as leaflet structures, flow control components, or mounting elements for flexible reciprocating sleeves or sleeve valves. Depending on the embodiment, such leaflet structures or flow control components may or may not be included. Such members may be referred to herein as “ring support frames,” “tubular frames,” “wire frames,” “valve frames,” “flanges,” “collars,” and / or any other similar terms.

[0048] The term “flow control component” can, in an unrestricted sense, refer to a leaflet structure having two, three, or four leaflets of a flexible, biocompatible material such as treated or untreated pericardium, sewn or bonded to an annular support frame, in order to function as an artificial heart valve. Such a valve may be a heart valve such as a tricuspid, mitral, aortic, or pulmonary valve, which opens to blood flowing from the atrium to the ventricle during diastole and closes due to systolic ventricular pressure applied to its outer surface. The continuous opening and closing motion can be described as a “reciprocating motion.” Flow control components are expected to include a wide variety of (bio)artificial heart valves. Bioartificial pericardial valves may include bioartificial aortic valves, bioartificial mitral valves, bioartificial tricuspid valves, and bioartificial pulmonary valves.

[0049] Any of the disclosed valve embodiments may be delivered by a transcatheter approach. The term “transcatheter” is used to define medical devices or instruments within the lumen of a catheter deployed into a cardiac chamber (or other desired location in the body), and the process of accessing, controlling, and / or delivering items delivered or controlled by such a process. Transcatheter access is known to include 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 space (ribs) and / or subxiphoid space, and / or similar. Furthermore, transcatheter cardiac access may be via the inferior vena cava (IVC), superior vena cava (SVC), and / or transatrial (e.g., fossa ovale or lower). Transcatheter may be synonymous with translumen, which is functionally related to the term “percutaneous” in relation to the delivery of cardiac valves. As used herein, the term “lumen” may refer to the inside of a cylinder or tube. The term "perforation" can refer to the inner diameter of a lumen.

[0050] The mode of cardiac access is obtained at least in part on a “body channel,” which may be used to define a blood conduit or blood vessel within the body, and the body channel in question is determined by the specific application of the disclosed embodiment of the prosthetic valve. For example, an aortic valve replacement is implanted in or adjacent to the aortic annulus. Similarly, a tricuspid or mitral valve replacement is implanted in the tricuspid or mitral annulus. Certain mechanisms are particularly advantageous for one implantation site or the other. However, unless the combination is structurally impossible or excluded by the language of the claims, any embodiment of the valve described herein can be implanted in any body channel.

[0051] The term “expandable,” as used herein, may refer to a component of a heart valve that can expand from a first delivery diameter to a second implantation diameter. Therefore, an expandable structure does not mean a structure that may undergo slight expansion due to rising temperature or other such incidental causes. Conversely, “non-expandable” should not be interpreted as meaning completely rigid or dimensionally stable, as some expansion may be observed in, for example, conventional “non-expandable” heart valves.

[0052] Any of the disclosed valve embodiments may be delivered by conventional transcatheter delivery techniques or by orthogonal delivery techniques. For example, conventional delivery of an artificial valve may be such that the central cylinder axis of the valve is substantially parallel to the longitudinal axis of the delivery catheter. Typically, the valve is compressed radially with respect to the central cylinder axis and advances 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.

[0053] Where used herein, terms such as “lateral delivery,” “lateral delivery,” “orthogonal delivery,” and “orthogonal delivery” may be used interchangeably to describe such delivery methods and / or valves delivered using such methods. Lateral or orthogonal delivery of an artificial valve may be such that the central cylinder axis of the valve is substantially orthogonal to the longitudinal axis of the delivery catheter. In orthogonal delivery, the valve is compressed (or otherwise reduced in size) in a direction substantially parallel to the central cylinder axis and / or laterally with respect to the central cylinder axis. Thus, the long axis (e.g., longitudinal axis) of an orthogonally delivered valve is substantially parallel to the longitudinal axis of the delivery catheter. In other words, an orthogonally delivered artificial valve is compressed and / or delivered at an angle of about 90 degrees compared to conventional processes for compressing and delivering transcatheter artificial valves. Furthermore, artificial valves configured to be orthogonally delivered and processes for delivering such valves are described in detail in the '957 PCT and / or '010 PCT, which are incorporated herein by reference.

[0054] Mathematically, the term “orthogonal” refers to a 90-degree intersection angle between two lines or planes. As used herein, the term “substantially orthogonal” refers to an intersection angle of 90 degrees ± a preferred tolerance. For example, “substantially orthogonal” may refer to an intersection angle in the range of 75 to 105 degrees.

[0055] As used herein, the term “tissue anchor” generally refers to a fastening device that connects a portion of the outer frame of an artificial valve to the annular tissue, typically the periphery or vicinity of the collar of the artificial valve. The tissue anchor may be positioned to avoid penetrating the tissue and rely solely on the compressive force of two plate-like collars on the captured tissue, or it may provide fixation by penetrating the tissue (with or without an integrated fixing wire), or a combination of both. The tissue anchor may have a fixing mechanism such as a pointed tip, groove, flanged shoulder, fastener, or one or more openings. In some embodiments, the fixing mechanism may be attached to or fixed to a portion of the outer frame by any attachment or fixing mechanism including knots, sutures, wire crimps, wire stoppers, cam mechanisms, or a combination thereof.

[0056] Artificial valves and / or their components may be manufactured from 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 components), and / or their components may be manufactured from biocompatible metals, metal alloys, polymer-coated metals, etc. Suitable biocompatible metals and / or metal alloys include stainless steel (e.g., 316L stainless steel), cobalt-chromium (Co-Cr) alloys, and nickel-titanium alloys (e.g., Nitinol®). Furthermore, either the outer frame or inner frame described herein may be formed from a superelastic alloy or shape memory alloy such as nickel-titanium alloy (e.g., Nitinol®). Suitable polymer coating materials include polyethylene vinyl acetate (PEVA), polybutyl methacrylate (PBMA), transroot styrene-isoprene butadiene (SIBS) copolymer, polylactic acid, polyester, polylactide, D-polylactic acid (DLPLA), and polyglycolic acid (PLGA). Some such polymer coatings can form suitable carrier matrices for drugs such as sirolimus, zotalolimus, biolimus, novolimus, tacrolimus, paclitaxel, and probucol.

[0057] Some biocompatible synthetic materials include, for example, polyester, polyurethane, and polytetrafluoroethylene (PTFE) (e.g., Teflon). When thin and durable synthetic materials are required (e.g., for coatings), synthetic polymer materials such as foamed PTFE or polyester may be used optionally. Other suitable materials may optionally include elastomers, thermoplastics, polyurethanes, thermoplastic polycarbonate urethanes, polyether urethanes, segmented polyether urethanes, silicone polyether urethanes, polyether ether ketones (PEEK), silicone polycarbonate urethanes, polypropylene, polyethylene, low-density polyethylene (LDPE), high-density polyethylene (HDPE), ultra-high-density polyethylene (UHDPE), polyolefins, polyethylene glycol, polyether sulfones, polysulfones, polyvinylpyrrolidones, polyvinyl chloride, other fluoropolymers, polyesters, polyethylene terephthalate (PET) (e.g., Dacron), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide / glycolide) copolymers (PDLA), silicone polyesters, polyamides (nylon), PTFE, stretched PTFE, foamed PTFE, siloxane polymers and / or oligomers, and / or polylactones, or block copolymers using the same.

[0058] The outer valve frame, the inner valve frame (e.g., of the flow control components), and / or any part or component thereof may be partially or completely covered internally or externally with a biocompatible material such as pericardium. The valve frame may be optionally partially or completely covered externally with a second biocompatible material such as polyester or Dacron®. In the disclosed embodiments, biological tissue may be used, which is a chemically stabilized pericardial tissue of an animal such as a cow (bovine pericardium), sheep (sheep pericardium), pig (pig pericardium), or horse (horse pericardium). Preferably, the tissue is bovine pericardial tissue. Examples of suitable tissues include those used in the products Duraguard®, Peri-Guard®, and Vascu-Guard®, which are currently used in surgical procedures and are commercially available, generally taken from cattle less than 30 months of age.

[0059] The embodiments described herein, and / or their various features or advantageous details, are more fully described with reference to non-limiting embodiments shown in the accompanying drawings and described in detail in the following description. Descriptions of well-known components and processing techniques are omitted so as not to unnecessarily obscure the embodiments described herein. The examples used herein are intended solely to aid in understanding how the embodiments described herein may be practiced and to further enable those skilled in the art to practice the embodiments described herein. Therefore, the examples should not be construed as limiting the scope of the embodiments described herein. Rather, these embodiments are provided so that this disclosure is complete and comprehensive and fully conveys the scope of the concepts of the invention to those skilled in the art. Similar figures refer to similar elements throughout.

[0060] Figures 1A to 1E are schematic diagrams of various transcatheter prosthesis valves 102 according to one embodiment. The transcatheter prosthesis valve 102 is configured to be deployed at a desired location within the body (e.g., a human patient) and to allow blood flow in a first direction through the inlet end of the transcatheter prosthesis valve 102 and to block blood flow in a second direction opposite to the first direction, through the outlet end of the transcatheter prosthesis valve 102. For example, the transcatheter prosthesis valve 102 may be a transcatheter prosthesis valve configured to be deployed within the annulus of the human heart's own tricuspid valve or mitral valve to complement and / or replace the function of the own valve.

[0061] The transcatheter prosthetic valve 102 (also referred to herein as the “prosthetic valve” or simply the “valve”) is compressible and expandable in at least one direction with respect to the long axis 111 of the valve 102 (also referred herein as the “horizontal axis,” “longitudinal axis,” or “length axis”). The valve 102 is compressible and expandable between an expandable configuration for implantation at a desired location within the body (e.g., a human heart) (Figures 1A, 1C, and IE) and a compressible configuration for introduction into the body using a delivery catheter 172 (Figures 1B and 1D).

[0062] In some embodiments, the valve 102 may be centrally or radially symmetric. In other embodiments, the valve 102 may be eccentric with respect to the y-axis or central axis 113, or radially asymmetric. In some eccentric embodiments, the valve 102 (or its outer frame) may have a D-shape (viewed from above) so that the flat portion can coincide with the anatomical structure into which the valve 102 is deployed. For example, in some cases, the valve 102 may be deployed within the tricuspid annulus and may have a complex shape determined by the anatomical structure into which the valve 102 is fitted. In the tricuspid annulus, the periphery of the tricuspid valve may be a rounded ellipse, the septum is known to be substantially vertical, and the tricuspid valve is known to expand in diseased conditions along the anterior-posterior line. In other examples, the valve 102 may be deployed within the mitral annulus (e.g., near the anterior leaflet of the mitral valve) and may have a complex shape determined by the anatomical structure into which the valve 102 is fitted. For example, in the mitral valve annulus, the area around the mitral valve can be a rounded oval shape, the septal wall is known to be substantially vertical, and the mitral valve is known to enlarge in diseased conditions.

[0063] In some embodiments, the valve 102 (and / or at least a portion thereof) may begin as a broadly tubular structure and be heat-molded and / or formed into any desired shape. In some embodiments, the valve 102 may include an upper atrial cuff or flange for sealing the atrium and a lower transannular portion (e.g., body portion, tubular portion, cylinder portion, etc.) having an hourglass cross-section over about 60–80% of its circumference, which may be matched to the septal annular segment while maintaining substantially vertical flattening along 20–40% of the circumference of the annulus, while matching the annular segment along the posterior and anterior annular segments. The valve 102 is shown in Figures 1A–1E as having a given shape, but it should be understood that the size and / or shape of the valve 102 (and / or at least a portion thereof) may be based on the size and / or shape of the anatomical structure of the own tissue.

[0064] As shown, the valve 102 generally includes an annular support frame 110 and a flow control component 150. In addition, the valve 102, and / or at least the annular support frame 110 of the valve 102, may optionally include one or more fixing elements. For example, in the embodiments shown in Figures 1A-1E, the annular support frame 110 includes at least a distal fixing element 132. In other embodiments, the annular support frame 110 may optionally include a proximal fixing element 134, an anterior fixing element 135, and / or any other suitable fixing elements (not shown in Figures 1A-1E). In some implementations, the distal fixing element 132, the proximal fixing element 134, and the anterior fixing element 135 may be lower fixing elements, and the valve 102 and / or the annular support frame 110 may include one or more upper fixing elements (e.g., a distal upper fixing element, a proximal upper fixing element, etc. (not shown)). In some implementations, valve 102 and / or embodiments or parts thereof may be similar to, and / or substantially identical to, valves (and / or corresponding embodiments or parts thereof) described in detail in the '957 PCT, '010 PCT, and / or '231 PCT, which are incorporated herein by the foregoing reference. Accordingly, certain embodiments, parts, and / or details of valve 102 may not be described in further detail herein.

[0065] The annular support frame 110 (also referred to herein as the “tubular frame,” “valve frame,” “wire frame,” “outer frame,” or “frame”) has or may have an opening or central channel 114 extending along a central axis 113 (e.g., the y-axis). The central channel 114 (e.g., a lumen or channel in the direction of the central axis) may be sized and configured to receive a flow control component 150 across a portion of the diameter of the central channel 114. The frame 110 may have an outer surface for engaging with annular tissue that can be pulled against the inner surface of the annular ring to provide structural patency to the weakened annular ring.

[0066] The frame 110 includes a cuff or collar (not shown), and a ring, body, and / or tubular portion (not shown). This cuff or collar (hereinafter referred to as "collar") may be attached to and / or formed on the upper edge of the frame 110. When the valve 102 is deployed in the human heart, the collar may be an atrial collar. The collar may be molded to match the self-deployment site. In mitral valve replacement, for example, the collar may have various portions to match the self-deployment valve and / or a portion of the atrial bed surrounding the mitral valve. In some embodiments, the collar may have distal and proximal upper collar portions. The distal collar portion may be larger than the proximal upper collar portion to accommodate annular geometry, circumferential geometry, and / or annular geometry. Examples of collars are described below with reference to specific embodiments.

[0067] The frame 110 may optionally have a separate atrial collar attached to the upper (atrial) edge of the frame 110 to deploy over the atrial bed, which is used to guide blood from the atrium to the flow control component 150 and to seal against blood leakage (perivalvular leakage) around the frame 110. The frame 110 may also optionally have a separate ventricular collar attached to the lower (ventricular) edge of the frame 110, which is used to prevent systolic regurgitation, deploy into the ventricle directly below the annulus, prevent valve 102 from dislodging during systole, sandwich or compress the annulus or adjacent tissue against the atrial cuff or collar, and / or optionally attach to the flow control component 150 to support the flow control component 150. Some embodiments may have both an atrial and a ventricular collar, while other embodiments may have a single atrial collar, a single ventricular collar, or no additional collar structure. In some embodiments, the atrial collar and / or ventricular collar may be formed separately from the ring or main body portion of the frame 110 and may be joined to the ring portion by any preferred joining method (e.g., suturing, joining, welding, etc.). In other embodiments, the atrial collar and / or ventricular collar may be formed integrally and / or separately with the ring or main body portion of the frame 110.

[0068] Frame 110, and / or at least the ring or body portion of its frame, may be a ring, cylinder tube, conical tube, D-tube, and / or any other suitable valve ring shape. In some embodiments, frame 110, and / or at least the ring or body portion of its frame, may have a side profile of a ring or cylinder having a flattened cone shape, an inverted flattened cone shape (narrower at the top and wider at the bottom), a concave cylinder (with a curved wall in the middle), a convex cylinder (with a raised wall), a square hourglass, a curved hourglass, an inclined hourglass, a flared top, a flared bottom, or both. Frame 110 may have a height in the range of about 5 to 60 mm, an outer diameter dimension R in the range of about 20 to 80 mm, and an inner diameter dimension in the range of about 21 to 79 mm, taking into account the thickness of frame 110 (e.g., the wire material forming frame 110).

[0069] The frame 110 is compressible for delivery and configured to return to its original (uncompressible) shape when released. The frame 110 may be constructed as a wire, braided wire, or laser-cut wire frame. In some embodiments, the frame 110 may include and / or be formed a set of compressible wire cells having an orientation and cell geometry substantially orthogonal to a central vertical axis 113 to minimize wire cell strain when the frame 110 is in a vertical compression configuration, a wound compression configuration, or a folded compression configuration. In some implementations, the frame 110 may include and / or be formed of shape memory elements that allow the frame 110 to self-expand. In some examples, suitable shape memory materials may include durable and biocompatible metals and / or plastics. For example, the frame 110 may be made from a superelastic metal wire such as Nitinol wire, or other similar functional materials. In some embodiments, the frame 110 may be formed from stainless steel, cobalt-chromium, titanium, and / or other functionally equivalent metals and / or alloys. In other embodiments, the frame 110 may be formed from any suitable material and may be expandable from a compressed configuration using a transcatheter inflation balloon or the like.

[0070] Frame 110 may also have, and / or form, additional functional elements (e.g., loops, fasteners, etc.) for attaching accessory components such as biocompatible covers, tissue fixation devices, releasable deployment and retrieval control guides, knobs, attachments, and rigging. Frame 110 may optionally be partially or entirely covered internally or externally with biocompatible materials such as pericardium, polyester, or Dacron®. In some implementations, frame 110 (or its embodiments and / or parts) may be structurally and / or functionally similar to frames (or their corresponding embodiments and / or parts) described in detail in '957PCT, '010PCT, and / or '231PCT'.

[0071] As described above, the frame 110 and / or the valve 102 may include at least a distal fixing element 132. In some embodiments, the frame 110 and / or the valve 102 may include the distal fixing element 132, as well as a proximal fixing element 134 and / or anterior fixing element 135. The fixing elements of the valve 102 and / or the frame 110 may be any preferred shape, size, and / or configuration, such as any of those described in detail in the '957 PCT, '010 PCT, '231 PCT, and / or any of those described herein with respect to a particular embodiment. For example, the distal, proximal, and anterior fixing elements 132, 134, and 135 may be lower fixing elements (e.g., coupled to and / or encompassed at the bottom of the frame 110). In some embodiments, the frame 110 and / or the valve 102 may also optionally include one or more of a distal upper fixing element, one or more proximal upper fixing elements, and / or any other preferred fixing elements. The fixing elements of frame 110 may include and / or be formed from wire loops or wire frames, integrated frame portions, and / or stents extending approximately 10 to 40 mm away from frame 110.

[0072] In some embodiments, the frame 110 may optionally include a guidewire coupler 133 configured to selectively engage and / or receive a portion of a guidewire or a portion of a guidewire assembly. In certain embodiments, the distal lower fixing element 132 may form and / or incorporate a feature that forms the guidewire coupler 133. In other implementations, the guidewire coupler 133 may be attached to any preferred portion of the frame 110, to the proximal fixing element 134, to the forward fixing element 135, and / or to any other fixing element and / or feature of the frame 110 (e.g., the distal or proximal upper fixing element). In some embodiments, the guidewire coupler 133 is configured to allow a portion of the guidewire to extend through an opening in the guidewire coupler 133, thereby allowing the valve 102 to advance on or along the guidewire. In some embodiments, the guidewire coupler 133 may selectively allow the guidewire to advance through the guidewire coupler while blocking or preventing other elements and / or components, such as a pusher.

[0073] In some embodiments, the distal fixation element 132 may include a guidewire coupler 133 and may be configured to transition between one or more states and / or configurations, at least partially based on its interaction with the guidewire. For example, in some embodiments, the distal fixation element 132 may have an extended configuration and / or be mounted in that configuration when the guidewire is coupled to and / or extends through the guidewire coupler 133, and may have a shortened configuration or a folded configuration and / or be mounted in that configuration when the guidewire is released from the guidewire coupler 133.

[0074] The valve fixing elements 132, 134, and 135 of the valve 102 may be configured to engage with desired portions of their own tissue to mount the frame 110 onto the annulus of the self-valve from which the valve 102 is deployed. For example, in some implementations, the distal fixing element 132 may extend from the lower distal side of the frame 110 to the RVOT or LVOT. In such implementations, the distal fixing element 132 may be molded and / or biased such that it exerts force on the subannular tissue that is operable to fix the distal end of the valve 102 at least partially within the self-valve annulus. In some implementations, the proximal fixing element 134 may be, for example, a proximal lower fixing element and may be configured to engage with the subannular tissue on the proximal side of the self-valve annulus to help fix the valve 102 within the annulus. Similarly, the anterior fixing element 134 may be an anterior lower fixing element that engages with the subannular tissue on the anterior side of the valve annulus, thereby helping to fix the valve 102 within the valve annulus.

[0075] In some implementations, the distal fixed element 132, the proximal fixed element 134, and / or the anterior fixed element 135 may be configured to transition, move, and / or to reconfigure between a first configuration in which the fixed elements 132, 134, and / or 135 each extend a first amount or distance from the frame 110, and a second configuration in which the fixed elements 132, 134, and / or 135 each extend a second amount or distance from the frame 110. For example, in some embodiments, the fixing elements 132, 134, and / or 135 may have a first configuration in which the fixing elements 132, 134, and / or 135 are compressed, unfolded, folded, and / or constrained (e.g., in a position near, adjacent to, and / or in contact with the annular portion of the frame 110), and a second configuration in which the fixing elements 132, 134, and / or 135 are extended, extended, unfolded, unfolded, and / or unconstrained (e.g., extending away from the annular portion of the frame 110). As will be described in more detail herein, any of the fixing elements 132, 134, and / or 135 may be actuated and / or transition between the first configuration and the second configuration during or after deployment, and may selectively engage with self-tissue, notochord, and / or any other anatomical structures to help fix the valve 102 within its own annulus.

[0076] The flow control component 150 may, in a non-limiting sense, refer to a device for controlling the flow of fluid through it. In some embodiments, the flow control component 150 may be a leaflet structure having 2 leaflets, 3 leaflets, 4 leaflets, or more, made from a flexible biocompatible material such as treated or untreated pericardium. These leaflets may be sutured or joined to a support structure such as an inner frame, and subsequently sutured or joined to an outer frame 110. For example, in some embodiments, the flow control component 150 may be bonded to the frame 110 (e.g., a drum, collar portion, warp ring portion, etc.) via tissue, biocompatible mesh, one or more woven or knitted fabrics, or one or more superelastic or shape memory alloy structures, and they may be sutured, stitched, and / or fixed to a portion of the frame. In some embodiments, the flow control component 150 (or portions and / or embodiments thereof) may be similar to any of the flow control components described, for example, in 231PCT.

[0077] In some embodiments, the flow control component 150, and / or its inner frame, may have a substantially cylindrical or tubular shape when the valve 102 is in an expanded configuration (see, for example, Figure 1C), and may be configured to deform elastically when the valve 102 is placed in a compressed configuration (see, for example, Figures 1B and 1D). The inner frame, and / or its parts or embodiments, may be similar to the outer frame 110, and / or its parts or embodiments, at least in form and / or function. For example, the inner frame may be compressible for delivery and configured to return to its original (uncompressible) shape when released. The inner frame may be formed of a shape memory element that allows the inner frame to self-expand. In some cases, suitable shape memory materials may include durable and biocompatible metals and / or plastics, such as nitinol.

[0078] The inner frame of the flow control component 150 may be similar, at least in form and / or function, to the inner frame of the flow control component 150 described in 231PCT. For example, the inner frame may be constructed as a wire, braided wire, or laser-cut wire frame. In some embodiments, the inner frame may include and / or form a set of compressible wire cells having an orientation and cell geometry substantially orthogonal to the axis of the flow control component 150, thereby minimizing wire cell strain when the inner frame is in a compression configuration. In some embodiments, the inner frame may have and / or form any preferred number of elastically deformable rhomboid or pupil-shaped wire cells, etc. Although not shown in Figures 1A-1E, in some embodiments the inner frame may include and / or be formed of two halves, which may be joined together to allow the inner frame to be elastically deformed in response to lateral compression or folding along or in the direction of the transverse axis 115, as will be described in more detail herein.

[0079] The flow control component 150 is mounted within the frame 110 and may be configured to allow blood flow in a first direction through the inlet end of the valve and to block blood flow in a second direction opposite to the first direction, through the outlet end of the valve. For example, the flow control component 150 may be configured so that the valve 102 functions as a cardiac valve, such as a tricuspid valve, mitral valve, aortic valve, or pulmonary valve, and can be opened to allow blood to flow from the atrium to the ventricle during diastole and closed by systolic ventricular pressure applied to its outer surface. The continuous opening and closing can be described as a “reciprocating motion.”

[0080] As shown in Figures 1A-1D, the flow control component 150 is mounted within the central channel 114 of the frame 110. More specifically, the flow control component 150 may be mounted 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 113 of the frame 110. In some embodiments, the flow control component 150 may be positioned in the center of the central channel 114 of the frame 110. In other embodiments, the flow control component 150 may be positioned off-center within the central channel 114. In some embodiments, the central channel 114 may have a diameter and / or circumference larger than the diameter and / or circumference of the flow control component 150. Although not shown in Figures 1A-1E, in some embodiments, the valve 102 may include a spacer, etc., which may be disposed within the central channel 114 adjacent to the flow control component 150. In other embodiments, the spacer may be a cover, etc., which is coupled to a portion of the frame 110 and configured to cover a portion of the central channel 114. In some cases, this spacer can be used to facilitate the coupling of the flow control component 150 to the frame 110.

[0081] As described above, the valve 102 is compressible and expandable between an expanded configuration and a compressed configuration. When in the expanded configuration, the valve 102 may have a first height or size along the central axis 113, and when in the compressed configuration, it may have a second height or size along the central axis 113 that is less than the first height or size. The valve 102 can also be compressed in further directions. For example, the valve 102 can be compressed along a transverse axis 115 that is perpendicular to both the longitudinal axis 111 and the central axis 113 (see, for example, Figure 1D).

[0082] The valve 102 is configured to be compressed during delivery and expanded when released from the delivery catheter. More specifically, the valve 102 is configured for transcatheter orthogonal delivery to a desired location in the body (e.g., the annulus of a prostate valve), where the valve 102 is compressed orthogonal or lateral (e.g., along the central axis 113 and / or lateral axis 115) to the dimensions of the valve 102 in an expanded configuration. During delivery, the longitudinal axis 111 of the valve 102 is substantially parallel to the longitudinal axis of the delivery catheter. In orthogonal delivery, the longitudinal axis 111 is oriented at an intersection angle of 45 to 135 degrees with respect to the central axis 113 (e.g., vertical or about 90 degrees) and is oriented substantially parallel to the longitudinal cylinder axis of the delivery catheter.

[0083] The valve 102 is in an expanded configuration before being loaded into the delivery catheter and / or 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. The shape of the expanded valve 102 may be that of a shortened cylinder with a large diameter having an extended collar (e.g., its collar). When in the expanded configuration shown in Figures 1A, 1C, and 1E, the valve 102 has an extension in any direction perpendicular to the longitudinal axis 111 or laterally (e.g., along the central axis 113 and / or the lateral axis 115) that is larger than the diameter of the lumen of the delivery catheter used to deliver the valve 102. For example, in some embodiments, the valve 102 may have an expanded height of 5 to 60 mm (e.g., along the central axis 113). In certain embodiments, the valve 102 may have an extended height, which includes, for example, any size or fraction of the sizes between 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, and 60 mm and / or in between. In some embodiments, the valve 102 may have an extended diameter length (e.g., along the longitudinal axis 111) and width (e.g., along the transverse axis 115) of about 20 to 80 mm, or about 40 to 80 mm. In certain embodiments, the valve 102 may have an extended length and / or width, which includes, for example, any size or fraction of the sizes between 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, and 80 mm and / or in between.

[0084] When in the compressed configuration shown in Figures 1B and 1D, the valve 102 has an extension in any direction perpendicular to the longitudinal axis 111 or laterally (e.g., along the central axis 113 and / or the transverse axis 115), such that the extension is smaller than the diameter of the lumen of the delivery catheter, allowing the valve 102 to be delivered through that lumen. For example, in some embodiments, the valve 102 may have a compressed height (e.g., along the central axis 113) and a compressed width (e.g., along the transverse axis 115) of about 6–15 mm, about 8–12 mm, or about 9–10 mm. In certain embodiments, the valve 102 may have a compressed height and / or width that includes, for example, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, and 15 mm, and / or any size or fraction in between. Valve 102 can be compressed by compression, rolling, folding, and / or any other preferred mode, as well as combinations thereof, as described in detail in '957PCT, '010PCT, and / or '231PCT'. In some embodiments, the length of valve 102 (e.g., along the longitudinal axis 111) is assumed not to be compressed for delivery. Rather, in some embodiments, the length of valve 102 may increase with compression of valve 102 along the central axis 113 and / or the transverse axis 115.

[0085] Although not shown in Figures 1A-1E, in some implementations, the delivery system may include one or more features or components configured to deliver the valve 102 to a desired location in the body (e.g., the annulus of a native valve). For example, the delivery system may include a delivery catheter, a positioning tool, and a guidewire. The delivery system may be configured to orthogonally deliver the compressed valve 102 and / or a portion of the valve 102 (e.g., a compressed frame 110 or a compressed flow control component 150) to a desired location in the body, such as the annulus of a native tricuspid valve and / or the annulus of a native mitral valve in a human heart. For example, the delivery catheter may be 12-34 Fr and have any suitable corresponding internal lumen diameter and / or internal lumen diameter sufficient to receive the prosthetic valve 102 in the compressed configuration. In some implementations, the delivery system, and / or any aspect or part thereof, may be substantially similar, at least in form, function, and / or operation, to those described in detail in '957PCT, '010PCT, and / or '231PCT, and therefore will not be described in further detail herein.

[0086] As shown in Figure 1E, valve 102 may be delivered to, for example, the atrium of a human heart, and may be disposed 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, valve 102 may be in a compression configuration, delivered to the annulus via a delivery system, and released from the delivery system to expand into an expansion configuration. For example, valve 102 may be delivered to the atrium of a human heart via any of the delivery systems, devices, and / or methods described in detail in '957PCT, '010PCT, and / or '231PCT, and released from a delivery catheter (not shown).

[0087] In some implementations, delivery of the valve 102 may involve advancing a guidewire into the atrium of a human heart, through the own valve, to a desired position within the ventricle (e.g., RVOT or LVOT). After positioning the guidewire, the delivery catheter may advance into the atrium along and / or over the guidewire (e.g., via the IVC, SVC, and / or transseptal access). In some embodiments, a guidewire connector 136 may be coupled to the proximal end of the guidewire, and the valve 102 may be placed in a compressed configuration, allowing the valve 102 to advance into the atrium along the guidewire and through the lumen of the delivery catheter.

[0088] Deployment of the valve 102 may involve positioning the distal fixation element 132 (e.g., distal lower fixation element 132) within the ventricle (RV, LV) below the valve annulus while the rest of the valve 102 remains within the atrium (RA, LA). In some cases, the distal fixation element 132 may advance along and / or be along a guidewire to a desired position within the ventricle, such as the ventricular outflow duct. For example, in some implementations, the valve 102 may be delivered to the annulus of the patient's own tricuspid valve (TV), and at least a portion of the distal fixation element 132 may be positioned within the RVOT. In other implementations, the valve 102 may be delivered to the annulus of the patient's own mitral valve (MV), and at least a portion of the distal fixation element 132 may be positioned within the LVOT.

[0089] In some implementations, the distal fixation element 132 may be positioned and / or transitioned from a first or folded configuration to a second or extended configuration during delivery and / or deployment, before the valve 102 is fully seated within its own annulus. In some embodiments, for example, the distal fixation element 132 may be in the second or extended configuration state by the effect of a guidewire connector 136 that connects and / or engages with a guidewire. Thus, the distal fixation element 132 may be in the second or extended configuration state when inserted into the ventricle through its own annulus. In some cases, the distal fixation element 132 may extend around and / or through one or more parts of the own tissue, notochord, etc., thereby allowing the distal fixation element 132 to capture and / or engage with the own tissue, notochord, etc., when the distal fixation element 132 transitions and / or returns to the first configuration, as will be described in more detail here.

[0090] In some implementations, the artificial valve 102 may be temporarily maintained in a partially deployed state. For example, the valve 102 may be partially inserted into the annulus and maintained at a certain angle to the annulus to allow blood to flow from the atrium to the ventricle by partially passing through the annulus and partially through the valve 102, thereby enabling evaluation of valve function.

[0091] The valve 102 may be placed or seated within the annulus (PVA, MVA, AVA, and / or TVA) of the intrinsic valve (PV, MV, AV, and / or TV), so that the trans-annular portion of the valve frame 110 extends through the annulus into the ventricle, while the collar (e.g., an atrial collar) remains in the atrium (for tricuspid or mitral valves, or the aorta for aortic valves, or the pulmonary artery for pulmonary valves) within the annular position. For example, in some embodiments, a positioning tool and / or pusher (not shown) may be used to push at least the proximal end of the valve 102 into the annulus. In some implementations, the proximal fixation element 134 may be maintained in its first configuration when the valve 102 is seated in the annulus. For example, as described above, the proximal fixing element 134 may be in contact with, adjacent to, and / or near the annular portion of the frame 110 while in the first configuration, thereby restricting the entire perimeter of the lower portion of the frame 110, thereby allowing the annular portion of the frame 110 to be inserted through the valve ring.

[0092] Upon seating, the proximal fixation element 134 may transition from its first configuration to its second configuration, as described in detail in the '010 PCT. Thus, when the valve 102 is seated in the annulus, the proximal fixation element 134 may be positioned in its second configuration, in which the proximal fixation element 134 contacts, engages with, and / or otherwise is positioned adjacent to the subannular tissue. In some implementations, the proximal fixation element 134 may be configured to engage with and / or capture the proximal tissue, notochord, etc., when the proximal fixation element 134 is positioned within the ventricle. For example, in some implementations, after the valve 102 is seated in the annulus, the proximal fixation element 134 may transition from a first (compression) configuration to a second (extension) configuration, so that the proximal fixation element 134 extends around and / or passes through one or more parts of the proximal tissue, notochord, etc. Subsequently, the proximal fixation element 134 may be returned to the first configuration, and one or more portions of the proximal fixation element 134 and, for example, the transannular portion of the outer frame 110 may be captured and / or fixed. In other implementations, the proximal fixation element 134 may be maintained in a second (extended) configuration after the valve 102 has been seated in the proximal annulus. In such an implementation, the proximal fixation element 134 may, for example, contact and / or engage with the subannular tissue proximal to the annulus, so that the proximal fixation element and the proximal portion of the atrial collar exert compressive force on the proximal portion of the annular tissue.

[0093] In embodiments in which the valve 102 includes a selectable forward fixing element 135, the forward fixing element 135 may be in a first (compressed or retracted) configuration before the valve 102 is fully seated within its own valve ring, as described above with reference to the proximal fixing element 134. Thus, the circumference of the annular portion may be small enough to allow the annular portion to be inserted through the valve ring of the valve itself. Upon seating, the forward fixing element 135 may transition from its first configuration to its second (extended) configuration. For example, in some embodiments, the valve 102 and / or frame 110 may include a sleeve, conduit, tube, channel, etc., when the first portion of the forward fixing element 135 is arranged in the first configuration and when transitioning to the second configuration, and the second portion of the forward fixing element 135 below the first portion is arranged within its sleeve, conduit, tube, channel, etc. In the alternative method described above, the forward fixing element 135 may extend from a sleeve, conduit, pipe, channel, etc., in the second configuration.

[0094] In some embodiments, the forward fixing element 135 may form a hook or clip when in a second configuration. For example, the forward fixing element 135 may be formed of a shape memory alloy or the like that is biased or heat-set to the shape or configuration of a hook or clip. In some implementations, such configurations may allow the forward fixing element 135 to extend around and / or through a portion of a self-organizing structure, notochord, etc. The forward fixing element 135 may then be actuated, transitioned, moved, etc., to return from a second (extended) configuration to a first (compressed or folded) configuration. For example, the forward fixing element 135 may be retracted, or at least partially retracted, into a sleeve, conduit, tube, channel, etc. of the valve 102. With the anterior fixing element 135 positioned around, through, and / or engaged with, the self-organizing tissue, notochord, etc., the transition of the anterior fixing element 135 from the second configuration to the first configuration may result in the anterior fixing element 135 capturing and / or fixing at least a portion of the self-organizing tissue, notochord, etc. between the anterior fixing element 135 and, for example, the annular portion of the frame 110.

[0095] In this way, the distal fixing element 132 may be configured to engage with the self-tissue on the distal side of the valve ring, the proximal fixing element 134 may be configured to engage with the self-tissue on the proximal side of the valve ring, and the anterior fixing element 135 may be configured to engage with the self-tissue on the anterior side of the valve ring, thereby enabling the valve 102 to be securely seated within its own valve ring, as shown in Figure 1E.

[0096] Although not shown in Figures 1A-1E, in some implementations, as described in detail in '957PCT, the valve 102 and / or delivery system may include one or more tissue anchors, which can be used to fix one or more portions of the valve 102 to the annular tissue. In some embodiments, these tissue anchors may be configured to puncture, penetrate, and / or fix to the fixation elements 132, 134, and / or 135, and / or the atrial collar, and / or to the annular tissue. In other embodiments, the tissue anchors may be traumatic anchors configured to fix the fixation elements 132, 134, and / or 135, and / or the atrial collar to the annular tissue, for example, without puncturing, penetrating, and / or causing trauma to the own tissue.

[0097] A consideration of certain aspects or embodiments of a transcatheter prosthetic valve (e.g., an artificial heart valve) that can be delivered laterally is provided below. With respect to a particular embodiment, the transcatheter prosthetic valve (or aspects or parts thereof) described below may be substantially similar in form and / or function to the valve 102 and / or corresponding aspects or parts thereof described above with reference to Figures 1A to 1E. Similarly, the valve (or aspects or parts thereof) described below may be similar in form and / or function to the valve described in detail in '957PCT, '010PCT, and / or '231PCT'. Therefore, certain aspects and / or parts of a particular embodiment may not be described in further detail herein.

[0098] Any of the prosthetic valves described herein may be used to replace the native valves of the human heart, including, for example, the mitral valve, tricuspid valve, aortic valve, and / or pulmonary valve. While examples of specific valves are described herein, it should be understood that they are presented merely as examples and not as an limitation. Therefore, while some prosthetic valves are described herein as being configured to replace a native mitral valve or native tricuspid valve, it should be understood that any prosthetic valve can be replaced with such a valve unless otherwise explicitly stated, or unless one or more components and / or features would otherwise be clearly recognized by those skilled in the art as not corresponding to such use.

[0099] In some embodiments, a laterally deliverable transcatheter artificial heart valve may be configured, for example, to replace the native mitral valve of a human heart. Figure 2A is an illustrative top view of a native mitral valve showing the approximate locations of the anterior (A) portion A1-A2-A3 and the posterior (P) portion P1-P2-P3 of the native leaflet.

[0100] Figures 2B and 2C illustrate a side perspective view and an exploded view, respectively, of a laterally deliverable (orthogonally deliverable) transcatheter artificial heart valve 202 (also referred to herein as the “artificial valve” or “valve”) according to one embodiment. In some implementations, the valve 202 may be deployed, for example, within the annulus of a native mitral valve. The valve 202 is configured to allow blood flow in a first direction through the inflow end of the valve 202 and to block blood flow in a second direction opposite to the first direction, through the outflow end of the valve 202. For example, the artificial valve 202 may be a laterally deliverable transcatheter artificial heart valve configured to be deployed within the annulus of a native tricuspid or native mitral valve of a human heart to complement and / or replace the functionality of a native valve.

[0101] The valve 202 is compressible and expandable in at least one direction with respect to its x-axis (also referred herein as the “horizontal axis,” “longitudinal axis,” “major axis,” and / or “vertical axis”). The valve 202 is compressible and expandable between an expanded configuration for implantation at a desired location within the body (e.g., a human heart) and a compressed configuration for introduction into the body using a delivery catheter (not shown in Figures 2B and 2C). In some embodiments, the horizontal x-axis of the valve 202 is perpendicular (90 degrees), substantially perpendicular (75–105 degrees), or substantially inclined (45–135 degrees) with respect to the central (vertical) y-axis in the expanded and / or compressed configurations. Furthermore, the horizontal x-axis of the valve 202 in the compressed configuration is substantially parallel to the longitudinal cylinder axis of the delivery catheter in which the valve 202 is arranged.

[0102] In some embodiments, the valve 202 has an expanded or unfolded height of about 5–60 mm, about 5–30 mm, about 5–20 mm, about 8–12 mm, or about 8–10 mm, and an expanded or unfolded diameter (e.g., length and / or width) of about 25–80 mm or about 40–80 mm. In certain embodiments, the expanded or unfolded diameter (e.g., length and / or width) may be about 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, and 80 mm (or any value or fraction between them). In some embodiments, the valve 202 has a compressed height (y-axis) and width (z-axis) of about 6–15 mm, about 8–12 mm, or about 9–10 mm. In a preferred embodiment, the length of the valve 202 (e.g., along the x-axis) is assumed to be uncompressed or reduced because it may extend along the length of the central cylinder axis of the delivery catheter.

[0103] In certain preferred embodiments, the valve 202 is centered or radially symmetrical. In other preferred embodiments, the valve 202 is eccentric or radially asymmetrical (e.g., along or with respect to the y-axis). In some eccentric embodiments, the frame 210 may have a D-shaped cross-section, and a flat portion or surface is configured to substantially fit with the annulus of the self-mitral valve, either in the forward leaflet or in its vicinity.

[0104] The valve 202 includes an annular lateral support frame 210 and a foldable flow control component 250 mounted within the annular lateral support frame 210. The annular lateral support frame 210 (also referred to herein as the “outer frame”) is made from a shape memory material such as nickel-titanium alloy, e.g., nitinol, and is therefore a self-expanding structure from a compression configuration to an expansion configuration. The outer frame 210 has a transring and / or body portion 212 that circumscribes, forms, and / or defines a central (internal) channel 214 around and / or along the vertical or central axis (y-axis), and has an atrial collar 220 attached to the upper edge of the transring and / or circumferentially to the body portion 212 of the outer frame 210. The atrial collar 220 is molded to match the self-expanding location. In the replacement of a tricuspid valve, for example, the atrial collar 220 may have a tall dorsal wall portion to match the septal portion of the own valve, and may have distal and proximal upper collar portions. The distal upper collar portion can be larger than the proximal upper collar portion, justifying the consideration of a larger flat space above the subannular region of the ventricular outflow duct (VOT) (atrium). In mitral valve replacement, for example, the annular collar 220 and / or lateral frame 210 may be D-shaped or similar in shape to a hyperbolic paraboloid closely resembling the progenitor structure.

[0105] The outer frame 210 further comprises a proximal section 219 and a distal section 222. A distal fixation element 232 (e.g., a hyperelastic wire loop distal tab) is coupled to and / or extends from the distal section 222. In some embodiments, the distal fixation element 232 is a single-piece tab constructed integrally with the main body section 212 of the outer frame 210. The size and shape of the distal fixation element 232 may vary. For example, in some embodiments, the distal fixation element 232 (e.g., a right VOT tab) may be long enough to reach the ostium of the pulmonary artery (in the case of tricuspid replacement).

[0106] In other embodiments, the shape of the distal fixation element 232 is configured to match the A1 commissure region of the mitral valve. For example, in some embodiments, the length of the distal fixation element 232 may be about 10 to 40 mm. Furthermore, the distal fixation element 232 may be a reconfigurable distal fixation element 232 configured to transition between, for example, a compression configuration, a shortened configuration, and / or a folded configuration (e.g., a first configuration) and an extended configuration or an unfolded configuration (e.g., a second configuration).

[0107] For example, in some implementations, the distal fixation element 232 is configured to track a guidewire (not shown) inserted near the A1 leaflet / comment of the mitral valve. In some implementations, the guidewire is pre-aligned around the leaflet and / or notochord of the mitral valve, particularly the A2 leaflet of the mitral valve, to facilitate the overwire placement of the distal fixation element 232 around the "back side" of the A2 leaflet and clamp the mitral A2 leaflet to the frame 210. In some implementations, the distal fixation element 232 may be configured in an extended configuration to reach around the P2 and / or P3 leaflets of the mitral valve and / or notochord associated with it, and may transition to a compressed configuration to capture and / or pin self-tissue, notochord, etc. between the distal fixation element 232 and the transannular portion 212 of the outer frame 210.

[0108] As shown in Figure 2C, at least the outer support frame 210 of the valve 202 is covered, wrapped around, and / or surrounded by a biocompatible cover 240. The biocompatible cover 240 may be any other suitable biocompatible material such as mesh material, pericardial tissue, woven synthetic polyester material, and / or the above.

[0109] The foldable (internal) flow control component 250 is mounted within the outer frame 210. The flow control component 250 has a foldable and compressible inner wire frame 252 (also referred to as the "inner leaflet frame" or "inner frame") having two or more folding regions, hinge regions, connecting regions, elastically deformable portions, etc. Two to four sets of flexible leaflets 261 are mounted inside or on the inner frame 252. In some embodiments, the flow control component 250 has three leaflet 261 tips or pockets mounted within the inner frame 252.

[0110] The internal flow control component 250, like the outer frame 210, is foldable and compressible. For example, the inner frame 252 is foldable along or in the z-axis from a cylinder configuration to a flattened cylinder configuration (or a two-layer band) (e.g., foldable in a folding region), in which case the folding region rests on the distal and proximal sides of the inner frame 252. The flow control component 250, like the outer frame 210, is also compressible in the vertical (y-axis) direction into a shortened or compressed configuration. By folding (compressing) in the z-axis direction and vertically compressing in the y-axis direction, the valve 202 can maintain relatively large dimensions along the horizontal (x-axis). In some implementations, the outer frame 210 and the flow control component 250 are reduced along the z-axis until their side walls touch or nearly touch. Furthermore, this allows the outer frame 210 and flow control components 250 to maintain a radius along the horizontal axis (x-axis), and minimizes the number of wire cells that could be damaged by the forces applied during folding and / or compression necessary to construct the outer and inner frames and load them into the delivery catheter.

[0111] The flow control component 250 has a diameter and / or perimeter smaller than the diameter and / or perimeter of the central channel 214 of the outer frame 210. The flow control component 250 is mounted on or inside the outer frame 210 such that the central axis or vertical axis (y-axis) of the inner frame 252 is parallel to the central axis or vertical axis (y-axis) of the outer frame 210. In some embodiments, the y-axis defined by the inner frame 252 is parallel to, but offset from, the y-axis defined by the outer frame 210 (Figure 2B). In some implementations, a spacer element 230 is disposed within the central channel 214 to facilitate mounting of a portion of the flow control component 250 (e.g., an otherwise unsupported portion) to the outer support frame 210. In some embodiments, the spacer element 230 may be a cylinder tube or frame configured to support a portion of the flow control component 250. In other embodiments, the spacer element 230 may be any preferred shape, size, and / or configuration. The spacer element 230 may be a covered or uncovered wire loop, etc., which may be coupled to and / or integrated with the drum or collar of the frame 210.

[0112] In some embodiments, the spacer element 230 may also be provided to control regurgitation of the valve 202. For example, in some embodiments, the spacer 230 may be covered with or uncovered a fluid-permeable mesh, cloth, and / or biocompatible material. In some embodiments, the uncovered spacer 230 may be inserted later with a stent, cover, plug, etc. (for example, when regurgitation is no longer desirable for proper functioning of the patient's heart). In some embodiments, the spacer element 230 may be used to penetrate a hole for pacemaker wiring or for planned partial regurgitation. In one embodiment where planned partial regurgitation is permitted, control of valve regurgitation is provided by using an uncovered spacer 230 instead of the spacer element 230. The uncovered spacer 230 may be inserted later with a stent, cover, or plug if regurgitation is no longer desirable for the patient.

[0113] In some embodiments, the spacer element 230 may be similar to, or substantially similar to, the inner frame 252 of a flow control component 250 without a leaflet installed inside. In other embodiments, the spacer element 230 may include a leaflet installed inside (for example, similar in form and / or configuration to, or different from, the form and / or configuration of, the leaflet 261). In other words, the valve 202 may include two flow control components 250, each flow control component 250 acting as a spacer to the other flow control component 250.

[0114] In a particular embodiment, the inner frame 252 may have a diameter of approximately 25–30 mm, the outer frame 210 may have a diameter of approximately 50–80 mm, and the atrial collar 220 may extend approximately 20–30 mm beyond the upper edge of the outer frame, providing a seal on the atrial bed against perivalvular leakage (PVL). The flow control components 250 and the outer frame 210 may be foldable (e.g., in the z-axis direction) and / or compressible (e.g., in the y-axis direction) to reduce the lateral surface area of ​​the entire valve 202 so that it fits within the inner diameter of a delivery catheter (not shown in Figures 2B and 2C) of 24–36 Fr (8–12 mm inner diameter).

[0115] Figures 3A and 3B illustrate a side perspective view and an exploded view, respectively, of a laterally deliverable (orthogonally deliverable) transcatheter artificial heart valve 302 (also referred to herein as the “artificial valve” or “valve”) according to one embodiment. In several implementations, the valve 302 may be deployed, for example, within the annulus of a native mitral valve. The valve 302 is configured to allow blood flow in a first direction through the inflow end of the valve 302 and to block blood flow in a second direction opposite to the first direction, through the outflow end of the valve 302. The valve 302 is compressible and expandable between an expandable configuration for implantation into the annulus of a target valve (e.g., in a human heart) and a compressible configuration for introduction into the body using a delivery catheter (not shown in Figures 3A and 3B).

[0116] The valve 302 includes an annular outer support frame 310 and a foldable flow control component 350 mounted within the annular outer support frame 310. The annular outer support frame 310 (also referred to herein as the “outer frame”) is made of a shape memory material such as nickel-titanium alloy, e.g., nitinol, and is therefore a self-expanding structure from a compressed configuration to an expanded configuration. At least a portion of the outer frame 310 is covered, wrapped around, and / or surrounded by a biocompatible cover 340 as described above.

[0117] The outer frame 310 has a transring portion and / or body portion 312 that circumscribes, forms, and / or defines the central (internal) channel 314 vertically or around and / or along the central axis (y-axis), and has an atrial collar 320 attached circumferentially to the upper edge of the transring and / or the body portion 312 of the outer frame 310. The outer frame 310 has a proximal side 319 and a distal side 322.

[0118] The foldable (internal) flow control component 350 is mounted within the outer frame 310 adjacent to covered or uncovered spacers 330. The flow control component 350 has an inner frame 352 having two or more folding regions, hinge regions, coupling regions, elastically deformable regions, etc. Two to four sets of flexible leaflets 361 are mounted inside or on the inner frame 352. The internal flow control component 350 is foldable and compressible, similar to the outer frame 310. The flow control component 350 is mounted in or inside the outer frame 310 such that the central axis or vertical axis (y-axis) of the inner frame 352 is coaxial with the central axis (y-axis) of the outer frame 310, and / or at least parallel thereto (e.g., parallel thereto but offset therefrom).

[0119] Figures 3A and 3B further illustrate the valve 302, including a distal fixing element 332 and a proximal fixing element 334. The distal fixing element 332 (e.g., a hyperelastic wire loop distal tab) is coupled to and / or extends from the distal side 322 of the outer frame 310, and the proximal fixing element 334 (e.g., a hyperelastic wire loop proximal tab) is coupled to and / or extends from the proximal side 319 of the outer support frame 310. In some embodiments, the distal fixing element 332 and the proximal fixing element 334 may be a single, integrated tab constructed in a single unit on the main body portion 312 of the outer frame 310. The size and shape of the fixing elements 332 and 334 may vary. For example, in some embodiments, the shape of the distal fixing element 332 is configured to conform to the A1 commissure region of the mitral valve. In some embodiments, the shape of the proximal fixing element 334 is configured to conform to the A3 commissure region of the mitral valve.

[0120] In some embodiments, at least the distal fixation element 332 can transition between, for example, a compression configuration, a shortened configuration, and / or a folded configuration (e.g., a first configuration) and an extended configuration or an unfolded configuration (e.g., a second configuration). In the extended configuration, the distal fixation element 332 may reach around the P2 and / or P3 leaflets of the associated mitral valve and / or notochord, and when transitioned to the compression configuration, the distal fixation element 332 may capture and / or pin the patient's own tissue, notochord, etc., between the distal fixation element 332 and the trans-annular portion 312 of the outer frame 310.

[0121] Figures 4A and 4B illustrate a side perspective view and an exploded view, respectively, of a laterally deliverable (orthogonally deliverable) transcatheter artificial heart valve 402 (also referred to herein as the “artificial valve” or “valve”) according to one embodiment. In several implementations, the valve 402 may be deployed, for example, within the annulus of a native mitral valve. The valve 402 is configured to allow blood flow in a first direction through the inflow end of the valve 402 and to block blood flow in a second direction opposite to the first direction, through the outflow end of the valve 402. The valve 402 is compressible and expandable between an expandable configuration for implantation into the annulus of a target valve (e.g., in a human heart) and a compressible configuration for introduction into the body using a delivery catheter (not shown in Figures 4A and 4B).

[0122] The valve 402 includes an annular outer support frame 410 and a foldable flow control component 450 mounted within the annular outer support frame 410. The annular outer support frame 410 (also referred to herein as the “outer frame”) is made from a shape memory material such as nickel-titanium alloy, e.g., nitinol, and is therefore a self-expanding structure from a compressed configuration to an expanded configuration. At least a portion of the outer frame 410 is covered, wrapped around, and / or surrounded by a biocompatible cover 440 as described above.

[0123] The outer frame 410 has a transring and / or body portion 412 that circumscribes, forms, and / or defines the central (internal) channel 414 vertically or around and / or along the central axis (y-axis), and has an atrial collar 420 attached circumferentially to the upper edge of the transring and / or the body portion 412 of the outer frame 410. The outer frame 410 has a proximal side 419 and a distal side 422.

[0124] The foldable (internal) flow control component 450 is mounted within the outer frame 410 adjacent to covered or uncovered spacers 430. The flow control component 450 has an inner frame 452 having two or more folding regions, hinge regions, coupling regions, elastically deformable regions, etc. Two to four sets of flexible leaflets 461 are mounted inside or on the inner frame 452. The internal flow control component 450 is foldable and compressible, similar to the outer frame 410. The flow control component 450 is mounted in or inside the outer frame 410 such that the central axis or vertical axis (y-axis) of the inner frame 452 is coaxial with the central axis (y-axis) of the outer frame 410, and / or at least parallel thereto (e.g., parallel thereto but offset therefrom).

[0125] Figures 4A and 4B further illustrate the valve 402, including a distal fixing element 432, an anterior fixing element 435, and a sleeve 436. The distal fixing element 432 (e.g., a hyperelastic wire loop distal tab) is coupled to and / or extends from the distal side 422. In some embodiments, the distal fixing element 432 is a single-piece tab constructed integrally with the body portion 412 of the outer frame 410. In some embodiments, the shape of the distal fixing element 432 is configured to conform to the A1 commissure region of the mitral valve and can transition between, for example, a compression configuration, a shortened configuration, and / or a folded configuration (e.g., a first configuration) and an extended configuration or an unfolded configuration (e.g., a second configuration). In some implementations, the distal fixation element 432 may be configured in an extended configuration to reach around the P2 and / or P3 leaflets of the associated mitral valve and / or notochord, or it may transition to a compression configuration to capture and / or pin the self-tissue, notochord, etc. between the distal fixation element 432 and the transannular portion 412 of the outer frame 410.

[0126] The front fixing element 435 and sleeve 436 are mounted on the front side of the annular portion 412 of the outer frame 410. At least a portion of the front fixing element 435 is disposed within the sleeve 436. The front fixing element 435 is reconfigurable between a first configuration (e.g., a retracted configuration) and a second configuration (e.g., an extended configuration). In some implementations, the front fixing element 435 may be extended below the valve ring (e.g., to the second configuration) during the deployment of the valve 402 (e.g., after the valve 402 has been at least partially seated within the valve ring), so that a portion of the front fixing element 435 extends from the sleeve 436 to engage with and / or capture self-leaflet tissue (e.g., A2 leaflet, tissue, notochord, etc.). The front fixing element 435 may be retracted (e.g., to the first configuration) to capture and secure tissue between the front fixing element 435 and the annular portion 412 of the outer frame 410.

[0127] In some embodiments, the anterior fixation element 435 may be actuated and / or moved using a maneuverable catheter and / or guidewire. In some embodiments, the anterior fixation element 435 and / or sleeve 436 may include imaging markers, etc., that can assist in guiding the maneuverable catheter or guidewire to the anterior fixation element 435. Although the anterior fixation element 435 has been described as moving, acting and / or moving relative to the sleeve 436, in some embodiments, the sleeve 436 may be retracted or moved relative to the anterior fixation element 435 to expose a larger portion of the anterior fixation element, allowing the anterior fixation element 435 to engage with self-tissue. In some embodiments, both the anterior fixation element 435 and the sleeve 436 may be actuated, moved, moved and / or reconfigured.

[0128] In some implementations, by using the forward fixing element 435 on one side (A2) and the distal fixing element 432 that wraps around it on the opposite side (P2), resistance anchoring and fixation can be provided, minute movements can be reduced, and the inward growth of the valve can be promoted.

[0129] Figures 5A and 5B illustrate a side perspective view and an exploded view, respectively, of a laterally deliverable (orthogonally deliverable) transcatheter artificial heart valve 502 (also referred to herein as the “artificial valve” or “valve”) according to one embodiment. In several implementations, the valve 502 may be deployed, for example, within the annulus of a native mitral valve. The valve 502 is configured to allow blood flow in a first direction through the inflow end of the valve 502 and to block blood flow in a second direction opposite to the first direction, through the outflow end of the valve 502. The valve 502 is compressible and expandable between an expandable configuration for implantation into the annulus of a target valve (e.g., in a human heart) and a compressible configuration for introduction into the body using a delivery catheter (not shown in Figures 5A and 5B).

[0130] The valve 502 includes an annular outer support frame 510 and a foldable flow control component 550 mounted within the annular outer support frame 510. The annular outer support frame 510 (also referred to herein as the “outer frame”) is made of a shape memory material such as nickel-titanium alloy, e.g., nitinol, and is therefore a self-expanding structure from a compression configuration to an expansion configuration. At least a portion of the outer frame 510 is covered, wrapped around, and / or surrounded by a biocompatible cover 540 as described above.

[0131] The outer frame 510 has a transring and / or body portion 512 that circumscribes, forms, and / or defines the central (internal) channel 514 vertically or around and / or along the central axis (y-axis), and has an atrial collar 520 attached circumferentially to the upper edge of the transring and / or the body portion 512 of the outer frame 510. The outer frame 510 has a proximal side 519 and a distal side 522.

[0132] The foldable (internal) flow control component 550 is mounted within the outer frame 510 adjacent to covered or uncovered spacers 530. The flow control component 550 has an inner frame 552 having two or more folding regions, hinge regions, coupling regions, elastically deformable regions, etc. Two to four sets of flexible leaflets 561 are mounted inside or on the inner frame 552. The internal flow control component 550 is foldable and compressible, similar to the outer frame 510. The flow control component 550 is mounted in or inside the outer frame 510 such that the central axis or vertical axis (y-axis) of the inner frame 552 is coaxial with the central axis (y-axis) of the outer frame 510, and / or at least parallel thereto (e.g., parallel thereto but offset therefrom).

[0133] Figures 5A and 5B further illustrate the valve 502, which includes a distal fixing element 532, a proximal fixing element 534, an anterior fixing element 535, and a sleeve 536. The distal fixing element 532 (e.g., a hyperelastic wire loop distal tab) is coupled to and / or extends from the distal side 522 of the outer frame 510, and the proximal fixing element 534 (e.g., a hyperelastic wire loop proximal tab) is coupled to and / or extends from the proximal side 519 of the outer support frame 510. In some embodiments, the distal fixing element 532 and the proximal fixing element 534 may be a single, integrated tab constructed in conjunction with the body portion 512 of the outer frame 510. The anterior fixing element 535 and the sleeve 536 are mounted on the anterior side of the annular portion 512 of the outer frame 510. At least a portion of the anterior fixing element 535 is disposed within the sleeve 536. The size and shape of the fixing elements 532, 534, and / or 535 may vary. For example, in some embodiments, the shape of the distal fixing element 532 is configured to match the A1 commissure region of the mitral valve, the shape of the proximal fixing element 534 is configured to match the A3 commissure region of the mitral valve, and the shape of the anterior proximal fixing element 535 is configured to match the A2 commissure region of the mitral valve.

[0134] In some embodiments, the distal fixation element 532 can transition between, for example, a compression configuration, a shortened configuration, and / or a folded configuration (e.g., a first configuration) and an extended configuration or an unfolded configuration (e.g., a second configuration). In the extended configuration, the distal fixation element 532 may reach around the P2 and / or P3 leaflets of the associated mitral valve and / or notochord, and when transitioned to the compression configuration, the distal fixation element 532 may capture and / or pin the patient's own tissue, notochord, etc., between the distal fixation element 532 and the trans-annular portion 512 of the outer frame 510.

[0135] In some embodiments, the anterior fixation element 535 is reconfigurable between a first configuration (e.g., retracted) and a second configuration (e.g., extended configuration). In some implementations, the anterior fixation element 535 may be extended below the annulus (e.g., to the second configuration) during the deployment of the valve 502 (e.g., after the valve 502 has been at least partially seated within the annulus), so that a portion of the anterior fixation element 535 extends from the sleeve 536 to engage with and / or capture self-leaflet tissue (e.g., A2 leaflet, tissue, notochord, etc.). The anterior fixation element 535 may be retracted (e.g., to the first configuration) to capture and fix tissue between the anterior fixation element 535 and the trans-annular portion 512 of the outer frame 510. In some embodiments, the distal fixation element 532 and / or the anterior fixation element 535 may be actuated and / or moved using a maneuverable catheter and / or guidewire. In some implementations, retracting the guidewire may allow the distal fixing element 532 and / or the anterior fixing element 535 to transition, for example, from an extended configuration to a retracted configuration or a folded configuration.

[0136] Figures 6A and 6B illustrate a side perspective view and an exploded view, respectively, of a laterally deliverable (orthogonally deliverable) transcatheter artificial heart valve 602 (also referred to herein as the “artificial valve” or “valve”) according to one embodiment. In several implementations, the valve 602 may be deployed, for example, within the annulus of a native mitral valve. The valve 602 is configured to allow blood flow in a first direction through the inflow end of the valve 602 and to block blood flow in a second direction opposite to the first direction, through the outflow end of the valve 602. The valve 602 is compressible and expandable between an expandable configuration for implantation into the annulus of a target valve (e.g., in a human heart) and a compressible configuration for introduction into the body using a delivery catheter (not shown in Figures 6A and 6B).

[0137] The valve 602 includes an annular outer support frame 610 and a foldable flow control component 650 mounted within the annular outer support frame 610. The annular outer support frame 610 (also referred to herein as the “outer frame”) is made from a shape memory material such as nickel-titanium alloy, e.g., nitinol, and is therefore a self-expanding structure from a compressed configuration to an expanded configuration. At least a portion of the outer frame 610 is covered, wrapped around, and / or surrounded by a biocompatible cover 640 as described above.

[0138] The outer frame 610 has a transring and / or body portion 612 that circumscribes, forms, and / or defines the central (internal) channel 614 vertically or around and / or along the central axis (y-axis), and has an atrial collar 620 attached circumferentially to the upper edge of the transring and / or the body portion 612 of the outer frame 610. The outer frame 610 has a proximal side 619 and a distal side 622.

[0139] The foldable (internal) flow control component 650 is mounted within the outer frame 610 adjacent to covered or uncovered spacers 630. The flow control component 650 has an inner frame 652 having two or more folding regions, hinge regions, coupling regions, elastically deformable regions, etc. Two to four sets of flexible leaflets 661 are mounted inside or on the inner frame 652. The internal flow control component 650 is foldable and compressible, similar to the outer frame 610. The flow control component 650 is mounted in or inside the outer frame 610 such that the central axis or vertical axis (y-axis) of the inner frame 652 is coaxial with the central axis (y-axis) of the outer frame 610, and / or at least parallel thereto (e.g., parallel thereto but offset therefrom).

[0140] Figures 6A and 6B further illustrate the valve 602, which includes a distal fixing element 632, a proximal fixing element 634, and an anterior fixing element 635. The distal fixing element 632 (e.g., a hyperelastic wire loop distal tab) is coupled to and / or extends from the distal side 622 of the outer frame 610, and the proximal fixing element 634 (e.g., a hyperelastic wire loop proximal tab) is coupled to and / or extends from the proximal side 619 of the outer support frame 610. In some embodiments, the distal fixing element 632 and the proximal fixing element 634 may be a single, integrated tab constructed in conjunction with the body portion 612 of the outer frame 610. In the embodiments shown in Figures 6A and 6B, the anterior fixing element 635 is not disposed within the sleeve, as described above with reference to the fixing element 535. Rather, the anterior fixing element 635 is mounted on the anterior side of the annular portion 612 of the outer frame 610 via one or more mounting points 638.

[0141] The size and shape of the fixing elements 632, 634, and / or 635 may vary. For example, in some embodiments, the shape of the distal fixing element 632 is configured to match the A1 commissure region of the mitral valve, the shape of the proximal fixing element 634 is configured to match the A3 commissure region of the mitral valve, and the shape of the anterior proximal fixing element 635 is configured to match the A2 commissure region of the mitral valve.

[0142] In some embodiments, the distal fixation element 632 can transition between, for example, a compression configuration, a shortened configuration, and / or a folded configuration (e.g., a first configuration) and an extended configuration or an unfolded configuration (e.g., a second configuration). In the extended configuration, the distal fixation element 632 can reach around the P2 and / or P3 leaflets of the associated mitral valve and / or notochord, and when transitioned to the compression configuration, the distal fixation element 632 can capture and / or pin the patient's own tissue, notochord, etc., between the distal fixation element 632 and the trans-annular portion 612 of the outer frame 610.

[0143] In some embodiments, the anterior fixation element 635 is reconfigurable between a first configuration (e.g., a retracted configuration) and a second configuration (e.g., an extended configuration). In some implementations, the anterior fixation element 635 may extend beneath the valve annulus (e.g., to the second configuration) during valve deployment of the valve 602 to engage with and / or capture self-leaflet tissue (e.g., A2 leaflet, tissue, notochord, etc.). The anterior fixation element 635 may be retracted (e.g., to the first configuration) to capture and fix tissue between the anterior fixation element 635 and the trans-annular portion 612 of the outer frame 610. In some embodiments, the distal fixation element 632 and / or the anterior fixation element 635 may be actuated and / or transitioned using a maneuverable catheter and / or guidewire. In some implementations, retracting the guidewire may allow the distal fixation element 632 and / or the anterior fixation element 635 to transition, for example, from an extended configuration to a retracted or folded configuration.

[0144] Figures 7A–7E are a series of illustrative examples of an artificial valve 702 showing the capture of self-tissue P1, P2 by a distal fixation element 732. Figure 7A shows the distal fixation element 732 tracking along the guidewire 785 toward a desired position relative to the self-tissue P1, P2. Figure 7B shows the distal fixation element 732 and the withdrawal of the guidewire 785 within the desired position. The distal fixation element 732 acts and / or shortens when the guidewire 785 is withdrawn (for example, the distal fixation element 732 may be a shape memory device, etc.). Figure 7C shows the distal fixation element 732 pulling the self-tissue P1, P2 against the distal wall of the outer frame 710 of the valve 702. Figure 7D shows the completion of the capture of self-tissue P1, P2 and the fixation of the valve 702 with the distal fixation element 732 pressing the self-tissue against the outer frame 710 to facilitate inward growth of the valve and reduce minute movements. Figure 7E shows that in several implementations, the distal fixing element 732 may be configured to wrap around substantially all or a relatively large portion of the valve 702 to capture the P1 / A1, P2, and P3 / A3 self-organizations.

[0145] Figure 8 is an illustrative top view of a laterally deliverable transcatheter heart valve 802 according to one embodiment. The valve 802 has an outer frame 810 and a flow control component 850 mounted therein. The outer frame 810 is eccentric while having a D-shape that can match the patient's own annulus (e.g., the annulus of the patient's own mitral valve). The outer frame 810 can also be designed to be somewhat oversized (e.g., only about 10-15% oversized for a particular patient's anatomical structure, as determined by preoperative planning and intraoperative or preoperative imaging).

[0146] The outer frame 810 includes and / or is coupled to a distal fixation element 832 that can track the guidewire 885. In addition, the prosthetic valve 802 and / or the outer frame 810 include or are coupled to a proximal fixation element 834, an anterior fixation element 835, and two posterior fixation elements 837. Figure 8 also shows a positioning tool 890 (e.g., a catheter such as a guidewire catheter) that can engage with and / or transition to any of the fixation elements 832, 834, 835, and / or 837 to capture the self-leaflet and / or notochord. In some implementations, the positioning tool 890 can first advance the valve 802 out of the delivery catheter (not shown), and secondarily, steer and / or position the valve 802 within the annulus or one or more of the fixation elements 832, 834, 835, and / or 837 relative to that annulus. In some embodiments, one or more of the rear fixing elements 837 may be configured to engage and / or contact a portion of the distal fixing element 832 that wraps around the rearward side of the valve 802. In such embodiments, the one or more rear fixing elements 837 may fix the distal fixing element 832 in a desired configuration (e.g., wrap-around).

[0147] Figure 8 further shows that in some embodiments, the outer frame 810 may include a distal stabilizing element 832A adjacent to the distal fixing element 832. In some implementations, the distal stabilizing element 832A may contact the subannular tissue to stabilize, reduce, and / or minimize undesirable rotation or twisting of the valve 802 relative to the annulus.

[0148] Figure 9A is an example of a cross-sectional view of a human heart showing the relative locations of the mitral valve (MV), tricuspid valve (TV), aortic valve (AV), and pulmonary valve (PV) according to one embodiment.

[0149] Figure 9B is an illustrative side view of a human heart having a transseptal (transfemoral / IVC or SVC) delivery catheter 972 that traverses from the right atrium to the left atrium to access the mitral valve, according to one embodiment. Using this delivery catheter 972, a transcatheter mitral valve prosthesis, such as any of those described herein, can be delivered orthogonally or laterally.

[0150] Figures 10 and 11 are illustrative side perspective and side view, respectively, of a delivery catheter 1072 (or guidewire 1085) relating to accessing the self-valve via the IVC to access the P2 location of the self-valve and wrapping under and / or around the self-A2 leaflet, according to one embodiment.

[0151] Figures 12-16 illustrate various examples of the process for delivering and deploying a laterally deliverable transcatheter artificial heart valve 1102, for example, within an autologous mitral valve, according to one embodiment. Figure 12 shows a guidewire 1185 that guides the artificial valve 1102 to the A1 leaflet, with the valve 1102 in a compressed configuration within the delivery catheter 1172, according to one embodiment. The artificial valve 1102 includes a distal fixation element 1132 that is positioned on or passes through the guidewire 1185 for guiding the distal fixation element 1132 (and therefore the valve 1102) to a desired deployment location.

[0152] Figure 13 shows the distal fixation element 1132 deployed at location A1 of the progenitor mitral valve. The valve 1102 is shown in a partially deployed state, partially released from the delivery catheter 1172.

[0153] Figure 14 shows the outer frame 1110, atrial collar 1120, flow control component 1150, and spacer 130 of the prosthetic valve 1102. The valve 1102 is shown fully ejected from the delivery catheter 1172 and temporarily positioned at an upward angle relative to the distal fixation element 132 located at position A1 of the atrial collar around the annulus of the mitral valve. This oblique positioning avoids a pop-off effect and allows the prosthetic valve 1102 to engage in blood flow while the proximal valve continues to function. The proximal fixation element 1134 is shown above the annulus before the proximal side of the valve 1102 is pushed into place to fix the proximal side of the valve 1102.

[0154] Figure 15 is a top view showing the prosthetic valve 1102 deployed within its own valve ring (shown by a dashed line). Figure 16 is a side perspective view showing the prosthetic valve 1102 deployed within its own valve ring (shown by a dashed line). The flow control component 1150 is offset within the outer frame 1110 and is shown to be positioned distally within the outer frame 1110 relative to the spacer 1130. The distal fixing element 1132 is shown to wrap around a portion of the self-tissue to secure the self-tissue to the annular portion of the outer frame 1110.

[0155] Figures 17A and 17B are side perspective views of a laterally deliverable transcatheter artificial heart valve 1202 deployed within the annulus of a self-propagating valve, such as a self-propagating mitral valve (shown by a dashed line), according to one embodiment. The artificial valve 1202 includes an outer frame 1210 having a flow control component 1250 mounted in the central channel of the outer frame 1210 and a spacer 1230 mounted adjacent to the flow control component 1250. The valve 1202 further includes a distal fixing element 1232 coupled to and / or extending from the distal side of the outer frame 1210 and an anterior fixing element 1235 coupled to and / or extending from the anterior side of the outer frame 1210.

[0156] Figure 17A shows the valve 1202 deployed within the valve ring, with the distal fixation element 1232 wrapped around a portion of the self-tissue to secure it to the annular portion of the outer frame 1210. The anterior fixation element 1235 is shown in an extended configuration for engaging with self-tissue such as the A2 leaflet and notochord. Figure 17B shows the anterior fixation element 1235 in a retracted or compressed configuration that secures at least a portion of the A2 leaflet, notochord, and / or anterior self-tissue to the annular portion of the outer frame 1210.

[0157] Figures 18A and 18B are side perspective views of a laterally deliverable transcatheter artificial heart valve 1302 deployed within the annulus of a self-propagating valve, such as a self-propagating mitral valve (shown by a dashed line), according to one embodiment. The artificial valve 1302 includes an outer frame 1310 having a flow control component 1350 mounted in the central channel of the outer frame 1310 and a spacer 1330 mounted adjacent to the flow control component 1350. The valve 1302 further includes a distal fixing element 1332 coupled to and / or extending from the distal side of the outer frame 1310, a proximal fixing element 1334 coupled to and / or extending from the proximal side of the outer frame 1310, and an anterior fixing element 1335 coupled to and / or extending from the anterior side of the outer frame 1310.

[0158] Figure 18A shows a valve 1302 deployed within an annulus, having a distal fixing element 1332 extending from the outer frame 1310 and engaging with self-tissue on the distal side of the annulus, and a proximal fixing element 1334 extending from the outer frame 1310 and engaging with self-tissue on the proximal side of the annulus. The anterior fixing element 1335 is shown in an extended configuration for engaging with self-tissue such as the A2 leaflet and notochord. Figure 18B shows the anterior fixing element 1335 in a retracted or compressed configuration, where the anterior fixing element 1335 fixes at least a portion of the A2 leaflet, notochord, and / or anterior self-tissue to the trans-annular portion of the outer frame 1310.

[0159] Figures 19A and 19B are side perspective views of a laterally deliverable transcatheter artificial heart valve 1402 deployed within the annulus of a self-propagating valve, such as a self-propagating mitral valve (shown by a dashed line), according to one embodiment. The artificial valve 1402 includes an outer frame 1410 having a flow control component 1450 mounted within a central channel of the outer frame 1410 and a spacer 1430 mounted adjacent to the flow control component 1450. The valve 1402 further includes a distal fixing element 1432 coupled to and / or extending from the distal side of the outer frame 1410, a proximal fixing element 1434 coupled to and / or extending from the proximal side of the outer frame 1410, and an anterior fixing element 1435 coupled to and / or extending from the anterior side of the outer frame 1410.

[0160] Figure 19A shows the valve 1402 deployed within the valve annulus, with the distal fixation element 1432 securing the self-tissue to the trans-annular portion of the outer frame 1410 by wrapping around a portion of the self-tissue. The proximal fixation element 1334 is shown extending from the outer frame 1310 and engaging with the self-tissue on the proximal side of the valve annulus. The anterior fixation element 1435 is shown in an extended configuration for engaging with self-tissue such as the A2 leaflet and notochord. Figure 19B shows the anterior fixation element 1435 in a retracted or compressed configuration, where the anterior fixation element 1435 secures at least a portion of the A2 leaflet, notochord, and / or anterior self-tissue to the trans-annular portion of the outer frame 1410.

[0161] Figures 20–24 illustrate various examples of the process for delivering and deploying a transcatheter prosthetic heart valve 1502 that can be delivered laterally within, for example, the patient's own mitral valve, according to one embodiment. Figure 20 is a side view of the prosthetic valve 1502 in an expanded configuration and having a distal fixation element 1532 extending from the outer frame 1510 of the prosthetic valve 1502. The outer frame 1510 is also shown to include and / or be coupled to an atrial collar 1520.

[0162] Figure 21 is a top view of the prosthetic valve 1502 in an expanded configuration, showing a distal fixation element 1532 extending from the outer frame 1510, an atrial collar 1520 coupled to and / or contained within the outer frame 1510, and a flow control component 1550 fitted within the central channel of the outer frame 1510.

[0163] Figure 22 is a side view of the prosthetic valve 1502, which is in a compressed configuration and positioned within a delivery catheter 1572 from delivery to the atrium of the heart. The valve 1502 is in an orthogonal folded configuration and / or compressed configuration, which allows the valve 1502 to advance through the lumen of the delivery catheter 1572.

[0164] Figure 23 is a side view of the prosthetic valve 1502 partially released from the delivery catheter 1572 for deployment. The valve 1502 is configured to transition from a compressed configuration to an expanded configuration when the valve 1502 is released from the delivery catheter 1572. Furthermore, the distal fixation element 1532 is shown to extend distally from the valve 1502.

[0165] Figure 24 is a side view of a delivery catheter 1572 at least partially positioned within the atrium of the heart, shown together with a valve 1502 partially released from the delivery catheter 1572. A distal fixation element 1532 is shown to be tracked on and / or along the guidewire 1585 in the process of capturing the patient's own tissue (e.g., the patient's leaflet(s) and / or notochord).

[0166] Figures 25A–25E illustrate a laterally delivered transcatheter artificial heart valve 1602 according to one embodiment, which is shown to transition to a compressed configuration, be loaded into a delivery catheter 1672 for transcatheter delivery to the annulus of the heart, and partially released from the delivery catheter 1672 for deployment to the annulus of the heart.

[0167] Figure 25A shows valve 1602 in a folding configuration along the z-axis (from front to back when viewed from the wider side). Figure 25A shows outer frame 1610, within which flow control components 1650 and spacers 1630 are disposed in the central channel of outer frame 1610. Distal fixing element 1632 is shown to extend from the distal side of outer frame 1610. Collar 1620 of outer frame 1610 is shown to fold / flatten at proximal and distal hinge points or folding regions 1619 and 1622. Flow control component 1650 is shown to include leaflet 1661 mounted within inner frame 1652 which folds / flattens.

[0168] Figure 25B shows valve 1602 in a vertically compressed configuration. For example, valve 1602 can be folded laterally (e.g., in the z-axis direction, at the hinge points and / or folding regions 1619 and 1622 of the outer frame 1610) and compressed vertically (e.g., in the y-axis direction). Flow control components 1650 and spacer 1630 are also folded and compressed. Figure 25B also shows guidewire 1685, which can be passed through guidewire coupler 1633 of distal fixing element 1632.

[0169] Figure 25C shows the valve 1602 partially loaded into the delivery catheter 1672. The flow control component 1650, which has an outer frame 1610, a folding collar 1620, a spacer 1630, and a leaflet 1661 and an inner frame 1652, is in a folded and compressed configuration and / or is in a state of transition to a folded and compressed configuration.

[0170] Figure 25D is an end view of the delivery catheter 1672 showing the loaded valve 1602 in a folded and compressed configuration.

[0171] Figure 25E shows the folded and compressed valve 1602 being released from the delivery catheter 1672 and beginning to transition from the folded and compressed configuration to the expanded configuration for deployment into the annulus of the valve itself. The guidewire connector 1633 of the distal fixation element 1632 is shown to be positioned on or through the guidewire 1685.

[0172] Figures 26A-26C illustrate a laterally delivered transcatheter artificial heart valve 1702 according to one embodiment, showing that it is converted to a compressed configuration and loaded into a delivery catheter 1772 for transcatheter delivery to the heart's own annulus.

[0173] Figure 26A shows valve 1702 in a folding configuration along the z-axis (from front to back when viewed from the wider side). Figure 26A shows outer frame 1710, within which flow control components 1750 and spacers 1730 are disposed in the central channel of outer frame 1710. Distal fixing element 1732 is shown to extend from the distal side of outer frame 1710. Front fixing element 1735 is shown to be mounted on the front side of outer frame 1710. Front fixing element 1735 is in a non-extending or non-acting configuration. The collar 1720 of outer frame 1710 is shown to fold / flatten at proximal and distal hinge points or folding regions 1719 and 1722. Flow control components 1750 are shown to include leaflet 1761 mounted within inner frame 1752 which folds / flattens.

[0174] Figure 26B shows valve 1702 in a vertically compressed configuration. For example, valve 1702 is folded laterally (e.g., in the z-axis direction, at the hinge points and / or folding regions 1719 and 1722 of the outer frame 1710) and compressed vertically (e.g., in the y-axis direction). Flow control components 1750 and spacer 1730 are also folded and compressed. The forward fixing element 1735 is shown to be compressed vertically in response to the vertical compression of the outer frame 1710. Figure 26B also shows a guide wire 1785, which can be passed through the guide wire coupler 1733 of the distal fixing element 1732.

[0175] Figure 26C shows the valve 1702 partially loaded within the delivery catheter 1772. The outer frame 1710, which has a forward fixing element 1735, a folding collar 1720, a spacer 1730, and a flow control component 1750 having a leaflet 1761 and an inner frame 1752, is in a folded and compressed configuration and / or is in a state of transition to a folded and compressed configuration.

[0176] Figures 27A-27C illustrate a laterally delivered transcatheter artificial heart valve 1802 according to one embodiment, showing that it is converted to a compressed configuration and loaded into a delivery catheter 1872 for transcatheter delivery to the heart's own annulus.

[0177] Figure 27A shows valve 1802 in a folding configuration along the z-axis (from front to back when viewed from the wider side). Figure 27A shows outer frame 1810, within which flow control components 1850 and spacers 1830 are disposed in the central channel of outer frame 1810. Distal fixing element 1832 is shown to extend from the distal side of outer frame 1810, and proximal fixing element 1834 is shown to extend from the proximal side of outer frame 1810. The collar 1820 of outer frame 1810 is shown to fold / flatten at the proximal and distal hinge points or folding regions 1819 and 1822. Flow control component 1850 is shown to include leaflet 1861 mounted within inner frame 1852 which folds / flattens.

[0178] Figure 27B shows valve 1802 in a vertically compressed configuration. For example, valve 1802 is folded laterally (e.g., in the z-axis direction, at the hinge points and / or folding regions 1819 and 1822 of the outer frame 1810) and compressed vertically (e.g., in the y-axis direction). Flow control components 1850 and spacer 1830 are also folded and compressed. The forward fixing element 1835 is shown to be compressed vertically in response to the vertical compression of the outer frame 1810. Figure 27B also shows a guidewire 1885, which can be passed through the guidewire coupler 1833 of the distal fixing element 1832.

[0179] Figure 27C shows the valve 1802 partially loaded into the delivery catheter 1872. The flow control component 1850, which has an outer frame 1810, a folding collar 1820, a spacer 1830, and a leaflet 1861 and an inner frame 1852, is in a folded and compressed configuration and / or is in a state of transition to a folded and compressed configuration.

[0180] Figures 28A-28C illustrate a laterally delivered transcatheter artificial heart valve 1902 according to one embodiment, showing that it is converted to a compressed configuration and loaded into a delivery catheter 1972 for transcatheter delivery to the heart's own annulus.

[0181] Figure 28A shows valve 1902 in a folding configuration along the z-axis (from front to back when viewed from the wider side). Figure 28A shows outer frame 1910, within which flow control components 1950 and spacers 1930 are disposed in the central channel of outer frame 1910. Distal fixing element 1932 is shown to extend from the distal side of outer frame 1910, and proximal fixing element 1934 is shown to extend from the proximal side of outer frame 1910. Front fixing element 1935 is shown to be mounted on the front side of outer frame 1910. Front fixing element 1935 is in a non-extending or non-acting configuration. The collar 1920 of outer frame 1910 is shown to fold / flatten at the proximal and distal hinge points or folding regions 1919 and 1922. The flow control component 1950 is shown to include a leaflet 1961 mounted within a foldable / flattened inner frame 1952.

[0182] Figure 28B shows valve 1902 in a vertically compressed configuration. For example, valve 1902 is folded laterally (e.g., in the z-axis direction, at the hinge points and / or folding regions 1919 and 1922 of the outer frame 1910) and compressed vertically (e.g., in the y-axis direction). Flow control components 1950 and spacers 1930 are also folded and compressed. The forward fixing element 1935 is shown to be compressed vertically in response to the vertical compression of the outer frame 1910. Figure 28B also shows a guidewire 1985 which can be passed through the guidewire coupler 1933 of the distal fixing element 1932.

[0183] Figure 28C shows the valve 1902 partially loaded into the delivery catheter 1972. The outer frame 1910, which has a forward fixing element 1935, a folding collar 1920, a spacer 1930, and a flow control component 1950 having a leaflet 1961 and an inner frame 1952, is in a folded and compressed configuration and / or is in a state of transition to a folded and compressed configuration.

[0184] Figures 29A-29C illustrate a transcatheter-delivered transcatheter-artificial heart valve 2002 according to one embodiment, showing that it is converted to a compressed configuration and loaded into a delivery catheter 2072 for transcatheter delivery to the heart's own annulus.

[0185] Figure 29A shows valve 2002 in a folding configuration along the z-axis (from front to back when viewed from the wider side). Figure 29A shows outer frame 2010, within which flow control components 2050 and spacer 2030 are disposed in the central channel of outer frame 2010. Distal fixing element 2032 is shown to extend from the distal side of outer frame 2010, and proximal fixing element 2034 is shown to extend from the proximal side of outer frame 2010. Front fixing element 2035 is shown to be mounted on the front side of outer frame 2010. Front fixing element 2035 is in a non-extending or non-acting configuration. The collar 2020 of outer frame 2010 is shown to fold / flatten at the proximal and distal hinge points or folding regions 2019 and 2022. The flow control component 2050 is shown to include a leaflet 2061 mounted within a foldable / flattened inner frame 2052.

[0186] Figure 29B shows valve 2002 in a vertically compressed configuration. For example, valve 2002 is folded laterally (e.g., in the z-axis direction, at the hinge points and / or folding regions 2019 and 2022 of the outer frame 2010) and compressed vertically (e.g., in the y-axis direction). Flow control component 2050 and spacer 2030 are also folded and compressed. The forward fixing element 2035 is shown to be compressed vertically in response to the vertical compression of the outer frame 2010. Figure 29B also shows a guide wire 2085, which can be passed through the guide wire coupler 2033 of the distal fixing element 2032.

[0187] Figure 29C shows the valve 2002 partially loaded into the delivery catheter 2072. The outer frame 2010, which has a forward fixing element 2035, a folding collar 2020, a spacer 2030, and a flow control component 2050 having a leaflet 2061 and an inner frame 2052, is in a folded and compressed configuration and / or transitioning to a folded and compressed configuration.

[0188] Figures 30-33 illustrate an inner leaflet frame 2152 of a flow control component according to one embodiment. Figure 30 is an illustrative top perspective view of the inner leaflet frame 2152. In some embodiments, the inner leaflet frame 2152 is formed of two separate wire frame sheets or members joined at lateral connection points 2165 and 2166 (e.g., folding portion, elastically deformable portion, joining edge portion, etc.). The inner leaflet frame 2152 is shown in an extended configuration or a cylinder configuration (e.g., before being folded and / or compressed).

[0189] Figure 31 shows the inner leaflet frame 2152 in a partially folded configuration. The inner leaflet frame 2152 is shown with wire frame sidewalls that allow rotation or hinge at least at lateral connection points 2165 and 2166. The inner leaflet frame 2152 may be configured to fold, as shown in response to the valve being folded and / or compressed for delivery. Figure 32 shows the inner leaflet frame 2152 in a fully folded configuration. The wire frame sidewalls are rotated, hinged and / or folded at their lateral connection points 2165 and 2166.

[0190] Figure 33 shows the inner leaflet frame 2152 in a state transitioning from a folded and vertically compressed configuration to a compressed configuration. The wire frame sidewalls can form cells (e.g., rhomboid-shaped cells) that can be oriented in the direction of compression to allow elastic compression of the inner frame 2152. In some embodiments, the inner frame 2152 can be compressed perpendicularly to a pleated or bellows (compression) configuration.

[0191] Figures 34-40 illustrate one or more parts of an internal flow control component 2250 according to one embodiment. Figure 34 is an illustrative side view of the inner leaflet frame 2252 of the flow control component. The inner leaflet frame 2252 is configured as a linear wire frame sheet and / or formed as a linear wire frame sheet before being further assembled into a cylinder structure. Figure 35 shows the inner leaflet frame 2252 in a cylinder structure or configuration (or conical structure or configuration), where the edge portions of the linear wire frame sheet are connected or joined at lateral connection points 2265 and 2266 (e.g., hinge area, folding area, etc.). Furthermore, the inner leaflet frame 2252 can be extended (e.g., driven, formed, bent, etc.) from a linear sheet configuration to a cylinder structure or configuration.

[0192] Figures 36 and 37 illustrate a pericardial tissue structural band 2264 having leaflet pockets 2261 sewn into the structural band 2264, a side view and a bottom view, respectively, before assembly into the cylinder leaflet component and before mounting on and / or inside the inner frame 2252 to form the foldable (foldable, compressible) flow control component 2250.

[0193] Figure 38 is an example of a side perspective view of a structural band 2264 formed of pericardial tissue having leaflet pockets 2261 sewn into the structural band 2264 after assembly into a cylinder leaflet configuration, wherein the leaflet pockets 2261 are located on the inner surface of the structural band 2264.

[0194] Figure 39 is an illustrative lateral perspective view of a portion of a structural band 2264 of pericardial tissue, showing a single leaflet pocket 2261 sutured within the structural band 2264. The leaflet pocket 2261 is shown partially joined to the structural band 2264, with an open edge 2263 extending outward and a sutured edge 2262 forming a closed upper parabolic edge providing attachment.

[0195] Figure 40 is an example of a bottom view of the flow control component 2250. The cylinder structure band 2264 and leaflet component 2261 are shown in a state where the partial joint is forming a closed fluid seal.

[0196] Figures 41A to 41D illustrate various diagrams illustrating the process of transitioning a laterally deliverable transcatheter artificial heart valve and / or its outer frame to a compressed configuration for delivery, according to one embodiment.

[0197] Figure 41A is an illustrative top perspective view of the outer frame 2310 of a valve 2302 in a cylinder configuration, showing the initial part of the folding and compression process of the outer frame 2310. Although not shown in Figure 41A, in some implementations, the outer frame 2310 can receive the flow control component 2350 within the central channel of the outer frame 2310 before folding and compression (e.g., the outer frame 2310 and the flow control component are folded, compressed, and delivered together). In other implementations, the outer frame 2310 may be delivered independently of the flow control component. In such implementations, the flow control component may undergo a similar folding and compression process and be mounted within the outer frame 2310 after delivery (e.g., within the atrium of the heart).

[0198] Figure 41B is a top perspective view of the outer frame 2310 in a partially folded configuration, with the side walls of the outer frame 2310 rotated or hinged at lateral connection points or hinge points 2319 and 2322. Figure 41C is a side view of the outer frame 2310 in a fully folded flattened configuration, with the frame side walls rotated or hinged at their lateral connection points or hinge points 2319 and 2322. Figure 41D is a side view of the outer frame 2310 in a folded and vertically compressed configuration, with the frame side walls vertically compressed in a pleated or bellows configuration. In some implementations, the outer frame 2310 in a folded and compressed configuration may have a size that allows the outer frame 2310 to be delivered via a delivery catheter.

[0199] Figures 42A–42C illustrate various diagrams illustrating the process of transitioning a laterally deliverable transcatheter artificial heart valve and / or its outer frame to a compressed configuration for delivery, according to one embodiment. Figure 42A is a top perspective view of the outer frame 2410 of the valve in a partially folded configuration, with the side walls of the outer frame 2410 rotated or hinged at their lateral connection points or hinge points 2419 and 2422. The outer frame 2410 includes at least an anterior fixing element 2435 which can be configured to contract or bend when the outer frame 2410 is transitioned to a folded and compressed configuration. Figure 42B is a side view of the outer frame 2410 in a fully folded flattened configuration, with the frame side walls rotated or hinged at their lateral connection points or hinge portions 2419 and 2422. Figure 42C is a side view of the outer frame 2410 in a folded and vertically compressed configuration, where the frame sidewalls are vertically compressed in a pleated or bellows configuration. The front fixing element 2435 is similarly vertically compressed when the outer frame 2410 is compressed. In some implementations, the outer frame 2410 in the folded and compressed configuration may have a size that allows the outer frame 2410 to be delivered via a delivery catheter.

[0200] Figures 43A–43C illustrate various diagrams illustrating the process of transitioning a laterally deliverable transcatheter artificial heart valve and / or its outer frame to a compressed configuration for delivery, according to one embodiment. Figure 43A is a top perspective view of the outer frame 2510 of the valve in a partially folded configuration, with the side walls of the outer frame 2510 rotated or hinged at lateral connection points or hinge points 2519 and 2522. The outer frame 2510 includes at least a distal fixation element 2532 and a proximal fixation element 2534. The distal fixation element 2532 includes a guidewire connector 2533 that may receive and / or be arranged around a portion of a guidewire (not shown) to allow the outer frame 2510 to advance to a desired location within the body. Figure 43B is a side view of the outer frame 2510 in a fully folded, flattened configuration, where the frame sidewalls are rotated or hinged at their lateral connection points or hinge regions 2519 and 2522. Figure 43C is a side view of the outer frame 2510 in a folded and vertically compressed configuration, where the frame sidewalls are vertically compressed in a pleated or bellows configuration. In some implementations, the outer frame 2510 in a folded and compressed configuration may have a size that allows the outer frame 2510 to be delivered via a delivery catheter. The arrangement of the distal fixation elements 2532 and proximal fixation elements 2534 may be such that the fixation elements 2532 and 2534 extend substantially longitudinally (e.g., along the x-axis), and thus may remain unfolded and / or uncompressed during delivery.

[0201] Figures 44A and 44B illustrate a valve 2602 according to one embodiment. Figure 44A is an illustrative top view of the valve 2602 in a compressed configuration and disposed within a delivery catheter 2672 (e.g., orthogonally loaded). The valve 2602 includes an outer frame 2610 having a distal fixing element 2632 extending forward along the x-axis and a proximal fixing element 2634 extending backward or following behind along the x-axis. A flow control component 2650 is shown to be disposed within the outer frame 2610. Figure 44B is an illustrative top view of the valve 2602 partially released from the delivery catheter 2672. The distal fixing element 2632 is shown to guide the valve 2602 to deployment (along the guidewire 2685). The flow control component 2650 is shown beginning to unfold, with two of the three leaflets 2661 unfolding from their folded pseudo-flattened configurations, and the third leaflet unfolding from its folded configuration, which would otherwise fold over itself while inside the delivery catheter 2672.

[0202] Figures 45 and 46 illustrate an example of a process using a distal fixation element of a laterally deliverable transcatheter prosthesis valve 2702 to capture self-tissue, according to one embodiment. In some cases, the process may include (1) providing a foldable, compressible orthogonal prosthesis mitral valve 2702 (Figure 26); (2) loading the lateral passage of the valve 2702 into a delivery catheter 2772; and (3) advancing the valve 2702 to the heart via an IVC or SVC over a pre-positioned guidewire 2785 that passes through a distal fixation element 2732. Next, the process continues by (4) partially releasing the straight end of the distal fixation element 2732 of the valve 2702 from the delivery catheter 2772, and (5) partially withdrawing the guidewire 2785 to capture and shorten, for example, the P2 leaflet and / or notochord, or to shorten the distal fixation element 2732 to a pre-curved, biased, or original configuration (Figure 46), (6) partially releasing the valve 2702 to allow a set of artificial leaflets to function and begin checking for perivalvular leakage (PVL), (7) positioning the valve 2702 within the annulus of the own valve, and (8) completing the deployment of the valve 2702 into the annulus of the own valve.

[0203] Figures 47–49 are side perspective views of a laterally deliverable transcatheter artificial heart valve 2802 according to one embodiment, illustrating the deployment process. Figure 47 shows the valve 2802 with an anterior fixation element 2835 in a folded, compressed, and / or non-operating position. The anterior fixation element 2835 is mounted on the anterior side of the valve 2802 (or its outer frame) via any number of mounting points 2838. A positioning tool 2890 (e.g., a maneuverable catheter / guidewire) is shown to deploy the engaging portion 2939 of the anterior fixation element 2835.

[0204] Figure 48 shows a positioning tool 2890 that places the engaging portion 2839 of the front fixing element 2835 in an extended position to engage and / or capture the leaflet tissue. The mounting point 2838 fixes a portion of the front fixing element 2835, thereby generating a spring-like repulsive force when the engaging portion 2839 is extended to capture the tissue grasped between the engaging portion 2839 and a portion of the outer frame of the valve 2802. Figure 49 shows the front fixing element 2835 returned to a folded and / or compressed configuration, with the front leaflet tissue and / or portion of the notochord positioned between the engaging portion 2839 and the outer frame.

[0205] Figures 50A–50D illustrate various diagrams of an anterior fixation element 2935 housed within a laterally deliverable transcatheter artificial heart valve according to one embodiment, shown as a first configuration, a second configuration, a third configuration, and a fourth configuration, respectively. Figure 50A shows an anterior fixation element 2935 having an engaging portion 2939 and at least partially tucked into the sleeve 2936 before deployment. The mounting point 2938 is shown adjacent to the engaging portion 2939 and is configured to mount the anterior fixation element 2935 to the outer frame of the valve and / or the sleeve 2936, which are then mounted to the outer frame. Figure 50B shows an anterior fixation element 2935 extending in the direction of the ventricle along the central (y) axis. The mounting point 2938 is positioned above the engaging portion 2939 of the anterior fixation element 2935. The engaging portion 2939 is shown folded and / or not extended in a position below the valve annulus. Figure 50C shows the forward fixing element 2935 fully unfolded to capture forward tissue. The mounting point 2938 is positioned above the engaging portion 2939 of the forward fixing element 2935. The engaging portion 2939 is shown unfolded and extended in a position below the valve ring to capture self-tissue. Figure 50D shows the forward fixing element 2935 in the folded and / or retracted position after tissue capture, with tissue (not shown) pinned to the outer wall of the outer frame. In the retracted position, the mounting point 2938 is positioned relatively adjacent to the engaging portion 2939 of the forward fixing element 2935. The engaging portion 2939 is shown in a partially unfolded configuration and / or a partially extended configuration (e.g., a capture configuration).

[0206] Figures 51A to 51G illustrate side perspective views of various anchor and / or anchor loop configurations for securing a portion of a laterally deliverable transcatheter prosthetic heart valve to the patient's own tissue, each according to a different embodiment. The anchor and / or anchor loop configurations may include, for example, an anterior fixation element and / or any other suitable fixation element of the prosthetic valve. For example, Figure 51A shows a post-type hook 3039, Figure 51B shows a loop-type hook 3139, Figure 51C shows a paddle-type hook 3239, Figure 51D shows a double-loop-type hook 3339, Figure 51E shows a footer-type hook 3439, Figure 51F shows a bent-loop-type hook 3539 with an optional locking nut 3531, and Figure 51G shows a bent-loop-type hook 3639 with an optional locking nut 3651.

[0207] Figures 52 and 53 are side perspective views of a laterally deliverable transcatheter artificial heart valve 3702 according to one embodiment, having a distal fixation element 3732, a proximal fixation element 3732, and a plurality of anterior fixation elements 3735A and 3735B. The valve 3702 has an outer frame 3710 having an atrial collar 3720 and a flow control component 3750 mounted within a central channel of the outer frame 3710. The distal fixation element 3732 extends from the distal side of the outer frame 3710 and includes a guidewire connector 3733 that can receive and / or pass a guidewire for delivering the valve 3702 to a desired location. The distal fixation element 3732 can provide subannular fixation on the distal side of the annulus and, in some implementations, can wrap around the posterior side or portion of the own valve. The proximal fixing element 3734 extends from the proximal side of the outer frame 3710 and provides sub-ring fixation on the proximal side of the valve ring. The valve 3702 includes two anterior fixing elements 3735A and 3735B mounted on the anterior side of the outer frame 3710. Figure 52 shows the two anterior fixing elements 3735A and 3735B in a folded configuration, a non-extending configuration, and / or a non-acting configuration. Figure 53 shows the two anterior fixing elements 3735A and 3735B in an extending configuration for engaging with and / or capturing the anterior self-organization and / or notochord. The anterior fixing elements 3735A and 3735B can retract from the extending configuration to fix and / or pin the self-organization and / or notochord to the outer frame 3710.

[0208] Figure 54 is a side view of a laterally deliverable transcatheter artificial heart valve 3802 according to one embodiment. The valve 3802 has, for example, a distal fixing element 3832 with gradient stiffness, which has softer stiffness in a position or portion near or adjacent to the outer frame 3810 of the valve 3802, and stiffer stiffness in a portion or portion further away from the outer frame 3810. The valve 3802 is shown having an offset flow control component 3850. Although the valve 3802 is shown having a distal fixing element 3832 with gradient stiffness, in other embodiments the valve 3802 may include a distal fixing element 3832 with gradient stiffness, and / or a proximal fixing element with similar or different gradient stiffness.

[0209] Figure 55A is a side view of a laterally deliverable transcatheter artificial heart valve 3902 according to one embodiment. The valve 3902 includes an outer frame 3910 having a distal fixing element 3932 extending from the distal side of the outer frame 3910 and a proximal fixing element 3934 extending from the proximal side of the outer frame 3910. A flow control component 3950 is shown mounted at an offset position within the central channel of the outer frame 3910. The fixing elements 3932 and 3934 are, for example, a single-piece structure that wraps around the outer frame 3910 of the valve 3902. Figure 55B is a cross-sectional side view of a heart showing the valve 3902 deployed within the annulus of the own valve. The fixing elements 3932 and 3934 work together to provide a fixing force to the valve 3902, for example, in a downward direction.

[0210] Figure 56A is a side view of a laterally deliverable transcatheter artificial heart valve 3802 according to one embodiment. The valve 4002 includes an outer frame 4010 having a distal fixation element 4032 extending from the distal side of the outer frame 4010 and a proximal fixation element 4034 extending from the proximal side of the outer frame 4010. A flow control component 4050 is shown mounted at an offset position within the central channel of the outer frame 4010. The fixation elements 4032 and 4034 are, for example, independent elements each that wrap around a portion of the outer frame 4010 and include portions or hooks that can engage with the body's own tissue. Figure 56B is a cross-sectional side view of a heart showing the valve 4002 deployed within the annulus of the body's own valve. The fixation elements 4032 and 4034 are shown having portions or fingers that wrap around the body's own tissue, such as the notochord. In some implementations, the fixing elements 4032 and 4034 may become entangled within their own notochord, promoting inward growth and fixing the anchor.

[0211] Figure 57A is a side perspective view of a laterally deliverable transcatheter artificial heart valve 3802 according to one embodiment. The valve 4102 includes an outer frame 4110 having a distal fixation element 4132 extending from the distal side of the outer frame 4110 and a proximal fixation element 4134 extending from the proximal side of the outer frame 4110. A flow control component 4150 is shown mounted at an offset position within the central channel of the outer frame 4110. The fixation elements 4132 and 4134 include, for example, curved loop portions and / or ends that can engage with the self-tissue, independent of elements that each wrap around a portion of the outer frame 4110. Figure 57B is a cross-sectional side view of a heart showing the valve 4102 deployed within the annulus of the self-valve. The fixation elements 4132 and 4134 are shown having curved loop portions or ends that wrap around the self-tissue, such as the notochord, to promote inward growth and secure anchors.

[0212] Figure 58A is an example of a guidewire delivery catheter 4287 according to one embodiment, which provides access to, for example, the A1-P1 target region of a self-valving valve. A guidewire 4285 may extend outward from a lateral port of the guidewire delivery catheter 4287 and can provide a path for positioning the valve at a desired location (e.g., the A1-P1 target location). Figure 58B is an example of a magnified view of a portion of the guidewire delivery catheter 4287.

[0213] Figure 59 shows an example of a delivery catheter 4372 according to one embodiment, for example, providing access to the atrium of the heart. The delivery catheter 4372 may be, for example, a 28Fr delivery catheter having an end disposed within the atrium (e.g., an end exposed toward the atrium). A circumferential balloon 4373 is shown in an inflated state around the atrium-exposed end of the delivery catheter 4372 to temporarily secure the delivery catheter 4372 to the atrial wall.

[0214] Figure 60 is a cross-sectional side view of a portion of the heart showing a guidewire delivery catheter 4487 extending into a cardiac chamber according to one embodiment. The guidewire delivery catheter 4487 is shown extending into the left ventricle through the annulus of the autologous valve. The guidewire 4485 is shown extending from the guidewire delivery catheter 4487 to the target A1-P1 portion. Figure 61 is an enlarged cross-sectional view of the guidewire delivery catheter 4487. The guidewire delivery catheter 4487 is shown having a non-traumatic closed end 448 that defines and / or encloses a lateral port 4489 to allow the guidewire 4485 to extend outward from the distal end of the guidewire delivery catheter 4487 without causing trauma to the autologous tissue.

[0215] Figure 62 is a side perspective view of a transcatheter artificial heart valve 4502 that can be delivered laterally according to one embodiment. The valve 4502 is shown having a septal tether, which includes a relatively rigid, elongated member 4592 attached to an anchor 4593 (e.g., a paddle-type anchor) at the end of the valve. The septal tether may be used to maintain the position of the deployed valve 4502, for example, within the annulus of the patient's own mitral valve, by placing the anchor 4593 in a transseptal puncture used for transseptal delivery from the IVC to the left atrium. Figure 63 is a cross-section of the heart showing the location of the deployed valve 4502 within the annulus of the patient's own mitral valve.

[0216] Figure 64 is a cross-section of the heart showing a guidewire delivery catheter 4687 (or positioning tool) inserted into the left atrium of the heart according to one embodiment. The guidewire 4685 is shown extending from the guidewire delivery catheter 4687. The distal end of the guidewire 4685 is shown together with a docking receptacle 4694 having a key-shaped tissue gripping feature 4695 for fixation to the open wall of the left ventricle. Figure 65 is a magnified cross-section of the heart showing the docking receptacle 4694 fixed to the open wall of the left ventricle.

[0217] Figure 66 is a flowchart illustrating a method 10 for deploying a transcatheter prosthetic heart valve that can be delivered laterally into the annulus of a proximal valve, according to one embodiment. The prosthetic valve may be any of the valves disclosed herein. For example, the valve may have (i) an outer frame having one or more distal fixation elements, proximal fixation elements, and / or anterior fixation elements; and (ii) a flow control component mounted within the outer frame, configured to allow blood flow in one direction through the inlet end of the valve and to block blood flow in the opposite direction through the outlet end of the valve. The valve may be delivered, for example, via lateral delivery or orthogonal delivery. For example, the valve may be delivered by any of the processes and / or methods described in detail herein and / or in '957 PCT.

[0218] Method 10 includes, in 11, advancing a guidewire into the atrium through a plane defined by the annulus of the native valve and behind the native leaflet of the native valve. In some implementations, the native valve may be a native tricuspid valve or a native mitral valve. In 12, the prosthetic valve advances into the atrium along the guidewire through the lumen of the delivery catheter in an orthogonal compression configuration. For example, in some embodiments, the prosthetic valve may include, for example, a distal fixation element having a guidewire connector, the guidewire connector may engage with and / or be positioned over or around the guidewire. In some embodiments, the guidewire connector may be a non-traumatic ball positioned at the end of the distal fixation element, defining an opening configured to receive the guidewire.

[0219] In 13, the prosthetic valve is released from the delivery catheter, allowing at least a portion of the prosthetic valve to transition to an extended configuration, with the distal fixation element of the prosthetic valve in an extended configuration. In some embodiments, for example, the distal fixation element may be a reconfigurable fixation element, which may be in an extended configuration during delivery and / or deployment, and may transition to a compressed or folded configuration, thereby fixing the prosthetic valve within the annulus of the own valve.

[0220] In 14, the prosthetic valve advances along the guidewire to position the distal fixation element posterior to the self-leaflet, seating the prosthetic valve within the annulus of the self-valve. For example, the self-valve may be a self-tricuspid valve, and the self-leaflet may be a posterior (e.g., P2) leaflet. In 15, the guidewire is withdrawn, releasing the distal fixation element from its extended position to its folded position, thereby allowing the distal fixation element to capture at least one of the self-leaflet or notochord, and to fix the self-leaflet or notochord between the distal fixation element and the outer wall of the prosthetic valve. For example, in some embodiments, the distal fixation element may be a fixation element that can return to the folded position when the guidewire is withdrawn, is biased, self-folds, and / or self-shortens. In some embodiments, the distal fixation element may be long enough to capture a desired amount of self-tissue and / or notochord, thereby fixing at least the distal end of the prosthetic valve within the annulus of the self.

[0221] Many modifications and variations can be made without departing from the spirit and scope, as will be obvious to those skilled in the art. In addition to the methods and apparatus enumerated herein, functionally equivalent methods and apparatus within the scope of this disclosure will be obvious to those skilled in the art. Such modifications and variations are intended to fall within the scope of the appended claims. This disclosure should be limited only by the conditions of the appended claims and the entire scope of equivalents to which such claims are granted. It should be understood that this disclosure is not limited to any particular method, reagent, compound, composition, or biological system, and is naturally subject to change. It should also be understood that the terminology used herein is intended solely to describe and not to limit any particular embodiment.

[0222] While various embodiments are described above, it should be understood that they are presented only as examples and are not limiting. If the above methods indicate a particular set of events occurring in a specific order, the order of those events may be changed. Additionally, the events may be executed concurrently in parallel, if possible, as well as sequentially, as described above.

[0223] Where the schematic diagrams and / or embodiments described above show certain components arranged in a particular orientation or position, the arrangement of the components may be changed. Although the embodiments are shown and described concretely, it should be understood that various modifications of form and detail are possible. Any part of the apparatus and / or method described herein may be combined in any combination, except for mutually exclusive combinations.

[0224] The embodiments described herein may include various combinations and / or subcombinations of the functions, components, and / or features of the different embodiments described. The various disclosed features described above, as well as other features and functions, or their substitutes, may be combined with many other different systems or applications. Various substitutes, modifications, variations, or improvements in which there are currently unforeseen or anticipated may subsequently be made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments.

Claims

1. A laterally deliverable artificial heart valve, wherein the artificial heart valve is The outer frame defines a central channel extending along the central axis of the outer frame, and includes a distal fixing element extending from the distal wall of the outer frame, the distal end of the distal fixing element including a guide wire coupling configured to allow a guide wire to pass through, A flow control component mounted within the central channel of the outer frame, wherein the flow control component includes an inner frame and a set of leaflets coupled to the inner frame, The artificial heart valve is configured to fold along its longitudinal axis and compress along its central axis to support the artificial heart valve in a compressed configuration for lateral delivery via a delivery catheter, the guide wire is passed through the guide wire connector, and the guide wire connector is configured to be distal to the central axis when the artificial heart valve advances through the delivery catheter. The artificial heart valve comprising: a distal fixation element configured to transition to an extended configuration when released from the delivery catheter, wherein the distal fixation element is configured to transition to a folded configuration in response to the artificial heart valve being extended while the artificial heart valve is deployed to its own valve and the guidewire being withdrawn from the guidewire connector, the distal fixation element can transition to a folded configuration in which at least one of the self-leaflet or notochord can be fixed between the distal fixation element and the distal wall of the outer frame.

2. The artificial heart valve according to claim 1, further comprising a proximal fixing element coupled to the proximal wall of the outer frame, wherein the proximal fixing element is configured to fix the proximal portion of the artificial heart valve to the subannular tissue when the artificial heart valve is positioned within the annulus of the native valve.

3. The proximal fixation element is configured to transition from a first configuration to a second configuration in order to fix the proximal portion of the artificial heart valve to the subannular tissue of the proximal valve, as described in claim 2.

4. An artificial heart valve according to claim 1, comprising an anterior fixing element coupled to the anterior wall of the outer frame, the anterior fixing element further comprising an engaging portion configured to transition between a first configuration in which the engaging portion extends in the direction of the central axis so as to enable the engaging portion to engage with at least one of an anterior self-leaflet or an anterior notochord, and a second configuration in which the engaging portion retracts at least partially so as to enable the engaging portion to capture and fix the anterior self-leaflet or the anterior notochord between the anterior fixing element and the anterior wall.

5. The artificial heart valve according to claim 4, wherein the anterior fixing element includes a sleeve, the engaging portion is at least partially disposed within the sleeve and extends from the sleeve when in the first configuration, and the engaging portion retracts at least partially into the sleeve when in the second configuration to capture and fix the anterior self-leaflet or the anterior notochord between the anterior fixing element and the anterior wall.

6. The artificial heart valve according to claim 4, wherein the engaging portion of the forward fixing element is a clip.

7. The artificial heart valve according to claim 4, wherein the forward fixing element is a wire, and the engaging portion of the forward fixing element is a reconfigurable portion of the wire.

8. The artificial heart valve according to claim 1, further comprising an atrial collar coupled to the atrial margin of the outer frame, wherein the atrial collar is configured to contact the tissue on the annulus when the artificial heart valve is positioned within the annulus of the own valve.

9. The artificial heart valve according to claim 1, configured to deploy within the annulus of the native mitral valve.

10. A laterally deliverable artificial heart valve, wherein the artificial heart valve is The outer frame defines a central channel extending along the central axis of the outer frame, and comprises a distal fixing element extending from the distal wall of the outer frame and a front fixing element extending from the front wall of the outer frame, wherein the distal end of the distal fixing element is configured to be releasably coupled to a guide wire. A flow control component mounted within the central channel of the outer frame, wherein the flow control component has an inner frame and a set of leaflets coupled to the inner frame, The artificial heart valve is configured to fold along its longitudinal axis for lateral delivery via a delivery catheter and to compress along its central axis to support the artificial heart valve in a compressed configuration, and the artificial heart valve is configured to transition to an expanded configuration when the artificial heart valve is released from the delivery catheter, the flow control component, The distal fixation element is configured to advance along the guidewire when it is in an extended configuration to capture at least one of the distal self-leaflet or the distal notochord, and the distal fixation element is configured to transition to a folded configuration when it is released from the guidewire, allowing the distal self-leaflet or the distal notochord to be fixed between the distal fixation element and the distal wall of the outer frame, The artificial heart valve, comprising an anterior fixing element, configured to transition between an extending configuration in which a portion of the anterior fixing element extends in the direction of the central axis to engage with at least one of an anterior self-leaflet or an anterior notochord, and a retracted configuration in which the end of the anterior fixing element retracts at least partially to fix the anterior self-leaflet or the anterior notochord between the anterior fixing element and the anterior wall of the outer frame.

11. The prosthetic heart valve according to claim 10, wherein the distal fixation element includes a guidewire connector disposed at the distal end of the distal fixation element, and the guidewire connector is configured to releasably receive the guidewire so that the distal fixation element can advance along the guidewire during deployment of the prosthetic heart valve.

12. The artificial heart valve according to claim 11, wherein the distal fixing element is configured to be distal to the central axis, and the guidewire connector is configured to pass the guidewire when the artificial heart valve is in a compression configuration and is placed in the delivery catheter for lateral delivery.

13. The artificial heart valve according to claim 11, wherein the forward fixing element is configured to be temporarily coupled to the guide wire and to transition from the extended configuration to the compressed configuration in response to the forward fixing element being released from the guide wire.

14. The artificial heart valve according to claim 13, wherein releasing the guidewire includes withdrawing the guidewire from the guidewire connector and the forward fixing element.

15. The artificial heart valve according to claim 10, further comprising a proximal fixing element extending from the proximal wall of the outer frame, wherein the proximal fixing element is configured to transition from a first configuration to a second configuration in order to fix the proximal portion of the artificial heart valve to the proximal subannular tissue.

16. The artificial heart valve according to claim 10, wherein the front fixing element includes a sleeve, the end of the front fixing element is at least partially disposed within the sleeve, and the end of the front fixing element is configured to retract at least partially into the sleeve when in the retracted configuration to fix the front self-leaflet or the front notochord between the front fixing element and the front wall of the outer frame.

17. The artificial heart valve according to claim 16, wherein the end of the forward fixing element includes a clip.

18. The artificial heart valve according to claim 10, wherein the forward fixing element is a wire, and the end of the forward fixing element is a reconfigurable portion of the wire.

19. The artificial heart valve according to claim 10, wherein the outer frame includes an annular wall defining the central channel, the distal wall is the distal portion of the annular wall, the anterior wall is the anterior portion of the annular wall, and the artificial heart valve further comprises an atrial collar coupled to the atrial rim portion of the annular wall of the outer frame, the atrial collar being configured to contact the annular tissue when the artificial heart valve is positioned within the annulus of the own valve.

20. The artificial heart valve according to claim 10, configured to deploy within the annulus of the native mitral valve.

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