Device and method for delivery and retrieval of transcatheter-deliverable prosthetic valves.

Abstract

To provide delivery and / or retrieval devices and methods for side-deliverable transcatheter prosthetic valves.SOLUTION: A delivery system for side-delivery of a prosthetic valve includes a compression device defining a lumen having a first perimeter at a proximal end that is larger than a second perimeter of the lumen at a distal end. A loading device is couplable to the compression device and defines a lumen having substantially the second perimeter. A distal end of the loading device includes a first gate that is movable between an open state and a closed state to at least partially occlude the lumen of the loading device. A delivery device defines a lumen having substantially the second perimeter. A proximal end of the delivery device is couplable to the distal end of the loading device and includes a second gate movable between an open state and a closed state to at least partially occlude the lumen of the delivery device.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0003] ,

[0002] , , ,

[0001] Cross - reference to Related Applications This application claims priority and benefit from U.S. Provisional Patent Application No. 63 / 038,807, filed on June 13, 2020, titled "Retrieval Device and Method for Side - Deliverable Transcatheter Prosthetic Valves", U.S. Provisional Patent Application No. 63 / 027,345, filed on May 19, 2020, titled "Side - Deliverable Transcatheter Prosthetic Valves and Method for Delivering and Anchoring the Same", U.S. Provisional Patent Application No. 62 / 891,964, filed on August 27, 2019, titled "Wrap Around Anchor Arm and Catheter Delivery System for Side - Delivered Transcatheter Heart Valve Prosthesis", and U.S. Provisional Patent Application No. 62 / 889,327, filed on August 20, 2019, titled "Loader System for Side - Delivered Transcatheter Heart Valve Prosthesis", the entire disclosure of each of which is incorporated herein by reference.

Background Art

[0002] The embodiments described herein generally relate to transcatheter prosthetic valves, and more specifically, to devices and methods for delivery and / or retrieval for side - deliverable transcatheter prosthetic valves. <00​​Artificial heart valves can present challenges in delivery, deployment, and / or retrieval within the heart, particularly in catheter-based delivery via the patient's vascular system rather than through a surgical approach. Delivery of conventional transcatheter valves generally involves radially compressing the valve and loading it into the delivery catheter such that the valve's central annular axis is parallel to the longitudinal or longitudinal axis of the delivery catheter. The valve is deployed from the end of the delivery catheter and expands radially outward from the central annular axis. However, the expansion size (e.g., diameter) of a conventional valve can be limited by the inner diameter of the delivery catheter. The competing objective of minimizing the size of the delivery catheter presents challenges in increasing the expanded diameter of a conventional valve (e.g., attempting to compress excess material and structure into too small a space). Furthermore, the orientation of conventional valves during deployment can present additional challenges when attempting to align the valve with the patient's own annulus.

[0004] Some transcatheter prosthetic valves may be configured for lateral and / or orthogonal delivery, which may allow for an increased expansion diameter of the lateral delivery valve compared to conventional valves. For example, in lateral (orthogonal) delivery, the valve may be compressed or positioned in a delivery configuration and loaded into the delivery catheter such that the valve's central annular axis is substantially perpendicular and / or orthogonal to the longitudinal or longitudinal axis of the delivery catheter. More specifically, the valve may be compressed axially (e.g., along the central annular axis) and laterally (e.g., perpendicular to the central annular axis and longitudinal axis of the valve, respectively), and may be uncompressed or stretched longitudinally (e.g., in a direction parallel to the longitudinal or longitudinal axis of the delivery catheter). A compressed valve (e.g., a valve in a delivery configuration) may be loaded into the delivery catheter, advanced through its lumen, and deployed from the end of the delivery catheter. Furthermore, a laterally delivered valve, when deployed from the end of the delivery catheter, is generally oriented in a desired direction relative to its own annulus.

[0005] However, in some implementations, challenges related to compressing the lateral delivery valve and / or loading the valve into the delivery system may persist. Furthermore, in some cases, it may be desirable to retrieve the valve, or at least partially retrieve it, after deploying it from the end of the delivery catheter.

[0006] Therefore, there is a need for delivery and / or retrieval devices and methods for transcatheter prosthetic valves that can be delivered laterally. [Overview of the project]

[0007] Embodiments described herein relate to laterally deliverable prosthetic valves and / or devices and / or methods for delivering and / or retrieving laterally deliverable prosthetic valves. In some embodiments, the delivery system for later delivery of a transcatheter prosthetic valve includes a compression device, a loading device, and a delivery device. The compression device defines a lumen extending through its proximal and distal ends, the circumference of the lumen at the proximal end being greater than the circumference of the lumen at the distal end. The loading device defines a lumen extending through its proximal and distal ends. The circumference of the lumen of the loading device is substantially similar to the circumference of the lumen at the distal end of the compression device. The proximal end of the loading device is connectable to the compression device, and the distal end of the loading device has a first gate movable between an open and closed position, the first gate at least partially occluding the lumen of the loading device. The delivery device has a handle and a delivery catheter extending distally from this handle. The handle and delivery catheter collectively define the lumen extending through the delivery device. The perimeter of the lumen of the delivery device is substantially the same as that of the lumen of the loading device. The proximal end of the handle is connectable to the distal end of the loading device and includes a second gate movable between an open and closed position, which at least partially occludes the lumen of the delivery device. [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 and a compressed configuration, respectively. [Figure 1B] 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 and a compressed configuration, respectively. [Figure 1C] Figures 1A and 1B are schematic top views of the artificial valve, showing the expansion configuration and compression configuration, respectively. [Figure 1D] Figures 1A and 1B are schematic top views of the artificial valve, showing the expansion configuration and compression configuration, respectively. [Figure 1E] Figures 1A to 1D are schematic diagrams of the artificial valve deployed within the annulus of the native heart valve. [Figure 2A] These are schematic side views of an artificial valve in a first configuration and a second configuration, respectively, according to one embodiment. [Figure 2B] These are schematic side views of an artificial valve in a first configuration and a second configuration, respectively, according to one embodiment. [Figure 2C] Figures 2A and 2B show schematic diagrams of the bottom and side views of the artificial valve, respectively, illustrating the second and third configurations. [Figure 2D] Figures 2A and 2B show schematic diagrams of the bottom and side views of the artificial valve, respectively, illustrating the second and third configurations. [Figure 3] Figures A to C are schematic diagrams of the outer frame of a laterally delivered transcatheter artificial heart valve according to one embodiment, and are shown as the delivery configuration, placement configuration, and deployment configuration, respectively. [Figure 4] This is a perspective view of an artificial valve according to one embodiment. [Figure 5] Figure 4 is a top perspective view of the region above the valve annulus of the outer support frame of the artificial valve shown. [Figure 6] Figure 4 is a distal perspective view of the transannular region of the lateral support frame of the artificial valve shown. [Figure 7]Figure 4 is a distal perspective view of the annular region of the lateral support frame of the artificial valve shown. [Figure 8] Figure 4 is a top perspective view of the inner frame of the flow control component included in the artificial valve. [Figure 9] This is a side perspective view of the leaflet band of an internal flow control component having a leaflet pocket sewn to a structural band, and is shown in a cylindrical configuration suitable for coupling to the internal frame in Figure 8. [Figure 10] Figure 9 is a bottom view of the valve leaflet band, which has a cylindrical structure, and shows a partial joining of the valve leaflets to form a partially closed fluid seal. [Figure 11] This is a bottom perspective view of a laterally delivered transcatheter artificial heart valve according to one embodiment, showing a sequence of actions for activating one or more parts of the artificial valve to reduce the circumference and / or outer circumference of the subannular member to facilitate valve deployment in the annulus of the progenitor. [Figure 12] This is a bottom perspective view of a laterally delivered transcatheter artificial heart valve according to one embodiment, showing a sequence of actions for activating one or more parts of the artificial valve to reduce the circumference and / or outer circumference of the subannular member to facilitate valve deployment in the annulus of the progenitor. [Figure 13] This is a bottom perspective view of a laterally delivered transcatheter artificial heart valve according to one embodiment, showing a sequence of actions for activating one or more parts of the artificial valve to reduce the circumference and / or outer circumference of the subannular member to facilitate valve deployment in the annulus of the progenitor. [Figure 14] This is a bottom perspective view of a laterally delivered transcatheter artificial heart valve according to one embodiment, showing a sequence of actions for activating one or more parts of the artificial valve to reduce the circumference and / or outer circumference of the subannular member to facilitate valve deployment in the annulus of the progenitor. [Figure 15] These are a top view and a bottom perspective view, respectively, of an artificial valve that is detachably coupled to at least a portion of a delivery and / or operating system, according to one embodiment. [Figure 16]Top and bottom perspective views of an artificial valve removably coupled to at least a portion of a delivery and / or actuation system, according to an embodiment. [Figure 17] Bottom perspective view of an artificial valve, showing a process of transitioning a proximal fixation element of the artificial valve between a first configuration and a second configuration, according to an embodiment. [Figure 18] Bottom perspective view of an artificial valve, showing a process of transitioning a proximal fixation element of the artificial valve between a first configuration and a second configuration, according to an embodiment. [Figure 19] Bottom perspective view of an artificial valve, showing a process of transitioning a proximal fixation element of the artificial valve between a first configuration and a second configuration, according to an embodiment. [Figure 20] Bottom perspective view of an artificial valve, showing a process of transitioning a proximal fixation element of the artificial valve between a first configuration and a second configuration, according to an embodiment. [Figure 21] Side and bottom views of an artificial valve, showing a member on a valve annulus having a curved configuration, according to an embodiment. [Figure 22] Side and bottom views of an artificial valve, showing a member on a valve annulus having a curved configuration, according to an embodiment. [Figure 23] A - C are schematic views of at least a portion of a side - deliverable artificial valve and a delivery system for delivering the artificial valve, according to an embodiment. [Figure 24] Partially exploded perspective view of a delivery system for side delivery of an artificial valve, according to an embodiment. [Figure 25A] Various views of a compression device included in the delivery system of FIG. 24. [Figure 25B] Various views of a compression device included in the delivery system of FIG. 24. [Figure 25C] Various views of a compression device included in the delivery system of FIG. 24. [Figure 25D] Various views of a compression device included in the delivery system of FIG. 24. [Figure 25E]Figure 24 shows various diagrams of compression devices included in the delivery system. [Figure 26A] Figures 25A to 25E are side views of the compression device, shown without the coupling member. [Figure 26B] This is a cross-sectional view of the compression device taken along the line 26B to 26B in Figure 26A. [Figure 26C] Figure 26B is a side perspective view of a semi-compressed artificial valve corresponding to the size of the lumen of the compression device in the cross-section shown. [Figure 26D] This is a cross-sectional view of the compression device taken along the line 26B to 26B in Figure 26A. [Figure 26E] Figure 26D is a side perspective view of a semi-compressed artificial valve corresponding to the size of the lumen of the compression device in the cross-section shown. [Figure 26F] This is a cross-sectional view of the compression device taken along the line 26B to 26B in Figure 26A. [Figure 26G] Figure 26F is a side perspective view of a semi-compressed artificial valve corresponding to the size of the lumen of the compression device in the cross-section shown. [Figure 27] Figure 24 is a perspective view of the loading device included in the delivery system. [Figure 28] Figure 24 is a perspective view of a delivery device included in the delivery system. [Figure 29] Figure 24 is a perspective view of the control device included in the delivery system. [Figure 30] Figure 29 shows a cross-sectional view of a multi-lumen control catheter, taken along line 30-30, which is included in the control device. [Figure 31A] Figure 29 is a perspective view of the distal end of the control device, showing the yoke included in the distal end portion. [Figure 31B] Figure 29 is a perspective view of the distal end portion of the controlled delivery, which is at least partially installed in the delivery catheter of the delivery system, and is shown in the first and second configurations, respectively. [Figure 31C]Figure 29 is a perspective view of the distal end portion of the controlled delivery, which is at least partially installed in the delivery catheter of the delivery system, and is shown in the first and second configurations, respectively. [Figure 32] Figure 29 is a perspective view of the distal end of the control device, showing a yoke detachably coupled to a pair of tethers. [Figure 33] Figure 29 is a side perspective view of the distal end of the control device, showing the yoke and a pair of tethers that detachably connect the yoke to the artificial valve. [Figure 34] Figures A and B are side perspective views of the distal end portion of the control device in Figure 29, showing the yoke, tether pair, tension member, and guidewire catheter extending from the multi-lumen control catheter, which is shown in a first configuration and a second configuration, respectively. [Figure 35] Figure 24 is a cross-sectional view of a portion of the delivery system, illustrating the process of compressing the artificial valve and loading it into the delivery device for lateral delivery to the target location in the patient. [Figure 36] Figure 24 is a cross-sectional view of a portion of the delivery system, illustrating the process of compressing the artificial valve and loading it into the delivery device for lateral delivery to the target location in the patient. [Figure 37] Figure 24 is a cross-sectional view of a portion of the delivery system, illustrating the process of compressing the artificial valve and loading it into the delivery device for lateral delivery to the target location in the patient. [Figure 38] Figure 24 is a cross-sectional view of a portion of the delivery system, illustrating the process of compressing the artificial valve and loading it into the delivery device for lateral delivery to the target location in the patient. [Figure 39] This is an enlarged cross-sectional view of a portion of the delivery system identified by region A in Figure 32, showing a lateral delivery valve loaded into the delivery device. [Figure 40] These are various diagrams of artificial valves, each illustrating a different embodiment of how at least one of a guidewire and / or a control catheter is attached to one or more parts of the artificial valve. [Figure 41] These are various diagrams of artificial valves, each illustrating a different embodiment of how at least one of a guidewire and / or a control catheter is attached to one or more parts of the artificial valve. [Figure 42] These are various diagrams of artificial valves, each illustrating a different embodiment of how at least one of a guidewire and / or a control catheter is attached to one or more parts of the artificial valve. [Figure 43] This is a partially exploded perspective view of at least a portion of a delivery system for lateral delivery of an artificial valve according to one embodiment. [Figure 44] Figure 43 is a side perspective view of the loading device included in the delivery system, illustrating the compression process associated with inserting the artificial valve into the loading device. [Figure 45] Figure 43 is a side perspective view of the loading device included in the delivery system, illustrating the compression process associated with inserting the artificial valve into the loading device. [Figure 46] Figure 42 is a side perspective view of a loading device connected to a delivery device in the delivery system, in which a compressed artificial valve is disposed. [Figure 47A] This is a cross-sectional view of a portion of the delivery system, illustrating, according to one embodiment, the process of compressing an artificial valve using the compression device of the delivery system for insertion into the loading device of the delivery system. [Figure 47B] This is a cross-sectional view of a portion of the delivery system, illustrating, according to one embodiment, the process of compressing an artificial valve using the compression device of the delivery system for insertion into the loading device of the delivery system. [Figure 47C] This is a cross-sectional view of a portion of the delivery system, illustrating, according to one embodiment, the process of compressing an artificial valve using the compression device of the delivery system for insertion into the loading device of the delivery system. [Figure 47D]This is a cross-sectional view of a portion of the delivery system, illustrating, according to one embodiment, the process of compressing an artificial valve using the compression device of the delivery system for insertion into the loading device of the delivery system. [Figure 47E] This is a cross-sectional view of a portion of the delivery system, illustrating, according to one embodiment, the process of compressing an artificial valve using the compression device of the delivery system for insertion into the loading device of the delivery system. [Figure 47F] Figure 47A is a cross-sectional view of a portion of the delivery system, illustrating the process of using the delivery system's pressing device to press a compressed artificial valve from the loading device into the lumen of the delivery catheter. [Figure 47G] Figure 47A is a cross-sectional view of a portion of the delivery system, illustrating the process of using the delivery system's pressing device to press a compressed artificial valve from the loading device into the lumen of the delivery catheter. [Figure 48A] This is a cross-sectional view of a portion of a delivery system, illustrating, in one embodiment, the process of compressing an artificial valve using a compression device of the delivery system, which has a guidewire device and a control device attached to its proximal portion for insertion into a loading device of the delivery system. [Figure 48B] This is a cross-sectional view of a portion of a delivery system, illustrating, in one embodiment, the process of compressing an artificial valve using a compression device of the delivery system, which has a guidewire device and a control device attached to its proximal portion for insertion into a loading device of the delivery system. [Figure 48C] This is a cross-sectional view of a portion of a delivery system, illustrating, in one embodiment, the process of compressing an artificial valve using a compression device of the delivery system, which has a guidewire device and a control device attached to its proximal portion for insertion into a loading device of the delivery system. [Figure 48D]This is a cross-sectional view of a portion of a delivery system, illustrating, in one embodiment, the process of compressing an artificial valve using a compression device of the delivery system, which has a guidewire device and a control device attached to its proximal portion for insertion into a loading device of the delivery system. [Figure 48E] Figure 48A is a side view of a portion of the delivery system, showing that the compression device is laterally separated from the guidewire device and control device to allow the compression device to be removed from the loading device. [Figure 48F] Figure 48A is a side view of a portion of the delivery system, showing a part of the loading device, which is located within the lumen of the delivery catheter included in this delivery system, and contains a compressed artificial valve. [Figure 48G] Figure 48A is a side view of a portion of the delivery system, illustrating the process of using the delivery system's pressing device to press a compressed artificial valve from this loading device into the lumen of the delivery catheter. [Figure 49] Figures A through C are side perspective views and partial cross-sectional views of the compression device and artificial valve of the delivery system, respectively, illustrating a process in one embodiment in which the artificial valve is pulled through the compression device into the loading device using a tension device coupled to the proximal side of the artificial valve. [Figure 50A] A proximal view of an artificial valve, illustrating, by one embodiment, the process of compressing the artificial valve from an expanded or deployed configuration to a compressed or delivered configuration in the axial and lateral directions. [Figure 50B] A proximal view of an artificial valve, illustrating, by one embodiment, the process of compressing the artificial valve from an expanded or deployed configuration to a compressed or delivered configuration in the axial and lateral directions. [Figure 50C] A proximal view of an artificial valve, illustrating, by one embodiment, the process of compressing the artificial valve from an expanded or deployed configuration to a compressed or delivered configuration in the axial and lateral directions. [Figure 50D]A proximal view of an artificial valve, illustrating, by one embodiment, the process of compressing the artificial valve from an expanded or deployed configuration to a compressed or delivered configuration in the axial and lateral directions. [Figure 50E] A proximal view of an artificial valve, illustrating, by one embodiment, the process of compressing the artificial valve from an expanded or deployed configuration to a compressed or delivered configuration in the axial and lateral directions. [Figure 50F] This is a cross-sectional view of a delivery catheter showing an artificial valve with a compression or delivery configuration placed within its lumen. [Figure 51] A and B are side views of an artificial valve in a compression or delivery configuration disposed on an loading (or control) catheter device, which can be used, in one embodiment, to advance the artificial valve in a compression or delivery configuration through a delivery catheter to a target location in the patient (e.g., a space within the human heart). [Figure 52] Figures A to C are side perspective views of a portion of the proximal fixation element of an artificial valve, which is coupled to and disconnected from an actuator or the like, according to one embodiment. [Figure 53] Figures A through C are schematic side views of an artificial valve, illustrating the sequence for retracting the valve into a portion of the delivery and / or contraction system according to one embodiment. [Figure 54] This is a top perspective view of the valve sequence, showing the sequence by which an artificial valve is placed in part of the delivery and / or storage system according to one embodiment. [Figure 55] Figures A to D are schematic front and side views of a delivery catheter, according to one embodiment, which has an expandable capture element for capturing and / or surrounding at least a portion of an artificial valve to facilitate its compression and retrieval process. [Figure 56] Figures A and B are schematic front and side views of a delivery catheter, illustrating in one embodiment a pressing / pulling member extending from the delivery system and attached to the proximal side of the prosthetic valve, and a compression tether for at least partially compressing the proximal side of the prosthetic valve, thereby enabling at least partial retrieval of the prosthetic valve into the delivery catheter. [Figure 57]Figures A and B are schematic front and side views of a delivery catheter, illustrating in one embodiment a pressing / pulling member extending from the delivery system and attached to the proximal side of the prosthetic valve, and (i) a compression tether and (ii) an expandable capture element for at least partially compressing the proximal side of the prosthetic valve, thereby enabling at least partial retrieval of the prosthetic valve into the delivery catheter. [Figure 58] Figures A and B are schematic diagrams of the proximal end of an artificial valve, and in one embodiment, a compression tether routed through one or more portions of the proximal end of the artificial valve is shown, which is used to compress the proximal side of the artificial valve at least partially to facilitate the recovery process. [Figure 59] Figures A-C are schematic front and side views of a delivery catheter, illustrating, in one embodiment, the process of retrieving an artificial valve into the delivery catheter using a pressing / pulling member, at least one compression tether, and an expandable capture element. [Figure 60A] For example, this is an exploded side view of at least a portion of a delivery and / or retrieval system 180 according to one embodiment, which includes a capture element, an artificial valve, and a delivery catheter. [Figure 60B] Figure 60A is a side view of a portion of the delivery and / or retrieval system 180, showing the capture elements positioned in the lumen of each artificial valve and delivery catheter in the compressed configuration. [Figure 60C] Figure 60A is a side view of a portion of the delivery and / or retrieval system 180, showing the prosthetic valve distal to the delivery catheter and the capture element that extends from the delivery catheter and at least partially surrounds the prosthetic valve. [Figure 61A] The diagrams show various aspects of at least a part of the delivery and / or retrieval system 180, illustrating by one embodiment a capture element used to facilitate the compression of the artificial valve, thereby enabling the artificial valve to be retrieved into the lumen of the delivery catheter. [Figure 61B]The diagrams show various aspects of at least a part of the delivery and / or retrieval system 180, illustrating by one embodiment a capture element used to facilitate the compression of the artificial valve, thereby enabling the artificial valve to be retrieved into the lumen of the delivery catheter. [Figure 61C] The diagrams show various aspects of at least a part of the delivery and / or retrieval system 180, illustrating by one embodiment a capture element used to facilitate the compression of the artificial valve, thereby enabling the artificial valve to be retrieved into the lumen of the delivery catheter. [Figure 61D] The diagrams show various aspects of at least a part of the delivery and / or retrieval system 180, illustrating by one embodiment a capture element used to facilitate the compression of the artificial valve, thereby enabling the artificial valve to be retrieved into the lumen of the delivery catheter. [Figure 61E] The diagrams show various aspects of at least a part of the delivery and / or retrieval system 180, illustrating by one embodiment a capture element used to facilitate the compression of the artificial valve, thereby enabling the artificial valve to be retrieved into the lumen of the delivery catheter. [Figure 61F] The diagrams show various aspects of at least a part of the delivery and / or retrieval system 180, illustrating by one embodiment a capture element used to facilitate the compression of the artificial valve, thereby enabling the artificial valve to be retrieved into the lumen of the delivery catheter. [Figure 61G] The diagrams show various aspects of at least a part of the delivery and / or retrieval system 180, illustrating by one embodiment a capture element used to facilitate the compression of the artificial valve, thereby enabling the artificial valve to be retrieved into the lumen of the delivery catheter. [Figure 62] Figures A and B are top views of at least a portion of the delivery and / or retrieval system 180, illustrating in one embodiment the process of extending a capture element around the proximal side of the prosthetic valve and a portion of a control device having a control catheter and a yoke coupled to the proximal side of the prosthetic valve. [Figure 63A]This is a perspective view of a portion of a capture element sheath with an extended function included in a delivery and retrieval system according to one embodiment. [Figure 63B] This is a side perspective view of a prosthetic valve and part of the delivery and retrieval system, showing the process of extending the delivery catheter beyond the extension of the capture element sheath and to a portion of the prosthetic valve. [Figure 63C] This is a side perspective view of a prosthetic valve and part of the delivery and retrieval system, showing the process of extending the delivery catheter beyond the extension of the capture element sheath and to a portion of the prosthetic valve. [Figure 63D] This is a side perspective view of a prosthetic valve and part of the delivery and retrieval system, showing the process of extending the delivery catheter beyond the extension of the capture element sheath and to a portion of the prosthetic valve. [Figure 63E] Figures 63B to 63D are side perspective views of the artificial valve and a portion of the delivery and retrieval system, showing capture elements that facilitate the process of compressing and / or retrieving at least a portion of the artificial valve into the delivery catheter. [Figure 64] A and B are top views, respectively, of laser-cut workpieces configured to be formed on at least a portion of the distal end of a control device, for example, having a yoke, according to different embodiments. [Figure 65] This flowchart shows a method, according to one embodiment, for compressing an artificial valve into a delivery configuration for lateral delivery to a patient via a delivery catheter. [Figure 66] This flowchart shows a method for preparing an artificial valve for lateral delivery to a patient via a delivery catheter, according to one embodiment. [Figure 67] This flowchart shows a method for preparing an artificial valve for lateral delivery to a patient through the lumen of a delivery catheter included in a delivery device, according to one embodiment. [Figure 68] This flowchart shows a method, according to one embodiment, for selectively controlling a transcatheter prosthetic valve that can be delivered laterally during at least one delivery and deployment, using a control device. [Modes for carrying out the invention]

[0009] The disclosed embodiments relate to laterally deliverable transcatheter prosthesis valves (and / or components thereof), and methods for loading, delivering, deploying, and / or retrieving the prosthesis valves (and / or components thereof). In some embodiments, the laterally deliverable prosthesis valve may comprise an outer frame and flow control components. The outer frame may have a supraannular region, a subannular region, and a transannular region coupled between them. The subannular region may form a distal fixation element and a proximal fixation element. The flow control components may be mounted on the supraannular region of the outer frame such that at least a portion of the flow control components is positioned in the transannular region. The prosthesis valve may be positioned in a delivery configuration for later delivery of the prosthesis valve to the patient's heart via a delivery catheter of the delivery system. The prosthesis valve may be able to transition to an expanded configuration or a free configuration when released from its delivery catheter. In some implementations, the subannular region of the outer frame can become the first configuration as the prosthetic valve is seated on the annulus of the own heart valve and transitions to a second configuration.

[0010] In some embodiments, the delivery and / or retrieval system 180 may facilitate the compression, loading, advancement, delivery, and / or deployment of the prosthetic valve to a desired position relative to its own annulus through the delivery catheter of the delivery system. In some implementations, the delivery and / or retrieval system 180 may include a self-expanding capture element that extends from the end of the delivery catheter and / or other members of the delivery system to a funnel, wrapper, and / or at least partially captures the prosthetic valve during or after deployment, thereby facilitating the compression of the valve and its at least partial retrieval.

[0011] In some embodiments, a delivery system for lateral delivery of a transcatheter prosthetic valve may comprise a compression device, a loading device, and a delivery device. The compression device defines a lumen extending through its proximal and distal ends. The circumference of the lumen at the proximal end is greater than the circumference of the lumen at the distal end. The loading device defines a lumen extending through its proximal and distal ends. The circumference of the lumen of the loading device is greater than the circumference of the lumen at the distal end of the compression device. The lumen circumference is substantially the same as that of the lumen of the loading device. The proximal end of the loading device is removably connectable to the compression device. The distal end of the loading device is provided with a first gate movable between an open and closed position, which at least partially occludes the lumen of the loading device. The delivery device has a handle and a delivery catheter extending distally from the handle. The handle and delivery catheter collectively define the lumen extending through the delivery device. The lumen circumference of the delivery device is substantially the same as that of the lumen of the loading device. The proximal end of the handle is connectable to the distal end of the loading device and is provided with a second gate movable between an open and closed position, which at least partially occludes the lumen of the delivery device.

[0012] In some implementations, the method of compressing the prosthetic valve into a delivery configuration for lateral delivery to the patient via a delivery catheter may involve compressing the prosthetic valve along a transverse axis of the prosthetic valve perpendicular to the central axis of the prosthetic valve, which is in turn parallel to the direction of fluid flow through the prosthetic valve. After compression, the prosthetic valve is inserted into the proximal end of a compression device. The compression device defines a lumen extending through its proximal and distal ends. The circumference of the lumen at the proximal end is greater than the circumference of the lumen at the distal end. The prosthetic valve advances through the lumen of the compression device, compressing the prosthetic valve along its central axis. The prosthetic valve of the delivery configuration is transferred from the distal end of the compression device to a loading device coupled to the distal end of the compression device. The loading device defines a lumen having a circumference substantially similar to (i) the circumference of the lumen at the distal end of the compression device and (ii) the circumference of the lumen of the delivery catheter.

[0013] In some implementations, a method for preparing a laterally deliverable prosthesis for lateral delivery to a patient via a delivery catheter may involve compressing the prosthesis along a transverse axis of the prosthesis perpendicular to the central axis of the prosthesis, which is in turn parallel to the direction of fluid flow through the prosthesis. After compression, the prosthesis is inserted into the lumen of a compression device. The prosthesis is then drawn through the lumen of the compression device into the lumen of a loading device coupled to the compression device via a tether attached to the distal end portion of the prosthesis. The prosthesis is compressed along its central axis, and as a result, the prosthesis is in a delivery configuration when it is in the lumen of the loading device. The tether is removed from the distal end portion of the prosthesis, and the distal ends of the loading device and the distal end are coupled to a delivery device containing a delivery catheter.

[0014] In some implementations, a method for preparing a laterally deliverable prosthetic valve for later delivery to a patient through the lumen of a delivery catheter contained in a delivery device may include compressing the prosthetic valve along a central axis parallel to the direction of fluid flow through the prosthetic valve, and a transverse axis perpendicular to the central axis with respect to the transition of the prosthetic valve from an expansion configuration to a delivery configuration. The prosthetic valve of the delivery configuration is advanced into the lumen of the loading device, while a first gate at the distal end of the loading device is closed to at least partially occlude the lumen of the loading device. The distal end of the loading device is coupled to the handle of the delivery device, where (i) the first gate is closed, and (ii) a second gate is closed at the proximal end of the handle to at least partially occlude the lumen of the handle. The lumen of the delivery catheter is in fluid communication with the lumen of the handle distal to the second gate. After coupling, the first and second gates are each transitioned from a closed to an open state.

[0015] In some embodiments, the device for selectively engaging a laterally deliverable transcatheter prosthetic valve may comprise a multi-lumen catheter having a distal end and a proximal end. A control portion is coupled to the proximal end of the multi-lumen catheter, and a yoke is coupled to the distal end of the multi-lumen catheter. A first tether is extendable through a first control arm of the control portion and a first lumen of the multi-lumen catheter, and a portion of the first tether is configured to loop through the first side of the yoke. A second tether is extendable through a second control arm of the control portion and a second lumen of the multi-lumen catheter, A portion of the second tether is configured to loop through the second side of the yoke. The tension member is extendable through the third control arm of the control portion and the third lumen of the multi-lumen catheter, and a portion of the tension member is configured to be removably coupled to the proximal subannular fixation element of the prosthetic valve.

[0016] In some embodiments, the control device may comprise at least a control catheter having a first tether, a second tether, and a tension member extending through them, and a yoke coupled to the distal end of the control catheter. In some implementations, a method of selectively controlling a laterally deliverable transcatheter prosthesis valve during at least one of delivery and deployment using the control device may include increasing tension along the first and second tethers to fix the yoke to the surface of the prosthesis valve. While the yoke is fixed to the surface of the prosthesis valve, the prosthesis valve advances through the lumen of the delivery catheter. The prosthesis valve is released from the distal end of the delivery catheter. After release, the tension along the tension member is increased to transition the proximal subannular fixation element from a first configuration to a second configuration. The prosthesis valve is seated on the annulus of the own valve in response to the force applied by the yoke to the surface of the prosthesis valve. After the prosthesis valve is seated, the tension along the tension member is released, allowing the proximal subannular fixation element to transition from a second configuration to a first configuration. Next, the control device is detached from the artificial valve.

[0017] In some embodiments, a delivery and retrieval system for a laterally deliverable prosthetic valve may comprise a catheter, a capture element, and a control device. The catheter has a distal end and defines a lumen. The prosthetic valve has a delivery configuration for later delivery through the lumen of the catheter and a deployed configuration when released from the distal end of the catheter. The capture element is disposable in the lumen of the catheter in a substantially closed configuration and can be transitioned to an open configuration when advancing beyond the distal end of the catheter. The control device may be at least partially disposed in the lumen of the catheter or attached to the prosthetic valve. The control device is operable to (i) exert a distally directed force to advance the prosthetic valve in the delivery configuration through the lumen of the catheter, and (ii) exert a proximal directed force to pull the prosthetic valve toward the distal end of the catheter in the deployed configuration. The capture element extends around at least a portion of the prosthetic valve as the control device pulls the prosthetic valve toward the distal end of the catheter, thereby transitioning the prosthetic valve from the deployed configuration to the delivery configuration.

[0018] In some embodiments, the retrieval system for a laterally deliverable prosthetic valve may comprise a control device and a self-expanding capture element. The control device is removably coupled to the prosthetic valve during delivery and deployment of the prosthetic valve in the annulus of the patient's own heart valve. The self-expanding capture element is expandable from the distal end of the delivery catheter to the funnel or encloses at least a portion of the prosthetic valve that is at least partially deployed in the annulus, facilitating compression of the prosthetic valve in response to a force exerted by the control device that moves the prosthetic valve proximal toward the delivery catheter.

[0019] In some implementations, a method for retrieving a laterally deliverable prosthetic heart valve may include extending a self-expanding capture element from the distal end of a catheter placed in the heart's own atrium. The capture element is configured to have and / or define a cavity shape when in the extended position. The prosthetic heart valve is drawn into the cavity of the expanded capture element, facilitating compression of the prosthetic heart valve. Drawing the prosthetic heart valve into the capture element is operable to move the capture element from the extended position to the retracted position, or toward the retracted position, where the prosthetic heart valve is enveloped by the capture element. After enveloping, the prosthetic heart valve, (at least partially) enveloped by the capture element, is drawn into the catheter using a cable.

[0020] Any of the artificial heart valves described herein are relatively small cross-sectional, laterally deliverable, and implantable artificial heart valves (also referred to herein as “artificial valves” or simply “valves”). It may be a transcatheter valve configured to be delivered into the heart via a delivery catheter. The prosthetic valve may have at least an annular lateral valve frame and an internal flow control component (e.g., a two-cusp or three-cusp valve, sleeve, etc.) fitted into and / or extending through the central lumen or opening of the valve frame. The flow control component 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. In addition, the prosthetic valve may have a single or more fixation elements configured to fix the valve within the annulus of the own valve.

[0021] Any artificial valve described herein may be configured to transition between a compression or delivery configuration for introduction into the body using a delivery catheter and an expansion or deployment configuration for implantation at a desired location within the body. For example, any embodiment described herein may be a balloon-inflatable artificial valve, a self-expanding artificial valve, and the like.

[0022] Any artificial valve described herein may be compressible into a compressible or delivery configuration in the longitudinal or perpendicular direction (e.g., along the longitudinal axis) relative to the central axis of the flow control component, thereby enabling, for example, the delivery and deployment of a large-diameter valve (e.g., having a height of about 5 to 60 mm and a diameter of about 20 to 80 mm) from the inferior vena cava into the annulus of the patient's own mitral or tricuspid valve using a 24 to 36 Fr delivery catheter. The longitudinal axis may be substantially parallel to the longitudinal cylindrical axis of the delivery catheter, thereby enabling the deployment of the artificial valve without the sharp-angled approach common in conventional transcatheter delivery.

[0023] Any of the artificial 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 or delivery configuration of the valve is perpendicular to the direction of blood flow. In some embodiments, the compression or delivery 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 or delivery configuration in two directions: perpendicular to the direction of blood flow (e.g., lateral) and parallel to the direction of blood flow (e.g., axial). In some embodiments, when in a compression or delivery configuration and / or expansion or deployment configuration, the long axis or longitudinal axis is oriented at an intersection angle of 45 to 135 degrees with respect to the first direction.

[0024] Any of the artificial 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 delivery configuration (e.g., a compression configuration, a rolled compression configuration, or a folded compression configuration).

[0025] Any outer frame described herein may have a supraannular region, a subannular region, and a transannular region coupled between them. The supraannular region may, for example, form the upper collar portion of the outer support frame and may have a number of functions configured to engage with the prosthesis tissue, internal flow control components of the prosthetic valve, and / or delivery, actuator, and / or retrieval mechanisms. The subannular region may form, for example, distal and proximal fixation elements configured to engage with the subannular (ventricular) tissue when the prosthetic valve is seated on the prosthesis annulus. The transannular region may be coupled between the supraannular and subannular regions. The transannular region may form shapes such as a funnel, cylinder, flattened cone, or circular hyperboloid when the outer support frame is in an expanded 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 have an inner surface covered with pericardial tissue, an outer surface covered with a woven synthetic polyester material, and / or an inner surface The outer support frame can be covered such that both its surface is covered with pericardial tissue and its outer surface is covered with a woven synthetic polyester material.

[0026] Any of the external support frames described herein may have a conical side-following cross-section with 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 tubular support frame has an hourglass-shaped side-following cross-section with 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.

[0027] Any prosthetic valve described herein may comprise one or more fixation elements that extend from, are coupled to, and / or are otherwise integral to, a portion of the valve frame. For example, any prosthetic valve may comprise a distal fixation element, which may be used, for example, as a Right Ventricular Outflow Tract ("RVOT") tab or a Left Ventricular Outflow Tract ("LVOT") tab. Any valve described herein may also include fixation elements extending from the proximal side of the valve frame, which may be used to fix, for example, the valve to the proximal subannular tissue of the ventricle. 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. For example, any prosthetic valve described herein may comprise a valve frame having wires or laser-cut subannular regions or members that form the distal and proximal fixation elements.

[0028] Any prosthetic valve described herein may also comprise (i) a distal upper (supra-annular) fixation element extending from, attached to, and / or otherwise integral with the distal upper end of the valve frame, and (ii) a proximal upper (supra-annular) fixation element extending from, attached to, and / or otherwise integral with the proximal upper end of the valve frame. The distal and proximal upper fixation elements may comprise or be formed from wire loops or wire frames extending about 2 to 20 mm away from the valve frame. In some embodiments, the prosthetic valve described herein may comprise wire or laser-cut subannular regions or members forming the distal and proximal upper fixation elements. The distal and proximal upper fixation elements are configured to be positioned in contact with and / or adjacent to the supraannular tissue of the atrial region. In some implementations, the prosthetic valves described herein may be tightened or at least partially compressed after being seated on the annulus, such that the proximal and distal upper fixing elements exert force on the supranucular tissue and the proximal and distal lower fixing elements exert opposing forces on the subannular tissue, thereby securing the prosthetic valve to the annulus. Any valve described herein may also comprise anterior or posterior fixing elements extending from and / or fixed to the anterior or posterior side of the valve frame, respectively.

[0029] Any artificial heart valve described herein may comprise 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 comprise two or more panels of rhomboid or pupil-shaped wire cells made of a heat-setting shape memory alloy material such as Nitinol. The leaflet frame may be foldable along the z-axis (e.g., longitudinal axis) from a rounded or cylindrical configuration to a flattened cylindrical configuration, or compressible along the y-axis (e.g., central axis) perpendicular to the compression configuration. In some implementations, the leaflet frame may comprise a pair of hinge portions, folding portions, connection points, etc., which allow for... Before the valve leaflet frame is compressed along the vertical y-axis, it may be possible for the valve leaflet frame to be folded flat along the z-axis. This valve leaflet frame may be, for example, a one-piece structure with two or more living hinges (e.g., any suitable structure configured to allow elastic / non-permanent deformation of the stress concentration riser and / or the valve leaflet frame), or a two-piece structure in which the hinge region is formed using a secondary attachment method (e.g., sutures, fabric, molded polymer parts, etc.).

[0030] 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 valve leaflet frame having a flattened conical side cross section 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 valve leaflet frame is made of wire, braided wire, or laser-cut wire frame. In some embodiments, the valve leaflet frame may have one or more longitudinal supports integrated therein or mounted thereon, selected from rigid or semi-rigid struts, rigid or semi-rigid ribs, rigid or semi-rigid batons, rigid or semi-rigid panels, and combinations thereof.

[0031] Any artificial valve and / or its 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 component), and / or its 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) alloy, nickel-titanium alloy (e.g., Nitinol®). Furthermore, either the outer frame or the 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 coatings 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.

[0032] 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 include, optionally, 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 glycols, polyether sulfones, polysulfones, polyvinylpyrrolidones, polyvinyl chlorides, other fluoropolymers, polyesters, polyethylene terephthalate (PET) (e.g., Dacron), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide / glycolide) copolymer (PDLA), silicone polyesters, polyamides (nylon), PTFE, stretched PTFE, foamed PTFE, siloxane polymers and / or oligomers, and / or polylactones, or block copolymers using the same. It can be done.

[0033] Any outer valve frame, inner valve frame (e.g., of a flow control component), and / or parts or components thereof may be partially or completely covered internally or externally with a biocompatible material such as pericardium. The valve frame may be optionally externally covered partially or completely with a second biocompatible material such as polyester or Dacron®. In the disclosed embodiments, tissues such as biological tissue, which is chemically stabilized pericardial tissue of animals such as cattle (bovine pericardium), sheep (sheep pericardium), pigs (pig pericardium), or horses (horse pericardium), may be used. Preferably, this tissue is bovine pericardial tissue. Examples of suitable tissues include those used in the products Duraguard®, Peri-Guard®, and Vascu-Guard®, all of which are currently used in surgical procedures and are commercially available, generally taken from cattle less than 30 months of age.

[0034] Any method for manufacturing an artificial valve as described herein may include, for example, the use of additive or subtractive metal or metal alloy manufacturing to manufacture a compressible / expandable external support frame and / or a compressible / expandable internal valve leaflet frame. Additive metal or metal alloy manufacturing may include, but are not limited to, 3D printing, direct metal laser sintering (powder melting), etc. Subtractive metal or metal alloy manufacturing may include, but are not limited to, photolithography, laser sintering / cutting, CNC machining, electrical discharge machining, etc. Furthermore, any manufacturing process as described herein may include shaping and / or curing (e.g., thermosetting) a cut or machined workpiece into any suitable shape, size, and / or configuration. For example, any external support frame and / or internal valve leaflet frame as described herein may be laser-cut from one or more workpieces and thermoset to a desired shape, size, and / or configuration. Furthermore, any frame as described herein may comprise a plurality of independent components that are formed into a desired shape and joined together to form a frame.

[0035] In some embodiments, the manufacturing process may further include: attaching two to four flexible leaflets to an inner leaflet frame to collectively form a flow control component; mounting the flow control component within an outer support frame; and / or covering at least a portion of the outer support frame with pericardial material or similar biocompatible material.

[0036] Any delivery system described herein may be configured to deliver a laterally deliverable transcatheter prosthesis to a target location within a patient (e.g., to or within the annulus of the patient's own heart valve). Such a delivery system may comprise one or more of the following components: (i) a dilator for dilating at least a portion of an arterial pathway into the heart, such as the femoral artery, IVC, and / or SVC; (ii) a compression device, such as a funnel, for compressing the prosthesis into a delivery configuration; (iii) a loader, capsule, chamber, etc., for receiving the prosthesis in the delivery configuration; (iv) a delivery device comprising a handle and a delivery catheter extending therefrom for delivering the prosthesis in the delivery configuration into a space within the heart, such as the atrium; (v) an actuator, such as a control device, controller, and / or multi-lumen control catheter, for engaging and / or acting on one or more portions of the prosthesis; and (vi) a guidewire catheter for receiving a guidewire that connects to the prosthesis and allows the prosthesis to advance along the guidewire during delivery and / or deployment.

[0037] Any delivery system described herein may include a delivery catheter for lateral delivery of a laterally deliverable prosthetic 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 above It is closed with a non-traumatic ball fitted to it. This outer shaft lumen has an inner diameter of 8–10 mm, which is sized to allow a laterally delivered transcatheter prosthetic valve (e.g., a prosthetic tricuspid valve and / or prosthetic mitral valve) to pass through its outer shaft lumen.

[0038] Any delivery system described herein may comprise a delivery catheter, a control catheter, and / or other suitable parts, comprising one or more members, components, functions, etc., configured to facilitate the retrieval of at least a portion of the valve from the annulus of the heart valve itself. For example, such a delivery system may comprise, for example, a self-expanding capture element that can be positioned in an expanded position to at least partially surround and / or capture a portion of the prosthetic valve. In some implementations, the prosthetic valve may be pulled and / or retracted into the self-expanding capture element by a control catheter and / or other components attached to the prosthetic valve during delivery and / or deployment. Thus, the self-expanding capture element may surround and / or capture at least a portion of the prosthetic valve, thereby facilitating the transition of the prosthetic valve from at least partially expanded to at least partially compressed, thereby enabling the prosthetic valve to be at least partially housed within the delivery catheter used to deliver the prosthetic valve.

[0039] Any method for delivering and deploying a prosthetic valve to the annulus of a patient's own heart valve may include removably coupling the prosthetic valve or its outer frame to a portion of a delivery system. The prosthetic valve is positioned in the delivery configuration, loaded into a delivery device including a delivery catheter, and advanced through the lumen of the delivery catheter. The prosthetic valve can then be released from the distal end of the delivery catheter, which is positioned in the atrium of the heart. In some implementations, after the prosthetic valve is released, the proximal fixation element of the subannular member of the prosthetic valve may be positioned in a first configuration, and with the proximal fixation element remaining in the first configuration, the prosthetic valve is seated on the annulus of the patient's own heart valve. The proximal fixation element can then transition from the first configuration to a second configuration after the prosthetic valve has been seated on the annulus. In some implementations, the method for delivering and / or deploying the prosthetic valve may optionally include retrieving at least a portion of the prosthetic valve from the annulus to allow for repositioning and / or re-implantation of at least a portion of the prosthetic valve.

[0040] Any method for delivering and / or deploying an artificial heart valve as 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.

[0041] Any method for delivering an artificial valve as described herein may include arranging the artificial valve in a delivery configuration. The delivery configuration may include at least one of the following: (i) compressing the valve along a central vertical axis to reduce the vertical dimension of the valve from top to bottom and arranging the valve in the delivery configuration; (ii) flattening the valve into two equilibrium planes substantially parallel to its long axis and arranging the valve in the delivery configuration; or (iii) flattening the valve into two parallel panels substantially parallel to its 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 arranging the valve in the delivery configuration.

[0042] Any method for delivering an artificial valve described herein includes advancing a delivery catheter to a desired location in the body and releasing the valve from the delivery catheter to deliver the artificial valve to the desired location in the body. This may include orthogonal delivery. The valve is in a compression or delivery configuration when inside the delivery catheter and transitions to an expansion or release configuration when released from the delivery catheter.

[0043] Any method for delivering an artificial heart valve as described herein may include (i) pulling the valve out of the delivery catheter using a pulling member (e.g., a wire or rod) releasably connected to a side wall, drum or collar and / or a fixing element (e.g., a distal fixing element), and advancing the pulling member away from the delivery catheter to pull the valve out of the delivery catheter, or (ii) pressing the valve out of the delivery catheter using a pressing member (e.g., a wire, rod, catheter, delivery member, yoke, etc.) releasably connected to a side wall, drum or collar and / or a fixing element (e.g., a proximal and / or distal fixing element), and advancing the pressing member out of the distal end of the delivery catheter to push the valve out of the delivery catheter, thereby releasing the valve from the delivery catheter. Furthermore, by releasing the valve from the delivery catheter, the valve becomes capable of transitioning from its delivery configuration to an expanded and / or deployed configuration and / or expanding.

[0044] Any method for delivering and / or deploying an artificial 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 fitted or seated position within its own 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 positioned catheter and pulling or pressing a wire or rod, the delivery catheter, the actuator, and / or other suitable part of the delivery system.

[0045] In some implementations, prior to cutting and retraction, the method may optionally include moving the valve to a fixed or tightened state via an actuator or part of the delivery system so that the valve contacts the annular tissue and locks the valve to its own annulus. In some implementations, prior to cutting and retraction, the method may optionally include retrieving at least a portion of the valve from the annulus and repositioning at least a portion of the valve from the annulus. In some implementations, retrieval may include retrieving and / or retracting at least a portion of the valve into a delivery catheter.

[0046] Any method for delivering and / or deploying an artificial valve as 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 implementations, the method may include partially inserting the artificial valve into the annulus such that the distal portion is in contact with the patient's own annular tissue, while the proximal portion of the artificial valve is at least partially compressed and positioned within the delivery catheter. In some embodiments, the method may include rotating the valvular prosthesis using a maneuverable catheter, yoke, set of tethers, actuator, and / or other parts (or combinations thereof) of the delivery system along an axis parallel to the plane of the valve annulus. In some embodiments, this method moves one or more fixed elements to a desired position and / or state to engage with the self-organizing structure surrounding at least a portion of the valve ring. This may include fixing the valve in a desired position by fixing one or more tissue anchors to the valve and within its own tissue. In some embodiments, one or more tissue anchors may be fixed to the valve and within its own tissue.

[0047] Any method for at least partially recovering an artificial valve as described herein may include (i) extending a self-expanding capture element from the distal end of a delivery catheter disposed in the atrium of the heart, wherein the capture element is configured to have a cavity shape when in the extended position, and (ii) retracting the heart valve into the cavity of the extended capture element to facilitate compression of the heart valve into or in the direction of its delivery (compression) configuration, wherein the heart valve is retracted into the capture element and the capture element is moved from the extended position to the retracted position, wherein the heart valve is surrounded by the capture element in the retracted position, and the heart valve-capture element combination is retracted into a delivery and / or recovery catheter (e.g., using a cable, control catheter, actuator, and / or other suitable part of the delivery and recovery system). In some implementations, this method may optionally include pre-compressing the valve by (a) suturing a proximal subannular fixation element to the underside of the atrial or annular collar or member, (b) pinching the proximal lateral wall hip of the prosthesis valve, or (c) both before retracting the valve into the cavity of the capture element and then before retracting it into the delivery and / or retrieval catheter.

[0048] Any artificial heart valve (or its components, functions, and / or aspects), delivery system, manufacturing method, delivery method, deployment method, and / or recovery method described herein are subject to International Patent Application No. PCT / US2019 / 051087, filed September 19, 2019, entitled “Transcatheter Deliverable Prosthetic Heart Valves and Method of Delivery” (hereinafter referred to as “'957 PCT”); International Patent Application No. PCT / US2019 / 067010, filed December 18, 2019, entitled “Transcatheter Deliverable Prosthetic Heart Valves and Methods of Delivery” (hereinafter referred to as “'010PCT”); and “Collapsible Inner Flow Control Component for Side-Deliverable Transcatheter Heart Valve International Patent Application No. PCT / US2020 / 015231 (hereinafter referred to as "'231PCT"), titled "Prosthesis"; International Patent Application No. PCT / US2020 / 031390 (hereinafter referred to as "'390PCT"), filed on 4 May 2020, titled "Cinch Device and Method for Deployment of a Side-Delivered Prosthetic Heart Valve in a Native Annulus"; and / or International Patent Application No. PCT / US2020 / 045108 (hereinafter referred to as "'108PCT"), filed on 6 August 2020, titled "Side-Deliverable Transcatheter Prosthetic Valves and Methods for Delivering and Anchoring the Same" (their disclosures are incorporated herein by reference in their entirety).

[0049] Similarly, any artificial valve (or its components, functions, and / or aspects), delivery system, manufacturing method, delivery method, deployment method, and / or recovery method described herein are subject to U.S. Provisional Patent Application No. 62 / 889,327 (hereinafter referred to as “Provisional '327”); U.S. Provisional Patent Application No. 62 / 891,964 (hereinafter referred to as “Provisional '964”); U.S. Provisional Patent Application No. 63 / 027,345 (hereinafter referred to as “Provisional '345”); and / or U.S. Provisional Patent Application No. 63 / 038,807 (hereinafter referred to as “Provisional '807”) (if this application claims priority, its interests and disclosures are referred to above in their entirety). It may be similar to and / or substantially the same as any of those listed (incorporated).

[0050] The technical terms used herein are for the sole purpose of describing specific embodiments and are not intended to limit the scope of the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those widely understood by those skilled in the art. Nothing in this disclosure should be construed as an acknowledgment that the embodiments described herein have no prior rights to this disclosure under prior art.

[0051] Where used herein, the singular forms “a” (indefinite article), “an” (indefinite article), and “the” (definite article) 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.

[0052] 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 functions, completes (or parts thereof), steps, actions, elements, and / or components, but do not exclude the presence or addition of one or more other functions, completes (or parts thereof), steps, actions, elements, components, and / or groups thereof. Where used herein, the term “comprising” means “includes, but not limited to.”

[0053] As used herein, the term “and / or” includes any combination of one or more of the related enumerated items and all combinations thereof. Any appropriate separate “and / or” expression indicating two or more alternative terms should be understood to be construed as potentially including one of the terms, either of the terms, or both of the terms, whether in the specification, claims, or drawings. For example, the expression “A or B” is understood to include the possibilities of “A” or “B” or “A and B.”

[0054] 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 those skilled in the art will understand, the scope includes each individual member.

[0055] The terms “valve prosthesis,” “artificial heart valve,” and / or “prosthetic valve” may refer to a combination of a frame and leaflets or flow control structure or components 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).

[0056] Artificial valves disclosed herein may comprise components (e.g., frames) that can be seated within their own annulus and used as valve leaflet structures, flow control components, or mounting elements for flexible reciprocating sleeves or sleeve valves. Depending on the embodiment, the artificial valve may comprise such valve leaflet structures Alternatively, the system may or may not include flow control components. Such components may be referred to herein as “valve ring support frame,” “tubular frame,” “wire frame,” “valve frame,” “flange,” “collar,” and / or any other similar terms.

[0057] The term “flow control component” may, in an unrestricted sense, refer to a valve leaflet structure having 2-, 3-, or 4-leaflets of a flexible biocompatible material such as treated or untreated pericardium, which is sutured 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. Examples of bioartificial pericardial valves include bioartificial aortic valves, bioartificial mitral valves, bioartificial tricuspid valves, and bioartificial pulmonary valves.

[0058] 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), the 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.

[0059] The mode of cardiac access is obtained at least in part on a “body channel,” which is used to define a blood conduit or blood vessel within the body, and the body channel in question may be 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 valve or mitral valve replacement is implanted in the tricuspid valve or mitral annulus, respectively. While certain functions described herein may be particularly advantageous for a given implantation site, any embodiment of the valve described herein may be implanted in any body channel unless the combination of functions is structurally impossible or excluded by the language of the claims.

[0060] As used herein, the term “expandable” may refer to an artificial heart valve or component of an artificial heart valve that is expandable from a first delivery size or configuration to a second implantation size or configuration. Therefore, an expandable structure is not intended to refer to a structure that may expand slightly due to, for example, rising temperature or other such accidental causes, unless explicitly stated in the context. Conversely, “non-expandable” should not be interpreted as meaning completely rigid or dimensionally stable, since some expansion may be observed in, for example, conventional “non-expandable” heart valves.

[0061] The artificial valves and / or components disclosed herein can generally transition between two or more configurations, states, shapes, and / or arrangements. For example, the artificial valves described herein may be “compressible” and / or “expandable” between any suitable number of configurations. Different terms may be used to describe or refer to these configurations, unless otherwise clearly defined in the context. Unless otherwise specified, this is not intended to be limiting. For example, an artificial valve may be described as being in a “delivery configuration,” which could be any suitable configuration that enables or allows the delivery of the artificial valve. Examples of delivery configurations include compression configurations, folding configurations, rolling configurations, and / or similar configurations, or any suitable combination thereof. Similarly, an artificial valve may be described as being in an “expanded configuration,” which could be any suitable configuration that is not explicitly intended for the delivery of the artificial valve. Examples of expanded configurations may include released configurations, relaxed configurations, deployed configurations, non-delivery configurations, and / or similar configurations, or any suitable combination thereof. Some artificial valves and / or their components or functions described herein may have numerous additional configurations that can be associated with various modes, levels, states, and / or parts such as operation, deployment, and engagement. Examples of such configurations include operating configurations, seating configurations, safety configurations, engagement configurations, and / or similar configurations, or any suitable combination thereof. While specific examples are given above, it should be understood that these are not intended to be a complete enumeration of configurations. Other configurations are possible. Furthermore, different terms may be used to describe the same or substantially similar constructions, and therefore, the use of a particular term is not intended to restrict and / or exclude other terms unless the terms and / or constructions are mutually exclusive, or unless the context explicitly states otherwise.

[0062] Generally, conventional delivery of prosthetic valves may be such that the central cylindrical axis of the valve is substantially parallel to the longitudinal axis of the delivery catheter used to deliver the valve. Typically, the valve is compressed radially with respect to the central cylindrical axis and advances through the lumen of the delivery catheter. This valve then unfolds from the end of the delivery catheter and expands radially outward from the central cylindrical axis. Valve orientation generally means that the valve is located in the atrium of the heart and remains reoriented relative to the annulus while being completely released from the delivery catheter, which may, in some cases, limit the size of the valve.

[0063] The prosthetic valves described herein are configured to be delivered via lateral or orthogonal delivery techniques unless otherwise specified. Where used herein, terms such as “laterally delivered,” “lateral delivery,” “orthogonal delivery,” and “orthogonal delivery” may be used interchangeably to describe such delivery methods and / or valves delivered using such methods. Orthogonal delivery of a prosthetic 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 relative to the central cylinder axis. Thus, the longitudinal 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 prosthetic valve is compressed and / or delivered at an angle of approximately 90 degrees compared to conventional processes for compressing and delivering transcatheter prosthetic valves. Furthermore, in some cases, the orientation of the valve delivered orthogonal to the annulus allows the distal portion of the valve to be inserted at least partially into the annulus of the patient's own heart valve, while the proximal portion of the valve remains at least partially within the delivery catheter, thereby avoiding at least some of the size constraints faced by some known conventional delivery techniques. Examples of artificial valves configured to be delivered orthogonally and processes for delivering such valves are described in detail in the '957 PCT and / or '010 PCT' incorporated herein by reference.

[0064] 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.

[0065] For the embodiments described herein and / or for the various functional or advantageous details thereof, This will be described more fully with reference to non-limiting embodiments shown in the accompanying drawings and described in detail below. Descriptions of well-known components and processing techniques are omitted to avoid unnecessarily obscuring the embodiments herein. Similar figures refer to similar elements throughout.

[0066] Following a discussion of various embodiments, components, and / or functions of the prosthetic valve, there is a discussion of a delivery and / or retrieval system 180 used to deliver, deploy, and / or at least partially retrieve such prosthetic valves. The examples and / or embodiments described herein are intended to facilitate understanding of the structure, function, and / or aspects of this embodiment, and how to carry out the embodiment, and / or to further enable those skilled in the art to carry out the embodiments herein. Similarly, the methods and / or directions for using the embodiments described herein are provided merely as examples and are not limiting. Specific uses described herein are not provided to exclude other uses unless the context expressly specifies otherwise. For example, any prosthetic valve 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 some prosthetic valves are described herein in the context of replacing 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 functions are otherwise clearly recognized by those skilled in the art as not corresponding to such use. Accordingly, the specific examples, embodiments, methods, and / or uses described herein should not be construed as limiting the scope of the invention or concept of the invention herein. Rather, the examples and embodiments are provided to ensure that this disclosure is complete and comprehensive and fully conveys the scope of the concept of the invention to those skilled in the art.

[0067] Figures 1A to 1E are schematic diagrams of various transcatheter prosthetic valves 100 according to one embodiment. The transcatheter prosthetic valve 100 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 prosthetic valve 100 and to block blood flow in a second direction opposite to the first direction, through the outlet end of the transcatheter prosthetic valve 100. For example, the transcatheter prosthetic valve 100 may be a transcatheter prosthetic heart valve configured to be deployed within the annulus of the human heart's own tricuspid valve or mitral valve to complement and / or replace the function of the own valve.

[0068] The transcatheter prosthetic valve 100 (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 102 of the valve 100 (also referred herein as the “horizontal axis,” “longitudinal axis,” or “length axis”). The valve 100 is compressible and expandable between an expandable configuration (Figures 1A, 1C, and IE) for implantation at a desired location within the body (e.g., a human heart) and a compressible or delivery configuration (Figures 1B and 1D) for introduction into the body using a delivery catheter.

[0069] In some embodiments, the valve 100 (and / or at least a portion thereof) may begin as a substantially tubular configuration and may be heat-formed and / or otherwise formed into any desired shape. In some embodiments, the valve 100 may comprise an upper atrial cuff or flange for atrial sealing, a lower ventricular cuff or flange for ventricular sealing, and a transannular section or region (e.g., a body section, a tubular section, a cylindrical section, etc.) disposed between them. The transannular region may have an hourglass cross-section over about 60–80% of its circumference, matching the annulus along the posterior and anterior annular segments, while matching the septal annular segment, leaving substantially vertical flattening along 20–40% of the annular circumference. The valve 100 is shown in Figures 1A–1E as having a given shape, but the size and / or shape of the valve 100 (and / or at least a portion thereof) may be obtained based on the size and / or shape of the anatomical structure of the own tissue. Please understand this.

[0070] For example, the valve 100 may be central (e.g., radially symmetrical with respect to the central y-axis 104) or eccentric (e.g., radially asymmetrical with respect to the central y-axis 104). In some eccentric embodiments, the valve 100 or its outer frame may have a complex shape determined by the anatomical structure to which the valve 100 is attached. For example, in some cases, the valve 100 may be disposed on a tricuspid annulus that has a rounded elliptical circumference with a substantially vertical septum and is known to expand pathologically along the anterior-posterior line. In some cases, the valve 100 may be disposed on a mitral annulus (e.g., near the anterior leaflet) that has a rounded elliptical circumference with a substantially vertical septum and is known to expand pathologically. Thus, the valve 100 may have a complex shape determined at least in part by the pathology of the annulus and / or the valve itself. For example, in some such embodiments, the valve 100 or its outer frame may have a D-shape (when viewed from above), so that the flat portion may coincide with the anatomical structure into which the valve 100 is deployed.

[0071] As shown, the valve 100 generally comprises a valve ring support frame 110 and a flow control component 150. Furthermore, the valve 100 and / or at least the valve ring support frame 110 of the valve 100 may include and / or be coupled to an actuator 170 and / or a delivery system interface 180. In some implementations, the valve 100 and / or its embodiments or parts may be similar to, and / or substantially the same as, the valves (and / or their corresponding embodiments or parts) described in detail in '957PCT, '010PCT, '231PCT, '390PCT, '108PCT, provisional '327, provisional '964, provisional '345, and / or provisional '807, which are incorporated herein by the above reference. Accordingly, certain embodiments, parts, and / or details of the valve 100 may not be described in further detail herein.

[0072] The annular support frame 110 (also referred to herein as the “tubular frame,” “valve frame,” “wire frame,” “outer frame,” or “frame”) may have an annular region 120, an annular region 130, and a transannular region 112 disposed between them and / or connected thereto. In some embodiments, the annular region 120, the annular region 130, and the transannular region 112 may be separate, independent, and / or modular components that are combined to collectively form the frame 110. In some implementations, such a modular configuration may allow the frame 110 to be adapted to a given size and / or shape of the anatomical structure to which the valve 100 is attached. For example, one or more of the annular regions 120, annular regions 130, and / or transannular regions 112 may be designed and / or adapted so that the support frame has any desired height, outer diameter and / or inner diameter, e.g., any of the above. Furthermore, such a modular configuration may allow the frame 110 to be bent, flexed, compressed, folded, rolled, and / or otherwise reconfigured without any plastic or permanent deformation. For example, the frame 110 may be compressible into a compressed configuration for delivery and configured to return to its original shape (uncompressible or expanded configuration) when released.

[0073] The support frame 110 and / or the upper annular region 120, the lower annular region 130, and / or the trans-annular region 112 may be formed from or made of any suitable material. In some embodiments, the upper annular region 120, the lower annular region 130, and the trans-annular region 112 may be formed from or made of a shape memory alloy or superelastic metal, metal alloy, plastic, etc. For example, the upper annular region 120, the lower annular region 130, and the trans-annular region 112 may be formed from or made of nitinol, etc. Furthermore, the upper annular region 120, the lower annular region 130, and the trans-annular region 112 may be joined to the wire frame portion of the support frame 110. Frame 110 is covered with a biocompatible material such as pericardial tissue (e.g., Duraguard®, Peri-Guard®, Vascu-Guard®, etc.) or polymer (e.g., polyester, Dacron®, etc.), as described above.

[0074] The annular region 120 of the frame 110 may be, and / or form, a cuff or collar that can be attached to or joined to, for example, the upper end or upper part of the transannular region 112, as will be described in more detail herein. When the valve 100 is deployed in the human heart, the annular region 120 may be an atrial collar that is molded to conform to its own deployed position. In the replacement of the tricuspid and / or mitral valves, for example, the annular region 120 collar may have various parts configured to conform to the own valve and / or a portion of the atrial bed surrounding the tricuspid and / or mitral valves, respectively. In some implementations, the annular region 120 may be positioned in the atrial bed to direct blood from the atrium to the flow control components 150 of the valve 100 and to seal blood leakage around the frame 110 (perivalvular leakage).

[0075] In some embodiments, the annular region 120 may be a wireframe laser-cut from any suitable material. In some embodiments, the annular region 120 may be formed from a shape memory material or a superelastic material such as Nitinol. In some embodiments, the annular region 120 may be laser-cut from a sheet of a shape memory metal alloy such as Nitinol and then heat-set, for example, to a desired shape and / or configuration. In some embodiments, forming the annular region 120 in such a manner may allow the annular region 120 to be reconfigured by bending, flexing, folding, compressing, and / or other means without substantially plastic deformation and / or fatigue that could result in failure or breakage of one or more of its parts. Furthermore, the wireframe of the annular region 120 may be covered with any suitable biocompatible material, such as any of the above materials. As shown in Figure 1A, the annular region 120 includes a distal portion 122 and a proximal portion 124. In some embodiments, the distal portion 122 may be and / or include a distal annular fixation element that can engage with the distal self-tissue of the annulus when the prosthetic valve 100 is seated on the annulus. In some embodiments, the distal portion 124 may be and / or include a proximal annular fixation element that can engage with the proximal self-tissue of the annulus when the prosthetic valve 100 is seated on the annulus. In some embodiments, the distal portion 122 and / or the distal annular fixation element may be sized and / or molded to correspond to the size and / or shape of the distal portion of the atrial bed of the heart in which the prosthetic valve 100 is seated. Similarly, the proximal portion 124 and / or the proximal annular fixation element may be sized and / or molded to correspond to the size and / or shape of the proximal portion of the atrial bed of the heart.

[0076] Although not shown in Figures 1A-1E, the annular region 120 may be molded and / or formed to include any number of functions configured to engage with self-organizing and / or one or more other parts of the valve 100, actuator 170, and / or delivery system interface 180. For example, in some embodiments, the annular region 120 may include an outer portion, an inner portion, and one or more splines disposed between the outer and inner portions. In some implementations, the outer portion may be sized and / or molded to engage with self-organizing, the inner portion may provide a structure for mounting the flow control component 150 to the support frame 110, and one or more splines may receive, connect to, and / or otherwise engage with the actuator 170 and / or delivery system interface 180, as will be described in further detail herein with reference to specific embodiments.

[0077] The annular region 130 of the frame 110 may be, and / or form, a cuff or collar that may be attached to or joined to, for example, the lower end or upper part of the transannular region 112, as will be described in more detail herein. When the valve 100 is deployed in the human heart, the annular region 130 may be an atrial collar formed to conform to its own deployed position. In the replacement of the tricuspid and / or mitral valves, for example, the subannular region 130 collar may have various parts configured to conform to the own valve and / or a portion of the ventricular ceiling surrounding the tricuspid and / or mitral valves, respectively. In some implementations, the subannular region 130 or at least a portion thereof may engage with the ventricular ceiling surrounding the annulus to secure the valve 100 to the annulus, prevent the valve 100 from falling out, pinch or compress the adjacent tissue between the annulus or the adjacent supraannular region 120 and the subannular region 130, and / or seal against blood leakage around the frame 110 (perivalvular leakage and / or regurgitation during systole).

[0078] In some embodiments, the sub-annular region 130 may be a wireframe laser-cut from any suitable material. In some embodiments, the annular region 130 may be formed from a shape memory material or a superelastic material such as Nitinol. In some embodiments, the sub-annular region 130 may be laser-cut from a sheet of a shape memory metal alloy such as Nitinol and then heat-set, for example, to a desired shape and / or configuration. In some embodiments, forming the sub-annular region 130 in such a manner may make it possible to reconfigure the sub-annular region 130 by bending, flexing, folding, compressing, and / or other means without substantially plastic deformation and / or fatigue that could result in failure or breakage of one or more of its parts. Furthermore, the wireframe of the sub-annular region 130 may be covered with any suitable biocompatible material, such as any of the above materials.

[0079] The sub-annular region 130 may be molded and / or formed to include a number of functions configured to engage with self-organization, one or more other parts of the valve 100, and / or the actuator 170. For example, in some embodiments, the sub-annular region 130 may include and / or form a distal portion having a distal fixing element 132 and a proximal portion having a proximal fixing element 134. In some embodiments, the annular region 130 may include and / or form any other suitable fixing elements (not shown in Figures 1A-1E). In some embodiments, the fixing elements 132 and 134 are formed integrally and / or monolithically with the sub-annular region 130. The distal fixation element 132 and proximal fixation element 134 of the annular region 130 may be any suitable shape, size, and / or configuration, including '957PCT,' '010PCT,' '231PCT,' '390PCT,' '108PCT, provisional '327, provisional '964, provisional '345, and / or provisional '807, and / or any of the others described in detail herein with respect to a particular embodiment. For example, the fixation elements 132 and 134 may extend about 10 to 40 mm from a portion of the subannular region 130.

[0080] In some embodiments, the distal fixing element 132 may optionally include a guidewire coupler configured to selectively engage and / or receive a portion of the guidewire or a portion of the guidewire assembly. The guidewire coupler is configured to allow a portion of the guidewire to extend through an opening in the guidewire coupler, thereby allowing the valve 100 to advance on or along the guidewire during delivery and deployment. In some embodiments, the guidewire coupler may selectively allow the guidewire to advance through the guidewire coupler while blocking or preventing other elements and / or components, such as a pusher.

[0081] The fixing elements 132 and / or 134 of the lower valve ring region 130 engage with desired portions of the self-organizing structure to mount the valve 100 and / or support frame 110 onto the valve ring of the self-organizing valve that is deployed. It may be configured in such a way. For example, in some implementations, the distal fixing element 132 may be a projection or projection extending from the subannular region 130 to the RVOT or LVOT. In such implementations, the distal fixing element 132 may be molded and / or biased so that the distal fixing element 132 acts to act on subannular tissue that is capable of fixing the distal end of the valve 100 at least partially within its own annulus. In some implementations, the proximal fixing element 134 may be configured to engage with subannular tissue on the proximal side of its own annulus to help fix the valve 100 within the annulus.

[0082] In some implementations, at least the proximal fixing element 134 may be configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal fixing element 134 extends to a first amount or distance from the sub-annular region 130 and a second configuration in which the proximal fixing element 134 extends to a second amount or distance from the sub-annular region 130. For example, in some embodiments, the proximal fixing element 134 may have a first configuration in which the proximal fixing element 134 is compressed, contracted, stored, unfolded, folded, and / or constrained (e.g., in a position near, adjacent to, and / or in contact with, the trans-annular region 112 and / or the upper-annular region 120 of the support frame 110), and a second configuration in which the proximal fixing element 134 is expanded, extended, unfolded, unfolded, and / or unconstrained (e.g., extending away from the trans-annular region 112). Furthermore, in some implementations, as will be described in more detail herein, the proximal fixed element 134 may be moved in response to the operation of the actuator 170.

[0083] In some implementations, the proximal fixation element 134 may transition from a first configuration to a second configuration during deployment to selectively engage with the body's own tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure that assists in fixing the valve 100 in the body's own annulus. The proximal fixation element 134 (and / or distal fixation element 132) may have any suitable functions, surfaces, membranes, etc. configured to facilitate engagement between the proximal fixation element 134 (and / or distal fixation element 132) and the body's own tissue. For example, in some embodiments, the proximal fixation element 134 may have one or more functions configured to engage and / or entangle with the body's own tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure when in the second configuration, as will be further described herein with reference to specific embodiments.

[0084] The trans-annular region 112 of the support frame 110 is positioned between the upper annular region 120 and the lower annular region 130. In some embodiments, the trans-annular region 112 can be joined to each of the upper annular region 120 and the lower annular region 130 (e.g., by welding, joining, suturing, joining, and / or similar) so that a desired amount of movement and / or bending is possible between them. For example, in some implementations, the trans-annular region 112 and / or a portion thereof may be sewn to each of the upper annular region 120 and the lower annular region 130 (and / or a portion thereof).

[0085] The valve annular region 112 may be formed and / or shaped into a ring, cylindrical tube, conical tube, D-tube, and / or any other suitable valve annular shape. In some embodiments, the valve annular region 112 may have a side cross-section such as a flattened cone, an inverted flattened cone (narrower at the top and wider at the bottom), a concave cylinder (with curved walls in the middle), a convex cylinder (with raised walls), a square hourglass, a curved hourglass, an inclined hourglass, a flared top, a flared bottom, or both. Furthermore, the valve annular region 112 may form and / or define an opening or central channel 114 extending along a central axis 104 (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. In some embodiments, the valve annular region 112 is supported by a support frame 11 The annular region 120 and / or subannular region 130 of the annulus may have a shape and / or size that is at least partially based on the size, shape and / or configuration of its own annulus, and / or configuration in which it is configured to unfold. For example, the transannulus 112 may have an outer surface for engaging with the annular tissue of its own annulus, which can be tensioned against the inner surface of the annulus of its own annulus in order to provide structural patency to the weakened annulus of its own annulus.

[0086] In some embodiments, the transvalvular ring region 112 may be a wire frame laser-cut from any suitable material. In some embodiments, the transvalvular ring region 112 may be formed from a shape memory material or a superelastic material such as Nitinol. In some embodiments, the transvalvular ring region 112 may be laser-cut from a sheet of a shape memory metal alloy such as Nitinol and then heat-set, for example, to a desired shape and / or configuration. Although not shown in Figures 1A-1E, in some embodiments, the transvalvular ring region 112 may include and / or be formed from two laser-cut halves that can be formed into a desired shape and / or configuration and joined together to form the transvalvular ring region 112. The transvalvular ring region 112 may also be formed to include a set of compressible wire cells having an orientation and / or cell geometry substantially orthogonal to the central axis 104 (Figure 1A) to minimize wire cell strain when the transvalvular ring region 112 is in a vertical compression configuration, a wound compression configuration, or a folded compression configuration. In some embodiments, by forming the transvalve ring region 112 in such a manner, the transvalve ring region 112 may be able to bend, flex, fold, deform and / or otherwise reconfigure (without substantially any plastic alteration and / or excessive fatigue) along or in the direction of the transverse axis 106 (Figure 1C) and / or along or in the direction of the central axis 104 (Figure 1D), as will be described in further detail herein.

[0087] As described above with reference to the annular region 120 and the subannular region 130, the wireframe of the transannular region 112 may be covered with any suitable biocompatible material, e.g., any of the above materials. In some implementations, the wireframes of the annular region 120, the transannular region 112, and the subannular region 130 may be flexibly joined (e.g., sutured) to form a wireframe portion of the support frame 110, which is then covered with a biocompatible material. In other words, the annular region 120, the transannular region 112, and the subannular region 130 may be covered with a biocompatible material before or after joining. In embodiments where the wireframe is covered after joining, the biocompatible material may facilitate and / or support the joining between them.

[0088] Although not shown in Figures 1A to 1E, the frame 110 may also have and / or form additional functional elements (e.g., loops, fasteners, etc.) for mounting additional components, such as biocompatible covers, tissue fixation devices, and releasable deployment and retrieval controls (e.g., actuators 170, delivery system interfaces 180, and / or other suitable guides, knobs, attachments, rigging, etc.). In some implementations, the frame 110 (or its embodiments and / or parts) may be structurally and / or functionally similar to the frame (or its corresponding embodiments and / or parts) described in detail in '957PCT, '010PCT, '231PCT, '390PCT, '108PCT, provisional '327, provisional '964, provisional '345, and / or provisional '807.

[0089] 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 two, three, four, or more leaflets, made from a flexible biocompatible material such as treated or untreated pericardium. These leaflets may be sewn or joined to a support structure such as an inner frame, and subsequently sewn or joined to an outer frame 110. The leaflets are in an open and closed position, or The flow control component 150 may be configured to operate in a substantially sealed state, allowing blood to flow in a first direction through the inlet end of the valve 100, and blocking blood flow in a second direction opposite to the first direction, through the outlet end of the valve 100. For example, the flow control component 150 may be configured such that the valve 100 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 from the systolic ventricular pressure applied to the outside. The continuous opening and closing can be described as a “reciprocating motion.”

[0090] The inner frame, and / or parts or embodiments thereof, may be similar to the outer frame 110, and / or parts or embodiments thereof, at least in form and / or function. For example, the inner frame may be a laser-cut wire frame formed from or made of a shape memory material such as Nitinol. Furthermore, the inner frame may be configured to be compressible for delivery and to return to its original (uncompressible) shape when released (e.g., after delivery). In some embodiments, the inner frame may comprise and / or be formed of any preferred number of compressible, elastically deformable rhombic or pupil-shaped wire cells, etc. The wire cells may have an orientation and cell geometry substantially orthogonal to the axis of the flow control component 150 so as to minimize wire cell distortion when the inner frame is in a compressed configuration.

[0091] In some embodiments, the flow control component 150 and / or its inner frame may have a substantially cylindrical or tubular shape when the valve 100 is in an extended configuration (see, for example, Figure 1C), and may be configured to deform elastically when the valve 100 is placed in a compression configuration (see, for example, Figures 1B and 1D). Although not shown in Figures 1A to 1E, in some embodiments, the inner frame of the flow control component 150 may include and / or be formed of two halves, which may be joined together to allow the inner frame to deform elastically in response to lateral compression or folding along or in the direction of the lateral axis 106, as will be described in further detail herein (Figure 1C).

[0092] As shown in Figures 1A to 1D, the flow control component 150 is mounted within the central channel 114 of the frame 110. More specifically, the flow control component 150 is configured to be attached to and / or coupled to the annular region 120 (e.g., its internal portion) and to extend into and / or through the central channel 114 formed by and / or defined by the transannular region 112. In some embodiments, the flow control component 150 may be coupled to the annular region 120 via tissue, biocompatible mesh, one or more woven or knitted fabrics, one or more hyperelastic or shape memory alloy structures, which are sewn, sutured, and / or otherwise fixed to a portion of the annular region 120. In some embodiments, the flow control component 150 may be coupled to the annular region 120 such that a portion of the flow control component 150 is positioned on the annular region 120 and / or otherwise extends beyond the annular region 120 (for example, extending away from the annulus in the direction of the atrium). In some embodiments, the portion of the flow control component 150 extending on and / or beyond the annular region 120 may form projections, shelves, walls, step-ups, etc. In some implementations, such arrangement may facilitate the internal growth of self-tissue covering the annular region 120 without obstructing the flow control component 150.

[0093] The flow control component 150 may be at least partially disposed within the central channel 114 such that the axis of the flow control component 150, extending in the direction of blood flow through the flow control component 150, is substantially parallel to the central axis 104 of the frame 110. In some embodiments, the flow control component 150 is positioned in the center of the central channel 114, and the support frame A frame 110 may be positioned. In other embodiments, the support frame 110 may be positioned such that the flow control component 150 is off-center within the central channel 114. In some embodiments, the central channel 114 may have a diameter and / or perimeter larger than the diameter and / or perimeter of the flow control component 150. Although not shown in Figures 1A-1E, in some embodiments, the valve 100 may include a spacer, etc., which can 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 may be used to facilitate coupling the flow control component 150 to the frame 110.

[0094] In some embodiments, the flow control component 150 (or parts and / or aspects thereof) may be similar to any flow control component described, for example, in 231PCT. Therefore, the flow control component 150 and / or aspects or parts thereof are not described in further detail herein.

[0095] Referring back to Figure 1A, the valve 100 includes and / or is coupled to an actuator 170 and a delivery interface 180. The actuator 170 may be any suitable member, mechanism, and / or device configured to actuate at least a portion of the valve 100. For example, in some embodiments, the actuator 170 and / or a portion of the actuator 170 may be configured to be at least temporarily coupled to the upper ring region 120 of the support frame 110 (e.g., a spline and / or other portion) and to actuate one or more portions of the valve 100. More specifically, the actuator 170 may be configured to actuate at least a proximal fixing element 134 of the lower ring region 120 of the support frame 110 to move the proximal fixing element 134 between its first configuration and a second configuration. In some implementations, the actuator 170 may include one or more cables, tethers, linkages, joints, connections, etc., which may exert force on (or disengage from) a portion of the proximal restraint element 134 that is actuated to move the proximal restraint element 134 between a first configuration and a second configuration. For example, the lower region 130 of the support frame 110 may be formed of a proximal restraint element 134 biased in an uncompressed and / or expanded configuration, and the actuator 170 may be actuated to exert force via one or more cables, tethers, etc., which are actuated to move the proximal restraint element 134 to a compressed and / or contracted configuration.

[0096] In some implementations, the actuator 170 can fix and / or lock the proximal fixing element 134 in the first configuration (e.g., first configuration) when the proximal fixing element 134 is compressed and / or contracted. As described above, in some implementations, the proximal fixing element 134 may be in the first configuration for delivery and deployment before the valve 100 is seated on its own annulus. Once the valve 100 is seated on its own annulus, the user can operate the actuator 170 by manipulating part of the delivery system. In this embodiment, when the actuator 170 is operated, the actuator 170 can release and / or remove the force applied to the proximal fixing element 134 (e.g., via a cable, tether, etc.), thereby allowing the proximal fixing element 134 to return to its original configuration or biased configuration (e.g., second configuration), as described above.

[0097] The delivery system interface 180 shown in Figure 1A may comprise any number of components having any suitable shape, size, and / or configuration. In some implementations, the delivery system interface 180 may be, and / or comprise, the distal end portion of a delivery system used to deliver, for example, the valve 100 to a desired location on the patient's body (e.g., the annulus of the patient's own heart valve). In some embodiments, the delivery system interface may comprise, for example, a compressed configuration as described in '957PCT'. The delivery system may also include a delivery catheter, such as a 12-34 Fr delivery catheter, having any suitable corresponding lumen diameter sufficient to receive the artificial valve 100. Furthermore, the delivery system may include a secondary catheter, which may be, for example, a multi-lumen catheter configured to engage with the valve 100 and advance the valve 100 through the delivery catheter. In some embodiments, each lumen of the multi-lumen secondary catheter may include, for example, any other suitable components associated with and / or included in the actuator 170, such as cables, tethers, and / or components. Each cable, tether, and / or component may then be coupled to a portion of the valve 100 or support frame 110 and configured to actuate that portion, as will be described in further detail herein with reference to specific embodiments.

[0098] Furthermore, the lumen of the multi-lumen secondary catheter (e.g., the central lumen) may be equipped with and / or receive a torque cable and a guidewire. The guidewire extends through the secondary catheter to a desired position relative to the self-tissue (e.g., RVOT or LVOT) and provides a path for the valve 100 to move during delivery and / or deployment, as described in the '957 PCT. The torque cable may be any suitable cable configured to be detachably coupled to the annular region 120 of the frame 110 (e.g., coupled to the annular region 120 and / or a waypoint formed thereby). The torque cable may be a relatively rigid cable that can be configured to facilitate the delivery and / or deployment of the valve 100, and, if necessary, the retraction of the valve 100. Thus, the delivery system interface 180 shown in Figure 1A may be the distal end portion of the delivery system including any of the above components. Therefore, the delivery system interface 180 may be used for the delivery of the valve 100, the deployment and / or operation of the valve 100 or a part thereof (e.g., the proximal fixed element 134), and / or the retraction of the valve 100, and / or otherwise to facilitate this. Furthermore, the delivery system interface 180 may be configured to disconnect, remove, and / or otherwise release the valve 100 after it has been deployed to its own valve ring, as will be described in further detail herein with reference to specific embodiments.

[0099] As described above, the valve 100 is compressible and expandable between an expanded configuration and a compressed configuration. When in the expanded configuration, the valve 100 may have a first height or size along the central axis 104, and when in the compressed configuration, it may have a second height or size along the central axis 104 that is less than the first height or size. The valve 100 may also be compressed in further directions. For example, the valve 100 may be compressed along a transverse axis 106 that is perpendicular to both the longitudinal axis 102 and the central axis 104 (see, for example, Figures 1B and 1C).

[0100] The valve 100 is configured to be compressed during delivery of the valve 100 and to expand once released from the delivery catheter. More specifically, the valve 100 is configured for transcatheter orthogonal delivery to a desired location in the body (e.g., the annulus of a prostate valve), where the valve 100 is compressed orthogonal or lateral (e.g., along the central axis 104 and / or lateral axis 106) to the dimensions of the valve 100 in its expanded configuration. During delivery, the longitudinal axis 102 of the valve 100 is substantially parallel to the longitudinal axis of the delivery catheter, as described in the '957 PCT.

[0101] The valve 100 is in an expanded configuration before being loaded into the delivery system, after being released from the delivery catheter, and after being deployed or implanted (or ready to be deployed or implanted) at a desired location in the body. When in the expanded configuration shown in Figures 1A, 1B, and 1E, the valve 100 is in an orientation perpendicular or transverse to the longitudinal axis 102 (e.g., the central axis 104 and) which is larger than the diameter of the lumen of the delivery catheter used to deliver the valve 100. It has an extension in any direction (or along the transverse axis 106). For example, in some embodiments, the valve 100 may have an extended height of 5 to 60 mm (e.g., along the central axis 104). In some embodiments, the valve 100 may have an extended diameter length (e.g., along the longitudinal axis 102) and width (e.g., along the transverse axis 106) of about 20 to 80 mm, or about 40 to 80 mm.

[0102] When in the compression configuration shown in Figures 1B and 1D, the valve 100 has an extension in any direction perpendicular to the longitudinal axis 102 or transversely (e.g., along the central axis 104 and / or transverse axis 106), such that the extension is smaller than the diameter of the lumen of the delivery catheter, allowing the valve 100 to be delivered through that lumen. For example, in some embodiments, the valve 100 may have a compression height (e.g., along the central axis 104) and compression width (e.g., along the transverse axis 106) of about 6–15 mm, about 8–12 mm, or about 9–10 mm. The valve 100 may be compressed by compression, rolling, folding, and / or any other suitable method, or a combination thereof, as described in detail in '957PCT, '010PCT, '231PCT, '390PCT, '108PCT, provisional '327, provisional '964, provisional '345, and / or provisional '807. In some embodiments, the length of the valve 100 (e.g., along the longitudinal axis 102) is intended not to be compressed for delivery. Rather, in some embodiments, the length of the valve 100 may increase in response to compression of the valve 100 along the central axis 104 and / or the transverse axis 106.

[0103] As shown in Figure 1E, the valve 100 may be delivered to, for example, the atrium of a human heart, and may be disposed within the annulus of an intrinsic valve such as the pulmonary valve (PV), mitral valve (MV), aortic valve (AV), and / or tricuspid valve (TV). As described above, the valve 100 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, the valve 100 may be delivered to the atrium of a human heart via any delivery system, device, and / or method described in detail in '957PCT, '010PCT, '231PCT, '390PCT, '108PCT, provisional '327, provisional '964, provisional '345, and / or provisional '807, and released from a delivery catheter (not shown).

[0104] In some implementations, delivery of the valve 100 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 be advanced into the atrium along and / or over the guidewire (e.g., via the IVC, SVC, and / or transseptal access). In some embodiments, the guidewire coupler of the valve 100 (e.g., contained within or on the distal fixation element 132) may be coupled to the proximal end portion of the guidewire, and the valve 100 may be positioned in a compression configuration, thereby allowing the valve 100 to advance into the atrium along the guidewire and through the lumen of the delivery catheter.

[0105] Deployment of the valve 100 may involve positioning the distal fixation element 132 of the subannular region 130 within the ventricle (RV, LV) below the annulus while the rest of the valve 100 remains within the atrium (RA, LA). In some cases, the distal fixation element 132 may be advanced along and / or parallel to a guidewire to a desired position within the ventricle, such as the ventricular outflow duct. For example, in some implementations, the valve 100 may be delivered to the annulus of a native 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 100 may be delivered to the annulus of a native mitral valve (MV), and at least a portion of the distal fixation element 132 may be positioned within the LVOT.

[0106] In some implementations, the artificial valve 100 is temporarily maintained in a partially deployed state. For example, the valve 100 may be partially inserted into the annulus and maintained at a certain angle to the annulus in order to allow blood to flow from the atrium to the ventricle by partially passing through the annulus and partially through the valve 100, thereby enabling evaluation of valve function.

[0107] Valve 100 may be positioned or seated on the annulus (PVA, MVA, AVA, and / or TVA) of a native valve (PV, MV, AV, and / or TV) such that a subannular region 130 (e.g., ventricular collar) is positioned subannularly, a transannular region 112 of the valve frame 110 extends through the annulus, and an upper annular region 120 (e.g., atrial collar) remains in an upper annular position. For example, in some embodiments, at least the proximal end portion of valve 100 may be pressed against the annulus using a delivery system, a delivery system interface 180, an actuator 170, and / or any other suitable member, tool, etc. In some implementations, a proximal fixing element 134 may be maintained in its first configuration when valve 100 is seated on the annulus. For example, as described above, the proximal fixing element 134 may be in a configuration that compresses, shrinks, and / or retracts, in contact with, adjacent to, and / or near the trans-annular region 112 and / or upper-annular region 120 of the frame 110, which can then restrict the entire circumference of the sub-annular region 130 of the frame 110, thereby allowing the sub-annular region 130 and the trans-annular region 112 of the frame 110 to be inserted into and / or through the annulus.

[0108] Once seated, the proximal fixing element 134 can transition from its first configuration to a second configuration, as described in detail in '010 PCT', '108 PCT', and / or provisional '345'. For example, in some implementations, a user may operate a part of the delivery system to actuate the actuator 170. In some implementations, acting the actuator 170 may release and / or reduce the amount of tension in one or more tethers, cables, connections, and / or parts of the actuator 170, thereby allowing the proximal fixing element 134 to transition. Thus, once the valve 100 is seated on the annulus, the proximal fixing element 134 can be positioned in a second configuration in which the proximal fixing element 134 is in contact with, engaged with, and / or otherwise adjacent to the subannular tissue. In some implementations, the proximal fixation element 134 may be configured to engage and / or capture the progenitor tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, etc., when the proximal fixation element 134 is positioned within the ventricle. For example, in some implementations, after the valve 100 is seated within the annulus, the proximal fixation element 134 may transition from a first (compression) configuration to a second (extension) configuration, resulting in the proximal fixation element 134 extending around and / or through one or more portions of the progenitor tissue, chordae tendineae, etc. The proximal fixation element 134 may then be returned to the first configuration, capturing and / or fixing one or more portions of the progenitor tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, etc., between the proximal fixation element 134 and, for example, the transannular portion of the lateral frame 110. In other implementations, the proximal fixation element 134 may be maintained in the second (extension) configuration after the valve 100 is seated within the annulus. In such an implementation, the proximal fixation element 134 may, for example, contact and / or engage with the subannular tissue on the proximal side of the annulus, and as a result, the proximal fixation element and the proximal portion of the atrial collar exert a compressive force on the proximal portion of the annular tissue.

[0109] In this way, the distal fixing element 132 may be configured to engage with the self-tissue on the distal side of the annulus, and the proximal fixing element 134 may be configured to engage with the self-tissue on the proximal side of the annulus (e.g., second configuration or extended configuration), thereby enabling the valve 100 to be securely seated within the annulus, as shown in Figure 1E. In some implementations, any other or additional parts of the valve may similarly engage with the self-tissue to firmly seat the valve 100 within the annulus and / or form a seal between the support frame 110 and the tissue forming the annulus (e.g., the annular region 120, the transannular region 112, and / or the distal portion 122 and / or of one or more other or additional fixing elements (not shown in Figures 1A-1E)). (This is the proximal portion 124).

[0110] Although not shown in Figures 1A-1E, in some implementations, as described in detail in '957PCT, the valve 100 and / or delivery system may include one or more tissue anchors, which may be used to fix one or more portions of the valve 100 to the annular tissue. In some embodiments, the tissue anchors may be configured to puncture, penetrate, and / or otherwise fix to the annular tissue the fixation elements 132 and / or 134 and / or the atrial collar. In other embodiments, the tissue anchors may be non-traumatic anchors configured to fix the fixation elements 132 and / or 134 and / or the atrial collar to the annular tissue without puncturing, penetrating, and / or otherwise causing trauma to the own tissue.

[0111] Figures 2A to 2D are schematic diagrams of a valve ring support frame 210 according to one embodiment. The valve ring support frame 210 (also referred herein as the “tubular frame,” “valve frame,” “wire frame,” “outer frame,” “support frame,” or “frame”) may include and / or be coupled to actuators 270 configured to actuate one or more portions of the support frame 210. In some embodiments, the support frame 210 and / or actuators 270 may be substantially similar, at least in form and / or function, to the support frame 110 and / or actuator 170 described above with reference to Figures 1A to 1E. Therefore, parts and / or aspects of the support frame 210 and / or actuators 270 are not described in further detail herein.

[0112] As shown, the annular support frame 210 has an annular upper member and / or region 220, an annular lower member and / or region 230, and a trans-annular member and / or region 212 disposed and / or coupled between them. In the embodiments shown in Figures 2A to 2D, the annular upper member and / or region 220, the annular lower member and / or region 230, and the trans-annular member and / or region 212 are separate, independent, and / or modular components coupled together to collectively form the frame 210. Each of the annular upper member and / or region 220, the annular lower member and / or region 230, and the trans-annular member and / or region 212 (hereinafter referred to as annular upper, annular lower, and trans-annular “members”) is a wireframe laser-cut from any suitable material such as a shape memory material or a superelastic material such as Nitinol. In some implementations, the upper annular member 220, the lower annular member 230, and the trans-annular member 212 may each be laser-cut from a sheet of nitinol and then heat-set, for example, to a desired shape and / or configuration. Forming the upper annular member 220, the lower annular member 230, and the trans-annular member 212 in this manner as described above may provide a desired amount of plasticity and / or resistance to plastic or permanent deformation, thereby allowing the frame 210 to be folded and / or compressed for delivery. Furthermore, the wireframe portions of the upper annular member 220, the lower annular member 230, and the trans-annular member 212 may be covered with any suitable biocompatible material, such as any of the above.

[0113] In some embodiments, the annular member 220 of the frame 210 may be similar, at least in form and / or function, to the annular member 120 described above with reference to Figures 1A to 1E. For example, the annular member 220 may be a cuff or collar, and / or form thereof, which may be attached to or joined to the upper end or top of the transannular region 212, as will be described in more detail herein. In some implementations, as will be described in detail above, the annular member 220 may be positioned in the atrial bed to direct blood from the atrium to a flow control component attached to the frame 210. The annular member 220 may be self-tissue and / or one or more other parts of the frame 210, and / Alternatively, it may be molded and / or formed to include any number of functions configured to engage with the actuator 270. For example, in some embodiments, the valve ring region 220 may include and / or form an outer portion or loop, an inner portion or loop, and one or more splines disposed between the outer portion and the inner portion or loop.

[0114] In some embodiments, the outer portion or loop (referred to herein as the “outer loop”) may be molded and / or sized to engage with the self-tissue. More specifically, the annular member 220 (or its outer loop) may have a distal portion 222 configured to engage with the distal annular tissue and a proximal portion 224 configured to engage with the proximal annular tissue. In some embodiments, the distal and proximal portions 222 and 224 may have a rounded and / or curved shape, with the radius of curvature of the proximal portion 224 being greater than that of the distal portion 222. In some implementations, the distal portion 222 may, for example, engage with the distal annular tissue to form a distal upper fixing element that can at least partially stabilize and / or secure the frame 210 to the self-annulus. Similarly, the proximal portion 224 may, for example, engage with the proximal annular tissue to form a proximal upper fixing element that can at least partially stabilize and / or secure the frame 210 to the self-annulus.

[0115] The inner portion or loop of the valve ring upper member 220 (referred to herein as the “inner loop”) may be substantially circular and may be coupled to and / or suspended from the outer loop by one or more splines. As will be further described herein with reference to specific embodiments, the inner loop may be coupled to the inner frame of a flow control component to at least partially attach the flow control component to the support frame 210. In some implementations, by suspending the inner loop from the outer loop (via one or more splines), the inner loop may be at least partially isolated from at least some of the forces associated with, for example, moving the frame 210 between an extended configuration and a compressed configuration, as will be further described herein. Furthermore, attaching the flow control component to the inner loop of the valve ring upper member 220 similarly at least partially isolates and / or reduces the amount of force transmitted to the flow control component when the frame 210 moves between its extended configuration and its compressed configuration.

[0116] One or more splines of the annular member 220 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the annular member 220 may include distal and proximal splines. As described above, the splines may be configured to support the inner loop and / or otherwise connect the inner loop to the outer loop. In some embodiments, the annular member 220 may include splines (e.g., proximal splines) configured to receive, connect to, and / or otherwise engage with the actuator 270 and / or a delivery system interface. For example, in some embodiments, the proximal splines may form connection points, mounting points, waypoints, and / or any other suitable functions that can be temporarily and / or detachably connected to the actuator 270, as will be described in further detail herein with reference to specific embodiments.

[0117] In some embodiments, the subannular member 230 of the frame 210 may be similar, at least in form and / or function, to the subannular region 130 described above with reference to Figures 1A to 1E. For example, the subannular member 230 of the frame 210 may be a cuff or collar, and / or form thereof, which may be attached to or joined to the lower end or upper part of the transannular region 212, as will be described in more detail herein. When the frame 210 is deployed in the human heart, the subannular member 230 may be a ventricular collar that is molded to conform to its deployed position. Tricuspid valve and / or mitral valve In valve replacement, for example, the sub-annular member 230 collar may have various parts configured to match the own valve and / or a portion of the ventricular ceiling surrounding the tricuspid valve and / or mitral valve, respectively. In some embodiments, the sub-annular member 230 or at least a portion thereof may engage with the ventricular ceiling surrounding the own annulus to secure the frame 210 to the own annulus, prevent the frame 210 from falling off, pinch or compress adjacent tissue between the own annulus or the upper annular member 220 and the sub-annular member 230, and / or seal against blood leakage around the frame 210 (perivalvular leakage and / or regurgitation during systole).

[0118] The lower ring member 230 may be molded and / or formed to include any number of functions configured to engage with self-organizing, one or more other parts of the frame 210, and / or the actuator 270. For example, in some embodiments, the lower ring member 230 may comprise and / or be formed a distal portion having a distal fixing element 232 and a proximal portion having a proximal fixing element 234. In some embodiments, the lower ring member 230 may include and / or be formed any other suitable fixing element (not shown in Figures 2A to 2D). In some embodiments, the fixing elements 232 and 234 are formed integrally and / or monolithically with the lower ring member 230. The distal fixing element 232 and proximal fixing element 234 of the lower valve ring member 230 may be of any suitable shape, size, and / or configuration, for example, any of those described in detail in '957PCT, '010PCT, '231PCT, '390PCT, '108PCT, provisional '327, provisional '964, provisional '345, provisional '807, any of those described above with reference to valve 100, and / or any of those described herein with respect to a particular embodiment.

[0119] In some embodiments, the distal fixing element 232 may optionally include a guidewire coupler 133 configured to selectively engage and / or receive a portion of the guidewire or a portion of the guidewire assembly. The guidewire coupler is configured to allow a portion of the guidewire to extend through an opening in the guidewire coupler, thereby allowing the frame 210 to advance on or along the guidewire during delivery and deployment. In some embodiments, the guidewire coupler may selectively allow the guidewire to advance through the guidewire coupler while blocking or preventing other elements and / or components, such as a pusher.

[0120] The fixing elements 232 and / or 234 of the sub-ring member 230 may be configured to engage with desired portions of their own tissue to mount the frame 210 onto the ring of the self-valve from which the valve is deployed. For example, in some implementations, the distal fixing element 232 may be a projection or protrusion extending from the sub-ring member 230 to the RVOT or LVOT. In such implementations, the distal fixing element 232 may be molded and / or biased such that it acts to apply force to the sub-ring tissue so as to fix the distal end of the frame 210 at least partially within the self-valve ring. In some implementations, the proximal fixing element 234 may be configured to engage with the sub-ring tissue on the proximal side of the self-valve ring to help fix the frame 210 within the ring.

[0121] In some implementations, at least the proximal fixing element 234 may be configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal fixing element 234 extends from the lower annulus member 230 to a first amount or distance, and a second configuration in which the proximal fixing element 234 extends from the lower annulus member 230 to a second amount or distance. As described above, the lower annulus member 230 of the frame 210 may be, and / or include, a laser-cut wire frame formed of a shape memory material such as Nitinol, which is heat-set to a desired shape. In some embodiments, the heat setting of the upper annulus member 230 may include forming one or more twists in a portion of the laser-cut wire, thereby, then, the lower annulus It may be possible to bias one or more portions of member 230 in different directions and / or orientations. For example, generally, the lower ring member 230 of frame 210 may be formed to provide greater plasticity in a direction (e.g., with respect to the longitudinal axis of the lower ring member 230) that allows the upper ring member 230 to be folded and / or compressed. However, in some embodiments, portions of the lower ring member 230 may be twisted and / or otherwise oriented to provide greater plasticity in a direction (e.g., perpendicular to the longitudinal axis of the lower ring member 230 and perpendicular to the folding and / or compression direction) that allows the proximal fixing element 234 to be actuated and / or otherwise transition between its first and second configurations.

[0122] In some embodiments, the proximal fixing element 234 may be compressed, contracted, retracted, unfolded, folded, and / or constrained (e.g., near, adjacent to, and / or in contact with, the trans-valve ring member 212 and / or the upper valve ring member 220 of the support frame 210) in the first configuration, and in the second configuration, it may be extended, extended, unfolded, unfolded, and / or unconstrained (e.g., extending away from the trans-valve ring region 212). In some embodiments, the proximal fixing element 234 may be biased to the second configuration and / or thermally set. Furthermore, in some implementations, as will be described in more detail herein, the proximal fixing element 234 may be moved in response to the operation of the actuator 270.

[0123] In some implementations, the proximal fixation element 234 may transition from a first configuration to a second configuration during deployment to selectively engage with the patient's own tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure that helps fix the frame 210 in the patient's own annulus. The proximal fixation element 234 (and / or distal fixation element 232) may have any suitable functions, surfaces, membranes, etc. configured to facilitate engagement between the proximal fixation element 234 (and / or distal fixation element 232) and the patient's own tissue. For example, in some embodiments, the proximal fixation element 234 may have one or more functions configured to engage and / or entangle with the patient's own tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure when in the second configuration, as will be further described herein with reference to specific embodiments.

[0124] In some embodiments, the trans-annular member 212 of the frame 210 may be similar, at least in form and / or function, to the trans-annular region 112 described above with reference to Figures 1A to 1E. For example, the trans-annular member 212 is disposed between the upper annular member 220 and the lower annular member 230. In some embodiments, the trans-annular member 212 may be coupled to each of the upper annular member 220 and the lower annular member 230 (e.g., by welding, joining, suturing, bonding, and / or similar) so that a desired amount of movement and / or bending is possible between them. For example, in some implementations, the trans-annular member 212 and / or a portion thereof may be sewn to each of the upper annular member 220 and the lower annular member 230 (and / or a portion thereof). The trans-annular region 212 may be formed and / or shaped into a ring, cylindrical tube, conical tube, D-tube, and / or any other suitable annular shape, as described above with reference to the trans-annular member 112. In some embodiments, the trans-valve ring member 212 may have a shape and / or size that is at least partially based on the size, shape and / or configuration of the upper and / or lower ring members 220 and / or lower ring members 230 of the support frame 210, the flow control components configured to be coupled to the support frame 210, and / or the size, shape and / or configuration of its own valve ring, which is configured to be deployed. For example, the trans-valve ring member 212 may have an outer surface for engaging with the valve ring tissue that can be tensioned against the inner surface of the valve ring in order to provide structural patency to the weakened ring of the valve ring.

[0125] As described above, the annular member 220, the annular member 230, and the transannular member 212 may be independent and / or modular components that are joined together to collectively form a frame 210. In some embodiments, the annular member 220 may be configured to engage with the annular tissue of its own valve and may be molded and / or biased to form a substantially fluid-tight seal with the atrial bed to limit and / or substantially prevent leakage around the frame (e.g., perianthal leakage). Similarly, the annular member 220 may be configured to engage with the annular tissue of its own valve and may be molded and / or biased to form a substantially fluid-tight seal with the ventricular ceiling to limit and / or substantially prevent leakage around the frame. Furthermore, in some implementations, the transannular member 212 may have a circumference that is slightly larger than its own annular tissue, for example, to form at least a partial seal between the transannular member 212 of the frame 210 and the own tissue forming the annular wall. In such an implementation, redundancy can be provided in the event of an incomplete or partial seal formed by one or more of the annular members 220, subannular members 230, and / or transannular members 212, by forming a seal against the atrial bed, ventricular ceiling, and annular wall.

[0126] In other configurations, distal and proximal fixing elements 232 and 234 can apply force to the movable subannular tissue by pulling the supraannular member 220 of the frame 210 toward the atrial bed, thereby facilitating seal formation. In such configurations, for example, the subannular member 230 and / or transannular member 212 may not need to form a seal, or may partially form a seal with their own tissue thanks to the seal formed by the supraannular member 220.

[0127] In some implementations, the frame 210 may be positioned such that structural support and / or rigidity is provided by the annular suprasin member 220 and the annular suprasin member 230, while the transannular member 212 does not need to provide substantial support and / or rigidity. In some such implementations, the transannular member 212 may be configured not to provide substantial support and / or rigidity, but to connect the annular suprasin member 220 to the annular suprasin member 230 and to deform easily (elastically) for delivery. Furthermore, although the transannular member 212 is described above as being formed by a laser-cut wire frame covered with a biocompatible material, in other embodiments, the transannular member 212 may be formed from any suitable flexible material such as pericardial tissue, woven fabric, or polyester. In some such embodiments, forming the flexible material without a laser-cut wire frame may reduce the size of the frame 210, for example, when in a compression configuration, thereby enabling the delivery of the valve using a smaller delivery catheter. In some embodiments, the frame 210 does not need to have a separate transannular member 212. For example, in such an embodiment, the flow control component may be coupled between the upper valve ring member 220 and the lower valve ring member 230, thereby making it possible to further reduce the size of the valve in the compression configuration.

[0128] As shown in Figures 2A-2D, the actuator 270 may be coupled at least temporarily to the upper ring member 220 and the lower ring member 230. In some embodiments, the actuator 270 or a part thereof may also be coupled at least temporarily to a part of the trans-ring member 212. The actuator 270 may be any suitable member, mechanism, and / or device configured to actuate at least a part of the frame 210. Furthermore, a part of the actuator 270 may extend through the frame 210 and / or a part of the delivery system used to deliver the valve including the frame 210. In this way, a user may actuate the actuator 270 by operating the proximal end portion of the actuator 270.

[0129] In some embodiments, the actuator 270 and / or part of the actuator 270 are the valve ring upper member 220 (e.g., mounting point, waypoint, connector, screw type The actuator 270 may be configured to at least temporarily connect to a spline (such as plastic), and may be configured to actuate one or more parts of the frame 210. The actuator 270 may be configured to actuate at least a proximal fixing element 234 of the lower valve ring member 220 of the support frame 210, thereby moving the proximal fixing element 234 between its first configuration and a second configuration (as described above).

[0130] In some implementations, the actuator 270 may include one or more cables, tethers, linkages, joints, connections, etc., which may exert force on (or remove exerted force on) a portion of the proximal restraint element 234 that is actuated to move the proximal restraint element 234 between a first configuration and a second configuration. For example, the actuator 270 may be coupled to a waypoint on the annular member 220, and may be coupled to the proximal restraint element 234 by comprising one or more tethers, cables, and / or members extending through the waypoint and / or one or more openings or openings. In some implementations, one or more tethers, cables, and / or members may be detachably and / or temporarily coupled to the proximal restraint element 234, for example, as described in '010 PCT', '108 PCT', and / or provisional '345'.

[0131] As described above, the lower valve ring member 230 may be formed by a proximal fixing element 234 biased in an uncompressed and / or expanded configuration. In this way, the actuator 270 may be actuated to apply a force via one or more cables, tethers, etc., that is operable to move the proximal fixing element 234 into a compressed and / or retracted configuration. More specifically, the user may operate the proximal end portion of the actuator 270 to actuate the distal end portion of the actuator 270 coupled to the frame 210. For example, acting the actuator 270 may be actuated such that one or more cables, tethers, and / or members are pulled in the proximal direction (e.g., away from and / or within the frame 210) as indicated by arrow AA in Figure 2B. The coupling of the distal end portion of the actuator 270 to the frame 210 may be such that the proximal movement of the cables, tethers, etc., pulls the proximal fixing element 234 toward the central axis of the frame 210, as indicated by arrow BB in Figure 2B. Therefore, by operating the actuator 270, a force may be applied to the proximal fixed element 234 so that it is operable to compress, retract, restrain, and / or position the proximal fixed element 234 in an actuated configuration, as shown in Figure 2B.

[0132] In some implementations, acting the actuator 270 may also be capable of moving the proximal anterior portion of the lower ring member and / or trans-ring wall, and the proximal posterior portion of the lower ring member and / or trans-ring wall, toward or toward the longitudinal axis of the valve 200. For example, Figure 2C shows that acting the actuator 270 (e.g., moving the actuator 270 or tether in the AA direction) compresses and / or moves the proximal fixing element 234 toward the central portion of the valve frame 210, as indicated by arrow BB, and compresses the posterior and anterior side walls toward the central portion of the valve frame 210, as indicated by arrow CC. Thus, by acting the actuator 270, the perimeter of at least the lower ring member 230 can be reduced, thereby allowing the desired portion of the valve frame 210 to be inserted into the valve ring of the valve itself.

[0133] In some implementations, the actuator 270 can be fixed and / or locked (e.g., in the first configuration) when the proximal fixing element 234 is compressed and / or contracted, thereby maintaining the proximal fixing element 234 in the first configuration at least temporarily. As described above, in some implementations, the proximal fixing element 234 may be in the first configuration for delivery and deployment before seating the frame 210 (or valve) of the self-valve ring. Once the frame 210 is seated on the self-valve ring, the user can operate the proximal portion of the actuator 270 to actuate and / or release the actuator 270. In this embodiment, the actuator 270 Activating the proximal fixation element 234 releases and / or removes at least a portion of the force applied to it (e.g., via a cable, tether, etc.), thereby allowing the proximal fixation element 234 (and / or one or more portions of the anterior and / or posterior wall) to return to its biased configuration or a second configuration (see, for example, 2A).

[0134] In some implementations, the actuator 270 may be configured to further actuate the frame 210 (or valve) after it has seated on its own valve ring. For example, in some implementations, a user may manipulate the proximal end portion of the actuator 270 (e.g., in the same manner as described in different ways) to move one or more cables, tethers, and / or members of the actuator 270 proximal (e.g., away from the frame 210 and / or in a manner that increases tension within it), as indicated by the arrow DD in Figure 2D. In this embodiment, the proximal fixing element 234 is in its uncompressed or non-actuated state after the frame 210 has seated on its own valve ring. The actuator 270 may be coupled to the upper ring member 220, the lower ring member 230, and / or the proximal fixing element 234 such that the operation of the actuator 270 generates a force capable of operating the proximal fixing element 234 to pull the upper ring member 220 toward the proximal portion 224 of the upper ring member 220, as shown by arrow EE in Figure 2D. For example, the actuator 270 may exert a compressive force capable of operating when tightening at least a portion of the frame 210.

[0135] As shown in Figure 2D, in some cases, the proximal fixation element 234 may bend toward the annulus itself (e.g., beyond its biased position), which may facilitate engagement between the proximal fixation element 234 and the proximal chordae tendineae of the annulus itself. In some implementations, the force resulting from the operation of the actuator 270 may be capable of pulling, moving, compressing, and / or tightening other parts of the lower annulus member 230 toward the upper annulus member 220, as indicated by arrow FF in Figure 2D. In some such implementations, the amount of tightening may vary across the entire frame 210. For example, the amount of tightening in or near the proximal portion of the frame 210 may be greater than the amount of tightening in or near the distal portion of the frame 210. In other implementations, the amount of tightening may be substantially consistent across the entire frame 210. Furthermore, when the frame 210 is seated on its own valve ring, and therefore the tightening of the upper and lower ring members 220 and 230 can operate to compress and / or sandwich self-organization between members 220 and 230, at least some self-organizational tissue may be arranged between the upper and lower ring members 220 and 230. In this way, the tightening can enhance the fixation of the frame 210 on its own valve ring.

[0136] Although not shown in Figures 2A to 2D, in some embodiments, when the frame 210 is tightened against or against its own annulus, the proximal fixation element 234 may be sized and / or shaped to engage with the body's own tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, etc. In some embodiments, the proximal fixation element 234 may be one or more projections, features, bumps, ribs, knobs, knots, beads, loops, etc., that engage with and / or facilitate engagement with the body's own tissue when the frame 210 is tightened against or against its own annulus.

[0137] As described above, one or more portions of the frame 210 and / or the lower valve ring member 230 are compressed to move inward toward the central axis of the frame 210 in response to the operation of the actuator 270. In other embodiments, the actuator 270 may be detachably coupled to one or more portions of the frame 210 and configured to move such portions in any suitable manner. For example, in some implementations, the operation of the actuator 270 may cause the proximal fixed element 234 to fold or the frame 210 around the lower valve ring member 212 to wrap forward, backward, or both, depending on the mode of operation. The actuator 270 (for example, one or more tethers as described above) may be coupled to the proximal fixing element 234. As described above, the folding and / or wrapping of the proximal fixing element 234 around the transannular member 212 can reduce the circumference or diameter of at least the subannular member 230, allowing the frame 210 to be inserted into the annulus of the own heart valve and / or at least a portion thereof.

[0138] Figures 3A to 3C are schematic diagrams of a valve ring support frame 310 according to one embodiment. The valve ring support frame 310 (also referred herein as the “tubular frame,” “valve frame,” “wire frame,” “outer frame,” “support frame,” or “frame”) may include and / or be coupled to actuators 370 configured to actuate one or more parts of the support frame 310. In some embodiments, the support frame 310 and / or actuators 370 may be substantially similar, at least in form and / or function, to the support frames 110, 210 and / or actuators 170, respectively. Therefore, parts and / or aspects of the support frame 310 and / or actuators 370 are not described in further detail herein.

[0139] As shown, the annular support frame 310 has an annular upper member and / or region 320, an annular lower member and / or region 330, and a trans-annular member and / or region 312 disposed and / or coupled between them. In the embodiments shown in Figures 3A to 3C, the annular upper member and / or region 320, the annular lower member and / or region 330, and the trans-annular member and / or region 312 are separate, independent, and / or modular components coupled together to collectively form the frame 310. Each of the annular upper member and / or region 320, the annular lower member and / or region 330, and the trans-annular member and / or region 312 (hereinafter referred to as annular upper, annular lower, and trans-annular “members”) is a wireframe laser-cut from any suitable material such as a shape memory material or a superelastic material such as nitinol. In some implementations, the upper annular member 320, the lower annular member 330, and the trans-annular member 312 may each be laser-cut from a sheet of nitinol and then heat-set, for example, to a desired shape and / or configuration. Forming the upper annular member 320, the lower annular member 330, and the trans-annular member 312 in this manner as described above may provide a desired amount of plasticity and / or resistance to plastic or permanent deformation, thereby allowing the frame 310 to be folded and / or compressed for delivery. Furthermore, the wireframe portions of the upper annular member 320, the lower annular member 330, and the trans-annular member 312 may be covered with any suitable biocompatible material, such as any of the above.

[0140] In some embodiments, the annular member 320 of the frame 310 may be similar to the annular members 120, 220 described above, at least in form and / or function. For example, the annular member 320 may be, and / or form, a cuff or collar that may be attached to or coupled to the upper end or top of the transannular region 312, for example. The annular member 320 may be molded and / or formed to include self-organizing and / or any number of functions configured to engage with one or more other parts of the frame 310 and / or the actuator 370. For example, the annular member 320 (or its outer loop) may have a distal portion 322 configured to engage with the distal annular tissue and a proximal portion 324 configured to engage with the proximal annular tissue.

[0141] As described above, the annular region 320 may include and / or form an outer portion or loop, an inner portion or loop, and one or more splines disposed between the outer portion and the inner portion or loop. The outer portion or loop (hereinafter referred to as the “outer loop”) may be formed to engage with self-organization and / or The size may be set. In some implementations, the outer loop may engage with, for example, the distal annular tissue to form one or more upper or annular fixing elements that can at least partially stabilize and / or secure the frame 310 to its own annulus. The inner portion or loop of the annular member 320 (referred to herein as the “inner loop”) is coupled to and / or suspended from the outer loop by one or more splines and is coupled to the inner frame of the flow control component, as described above with reference to the annular member 220, and at least partially mounts the flow control component to the support frame 310. One or more splines of the annular member 320 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the annular member 320 may include a distal spline and a proximal spline. In some embodiments, the annular member 320 may include a spline (e.g., a proximal spline) configured to receive, couple to, and / or otherwise engage with, the actuator 370 and / or the delivery system interface. For example, in the embodiments shown in Figures 3A to 3C, the valve ring member 330 (e.g., its splines) may form waypoints and / or similar that can be temporarily and / or detachably coupled to and / or receive them to the actuator 370 and any other suitable part of the delivery system, as will be described in further detail herein with reference to specific embodiments.

[0142] The annular member 330 of the frame 310 may be similar to the annular region and / or members 130, 230 described above, at least in form and / or function. For example, the annular member 330 of the frame 310 may be, and / or form, a cuff or collar that may be attached to or coupled to the lower end or upper part of the transannular member 312, for example. When the frame 310 is deployed in the human heart, the annular member 330 may be a ventricular collar that is molded to conform to its deployed position. In some implementations, the annular member 330 or at least a portion thereof may engage with the ventricular ceiling surrounding the annulus to secure the frame 310 to the annulus, prevent the frame 310 from falling off, and / or seal against blood leakage around the frame 310 (perivalvular leakage and / or regurgitation during systole).

[0143] The lower annulus member 330 included in the frame shown in Figures 3A to 3C may include and / or be formed a distal portion having a distal fixing element 332 and a proximal portion having a proximal fixing element 334. In some embodiments, the lower annulus member 330 may include and / or be formed any other suitable fixing element (not shown in Figures 3A to 3C). The fixing elements 332 and 334 may be formed integrally with and / or monolithically with the lower annulus member 330. The distal fixing element 332 and proximal fixing element 334 of the lower valve ring member 330 may be any suitable shape, size, and / or configuration, for example, any one described in detail in '957PCT', '010PCT', '231PCT', '390PCT', '108PCT', provisional '327', provisional '964', provisional '345', provisional '807', any one described above with reference to valve 100, and / or any one described herein with respect to a particular embodiment. The distal fixing element 332 may be substantially similar to the distal fixing elements 132, 232, and is therefore not described in further detail herein.

[0144] The proximal fixing element 334 may be configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal fixing element 334 extends from the lower annular member 330 to a first amount, distance, and / or direction, and a second configuration in which the proximal fixing element 334 extends from the lower annular member 330 to a second amount, distance, and / or direction. In some embodiments, the proximal fixing element 334 may be substantially similar, at least in form and / or function, to the proximal fixing element 234 described above with reference to Figures 2A to 2D. Such similarities are therefore not described in further detail herein.

[0145] In some embodiments, the proximal fixing element 334 may be compressed, contracted, retracted, unfolded, folded, and / or constrained (e.g., near, adjacent to, and / or in contact with the trans-valve ring member 312 and / or the upper valve ring member 320 of the support frame 310) in the first configuration, and in the second configuration, it may be extended, extended, unfolded, unfolded, and / or unconstrained (e.g., extending away from the trans-valve ring member 312). In some embodiments, the proximal fixing element 334 may be biased to the second configuration and / or thermally set. Furthermore, in some implementations, as will be described in more detail herein, the proximal fixing element 334 may be moved in response to the operation of the actuator 370.

[0146] The trans-annular member 312 is disposed between the upper annular member 320 and the lower annular member 330. In some embodiments, the trans-annular member 312 can be coupled to each of the upper annular member 320 and the lower annular member 330 (e.g., by welding, joining, suturing, bonding, and / or similar) so that a desired amount of movement and / or bending is possible between them. In some embodiments, the trans-annular member 312 of the frame 310 may be similar to the trans-annular regions 112, 212 described above, at least in form and / or function, and are therefore not described in further detail herein.

[0147] Although frame 310 has been described above as substantially similar to frame 210 with reference to Figures 2A to 2D, frame 310 may differ from frame 210 in its engagement with the actuator and the movement of the proximal fixed element 334. As shown in Figures 3A to 3C, actuator 370 may engage with the upper ring member 320 and the lower ring member 330, at least temporarily. Actuator 370 may be any suitable member, mechanism, and / or device configured to actuate at least a portion of frame 310. Furthermore, a portion of actuator 370 may extend through frame 310 and / or a portion of the delivery system used to deliver the valve containing frame 310. In this way, a user may actuate actuator 370 by operating the proximal end portion of actuator 370.

[0148] Figure 3A shows the actuator 370 engaged with the frame 310 while the frame 310 is in a compressed or delivery configuration. As described above with respect to the valve 100, the frame 310 can be compressed, folded, and / or otherwise positioned into a delivery configuration for lateral delivery via the delivery catheter. Before positioning the frame 310 in the delivery system, the actuator 370 can be detachably coupled to the frame 310 so that the frame 310 (or valve) and the actuator 370 advance together through the delivery catheter. In this embodiment, the actuator 370 may be a tether extending through a waypoint 328 defined by the upper annular member 320, looping through one or more mounting points on the lower annular member 330 (e.g., on the proximal fixing element 334 or one or more proximal mounting points), and then looping back through the waypoint 328. Therefore, both ends of the tether are located proximal to the frame 310 and can be maintained at the proximal and / or proximal end of the delivery system, allowing the operator to operate the actuator 370 (tether) to activate the proximal fixation element 334. Figure 3A shows the proximal fixation element 334 in an extended or deactivated configuration when the frame 310 is in a delivery configuration for lateral delivery via the delivery catheter.

[0149] Figure 3B shows an actuator 370 that is actuated to move the proximal fixation element 334 from a first position or configuration to a second position or configuration. More specifically, the frame 310 (and / or valve) may advance through the delivery catheter, and the frame 310 delivers As it is released from the delivery catheter, it becomes possible to expand at least partially. In some implementations, the frame 310 is inserted at least partially into the valve annulus while the proximal end portion of the frame 310 remains within the delivery catheter. After the frame 310 is completely released from the delivery catheter, the operator can manipulate the proximal end portion of the actuator 370 to actuate the distal end portion of the actuator 370, which is coupled to the proximal fixation element 334.

[0150] For example, by acting on the actuator 370, one or more tethers may be pulled proximal (e.g., away from the frame 310 and / or in a manner that increases tension within it), as shown by arrow GG in Figure 3B. By the actuator 370 passing through waypoint 328 of the upper ring member 320, which is not actuated by the actuator 370 in this embodiment, the proximal movement of cables, tethers, etc., pulls the proximal fixing element 334 toward waypoint 328, as shown by arrow HH in Figure 3B. Thus, by acting on the actuator 370, a force may be applied to the movable proximal fixing element 334, as shown in Figure 3B, causing the proximal fixing element 334 to be compressed, contracted, constrained, and / or placed in an actuated configuration. By compressing and / or placing the proximal fixing element 334 in an actuated configuration as described above, at least the perimeter length of the lower ring member 330 is reduced, allowing the lower ring member 330 to pass through the ring of the self-valve.

[0151] After the frame 310 (or valve) is seated on the valve ring, the actuator 370 may be actuated again and / or otherwise returned to a non-actuated state or configuration. Thus, the proximal fixing element 334 can be returned to the extended configuration and / or non-actuated configuration. In the embodiments shown in Figures 3A to 3C, the proximal fixing element 334 may, in the extended and / or non-actuated configuration, be biased to engage with its own sub-ring tissue to fix the frame 310 at least partially to the valve ring. Figure 3C shows that once the frame 310 is seated on the valve ring, an operator can operate the actuator 370 to remove the actuator 370 from the frame 310. For example, the operator may pull one end of the tether (e.g., actuator 370) so that the tether is pulled away from the mounting point of the upper ring member 330 and the waypoint 328 of the upper ring member 320. Therefore, the actuator 370 and / or the delivery system in which the actuator 370 is a part may be withdrawn from the patient while the frame 310 remains attached to the annulus of the patient's own heart valve.

[0152] A consideration of specific aspects or embodiments of transcatheter prosthetic valves (e.g., prosthetic valves) that can be delivered laterally is provided below. With respect to a particular embodiment, the transcatheter prosthetic valves (or aspects or parts thereof) described below may be substantially similar in at least morphology and / or function to valves 100 and / or 200 (or their corresponding aspects or parts thereof). Similarly, the valves (or aspects or parts thereof) described below may be similar in at least morphology and / or function to the valves described in detail in '957 PCT, '010 PCT, '231 PCT, '390 PCT, '108 PCT, provisional '327, provisional '964, provisional '345, and / or provisional '807. Accordingly, certain aspects and / or parts of a particular embodiment may not be described in further detail herein.

[0153] Figures 4 to 10 illustrate a laterally deliverable (orthogonally deliverable) transcatheter artificial heart valve 400 (hereinafter also referred to herein as the “artificial valve” or “valve”) according to one embodiment. Figure 4 is an illustrative top perspective view of the valve 400. In some implementations, the valve 400 may be deployed, for example, within the annulus of the body’s own tricuspid valve and / or mitral valve. The valve 400 is configured to allow blood flow in a first direction through the inflow end of the valve 400 and to block blood flow in a second direction opposite to the first direction through the outflow end of the valve 400. For example, the artificial valve 400 may be used to complement and / or replace the functionality of the body’s own valves in a human heart’s own tricuspid valves. It may be a laterally deliverable transcatheter artificial heart valve configured to deploy within the annulus of a cusp valve or the annulus of the native mitral valve.

[0154] The valve 400 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 400 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 Figure 4). In some embodiments, the horizontal x-axis of the valve 400 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 400 in the compressed configuration is substantially parallel to the longitudinal cylindrical axis of the delivery catheter in which the valve 400 is arranged.

[0155] In some embodiments, the valve 400 has an expanded or unfolded height of approximately 5–60 mm, approximately 5–30 mm, approximately 5–20 mm, approximately 8–12 mm, or approximately 8–10 mm, and an expanded or unfolded diameter (e.g., length and / or width) of approximately 25–80 mm, or approximately 40–80 mm. In some embodiments, the valve 400 has a compressed height (y-axis) and width (z-axis) of approximately 6–15 mm, approximately 8–12 mm, or approximately 9–10 mm. In some implementations, the length of the valve 400 (e.g., along the x-axis) may extend along the length of the central cylindrical axis of the delivery catheter, so that it is neither compressed nor shortened.

[0156] In certain embodiments, the valve 400 is central or radially symmetrical. In other embodiments, the valve 400 is eccentric or radially asymmetrical (e.g., along or with respect to the y-axis). In some eccentric embodiments, the frame 410 may have a D-shaped cross-section, and a flat portion or surface is configured to substantially fit with the annulus of the own mitral valve, either in the anterior leaflet or in its vicinity. In the embodiments shown in Figures 4 to 10, the valve 400 is eccentric, with one or more components being in an offset or asymmetric region with respect to the y-axis.

[0157] The valve 400 comprises 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 (Nitinol) and is therefore a self-expanding structure from a compressed configuration to an expanded configuration. As shown in Figure 4, at least the outer support frame 410 of the valve 400 is covered, wrapped around, and / or surrounded by a biocompatible cover 440. The biocompatible cover 440 may be any other suitable biocompatible material such as mesh material, pericardial tissue, woven synthetic polyester material, and / or the above.

[0158] The outer frame 410 has a transannular member 412 and / or body that circumscribes, forms, and / or defines a central (internal) channel about and / or along a vertical axis or central axis (y-axis). The outer frame 410 has an annular member 420 circumferentially attached to the upper end of the transannular member 412 and an annular member 410 circumferentially attached to the lower end of the transannular member 412. The annular member 420 is molded to match the self-deployment location. In the replacement of a tricuspid valve, for example, the annular member 420 or atrial collar may have a tall dorsal wall portion to match the septal region of the own valve and may have distal and proximal portions. The distal portion may be larger than the proximal portion to account for a larger flat space above (atrium) the subannular region of the ventricular outflow duct (VOT). In the replacement of the mitral valve, for example, the upper ring member 420 of the outer frame 410 may be D-shaped or conform to its own structure. It may have a shape similar to Kuri's hyperbolic paraboloid.

[0159] The foldable (internal) flow control component 450 is mounted within the outer frame 410. The flow control component 450 has a foldable and compressible inner wire frame 35 (also referred to as the "inner valve leaflet frame" or "inner frame") having two or more folding regions, hinge regions, coupling regions, elastically deformable regions, etc. Two to four sets of flexible valve leaflets 456 are mounted within or on the inner frame 451 (not shown in Figure 4). In some embodiments, the flow control component 450 has three valve leaflet 456 tips or pockets mounted within the inner frame 451, as described in further detail herein.

[0160] The internal flow control component 450, like the outer frame 410, is foldable and compressible. For example, the inner frame 451 is foldable along or in the z-axis from a cylindrical configuration to a flattened cylindrical configuration (or a two-layer band) (e.g., foldable in a folding region), in which case the folding region is located on the distal and proximal sides of the inner frame 451. The flow control component 450 is also compressible in the vertical (y-axis) direction to a shortened or compressed configuration, like the outer frame 410. By folding (compressing) in the z-axis direction and compressing vertically in the y-axis direction, the valve 400 can maintain relatively large dimensions along the horizontal (x-axis). In some implementations, the outer frame 410 and the flow control component 450 are reduced along the z-axis until their side walls touch or nearly touch. Furthermore, this allows the outer frame 410 and flow control components 450 to maintain a radius along the horizontal axis (x-axis) and to create the outer and inner frames, minimizing the number of wire cells that could be damaged by the forces applied during folding and / or compression required for loading into the delivery catheter.

[0161] The flow control component 450 has a diameter and / or perimeter smaller than the diameter and / or perimeter of the central channel of 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 451 is parallel to the central axis or vertical axis (y-axis) of the outer frame 410. In some embodiments, the y-axis defined by the inner frame 451 is parallel to, but offset from, the y-axis defined by the outer frame 410 (Figure 4). In some implementations, a spacer element 445 is disposed in and / or across the central channel to facilitate mounting of a portion of the flow control component 450 (e.g., an otherwise unsupported portion) to the outer support frame 410, and / or inward growth of self-organization over at least a portion of the valve ring member 420 of the valve 400, and in some embodiments, the spacer element 445 may be similar to any of those described in '231 PCT'.

[0162] In certain embodiments, the inner frame 451 may have a diameter of approximately 25–30 mm, the outer frame 410 (or its trans-annular member 412) may have a diameter of approximately 50–80 mm, and the annular member 420 (or atrial collar) may extend approximately 20–30 mm beyond the upper end of the trans-annular member 412, providing a seal on the atrial bed against perivalvular leakage (PVL). The flow control components 450 and the outer frame 410 may be foldable (e.g., in the z-axis direction) and / or compressible (e.g., in the y-axis direction) to reduce the overall size of the valve 400 so that it fits within the inner diameter of a delivery catheter (not shown in this Figure 4) of 24–36 Fr (8–12 mm inner diameter).

[0163] Figure 5 is a top perspective view showing the annular upper member 420 of the outer support frame 410 of the valve 400 shown in Figure 4. Figure 5 shows the rail of the annular upper member 420 to which the biocompatible material 426 is bonded. The diagram shows a cut wireframe, which facilitates the attachment of the inner flow control component 450 to the outer frame 410. In some embodiments, the ring-up member 420 of the outer frame 410 may be substantially similar to the ring-up members 120 and / or 220 described above, at least in form and / or function. Therefore, parts and / or aspects of the ring-up member 420 may not be described in further detail herein.

[0164] As shown, the annular member 420 comprises a distal portion 422, a proximal portion 424, an outer loop 421, an inner loop 425, and at least one spline 427. In some embodiments, the outer loop 421 may be molded and / or sized to engage with self-organization. For example, the distal portion 422 of the annular member 420 (at least partly formed by its outer loop 421) is configured to engage with the distal annular tissue, and the proximal portion 424 (at least partly formed by the outer loop 421) is configured to engage with the proximal annular tissue. The distal and proximal portions 422 and 424 may have a rounded and / or curved shape, with the radius of curvature of the proximal portion 424 being greater than the radius of curvature of the distal portion 422. The distal portion 422 may, for example, engage with the distal supraannular tissue to form a distal fixation loop 423 that can at least partially stabilize and / or secure the frame 410 to its own annulus. Although not shown in Figure 5, the proximal portion 424 may similarly engage with the proximal supraannular tissue to form a proximal upper fixation element that can at least partially stabilize and / or secure the frame 410 to its own annulus.

[0165] The inner loop 425 of the valve ring upper member 420 may be substantially circular and may be coupled to and / or suspended from the outer loop by one or more splines 427. As shown in Figure 5, the inner loop 425 may be coupled to a biocompatible material 426, which may be used to couple the inner frame 451 of the flow control component 450 to the inner loop 425 of the support frame 410. In some implementations, by suspending the inner loop 425 from the outer loop 421, the inner loop 425 (and the flow control component 450 coupled to the inner loop 425) may be at least partially isolated from at least some of the forces associated with moving the frame 410 between, for example, an expansion configuration and a compression configuration, as described above with reference to the frame 210.

[0166] One or more splines 427 of the annular member 420 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the annular member 420 may comprise a distal spline 427 and one or more distal splines 427. The distal splines 427 may couple the distal portion of the inner loop 425 to the distal portion of the outer loop 421. Similarly, the proximal splines 427 may couple the proximal portion of the inner loop 425 to the proximal portion of the outer loop 421. In some embodiments, the proximal splines 427 may be configured to receive, couple to, and / or otherwise engage with a part of the actuator and / or delivery system. For example, the proximal splines 427 may comprise, form, and / or couple to a waypoint 428 which can be used to couple to one or more parts of the actuator and / or delivery system, as described above with reference to frames 110 and 210.

[0167] Figure 6 is a distal perspective view showing the transvalvular ring member 412 of the outer frame 410 of the valve 400 shown in Figure 4. In some embodiments, the transvalvular ring member 420 of the outer frame 410 may be substantially similar in at least form and / or function to the transvalvular ring region and / or members 112 and / or 212 described above. Accordingly, parts and / or aspects of the transvalvular ring member 412 may not be described in further detail herein.

[0168] The valve ring member 412 may be formed and / or manufactured into a ring, cylindrical tube, conical tube, and / or any other suitable valve ring shape. In some embodiments, the valve ring portion Material 412 may have side cross-sections such as a concave cylinder (with a curved wall inside), a square hourglass, a curved hourglass, an inclined hourglass, a flared top, a flared bottom, or a ring or cylinder having both. Furthermore, the transvalve ring region 412 may form and / or define an opening or central channel 414 extending along the central axis 404 (e.g., the y-axis). The central channel 414 (e.g., a lumen or channel in the direction of the central axis) may be sized and configured to receive a flow control component 450 across a portion of the diameter of the central channel 414. In some embodiments, the transvalve ring region 412 may have a shape and / or size that is at least partially based on the size, shape and / or configuration of the upper and / or lower ring members 420 and / or the ring lower member 430 of the support frame 410 and / or the ring itself, as described above.

[0169] The transvalve ring member 412 may be, and / or include, a wire frame laser-cut from a material such as Nitinol and heat-set to a desired shape and / or configuration. The transvalve ring member 412 may be configured to comprise a set of compressible wire cells 413, the wire cells having an orientation and / or cell geometry substantially orthogonal to a central axis extending through a central channel 414, thereby minimizing wire cell strain when the transvalve ring member 412 is in a vertical compression configuration, a wound compression configuration, or a folded compression configuration. As shown in Figure 6, the transvalve ring member 412 comprises a first laser-cut half 415 (e.g., front side) and a second laser-cut half 416 (e.g., rear side) which can be formed into a desired shape and joined together to form the transvalve ring member 412. The front side 415 and the rear side 416 may be joined at one or more hinge points 417 along the distal and proximal portions of the transvalve ring member 412. More specifically, the front 415 and rear 416 may be joined along the distal side of the transvalvular annular member 412 via two sutures forming two hinges or connection points 417, or they may be joined along the proximal side of the transvalvular annular member 412 via one suture forming a single hinge or connection point 417.

[0170] In some embodiments, by forming the transvalve ring member 412 in such a manner, the transvalve ring member 412 may be able to bend, flex, fold, deform and / or otherwise reconfigure (without substantially plastic deformation and / or excessive fatigue) along the transverse or Z-axis or in response to lateral folding in that direction, and / or along the central or Y-axis or in response to vertical compression in that direction. Furthermore, the joining at the hinge point 417 using sutures may allow a desired amount of sliding between the suture and the anterior / rear side 415 / 416, which can then limit and / or substantially prevent joining, adhesion and / or breakage in response to folding along the transverse or Z-axis.

[0171] As shown in Figure 6, the proximal portion of the trans-annular member 412 comprises a single hinge or connection point 417. In some embodiments, the trans-annular member 412 may define a gap or space 418 below the proximal hinge or connection point 417, which may provide space that allows the proximal fixing element of the lower annular member 430 to transition between a first configuration and a second configuration, as will be described in more detail herein.

[0172] Figure 7 is a distal perspective view showing the lower ring member 430 of the outer frame 410 of the valve 400 shown in Figure 4. In some embodiments, the lower ring member 430 of the frame 410 may be substantially similar, at least in form and / or function, to the lower ring region and / or members 130 and / or 230 described above. Accordingly, parts and / or aspects of the trans-ring member 412 may not be described in further detail herein.

[0173] As shown, the lower valve ring member 430 of the frame 410 comprises and / or is formed of a distal portion having a distal fixing element 432 and a proximal portion having a proximal fixing element 434. The fixing elements 432 and 434 are integrally formed with and / or the lower valve ring member 430. The lower valve ring member 430 is formed monolithically. The distal fixing element 432 and the proximal fixing element 434 may be of any suitable shape, size, and / or configuration, for example, any of those described in detail in '957PCT', '010PCT', '231PCT', '390PCT', '108PCT', tentative '327', tentative '964', tentative '345', tentative '807', any of those described above with reference to frames 110 and / or 210, and / or any of those described herein with respect to a particular embodiment.

[0174] The distal fixation element 432 is shown having a non-invasive end that forms a guidewire coupler 433 configured to selectively engage and / or receive a portion of the guidewire or a portion of the guidewire assembly. The guidewire coupler 433 is configured, for example, to allow a portion of the guidewire to extend through the opening of the guidewire coupler 433, thereby allowing the frame 410 to advance on or along the guidewire during delivery and deployment. In some embodiments, the guidewire coupler 433 may selectively allow the guidewire to advance through the guidewire coupler while blocking or preventing other elements and / or components, such as a pusher.

[0175] The fixing elements 432 and / or 434 are configured to engage with desired portions of their own tissue to mount the frame 410 onto the annulus of the self-valve from which the valve is deployed. For example, the distal fixing element 432 may extend from the annular submember 430 into the RVOT or LVOT (e.g., about 10 to 40 mm). The distal fixing element 432 may be molded and / or biased such that it applies force to the annular subtissue that is operable to fix the distal end of the frame 410 at least partially within the self-valve annulus.

[0176] The proximal fixation element 434 may be configured to engage with the subannular tissue on the proximal side of the annulus itself to help fix the frame 410 within the annulus. More specifically, the proximal fixation element 434 is configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal fixation element 434 extends a first amount or distance from the subannular member 430 and a second configuration in which the proximal fixation element 434 extends a second amount or distance from the subannular member 430. As described above, the subannular member 430 of the frame 410 may be, and / or include, a laser-cut wire frame formed from a shape-memory material such as nitinol, which is heat-set to a desired shape, and wrapped in a biocompatible material (e.g., the woven fabric shown in Figure 7).

[0177] As described above, the proximal fixing element 434 may be compressed, contracted, retracted, unfolded, folded, and / or constrained (e.g., near, adjacent to, and / or in contact with the trans-valve ring member 412 and / or the upper ring member 420 of the support frame 410) in the first configuration, and in the second configuration, it may be expanded, extended, unfolded, unfolded, and / or unconstrained (e.g., extending away from the trans-valve ring member 412). In some embodiments, the proximal fixing element 434 may be biased to the second configuration and / or thermally set. Furthermore, in some implementations, the space 418 defined by the trans-valve ring member 412 of the outer frame 410 is configured to provide sufficient space for the proximal fixing element 434 to transition between the first and second configurations.

[0178] Figures 8-10 show at least some of the flow control components 450 included in the valve 400 shown in Figure 4. For example, Figure 8 is an illustration of a top perspective view of the inner valve leaflet frame 451. In some embodiments, the inner valve leaflet frame 451 is joined at lateral connection points 451 and 453 (e.g., folding regions, elastically deformable regions, connecting edge portions, etc.). It is formed from two separate wire frame sheets or members. The inner valve leaflet frame 451 is shown to be in an expanded or cylindrical configuration (for example, before being folded and / or compressed).

[0179] Although not shown, the inner valve leaflet frame 451 can transition from an expanded or cylindrical configuration to at least a partially folded configuration. The inner valve leaflet frame 451 may have wire frame sidewalls that allow rotation or hinge movement at at least the lateral connection points 451 and 453. The inner valve leaflet frame 451 may be configured to fold in response to the valve 400 being folded for delivery and / or compressed. For example, when transitioning to a fully folded configuration, the wire frame sidewalls may rotate, hinge, and / or fold at their lateral connection points 451 and 453. Furthermore, the inner valve leaflet frame 451 can be compressed perpendicular to a compression configuration. The wire frame sidewalls may form cells (e.g., rhomboid-shaped cells) that can be oriented in the direction of compression to allow elastic compression of the inner frame 451. In some embodiments, the inner frame 451 can be compressed perpendicular to a pleated or bellows (compression) configuration.

[0180] In some embodiments, the inner valve leaf frame 451 of the flow control component 450 may be formed from a linear wire frame or laser-cut sheet before being further assembled into a cylindrical structure (for example, as shown in Figure 8). The inner valve leaf frame 451 may be formed into a cylindrical structure or configuration (or a conical structure or configuration), and the edge portions of the linear wire frame sheet are connected or joined at lateral connection points 451 and 453 (e.g., hinge regions, folding regions, etc.). Furthermore, the inner valve leaf frame 451 may be extended (e.g., driven, formed, bent, etc.) from a linear sheet configuration into a cylindrical structure or configuration.

[0181] Figures 9 and 10 show a structural band 455 of pericardial tissue with a leaflet pocket 456 sewn to the structural band 455. Figures 9 and 10 are side perspective and bottom views, respectively, illustrating the structural band 455 and the leaflet pocket 456 before assembling and / or mounting the inner frame 451 to form a foldable (foldable, compressible) flow control component 450. Figure 9 shows the structural band 455 formed of pericardial tissue with a leaflet pocket 456 sewn to the structural band 455 after assembly to a cylindrical leaflet configuration, with the leaflet pocket 456 positioned on the inner surface of the structural band 455. The leaflet pocket 456 may be sewn to the structural band 455 such that an open edge extends outward and a sewn edge forms a closed upper parabolic edge providing attachment. Figure 10 is an example of a bottom view of the flow control component 450. The cylindrical structural band 455 and the valve leaflet component 456 are shown partially joined toward forming a closed fluid seal. Although not shown, the cylindrical structural band 455 may be mounted to or within the inner valve leaflet frame 451 (Figure 8) to collectively form the flow control component. The flow control component 450 is then mounted to the outer support frame 410, as described in detail above with reference to Figure 4.

[0182] Figures 11-14 are sequence diagrams showing bottom views of an artificial valve 500 detachably coupled to an actuator 570 used to actuate one or more portions of the valve 500 according to one embodiment. The valve 500 has a lower annular member 530 having and / or being formed (and attached to the side wall) a laser-cut or wire loop that is retracted inward to reduce the circumference or outer circumference of at least the upper annular member 530 and to facilitate the deployment of the valve 500 in its own annulus. In this embodiment, the actuator 570 may be and / or comprise a set of tethers, tension members, sutures, cables, and / or any other suitable connectors (e.g., proximal fixing elements of the lower annular member 530) that can be attached to one or more mounting points along the upper annular member 530. The actuator 570 may also include, and / or be at least partially disposed within, a catheter that can be inserted through dynamic waypoints, openings, mounting points, through-holes, etc., formed by the annular members of the valve frame. In some implementations, the actuator 570 may be, and / or include, separate tethers used to actuate (e.g., fold) the proximal fixation element, actuate (e.g., fold) the septal wall sidewall, and / or actuate (e.g., fold) the free wall sidewall.

[0183] Figures 11–14 show a set of tethers for actuators 570 extending from a catheter, extending through and / or partially beneath the annular member of the valve frame. For example, the tethers may be threaded through a relatively small dynamic waypoint catheter and actuated outside the patient to manipulate the shape of the proximal fixation element, the annular member 530, and / or the valve 500, facilitating the seating of the proximal side of the valve 500 on its own annulus. In some implementations, during delivery, the dynamic waypoint catheter may be located proximal to the compression valve 500 within the delivery catheter, thus avoiding the dynamic waypoint catheter being stacked on top of the compression valve 500 within the delivery catheter. Within the scope of the present invention, actuators are envisioned that have a single tether or multiple tethers (e.g., one tether, two tethers, three tethers, four tethers, five tethers, six tethers, seven tethers, eight tethers, nine tethers, ten tethers, or more, each of which may be detachably coupled to one or more mounting points on the valve 500). The actuator 570 and / or tethers may be equipped with a cutting element to allow the actuator 570 and / or tethers to be withdrawn after the valve 500 has been deployed and secured to its annulus. The dynamic waypoint catheter may also be included in and / or housed within a delivery system, such as a pusher catheter, a multi-lumen control catheter, etc., so that the dynamic waypoint catheter can fall through waypoints, through holes, through openings of the valve 500, etc., to a position below the annulus, while the pusher catheter, multi-lumen control catheter, and / or other parts of the delivery system may be too large to pass through waypoints. Therefore, the placement of at least a portion of the valve 500 may be controlled using the pusher catheter, control catheter, and / or other parts of the delivery system. For example, the pusher catheter, control catheter, and / or other parts of the delivery system may be used to push down the surface of the upper annular member so that the proximal portion of the annulus 500 is seated with its own annulus while the lower annular member 530 remains in the working configuration.

[0184] Figure 11 is a bottom perspective view of the valve 500 and actuator 570, showing the lower annulus member 530 in a configuration that is at least partially extended or not actuated. Figure 12 is a bottom perspective view of the valve 500 and actuator 570, showing the upper annulus member 530 which is partially actuated such that, for example, the proximal fixing element of the lower annulus member 530 is drawn toward the dynamic waypoint catheter and / or the internal flow control components of the valve 500. Figure 13 is a bottom perspective view of the valve 500 and actuator 570, showing the upper annulus member 530 which is configured to be compressed, folded and / or actuated such that the proximal fixing element, for example, the proximal portions of the septum sidewall and free wall sidewall of the valve 500, is drawn toward the dynamic waypoint catheter and / or the internal flow control components of the valve 500. Figure 14 is an inverted side perspective view of the valve 500 and actuator 570, showing the annular member 530 of the operating configuration, a dynamic waypoint catheter extending below the annular member of the valve frame, and a tether directed toward and / or contained within the dynamic waypoint catheter or pulled in. Figure 14 also shows that the dynamic waypoint catheter can also be used to pull the valve down into the ventricle (e.g., via a contracted tether), avoiding the need to push the compressible valve into its own annulus.

[0185] Although the actuator 570 is shown in Figures 11-14 and described above as including a waypoint catheter extending through the dynamic waypoints of the valve 500, in other implementations, the actuator 570 does not need to include a waypoint catheter. For example, any number of tethers, cables, tension members, sutures, etc., may be routed through one or more lumens of the multi-lumen control catheter, extending from waypoints, through-holes, openings, and / or similar elements defined by the valve 500 and removably coupled to a proximal subannular fixation element.

[0186] Figures 15 and 16 are top and bottom perspective views, respectively, of a laterally deliverable transcatheter prosthetic valve 600, removablely coupled to a delivery system 680, according to one embodiment. The valve 600 comprises a valve frame 610 and a flow control component 650 mounted therein. The valve frame 610 comprises an annular upper member 620, an annular lower member 630, and a transannular member 612 that connects the annular upper member 620 to the annular lower member 630. The delivery system 680 and / or at least a portion of the delivery system 680 comprises a delivery catheter 682 through which the valve 600 is delivered to the atrium of the heart. The delivery system 680 further comprises a connecting member 678 that is removablely coupled to the valve 600. Figures 15 and 16 show the connecting member 678 having a wishbone or yoke configuration, but other configurations are also possible. The connecting member 678 may be coupled to and / or included in the distal end portion of the multi-lumen maneuverable catheter, which may be used to deliver one or more components of the valve 600 and / or the delivery system 680.

[0187] Figure 15 shows a connecting member 678 (e.g., a yoke) in contact with the annular member 620 of the valve frame 610. In some embodiments, the connecting member 678 may be in contact with and / or detachably coupled to the drum or the annular member 612 of the frame 610. In other embodiments, the connecting member 678 may be in contact with and / or coupled to any suitable part of the valve 600. The connecting member 678 may be detachably coupled to the valve 600 via sutures, tethers, cables, clips, couplers, and / or any other detachable couplings. For example, Figure 15 shows a mounting member 638 of the valve 600 coupled to and / or extending from the annular member 620. In some embodiments, the mounting member 638 of the valve 600 may be a tether, suture, cable, frame structure, etc., which may be coupled to and / or extend from the wireframe portion of the annular member 620, or it may be, for example, a drum or a biocompatible cover. In such embodiments, the connecting member 678 of the delivery system 680 may be detachably coupled to the mounting member 638 of the valve 600 (for example, via sutures, tethers, and / or any other detachable couplings).

[0188] Figures 15 and 16 further show a guidewire catheter 684 of a delivery system 680 that extends, for example, through a waypoint or opening of the upper annular member 630 and / or its drum, and through a guidewire coupler 633 of the distal fixing element 632 of the lower annular member 630. Figure 16 shows a guidewire catheter 684 extending below the flow control component 650 of the valve 600. Prior to and / or as part of delivery, the guidewire catheter 684 may be advanced and / or inserted through the valve 600 (as shown in Figure 53) and advanced along a guidewire already positioned at a desired location within the heart. Thus, delivering the valve 600 in a compression configuration through the delivery catheter 682 involves advancing the guidewire catheter 684 along the guidewire. The guidewire catheter 684 may extend through the guidewire coupler 633 of the distal fixation element 632 (for example, the distal end of the guidewire catheter 684 may be about 0.1 cm to about 1.0 cm or more distal to the guidewire coupler).

[0189] The guidewire catheter 684, for example, allows the range of motion of the valve 600 during delivery to (at least They can be rigid enough to partially restrict and / or define. For example, the guidewire catheter 684 can define an axis that allows the valve 600 to rotate during delivery but substantially restricts or reverses the movement of the valve 600 in other directions. In some implementations, the arrangement of the connecting member 678 (e.g., a yoke) and the guidewire catheter 684 can allow for greater control over the position of the valve 600 during delivery. The guidewire catheter 684 and / or one or more parts of the valve 600 (e.g., subannular member 630) may also include radiopaque markers that allow for enhanced visualization during image-guided delivery. For example, in some cases, radiopaque markers or wires may be positioned relative to the annular surface of the valve itself to define a landmark during image-guided delivery. In such cases, radiopaque markers on the guidewire catheter 684 and / or other parts of the valve 600 (e.g., the subannular member 630) may be used to align, orient, locate, and index the valve 600 relative to the markers, which then correspond to the annular surface of the valve itself. Thus, image-guided delivery may allow the user to visualize the valve 600 during delivery and / or deployment, and to visualize the valve 600 when it is seated on the annulus (e.g., the radiopaque marker band on the valve 600 is below or below the annulus relative to the radiopaque markers).

[0190] Figure 16 further shows an actuator 670 (or at least a portion of an actuator 670) included in a portion of the delivery system 680. The actuator 670 may be, and / or include, one or more tethers, sutures, cables, tension members, ties, etc., detachably coupled to one or more mounting points on the valve 600. For example, a tether(s) is shown detachably coupled to a proximal fixing element 634 of the lower valve ring member 630. The actuator 670 (e.g., a tether(s)) may be used to actuate the proximal fixing element 634 between two or more configurations, positions, states, etc. Figure 16 shows the proximal fixing element 634 in an extended or non-actuated configuration. During deployment, the operator may actuate the proximal end portion of the actuator 670 (e.g., located outside the body) to pull, for example, a tether(s) proximal, thereby folding or compressing the proximal fixing element 634 toward the flow control component 650. The operation of the actuator 670 may also fold, compress, and / or pull in the proximal portions of the posterior and anterior walls of the transannular member 612 toward the flow control component 650 (for example, as described above with reference to Figures 11-14). After the valve 600 is positioned in the annulus of the patient's own valve, the actuator 670 may be removed or detached from the valve 600, the guidewire catheter 684 (and the guidewire extending through it) may be retracted through a waypoint or opening in the annular member 620, and portions of the delivery system 680 may be detached from the valve 600 and withdrawn from the patient, leaving the deployed prosthetic valve 600 in place within the annulus of the patient's own heart valve.

[0191] While valves 500 and / or 600 are described above as acting and / or transitioning the corresponding proximal fixing elements in a particular manner, it should be understood that the proximal fixing elements of a valve can be actuated, moved, swung, rotated, and / or transitioned in other appropriate ways. For example, Figures 17-20 are bottom perspective views of an artificial valve 700, which, in one embodiment, show the process of transitioning the proximal fixing element 734 of the artificial valve 700 between a first configuration and a second configuration. The valve 700 is shown to include an outer support frame 710 mounted within the central region of the outer support frame 710 and a flow control component 750. The frame 710 is shown to have at least an upper ring member 720 and a lower ring member 730. The upper ring member 720 and the lower ring member 730 may be similar to any of the above. Thus, certain embodiments and / or functions may not be described in further detail herein.

[0192] Figure 17 shows a distal fixation element 732 and a proximal fixation element 734 having and / or being formed The lower valve ring member 730 is shown. The upper valve ring member 720 is shown comprising a spline 727 (for example, extending between the outer and inner loops of the upper valve ring member 720 (not shown)) that defines a waypoint 728 in or near the proximal end portion of the upper valve ring member 720. The upper valve ring member 720 is further shown comprising a drum 3445 that extends between the inner and outer loops of the upper valve ring member 720 and / or is coupled thereto, covering a space not otherwise occupied by the flow control component 750. The upper valve ring member 720 (or its inner loop) is shown coupled to the flow control component 750 which is offset distally to the valve 700.

[0193] The valve 700 engages with or is configured to engage with at least a portion of the delivery system 780. The delivery system 780 may include any suitable components for delivering, retrieving, deploying, moving, manipulating, acting on, and / or otherwise interacting with one or more portions of the valve 700. In this embodiment, the delivery system 780 may include, for example, one or more catheters. For example, the delivery system 780 may include a delivery catheter through which the valve 700 is delivered to the annulus of its own heart valve. The delivery system 780 may also include one or more maneuverable catheters, control catheters, multi-lumen catheters, etc., or a combination thereof. In some embodiments, the delivery system 780 may include a multi-lumen control catheter having a distal end portion configured to removably engage and / or couple with one or more portions of the valve 700 to facilitate delivery, deployment, and / or retrieval of the valve 700. Although not shown in Figures 17-20, the delivery system 780 may also include a guidewire catheter that can be advanced on a guidewire during delivery and / or deployment. In such an implementation, the guidewire catheter may pass through the waypoint 728, under the flow control component 750, and through the guidewire coupler of the distal fixing element, as described above with reference to the valve 700 shown in Figures 15 and 16.

[0194] Figure 17 further shows a delivery system 780 including an actuator 770. The actuator 770 may be similar to those described above with reference to, for example, 170, 270, and / or 370. For example, the actuator 770 may be a tether extending through a waypoint 728 of a spline 727 and screwed into and / or along one or more attachment points 736 formed on the lower valve ring member 730, and / or comprising such a tether. The tether loops through the attachment(s) 736 and extends proximal through the waypoint 728 to return. In this way, both ends of the tether can be kept outside the body and allow the user to operate the tether (actuator 770). In this embodiment, the tether is shown passing through a plurality of attachment points 736 on or along the proximal fixing element 734 of the lower annular member 730, so that the operation of actuator 770 (e.g., the tether) transitions and / or moves at least the proximal fixing element 734 between the first and second configurations. The tether may be passed through the attachment points 736 in any suitable way, which can then control and / or determine how the proximal fixing element 734 transitions or moves. Furthermore, the attachment points 736 may be formed from any suitable material that can facilitate the passage or threading of the tether through there. For example, the attachment points 736 may be included in and / or formed integrally with the laser-cut wireframe of the upper annular member 720 (e.g., a small hole). In other embodiments, the attachment points 736 are in or formed by a suture loop and / or a biocompatible fabric, at least partially enclosing the upper annular member 720. In yet another embodiment, the mounting point 736 may be formed from a biocompatible polymer, such as polyethylene. In some such embodiments, the biocompatible material may be, for example, a self-lubricating polymer composite and / or similar that can facilitate the movement of the tether through the mounting point 736.

[0195] Figure 17 shows the proximal fixed element 734 in a first or non-actuated configuration, with the tether (actuator 770) meandering and looping through the mounting point 736. Figures 18 and 19 show the proximal fixed element 734 as it transitions from the first non-actuated configuration toward a second actuated configuration in response to the actuation of the actuator 770 (e.g., pulling the tether in the proximal direction and / or otherwise in a direction that generates tension along the length of the tether). Figure 20 shows the proximal fixed element 734 in the second actuated configuration.

[0196] In the embodiments shown in Figures 17-20, the actuator 770 engages the proximal fixing element 734 such that one of the mounting points 736 on the front or free-wall side of the upper valve ring member 730 acts as a pivot point, such as rotating, folding, or rolling up the proximal fixing element 734. In other embodiments, the actuator 770 may engage the proximal fixing element 734 such that a mounting point 736 on the rear or septum side of the lower valve ring member 730 acts as a pivot point. In other words, the proximal fixing element 734 may be rotated toward the front or rear of the valve 700, folded, rolled up, swung, and / or otherwise moved, depending on how the actuator 770 engages the mounting points 736 of the proximal fixing element 734.

[0197] Figures 19 and 20 also show a tab 737 that is incorporated on and / or formed by the proximal fixation element 734. In some implementations, the tab 737 may contact the subannular tissue of its own valve to facilitate the proximal fixation of the valve 700 in the annulus of its own valve. More specifically, the tab 737 may be positioned along and / or adjacent to the proximal fixation element 734 and may rotate, swing, pivot, and / or move together with the proximal fixation element 734 in response to the operation of the actuator 770. In some implementations, the position of the tab 737 may be such that, as the proximal fixation element 734 moves (e.g., from a compressed configuration to an extended configuration after the valve 700 has expanded and / or seated in the annulus), the tab 737 moves or slides behind, for example, the joint surface, the posterior or septal cusp, the chordae tendineae, the trabeculae, and / or any other desired portion of its own tissue. While one tab 737 is shown in Figures 19 and 20, in other embodiments the proximal fixation element 734 may comprise two or more tabs 737, which may be arranged and / or function as hooks, hooking into or behind the own tissue, thereby fixing the proximal fixation element 734 to the tissue beneath the annulus of the valve.

[0198] Figures 21 and 22 are various diagrams of a laterally deliverable artificial valve 800, showing a portion of a curved upper ring member 820 according to one embodiment. The valve 800 is shown as including an outer support frame 810 mounted within the central region of the outer support frame 810 and a flow control component 850. The frame 810 is shown having at least an upper ring member 820, a lower ring member 830, and a trans-ring member 812 coupled between them. The frame 810 and / or its embodiments may be similar to any of those described above. Therefore, specific embodiments and / or functions may not be described in further detail herein.

[0199] The valve 800 shows a sub-annular member 830 having and / or forming a distal fixing element 832 and a proximal fixing element 834. The distal fixing element 832 comprises a guidewire coupler 833 that can receive a guidewire and / or guidewire catheter through an opening, hole, opening, port, etc., defined by the guidewire coupler 833. In some implementations, the guidewire catheter may extend beyond the distal fixing element 832 and may have and / or be provided with sufficient rigidity to allow the valve 800 to advance along the guidewire passed through the lumen of the guidewire catheter. The proximal fixing element 834 is, for example, to reduce the circumferential length of the sub-annular member 820 during delivery and / or deployment. A movable fixed element may be configured to move and / or otherwise transition between configuration 1 and configuration 2 (for example, by an actuator).

[0200] The proximal fixing element 834 may be configured to move in any suitable direction from a first extension configuration (Figure 21) to a second compression configuration, at least in part based on how the proximal fixing element 834 is coupled to the actuator. For example, the proximal fixing element 834 may be moved inward toward the inner flow control component 850, moved upward toward the upper ring member 820 and / or part thereof, and / or moved toward the front or rear side of the valve 800. Furthermore, with the trans-ring member 812 of the frame 810 coupled to the lower ring member 830, the operation of the actuator may, in some implementations, move one or more portions of the trans-ring member 812.

[0201] The annular member 820 is shown to have a laser-cut wireframe encased or covered with a biocompatible material. The annular member 820 comprises a distal portion 822, a proximal portion 824, an outer loop 821, an inner loop 825, and at least one spline 827. In some embodiments, the outer loop 821 may be molded and / or sized to engage with self-tissue. For example, the distal portion 822 of the annular member 820 (at least partly formed by its outer loop 821) is configured to engage with distal annular tissue, and the proximal portion 824 (at least partly formed by the outer loop 821) is configured to engage with proximal annular tissue. The distal and proximal portions 822 and 824 may have a rounded and / or curved shape, with the radius of curvature of the proximal portion 824 being greater than that of the distal portion 822. The distal portion 822 and / or the proximal portion 824 may, for example, form a distal annular fixation element and / or a proximal annular fixation element, each of which may engage with the annular tissue to at least partially stabilize and / or fix the frame 810 to its own annulus.

[0202] The inner loop 825 of the valve ring upper member 820 may have a rectangular shape, or a teardrop shape may be coupled to the outer loop 821 by one or more splines 827 and / or suspended from there. The inner loop 825 may be coupled to the flow control component 850, for example, via a biocompatible material 826. The inner loop 825 is shown coupled to the flow control component 850 such that the flow control component 850 is offset distally with respect to the valve 800. In some implementations, by suspending the inner loop 825 from the outer loop 821, the inner loop 825 (and the flow control component 850 coupled to the inner loop 825) may be at least partially isolated from at least some of the forces associated with transitioning the frame 810 between expansion and compression configurations (e.g., during delivery and / or deployment).

[0203] One or more splines 827 of the valve ring upper member 820 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the valve ring upper member 820 may include a distal spline 827 that defines a waypoint 828. The waypoint 828 can be, for example, an aperture, hole, opening, port, coupler, sealable / re-sealable access point, etc. configured to at least temporarily couple to and / or receive a part of the delivery system. For example, in some implementations, the part of the delivery system may include at least an actuator and a guide wire catheter.

[0204] The valve ring upper member 820 is further shown as including a drum 845 that extends between and / or is coupled to the outer loop 821 and the inner loop 825 and covers a space not otherwise occupied by the flow control component 850. FIG. 21 shows a drum 845 having a set of spokes 845A that can be used to increase the rigidity of the drum 845 and / or form the drum 845. The spokes 845A can be, for example, sutures sewn to the drum 845 to increase the rigidity of the drum 845 and / or, otherwise, for example, to change the deformation mode of the drum 845 during systole, which can in turn improve the performance of the valve 800 and / or reduce fatigue within or along the drum 845. Although particularly shown in FIG. 21, the spokes 845A can be arranged in any suitable manner that results in an increase in drum rigidity. For example, the spokes 845A can be arranged longitudinally, transversely, and / or at an angle with respect to the longitudinal or transverse direction. In other embodiments, the spokes 845A can be arranged in a mesh pattern and / or any other suitable pattern.

[0205] FIG. 21 further shows a drum 845 with an attachment member 838 that can facilitate temporary attachment to a portion of the delivery system. The attachment member 838 may be, for example, a braided thread, a suture, a tether, a cable, or the like. As described above, in some implementations, the delivery system may include a controlled or steerable catheter with an integrated yoke or other suitable detachable coupler. More specifically, the attachment member 838 may include a set of loops 839 that can thread a set of tethers and removably couple the yoke of the delivery system to the valve 800. The tethers may be passed through the loops 839 such that each end of the tether is maintained outside the patient, thereby enabling the operator to manipulate the tethers to control the contact between the yoke and the drum 845.

[0206] The attachment member 838 is shown coupled to the drum 845 near or at its proximal end, but in other embodiments, the attachment member 838 may be coupled to the drum 845 at any suitable location (e.g., a proximal location adjacent to the flow control component 850, a distal location as shown in FIG. 21, or any suitable location therebetween). The attachment member 838 has been described above as being coupled to the drum 845, but in other embodiments, any portion of the valve 800 may include the attachment member 838. In some embodiments, for example, the valve ring upper member 820 may include a laser cut portion of a wire frame that extends across a portion of the outer loop 825 (e.g., perpendicular to the spline 827).

[0207] Figures 21 and 22 further show a spline 827 of the upper valve ring member 820 having a curved shape and / or configuration, the spline 827 protruding from the lower valve ring member 820. For example, in some embodiments, the laser-cut frame of the upper valve ring member 820 may be formed with a spline 827 having a curved configuration. In some implementations, the curved spline 827 can apply force to the drum 845, bending the drum 845 and increasing the tension throughout the area of ​​the drum 845. The increased tension then increases the relative stiffness of the drum 845, which can reduce and / or limit the amount of drum deformation, for example, during expansion or contraction, thereby enhancing the performance of the valve 800 and / or reducing fatigue in or along the drum 845. In other words, the pressure generated on the atrial side of the drum 845 during atrial (diastolic) contraction is not sufficient to invert the curved configuration of the drum 845 due to the curved spline 827 (i.e., it does not produce a deflection like an oil can). The curved configuration of the drum 845 can also withstand the greater pressure generated on the ventricular side of the drum 845 during ventricular (systolic) contraction without substantial deflection. Furthermore, the arch of the spline 827 may be such that the waypoint 828 is positioned at a desired angle and / or orientation to facilitate the insertion or retrieval of one or more parts of the delivery system through the waypoint 828.

[0208] The valves described herein are configured to be delivered to a desired target location within a patient via lateral or orthogonal delivery techniques, methods, and / or systems. Delivery systems for lateral delivery of transcatheter prosthetic valves may be of any shape, size, and / or configuration and may comprise any suitable functions, components, members, mechanisms, assemblies, subsystems, etc. In some implementations, the delivery system may be similar to, and / or include, any suitable combination of components derived from the delivery systems described in any of '957 PCT, '010 PCT, '231 PCT, '390 PCT, '108 PCT, Provisional '327, Provisional '964 Provisional, Provisional '345, and / or Provisional '807.

[0209] For example, Figures 23A to 23C are schematic diagrams of at least a portion of a laterally deliverable prosthetic valve 900 and a delivery system 980 for laterally delivering the prosthetic valve to the annulus of the patient's own heart valve, according to one embodiment. The laterally deliverable prosthetic valve 900 ("valve") may be substantially similar to, for example, valves 100, 400, 500, 600, 700, and / or 800. For example, valve 900 may have an outer frame with internal flow control components mounted therein. Valve 900 is compressible and expandable in at least one direction with respect to its longitudinal axis, as will be described in more detail herein.

[0210] The delivery system 980 comprises any suitable components(s) configured to position the valve 900 in a delivery configuration, load the valve 900 into a portion of the delivery system 980, deliver the valve 900 in the delivery configuration through a portion of the delivery system 980, control and / or facilitate the deployment of the valve 900 in the annulus of the own valve, and optionally retrieve the valve 900 at least partially from the annulus to allow adjustment and / or re-implantation of the valve 900 or removal of the valve 900 from the heart (e.g., in case of failure or patient distress).

[0211] In the embodiments shown in Figures 23A to 23C, the delivery system 980 comprises at least a control device 970, a compression device 990, a loading device 960, and a delivery device 981. The control device 970 may be and / or include any number of components that can at least temporarily connect to and / or contact one or more portions of the valve 900 and can be configured to control and / or facilitate, for example, the delivery, deployment, and / or retrieval of the valve 900. For example, in some embodiments, the control device 970 may comprise a control catheter having a connecting member disposed at the distal end of the control catheter. In some embodiments, the connecting member may have a wishbone or yoke configuration, but other configurations are also possible.

[0212] The connecting member is detachably coupled to the valve 900. More specifically, the connecting member may be detachably coupled to and in contact with the ring member or region of the valve frame. In some embodiments, the connecting member may be in contact with and / or detachably coupled to a drum extending across the ring member or region, the ring member or region of the frame, and / or any other suitable portion of the valve 900. The connecting member may be detachably coupled to the valve 900 via sutures, tethers, cables, clips, couplers, and / or any other detachable couplings. For example, in some embodiments, the valve 900 may have one or more mounting members such as tethers, sutures, cables, frame structures, drum structures, to which the connecting member of the control device 970 may be detachably coupled (e.g., via sutures, tethers, and / or any other detachable couplings).

[0213] The control device 970 may be coupled at its distal end to a connecting member and / or otherwise comprises a control catheter having such a connecting member. In some embodiments, this control catheter may be a maneuverable multi-lumen catheter. The multiple lumens may be configured to provide one or more pathways through which one or more components can selectively engage with the valve 900. For example, as shown in Figure 23A, the delivery system 980 may comprise a guidewire catheter 984 extending through the lumen of the control catheter and through one or more portions of the valve 900. More specifically, the guidewire catheter 984 may extend over a member or region of the valve annulus of the valve 900, or through a waypoint or opening defined thereby, and through an internal flow control component of the valve 900. The distance below may be traversed and may extend through a guidewire coupler included in the distal valve ring lower fixing element, for example, as described in detail above with reference to the valve 600 shown in Figures 15 and 16.

[0214] Furthermore, one or more lumens of the multi-lumen control catheter may receive tethers, sutures, wires, etc., configured to loop through part or side of a connecting member (e.g., a yoke), around the attachment point of the valve 900, through part or side of the connecting member again, and return through the same lumen of the control catheter, thereby connecting the connecting member to the valve 900. Moreover, such arrangement may allow an operator to pull one end of a tether, suture, wire, etc. ("tether") to detach the tether from the control device 970, thereby detaching the connecting member from the valve 900, at least partially (e.g., after successful valve deployment). Similarly, one or more lumens of the control catheter may receive actuators, tension members, tethers, cables, wires, etc., which may be routed through the lumen of the control catheter and engage with the proximal fixation element of the valve 900. Therefore, the tensile members and the like may be activated (for example, placed under tension) to move the proximal fixing elements between two or more configurations, as described in detail above with reference to valves 500, 600, and / or 700.

[0215] Figure 23A shows a compression device 990 detachably coupled to a loading device 960, and a valve 900 at least partially disposed within the lumen 995 of the compression device 990. In some implementations, it is desirable to couple a control device 970 to the valve 900 before inserting the valve 900 into the compression device 990. Thus, the compression device 990 may be a multi-component device that can be separated to allow the compression device 990 to be detached from the loading device 960 and from at least part of the control device after the valve 900 has advanced through it, for example, as will be described in more detail herein.

[0216] Figure 23A shows that the lumen 995 of the compression device 990 tapers in at least one direction as the lumen extends from the proximal end to the distal end of the compression device 990. In some embodiments, for example, the lumen 995 may taper in one direction, such as an axial direction (e.g., parallel to the fluid flow through the valve) perpendicular to the longitudinal direction (e.g., the proximal-distal direction). In such embodiments, the size and / or perimeter of the lumen 995 at the proximal end of the compression device 990 may be such that the operator or user compresses and / or folds the valve 900 in a transverse direction perpendicular to both the axial and longitudinal directions before inserting the valve 900 into the proximal end of the compression device. In other embodiments, the lumen 995 may taper in two directions, namely the axial and transverse directions. In any embodiment, the size and / or circumference of the lumen 995 at the proximal end of the compression device 990 is greater than the size and / or circumference of the lumen 995 at the distal end of the compression device 990. Furthermore, in some embodiments, the shape of the lumen 995 at the proximal end of the compression device 990 may differ from the shape of the lumen at the distal end of the compression device 990. For example, in some embodiments, the lumen 995 at the proximal end of the compression device 990 may have a substantially rectangular circumference, while the lumen 995 at the distal end of the compression device 990 may have a substantially circular circumference. In other embodiments, the lumen 995 may have substantially the same shape at the proximal and distal ends, or it may have any suitable combination of shapes at the proximal and distal ends.

[0217] In some implementations, after first inserting the valve 900 into the proximal end of the compression device 990, the user or operator may apply force to the control device 970 so that, for example, a connecting member (e.g., a yoke) pushes the valve 900 through the compression device 990. In other implementations, the control device 970 may include a pusher and / or a guide wire catheter. The tel 984 may include a pusher that selectively engages with a portion of the distal valve ring lower fixing element, allowing it to pull the valve 900 through the compression device 990 in response to a distally directed force applied to the control device 970. In some implementations, the delivery system 980 may also include a pull device and / or similar (not shown) that can be detachably coupled (e.g., via a tether) to the distal portion of the loading device 960 and the distal end of the valve 900, and may be operated to pull the valve 900 through the compression device 990. In some implementations, the valve 900 may be pulled using the pull device, and the valve 900 may be pressed and / or pulled using the control device 970 to advance the valve 900 collectively through the compression device 990.

[0218] In Figure 23A, the valve 900 is shown advancing through the lumen 995 of the compression device 990 from its proximal end to its distal end, and the compression device 990 is shown compressing the valve 900 at least axially as the valve 900 advances through it. In some cases, the valve 900 may be substantially uncompressible or laterally compressed when inserted into the proximal end of the compression device 990, and may be compressed into a compressed or delivery configuration as it advances to and / or through the distal end of the compression device 990. Although not shown, in some cases the valve 900 may be loaded into the compression device 990 and advance through the lumen 995, while at least the compression device 990 may be disposed in a saline bath or the like, which can facilitate the advancement of the valve 900 through the compression device 990 and maintain the substantial sterility of the valve 900.

[0219] Figure 23A shows the proximal end of a loading device 960, which is detachably coupled to the distal end of a compression device 990. The loading device 960 can be any suitable shape, size, and / or configuration. Figure 23A defines a lumen 963 extending through the loading device 960 and shows the loading device 960 as having a gate 966 at its distal end. The gate 966 is movable between a closed state (Figures 23A and 23B) and an open state (Figure 23C). As will be described in more detail herein, the closed gate 966 can selectively occlude a portion of the lumen 963.

[0220] The distal end of the loading device 960 is further shown to include at least one port 967. The at least one port 967 is in fluid communication with the lumen 963 and is configured to provide selective flushing of at least a portion of the lumen 963. In some embodiments, for example, the loading device 960 may include a first port located proximal to the gate 966 and in fluid communication with at least a portion of the lumen 963 proximal to the gate 966, and a second port located distal to the gate 966 and in fluid communication with at least a portion of the lumen 963 distal to the gate 966. In some implementations, the port 967 (e.g., via the first portion of the port 967 or the first port) may be used to provide suction to at least a portion of the lumen 963 and to provide fluid flow (e.g., via the second portion of the port 967 or the second port) for flushing at least a portion of the lumen 963. In some cases, port 967 may provide flushing of at least a portion of the lumen 963 (e.g., flow of a sterile fluid such as saline solution, with or without simultaneous aspiration) while gate 966 is closed and / or after gate 966 has transitioned to an open state.

[0221] The lumen 963 of the loading device 960 has a diameter and / or circumference substantially similar to the diameter and / or circumference of the lumen 995 at the distal end of the compression device 990. Thus, the valve 900 can be compressed into the delivery configuration and advanced from the compression device 990 into the lumen 963 of the loading device 960. Figure 23B shows the valve 900 of the delivery configuration positioned in the lumen 963 of the loading device 900. Figure 23B further shows that after the valve 900 has advanced into the lumen 963, the compression device 990 is removed from the proximal end of the loading device 960 and / or detached. In some implementations, for example, the compression device As described above, the compression device 990 may be separated laterally, removed from around the control device 970, and withdrawn from the loading device 960. Although not shown in Figures 23A-23B, after the compression device 990 is removed from the loading device 960, a hemostatic valve or the like may be advanced over a portion of the control device 970 and coupled to the proximal end of the loading device 960. The hemostatic valve and / or similar may form a substantially fluid-tight seal around the proximal end of the loading device 960 (e.g., around the control device 970 and / or its control catheter). Furthermore, in an implementation where a tension device or the like is coupled to the distal end of the loading device 960 to pull the valve 900 into the loading device, the tension device may be detached from the loading device 960, and any tethers, cables, and / or connections attached to the distal end of the valve 900 may be removed therefrom.

[0222] Figure 23B shows that the valve 900 is loaded into the loading device 960 while the gate 966 is in the closed position. In some implementations, the valve 900 may advance through the lumen 963 until, for example, the distal fixing element (or most of the distal portion) of the valve 900 contacts and / or is adjacent to the proximal surface of the gate 966 in the closed position. Figure 23B further shows that the guidewire catheter 984 extends distally from the valve 900, through the gate 966 in the closed position, and beyond the distal end of the loading device 960. In some embodiments, for example, the gate 966 may have a shape and / or size such that a space is defined between the end of the gate 966 and the inner surface of the loading device 960, allowing the guidewire catheter 984 to extend through it. In some embodiments, the gate 966 may define an opening, hole, notch, recess, etc., through which the guidewire catheter 984 can extend.

[0223] Figures 23B and 23C show that the distal end of the loading device 960 may be coupled to the proximal end of the delivery device 981. In some implementations, the delivery device 981 and / or at least its delivery catheter may be inserted into the patient and advanced through the patient so that the distal end of the delivery device 981 (delivery catheter) is positioned in the space or volume of the heart. Furthermore, the delivery device 981 and / or at least its delivery catheter may be tracked and / or advanced on a guidewire 985 that has been previously inserted through the patient and positioned at a desired position relative to the annulus of the patient's own heart valve. Figure 23B shows that the proximal end of the guidewire 985 extends from the proximal end of the delivery device 981. As described above, in some cases, the valve 900 is loaded into the loading device 960 while the compression device 990 and loading device 960 remain in a fluid (e.g., saline) bath. In such cases, the loading device 960, which includes a delivery valve 900 disposed in the lumen 963, a hemostatic valve coupled to its proximal end, and a closed gate 966, may be removed from the bath and brought to, for example, an operating table to be coupled to the proximal end of a delivery device 981 already inserted into the patient.

[0224] Figure 23B shows that a guidewire 985 extending through the proximal end of the delivery device 981 is inserted into the guidewire catheter 984 before the distal end of the loading device 960 is coupled to the delivery device 981. The delivery device 981 is shown defining a lumen 983 having a perimeter and / or diameter substantially similar to the perimeter and / or diameter of the lumen 963 of the loading device 960. Figure 23B shows that the proximal end of the delivery device 981 includes a gate 966 that is movable between a closed state (Figure 23B) and an open state (Figure 23C). The proximal end of the delivery device 981 is further shown to include at least one port 987. At least one port 987 is in fluid contact with the lumen 983 and is configured to provide selective flushing of at least a portion of the lumen 983. In some embodiments, for example, the delivery device 981 is located proximal to the gate 986 and has a first port that is in fluid contact with at least a portion of the lumen 983 proximal to the gate 986, and is located distal to the gate 986 and has at least It may also include a second port that is in fluid contact with a portion of it. In some implementations, port 987 (e.g., via the first portion of port 987 or the first port) may be used to provide suction to at least a portion of the lumen 983 and to provide a fluid flow (e.g., via the second portion of port 987 or the second port) for flushing out at least a portion of the lumen 983, as described above with reference to the loading device 960.

[0225] FIG. 23B shows the distal end of the loading device 960 coupled to the proximal end of the delivery device 981 while the gates 966 and 986 remain closed. In some implementations, after coupling the loading device 960 to the delivery device 981, the volume collectively defined by the lumens 963 and 983 disposed between the closed gates 966 and 986 may be flushed via ports 967 and 987. For example, in some implementations, port 987 may provide a flow to a volume of saline and / or other sterile fluid, while port 967 may provide suction to and / or through at least this volume (or vice versa).

[0226] FIG. 23C shows that after coupling the loading device 960 to the delivery device 981 and flushing the volume defined between the gates 966 and 986, the gates 966 and 986 can be transitioned from a closed state to an open state. Thus, the lumens 963 and 983 are either substantially open or otherwise unobstructed. Thus, the user and / or operator can apply a distal force to a portion of the control device 970 to advance the valve 900 from the loading device 960 into the lumen 983 of the delivery device 981 in the delivery configuration. Further, the distal force can be operable to advance the valve 900 through a delivery catheter of the delivery device (not shown) and release the valve 900 from its distal end. Once released (or at least partially released), the control device 970 can control and / or manipulate the valve 900 to seat the valve on the annulus of its native heart valve.

[0227] In some cases, it may be desirable to retrieve the valve 900 at least partially from the annulus during deployment (e.g., to adjust the position, orientation, and / or seating of the valve 900 on the annulus). In such cases, the control device 970 may further be used to retrieve the valve 900 at least partially to the distal end of the delivery catheter (included in the delivery device). For example, if a connecting member (e.g., a yoke) is coupled to a portion of the valve 900, the user and / or operator may apply a proximal force to the control device 970 that can pull the valve 900 proximal and / or towards the delivery catheter. Furthermore, the delivery system 980 may include any suitable capture elements, functions, members, mechanisms, etc. configured to facilitate compression of the valve 900 as it is pulled proximal toward and / or into the delivery catheter. In some cases, after partially retrieving the valve 900, the control device 970 may be operated to reseat the valve 900 on the annulus in the desired orientation and / or configuration.

[0228] Figures 24 to 39 show various parts of a delivery and / or retrieval system 1080 for delivering, deploying, and / or at least partially retrieving an artificial valve 1000 according to one embodiment. The delivery and / or retrieval system 1080 ("delivery system") may be any suitable shape, size, and / or configuration, and may comprise any suitable components or combinations of components. In some embodiments, for example, the delivery system 1080 and / or at least a part or aspect thereof may be similar and / or substantially the same as the delivery system 980 described above with reference to Figures 23A and 23C. Therefore, parts and / or aspects of the delivery system 1080 may not be described in further detail herein. Furthermore, the delivery system 1080 may be used to deliver, deploy, and / or at least partially retrieve any suitable valve, such as any of valves 100, 400, 500, 600, 700, 800, and / or 900. For example, valve 100 Valve 0 may have an outer frame with internal flow control components mounted therein. Valve 1000 is compressible and expandable axially and transversely with respect to the longitudinal axis of valve 1000, as will be described in more detail herein.

[0229] The delivery system 1080 may include any suitable components configured to position the valve 1000 in a delivery configuration, load the valve 1000 into a portion of the delivery system 1080, deliver the valve 1000 in the delivery configuration through a portion of the delivery system 1080, control and / or facilitate the deployment of the valve 1000 in the annulus of the own valve, and optionally retrieve the valve 1000 at least partially from the annulus to allow adjustment and / or re-implantation of the valve 1000, or removal of the valve 1000 from the heart (e.g., in case of failure or patient distress).

[0230] Figure 24 is a partially disassembled perspective view of the delivery system 1080. As shown, the delivery system 1080 comprises a dilator 1058, a loading device 1060, a control device 1070, a delivery device 1081, a compression device 1090, a guidewire catheter 1084, and a traction device 1098. The dilator 1058 may be any suitable dilator configured to dilate at least a portion of a pathway in the body to allow, for example, a delivery catheter and / or other relatively large gauge catheters to advance through the pathway. In this embodiment, the dilator 1058 may be configured to dilate, for example, a pathway through the femoral vein and IVC to allow the delivery catheter 1082 of the delivery device 1081 to advance into the patient's heart.

[0231] The tension device 1098 may be any suitable device configured to be detachably coupled to the valve 1000 to facilitate the advancement (e.g., pulling) of the valve 1000 through one or more portions of the delivery system 1080. For example, in some embodiments, the tension device 1098 may comprise a tether (e.g., a suture, tension member, cable, wire, etc.) which can be coupled at a first end to the distal end of the valve 1000. The opposite end of the tether may be coupled to the tension device 1098, which may be and / or comprise a spool mechanism, etc., capable of spooling or winding at least a portion of the tether. As will be described in further detail herein, winding and / or winding of the tether may be operable to pull the valve 1000 through one or more portions of the delivery system 1080.

[0232] Figures 25A-25E and 26A-26G show various diagrams and / or embodiments of the compression device 1090. As described above, the valve 1000 can be inserted into the compression device 1090 to transition the valve 1000 from an uncompressed or partially compressed (e.g., laterally compressed) configuration to a compressed or delivery configuration. The compression device 1090 is shown to include a first member 1091, a second member 1091, and a coupler 1092. The compression device 1090 may have a funnel-like shape and define a lumen 1095 extending through the proximal and distal ends of the compression device. Figures 25A-25C show that the coupler 1092 may be detachably disposed around at least portions of the first member 1091 and the second member 1092 to connect the members 1091 and 1092 together. Figure 25A shows that the funnel shape of the compression device 1090 allows the coupler 1092 to slide over a portion of the first member 1091 and the second member 1092, advancing to a position where the outer surface of the compression device 1090, collectively formed by the first and second members 1091 and 1092, advances to form a friction fit with the inner surface of the coupler 1092, thereby enabling the formation of the compression device 1090. Figure 25B shows that the coupler 1092 can be removed from the first member 1091 and the second member 1092, for example, in the distal direction.

[0233] Figure 25C shows that the first member 1091 and the second member 1092 are separable in the lateral direction. That is, the first member 1091 and the second member 1092 are separable in the longitudinal direction ( For example, they are separable around a plane that extends in the proximal-distal direction and the axial direction, and is perpendicular to the transverse axis and / or direction. The first member 1091 and the second member 1092 are shown having a substantially mirror-image arrangement. Furthermore, the inner surfaces of the first member 1091 and the second member 1092 collectively define the lumen 1095.

[0234] Figure 25D is a proximal view of the compression device 1090, showing a lumen 1095 extending through the proximal end of the compression device 1090. The lumen 1095 at the proximal end is substantially rectangular in shape. Specifically, the lumen 1095 and / or the periphery of the lumen 1095 have an axial dimension substantially corresponding to the axial height of the valve 1000 configured to be inserted therein. In some embodiments, the axial dimension may be slightly larger than the axial height of the valve 1000, allowing the valve 1000 not to be substantially compressed axially when inserted into the proximal end of the compression device 1090. In other embodiments, the axial dimension may be slightly smaller than the axial height of the valve 1000, resulting in the insertion of the valve 1000 into the proximal end of the compression device 1090 involving at least slight axial compression of the valve 1000.

[0235] The lumen 1095 and / or the circumference of the lumen 1095 has a lateral dimension at its proximal end that substantially corresponds to the width of the valve 1000 configured to be inserted therein. More specifically, the lateral dimension substantially corresponds to the width of the valve 1000 in a laterally compressed configuration. As described in detail above, the valve 1000 may be laterally compressed and / or folded. In this embodiment, the lateral dimension of the lumen 1095 at its proximal end is such that the valve 1000 is manually compressed and / or folded before being inserted into the proximal end of the compression device 1090.

[0236] Figure 25E is a distal view of the compression device 1090, showing the lumen 1095 extending through the distal end of the compression device 1090. The distal end of the lumen 1095 has a substantially annular shape. Specifically, the lumen 1095 and / or the perimeter of the lumen 1095 has a size and / or diameter substantially corresponding to the perimeter and / or axial-to-lateral degree of the valve 1000 of the delivery configuration. In some embodiments, the lateral dimension of the lumen 1095 at the distal end of the compression device 1090 (e.g., the diameter of the lumen 1095 at the distal end) may be substantially the same as the lateral dimension of the lumen 1095 at the proximal end of the compression device 1090. Thus, in such embodiments, the compression device 1090 is configured to compress the valve 1000 axially. In other embodiments, the diameter of the lumen 1095 at the distal end may be smaller than the axial and lateral dimensions of the lumen 1095 at the proximal end. The decreasing size and / or perimeter of the lumen 1095 of the compression device 1090 is configured to transition the valve 1000 to a compression or delivery configuration as the valve 1000 moves forward through it.

[0237] Figure 26A is a side view of the compression device 1090, showing three planes 26B-26B, 26D-26D, and 26F-26F along the length of the compression device 1090, corresponding to a cross-sectional view showing the size and / or shape of the lumen 1095 in a planar position. For example, Figure 26B is a cross-sectional view of the compression device 1090 taken along planes 26B-26B of Figure 26A. The lumen 1095 of the compression device 1090 is shown as substantially rectangular with corners that are more rounded than the corresponding corners of the lumen 1095 at the proximal end of the compression device 1090 (see, for example, Figure 25D). The lumen 1095 is further shown as having a perimeter with axial dimensions (e.g., maximum axial dimension) and lateral dimensions (e.g., maximum lateral dimension) substantially similar to the perimeter of the lumen 1095 at the proximal end. Figure 26C shows a valve 1000 in a partially compressed configuration corresponding to the circumferential length of the lumen 1095 shown in Figure 26B. For example, the valve 1000 can be compressed laterally with little or no axial compression.

[0238] Figure 26D is a cross-sectional view of the compression device 1090 taken along the plane 26D-26D of Figure 26A. The lumen 1095 of the compression device 1090 is shown as substantially elliptical or oval, having corners that are more rounded than the corresponding corners of the lumen 1095 at the position shown in Figure 26B. The lumen 1095 is further shown as having a perimeter that has a lateral dimension (e.g., maximum lateral dimension) substantially similar to the lateral dimension of the perimeter of the lumen 1095 at the proximal end. Figure 26D shows that the perimeter of the lumen 1095 has an axial dimension (e.g., maximum axial dimension) that is smaller than the axial dimension of the perimeter of the lumen 1095 at the position shown in Figure 26B. Figure 26E shows a valve 1000 in a partially compressed configuration corresponding to the perimeter of the lumen 1095 shown in Figure 26D. For example, the valve 1000 may be laterally compressed and partially compressed axially.

[0239] Figure 26F is a cross-sectional view of the compression device 1090 taken along the planes 26F-26F of Figure 26A. The lumen 1095 of the compression device 1090 is shown as substantially circular, having a perimeter and / or diameter substantially similar to the perimeter and / or diameter of the lumen 1095 at the distal end of the compression device 1090 (see, for example, Figure 25E). Figure 26G shows a substantially compressed and / or delivery configuration valve 1000 corresponding to the perimeter of the lumen 1095 shown in Figure 26G. Thus, the compression device 1090 is configured to compress the valve 1000 into a delivery configuration as the valve 1000 advances through it. As will be described in more detail herein, a control device 1070 and / or a tension device 1098 may be used to press, pull, and / or otherwise advance the valve 1000 through the compression device 1090.

[0240] Figure 27 is a perspective view of a loading device 1060 included in the delivery system 1080. The loading device 1060 has a distal end and a proximal end, defining a lumen 1063 extending through the loading device 1060. The lumen 1063 has a substantially annular circumference with a diameter similar to, and / or substantially the same as, the diameter of the lumen 1095 at the distal end of the compression device 1090. The proximal end of the loading device 1060 is configured to be detachably coupled to the distal end of the compression device 1090, and the distal end of the loading device is configured to be detachably coupled (e.g., one at a time) to the pull device 1098 and the delivery device 1081, respectively, as will be described in more detail herein. Figure 27 further shows the proximal end of the loading device 1060, which includes a gate 1066 that is movable between an open and closed position and at least partially occludes the lumen 1063 of the loading device 1060, as will be described in more detail herein. The proximal end of the loading device 1060 is also shown to include a set of ports 1067 to which a sterile flexible tube is coupled, which may be used to flush and / or aspirate at least a portion of the lumen 1063, as will be described further herein.

[0241] Figure 28 is a perspective view of a loading device 1081 included in the delivery system 1080. The delivery device 1081 comprises a handle 1088 and a delivery catheter 1082 extending from the distal end of the handle 1081. The handle 1088 and the delivery catheter 1082 collectively define a lumen 1083 extending through the delivery device 1081. The lumen 1083 has a substantially annular circumference with a diameter similar to, and / or substantially the same as, the diameter of the lumen 1063 of the loading device 1060. The proximal end of the handle 1088 is configured to be detachably coupled to the distal end of the loading device 1060, as will be described in further detail herein. Figure 28 further shows the proximal end of the handle 1088, which comprises a gate 1086 that is movable between an open and closed position and at least partially occludes the lumen 1083 of the delivery device 1081, as will be described in further detail herein. The proximal end of the handle 1088 is also shown to include a pair of ports 1087 to which a sterile flexible tube can be attached, which may be used to flush and / or aspirate at least a portion of the lumen 1083, as further described herein. The proximal end is also shown to include a coupler with an indexing function 1089 configured to align the delivery handle 1088 when coupled to the loading device 1060. The indexing function 1089 is shown as a slot capable of receiving a corresponding indexing function (e.g., a projection) included in the distal end of the loading device 1060. In this way, the delivery device 1081 and the loading device 1060 may be in a predetermined direction and / or a desired direction when coupled.

[0242] Figures 29 to 34B show various parts of the control device 1070 included in the delivery system 1080. The control device 1070 may consist of any number of components that can at least temporarily connect to and / or contact one or more parts of the valve 1000 and can be configured to control and / or facilitate, for example, the delivery, deployment, and / or retrieval of the valve 1000. For example, in some embodiments, the control device 1070 may consist of a control catheter 1071 having connecting members 1078 disposed on the distal end of the control catheter 1071 and on the control portions 1072 at the proximal end of the control catheter 1071.

[0243] The control section 1072 may be of any suitable shape, size, and / or configuration and may provide a way for a user and / or operator to engage with one or more parts of the control device 1072. The control section 1072 may have several control arms 1077, each of which may provide a way to receive and control a part of the control device 1070, such as one or more tethers, tension members, cables, wires, sutures, etc.

[0244] The control catheter 1071 may be a maneuverable multi-lumen catheter. For example, Figure 30 is a cross-sectional view of the control catheter 1071 taken along line 30-30 of Figure 29. The control catheter 1071 is shown as comprising a pair of tether or tension member lumens 1073 and a guidewire catheter lumen 1074. Each tether or tension member lumen 1073 is in contact with different and / or corresponding control arms 1077 of the control portion 1072, providing proximal access to the corresponding lumen 1073. The tether or tension member lumen 1073 is shown as having a smaller diameter than the guidewire catheter lumen 1074 and extending through the sidewall portion of the control catheter 1071 between the outer and inner surfaces defining the guidewire catheter lumen 1074. The lumen 1073 of the tether or tension member provides one or more paths through which one or more tethers, tension members, cables, wires, sutures, etc., may extend to selectively engage with a portion of the valve 1000, as described in further detail herein. The guidewire catheter lumen 1074 extends through the control portion 1072 of the control device 1070 and provides a path through which the guidewire catheter 1084 may extend, allowing the distal end of the guidewire catheter 1084 to engage with and / or extend through one or more portions of the valve 1000, as described in further detail herein.

[0245] Figures 31A to 31C are perspective views of the distal end of the control device 1070, showing a connecting member 1078 transitioning between an expanded configuration and a compressed configuration. The connecting member 1078 may be formed from any suitable material, such as a shape memory alloy like Nitinol. Figure 31A shows a connecting member 1078 having a wishbone or yoke design as described above, for example, with reference to the connecting member 1078 shown in Figure 15. Thus, the connecting member 1078 may have a first portion, side, and / or arm, and a second portion, size, and / or arm opposite this first portion, side, and / or arm. Figure 31A shows the connecting member 1078 in the expanded configuration. Figure 31B shows the connecting member 1078 beginning to transition from the expanded configuration to the compressed configuration in response to a delivery catheter 1082 located at or near the distal end of the control device 1070. Figure 31C shows the compression configuration when the connecting member 1078 is at least partially disposed within the lumen of the delivery catheter 1082. The connecting member 1078 is shown. Since the diameter of the lumen of the delivery catheter 1082 is smaller than the width of the connecting member 1078 in the expanded configuration, it is shown that when the connecting member 1078 is at least partially positioned within the delivery catheter 1082, the delivery catheter 1082 compresses the connecting member 1078 into the compressed configuration. The connecting member 1078 in the compressed configuration allows the control catheter 1071 to advance through the delivery catheter 1082, and the connecting member 1078 may automatically transition from the compressed configuration to the expanded configuration when it is released from the delivery catheter 1082 and / or otherwise moved distally relative to the delivery catheter 1082.

[0246] Figure 32 is a perspective view of the distal end of the control device 1070, showing the connecting member 1078, a pair of tethers 1075 extending from the corresponding tether, and / or the lumen 1073 of the tension member of the control catheter 1071. The tethers 1075 are shown to extend from the control catheter 1071, loop through a pair of openings 1079 defined along each side or arm of the connecting member 1078 (yoke), and extend back to the lumen 1073 of the corresponding tether and / or tension member. The tethers 1075 can be used to removably connect the connecting member 1078 to the valve 1000.

[0247] Figure 33 is a side perspective view of the distal end of a control device 1070, showing a connecting member 1078 detachably coupled to valve 1000. Valve 1000 is shown to have an outer frame 1010 with a flow control component 1050 mounted therein, as described above with respect to valves 400, 500, 600, 700, and / or 1000. The outer frame 1010 has an upper ring region 1020 and a lower ring region 1030 and a trans-ring region coupled between them.

[0248] The annular region 1020 is shown to have a laser-cut frame that is wrapped or covered with a biocompatible material. The annular region 1020 includes a proximal spline 1027 extending between the outer and inner loops of the annular region 1020, as described above with respect to the valve 800. The flow control component 1050 is shown attached to the inner loop of the annular region 1020. The spline 1027 has a curved configuration and is shown defining a waypoint 1028. The waypoint 1028 may be, for example, an opening, hole, opening, port, coupler, sealable / resealable access point, etc., configured to at least temporarily couple to and / or receive a portion of the delivery system 1080.

[0249] The valve ring region 1020 is further shown as including a drum 1045 that extends between the outer loop and the inner loop and / or is coupled thereto, covering a space not otherwise occupied by the flow control component 1050. The drum 1045 may have and / or be formed a set of spokes that can be used to increase the stiffness of the drum 1045, as described above with respect to the valve 800. The curved splines 1027 can apply force to the drum 1045, bending the drum 1045 and increasing the tension throughout the region of the drum 1045. The increased tension of the drum 105 and the increased stiffness of the drum 1045 due to the spokes can then reduce and / or limit the amount of drum deformation, for example, during expansion or contraction, thereby enhancing the performance of the valve 1000 and / or reducing fatigue in or along the drum 1045, as described in detail above with respect to the valve 800. The valve ring region 1020 and / or drum 1045 are further shown to have a mounting member 1038 that may extend along or across a portion of the drum 1045. The mounting member 1038 facilitates temporary and / or removable attachment to a portion of the control device 1070. The mounting member 1038 may include, for example, a pair of loops 1039 that allow selective engagement of the mounting member 1038, and / or may form a braided thread, suture, tether, cable, etc.

[0250] Figure 33 shows the distal end of a control device 1078 that is detachably connected to the valve 1000. Specifically, the connecting member 1078 (yoke) is shown in contact with the drum 1045. The tether 1075 extends from the control catheter 1071 and is shown looping through or around each side of the connecting member 1078 or the corresponding loop 1039 of the arms and mounting member 1038. The looping arrangement of the tether 1075 is through and / or around the connecting member 1078 and the mounting member 1038 of the valve 1000, so that the proximal and distal ends of the tether 1075 each extend outward (e.g., proximal) through a single control arm 1077 of the control portion 1072. Therefore, a proximal force may be applied to the proximal and distal ends of the tether 1075, respectively, to increase the tension along the tether 1075, thereby pulling the connecting member 1038 toward the drum 1045, thereby securing the connecting member 1078 to the valve. Conversely, a proximal force applied to only one of the proximal or distal ends of the tether 1075 may detach the tether 1075 from the connecting member 1078, thereby pulling the tether 1075 away from the control device, which may then allow the device 1070 to detach or remove the connecting member 1078 from the valve 1000.

[0251] Figure 33 further shows a tension member 1076 extending from the control catheter 1071 (e.g., through one of the lumens 1073 of the tether or tension member) through waypoint 1028. The tension member 1076 could be, for example, an actuator that can selectively engage with a proximal fixation element 1034 formed by the subannular region 1030 of the valve 1000. The tension member 1076 can be routed to pass through one of the control arms 1077 of the control section 1072, through one of the lumens 1073 corresponding to that control arm 1077, around and / or through one or more portions of the proximal fixation element 1034, and back through the corresponding lumen 1073. Thus, the tension member 1076 may be actuated (or placed under tension) and / or released in a similar manner to that described above with respect to the tether 1075. Furthermore, increasing the amount of tension along the tension member 1076 may be operable to move the proximal fixing element 1034 between the first and second configurations, as described in detail above with respect to the valves 600 and / or 700.

[0252] Figure 33 further shows a guidewire catheter 1084 extending from a control catheter 1071 (e.g., through the guidewire catheter lumen 1074) and through a waypoint 1028. Valve 1000 is shown and comprises a sub-annular member 1030 having a distal fixing element 1032 with a guidewire coupler 1033 through which the guidewire catheter 1084 can be received through an opening, hole, opening, port, etc., defined by the guidewire coupler 1033. Thus, the guidewire catheter 1084 is shown extending from the control catheter 1071 (located on the annulus relative to the valve 1000), through a waypoint 1028 of the valve 1000, under the flow control component 1050, and through the distal sub-annular fixing element 1032. Furthermore, the guidewire catheter 1084 may extend beyond the distal fixation element 1032 and have and / or be provided with sufficient rigidity to allow the guidewire catheter 1084 to advance the valve 1000 along the guidewire 1085 on which it is positioned. The arrangement of the control device 1072 described above allows the control device 1072, comprising the connecting member 1078, tether 1075, tension member 1076, and guidewire catheter 1084, to be detached from the valve 1000 and withdrawn through the delivery catheter 1082 after successful deployment of the valve 1000.

[0253] Figures 34A and 34B show the distal end of the control device 1070 in the first and second configurations, respectively. The distal end of the control device 1070 is detachably coupled to the valve 1000 as described above. Figure 34A shows the substantially straight configuration when in the first configuration. Figure 34B shows the distal end of the control catheter 1071 having an undeformed shape. Figure 34B shows the distal end of the control catheter 1071 in a second configuration in which the distal end is bent, flexed, maneuvered, curved, deflected, deformed, etc. For example, as described above, the tether 1075 may be looped through the attachment member 1038 to removably connect the connecting member 1078 to the annular region 1020 of the valve 1000, while the tension member 1076 may be looped around and / or through one or more portions of the proximal annular fixation element 1034. In some cases, increasing the tension along the tension member 1076 may cause the proximal fixation element 1034 to move between the first and second configurations. In some cases, the tension along the tether 1075 and the tension along the tension member 1076 may be at least partially counteracting forces applied to a relatively small portion of the valve 1000, while the valve 1000 has a somewhat limited range of motion (for example, due to the guidewire catheter 1084 as described above). Thus, a tension along the tension member 1076 exceeding a threshold amount of tension may be able to bend, flex, steer, curve, deflect, and / or otherwise deform the distal end of the control catheter 1071. In other words, increasing the tension along the tension member 1076 may, in some cases, enable steering and / or other methods of deflection of the control catheter 1071. In some cases, for example, the control catheter 1071 may be deflected and / or bent upward relative to the valve 1000 relative to the valve 1000, such that a distal force along the control catheter 1071 exerts a force on the connecting member 1078, applying force to the valve 1000 which is at least partially below the annulus, thereby facilitating the deployment and / or seating of the valve 1000 in its own annulus.

[0254] Figures 35-39 are cross-sectional views of the delivery system 1080 showing the process of positioning the valve 1000 in the delivery configuration and loading the valve 1000 into the delivery device 1081 for lateral delivery to the heart. Before loading the valve 1000 (or in a process that is at least partially simultaneous), a user, operator, surgeon, etc., may manipulate the delivery device 1081 to advance the guidewire 1085 along the path through the patient to a desired position in the heart. In some cases, a dilator 1058 may be advanced along the guidewire 1085 and manipulated to dilate at least a portion of the path through the patient. Next, the delivery catheter 1082 may be advanced along the path such that the distal end of the delivery catheter 1082 is positioned in the volume of the heart (e.g., the atrium). Furthermore, the arrangement of the delivery device 1081 is such that the proximal end of the guidewire 1085 extends from the proximal end of the handle 1088 of the delivery device 1081, as will be described in more detail herein.

[0255] Figure 35 shows a compression device 1090 detachably coupled to the proximal end of a loading device 1060 and the distal end of the loading device 1060 detachably coupled to a tension device 1098. More specifically, the tether 1099 of the tension device 1098 may extend through the lumen 1063 of the loading device 1060 and the lumen 1095 of the compression device, and may be detachably coupled to the distal end of the valve 1000 (for example, looping around or through one or more portions of the distal end of the valve 1000). The end of the tether 1099 is shown disposed around and / or at least partially wrapped around the spool of the tension device 1098. In this embodiment, rotation of the spool or portion of the tension device 1098 increases the tension along the tether 1099, which can act to pull the valve 1000 through the compression device 1090 and / or loading device 1060. Furthermore, while the valve 1000 is being loaded into the loading device 1060, the gate 1066 is in a closed state, and therefore the tether 1099 may be configured to extend through a space defined between the gate 1066 and the inner surface of the loading device 1060 (as described above).

[0256] Figure 35 shows the distal end of valve 1000 detachably coupled to the tether 1099 of the tension device 1098, and the distal end of valve 1000 detachably coupled to the control device 1070. Figure 35 shows the terminal end. The guidewire catheter 1084 is shown extending distally through the valve 1000 to the distal subannular fixation element. Figure 35 further shows the valve 1000 partially inserted into the lumen 1095 of the compression device 1090. As described above, the valve 1000 can be at least partially compressed in the rearward direction before the valve 1000 is inserted into the compression device 1090. Thus, it is shown that the valve 1000 is compressed laterally but not yet compressed axially (substantially). As described above, in some cases the valve 1000 can be loaded into the compression device 1090 and advanced through the lumen 1095, on the other hand, the compression device 1090 can be disposed in a saline bath or the like, which can facilitate the advancement of the valve 1000 through the compression device 1090 and maintain the substantial sterility of the valve 1000.

[0257] Figure 36 shows that the valve 1000 has advanced at least partially into the lumen 1063 of the loading device 1060 through the compression device 1090. For example, after the valve 1000 has been initially inserted into the proximal end of the compression device 1090, the user or operator may, for example, operate the tension device 1098 to further spool and / or wrap the tether 1099. In some implementations, the user and / or operator may also apply force to the control device 1070 so that a connecting member (not shown) presses the valve 1000 through the compression device 1090. The valve 1000 is shown here advancing from the proximal end to the distal end through the lumen 1095 of the compression device 1090, and the compression device 1090 compresses the valve 1000 at least axially as the valve 1000 advances through it. In some cases, the valve 1000 may be substantially uncompressible or laterally compressed when inserted into the proximal end of the compression device 1090, and may be compressed into a compressed or delivery configuration when advancing to the distal end of the compression device 1090 and / or through it into the lumen 1063 of the loading device 1060 (Figure 36).

[0258] Figures 35-37 show that the valve 1000 is loaded into the loading device 1060 while the gate 1066 is closed. Figure 37 shows that the valve 1000 has advanced through the lumen 1063 until, for example, the distal fixing element (or most of the distal portion) of the valve 1000 contacts and / or is adjacent to the proximal surface of the gate 1066 in the closed state. The guidewire catheter 1084 extends distally from the valve 1000, through the gate 1066 in the closed state, and beyond the distal end of the loading device 1060. In some embodiments, for example, the gate 1066 may have a shape and / or size such that a space is defined between the end of the gate 1066 and the inner surface of the loading device 1060, allowing the guidewire catheter 1084 and the tether 1099 of the tensile device 1098 to extend through it. In some embodiments, the gate 1066 may define an opening, hole, notch, recess, etc., through which the guidewire catheter 1084 and tether 1099 can extend.

[0259] After advancing the valve 1000 into the loading device 1060, the compression device 1090 may be removed from the proximal end of the loading device 1060. As described above, the first member 1091 and the second member 1092 of the compression device 1090 are laterally separable when the coupler 1093 is removed. Therefore, the coupler 1093 may be removed, and the first member 1091 and the second member 1092 may be separated to detach the compression device 1090 from the proximal end of the loading device 1060 without, for example, cutting, removing, and / or substantially modifying the control device 1070 relative to the valve 1000. After removing the compression device 1090 from the loading device 1060, the hemostatic valve 1068, etc., may be advanced over a portion of the control device 1070 and coupled to the proximal end of the loading device 1060 (see, for example, Figure 38). The hemostatic valve 1068 may form a substantially fluid-tight seal around the proximal end of the loading device 1060 (e.g., around the control device 1070 and / or its control catheter). Furthermore, the tether device 1098 may also be detached from and / or removed from the distal end of the loading device 1060, and the tether 1098 may be removed from the valve 1000. It may be detached and withdrawn from the loading device 1060.

[0260] With the hemostatic valve 1068 coupled to the proximal end of the loading device 1060 and the distal end of the loading device 1060 detached from it, the loading device 1060 is ready to be coupled to the delivery device 1081. Thus, while still in a liquid (e.g., saline) bath, the valve 1000 is loaded into the loading device, and the loading device 1060, which has the valve 1000 of the delivery configuration disposed in the lumen 1063, the hemostatic valve 1068 coupled to its proximal end, and the gate 1066 in a closed state, can be removed from the bath and brought to, for example, an operating table, and coupled to the proximal end of the delivery device 1081 that has already been inserted into the patient.

[0261] Figure 38 shows the distal end of the loading device 1060 coupled to the proximal end of the delivery device 1081. Figure 39 is an enlarged view of a portion of the delivery system 1080, showing the indexing function 1089 of the handle 1088 engaging with the indexing function 1069 included in the distal end portion of the loading device 1069. The indexing functions 1089 and 1069 are shown having a key-and-slot arrangement, but other indexing modes are possible. The indexing functions 1089 and 1069 ensure that the delivery device 1081 is in a predetermined and / or desired orientation relative to the loading device 1060, and thus the valve 1000 may be moved to the delivery device 1000 in a predetermined and / or desired orientation (for example, by the way the valve 1000 is inserted into the lumen 1095 of the compression device 1090 - set and / or defined according to the circumferential length of the lumen 1095 at the proximal end of the compression member 1090).

[0262] As described above, the delivery catheter 1082 is pre-inserted into the patient, and the proximal end of the guidewire 1085 extends from the proximal end of the handle 1088 of the delivery device 1081. Therefore, the proximal end of the guidewire 1085 is inserted into the guidewire catheter 1084 before the distal end of the loading device 1060 is coupled to the proximal end of the handle 1088. As described above, the loading device 1060 is coupled to the proximal end of the handle 1088, while the valve 1000 is proximal to the 1066 of the loading device 1060, and to the gates 1066 and 1086 of the loading device 1060 and the delivery device 1081, respectively, and is in a closed state. In some implementations, after the loading device 1060 is coupled to the delivery device 1081 and before the gates 1066 and 1086 are opened, the volume collectively defined by the lumens 1063 and 1083 located between the gates 1066 and 1086 may be flushed through ports 1067 and 1087. For example, in some implementations, port(s) 1087 may provide a flow into the volume of saline and / or other sterile fluid, while port(s) 1067 may provide suction to and / or through that volume (and vice versa).

[0263] Figures 38 and 39 show that after the loading device 1060 is coupled to the handle 1088 of the delivery device 1081, and after the defined volume between gates 1066 and 1086 has been flushed out, gates 1066 and 1086 can transition from a closed state to an open state. Thus, lumens 1063 and 1083 are substantially open or at least not blocked. Therefore, the user and / or operator can, for example, apply distal force to the control portion 1072 of the control device 1070 to advance the valve 1000 in the delivery configuration from the loading device 1060 to the lumen 1083 of the delivery device 1081 and through the delivery catheter 1082. Next, the valve 1000 may be at least partially released from the distal delivery catheter 1082, and once released (or at least partially released), the control device 1070 may control and / or operate the valve 1000 to seat it on the annulus of its own heart valve (for example, as described above with reference to Figures 29-34B).

[0264] In some cases, it is desirable to recover at least partially the valve 1000 from the valve ring during deployment. There may be cases where it is necessary to adjust the position, orientation, and / or seating of the valve 1000 in the annulus. In such cases, the control device 1070 may further be used to retrieve the valve 1000 at least partially to the distal end of the delivery catheter 1082. For example, if a connecting member 1078 (e.g., a yoke) is removably coupled to the valve 1000, the user and / or operator may apply a proximal force to the control device 1070 that can pull the valve 1000 proximal and / or towards the delivery catheter 1082. Furthermore, the delivery system 1080 may include any suitable capture elements, functions, members, mechanisms, etc. (e.g., those described herein with reference to specific embodiments) configured to facilitate the compression of the valve 1000 as the valve 1000 is pulled proximal toward and / or into the delivery catheter 1082. In some cases, after partially recovering the valve 1000, the control device 1070 may be operated to reseat the valve 1000 onto the valve ring in the desired direction and / or configuration.

[0265] Figure 40 is a top perspective view of valve 1100, which includes a guidewire 1185 passed through waypoint 1128 and a positioning and / or control catheter 1171 attached to the proximal side of valve 1100. A delivery catheter 1182 is shown, which includes the guidewire 1185 and a positioning and / or control catheter 1171 disposed within the lumen of the delivery catheter 1182.

[0266] Figure 41 shows a side perspective view of valve 1200, in which a guidewire 1285 is passed through waypoint 1228, and a positioning and / or control catheter 1271 is attached to the proximal side of valve 1200. A delivery catheter 1282 is shown, which has a guidewire 1285 and a positioning and / or control catheter 1271 disposed within the lumen of the delivery catheter 1282.

[0267] Figure 42 illustrates a perspective view below the valve 1300 coupled to a positioning and / or control catheter 1371. Catheter guides and / or supports may provide additional connection and support for the positioning and / or control catheter 1371 during attachment with the valve 1300. A mount 1335 for attaching the positioning and / or control catheter 1371 to the valve 1300 is shown. In some embodiments, the positioning and / or control catheter 1371 has a threaded portion that engages with a corresponding threaded component on the valve 1300, thereby allowing the positioning and / or control catheter 1371 to be rotated to engage / disengage from the valve 1300. Distal and proximal anchor channels may be enclosed and / or formed by the outer portion of the side wall 1312 of the valve 1300, for example, from a collar portion 1320 through the channel, providing subannular access to the subannular space for tissue anchor deployment (not shown). The distal fixing element 1332 and the guidewire coupler or anchor head 1333 are shown extending distally from the lower part of the valve 1300 or the valve annular region 1320.

[0268] Figure 43 is a side perspective view of the components of the delivery system 1480. The loading device 1460, which includes a loading compression cylinder 1462, is shown in one component. The delivery device 1481 and threaded mount 1435 are shown in a second component. The guidewire 1485 and the positioning and / or control catheter 1471 are shown threaded through a receiver at the proximal end of the delivery catheter 1482. The positioning and / or control catheter 1471 may be equipped with a Luer lock or the like to provide a port 1487 for flushing fluid through the lumen of the positioning and / or control catheter 1471 and / or the delivery catheter 1482.

[0269] Figure 44 shows a side perspective view of valve 1400 initiating a compression process related to loading valve 1400 into loading device 1460. The distal fixing element 1432 loads valve 1400. The valve collar or ring-up region 1420 of the valve 1400 is shown to begin folding downward and / or inward at its lateral portion, so that it becomes flat against the side wall of the valve 1400.

[0270] Figure 45 shows a side perspective view of valve 1400 partially inserted into the loading compression cylinder 1462. As valve 1400 is inserted into the loading device 1460, valve 1400 is further compressed. Figure 45 shows valve 1400 almost completely loaded into the loading compression cylinder 1462. Guide wire 1485 and positioning and / or control catheter 1471 are shown attached to valve 1400 as it is compressed.

[0271] Figure 46 shows a side perspective view of the loading device 1460 connected to the delivery device 1481. The valve 1400 is shown compressed within the loading compression cylinder 1462 or fully compressed into the delivery configuration. The connection of the loading device 1460 to the delivery device 1481 allows the valve 1400 to be advanced from the loading device 1460 through the delivery catheter 1482 and deployed to the patient.

[0272] Figure 47A illustrates a side view of a compression device 1590 according to one embodiment, comprising a loading device 1560 (e.g., a compression or receiver catheter) located at the distal end and a tether 1599 attached to a lateral delivery valve 1500. Figure 47A shows a valve 1500 having a distal tethering ring 1511 adjacent to a distal fixing element 1532. The compression device 1590 has and / or defines a rectangular cavity 1595A (e.g., at the proximal end) which leads to a transition cavity 1595B that connects to a circular cavity 1595C (e.g., at the distal end and adjacent to the loading device 1560).

[0273] Figure 47B shows a side view of valve 1500 being pulled from right to left into the rectangular cavity 1595A of compression device 1590, toward the transition cavity 1595B, by a tether 1599. Loading device 1560 is connected to compression device 1590 at its distal end (e.g., adjacent to the circular cavity 1595C). This connection may be of other types, such as a threaded connection, a tension / shape-fitting connection, or a bead-and-channel or clamp-on connection. Figure 47C shows a side view of valve 1500 being pulled further from right to left through the rectangular cavity 1595A through the transition cavity 1595B into the circular cavity 1595C of compression device 1590. A distal fixing element 1532 is shown as guiding valve 1500 into the lumen of loading device 1560.

[0274] Figure 47D shows a side view of valve 1500, which is pulled from right to left out of compression device 1590 by a tether 1599 into the lumen of loading device 1560, which is coupled to compression device 1590 at its distal end (for example, adjacent to circular cavity 1595C). Figure 47E shows a side view of valve 1500 in a compression and / or delivery configuration fully disposed within loading device 1560. Loading device 1560 is shown detached from compression device 1590 and / or otherwise removed.

[0275] Figure 47E shows a side view of a pressing device 1519 that engages the valve 1500 in a compression configuration within the loading device 1560. Furthermore, the loading device 1560 is shown connected to a delivery catheter 1582. The pressing device 1519 may include a screw mechanism, etc., which can be used to advance a push rod 1519A to press the compression valve 1500. The push rod 1519A is shown with a distal end 1519B that engages with the side wall of the valve 1500 to advance and / or press the valve 1500 in a delivery configuration from the loading device 1560 to the delivery catheter 1582. Once the valve 1500 in the delivery configuration is positioned within the delivery catheter 1582... The distal fixation element 1532 may be positioned toward the distal open end of the delivery catheter 1582 through which the valve 1500 has been advanced. Figure 47G illustrates a side view of the valve 1500 of the delivery configuration disposed within the lumen of the delivery catheter 1582 via a pressing device 1519. The valve 1500 is shown successfully loaded into the delivery catheter 1582, and the loading device 1560 can be detached from the valve 1500 and withdrawn from the delivery catheter 1582. Thus, the valve 1500 is ready for lateral delivery to its own annulus via the delivery catheter 1582.

[0276] Figure 48A shows a side view of the compression device 1690, to which a loading device 1660 is disposed at the distal end, and a tether 1699 is attached to the distal end of a lateral delivery valve 1600, having a guide wire 1685 and a torque and / or positioning a cable 1647 attached to the proximal end of the valve 1600. Figure 48A shows the valve 1600 having a distal tethering 1611 adjacent to a distal fixing element 1632. The compression device 1690 has and / or defines a rectangular cavity 1695A (e.g., at the proximal end) which leads to a transiti...

Claims

1. A method for compressing an artificial valve into a delivery configuration for lateral delivery to a patient by a delivery catheter, wherein the artificial valve defines a central axis parallel to the direction of fluid flow through the artificial valve, and the method is as follows: Compressing the prosthetic valve along the transverse axis of the prosthetic valve which is perpendicular to the central axis; The insertion involves, after compression, inserting the artificial valve into the proximal end of a compression device, wherein the compression device defines a lumen extending through the proximal and distal ends, and the circumference of the lumen at the proximal end is greater than the circumference of the lumen at the distal end; The artificial valve is advanced through the lumen of the compression device and compressed along the central axis; The transfer of the artificial valve of the delivery configuration from the distal end of the compression device to a loading device coupled to the distal end of the compression device, wherein the loading device defines a lumen having a circumference substantially similar to (i) the circumference of the lumen of the distal end of the compression device and (ii) the circumference of the lumen of the delivery catheter. The method, including the method described above.

2. The method according to claim 1, wherein compressing the artificial valve along the horizontal axis includes manually folding the artificial valve in the direction of the horizontal axis.

3. The method according to claim 1, wherein the circumference of the lumen of the compression device at the proximal end is substantially rectangular in shape, and the circumference of the lumen of the compression device at the distal end is substantially circular in shape.

4. The method according to claim 3, wherein the perimeter of the lumen of the compression device has a width at the proximal end that is substantially equal to the diameter of the lumen at the distal end of the compression device.

5. The method according to claim 4, wherein the circumference of the lumen of the compression device has an axial height at the proximal end that is greater than the diameter of the lumen at the distal end of the compression device.

6. The method according to claim 1, further, After transferring the artificial valve of the delivery configuration from the distal end of the compression device to the loading device, the distal end of the compression device is disconnected from the loading device; After disconnecting the distal end of the compression device from the loading device, the hemostatic valve is connected to the proximal end of the loading device. The method, including the method described above.

7. The method according to claim 1, further, The method, comprising removably coupling a control device to the artificial valve before inserting the artificial valve into the proximal end of the compression device.

8. The method according to claim 7, wherein the control device extends proximal to the prosthetic valve through the compression device while advancing the prosthetic valve and moving the prosthetic valve, further comprising: After transferring the artificial valve, the coupling member is removed from the compression device; The method comprising laterally separating the first and second members of the compression device from the periphery of a portion of the control device.

9. The method according to claim 7, wherein the control device comprises a multi-lumen control catheter and a yoke disposed at the distal end of the multi-lumen control catheter, and the control device is detachably coupled to the prosthetic valve by detachably coupling the yoke to the proximal end of the prosthetic valve via a first tether extending through a first lumen of the multi-lumen control catheter and a second tether extending through a second lumen of the multi-lumen control catheter.

10. The method according to claim 9, wherein the control device comprises a guidewire catheter extending through a third lumen of the multi-lumen control catheter, and the control device is removably coupled to the prosthetic valve by inserting the guidewire catheter through a waypoint of the valve, under the flow control components of the prosthetic valve, and through the distal subannular fixation element, such that the distal end of the guidewire catheter is distal to the distal subannular fixation element.

11. The method according to claim 1, further comprising: Before inserting the artificial valve into the proximal end of the compression device, attaching the tether to the distal end of the artificial valve, advancing the artificial valve, and moving the artificial valve is in response to the force applied by the tether to the artificial valve, which is capable of pulling the artificial valve through the lumen of the compression device and the lumen of the loading device. When the artificial valve of the delivery configuration is in a desired position in the lumen of the loading device, Removing the tether from the distal end of the artificial valve, The method, including the method described above.

12. The method according to claim 11, further comprising: The pulling device is connected to the distal end of the loading device, The tether is coupled to the tension device, wherein the force applied to the artificial valve by the tether is in response to the user operating the tension device. When the artificial valve of the delivery configuration is in the desired position within the lumen of the loading device, the pulling device is removed from the distal end of the loading device, Methods that include...

13. The method according to claim 12, further comprising: After disconnecting the pulling device from the distal end of the loading device, the distal end of the loading device is connected to the proximal end of the delivery device. The method, including the method described above.

14. The method according to claim 13, wherein the distal end of the loading device comprises a first gate, and the proximal end of the delivery device comprises a second gate, further: (i) the loading device is coupled to the delivery device, (ii) the first gate and the second gate are closed, and (iii) the artificial valve selectively flushes a volume collectively defined by the lumen of the loading device and the lumen of the delivery device between the first gate and the second gate, while the artificial valve is in the lumen of the loading device proximal to the first gate; Transitioning the first gate from the closed state to the open state; Transitioning the second gate from the closed state to the open state; The method comprising advancing the artificial valve in the delivery configuration from the lumen of the loading device located proximal to the first gate to the lumen of the delivery device located distal to the second gate.

15. A method according to claim 14, wherein the volume collectively defined between the first gate and the second gate is selectively flushed: To provide fluid flow to the volume collectively defined between the first gate and the second gate via at least one port of the delivery device, This includes drawing airflow through at least one port of the loading device from the volume collectively defined between the first gate and the second gate, or from at least one of the lumens of the loading device proximal to the first gate, The aforementioned method.

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